CAJ | 학술논문

目的：考察国内不同药品生产企业盐酸贝那普利片的溶出度情况。方法：采用浆法，以水500 mL为溶出介质，转速50 r·min-1。用?2因子法，考察国内3家生产企业的盐酸贝那普利片与参比制剂的溶出度差异。结果与结论：3家企业的盐酸贝那普利片溶出曲线与参比制剂均不相似，2家企业样品的批间重复性良好，部分样品的批内均一性较差，1家企业样品的批内均一性和批间重复性均较差。
목적：고찰국내불동약품생산기업염산패나보리편적용출도정황。방법：채용장법，이수500 mL위용출개질，전속50 r·min-1。용?2인자법，고찰국내3가생산기업적염산패나보리편여삼비제제적용출도차이。결과여결론：3가기업적염산패나보리편용출곡선여삼비제제균불상사，2가기업양품적비간중복성량호，부분양품적비내균일성교차，1가기업양품적비내균일성화비간중복성균교차。
Objective:To compare the dissolution of benazepril hydrochloride tablets from different manufacturers.Methods: The dissolution tests were proceeded by using the paddle method at 50 r·min-1, and 500 mL water was used as the medium. The difference in dissolution rate of the three domestic benazepril hydrochloride tablets and the reference preparation was evaluated by ?2 factor method.Results and Conclusion:Solution curves of benazepril hydrochloride tablets from three manufacturers were not similar with those of the reference preparation. Samples from two manufacturers had good inter-batch reproducibility. Part of samples had poor intra-batch homogeneity and samples from one manufacturer had both poor intra-batch homogeneity and poor inter-batch reproducibility.