炎黄保肾胶囊的质量控制研究  

Quality Control of Yanhuangbaoshen Capsules

作　　者：钱文慧[1] 廖欣[1] 汪玥[1] 黄鲁[1] 苏华[1] 王曙东[1] 

机构地区：[1]南京军区南京总医院制剂科,江苏南京210002

出　　处：《解放军药学学报》2015年第1期46-48,56,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：全军医疗机构制剂标准提高科研专项课题重点项目;No.13ZJZ13

摘　　要：目的制定炎黄保肾胶囊的质量控制方法。方法采用HPLC法测定炎黄保肾胶囊中大黄酸、大黄素、大黄酚的含量,并制定含量限度。结果 HPLC法测得炎黄保肾胶囊中大黄酸、大黄素、大黄酚检测浓度分别在8.88~44.40μg·ml^-1（r=0.9998）、2.28~11.40μg·ml^-1（r=0.9998）、2.08~10.40μg·ml^-1（r=0.9999）范围内与峰面积呈良好的线性关系,平均加样回收率为98.04%、99.20%、99.68%。结论该制剂制备工艺稳定,建立的含量测定方法简便、可靠,可用于该制剂的质量控制。Objective To establish a quality control method of Yanhuangbaoshen capsules. Methods HPLC was used to determine the content of Rhein,Emodin and Chrysophanol in Yanhuangbaoshen capsules and before the lower limit of Rhein and the upper limit of Emodin and Chrysophanol were established. Results The linear range of Rhein,Emodin and Chrysophanol was 8. 88- 44. 40 μg·ml^-1（ r = 0. 9998）,2. 28- 11. 40 μg·ml^-1（ r =0. 9998） and 2. 08- 10. 40 μg·ml^-1（ r = 0. 9999）,respectively. The average recovery was 98. 04%,99. 20% and99. 68%,respectively. Conclusion This method is simple and practical,the result is accurate and reliable and it can be used for quality control of Yanhuangbaoshen capsules.

关 键 词：炎黄保肾胶囊 大黄酸 大黄素 大黄酚 质量控制 HPLC 

分 类 号：R917[医药卫生—药物分析学]