米索前列醇栓的制备及质量标准研究  

Study on Preparation and Quality Control of Misoprostol Suppository

作　　者：虎亚光[1] 李兰兰[1] 杨威虎[1] 晋梅[1] 杨天才[1] 谭建伟[1] 

机构地区：[1]甘肃省妇幼保健院药事管理科,甘肃兰州730050

出　　处：《中国医院用药评价与分析》2017年第12期1660-1662,共3页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:制备米索前列醇栓,并建立其质量评定标准。方法:以聚乙二醇为基质制备米索前列醇栓,根据《中华人民共和国药典》(2015年版)进行质量控制,采用高效液相色谱法测定米索前列醇栓中米索前列醇的含量及累计溶出度。结果:米索前列醇栓的性状、重量差异和溶出度均符合要求。米索前列醇在10.17~35.60μg/ml范围内线性关系良好,平均加样回收率为(99.02±1.52)%,RSD为0.90%。结论:米索前列醇栓的制备方法简单易行,质量控制方法稳定可靠。OBJECTIVE： To prepare misoprostol suppository and establish the method of quality control of the suppository. METHODS： The polyethylene glycol was used as the substrate of misoprostol suppository, the Pharmacopoeia of the People＇s Republic （2015 Edition） was adopted for qualitycontrol, content and accumulative dissolution of misoprostol in misoprostol suppository were determined by HPLC. RESULTS： The character, weight variation and dissolution were in line with the standard. The content of misoprostol suppository showed a good linear relationship in 10. 17-35.60 μg/ml, the average standard recovery was （99.02 ± 1.52） % , with RSD of 0. 90%. CONCLUSIONS： This preparation method is easy to operate, the method for quality control was stable and reliable.

关 键 词：米索前列醇 栓剂 质量标准 高效液相色谱 

分 类 号：R927.11[医药卫生—药学]