微生物学检定法评价不同复方磺胺甲恶唑片剂
Evaluation of Compound Sulfamethoxazole Tablets by Means of the Microbiological Assay
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摘要: 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。Abstract: 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
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