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1、滋肾通关胶囊质量标准研究摘要:目的建立滋肾通关胶囊的质量标准。方法采用薄层色谱法对制剂中知母、黄柏进行定性鉴别。采用高效液相色谱法同时对制剂中新芒果昔、盐酸黄柏碱、芒果昔、盐酸小槃碱进行定量检测。结果通过薄层鉴别分别检出知母中的芒果昔、黄柏中的盐酸黄柏碱。新芒果昔、盐酸黄柏碱、芒果昔、盐酸小漿碱分别在0.02525〜2.02?g(r=0.9997).0.0255〜2.04?g(r=0.9997).0.026〜2.08?g(r=0.9997)、0.0255〜2.04?g(r=0.9996)范围内有良好的线性关系,平均加样回收率分别为99.99%、101.06%、
2、103.05%、100.55%,RSD分别为2.69%、5.62%、2.49%、2.06%。结论本方法准确、快速、稳定、可靠,重复性好,可用于该制剂的质量控制及评价关键词:滋肾通关胶囊;质量标准;薄层色谱法;高效液相色谱法;新芒果昔;盐酸黄柏碱;芒果昔;盐酸小樂碱D0I:10.3969/j.issn.1005-5304.2016.07.027中图分类号:R284.1文献标识码:A文章编号:1005-5304(2016)07-0104-04StudyonQualityStandardforZishenTongguanCapsulesLIUDong-shunl,2
3、,XIONGXiao-juan2,WUZhi-junl,PIAOShu-juanl,LUWen-quanl(1.ChangzhengHospital,SecondMilitaryMedicalUniversity,Shanghai200003,China;2.CollegeofChemicalandBiologicalEngineering,YichunUniversity,Yichun336000,China)Abstract:ObjectiveToestablishaqualitystandardforZishenTongguanCapsules・Meth
4、odsAnemarrhneaeRhizomaandPhellodendriChinensisCortexwerequalitativelyidentifiedbyTLCmethod.Thecontentsofneomangferin,phellodendrinehydrochloride,mangiferinandberberinehydrochlorideinZishenTongguanCapsuleswerequantitativelydeterminedbyHPLCmethod.ResuItsThespotsofqualitativeidentifica
5、tionmethodwereclearwithoutinterference・NeomangferininAnemarrhneaeRhizomaandphellodendrinehydrochlorideinPhellodendriChinensisCortexwereidentified・Neomangferin,phellodendrinehydrochloride,mangiferinandberberinehydrochlorideshowedgoodlinearityintherangeof0.02525❷C2・02?g(r=0.9997),0.02
6、55❷C2・04?g(r=0.9997),0・026❷C2・08?g(r=0.9997),and0.0255❷C2・04?g(r=0.9996)respectively.Theaveragerecoveriesofneomangferin,phellodendrinehydrochloride,mangiferinandberberinehydrochloridewere99.99%,101.06%,103.05%,and100.55%,respectively.TheRSDwere2.69%,5.62%,2.49%,and2.06%,respectively
7、.ConclusionThemethodisaccurateandrapid,withgoodstability,reliabilityandreproducibility,whichcanbeusedforthequalitycontrolandevaluationofthepreparationofZishenTongguanCapsules・Keywords:ZishenTongguanCapsules;qualitystandard;TLC;HPLC;neomangferin;phellodendrinehydrochloride;mangiferin
8、;berberinehydrochlo