替硝唑滴丸的制备及质量控制

The Preparation and Quality Control of Dripping Pills of Tinidazole

目的 研究替硝唑滴丸的质量标准。方法 用紫外分光光度法测定滴丸中替硝唑含量 ,小杯法考察其体外溶出度。结果 替硝唑平均回收率为 10 0 .0 % ,RSD为 0 .72 % (n =5 ) ,溶出参数分别为T50 =5 .5 3min ,Td=7.14min ,m =1.4 36 4。结论 本品制备工艺可行 。

Aim To study the method of preparation of dripping pills of Tinidazole.Methods UV-Spectrophotometry was used to determine the content of Tinidazole in dripping pills.Small glass method was used to observe in vitro dissolution of dripping pills.Results The average recovery of Tinidazole was 100.0%,RSD=0.72%(n=5),the dissolution parameters were T 50 =5.53min,T d=7.14min,m=1.436 4.Conclusion The preparation technology was feasible and the method of quality control was reliable.