醒脑静注射液质量分析

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。

Quality Analysis of Xinaojing Injection

Objective: Analyzing the testing result of Xingnaojing injection and comparing and appraising the quality of different products. Method: Technical test and tcorrelation analysis were used to analyze the unqualified cause and calculating mean and relative standard deviation with testing data. Cluster analysis was applied to compare the stability of different products quality and differences. Result: Correlation analysis indicated that camphor was closely positive correlated to isoborneol (P<0.01) and osmetic pressure (P<0.05), and negative correlated to borneol (P<0.01). pH was negative correlated to isoborneol (P<0.05). The cause of pH unqualified is related to technical control. Mean and relative standard deviation indicated that the product of W enterprise is better than the others. Cluster analysis indicated the products can be identified. Conclusion : Each of three enterprises has its individual characteristics in materials and technical control. May choose according to needs.