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The development of an herbal material quality control strategy considering the effects of manufacturing processes

机译:考虑生产过程影响的草药材料质量控制策略的开发

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摘要

BackgroundQuality by design (QbD) is an advanced drug quality control concept that has been gradually implemented in the optimization of manufacturing processes of Chinese medicines. However, the variation of Chinese medicinal material quality has rarely been considered in published works. Because manufacturing processes may lower the variation introduced through different batches of materials, a material quality control strategy should be developed considering the influences of manufacturing processes.
机译:背景设计质量(QbD)是一种先进的药物质量控制概念,已在优化中药制造工艺中逐步实施。但是,在出版的著作中很少考虑中药材质的变化。由于制造工艺可以降低通过不同批次的材料引入的变化,因此应考虑制造工艺的影响来制定材料质量控制策略。

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