妇科养荣胶囊的质量标准研究.doc

妇科养荣胶囊的质量标准研究.doc妇科养荣胶囊的质量标准研究
作者：江海峰王青华孟祥军
【摘要】目的：按新药审批标准为妇科养荣胶囊制定质量标准。方法：以 TLC法对妇科养荣胶囊中的当归、陈皮、黄芷三味药进行定性鉴别；以HPLC法 测定妇科养荣胶囊白芍中芍药昔（C23H280U）的含量。结果：试验采用薄层色 谱法定性鉴别，色谱斑点清晰，阴性液无干扰；以HPLC法测定该胶囊白芍中芍 药苜的含量，方法精密度、稳定性、重复性良好，平均回收率为100. 25%, RSD 为1. 7%。结论：本试验所确定的质量分析方法稳定可靠，能作为妇科养荣胶囊
的质控标准。
【关键词】妇科养荣胶囊质量标准化方法学研究
Study on the Quality Standard of FukeYangrong Capsules
[Summary] Objectformulate the quality standard for the FukeYangrong Capsules according to the requirement by Evaluation of Chinese Government. Methods * the qualitative identifying method by TLC was established for Danggui、 Chenpi、 Huangqi and Shaoyaogan was quantitatively determined by HPLC. Result shows * the spots on the TLC are clear by the methods of qualitative identification by TLC, the resolution is well and have no negative sample interference. The method for determinating the content of Capsules by HPLC is suitable for the formulate of the quality standard with sufficient accuracy、 stability and reappearance. The everage of recovery rate is 100. 25%, RSD is 1. 7%. Conclusion：the qualitative and quantitative analytic methods are stable and reliable.
[Key word] The FukeYangrong Capsules；Quality Standard；Method Appraise
妇科养荣胶囊是根据已有国家标准的妇科养荣丸改变剂型制得，属中药 8类品种。方中当归、川萼、白芍对补血活血、调经止痛、月经不调、经闭痛 经有较好的作用。根据药品标准[中药成方制剂标准1998年，标准号：WS3-B- 2893-98]进行了质量标准的研究工作，拟定了质量标准。本专题对处方中各药 味定性、定量方法加以筛选和分析，从而确立稳定可靠的生产质控标准。
1薄层定性鉴别
妇科养荣胶囊由当归、白术、熟地黄、川萼、白芍（酒炒）