复方叶下珠滴丸质量标准及稳定性研究  

Study on Quality Standard and Stability of Compound Phyllanthus urinaria Dripping Pills

作　　者：徐晓梅[1] 谭本仁[1] 朱兴保 郭基燕 张伟明[1] 许卫关[1] 刘贤英 

机构地区：[1]汕头大学医学院附属粤北人民医院药剂科,广东韶关512026 [2]韶关市食品药品检验所,广东韶关512028 [3]顺德顺峰药业有限公司,广东顺德528300

出　　处：《中药新药与临床药理》2014年第4期483-487,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省中医药局科研项目(2008045)

摘　　要：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 establish a method for the quality standard of the compound Phyllanthus uainaria drippingpills and to inspect the stability. Methods Qualitative identification was made by thin layer chromatography （TLC） for Phyllanthus urinaria and Herba Lobeliae Chinesis in the dripping pills. Determination of gallic acid and chlorogenic acid in the dripping pills was carried out by HPLC. Accelerated test and long-term test were used for evaluating the stability of the dropping pills. Results Phyllanthus urinaria and Herba Lobeliae Chinesis in the dripping pills could be identified by TLC. The gallic acid showed good linearity in the range of 15.04 ～120.32 μg·mL^-1 （r=0.9992） , the average recovery rate was 99.50 % with RSD of 0.9 %（n=6）. Chlorogenic acid showed good linearity in the range of 10.12 - 202.4 μg·mL^-1（r =0.9996）, the average recovery rate was 99.89 %, and RSD was 0.7 %（n=6）. The results of six-month accelerated test and 12-month long-term test showed that the quality indexes of three batches of the compound Phyllanthus uainaria dripping pills were consistent with the regulations of drug quality criteria. Conclusion The method is simple, highly specific and reproducible, and it can be applied for the quality control of compound Phyllanthus uainaria dripping pills. The dripping pills are stable at room temperature.

关 键 词：复方叶下珠滴丸 叶下珠 半边莲 质量标准 稳定性 

分 类 号：R284.1[医药卫生—中药学]