ROC曲线方法确定恒山仿野生黄芪毛蕊异黄酮葡萄糖苷的含量限度

Determination of Content Limit of Isoflavone Glucoside of Hengshan Wild-simulated Astragali Radix by ROC Curve Method

目的:探索确立黄芪药材中毛蕊异黄酮葡萄糖苷含量限度的受试者工作特征(ROC)曲线数理统计方法,以区分山西恒山仿野生芪与甘肃移栽芪毛蕊异黄酮葡萄糖苷含量差异。方法:选取45批共225个山西恒山仿野生芪样本与42批共210个甘肃移栽芪样本为研究对象,采用2015年版《中国药典》黄芪项下毛蕊异黄酮葡萄糖苷含量测定方法测定黄芪样本毛蕊异黄酮葡萄糖苷含量。统计分析数据并采用ROC曲线判定山西恒山仿野生芪与甘肃移栽芪毛蕊异黄酮葡萄糖苷临界值。结果:恒山仿野生芪和甘肃移栽芪毛蕊异黄酮葡萄糖苷平均质量分数分别为0. 107%和0. 039%,两者差异有统计学意义(P <0. 01)。ROC曲线判定恒山仿野生芪与甘肃移栽芪毛蕊异黄酮葡萄糖苷质量分数差异的临界值为0. 069%。该曲线的灵敏度为100%,特异度为93. 33%,模型诊断准确率为0. 978,说明预测结果准确。结论:ROC曲线法可确定山西恒山仿野生芪与甘肃移栽芪毛蕊异黄酮葡萄糖苷临界值,提高恒山仿野生芪毛蕊异黄酮葡萄糖苷含量限度,体现市场"优质优价"规律,为建立优质黄芪中药材标准提供理论基础。

Objective: To explore the receiuer operating characteristic( ROC) curve mathematical statistics method to establish the content limit of isoflavones glucoside contents in Astragali Radix,in order to distinguish the difference in isoflavones glucoside content between Hengshan wild-simulated Astragali Radix in Shanxi and cultivated Astragali Radix in Gansu. Method: A total of 225 samples of 45 batches of wild-simulated Astragali Radix in Hengshan and 210 samples of 42 batches of cultivated Astragali Radix in Gansu were selected as research objects,and isoflavones glucoside contents of these samples were determined by using the method in the edition 2015 Chinese Pharmacopoeia. Data was statistically analyzed,and the ROC curve was used to determine the critical value of wild-simulated Astragali Radix in Hengshan and transplanted Astragali Radix in Gansu. Result:The average contents of isoflavones glucoside in imitative wild Astragali Radix in Henshan and cultivated Astragali Radix in Gansu were 0. 107% and 0. 039% respectively,with statistically significant differences( P < 0. 01). The ROC curve had a critical value of 0. 069%,and its sensitivity and specificity was 100% and 93. 33%,and its model diagnostic accuracy was 0. 978,which indicated accurate prediction results. Conclusion: ROC curve can be used to distinguish the critical value of the wild-simulated Astragali Radix in Hengshan and cultivated Astragali Radix in Gansu. The results reflected the regularity of " high quality and good price" in the market. The research provided a theoretical basis for the establishment of standard of high-quality Chinese herbal medicines.