麻仁润肠丸51批次质量分析  

Quality Analysis of Maren Runchang Pills in 51 Batches

作　　者：郭琪[1] 程利娟[1] 雷虹[1] 杨莹[1] 申睿[1] 李永申[1] 

机构地区：[1]北京军区联勤部药品仪器检验所,北京100071

出　　处：《解放军医药杂志》2013年第10期79-81,共3页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

基　　金：军队中医药科研专项课题(10ZYZ204)

摘　　要：目的对3个厂家51批次麻仁润肠丸进行质量分析。方法采用《中华人民共和国药典》方法进行测定,检测项目为:性状;大黄、陈皮及白芍的显微鉴别;白芍、陈皮、大黄、火麻仁及木香的薄层鉴别;水分、重量差异、微生物限度检查;含量测定为总大黄酚和总大黄素总量及结合蒽醌中大黄酚和大黄素总量。结果 51批次麻仁润肠丸全部符合规定。结论不同生产企业不同批次或相同生产企业不同批次的麻仁润肠丸所测定的总大黄酚和总大黄素总量稳定差异不大,而结合蒽醌中大黄酚和大黄素总量差异较大,应改进检测方法,以提高药品有效性和安全性。Objective To analyze the quality of Maren Runchang pills in 51 batches from 3 companies. Meth- ods The samples were detected according to Chinese Pharmacopoeia, and the test items included characteristics; micro- scopic identification of Rheum, Tangerine Peel and White Peony Root; thin layer identification of White Peony Root, Tangerine Peel, Rheum, Hemp Fruit and Costusroot; detection of moisture, weight variation, microbial limit; content determination of total Chrysophanol, total Emodin and the total Chrysophanol and Emodin in Anthraquinone analogues. Results The quality of Maren Runchang pills of all the 51 batches complied with the standard. Conclusion There are few variances in content of total Chrysophanol and total Emodin in Maren Runchang pills from different companies or dif- ferent batchs of the same company, but there are great variances in content of the Chrysophanol and Emodin in Anthraqui- none analogues in Maren Runchang pills, so the detection method of pharmaceutical technology needs improvement to in- crease the efficiency and safety.

关 键 词：麻仁润肠丸 质量评价 色谱法 高效液相 

分 类 号：R943.3[医药卫生—药剂学]