BA Xiao-yu, YAN Zhao-lei, MIAO Qiu-yan, et al. Contrastive Analysis on Quality Standards of Ginkgo Leaves Extract in and (USP36) and (EP8.0)[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(18): 180-185.
DOI:
BA Xiao-yu, YAN Zhao-lei, MIAO Qiu-yan, et al. Contrastive Analysis on Quality Standards of Ginkgo Leaves Extract in and (USP36) and (EP8.0)[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(18): 180-185. DOI: 10.13422/j.cnki.syfjx.2017180180.
Contrastive Analysis on Quality Standards of Ginkgo Leaves Extract in and (USP36) and (EP8.0)
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 (ChP2015) 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 ChP2015 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.