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通过应用过程控制技术前后内控指标波动情况,评价过程质量控制对桂枝茯苓胶囊内在质量的影响。采用统计分析的方法,对应用过程控制技术前(2009—2011年)96批样品及应用过程控制技术后(2012—2014年)96批样品中主要质控指标进行统计分析。依据桂枝茯苓胶囊内控质量标准,对192批药品进行分析,结果显示所有批次内控指标均符合规定,应用过程控制技术后内控指标与应用过程控制技术前质量均一性存在较为显著地差异。应用过程控制技术可提高桂枝茯苓胶囊批间质量的一致性。
Through the application of process control technology before and after the fluctuation of internal control indicators to evaluate the process quality control Guizhi Fuling capsule internal quality. Statistical analysis was used to analyze the main quality control indexes of 96 batches of samples before applying (2009-2011) 96 batch samples and applying process control technology (2012-2014). According to the internal quality control standard of Guizhifuling Capsule, 192 batches of drugs were analyzed. The results showed that all the batches of internal control indicators were in accordance with the regulations. There was a significant difference in the quality of the internal control indicators after application of the process control technology and before application of the process control technology. Application of process control technology can improve the quality of Guizhi Fuling Capsules consistency between batches.