枳实终端市场的质量现状调查及现行标准适用性的探讨

Investigation on the Current Status of Aurantii Fructus Immaturus Quality in Terminal Market and Discussion on the Applicability of the Current Standard

目的掌握市场上枳实的质量情况,探讨现行质量标准的适用性,为规范枳实市场秩序、提升枳实质量标准提供参考。方法按照《中国药典》(2015年版)和《浙江省中药炮制规范》(2015年版)标准,对浙江省11个地市的药品批发零售企业及医疗机构的枳实饮片进行专项检查,从性状、鉴别、检查、含量测定角度进行分析,对各批次样品数据间相关性、标准的适用性进行了分析。结果在抽查的84批次样品中,检验总合格率为48%,其中麸炒枳实、枳实片按《中国药典》(2015年版)检验合格率为41%,麸枳实按《浙江省中药炮制规范》(2015年版)检验合格率为49%。并发现药典标准中[鉴别]项专属性不强[含量测定],项无法全面反映枳实的内在质量。结论目前市场上枳实质量状况令人堪忧,监管力度有待加强;现行标准不能有效控制枳实的质量,存在较多漏洞,亟需改进和提升。

OBJECTIVE To know the quality of Aurantii fructus immaturus in the market and discuss the applicability of the eurrent quality standard, in order to regulate the market order and provide reference to enhance the quality standard of Aurantii fructus immaturus. METHODS According to Chinese Pharmacopoeia （2015 Edition） and Zhejiang province Concoct Standard （2015 Edition） , the special inspection on the 11 cities in Zhejiang Province pharmaceutical wholesale and retail enterprises and medical institutions were carried out, analysis was made on the basis of properties, identification, examination and content determination. The applicability of standard, data correla- tion of each batch of samples was analyzed. RESULTS In the sampling of 84 batches of samples, the total qualified rate was 48%, of those, according to Chinese Pharmacopoeia （2015 Edition） test of the qualified rate as high as 41% ,according to Zhejiang province Concoct Standard （2015 standards [ identification] special attribute is not strong, and quality of Aurantii fructus immaturus. CONCLUSION rantii fructus immaturus, thus it is necessary to tighten Edition） test of the qualified rate of 49%. Quality [ determination ] unable to fully control the intrinsic The current market situation is worrying the quality of Au- supervision;the quality of the current standard can not effec- tively control Aurantii fructus immaturus, there are many loopholes, needing to improve and upgrade.