止血镇痛散的制备及质量标准研究

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1、止血镇痛散的制备及质量标准研究邱建国，张泉龙，尉丽力，李茂星，贾正平★，张汝学，周珺，邱宜农（兰州军区兰州总医院药材科，全军高原环境损伤防治重点实验室，甘肃，兰州，730050）摘要：目的：制备止血镇痛散并建立其质量控制方法。方法：独一味水提物经聚酰胺去除总黄酮，大孔树脂富集得到总环烯醚萜苷，并以环烯醚萜苷为原料制备独一味止血镇痛散。以8-O-乙酰山栀子苷甲酯为对照品进行薄层色谱定性鉴别；含量测定采用一阶导数紫外分光光度法测定总环烯醚萜苷；HPLC法测定山栀子苷甲酯和8-O-乙酰山栀子苷甲酯。结果：TLC法可以较好地鉴别8-O-乙酰山栀子苷甲酯，阴性对照显示无干

2、扰；建立的一阶导数紫外分光光度法测定总环烯醚萜苷的含量，总环烯醚萜苷平均加样回收率为104.40%，RSD%=0.64%；建立的HPLC法测定山栀子苷甲酯和8-O-乙酰山栀子苷甲酯的含量，平均加样回收率分别为94.74%和100.59%，RSD分别为2.27%和1.61%。结论：提取工艺可行，可进行工业化生产制备；质控方法准确、可靠，可有效评价止血镇痛散的质量。关键词：独一味环烯醚萜苷；止血镇痛散；制备；质量标准中图分类号：R283161;R92711文献标识码A[收稿日期][基金项目]甘肃省科技重大专项（1102FKDA012）；全军中医药研发推广项目（200

3、6032001）[第一作者]邱建国，副主任药师，主要从事高原植物药和新药的研究。Tel：0931－8994676，13609354193；E-mail：qjianguo@163.com[通讯作者]★贾正平，主任药师，教授，博士生导师，主要从事医院药学专业的研究。Tel：0931－8994652；E-mail：jiazp166@sina.comPreparationandQualityCriteriaofZhiXueZhenTongPowderQiuJian-guo,ZhangQuan-long,WeiLi-li,LiMao-xing,JiaZheng-ping★

4、,ZhangRu-xue,ZhouJun,QiuYi-nong（DepartmentofPharmacy，LanzhouGeneralHospitalofPLA;Keylaboratoryofthepreventionandcurefortheplateauenvironmentdamage,PLA,Lanzhou,Gansu,730050）OBJECTIVE:TopreparationZhiXueZhenTongPowder,andestablishitsqualitystandardtocontrolitstherapeuticefficacy.METHOD

5、S:ZhiXueZhenTongPowderwascomposedwiththeiridoidglycosidesingredients,whichwasenrichedbythemacroporousadsorptiveresinschromatographiccolumncombiningwithpolyamidechromatographiccolumnandpre-columntoeliminateflavonoidsfromtheaqueousextractofLamiophlomisrotata(Benth.)Kudo(LRAE).Lamiophlo

6、misrotatawasidentifiedbyTLCandthecontentoftotaliridoidglycosideswasdeterminedbythefirstderivativespectrophotometry,thecontentofshanzhisidemethylesterand8-O-acetylshanzhisidemethylesterwasdeterminedbyHPLC.RESULTS:theTLCspotsofshanzhisidemethylesterand8-O-acetylshanzhisidemethylesterwe

7、reallclear.Thetotaliridoidglycosidesdeterminationforthepreparationwasestablished,andtheaveragerecoveryofthemethodswas104.40%,RSDwas0.64%.AHPLCmethodforthedeterminationofshanzhisidemethylesterand8-O-acetylshanzhisidemethylesterinthepreparationwasestablished.Theaveragerecoverieswere94.

8、74%and100.59