外用半固体制剂质量研究与体外评价技术进展_OpenScirbe Publishing

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外用半固体制剂质量研究与体外评价技术进展

Author(s)：
潘磊

Publication Title：

Wen Yuan (Primary School Edition) 2020 No.02

Affiliations：
正大天晴药业集团股份有限公司　江苏　连云港　222000

Abstract：
外用半固体制剂用途广泛，但处方、制剂特性复杂，工艺参数控制难度高，微小的处方工艺变化都可能导致产品质量的显著差异，其与吸入制剂、透皮贴剂等都属于研发难度大，在审评过程中需要根据具体品种个性化考虑的复杂制剂。能区分不同处方和工艺，且具有体内外相关性的体外评价研究，可以更好地满足外用半固体制剂的质量研究和审评技术要求。本文以复杂制剂的研究为重点，着重对如何建立科学的外用半固体制剂的体外评价体系进行了探讨。

Keywords：
复杂制剂;外用半固体制剂;体内外相关性

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[1] 潘磊.外用半固体制剂质量研究与体外评价技术进展[J].Wen Yuan (Primary School Edition),2020(02),.

文渊(小学版)

Wen Yuan (Primary School Edition)

Language: 中文

CN：11-9274/G

ISSN：2096-6261

Publication Frequency: 月刊

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