复方妇炎康栓的制备及质量控制

Preparation and Quality Control of Compound Fuyankang Suppository

目的:制备复方妇炎康栓剂并建立其质量标准、方法:以替硝唑、呋喃西林等为主药制备栓剂;以高效液相色谱法控制含量。结果:复方妇炎康栓中替硝唑和呋喃西林分别在192.0 480μg/ml～448.1 120μg/ml(r替=0.9 999)和9.6 672μg/ml～22.5 568μg/ml(r呋=0.9 998)浓度范围内线性关系良好;平均回收率分别为100.37％、101.45％,相对标准差分别为1.171％(n=5)、1.771％(n=5)。结论:复方妇炎康栓性质稳定,质量控制方法简便,含量测定准确、可靠。

OBJECTIVE: To prepare the compound Fuyankang suppository and establish the quality control method. METHODS :Funancillin and Tinidazole were used to prepare compound Fuyankang suppository and HPLC method was established for content determination of funancillin and Tinidazole in the suppository .RESULTS: The standard curves of fu-nancillin and Tinidazole were linear in the ranges of (9.6672-22.5 568)μg/ml(r = 0.9 998, n = 5) and (192.048-448.112) μg/ml(r = 0.9 999,n= 5)and the average recoveries were 101.45% and 100.37% with RSD 1.771%(n= 5) and 1.177%(n = 5) respectively .CONCLUSION: The suppository is stable in quality.The method of determination of the contents is simple, rapid and reliable.