我国地区性民间习用药材质量标准概况及相关问题探讨
投稿时间:2023-08-29  修订日期:2023-08-29   点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
吴晨悦 WU Chenyue 国家药品监督管理局药品审评中心 Center for Drug Evaluation,National Medical Products Administration wuchenyue525@163.com 
李灿 Li Can 国家药品监督管理局药品审评中心 Center for Drug Evaluation,National Medical Products Administration lic@cde.org.cn 
吴静义 Wu Jingyi 国家药品监督管理局药品审评中心 Center for Drug Evaluation,National Medical Products Administration wujy@cde.org.cn 
周跃华* Zhou Yuehua 国家药品监督管理局药品审评中心 Center for Drug Evaluation,National Medical Products Administration yhztcm163@163.com 
中文摘要:目的:调研我国地区性民间习用药材标准(即省级中药材标准)现状,分析存在问题,为省级中药材标准的制定修订和管理提供参考。方法:对我国省级中药材标准的现状及其收载的药材品种进行梳理,分别对动植物药材的品种数量、科属分布、药用部位,以及矿物药的主要元素分布进行了分析,并就相关问题进行讨论。结果:据不完全统计,省级中药材标准共收载药材2712种。其中,植物药2247种,动物药327种,矿物药63种,其他75种。植物药涉及240个科,以菊科占比最高(6.63%),药用部位以根入药最多(27.9%),单基原植物药材有1856种(82.6%)。动物药涉及127个科,以牛科占比最高(11.3%),药用部位以动物全体入药最多(40.1%),单基原动物药材有204种(62.4%)。此外,动物药材的科属分布较分散,有185种药材分布于111个科。结论:省级中药材标准作为国家药材标准的补充,经过多年发展已形成较完整的标准体系,但大多数省级中药材标准的质量控制水平有待提高。建议加强省级中药材标准的管理,进一步协调省级中药材标准与国家标准的关系,建立药材标准共享机制以及快速修订机制,提高药材标准的可控性。
中文关键词:地方习用药材  质量标准  现状  建议
 
General situation of the quality standard of traditional folk medicinal materials in China and related problems
Abstract:Purpose: To investigate the status quo of quality standards of regional traditional medicinal materials (Provincial medicinal materials) and analyze the existing problems, so as to provide reference for the formulation,revision and management of local medicinal materials standards. Method: The varieties of provincial medicinal materials were sorted out, the distribution of species number, family, medicinal parts, and main elements of mineral medicinal materials were analyzed, and related issues were discussed. Results: According to incomplete statistics, a total of 2712 kinds of medicinal materials were collected by the provincial standard of medicinal materials, including 2,247 kinds of botanical drugs, 327kinds of animal drugs, 63 kinds of mineral drugs, and 75 other kinds. There are 240 families involved in plant medicine, of which compositae accounted for the highest proportion (6.63%), and root accounted for the most medicinal parts (27.9%). There were 1856 species (82.6%) of single primitive plant herbs. Animal drugs involved 127 families, cattle accounted for the highest proportion (11.3%), the medicinal parts of all animals were the most (40.1%), and there were 204 species (62.4%) of single primitive animal drugs. In addition, the family distribution of animal medicinal materials was relatively dispersed, with 185 species distributed in 111 families. Conclusion: As a supplement to the national drug standards, provincial medicinal materials standards have formed a relatively complete standard system after years of development, but the quality control level of most provincial medicinal materials standards need to be improved. It is suggested to strengthen the management of provincial medicinal material standards, further coordinate the relationship between provincial medicinal material standards and national standards, establish a sharing mechanism of medicinal material standards and a rapid revision mechanism, and improve the controllability of medicinal material standards.
keywords:Regional traditional medicinal materials  Quality standard  Status quo  suggestion
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