肾康胶囊的质量控制研究及工艺优化

Optimization of Extracting Technology and Quality Standard for Shenkang Capsules

目的:建立肾康胶囊的质量控制方法和确定最佳提取工艺。方法:根据处方组成,采用薄层色谱法对白花蛇舌草、穿山龙、半枝莲、青风藤、莪术、龙葵进行定性鉴别,HPLC法对君药白花蛇舌草中齐墩果酸、穿山龙中薯蓣皂苷元,臣药丹参中丹参酮Ⅱ_A的含量测定。结果:白花蛇舌草、穿山龙、半枝莲、青风藤、莪术、龙葵定性鉴别分离度好,专属性强。丹参酮Ⅱ_A平均加样回收率为93.2%,RSD为2.718%,齐墩果酸平均加样回收率为99.8%,RSD为1.882%,薯蓣皂苷元平均加样回收率为101.9%,RSD为1.98%。最佳提取工艺为提取时间3 h,液料比10,提取次数2。结论:该方法简便,可靠,准确,可用于肾康胶囊的质量控制。

Objective：To optimize the extracting technology and establish the quality standard for Shenkang capsules. Methods ： Thin - layer chromatography was used to identify Hedyotis diffusa, Discorea nipponica Makino, Scutellaria barbata D. Don, Caulis sinomenii, Curcuma zedoaria and Solanum nigrum L. HPLC was used to determine the content of acidum oleanolecum in Hedyotis diffusa and diosgenin in Discorea nipponica Makino and tanshinone Ⅱ A in Salvia miltiorrhizaBge based on the constituents of prescriptions of Shenkang capsules. Results ： They could be identified by TLC with high resolution and strong specialization. The average recovery of tanshinone Ⅱ Awas 93.2% and RSD was 2. 718% ; the average recovery of acidum oleanolecum was 99.8% and RSD was 1. 882% ; the average recovery of diosgenin was 101.9% ,RSD was 1.98%. The optimum extraction process for the Shenkang capsules was selected as follows： processing time was 3h, the ratio of liquid - solid was 10 and extracting frequency was 2. Conclusion ： The method was simple, reliable and accuracy and could be applied to control quality of Shenkang capsules.