CAJ | 학술논문

建立差示扫描量热法测定比沙可啶原料药样品纯度的方法。考察了炉体气氛、升温速率、称样量3个因素对差示扫描量热法测定结果的影响，确定差示扫描量热法最佳实验条件：升温速率为2.0 K／min，称样量为2.0～4.0 mg，炉内气体为静态空气。差示扫描量热法测定比沙可啶样品纯度为99.86%，测定结果的相对标准偏差为0.02%(n=6)，差示扫描量热法测定比沙可啶样品纯度值与 HPLC 测定结果具有良好的一致性。该方法可以快速、准确地测定比沙可啶化学纯度，为比沙可啶纯度测定提供了一种新的分析方法。
건립차시소묘량열법측정비사가정원료약양품순도적방법。고찰료로체기분、승온속솔、칭양량3개인소대차시소묘량열법측정결과적영향，학정차시소묘량열법최가실험조건：승온속솔위2.0 K／min，칭양량위2.0～4.0 mg，로내기체위정태공기。차시소묘량열법측정비사가정양품순도위99.86%，측정결과적상대표준편차위0.02%(n=6)，차시소묘량열법측정비사가정양품순도치여 HPLC 측정결과구유량호적일치성。해방법가이쾌속、준학지측정비사가정화학순도，위비사가정순도측정제공료일충신적분석방법。
A method for determination of the purity of bisacodyl by differential scanning calorimetry(DSC) was established. Considering of three factors in experiment of Bisacodyl’s purity by using the DSC method, an optimization experiment conditions was obtained as the following: the heating rate was at 2.0 K/min,the sample mass was 2.0~4.0 mg, furnace gas was static air. The purity of bisacodyl determined by DSC was 99.86%,and the relative standard deviation of determination results was 0.02%(n=6). The measurement result by differential scanning calorimetry was shown good consistency with HPLC. This method can quickly and accurately determine the chemical purity of bisacodyl,which provides a new analysis method for the determination of purity of bisacodyl.