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基于市售重楼饮片质量研究对重楼饮片标准的思考

2020-08-07贾天颖高岩王海丽辛洁萍白玉莹王敏韩婷刘梦楠李向日林瑞超

世界中医药 2020年13期

贾天颖 高岩 王海丽 辛洁萍 白玉莹 王敏 韩婷 刘梦楠 李向日 林瑞超

摘要 目的:对重楼市售饮片进行基于性状鉴别、浸出物、含量测定等多方面分析,以期为重楼的质量评价和重楼饮片市场的良性发展提供数据支持。方法:建立了重楼饮片浸出物测定方法,采用热浸法测定其醇溶性浸出物,对重楼饮片炮制方法进行了研究,测定了重楼饮片外观性状及重楼皂苷Ⅰ、Ⅱ、Ⅵ、Ⅶ含量。结果:重楼饮片浸出物含量之间的差异性较大,云南产地浸出物的平均含量略小于四川产地浸出物含量;市售重楼饮片大部分为厚片,少数为段,均不符合《中华人民共和国药典》(2015年版)“重楼”炮制项“切薄片”的规定;重楼饮片皂苷含量差异较大,四川产地重楼饮片皂苷含量略大于云南产地,多数重楼饮片所含皂苷以重楼皂苷Ⅰ,Ⅱ,Ⅶ为主,少数样品重楼皂苷Ⅵ含量较高,可能存在掺伪现象。结论:为保证临床使用需求及药效,建议《中华人民共和国药典》修订饮片炮制项、含量测定项,并补充性状项。

关键词 重楼饮片;质量研究;《中华人民共和国药典》;标准修订;炮制;含量测定;饮片性状

Abstract Objective:To conduct analysis based on character identification,extracts,content determination and other aspects of Chonglou′s commercially available Decoction pieces,with a view to providing data support for Chonglou′s quality evaluation and the benign development of Chonglou′s Decoction Pieces market.Methods:The determination method of extracts of Chonglou Decoction Pieces was established,and the alcohol-soluble extractives were determined by hot dip method.The processing method of Chonglou Decoction Pieces was studied.The appearance characteristics of Chonglou Decoction Pieces and Chonglou SaponinⅠ,Ⅱ,Ⅵ,Ⅶ content was determined.Results:The difference in extract content of Chonglou Decoction Pieces was large.The average content of extract from Yunnan origin was slightly smaller than that in Sichuan; the majority of commercially available Chonglou Decoction Pieces were thick tablets,and a few were segments,which were not in line with “Chonglou” item of cutting thin slices in The Pharmacopoeia of the People′s Republic of China(2015 edition); the content of saponins in Chonglou Decoction Tablets is quite different,the content of saponins in Sichuan province is slightly larger than that in Yunnan,and saponins IN most of the tablets contained in Zhonglou Decoction were Chonglou saponins Ⅰ,Ⅱ,and Ⅶ.A few samples have a high content of Chonglou saponins VI,and adulteration may exist.Conclusion:In order to ensure the clinical use requirements and efficacy,it is recommended that in Chinese Pharmacopoeia we should revise the processing items and content determination items of decoction pieces,and supplement the trait items.

Keywords Chonglou Decoction Pieces; Quality Research; Chinese Pharmacopoeia; Standard revision; Processing; Content determination; Decoction characteristics

中图分类号:R283;R921.2文献标识码:Adoi:10.3969/j.issn.1673-7202.2020.13.007

《中华人民共和国药典》(2015年版)规定重楼为百合科植物云南重楼Paris polyphylla Smith var.yunnanensis(Franch.)Hand.-Mazz.或七葉一枝花Paris polyphylla Smith var.chinensis(Franch.)Hara的干燥根茎[1]。重楼始载于汉代《神农本草经》,列为下品,其味苦,性微寒;有小毒,归肝经。主要用于惊痫,摇头弄舌,下三虫,去蛇毒等症[2]。其临床应用历史悠久,效果显著,具有抗肿瘤[3-4]、抗炎[5-6]、镇静镇痛[7-8]和止血[9]等作用,是中医常用药之一,也是多种常用传统复方中成药的原料药之一。……

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