Researching On Process And Quality Standard Of Yin Dan Hard Capsule

Cardiovascular diseases are common diseases that severely threaten health of human. It is ranked as one of top three severe diseases by WHO. This thesis is to illustrate relationship between cardiovascular disease and venation disease that is defined in terms of Traditional Chinese Medicine, and formulate more specific TCM dosage forms. TCM product, Yindan Soft Capsule is used for the research. The research is mainly focused on changing dosage form from soft capsule to hard gelatin capsule, which will provide a new dosage form for clinical application.Orthogonal experiment method is used for process funneling. Active ingredients are extracted and the optimized process is established. Production process is, wetting ingredient by 90% alcohol--granulation--drying by heating from 50℃～60℃--breaking--blending--filling. Key active ingredients include Garlic volatile oil, Ginkgo total flavonoids and TanshinoneⅡA. Distillation parameters are studied to validate its effect on volatile oil. Ginko total flavonoids and Tanshinone are extracted with alcohol. Alcohol extraction parameters are also studied for its effect on major ingredients.Specification study included identification, check items and assay test. TLC Identification test method is established on the basis of physical and chemical property of major ingredients. Check items included aspect and weight variation. RP-HPLC test method is used for assay testing, limit established as, Ginkgo total flavonoids more then 1.0mg/capsule, TanshinoneⅡA more than 0.4mg/capsule. In addition, stability of Yindan Hard Gelatin Capsule is studied. Pilot batch study is conducted afterwards. Finished product of pilot batch complies with Chinese Pharmacopeia. It demonstrates that repeatability of production process is reliable and the quality of finished product can be well controlled. The process can be easily applied in industrial production.Yindan Hard Gelatin Capsule, as a new cardiovascular drug, demonstrates advantages of reliable production process and better bioavailability. Successful development of this product will help clinical application but also create significant economic benefit, furthermore push innovation of TCM dosage forms and development of TCM industry.