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药物体外溶出行为的测定与解释。2. 溶出介质表面张力对市售制剂(片剂、糖衣丸)中药物释放的影响

[Determination and interpretation of in vitro solubility behavior of pharmaceutical agents. 2. The effect of surface tension of the dissolution medium on the liberation of drugs in commercial preparations (tablets, dragees)].

作者信息

Bornschein M, Eitz K, Voigt R

出版信息

Pharmazie. 1987 Feb;42(2):83-6.

PMID:3602064
Abstract

The influence of submicellar surfactants in the dissolution media on drug liberation from commercial products was investigated (paddle-method, flow through-method). The results depend on the product tested and the tester used. Addition of surfactants accelerates, retards or doesn't alter in vitro liberation with the paddle-method, accelerates or doesn't influence flow through-liberation. Equivalence of the release profiles of the individual products with both testers was proved. Addition of surfactants may alter in vitro drug release from commercial products but should be compulsory only when (improved) in vivo-in vitro correlation was demonstrated.

摘要

研究了溶解介质中的亚胶束表面活性剂对市售产品药物释放的影响(桨法、流通法)。结果取决于所测试的产品和所使用的测试方法。表面活性剂的添加在桨法中会加速、延缓或不改变体外释放,在流通法中会加速或不影响释放。证明了两种测试方法下各产品释放曲线的等效性。表面活性剂的添加可能会改变市售产品的体外药物释放,但只有在证明(改善)体内-体外相关性时才应强制添加。

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