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adike1731

银虫 (小有名气)

[求助] 做一个皂苷胶囊的溶出度试验,溶出度不好,辅料要改配方吗? 已有1人参与

本身原料水溶性差,胶囊用转篮法6个小时原料才溶出完全,(部分崩解的原料水溶性差)辅料 为 糊精60%  硬脂酸镁0.45%,微粉硅胶4%

溶剂采用 PH6.8的磷酸盐缓冲液(因为酸性水溶液根本不溶解原料)
是否应该在辅料中添加表面活性剂,一般常用什么,用量多少,我们有CTMAB,能用吗
还是在溶剂中添加表面活性剂?哪个做出来的溶出效果最好
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wangyc3

至尊木虫 (著名写手)

新药研发

【答案】应助回帖

感谢参与,应助指数 +1
要有完整的溶解度数据,比如四种介质中的,或者加入一定表面活性剂的,介质的选择要有依据,CTAB美国有的产品会用,国内用的少点,这东西比较贵,一般都是用SDS,用量尽量少,最大不超过3%。溶出好坏跟你药物有关,要具体实验比较,另外,这个处方很单一,看着也较老,糊精现在用的比较少,有时会出现一些问题
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2楼2014-03-24 08:56:28
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