替硝唑栓剂的制备及质量控制  

Preparation and quality control of tinidazole suppository

作　　者：金绮[1] 凌海燕[1] 赵轶[1] 

机构地区：[1]浙江大学医学院附属妇产科医院,浙江杭州310006

出　　处：《中国现代应用药学》2005年第z2期769-770,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的研制替硝唑栓,并制定质量控制方法。方法以聚乙二醇400及6000为基质,用熔融法制备。紫外分光光度法测定该栓剂中替硝唑的含量,测定波长317nm。结果替硝唑在浓度4~20μg·mL^(-1)范围内有良好的线性关系,r=0.9999,平均回收率100.86%,RSD为1.29%(n=9)。结论该制剂制备简便易行,稳定性好,其质量控制方法简单,专属性好,结果准确可靠。OBJECTIVE To prepare tinidazole suppository and establish quality control method.METHOD The suppository were prepared by using PEG-400 and PEG-6000.The tinidazole content in suppository were determined by UV-spectrophometry at317 nm.RESULTS The tinidazole contentration was linear within the range 4~20μg·mL^(-1) with r = 0.9999.The average recovery was 100.86%with RSD 1.29%(n =9).CONCLUTION The suppository can be prepared simply and feasibly.The method of quality control is simple,rapid and accurate.

关 键 词：替硝唑 栓剂 制备 质量控制 紫外分光光度法 

分 类 号：R944.23[医药卫生—药剂学]