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目的研究复方叶下珠滴丸的质量标准方法并考察其稳定性。方法采用薄层色谱法对滴丸中叶下珠和半边莲成分进行定性鉴别;用高效液相色谱法(HPLC)测定滴丸中没食子酸和绿原酸的含量;通过加速试验和长期试验考察其稳定性。结果定性鉴别分离度好,易于鉴别。含量测定中,没食子酸浓度在15.04耀120.32滋g·mL-1范围内,浓度与峰面积的线性关系良好(r=0.9992),没食子酸的平均回收率为:99.25%,RSD为0.95%(n=6);绿原酸在浓度10.12耀202.4滋g·mL-1范围内呈良好的线性关系(r=0.9996),绿原酸的平均回收率为:99.89%,RSD为0.7%(n=6)。3批次复方叶下珠滴丸试样经6个月加速试验和12个月长期试验考察,各项指标均符合质量标准要求。结论所建立方法操作简单,灵敏度高和重现性好;制剂在常温下保存稳定性良好;可作为该制剂的质量控制方法。
Objective To study the quality standard method of Compound Yexiazhu Drop Pills and investigate its stability. Methods The contents of gallic acid and chlorogenic acid in dropping pills and lobelia lotus were qualitatively identified by TLC. The contents of gallic acid and chlorogenic acid in dropping pills were determined by high performance liquid chromatography (HPLC) stability. The results of qualitative identification of good resolution, easy to identify. The content of gallic acid in the range of 120.32 g · mL-1 was good (r = 0.9992). The average recoveries of gallic acid were 99.25% and the RSD was 0.95% (r = 0.9996). The average recovery rate of chlorogenic acid was 99.89% and the RSD was 0.7% (n = 6). The average recovery of chlorogenic acid was 99.89% = 6). 3 batches of Compound Phyllanthus dropping pills 6 months accelerated test and 12 months long-term test study, the indicators are in line with quality standards. Conclusion The established method is simple, sensitive and reproducible. The preparation has good storage stability at room temperature and can be used as a quality control method.