Vijayalakshmi, P (2018) Development and Standardization of Polyherbal Antidiabetic Formulation. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
Herbal medicines are the oldest form of health care known to mankind. A number of traditional herbal medicinal practices have been adopted for the diagnostic prevention and treatment of various diseases. Based on the extensive review of literature, five raw materials were selected for the formulated as polyherbal capsules and the antidiabetic potency was evaluated in animal model. The herbal raw materials were analyzed for identity, quality and purity as per the standards prescribed by WHO and Ayurvedic Pharmacopeia of India. The Physiochemical parameters like Loss on drying, ash values and extractive values were determined, which will help in preventing variation in quality of the drugs. Preliminary phytochemical investigation revealed the presence of various phytoconstituents such as alkaloid, steroids, glycosides, Flavonoids, Phenols, Tannins, and terpenoid in the raw materials. The safety of the raw materials was analysed by heavy metals and microbial screening and the results found within the standard limits given by WHO. The coarse powders of the selected plants were extracted by using ethanol as solvent. The ethanolic extracts were dried by freeze drying and used for the formulation. TLC for the each individual plant extracts and polyherbal extract was performed. Further HPTLC fingerprinting of the polyherbal formulation was also performed and the resultant chromatogram showed the presence of peaks indicating different constituents. The chromatogram can be used as an index for the qualitative analysis of the formulation. The dried polyherbal extract was optimized for its quality measures and its batch consistency by making four different trial batches (Trial I, II, III, IV). The trials were subjected to preformulation parameters to confirm the uniformity and quality. The result concludes that the trial IV was excellent in all parameters and the values were found within the standard limits and it was used for formulate Polyherbal Capsule. The developed polyherbal capsules were standardized for its Description, uniformity of weight, disintegration time, moisture content, pH, Physiochemical parameters, and phytochemical studies. Quantitative estimation of phytoconstituents was done for flavonoid, phenols, and tannins. The heavy metal analysis and the microbial load was carried out in polyherbal formulation as per the WHO Guidelines and found within the limits. In vitro anti-diabetic activity was done by using α-amylase inhibition assay method. It possesses significant antidiabetic activity as compared to standard Acarbose. Acute toxicity study was carried as per OECD guidelines 423 and the polyherbal capsules were found to be safe upto 2000 mg/Kg body weight. The developed and standardized polyherbal capsule was evaluated for its therapeutic efficacy by in vivo method using Streptozotocin induced diabetes. Fasting blood glucose parameters and lipid profile were analyzed. The formulation showed significant effect compared to the normal range before induction of diabetes. The polyherformulation at the dose level of 400 mg/kg showed significant decrease in blood glucose level on 7th day. The elevated levels of total cholesterol, LDL and triglycerides were also reduced and increases HDL level. The phytochemical study showed the presence of flavonoids. This may be responsible for the potent anti diabetic activity. Further studies are recommended for stability studies in the formulated polyherbal capsules and also clinical trials have to perform in future in Human Volunteers.
| Item Type: | Thesis (Masters) |
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| Additional Information: | REG. NO: 261620659 |
| Uncontrolled Keywords: | Polyherbal Antidiabetic Formulation ; Development ; Standardization. |
| Subjects: | PHARMACY > Pharmacognosy |
| Depositing User: | Subramani R |
| Date Deposited: | 28 Jun 2019 04:05 |
| Last Modified: | 28 Jun 2019 04:05 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10641 |
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