复方替硝唑凝胶的制备及质量控制  

Preparation and Quality Control of Compound Tinidazole Gel

作　　者：张亚玲 韩跃春 熊小亚 张渊 

机构地区：[1]重庆市长寿区人民医院药剂科,重庆401220

出　　处：《中国药业》2007年第8期44-45,共2页China Pharmaceuticals

摘　　要：目的制备复方替硝唑凝胶并建立其质量控制方法。方法以替硝唑、氯霉素为主药,卡波姆-940、丙二醇等为辅料制备凝胶;采用双波长分光光度法测定主药含量。结果替硝唑、氯霉素检测质量浓度的线性范围分别为6.4～12.8 mg/L和8.0～16.0 mg/L,平均回收率分别为100.72%和99.64%,RSD分别为0.30%和0.98%。结论该制剂制备方法可行,所建立的质量控制方法简单、可靠。Objective To prepare compound tinidazole gel and to establish the quality control methed of this medicine, Methods Tinidazole and chloromycetin were used as the principal agents, carbomer-940, propylene glycol as preservatives to prepare compound tinidazole gel. The contents of the chief componrnts were determined by the dual- wavelength spectrophotpmetric method, Results The linear ranges for the concentration determination of tinidazole and chloromycetin were 6.4- 12.8 mg/L and 8.0- 16. 0 mg/L respectively, The average recovery rates of tinidazole and chloromycetin were 100. 72% and 99. 64% respectively, the relative standards deviations（RSD） were 0. 30% and 0. 98% respectively, Conclusion The preparation method is practicable and the established quality control method is simple, reliable.

关 键 词：替硝唑 氯霉素 凝胶 双波长分光光度法 

分 类 号：R944.15[医药卫生—药剂学] R984[医药卫生—药学]