ABSTRACT –
In homoeopathy, the key element is the quality of the medicine.Quality assessment of homoeopathic medicines is an essential need of time. The quality of a mother tincture can be defined by its identification, purity, content, and other physical, chemical, and biological properties, as well as the techniques used during manufacturing.Quality should not only be tested at the end but must be carried out right from the moment of receipt of raw materials, right through processing, till the final packaging. Homeopathic medicines are often prepared from natural and synthetic source materials. Evaluating the genuineness and origin of the raw materials in accordance with homoeopathic tradition and specifying the production process are two critical factors that determine the quality of homoeopathic mother tincture. The quality of Homoeopathic Medicine ascertained and standardized as outlined in HPI.
INTRODUCTION-
Quality control is the only tool to ensure highest quality and purity of medicine. In the beginning of 20th century the drug industry was nonexistent in India and drugs were imported from abroad.The First World War raised demand for medications, which led to a large-scale import of inexpensive drugs.In 1945, the drug regulations were established to implement the provisions of the act. In September 1975, the Homoeopathic Pharmacopoeia Laboratory (HPL) in Ghaziabad was established as an apex organization for quality monitoring.Quality control needs to be implemented from the time raw materials are received, throughout processing, and up until the point of final packing. Quality control encompasses not only laboratory processes but also the processes that convert a raw material into a medication and then the completed product up until the patient uses it. Setting standards for intermediates, final products, packing materials, and raw materials is a crucial part of ensuring product quality and safety.
STANDARDISATION–
The success of homoeopathic prescribing depends on the purity and the quality of raw drugs and finished products. A substandard drug will not help a sick person. Drug standardisation involves a thorough evaluation of homoeopathic drugs based on their pharmacognosy, physico-chemistry and pharmacology profiles to study various qualitative and quantitative properties of drugs. Pharmacognostical studies on raw drug plant material includes study of gross morphology, macro and microscopic properties of raw drug and after proper processing enumeration of characteristics of cell, tissue and organ structures under the microscope and determination of their essential biological statistical dimensions. Physico-chemical parameters for the raw drug and ready mother tincture are moisture content, ash content, extractive value and presence of active constituents and organoleptic properties, carrying out specific testing and TLC and UV spectrophotometric of mother tincture, which can be used as reference against any commercial sample in the future or whenever needed.
QUALITY CONTROL OF MOTHER TINCTURE:-
The quality of a drug can be determined by its identity purity, content, and other chemicals, physical or biological properties or by its manufacturing processes. Quality control is the process of maintaining the quality and validity of a manufactured product.
Quality control is not only the analytical testing of the finished product, but also the procedures beginning with receipt of raw materials and continuing throughout the production and packaging operations, finished product testing, documentation, surveillance and distribution. An Analytical Control Laboratory is responsible for testing and approving raw materials, the work in process and the finished product.
Objectives of quality control are following-:
- According to defined procedure and correctly processed
- In properly packed container
- It is correctly labelled
- It complies with the specification of quality
- Contains the correct proportion of correct ingredients
- It is properly stored for maintaining proper quality
Quality of Homoeopathic medicines is determined by identity, purity, content and other physical, chemical or biological properties or by manufacturer’s process. The term quality control is refers to the process of maintaining the purity and quality of end product.
Aim of quality control-
- Providing the standard medicine to patient
- Efficacy and safety of Homoeopathic drug
Factors for quality control- there are various factors which affect the quality of
Homoeopathic medicine-
l) Infrastructure- The infrastructure should be constructed as per GMP (Good manufacture practice) guidelines.
2) Equipments- All equipment’s used in manufacturing process must be accurate and capable of reproducing quality.
3) Material- Quality of all material must be carefully controlled and supervised from the raw product to finished product including packaging. All crude drug substances and vehicles must be confirmed to the specified standard as in the pharmacopoeia.
4) Environment- Environment is very important to maintain quality of products. Quality of product may be deteriorate by contamination of pollutants.
5) Method- Method employed for the manufacture of Homoeopathic medicine is also have important contribution to make to the quality of product. The pharmacopoeia guidelines should be followed for procedure of identification, collection, preparation and its analysis.
6) Personnel- Every manufacturer must have a well-trained worker with proper training of the personnel. They become an important part in the preparation of Homoeopathic medicine.
Quality Control of Finished Products: –
The following tests are conducted:
1. Alcohol content: – Estimation of the alcohol content of mother tincture is a test for potency of the mother tincture and an evaluation of the extraction process. Alcohol content with in the normal range indicates that proportion of drug and vehicle in the tincture is as per pharmacopoeia guidelines and that the tincture has uniform drug strength. Specific gravity of the distillate is determined pycnometrically/specific gravity bottle and the corresponding alcohol content in percent by volume read of in alcohol metric tables.
2. Weight per ml:- The weight per ml of liquid is the weight in gm of 1 ml of a liquid when weighed in air 20°C or 25°C .
3. pH value:- The pH value of an aqueous solution may be defined as the negative logarithm of the hydrogen ion concentration, express in grams per liter. (Hydrogen ion concentration is measure of the extent of acidity or alkalinity of solution).
4. Total solid:- The ‘Total Solid’ means “residue” obtained when the prescribed amount of the preparation is dried to constant weight under the conditions specified.
5. Thin layer chromatography (TLC):- TLC is one of the simplest fastest easiest and least expensive of several chromatographic techniques used in qualitative and quantitative analysis to separate organic compounds.
Conclusion –
As a conclusion one can state that the Homeopathic preparations with the help of Quality Control have a therapeutic relevance, are pure, safe, cost saving and having standards with quality specifications thus beneficial to physician and patient.
REFERENCES-
- Mandal and Mandal. A Textbook of Homoeopathic Pharmacy.3rded.Kolkata: New Central Book Agency (P) Ltd; 2012
- Homoeopathic Pharmacopoeia of India.1sted. New Delhi: 1971
- Dr. Sumit Goel. Art and Science of Homoeopathic Pharmacy. 3rded. New Delhi: IndianBooks&Periodicals;2014
- https://www.researchgate.net/publication/343253767_REVIEW_OF_HOMOEOPATHIC_PHARMACY_IN_THE_LIGHT_OF_QUALITY_CONTROL
- https://www.ccrhindia.nic.in/index1.aspx?lsid=8682&lev=2&lid=6622&Regid=0&langid=1
