罗红霉素胶囊及片剂的溶出度考察

Study on the dissolubility of roxithromycin capsules and tablets from different manufactures

目的考察不同厂家及同一厂家不同批号罗红霉素胶囊或片剂的溶出度。方法采用转篮法和分光光度法测定模拟胃液中罗红霉素体外溶出度,绘制累积溶出曲线图,以溶出百分率的对数对时间进行线性直线拟合,求得溶出参数T50、T75。并进行统计学分析。结果经t检验,不同厂家中除了B与D、E与F、E与G的T50与T75平均值差异不显著(P>0.05),其他都有显著差异(P<0.01);而同一厂家不同批号的均值差异不显著(P>0.05)。结论不同厂家罗红霉素制剂体外溶出度存在显著差异。

Objective To investigate the dissolubility of roxithromycin capsules and tablets from different factories and from the same factory but different batches.Methods The spectrophotometry was used to determine the dissolubility in virto in the simulated gastric juice,accmulative dissolution curves were obtained.Fit the curves by means of the logest model.The results“Parameters T_ 50 and T_ 75 ”were compared with each other.Results The T_ 50 and T_ 75 between any two of the different manufactures have significant differences except for B and D,E and F,E and G(P<0.05)but no differences among the four different batches of the same manufactures(P>0.05)via t-test.Conclusion Significant differences were found in the comparence of roxithromycin dissolution of different manufactures in vitro.