摘要
目的考察3种市售伊曲康唑胶囊(制剂A、B和C)在4种pH条件下不同时间点的体外溶出度,并比较它们的差异。方法采用桨法测定溶出度,计算3种制剂在不同pH条件下的累积溶出百分率,并绘制累积溶出曲线。对于pH1.0条件下的溶出数据用威布尔(Weibull)方程进行拟合,并对溶出参数t_(50)、t_d、m采用方差分析及t检验进行统计分析。同时用相似因子法考察3种制剂的体外溶出差异。结果在pH 1.0的溶出介质中,制剂A的t_(50)、t_d均小于制剂B;而制剂A在30min之后的累积溶出百分率均大于制剂C,差异均具有统计学意义(P<0.05)。在pH 1.0中制剂A与B、C的相似因子分别为63.58和67.03。结论3种制剂的体外溶出度随pH不同而不同,其中药物在pH 1.0的介质中溶出较快,而在其他3种介质中3种制剂1 h溶出量均不足5%。在pH 1.0条件下,制剂A的体外溶出20 min前均快于制剂B,而其30 min后的溶出量均高于制剂C,可供临床用药参考。
AIM To investigate the dissolution characteristics in vitro under four different pH conditions of three commercial itraeonazole eapsules （formula A,B and C）and to compare their difference.METHODS The dissolution tests were carried out with paddle method.The accumulative dissolution percent under different pH conditions of three formulations was ealeulated,and the accumulative dissolution curves were made.The Weibull＇s equation was used to fit the data which was got under pH 1.0 condition.The dissolution parameters such as t50,td and m were statistically analyzed by variance analysis and t test.Meanwhile the difference of dissolution in vitro among the three formulations was compared by f2 fit factors method.RESULTS Under pH 1.0 eonditions,t50and td of formula A were smaller than those of formula B,and the aeeumulative dissolution percent of formula A were higher than those of formula C.All the differenee had significant meaning（P〈0.05）.The f2 value was 63.58 and 67.03 between formula A and B,formula A and C respectively.CONCLUSION The dissolution characteristics of the three formulas in vitro vary with different pH values. All the formulas have higher dissolution rates under pH 1.0 condition,but their dissolution quantity after 1 h are less than 5%under the other three conditions.Under pH 1.0 condition,the dissolution rate of formula A are more rapid than those of formula B before 20 min,and the dissolution quantity of formula A are higher than those of formula C,which eould be the basis for the clinical use.
出处
《中国临床药学杂志》
CAS
2007年第6期376-379,共4页
Chinese Journal of Clinical Pharmacy
