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一种崩解加溶出考察固体制剂质量的序贯检测方法

     

摘要

Objective:To establish a sequential analysis method for quality investigation of solid preparation .Methods:9 representative solid preparations were selected , according to the sequential analysis method: firstly, disintegration times were respectively tested in 3 disintegration liquids of different acidity , and successively , dissolution of the durgs were monitored in pH 7.6 phosphate buffer , with an optical fiber in site dissolution testing instrument at a fixed speed .Simultaneously,the drug dissolution results of new method were com-pared with that of ChP demanded media .Drug dissolution curves were fitted by model weibull , the differences of the preparations were e-valuated by the variation of the fitting parameters .Results:Some preparations had good consistency and some had significant difference by comparing the disintegration time of the preparations in 3 disintegration liquids .And compared with the reference preparation , the difference of drug disintegration time was obviously great , the difference of the dissolution was also great by new method .Conclusion:The sequential analysis method of drug disintegration and dissolution test can promote efficacy of quality test of solid preparation .%目的:建立固体制剂的崩解和药物溶出度质量考察的序贯试验方法。方法:选取9种具有代表性的固体制剂,按照序贯试验方法,分别在三种不同酸度的崩解液中测定药品的崩解时限。统一在pH 7.6的磷酸盐缓冲液中,固定实验装置和转速,采用光纤实时药物溶出度仪监测药物溶出度,并用《中国药典》各品种项下溶出度检查规定的溶出介质作对照;药物溶出曲线采用weibull模型拟合,通过其拟合参数的变异度,评估制剂间药物溶出行为的差异程度。结果:比较各制剂在三种崩解液中的崩解时限,有的一致性好,有的差异较大;与参比制剂比较,药品崩解时限差异明显的受试制剂,其用新方法监测的药物溶出度差异也较大。结论:药品崩解加药物溶出的序贯检测方法,可以提高固体制剂质量的检验效能。

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