Study On Yimucao Soft Capsule Drug Quality Control Method

Yimucao soft capsule is kinds of class8new drug for Beijing Greatwall Pharmaceutical Factory,Drug approval numbe:The country medicine accurate Z20050784;The new drug certificate No:The Chinese medicine card characters Z20050806;Drug Standard No:YBZ29422005. Yimucao can promote blood circulation and remove blood stasis. It is been used for irregular or stagnant menstruation and postpartum abdominal pain. Stachydrine is predominantly effective component and also high content in Yimucao, therefore the contents of Stachydrine has been widely accepted as a main quality control factor of Yimucao. The measurement method of Stachydrine is hard to operate; we will study the influence factors and Revise the standard quality control of the products. The specific content includes the following parts:1、Study on Yimucao soft capsule drug old quality standardsStudy on Yimucao soft capsule drug old quality standards and investigate the feasibility of the method.2、Ultraviolet Rays-visible spectrophotometric method for the determination of alkaloid contentWe applied UV to determine alkaloids in Yimucao soft capsule, set the detection wavelength as512nm and studied the influence factors by orthogonal design. Time of ultrasonic extraction, redwood ammonium salt preparation is key factors to influence the determination of alkaloids in Yimucao soft capsule。 The method determines the content of total motherwort alkaloid, not the content of stachydrine hydrochloride, So we consider to modify the method of assaying。3、The HPLC method for the determination of alkaloid contentWe use HPLC method for the determination of motherwort soft capsule of stachydrine hydrochloride to control the quality of the products better, HPLC method is simpler, accurate than UV and with good reproducibility, as an important quality standard. The content of stachydrine hydrochloride cannot be less than6.0mg in1soft capsule.4、The stabilityFrom the long term room temperture stability experiment, as character, identification, content, determination of content indexes, the result shows that the24 months index of Yimucao soft capsule drug and the "0months" were not altered significantly, so the medicine valid period is at least24months.