三味补肾片的药学部分分析-pharmaceutical analysis of sanwei bushen tablets.docxVIP

中文摘要三味补肾片是由制何首乌、黄精（制）、女贞子（酒蒸）等组成 的中药复方制剂，具有补肝肾，益精血，壮筋骨的功效。用于失眠多 梦，耳鸣健忘，头发脱落及须发早白。本课题在中医理论的指导下， 根据文献资料和临床应用情况，结合方中药物性质，进行了详细的制 备工艺、质量和稳定性研究。 以指标成分的含量、干膏收率等为指标，通过单因素试验，对提 取、纯化、干燥等工艺过程进行筛选，以成品的稳定性、成型的难易 等为指标对成型工艺进行研究，以正交试验确定包衣工艺条件；进行 了详细质量研究和样品检测，包括 TLC 鉴别、HPLC 含量测定、残留 溶剂、一般杂质检查及微生物方法的验证，制订了本品质量标准；对 3 批中试样品进行了 3 个月加速试验和 12 个月长期试验。 结果表明，该制剂工艺科学、合理、可行，质量标准可控，产品 质量稳定。 关键词 三味补肾片 提取工艺 纯化工艺 质量 稳定性 Abst r actSanwei Bushen tablet is a compound preparation with Radix Polygoni Multiflori Preparata, Solomonscal Rhizome Preparata and Fructus Ligustri Lucidi Preparata. With the functions of nourishing Ganshen, supplementing Jingxue and strengthening Jingu, it can be used in insomnia, dreaminess, tinnitus, amnesia, hoariness, baldness and so on. Under the guidance of traditional Chinese medicine (TCM) theories, on the basis of the abundant literature materials and the requirment of clinical drug application, in combination with the property of the ingredients in this prescirption, experiments was designed.Single factor experimentations are applied to inspect the technology of extraction, purity, concentration and torrefaction according to index of major valid componets, dry substances ,ect. Simultaneously, it intends to select the optimal preparation process by testing the technology ofmoulding with the data of the product stability, formability, ect， and theconditions of film-coating were confirmed from the results of orthogonal design.On the basis of the experimentations, such as the analytical procedures and methods validation of TLC identification ， HPLC assay ，residual solvent ，general impurity and microbe ，the quality standard was set up, and the preliminary stability （ 3 months of Accelerated testing and 12 months of long-term testing） has beendone.The study shows that the preparations process were scientific, reasonable and practical; the quality standard was contrable and the quality of the sample was steady as well.Key words: Sanwei Bushen tablet, Extraction