《中国药典》银杏叶提取物质量标准与《美国药典》,《欧洲药典》的对比分析

Contrastive Analysis on Quality Standards of Ginkgo Leaves Extract in Chinese Pharmacopoeia and United States Pharmacopeia(USP36) and European Pharmacopoeia(EP8.0)

文章主要对比分析了《中国药典》,《美国药典》和《欧洲药典》中银杏叶提取物质量标准的异同,包括检查、含量测定和其他项几个主要指标的色谱条件、定量方法、前处理方法和限度等的分析比较,同时还对比分析了2015版《中国药典》修订内容和银杏叶提取物制剂的限度两方面内容。结果发现USP36执行的标准限度最为严格:总银杏酸≤5μg·g-1,总黄酮醇苷22.0%~27.0%,萜类内酯必须满足3个条件,且对银杏内酯J成分进行了检测;异鼠李素与槲皮素的峰面积比值≥0.1;USP36和Ch P2015检验指标较全:规定了农药残留和微生物限度等指标;2015版《中国药典》使用一测多评(QAMS)和指纹图谱等新技术手段:全面评估药品质量;银杏叶提取物不同剂型制剂间限度差异较大:注射剂限度要求更严格。掌握各药典间异同点,为制定一套可靠的质量评价标准提供依据,同时为规范和提高银杏叶提取物质量标准提供参考,以便更充分理解质量标准提高的必要性和在质量标准制定中需要考虑的问题,防止"银杏叶事件"的再次发生,同时保证临床用药安全,向国际化标准靠拢。

In this paper,the quality standards of ginkgo leaves extract in Chinese Pharmacopoeia were compared with those in the United States Pharmacopeia（ USP36） and European Pharmacopoeia（ EP8. 0）,and their similarities and differences were analyzed,including inspection,assay and the analysis and comparison of other main indicators of the chromatographic conditions,quantitative methods,pre-treatment methods and limits.At the same time,2015 revised version of Chinese Pharmacopoeia（ Ch P2015） and the limits of ginkgo leaves extract were compared and analyzed. The results showed that USP36 execution standard limitswere most stringent：total ginkgolic acid ≤ 5μg·g-1; total flavonol glycosides 22. 0%-27. 0%; terpene lactones must meet three conditions,and the ginkgolide J content was detected; isorhamnetinand quercetin peak area ratio was ≥0. 1. The USP36 and Ch P2015 test indicator were comprehensive： including the pesticide residue and microbial limit and so on. The 2015 version Chinese Pharmacopoeia used QAMS and fingerprint new technical means： comprehensive evaluation of drug quality; the difference of ginkgo leaves extract was largein limits between different dosage forms：the limit was more stringent in injection preparations. Understand the similarities and differences of each Pharmacopoeia,provide basis for developing a set of reliable quality evaluation criteria,and prevent the occurrence of ‘Ginkgo leaves incident＇. At the same time,we shall ensure the safety of its clinical medication and make it close to international standards.