四川省大黄药材及其饮片评价性抽检结果质量分析  

Quality Analysis of Random Inspection Results of Rhei Radix et Rhizoma and Its Decoction Pieces in Sichuan Province

作　　者：杨莎 袁军 高必兴 杨蕾 李曦 Yang Sha;Yuan Jun;Gao Bixing;Yang Lei;Li Xi(Sichuan Institute for Food and Drug Control,Chengdu 611370,China)

机构地区：[1]四川省食品药品检验检测院

出　　处：《中国药事》2019年第8期904-911,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:开展四川省内大黄药材及其饮片的专项评价性抽检工作,了解四川省内大黄药材及饮片的整体用药情况,保障公众用药安全有效。方法:依据法定标准进行检验,并开展探索性研究,建立不同基原大黄HPLC指纹图谱分析方法,确定3种不同基原大黄的区别特征和大黄共有成分,并对35批大黄样品(包括大黄药材5批次,大黄饮片24批次,酒大黄6批次)进行分析。结果:共抽样105批次大黄药材及其饮片,其中97批次合格,合格率92.4%;8批次不合格,不合格率为7.6%;3种不同基原大黄HPLC指纹图谱区别特征明显,不同基原大黄共有峰10个,35批大黄样品和对照指纹图谱的相似度均大于0.85。结论:通过本次抽检,发现四川省内大黄药材及其饮片总体质量良好,但仍然存在一些质量问题,提示应进一步加强监管。Objective: To carry out a specific random inspection of Rhei Radix et Rhizoma and its decoction pieces in Sichuan Province, to understand the overall application of Rhei Radix et Rhizoma there and ensure the safety and effectiveness of public medication. Methods: An exploratory research was carried out according to mandatory standards to establish the HPLC fingerprint method for Rhei Radix et Rhizoma of different species. The distinguishing characteristics of the three species and the common components of Rhei Radix et Rhizoma were determined. 35 batches of Rhei Radix et Rhizoma samples(including 5 batches of medicinal materials, 24 batches of decoction pieces and 6 batches of samples processed with wine) were analyzed. Results: A total of 105 batches of Rhei Radix et Rhizoma were sampled, of which 97 batches were qualified with a qualified rate of 92.4%, and8 batches were unqualified with an unqualified rate of 7.6%. There were obvious distinguishing characteristics among HPLC fingerprints of the three species of Rhei Radix et Rhizoma. 10 common chromatographic peaks were obtained from different species of Rhei Radix et Rhizoma, and the similarity degree between the fingerprints of 35 batches of Rhei Radix et Rhizoma samples and the reference fingerprint was greater than 0.85. Conclusion:The random inspection has shown that Rhei Radix et Rhizoma is of good quality in general in Sichuan Province,but there are still some quality problems. It is suggested that the supervision should be further strengthened.

关 键 词：大黄 中药材 饮片 质量分析 HPLC指纹图谱 

分 类 号：R95[医药卫生—药学]