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.
Table of Contents
1. Chapter-I: Introduction
2. 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
k 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 of Black cumin seeds
d Chemical constituents of Black cumin seeds
e Nutrition of Black cumin seeds
f Medicinal uses of Black cumin seeds
g Biological uses of Black cumin seeds
h Side Effects of Black cumin seeds
i Adverse effect of Black cumin seeds
Honey
a History of Honey
b Description of Honey
c Origin and distribution of Honey
d Chemical constituents of Honey
e Nutrients of Honey
f Medicinal uses of Honey
g Biological uses of Honey
h Side Effects of Honey
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
Objective of the work
Research protocol
3. 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
4. Chapter-IV : Conclusion
5. Chapter-V: References
Research Objectives and Key Topics
The primary objective of this work is to develop a stable herbal solid dosage form, specifically utilizing a combination of Black Cumin (Nigella sativa), Honey (Apis mellifera), and Jaitun Oil (Olea europaea), as these components are recognized for their diverse medicinal applications. The study aims to overcome technical challenges in formulation—such as the failure of tablet dosage forms due to oil content—by successfully engineering a capsule-based delivery system that meets pharmaceutical quality and stability standards.
- Formulation development of herbal solid dosage forms.
- Comparative analysis of tablet versus capsule delivery systems for oily herbal ingredients.
- Comprehensive literature review of the pharmacological benefits of Black Cumin, Honey, and Jaitun Oil.
- Implementation of standardized quality control parameters (physical, chemical, and organoleptic evaluation).
- Stability testing of final capsule products under varying environmental and humidity conditions.
Excerpt from the Book
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 Gatten and Ibn Sina, black seed has been regarded as a valuable remedy in hepatic and digestive disorders and has been described as a stimulant in a variety of conditions, ascribed to an imbalance of cold humors.
Summary of Chapters
Chapter-I: Introduction: Provides an overview of the long history of herbal medicine and the holistic philosophy underlying traditional healing systems across various cultures.
Chapter-II : Literature review: Offers a comprehensive scientific and historical background on herbal preparations, the specific medicinal properties of Black Cumin, Honey, and Jaitun oil, and established quality control protocols.
Chapter-III : Materials-method with result and discussion: Details the experimental process, including equipment used, formulation steps for tablets and capsules, and the results of quality control and stability evaluations.
Chapter-IV : Conclusion: Summarizes the successful development of the herbal capsule formulation and confirms that the final product adheres to the required safety and quality standards.
Chapter-V: References: Compiles the scholarly sources and literature utilized throughout the research study.
Keywords
Nigella sativa, Black Cumin, Apis mellifera, Honey, Olea europaea, Jaitun oil, Herbal formulation, Solid dosage form, Capsule, Tablet, Quality control, Stability testing, Phytotherapy, Medicinal plants, Traditional medicine
Frequently Asked Questions
What is the core focus of this research?
This work focuses on the formulation and physical evaluation of an herbal solid dosage form containing a synergistic combination of Black Cumin, Honey, and Jaitun oil.
What are the primary themes addressed?
The key themes include the traditional medicinal history of the chosen plants, modern formulation challenges for oily herbal ingredients, and pharmaceutical quality control standards.
What is the main research objective?
The main objective is to design a stable herbal solid dosage form (eventually a capsule) that successfully incorporates all three ingredients while passing standardized pharmaceutical tests.
Which scientific methods were applied?
The methodology included botanical identification, raw material preparation through milling, wet granulation, encapsulation, and physical parameter testing such as weight variation and disintegration time.
What content is covered in the main section of the study?
The main section details the materials, step-by-step manufacturing procedures for various tablet and capsule recipes, and the subsequent analysis of their stability and physical integrity.
How would you describe this study using keywords?
This study is best characterized by terms like herbal formulation, Nigella sativa, quality control, stability testing, and capsule development.
Why was a capsule preferred over a tablet dosage form in this study?
The initial attempts to create a tablet failed because the high oil content of the ingredients caused the tablets to remain soft and structurally unstable, leading the researchers to shift to a more effective capsule delivery system.
What did the stability tests in the incubator and refrigerator indicate?
The stability tests demonstrated that the capsules showed no physical changes in either the incubator or the refrigerator over the one-month testing period, confirming the robustness of the final shell property.
How do environmental conditions affect the stability of the capsules?
The study found that high humidity—specifically in 75% salt solutions—caused the capsules to become softer, tackier, and bloated, leading to the conclusion that they must be preserved in a tight, pressurized container with silica gel.
- Citation du texte
- Master of Pharmacy Sharmin Akhter (Auteur), Prof. M. Mohi Uddin Chowdhury (Auteur), Mohammed Ibrahim (Auteur), 2010, Preparation of Herbal Solid Dosage Form, Munich, GRIN Verlag, https://www.grin.com/document/377773
