SYSTEM 

  ADR III-7

  自動(dòng)釋放率取樣系統(tǒng)

Part.01

目的：

 Objective:  

             建立雷貝拉唑鈉腸溶

             片往復(fù)筒溶出試驗(yàn)方

             法，并考察不同廠家

             產(chǎn)品的溶出行為。

通過對(duì)往復(fù)頻率、篩網(wǎng)孔徑等關(guān)鍵試驗(yàn)條件的篩選考察，建立往復(fù)筒試驗(yàn)。溫度 37 ℃，往復(fù)頻率 10 dip · min-1，浸入時(shí)間 10 s，滴水時(shí)間 20 s，上篩網(wǎng) 20 目，下篩網(wǎng) 40 目，介質(zhì)分別為 pH 8.0 三羥基甲基氨基甲烷緩沖液、pH 7.4 磷酸鹽緩沖液和 pH 6.8 磷酸鹽緩沖液，介質(zhì)體積 250 mL。采用新建立的往復(fù)筒溶出條件和《中華人民共和國藥典》中規(guī)定的槳法溶出條件考察了原研制劑和 4 個(gè)仿制制劑的溶出行為，并以相似因子比較溶出行為的相似性。結(jié)果：采用槳法條件進(jìn)行溶出行為評(píng)價(jià)時(shí)，有 2 個(gè)仿制制劑與原研制劑的溶出行為相似（f2 ＞ 50），采用往復(fù)筒法溶出條件，這 2 個(gè)仿制制劑僅 1 個(gè)在 pH 8.0 和 pH 7.4 介質(zhì)條件下的溶出行為相似，其余條件均不相似。

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. 

新建立的往復(fù)筒法溶出試驗(yàn)方法具有一定的區(qū)分力，可為雷貝拉唑鈉腸溶片處方工藝優(yōu)化和仿制藥一致性評(píng)價(jià)提供支持。本研究亦為其他主藥易降解制劑體外溶出度研究提供了思路。

Part.04

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