金宝肾片质量标准研究  

Quality Standard of Jinbaoshen Tablets

作　　者：王曙东[1] 钱文慧[1] 廖欣[1] 易伟[1] 苏华[1] 

机构地区：[1]中国人民解放军南京军区南京总医院制剂科,江苏南京210002

出　　处：《中国药业》2017年第19期14-18,共5页China Pharmaceuticals

基　　金：全军医疗机构制剂标准提高科研专项课题重点项目[13ZJZ13]

摘　　要：目的建立金宝肾片的质量标准。方法采用薄层色谱(TLC)法对金宝肾片中的大黄素进行定性鉴别,并采用高效液相色谱法测定金宝肾片中卡托普利及大黄酸、大黄素、大黄酚的含量,并进行方法学验证。结果大黄素的薄层色谱斑点清晰,分离度好,阴性对照无干扰。卡托普利质量浓度在18.964~94.820μg/m L(R2=0.999 8)范围内与峰面积线性关系良好,平均加样回收率为96.97%(n=9);大黄酸、大黄素、大黄酚检测质量浓度分别在2.19~17.52μg/m L(R^2=0.999 9),1.47~11.76μg/m L(R2=0.999 9),6.97~55.76μg/m L(R^2=0.999 9)范围内与峰面积线性关系良好,平均加样回收率分别为102.91%,103.03%,102.06%(n=9)。结论该质量标准方法可行,专属性强,重复性好,可用于该制剂的质量控制。Objective To establish the quality standard of the Jinbaoshen Tablets. Methods The emodin in Jinbaoshen Tablets was qualitative identified by thin layer chromatography （ TLC ） method. The contents of captopril, rhein, emodin and chrysophanol in Jinbaoshen Tablets were determined by HPLC and then carried out the verification methodology. Results The TLC spot of emodin were clear, separation was good, and negative control without interference. The liner range of captopril was 18. 964-94. 820 μg/mL （ R2=0. 9998 ） , and the average recovery was 96. 97% （ n=9 ） . The liner range of rhein, emodin and chrysophanol were 2. 19-17. 52 μg/mL （ R2=0. 9999 ） , 1. 47-11. 76 μg/mL （ R2=0. 9999 ） , 6. 97-55. 76 μg/mL （ R2=0. 9999 ） , and the average recoveries was 102. 91% , 103. 03% , 102. 06% （ n=9 ） , respectively. Conclusion The established method for the quality standard of the Jinbaoshen Tablets is feasible, has strong specificity and good repeatability, which can be used for the quality control of the preparation.

关 键 词：金宝肾片 卡托普利 大黄酸 大黄素 大黄酚 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]