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复方利福平滴耳液的制备及质量控制
引用本文:马丽君,刘素艳,唐立宾,刘蕴秀. 复方利福平滴耳液的制备及质量控制[J]. 中国药房, 2005, 16(15): 1146-1147
作者姓名:马丽君  刘素艳  唐立宾  刘蕴秀
作者单位:1. 河北省唐山市中医院,唐山市,063000
2. 河北省唐山市人民医院,唐山市,063001
3. 北京赛科药业有限责任公司,北京市,100021
摘    要:目的:制备复方利福平滴耳液并建立其质量控制方法。方法:采用高效液相色谱法测定利福平含量,并将样品置于(6±2)℃下保存6mo。结果:利福平检测浓度在6~60μg/ml范围内线性关系良好,平均回收率为100.33%(RSD=1.23%)。保存6mo后其外观、pH值、含量均符合要求。结论:该制剂制备方法简单,成本低,质量可控。

关 键 词:复方利福平滴耳液  制备  质量控制
文章编号:1001-0408(2005)15-1146-02
收稿时间:2004-12-06
修稿时间:2005-02-14

Preparation and Quality Control of Compound Rifampicin Auristilla
Ma Lijun,LIU Suyan,TANG Libin,Liu Yunxiu. Preparation and Quality Control of Compound Rifampicin Auristilla[J]. China Pharmacy, 2005, 16(15): 1146-1147
Authors:Ma Lijun  LIU Suyan  TANG Libin  Liu Yunxiu
Abstract:OBJECTIVE:To prepare compound rifampicin auristilla and to establish a method for its quality control.METHODS:The content of rifampicin was determined by HPLC and the sample was stored under the temperature of(6±2)℃for6months.RESULTS:The linear range for rifampicin was6~60μg/ml,the average recovery was100.33%(RSD=1.23%).The appearance,pH value and contents of the preparation were in conformity with the requirements after storage for6months.CONCLUSION:This preparation method of compound rifampicin auristilla is simple and cheap,and its quality is controllable.
Keywords:Compound rifampicin auristilla  Preparation  Quality control  
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