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使用商用溶出度模拟器II进行体内-体外相关性研究:罂粟碱、苯妥英和磺胺异恶唑。

In vivo-in vitro correlations with a commercial dissolution simulator II: papaverine, phenytoin, and sulfisoxazole.

作者信息

Yau M K, Meyer M C

出版信息

J Pharm Sci. 1983 Jun;72(6):681-6. doi: 10.1002/jps.2600720621.

Abstract

The dissolution profiles of 11 commercially available papaverine, phenytoin, and sulfisoxazole dosage forms were determined using a dissolution simulator. The products had been the subject of earlier in vivo bioavailability studies with human subjects. The use of an absorption simulator, which is designed to provide an estimate of the optimum sampling scheme for the dissolution simulator, did not provide useful data for this purpose. Good in vivo-in vitro correlations were found for the papaverine dosage forms, which included nine controlled-release products. Less satisfactory correlations were obtained for the phenytoin capsules and the sulfisoxazole tablet products.

摘要

使用溶出度模拟器测定了11种市售罂粟碱、苯妥英和磺胺异恶唑剂型的溶出曲线。这些产品曾是早期针对人类受试者进行的体内生物利用度研究的对象。旨在为溶出度模拟器提供最佳取样方案估计值的吸收模拟器,在此目的上并未提供有用数据。在包括9种控释产品的罂粟碱剂型中发现了良好的体内-体外相关性。对于苯妥英胶囊和磺胺异恶唑片剂产品,相关性不太令人满意。

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