市售赭石紫石英饮片质量考察及矿物药相关问题探讨.docVIP

市售赭石紫石英饮片质量考察及矿物药相关问题探讨 　　[摘要] 通过市售赭石、紫石英饮片质量考察，探讨临床用矿物药生品饮片存在的主要问题。采用2010年版《中国药典》一部赭石、紫石英项下要求对市售赭石、紫石英饮片进行外观质量和内在质量考察。结果临床用矿物药外观和内在质量差异均较大，12批市售赭石饮片的不合格率达41.67%，13批紫石英饮片的不合格率达53.85%。建议药典明确矿物药粉碎粒度，进一步完善质量标准;药监系统加强检查和监管力度，以确保矿物药临床疗效的稳定性和可靠性。 　　[关键词] 赭石;紫石英;质量考察;矿物药 　　[收稿日期] 2015-02-02 　　[基金项目] 国家中医药行业专项（201007011）;国家中医药管理局全国名老中医药专家传承工作室建设项目;山东省科技发展计划项目（2011-170） 　　[通信作者] *孙立立，研究员，主要从事中药炮制研究，Tel： （0531E-mail：xingerx@163.com 　　[作者简介] 石典花，助理研究员，主要从事中药炮制研究，Tel： （0531E-mail：shidianhua81@163.com 　　Investigation on quality of Haematitum and Fluoritum pieces in venalicium 　　and study on related problems of mineral drugs 　　SHI Dian-hua， ZHANG Jun， SUN Li-li* 　　（Shandong Academy of Chinese Medicine， Ji′nan 250014， China） 　　[Abstract] The main problems and solutions of mineral drugs in clinical use were studied based on the investigation on the quality of Haematitum and Fluoritum pieces in venalicium. The outward appearance and intrinsic quality of Haematitum and Fluoritum pieces in venalicium were studied by the requires which were in the first part of Chinese Pharmacopoeia published in 2010. The outward appearance and intrinsic quality of mineral drugs had large differences， the disqualification rate was 41.67% in 12 batches of Haematitum pieces and the disqualification rate was 53.85% in 13 batches of Fluoritum pieces. The crushing granularity of mineral drugs should be defined， the quality standards should be further improved. The drug adiministration ought to strengthen inspection and supervision in order to ensure the stability and reliability of the clinical efficacy. 　　[Key words] Haematitum; Fluoritum; quality study; mineral drugs 　　doi：10.4268/cjcm 　　矿物药是祖国医学临床用药的三大来源（植物药、动物药和矿物药）之一，在我国已经有3 000多年的应用历史，《本草纲目》中记载的矿物药多达350余种，我国现有矿物药80余种，常用的只有30余种[1]。2010年版《中国药典》一部收载有大青盐、石膏、白矾、玄明粉、芒硝、朱砂、自然铜、红粉、赤石脂、花蕊石、皂矾、青礞石、金礞石、炉甘石、轻粉、钟乳石、禹余粮、硫黄、雄黄、紫石英、滑石、滑石粉、磁石、赭石等23种矿物药[2]，其中15种矿物药有含量测定项。 　　矿物药虽种类相对较少，但其在疾病的防治中具有不可替代的作用。一般含铜、铁、钙、磷、锰等成分的矿物药具