降防保心胶囊的质量标准研究

Study on Quality Standard for Jiangfang Baoxin Capsule

目的建立降防保心胶囊的质量标准。方法采用TLC鉴别制剂中防己、当归、川芎;采用HPLC法测定降防保心胶囊中粉防己碱的含量。结果在TLC色谱中均能检出防己、当归、川芎,粉防己碱在0.009 772~0.195 44 mg/mL范围呈良好的线性关系,r=0.999 9,平均回收率为94.90%,RSD为1.36%。结论该方法操作简单,可靠,重现性好,专属性强,可用于降防保心胶囊的内在质量控制。

OBJECTIVE To establish the quality standard for Jiangfang Baoxin Capsule.METHODS The thin-layer chromatography was used to identify Radix Stephaniae Tetrandrae,Radix Angelicae Sinensis;Rhizoma Chuanxiong,and the content of Tetrandrine was determined by HPLC.RESULTS The spots in the TLC were clear and distinguished well,the linear range of Tetrandrine was 0.009 772～0.195 44 mg/mL（r=0.999 9）.The average rate recovery was 94.90% with RSD of 1.36%.CONCLUSION This method is simple,reliable and of good reproducibility and accuracy,so it can be used for quality control of Jiangfang Baoxin Capsule.