摘 要 目的：分析茵栀黄注射液的评价性抽验结果，对该品种进行总体质量评价。方法：采用因子分析方法对110批茵栀黄注射液的评价性抽验定量检测结果进行统计分析，并将公共因子得分做聚类分析。结果：12个原始变量通过因子分析提取出4个公共因子，分别解释为主药成分因子、杂质和残留物因子以及辅料因子。4个公共因子的得分大小反映各批号产品的主药成分、杂质残留和辅料等方面的质量情况。因子得分的聚类结果表明，茵栀黄注射液的质量与原材料来源和工艺相关。结论：因子分析作为一种降维统计方法，适用于以大量定量数据为基础的药品质量综合评价分析。

　　关键词因子分析 茵栀黄注射液 质量评价

　　中图分类号：R927.11 文献标识码：A 文章编号：1006-1533(2011)09-0449-05

　　Evaluation on the quality of Yinzhihuang injection based on Factor Analysis

　　LI Rui1,2，CAO Lin2，WANG Yu2，XIANG Bing-ren1*

　　（1. China Pharmaceutical University，Nanjing，210009；

　　2. Jiangsu Institute for Food and Drug Control，Nanjing， 210008）

　　ABSTRACTObjective: To make the general evaluation on the quality of Yinzhihuang injection by analyzing their test results statistically. Methods: The sampling inspection results of 110 batches of Yinzhihuang injection were analyzed on the basis of Factor Analysis，and then the 110 batches were classified by Hierarchical Cluster Analysis based on their factor scores. Results: Four common factors were extracted from twelve original variables，which were explained as main component factor，impurity & residue factor and excipient factor. The classification result of factor scores showed that the quality of this medicine was mainly related to the sources of raw materials and the production process. Conclusion: As a kind of descending dimension algorithm，Factor Analysis could be successfully applied in overall evaluation of pharmaceutical quality with abundant quantitative data.

　　KEY WORDSFactor Analysis；Yinzhihuang injection；quality evaluation

　　近年来，药品不良反应事件和药害事件的频频发生对药品监管工作提出了新的要求。（剩余1469字）

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