药品抽验结果模糊聚类分析与风险评估专家系统的建立

Fuzzy cluster analysis on the result of drug random inspection and the establishment of professional risk assessment system

目的提高抽验统计分析效率,深化对制剂配方、工艺、质量可控性与临床用药安全性的综合分析,为药品监管提供预警报告。方法用抽验数据建立模糊聚类分析和模式识别的数学模型,结合风险因子数据库对其实施质量分级与风险评定。结果仅用1分钟即可完成139×139模糊相似矩阵5次合成和模式识别分级评定的计算。结论我们开发的专家系统适用于评价化学药品的质量,可为药品监管与标准提高提供依据。

Objective Improve the efficiency of the statistical analysis of inspection,deepen the comprehensive analysis on the formulation of the drug substances and products,process,quality controllability and clinical application safety,to provide early warning report to drug administration.Methods With the sampling investigation and testing drug test data to establish the fuzzy cluster analysis and pattern recognition model,and achieve the quality classification and risk assessment by risk factor database.Results Only 1 minute to complete 5 times synthesis and grades of pattern recognition calculations of the 139×139 fuzzy similar matrix.Conclusion We have developed an expert system for evaluating the quality of pharmaceuticals,which can provide the basis for drug regulatory and improving drug standards.