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目的:分析醒脑静注射液检验结果,比较各厂产品质量。方法:根据检验数据,进行相关分析、工艺试验,分析不合格原因;计算均值及RSD,进行聚类分析,比较各厂产品生产质量的稳定性及差异。结果:相关分析表明樟脑含量与异龙脑含量(P<0.01)、渗透压值(P<0.05)成正相关,与龙脑含量(P<0.01)成负相关,pH与异龙脑含量(P<0.05)成负相关;pH不合格与工艺控制有关;均值、RSD表明W厂产品质量控制稳定;各厂产品可通过聚类分析进行区分。结论:3家醒脑静注射液的物料、工艺控制各有特点,可根据需要选用。
OBJECTIVE: To analyze the results of Xingnaojing Injection and compare the quality of each plant. Methods: According to the test data, the correlation analysis and the technology test were conducted to analyze the causes of the unqualified ones. The average value and the RSD were calculated and the cluster analysis was conducted to compare the stability and difference of the product quality of each plant. Results: Correlation analysis showed that camphor content was positively correlated with isoborneol content (P <0.01) and osmotic pressure (P <0.05), and negatively correlated with content of borneol (P <0.01) <0.05). The unqualified pH was related to the process control. The average value and RSD showed that the quality control of W factory was stable. The products of each factory could be distinguished by cluster analysis. Conclusion: Three Xingnaojing injection of materials, process control has its own characteristics, according to need to choose.