益脑胶囊质量标准的研究

Study on Quality Standards for Yinao Capsules

目的:制定益脑胶囊的简便快捷的质量标准。方法:对制剂中的远志与人参在同一块薄层板上进行了鉴别,对麦冬进行了薄层鉴别,采用高效液相法测定了益脑胶囊中人参皂苷Rb1的含量。结果:通过方法学考察,人参皂苷Rb1的进样量在0.187～4.68μg范围内,呈良好的线性关系。人参皂苷Rb1的平均回收率为99.20%(n=9),RSD为2.02%。结论:方法简便、准确、重现性好、精密度高。可用于快速、准确地控制中药制剂质量。

Objective：To establish a quality standard for Yinao Capsules. Method：Thin layer chromatography was used for identification of Radix Polygalae and Radix et Rhizoma Ginseng at the same time. Radix Ophiopogonis was identified by TLC. The content of Ginsenoside Rb1 in preperation was determinated by HPLC. Results：The methodological study showed that a good linear correlation existed in the range of 0. 18705 to 4. 67625μg of Ginsenoside Rb1. The average recovery of Ginsenoside Rb1 was 99.20% （n=9） and RSD was 2.02%. Conclusion.. This method is simple,accurate and with good repeatability and high precision. The method can be used for quality control rapidly and accurately for Chinese preparations.