清热祛湿胶囊质控方法研究

Research on Quality Control of Qingre Qushi Capsule

关键词:  清热祛湿胶囊  薄层扫描  苦参碱  槐定碱  质控方法

Key words:  Qingre Qushi Capsule  TLC  matrine  sophocarpine  quality control

摘要:

目的: 建立清热祛湿胶囊的质量检测方法。方法: 采取TLC法对处方中苦参进行定性鉴别,并用TLC法测定其中苦参碱、槐定碱的含量。结果: 用TLC法测定苦参碱、槐定碱在0 5～3μg范围内呈良好的线性关系,γ=0.998,γ=0.994,平均回收率分别为: 101.4%,102.1%,RSD值分别为2.7%,2.1%.结论: 所建立的方法准确、可靠,可用于该制剂的质量控制。

Abstract:

Objective: To establish the quality control of Qingre Qushi Capsule. Methods: After Kushen (Radix Sophorae Flavescentis) in this capsule was idetified the content of matrine and sophocarpine was detected by TLC.Results: Kushen could be differentiated by TLC. The change of matrine and sophocarpine determined by TLC had a good linear relationship in the range of 0.5～3 μg(r=0.998,r=0.994). The average recovery rate was 101.4%,102.1% and RSD was 2.7%,2.1% respectively. Conclusion: The quality of Qingre Qushi Capsule can be controlled by this accurate and reliable technique.