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使用转篮法、桨法和流通池法对直肠制剂进行的比较溶出度研究。I. 对乙酰氨基酚在亲水性和疏水性类型的栓剂和软胶囊中的研究。

Comparative dissolution studies of rectal formulations using the Basket, the Paddle and the Flow-Through methods. I. Paracetamol in suppositories and soft gelatin capsules of both hydrophilic and lipophilic types.

作者信息

Gjellan K, Graffner C

出版信息

Acta Pharm Nord. 1989;1(6):343-54.

PMID:2624705
Abstract

The applicabilities of the Paddle, the Basket and the Flow-Through methods have been investigated for seven different rectal compositions of hydrophilic and lipophilic type. The formulations were studied with respect to in vitro dissolution rate and behaviour in the different techniques. It was found that the composition has a considerable influence on the behaviour of the dosage form and this must be taken into account when judging the applicabilities of the three dissolution tests. The Paddle, the Basket and the Flow-Through methods are considered to be equivalent methods for the dissolving suppositories tested. The Flow-Through method is applicable for all the seven compositions tested; however, a low flow rate (8 ml/min) is necessary to use for soft gelatin capsules when both the coefficient of variation and the behaviour of the dosages within the techniques is taken into consideration.

摘要

针对七种不同亲水性和疏水性类型的直肠组合物,研究了桨法、篮法和流通池法的适用性。对这些制剂在不同技术下的体外溶出速率和行为进行了研究。发现组合物对剂型行为有相当大的影响,在判断这三种溶出试验的适用性时必须考虑到这一点。对于所测试的溶解栓剂,桨法、篮法和流通池法被认为是等效方法。流通池法适用于所有测试的七种组合物;然而,当考虑到技术内的变异系数和剂型行为时,软明胶胶囊需要使用低流速(8毫升/分钟)。

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