Preparation of Herbal Solid Dosage Form


Project Report, 2010
73 Pages, Grade: A

Excerpt

Contents

Chapter-I: Introduction

Chapter-II : Literature review
2.1 General literature review of herbal preparations
a Herbal history
b WHO definitions related to Herbal medicine
c Types of herbal medicine systems
d Biological background of herbal medicine
e Role of herbal medicine in modern human society
f Contribution of herbal drugs and development of herbal drug
g Effectiveness of herbal medicine
h Herbal medicine risks to health
i Adverse effect of herbs and drug herbal interaction
j Limitation of herbal medicine
к Comparison between herbal medicine and conventional medicine
2.2 Literature review of Herbs used in my present work Black Cumin Seeds
a History of Black cumin seeds
b Description of Black cumin seeds
c Origin & distribution ofBlack cumin seeds
d Chemical constituents ofBlack cumin seeds
e Nutrition ofBlack cumin seeds
f Medicinal uses ofBlack cumin seeds
g Biological uses of Black cumin seeds
h Side Effects ofBlack cumin seeds
i Adverse effect of Black cumin seeds
Honey
a History of Honey
b Description ofHoney
c Origin and distribution ofHoney
d Chemical constituents ofHoney
e Nutrients ofHoney
f Medicinal uses of Honey
g Biological uses ofHoney
h Side Effects ofHoney
i Adverse effects of Honey
Jaitun Oil
a History of Jaitun oil
b Description of Jaitun oil
c Origin & distribution of Jaitun oil
d Chemical Constituent of Jaitun oil
e Nutrition of Jaitun oil
f Medicinal uses of Jaitun oil
g Biological uses of Jaitun oil
h Side effects of Jaitun oil
i Adverse effects of aitun oil
2.3 Quality Control of Herbal Drug
a Parameters for quality control of herbal drugs
b WHO guidelines for quality standardized herbal formulations
Ob jective of the work
Research protocol

Chapter-III : Materials-method with result and discussion
3.1 Materials
3.2 Tablet
3.3 Capsule
3.4 Method of evaluation of quality control parameters for raw materials
3.5 Method of evaluation of quality control parameters for finished product

Chapter-IV : Conclusion

Chapter-V: References

Table

2.1 Scientific classification of Black Cumin

2.2 Component of black cumin seeds with their biological action

2.3 Scientific classification of Honey

2.4 Average composition ofU.S honeys and ranges of values

2.5 Nutrients in honey

2.6 Scientific classification ofjaitun

2.7 Nutrients injaitun oil

2.8 Limits for Microbial Contamination

3.1 Tablet formulation (Recipe-1)

3.2 Tablet formulation (Recipe-2)

3.3 Tablet formulation (Recipe-3)

3.4 Capsule formulation (Recipe)

3.5 Weight variation

3.6 Disintegration time (Herbal capsule)

3.7 Disintegration time (Nigella capsule)

Figure

3.1 Tablet (Formula-1)

3.2 Tablet Formula-2)

3.3 Tablet (Formula-3)

3.4 Capsule

3.5 Graph (Disintegration time of Herbal capsule)

3.6 Graph (Disintegration time of Nigella capsule)

3.7 Capsules kept in incubator (after 1 month)

3.8 Capsules kept in refrigerator (after 1 month)

3.9 In Desecrator 50% salt solution (at 1st day)

3.10 In Desecrator 50% salt solution (after 10 days)

3.11 In Desecrator 50% salt solution (after 20 days)

3.12 In Desecrator 50% salt solution (after 30 days)

3.13 In Desecrator 75% salt solution (at 1st day)

3.14 In Desecrator 75% salt solution (at 10 days)

3.15 In Desecrator 75% salt solution (at 20 days)

3.16 In Desecrator 75% salt solution (at 30 days)

Abstract

Herbal medicines formulations are used to alleviate many types of diseases in the recent world. Because of the similar properties and the combination of the ingredients synergistically increase the efficacy, Nigella sativa (family-Ranunculaceae), Apis mellifera (family-Apidae) and Olea europaea (family-Oleaceae) were collected from the market for preparing an herbal product in a suitable solid dosage form preferably tablet. First time tried to prepare a tablet dosage form but it did not satisfy the parameter of a standard tablet dosage form due to oil containing ingredients and technical error. Then choose to prepare capsule dosage form with granules by using zero size capsule shell (#0) & eventually prepared successful herbal capsules. The most important challenges faced by herbal formulations arise because of their lack of complete evaluation. Moreover, for evaluation of capsule containing multiple herb, various parameters were tested such as organoleptic parameters, ash value etc & for finished product (capsule) include uniformity of weight, pH, disintegration time and effect of temperature & humidity of the product and all test accomplished the satisfactory results with the standard specifications.

Chapter I Introduction

Plants had been used for medicinal purposes long before recorded history. Ancient Chinese and Egyptian papyrus writings describe medicinal uses for plants. Indigenous cultures (such as African and Native American) used herbs in their healing rituals, while others developed traditional medical systems (such as Ayurveda and Traditional Chinese Medicine) in which herbal therapies were used. Researchers found that people in different parts of the world tended to use the same or similar plants for the same purposes.[1]

In the early 19th century, when chemical analysis first became available, scientists began to extract and modify the active ingredients from plants. Later, chemists, pharmacists began making their own version of plant compounds, and over time, the use of herbal medicines declined in favor of drugs. [1] Herbal medicine include herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients parts of plants, or other plant materials, or combinations. Traditional use of herbal medicines refers to the long historical use of these medicines. Their use is well established and widely acknowledged to be safe and effective, and may be accepted by national authorities.[2] Herbalism herbal medicine is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbal medicine is also known as botanical medicine, medical herbalism, Herbalism, herbology, and phytotherapy.

Herbal medicine also called botanical medicine or phytomedicine - refers to using a plant's seeds, berries, roots, leaves, bark, or flowers for medicinal purposes. Herbalism has a long tradition of use outside of conventional medicine. It is becoming more main stream as improvements in analysis and quality control along with advances in clinical research show the value of herbal medicine in the treating and preventing disease.[1]

The theories and concepts of prevention, diagnosis, improvement and treatment of illness in traditional medicine historically rely on a holistic approach towards the sick individual, and disturbances are treated on the physical, emotional, mental, spiritual and environmental levels simultaneously. As a result, most systems of traditional medicine may use herbal medicines or traditional procedure-based therapies along with certain behavioural rules promoting healthy diets and habits. Holism is a key element of all systems of traditional medicine. Therefore, when reviewing the literature on traditional medicine (both herbal medicines and traditional procedure based therapies), the theories and concepts of the individual practice of traditional medicine, as well as the cultural background of those involved, must be taken into account.[3]

Chapter II Literature Review

2.1. General literature review ofherbal preparations

a. Herbal history

In the written record, the study of herbs dates back over 5,000 years to the Sumerians, who described well-established medicinal uses for such plants as laurel, caraway, and thyme. Ancient Egyptian medicine of 1000 B.C. are known to have used garlic, opium, castor oil, coriander, mint, indigo, and other herbs for medicine and the Old Testament also mentions herb use and cultivation, including mandrake, vetch, caraway, wheat, barley, and rye.

Indian Ayurveda medicine has been using herbs such as turmeric possibly as early as 1900 B.C. Many other herbs and minerals used in Ayurveda were later described by ancient Indian herbalists such as Charaka and Sushruta during the 1st millenium ВС. The Sushruta Samhita attributed to Sushruta in the 6th century BC describes 700 medicinal plants, 64 preparations from mineral sources, and 57 preparations based on animal sources.

The first Chinese herbal book, the Shennong Bencao Jing, compiled during the Han Dynasty but dating back to a much earlier date, possibly 2700 B.C., lists 365 medicinal plants and their uses - including ma-Huang, the shrub that introduced the drug ephedrine to modern medicine. Succeeding generations augmented on the Shennong Bencao Jing, as in the Yaoxing Lun (Treatise on the Nature of Medicinal Herbs), a 7th century Tang Dynasty treatise on herbal medicine.

The ancient Greeks and Romans made medicinal use of plants. Greek and Roman medicinal practices, as preserved in the writings of Hippocrates and - especially - Galen, provided the patterns for later western medicine. Hippocrates advocated the use of a few simple herbal drugs - along with fresh air, rest, and proper diet. Galen, on the other hand, recommended large doses of drug mixtures - including plant, animal, and mineral ingredients. The Greek physician compiled the first European treatise on the properties and uses of medicinal plants, De Materia Medica. In the first century AD, Dioscorides wrote a compendium of more than 500 plants that remained an authoritative reference into the 17th century. Similarly important for herbalists and botanists of later centuries was the Greek book that founded the science of botany, Theophrastus’ Historia Plantarum, written in the fourth century B.C.[4]

- Middle ages

The uses of plants for medicine and other purposes changed little in early medieval Europe. Many Greek and Roman writings on medicine, as on other subjects, were preserved by hand copying of manuscripts in monasteries. The monasteries thus tended to become local centers of medical knowledge, and their herb gardens provided the raw materials for simple treatment of common disorders. At the same time, folk medicine in the home and village continues uninterrupted, supporting numerous wandering and settled herbalists. Among these were the “wise-women,” who prescribed herbal remedies often along with spells and enchantments. It was not until the late Middle Ages that women who were knowledgeable in herb lore became the targets of the witch hysteria. One of the most famous women in the herbal tradition was Hildegard of Bingen. A twelfth century Benedictine nun, she wrote a medical text called Causes and Cures.

Medical schools known as Bimaristan began to appear from the 9th century in the medieval Islamic world, which was generally more advanced than medieval Europe at the time. The Arabs venerated Greco-Roman culture and learning, and translated tens of thousands of texts into Arabic for further study. As a trading culture, the Arab travellers had access to plant material from distant places such as China and India. Herbáis, medical texts and translations of the classics of antiquity filtered in from east and west. Muslim botanists and Muslim physicians significantly expanded on the earlier knowledge of materia medica. For example, al-Dinawari described more than 637 plant drugs in the 9th century, and Ibn al-Baitar described more than 1,400 different plants, foods and drugs, over 300 of which were his own original discoveries, in the 13th century. The experimental scientific method was introduced into the field of materia medica in the 13th century by the Andalusian-Arab botanist Abu al-Abbas al-Nabati, the teacher of Ibn al-Baitar. Al-Nabati introduced empirical techniques in the testing, description and identification of numerous materia medica, and he separated unverified reports from those supported by actual tests and observations. This allowed the study of materia medica to evolve into the science of pharmacology.

Avicenna's The Canon of Medicine (1025) is considered the first pharmacopoeia and lists 800 tested drugs, plants and minerals. Book Two is devoted to a discussion of the healing properties of herbs, including nutmeg, senna, sandalwood, rhubarb, myrrh, cinammon, and rosewater. Baghdad was an important center for Arab herbalism, as was Al-Andalus between 800 and 1400. Abulcasis (936-1013) of Cordoba authored The Book of Simples, an important source for later European herbáis, while Ibn al-Baitar (1197-1248) of Malaga authored the Corpus of Simples, the most complete Arab herbal which introduced 200 new healing herbs, including tamarind, aconite, and nux vomica. Other pharmacopoeia books include that written by Abu-Rayhan Biruni in the 11th century and Ibn Zuhr (Avenzoar) in the 12th century (and printed in 1491), The origins of clinical pharmacology also date back to the Middle Ages in Avicenna's The Canon of Medicine, Peter of Spain's Commentary on Isaac, and John of St Amand's Commentary on the Antedotary of Nicholas. In particular, the Canon introduced clinical trials, randomized controlled trials and efficacy tests.

Alongside the university system, folk medicine continued to thrive. The continuing importance of herbs for the centuries following the Middle Ages is indicated by the hundreds of herbáis published after the invention of printing in the fifteenth century. Theophrastus’ Historia Plantarum was one of the first books to be printed, but Dioscorides’ De Materia Medica, Avicenna's Canon ofMedicine and Avenzoar's pharmacopoeia were not far behind.[4]

- Modern era

The fifteenth, sixteenth, and seventeenth centuries were the great age of herbáis, many of them available for the first time in English and other languages rather than Latin or Greek. The first herbal to be published in English was the anonymous Grete Herball of 1526. The two best- known herbáis in English were The Herball or General History of Plants (1597) by John Gerard and The English Physician Enlarged (1653) by Nicholas Culpeper. Gerard’s text was basically a pirated translation of a book by the Belgian herbalist Dodoens and his illustrations came from a German botanical work. The original edition contained many errors due to faulty matching of the two parts. Culpeper’s blend of traditional medicine with astrology, magic, and folklore was ridiculed by the physicians of his day yet his book - like Gerard’s and other herbáis - enjoyed phenomenal popularity. The Age of Exploration and the Columbian Exchange introduced new medicinal plants to Europe. The Badianus Manuscript was an illustrated Aztec herbal translated into Latin in the 16th century.

The second millennium, however, also saw the beginning of a slow erosion of the pre-eminent position held by plants as sources of therapeutic effects. This began with the introduction of the physician, the introduction of active chemical drugs (like arsenic, copper sulfate, iron, mercury, and sulfur), followed by the rapid development of chemistry and the other physical sciences, led increasingly to the dominance of chemotherapy - chemical medicine - as the orthodox system of the twentieth century.[4]

b. WHO definitions related to Herbal medicine

In order to make WHO definitions consistent, certain terms have now been redefined. Furthermore, the following definitions have been developed in order to meet the demand for the establishment of standard, internationally accepted definitions to be used in the evaluation and research of herbal medicines. These definitions may differ from those in regulations in countries where traditional medicine is used. Therefore, these definitions are for reference only.

- Herbs

Herbs include crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.

- Herbal materials

Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stir baking with honey, alcoholic beverages or other materials.

- Herbal preparations

Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include reparations made by steeping or heating herbal materials in alcoholic beverages and/or honey or in other materials.

c. Types of herbal medicine systems

Use of medicinal plants can be as informal as, for example, culinary use or consumption of an herbal tea or supplement, although the sale of some herbs considered dangerous is often restricted to the public. Sometimes such herbs are provided to professional herbalists by specialist companies. Many herbalists, both professional and amateur, often grow or "wildcraft" their own herbs.

Some researchers trained in both western and traditional Chinese medicine have attempted to deconstruct ancient medical texts in the light of modern science. One idea is that the yin-yang balance, at least with regard to herbs, corresponds to the pro-oxidant and anti-oxidant balance. This interpretation is supported by several investigations of the ORAC ratings of various yin and yang herbs.

Eclectic medicine came out of the vitalist tradition, similar to physiomedicalism and bridged the European and Native American traditions. Cherokee medicine tends to divide herbs into foods, medicines and toxins and to use seven plants in the treatment of disease, which is defined with both spiritual and physiological aspects, according to Cherokee herbalist David Winston.

In India, Ayurvedic medicine has quite complex formulas with 30 or more ingredients, including a sizable number of ingredients that have undergone "alchemical processing", chosen to balance "Vata", "Pitta" or "Kapha."

In addition there are more modern theories of herbal combination like William LeSassier's triune formula which combined Pythagorean imagery with Chinese medicine ideas and resulted in 9 herb formulas which supplemented, drained or neutrally nourished the main organ systems affected and three associated systems. His system has been taught to thousands of influential American herbalists through his own apprenticeship programs during his lifetime, the William LeSassier Archive and the David Winston Center for Herbal Studies.

Many traditional African remedies have performed well in initial laboratory tests to ensure they are not toxic and in tests on animals. Gawo, a herb used in traditional treatments, has been tested in rats by researchers from Nigeria's University of Jos and the National Institute for Pharmaceutical Research and Development. According to research in the African Journal of Biotechnology, Gawo passed tests for toxicity and reduced induced fevers, diarrhoea and inflammation.[4]

d. Biological background of herbal medicine

All plants produce chemical compounds as part of their normal metabolic activities. These include primary metabolites, such as sugars and fats, found in all plants, and secondary metabolites found in a smaller range of plants, some useful ones found only in a particular genus or species. Pigments harvest light, protect the organism from radiation and display colors to attract pollinators. Many common weeds have medicinal properties.

The functions of secondary metabolites are varied. For example, some secondary metabolites are toxins used to deter predation, and others are pheromones used to attract insects for pollination. Phytoalexins protect against bacterial and fungal attacks. Allelochemicals inhibit rival plants that are competing for soil and light.

Plants up regulate and down regulate their biochemical paths in response to the local mix of herbivores, pollinators and microorganisms. The chemical profile of a single plant may vary over time as it reacts to changing conditions. It is the secondary metabolites and pigments that can have therapeutic actions in humans and which can be refined to produce drugs.

Plants synthesize a bewildering variety of phytochemicals but most are derivatives of a few biochemical motifs.

- Alkaloids contain a ring with nitrogen. Many alkaloids have dramatic effects on the central nervous system. Caffeine is an alkaloid that provides a mild lift but the alkaloids in datura cause severe intoxication and even death.

- Phenolics contain phenol rings. The anthocyanins that give grapes their purple color, the isoflavones, the phytoestrogens from soy and the tannins that give tea its astringency are phenolics.

- Terpenoids are built up from terpene building blocks. Each terpene consists of two paired isoprenes. The names monoterpenes, sesquiterpenes, diterpenes and triterpenes are based on the number of isoprene units. The fragrance of rose and lavender is due to monoterpenes. The carotenoids produce the reds, yellows and oranges of pumpkin, corn and tomatoes.

- Glycosides consist of a glucose moiety attached to an aglycone. The aglycone is a molecule that is bioactive in its free form but inert until the glycoside bond is broken by water or enzymes. This mechanism allows the plant to defer the availability of the molecule to an appropriate time, similar to a safety lock on a gun. An example is the cyanoglycosides in cherry pits that release toxins only when bitten by a herbivore.

The word drug itself comes from the Dutch word "druug" (via the French word Drogue), which means 'dried plant'. Some examples are inulin from the roots of dahlias, quinine from the cinchona, morphine and codeine from the poppy, and digoxin from the foxglove.

The active ingredient in willow bark, once prescribed by Hippocrates, is salicin, which is converted in the body into salicylic acid. The discovery of salicylic acid would eventually lead to the development of the acetylated form acetylsalicylic acid, also known as "aspirin", when it was isolated from a plant known as meadowsweet. The word aspirin comes from an abbreviation of meadowsweet's Latin genus Spiraea, with an additional "A" at the beginning to acknowledge acetylation, and "in" was added at the end for easier pronunciation. "Aspirin" was originally a brand name, and is still a protected trademark in some countries. This medication was patented by Bayer AG.[4]

e. Role of herbal medicine in modern human society

Botánicas, such as this one in Jamaica Plain, Massachusetts, cater to the Latino community and sell herbal cures and folk medicine alongside statues of saints, candles decorated with prayers, lucky bamboo, and other items.

The use of herbs to treat disease is almost universal among non-industrialized societies. A number of traditions came to dominate the practice of herbal medicine at the end of the twentieth century:

- The herbal medicine system, based on Greek and Roman sources
- The Siddha and Ayurvedic medicine systems from various South Asian Countries
- Chinese herbal medicine (Chinese herbology) (zhôngyào)
- Unani-Tibb medicine
- Shamanic Herbalism

Many of the pharmaceuticals currently available to physicians have a long history of use as herbal remedies, including opium, aspirin, digitalis, and quinine. The World Health Organization (WHO) estimates that 80 percent of the world's population presently uses herbal medicine for some aspect of primary health care. Pharmaceuticals are prohibitively expensive for most of the world's population, half of which lives on less than $2 U.S. per day. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost. Herbal medicine is a major component in all traditional medicine systems, and a common element in Siddha, Ayurvedic, homeopathic, naturopathic, traditional Chinese medicine, and Native American medicine.

The use of, and search for, drugs and dietary supplements derived from plants have accelerated in recent years. Pharmacologists, microbiologists, botanists, and natural-products chemists are combing the Earth for phytochemicals and leads that could be developed for treatment of various diseases. In fact, according to the World Health Organisation, approximately 25% of modern drugs used in the United States have been derived from plants.

- Three quarters of plants that provide active ingredients for prescription drugs came to the attention of researchers because of their use in traditional medicine.

- Among the 120 active compounds currently isolated from the higher plants and widely used in modern medicine today, 80 percent show a positive correlation between their modern therapeutic use and the traditional use of the plants from which they are derived.

- More than two thirds of the world's plant species - at least 35,000 of which are estimated to have medicinal value - come from the developing countries.

At least 7,000 medical compounds in the modern pharmacopoeia are derived from plants.[4] ƒ. Contribution of herbal drugs and development of herbal drug Allopathic medicines are very costly. In contrast, herbal medicines are very cheap. This cost effectiveness makes them all the more alluring. Herbal medicines can be brought without prescription and they are available in all most all health stores. Some herbs can even be grown at home. For certain ailments, herbal medicines are considered to be more effective than allopathic medicines and do not have any side effects, as they are free from chemicals. They are also milder than allopathic medicines. One of the advanced research areas of herbáis includes use of advanced formulation techniques for delivering herbal actives. Various herbal drugs become less utilized due to their poor absorption and poor bioavailability after oral administration. The problem can be resolved by opting a suitable delivery system which can enhance the rate and extent of drug solubilizing into aqueous body fluids as well as its ability to go through the lipophilic biomembranes. Here we have presented some of the techniques of Novel drug delivery systems for herbal extracts as a tool of improving the therapeutic indices and their efficacy. Development of phytosomes can be proved to be an efficient delivery system with numerous advantages over conventional. Herbal Transdermal Therapy (HTT) connects the ancient Ayurvedic formula with Novel technique of Allopathic system. Transdermal Marma Therapy (TMT); where modern research of transdermal absorption meet the ancient practice of marma (massage & pressure to particular point) Nanoparticals, a newly emerging technology are subnanosized structures composing polymers. Herbal drug or drug extracts can be incorporated in the nanoparticles according to their properties. This technology has been effectively enhanced the bioavailability of many popular herbal extracts including milk thistle, Ginkgo biloba, grape seed, green tea, hawthorn, ginseng etc.

Recently, the World Health Organization estimated that 80% of people worldwide rely on herbal medicines for some part of their primary health care. In Germany, about 600 - 700 plant-based medicines are available and are prescribed by some 70% of German physicians. In the last 20 years in the United States, public dissatisfaction with the cost of prescription medications, combined with an interest in returning to natural or organic remedies, has led to an increase in herbal medicine use.

Traditional medicine is the synthesis of therapeutic experience of generations of practicing physicians of indigenous systems of medicine. A vast majority of population particularly those living in villages depend largely on herbal medicines. Throughout the history of mankind, many infectious diseases have been treated with herbáis. The traditional medicine is increasingly solicited through the tradipractitioners and herbalists in the treatment of infectious diseases. The rapid increase in consumption of herbal remedies worldwide has been stimulated by several factors, including the notion that all herbal products are safe and effective.

g. Effectiveness of herbal medicine

The gold standard for pharmaceutical testing is repeated, large-scale, randomized, double-blind tests. Some plant products or pharmaceutical drugs derived from them are incorporated into medicine. To recoup the considerable costs of testing to the regulatory standards, the substances are patented and marketed by pharmaceutical companies.

Many herbs have shown positive results in-vitro, animal model or small-scale clinical tests but many studies on herbal treatments have also found negative results. The quality of the trials on herbal remedies is highly variable and many trials of herbal treatments have been found to be of poor quality, with many trials lacking an intention to treat analysis or a comment on whether blinding was successful. The few randomized, double-blind tests that receive attention in medical publications are often questioned on methodological grounds or interpretation. Likewise, studies published in peer-reviewed medical journals such as Journal of the American Medical Association receive more consideration than those published in specialized herbal journals. This preference may be due to the possibility of location bias for such trials. One study found that non-impact factor alternative medicinejournals published more studies with positive results than negative results and that trials finding positive results were of lower quality than trials finding negative results. High impact factor mainstream medical journals, on the other hand, published equal numbers of trials with positive and negative results. In high impact journals, trials finding positive results were also found to have lower quality scores than trials finding negative results. Another study reported that some clinical studies of herbal medicines were not inferior to similar medical studies. However, this study used a matched pair design and excluded all herbal trials that were not controlled, did not use a placebo or did not use random or quasi random assignment.

Herbalists criticize mainstream studies on the grounds that they make insufficient use of historical usage, which has no relevance to the medical efficacy of a product's usage. They maintain that tradition can guide the selection of factors such as optimal dose, species, time of harvesting and target population.

Dosage is in general an outstanding issue for herbal treatments: while most medicines are heavily tested to determine the most effective and safest dosages (especially in relation to things like body weight, drug interactions, etc.), there are fewer varieties of dosages for various herbal treatments on the market. Furthermore, herbal medicines taken in whole form cannot generally guarantee a consistent dosage or drug quality, since certain samples may contain more or less of a given active ingredient.

Several methods of standardization may be applied to herbs. One is the ratio of raw materials to solvent. However different specimens of even the same plant species may vary in chemical content. Another method is standardization on a signal chemical.[4]

h. Herbal medicine risks to health

In some cases, herbal medicines offer an inexpensive and safe alternative to pharmaceuticals. In the U.S., which hasjust 4% of the world's population, 106,000 patients died from and 2.2 million were seriously injured by adverse effects of pharmaceuticals in the year 1994 (Journal of the American Medical Association.

Proper double-blind clinical trials are needed to determine the safety and efficacy of each plant before they can be recommended for medical use. In addition, many consumers believe that herbal medicines are safe because they are natural. Herbal medicines may interact with synthetic drugs causing toxicity to the patient, herbal products may have contamination that is a safety consideration, and herbal medicines, without proven efficacy, may be used to replace medicines that have a proven efficacy.

Standardization of purity and dosage is not mandated in the United States, but even products made to the same specification may differ as a result of biochemical variations within a species of plant. Plants have chemical defense mechanisms against predators that can have adverse or lethal effects on humans. Examples of highly toxic herbs include poison hemlock and nightshade. They are not marketed to the public as herbs, because the risks are well known, partly due to a long and colorful history in Europe, associated with "sorcery", "magic" and intrigue. Although not frequent, adverse reactions have been reported for herbs in widespread use. On occasion serious untoward outcomes have been linked to herb consumption. A case of major potassium depletion has been attributed to chronic licorice ingestion. Black cohosh has been implicated in a case of liver failure. Few studies are available on the safety of herbs for pregnant women.

Herb drug interactions are a concern. In consultation with a physician, usage of herbal remedies should be clarified, as some herbal remedies have the potential to cause adverse drug interactions when used in combination with various prescription and over-the-counter pharmaceuticals. Dangerously low blood pressure may result from the combination of an herbal remedy that lowers blood pressure together with prescription medicine that has the same effect. Some herbs may amplify the effects of anticoagulants. Certain herbs as well as common fruit interfere with cytochrome P450, an enzyme critical to drug metabolism.[4]

i. Adverse effect of herbs and drug herbal interaction

Herbs have a medicinal effect, but the effect is usually not nearly as strong as that of pharmaceutical drugs. This is because prescription drugs have been synthesized in a laboratory— taking the "active ingredient" found եւ some other form, usually plant based, and then concentrating the ingredient into a pill֊ Herbs usually are gentler because they are still in a more natural state, for example, roots, stems, bark, seed, etc. Even after they have been processed, the most active ingredients have not been separated from the other constituent parts.[6] A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contanı hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E fin the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.[7] A Chinese herb that damaged the Kidneys in 1990s appears to pack a second punch Cancer and pre cancerous lesions. This finding draws one of the strongest links yet between the use of an herbal product and cancer. The most important thing to remember is that if we want to use herbal medicines it is always safest to be under the care of a qualified herbalist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements.[8]

j. Limitation of herbal medicine

One of the advanced research areas of herbáis includes use of advanced formulation techniques for delivering herbal actives. Various herbal medicines become less utilized due to their poor absorption and poor bioavailability after oral administration. The problem can be resolved by opting a suitable delivery system which can enhance the rate and extent of drug solubilizing into aqueous body fluids as well as its ability to go through the lipophilic biomembranes. Here we have presented some of the techniques of Novel drug delivery systems for herbal extracts as a tool of improving the therapeutic indices and their efficacy. Development of phytosomes can be proved to be an efficient delivery system with numerous advantages over conventional. Herbal Transdermal Therapy (HTT) connects the ancient Ayurvedic formula with Novel technique of Allopathic system. Transdermal Marma Therapy (TMT); where modern research of transdermal absorption meet the ancient practice of marma (massage & pressure to particular point) Nanoparticals, a newly emerging technology are subnanosized structures composing polymers. Herbal medicine or drug extracts can be incorporated in the nanoparticles according to their properties. This technology has been effectively enhanced the bioavailability of many popular herbal extracts including milk thistle, Ginkgo biloba, grape seed, green tea, hawthorn, ginseng

k. Comparison between herbal medicine and conventional medicine

In today’s world we have literally millions of choices when it comes to drugs, whether prescribed to us or available over the counter, to help us through everything from the common cold to injury to major illness. Very often it is appropriate to leave ourselves in the hands of a traditional doctor and the pharmaceuticals he can provide when a condition requires more than herbal medicine can offer, but for the majority of us herbal remedies can replace many of the medications we have come to rely on. There are three major differences between conventional pharmaceuticals and herbal medicine.

The first difference is that herbal medicines, unlike conventional medicines that treat a specific symptom, treat the whole person, mind, body and spirit. Herbal medicines help to create a balance in the body whereas conventional medicines often create an imbalance. For example, when a patient goes on a medication to lower blood pressure he will frequently need a water pill, such as Lasix, to accompany it. Because the water pill leeches Potassium from the system the patient will then need to take Potassium supplements to replace what is lost. Taking an herbal alternative will not only save the patient from buying expensive medications but will also help to create harmony and balance in the body which will improve his general well being, uplifting and energizing the spirit. Herbal medicines are bioactive, meaning they contain several constituents that provide vitamins, nutrients and medicinal properties that work together to heal holistically and treat the whole person rather than a symptom or particular body function, as conventional medicines are designed to do. Herbal medicines are natural and, for the most part, not toxic. They generate few to no side effects and are gentle on the body, healing in a slower but more efficient way.

Conventional medications are more often than not synthetic chemical compositions that may help one symptom or function but wreak havoc on the rest of the body. I have often heard people say, “The cure is worse than the disease.” There is a lot of truth in that. The side effects from many conventional medications cause more discomfort to the patient than the initial problem. A perfect example is Aspirin, commonly taken for headache. When taken regularly Aspirin can cause Tinnitus (ringing in the ears), which is a very uncomfortable condition, sometimes accompanied by vertigo. Long after the patient’s headache is gone the Tinnitus can remain. Herbal medicines, with all of their multiple healing components working together, help the body function better overall which instead of just resolving one symptom, as conventional medicines do, offers the patient the multiple benefits of increased energy and enthusiasm, better health and overall sense of wellness. Conventional medications, at best, may alleviate one symptom and at worst may cause serious harm to the patient. They are designed to solve one problem without focusing on the rest of the body as herbal medicines do, doing nothing for the patient’s overall health.

The second difference is that conventional medications require either a trip to the doctor to obtain a prescription or the local drug store. This will cost the patient time as well as money. Herbal medicines can be grown at home, unlike conventional remedies. Common ailments such as stomachaches, sore throats, colds and flu, headaches, insomnia and indigestion can all be treated at home with plants growing in our own garden and neighborhood. Herbal medicines can be as convenient as snipping a few leaves in the garden or herbs from the windowsill and brewing a pot of tea.

The third striking difference between herbal and conventional medicine is the lack of research into the actions and benefits of medicinal herbs and plants. While millions, maybe billions, of dollars are being spent each year on conventional drugs very little is being spent on herbal medicines. The pharmaceutical companies do not see a large profit potential in herbal medicine because they can’t patent a plant and make billions of dollars from it. Instead they take one constituent from the plant and add to it chemicals and ingredients that do nothing for human benefit in any way and may cause harmful side effects, market the pill and make a fortune from it but it can’t help the person using it as much as the whole plant, with all of it’s constituents working together synergistically to work at every level in the body to make the system strong from the inside out. Therefore, if the pharmaceutical companies invested large amounts of money, time and energy into research they believe the profits would be low in comparison to the cost of research.[9]

2.2. Literature review of herbs used in my present work Black Cumin Seeds

a. History of Black cumin seeds

Nigella sativa was discovered in Tutankhamen's tomb, implying that it played an important role in ancient Egyptian practices. Although its exact role in Egyptian culture is not known, we do know that items entombed with a king were carefully selected to assist him in the afterlife.

The earliest written reference to black seed is found in the book of Isaiah in the Old Testament. Isaiah contrasts the reaping of black cumin with wheat: For the black cumin is not threshed with a threshing sledge, nor is a cart wheel rolled over the cumin, but the black cumin is beaten out with a stick, and the cumin with a rod. (Isaiah 28:25, 27 NKJV). Easton's Bible Dictionary clarifies that the Hebrew word for black cumin, "ketsah," refers to "without doubt the Nigella sativa, a small annual of the order Ranunculaceae which grows wild in the Mediterranean countries, and is cultivated in Egypt and Syria for its seed."

Dioscoredes, a Greek physician of the 1st century, recorded that black seeds were taken to treat headaches, nasal congestion, toothache, and intestinal worms. They were also used, he reported, as a diuretic to promote menstruation and increase milk production.

The Muslim scholar al-Biruni (973-1048), who composed a treatise on the early origins of Indian and Chinese drugs, mentions that the black seed is a kind of grain called alwanak in the Sigzi dialect. Later, this was confirmed by Suhar Bakht who explained it to be habb-i-Sajzi (viz. Sigzi grains). This reference to black seed as "grains" points to the seed's possible nutritional use during the tenth and eleventh centuries.

In the Greco-Arab/Unani-Tibb system of medicine, which originated from Hippocrates, his contemporary Galen and Ibn Sina, black seed has been regarded as a valuable remedy in hepatic growth in the worldwide phytotherapeutic market has occurred over the last 15 years. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids etc.

[...]


1. Steven D. Ehrlich, NMD, Solutions Acupuncture, a private practice specializing in complementary and alternative medicine, Phoenix, AZ. Review provided by VeriMed Healthcare Network. 9/27/2009

2. Generai Guidelines for Methodologies on Research and Evaluation of Traditional MedicineWHO/EDMSTRMIlOM. 1

3. WHO Drug Information Vol. 14, No. 4, 2000(2000; 78 pages)

4. http://1epir.com/en/pages/mdex/id/12/Herbs-in-histo1y.htmi

5. Journal WHO Guidelines For Herbal Drug Standardization. Sapna Shrikumar, M. Uma Maheswari, A. Suganthi, т.к. Ravi. Department of Pharmaceutical Analysis, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore-44. Lidia. 19/09/2004

6. http://www. acıı-care4health. com/oiiental-medicine/safeherbs. htm

7. Journal Brazilian Journal of Medical and Biological Research 2000 Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic *genti) Authors :Calixto, J. B. ,Vol. 33 No. 2 pp. 179-189

8. National Conference on''Recent Advances in Herbal Drug Technology"26 & 27 March 2010 Organized ByıLakshmi Naranı College of Pharmacy. Bhopal

9. Journal Three Differences Between Herbal and Traditional Medicine. By kelly marks ,10/9/ 2008

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Details

Title
Preparation of Herbal Solid Dosage Form
Grade
A
Authors
Year
2010
Pages
73
Catalog Number
V377773
ISBN (eBook)
9783668542990
ISBN (Book)
9783668543003
File size
1721 KB
Language
English
Tags
preparation, herbal, solid, dosage, form
Quote paper
Master of Pharmacy Sharmin Akhter (Author)Prof. M. Mohi Uddin Chowdhury (Author)Mohammed Ibrahim (Author), 2010, Preparation of Herbal Solid Dosage Form, Munich, GRIN Verlag, https://www.grin.com/document/377773

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