新诺明片生物利用度的研究——2.新诺明片释放度质量标准

<正> 由于新诺明(磺胺甲基异(口恶)唑)溶解度低,多晶现象,产品质量波动等原因,新诺明片及其制剂的生物利用度研究已引起人们的注意。某些国家的药典对其片剂已有溶出速度方面的规定。鉴于以上情况,有必要对国产新诺明片生物利用度进行考查。以供药典制订标准作为依据。作者在第一报新诺明片体外释放兔体和人体生物利用度的研究一文所建立的体内外参数间定量关系的基础之上,收集全国十个生产厂十七个批号的产品,进行体外释放度试验(溶出试验),摸索其规律,并根据实验结果,提出了质量标准。

STUDIES ON THE BIOAVAILABILITY OF SULFAMETHOXAZOLE TABLETS 2.Investigation of Sulfamethoxazole Tablets Release Standands

Seventeen sulfamethoxazole tablet samples from different fac- tories of the country were used in this study.Their release in vivo(dissolution test)using the rotating basket method(37 0.5,rpm= 100),dilute hydrochloric acid(7 in 100)as the dissolotion medium) was investigated.Parameters plots of T_(50)-T_d and m-T_(50)indicated that for most samples(70.59%)m=1.05,T_(50)=20 and T_d=35.The auth- ors suggest that release not less than 50% of the labelled amount in 20 min.be adopted as criterion in the standardization of qua- lity control of sulfamethoxazole tablets in the pharmacopoeia.