参辛胶囊质量标准研究

Studies on the Quality Standard of Shenxin Capsules

目的研究复方制剂参辛胶囊的质量标准。方法采用HPLC法对参辛胶囊中的人参皂苷Rg1和人参皂苷Re进行含量测定,流动相为乙腈-0.05%磷酸溶液(95∶405),检测波长203nm。采用薄层色谱法对制剂中的主要药味人参、羚羊角、细辛等进行定性鉴别。结果人参皂苷Rg1线性范围为1.032～9.288μg(r=0.9998,n=5),平均回收率为99.76%,RSD=2.10%。人参皂苷Re线性范围为0.850～7.650μg(r=0.9998,n=5),平均回收率为96.24%,RSD=1.67%。薄层图谱斑点清晰,可鉴别出与人参、细辛对应的斑点,阴性对照无干扰。结论该方法准确、重现性好,可用于参辛胶囊的质量控制。

Objective To establish the quality standard of Shenxin Capsules. Methods The contents of ginsenoside Rg1 and ginsenoside Re in Shenxin Capsules were determined by HPLC with the mobile phase consisting of acetonitrile - 0.05 % phosphoric acid water solution （95 ： 405） and UV detection wavelength at 203 nm. Qualitative analysis of Radix Ginseng, Cornu Saigae Tataricae and Herba Asari in Shenxin Capsule was carried out by TLC. Results Ginsenoside Rg1 showed a good linearity in the range of 1. 032 - 9. 288μg （ r = 0. 9998, n = 5） , the average recovery being 99.76 % and RSD being 2. 10 %. Ginsenoside Re showed a good linearity in the range of 0. 850 - 7. 650μg （ r =0. 9998, n = 5） , the average recovery being 96. 24 % and RSD being 1. 67 %. The chromatographic spots of Radix Ginseng, Cornu Saigae Tataricae and Herba Asari were identified without the interference of negative control. Conclusion The method is accurate , reproducible and can be used for the quality control of Shenxin Capsules.