微生物学检定法评价不同复方磺胺甲恶唑片剂

通过体内和体外实验评价了10 批4 种市售480 mg 复方磺胺甲恶唑片剂。在体外溶出实验中除一批外,其余各批均符合英国药典和USP XXII 的溶出要求。微生物学检定法或化学法的溶出度,结果没有显著差异。对十名男性受试者的尿排泄分析表明:片剂在批内和批间均有显著性差异。微生物学测定揭示:药物的溶出百分比比药典的化学分析法低。该法在评价药效,生物利用度乃至联合用药时对药物的测试都有重要意义。尿排泄与溶出度间有一定的相关性。

Evaluation of Compound Sulfamethoxazole Tablets by Means of the Microbiological Assay

Ten batches within 4 commercially available drug products of 480 mg compound sulfamethoxazole tablets were evaluated in vitro and in vivo . With the exception of one batch, all batches tested have met the USP XXII requirements for dissolution test in the case of the dissolution test. No significant difference was observed between the microbiological and the official chemical assays regarding the results of the dissolution test. Urinary excretion studies in 10 male volunteers revealed the significant variations in drug therapeutic efficiency within batch and from batch to batch. Microbiological assay revealed that sulfamethoxazole trimethoprim percentage dissolved was less than that obtained by the chemical assay using the official pharmacoepial method of analysis. Furthermore, the method was found to be of value in evaluating the therapeutic efficiency, and hence the availability of the drug combination in different drug products tested. Correlation was characterized between urinary excretion and dissolution behaviour.