显微技术在牛黄清心丸(局方)质量控制中应用.docVIP

显微技术在牛黄清心丸(局方)质量控制中的应用 　　[摘要]探讨显微技术在牛黄清心丸（局方）质量控制中的应用。对执行标准规定的显微特征进行了总结，并新建了未规定检验项目的山药、羚羊角、肉桂、防风4味药材的显微鉴别方法。首次采用显微技术检查中成药掺伪，建立了牛黄清心丸（局方）中山药混伪品山薯的检查方法。1个厂家的2批次样品未检出羚羊角，2个厂家的3批次抽样检出山薯。所建方法准确、简便、快速、直观、经济，可更加全面地控制牛黄清心丸（局方）的质量。传统的显微技术能够在指标成分缺乏或含量过低的中药的鉴别方面发挥重要作用 [关键词]牛黄清心丸（局方）； 显微； 鉴别； 检查； 掺伪 [Abstract]Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First， microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma， Saigae Tataricae Cornu， Cinnamomi Cortex and Saposhnikoviae Radix. Finally， microscopic spectroscopy was used for test of Dioscoreae Rhizoma′s adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate， simple， rapid， objective and economic， which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny. [Key words]Niuhuang Qingxin pills； microscopic spectroscopy； identification； test； adulteration doi：10.4268/cjcm 牛黄清心丸（局方）由牛黄、当归、川芎、甘草、山药、黄芩、炒苦杏仁、大豆黄卷、大枣、炒白术、茯苓、桔梗、防风、柴胡、阿胶、干姜、白芍、人参、六神曲（炒）、肉桂、麦冬、白蔹、蒲黄（炒）、人工麝香、冰片、水牛角浓缩粉、羚羊角、朱砂、雄黄等29味中药材粉碎配研制成，具有清心化痰，镇惊祛风的功效，用于风痰阻窍所致的头晕目眩、痰涎壅盛、神志混乱、言语不清及惊风抽搐、癫痫[1]。2014年我院承担了该品种的国家药品监督抽验任务，执行标准收载于《中国药典》2010年版一部第一增补本，除制剂通则外，包括【性状】、【鉴别】、【检查】3项。其中显微鉴别项涉及14个药味，包括茯苓、白芍、炒白术、麦冬、甘草、黄芩、桔梗、炒苦杏仁、大枣、大豆黄卷、蒲黄（炒）、朱砂、雄黄、水牛角浓缩粉等原料药材；薄层鉴别4项，包括牛黄、黄芩、人参、当归的鉴别。另有猪去氧胆酸的【检查】项，防止人工牛黄冒充牛黄投料。牛黄清心丸（局方）处方药味众多，且辅料炼蜜干扰