文献分享 I 采用往复筒法研究雷贝拉唑钠肠溶片体外溶出行为

  SYSTEM 

  ADR III-7

  自动释放率取样系统

Part.01

目的：

 Objective:  

             建立雷贝拉唑钠肠溶

             片往复筒溶出试验方

             法，并考察不同厂家

             产品的溶出行为。

通过对往复频率、筛网孔径等关键试验条件的筛选考察，建立往复筒试验。温度 37 ℃，往复频率 10 dip · min-1，浸入时间 10 s，滴水时间 20 s，上筛网 20 目，下筛网 40 目，介质分别为 pH 8.0 三羟基甲基氨基甲烷缓冲液、pH 7.4 磷酸盐缓冲液和 pH 6.8 磷酸盐缓冲液，介质体积 250 mL。采用新建立的往复筒溶出条件和《中华人民共和国药典》中规定的桨法溶出条件考察了原研制剂和 4 个仿制制剂的溶出行为，并以相似因子比较溶出行为的相似性。结果：采用桨法条件进行溶出行为评价时，有 2 个仿制制剂与原研制剂的溶出行为相似（f2 ＞ 50），采用往复筒法溶出条件，这 2 个仿制制剂仅 1 个在 pH 8.0 和 pH 7.4 介质条件下的溶出行为相似，其余条件均不相似。

Through the screening and investigation of the key test conditions such as reciprocating frequency and screen aperture, the reciprocating cylinder apparatus test method was established. The temperature was 37 ℃ , the frequency of repetition was 10 dip· min-1 , the immersion time was 10 s, the drip time was 20 s, the upper screen was 20 mesh, the lower screen was 40 mesh, and with 250 mL pH 8.0 tris hydrochloride buffer, pH 7.4 phosphate buffer and pH 6.8 phosphate buffer as the dissolution medium. The dissolution profiles of rabeprazole sodium enteric-coated tables from different pharmaceutical manufacturers were determined by using the newly established reciprocating cylinder method and the dissolution conditions of paddle method specified in Chinese Pharmacopoeia and the dissolution curves of consistency were evaluated by calculating the similarity factor. Results: While using paddle method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar to those of the reference listed drug (f2 ＞ 50). While using reciprocating cylinder method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar only under the conditions of pH 8.0 and pH 7.4, and the other conditions were not similar. 

新建立的往复筒法溶出试验方法具有一定的区分力，可为雷贝拉唑钠肠溶片处方工艺优化和仿制药一致性评价提供支持。本研究亦为其他主药易降解制剂体外溶出度研究提供了思路。

Part.04

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