2020年版《中国药典》植物药材采收期标准情况分析及建议

Analysis and suggestions on harvest period standards of plant medicinal materials in 2020 edition of Chinese Pharmacopoeia

采收期标准的完善是中药材质量控制的关键环节之一。该文对2020年版《中国药典》(一部)植物药材的采收期标准收录情况进行统计分析,结合本草记载及现代研究文献分析采收期标准存在的问题,提出相应的建议,为标准提升提供参考。统计得到,499种植物药材中,486种有采收期标准,占97.4%;13种药材无采收期标准。只有银柴胡1种药材有采收年限标准;233种药材同时有采收季节和采收物候期标准,占46.7%;237种只规定了采收季节,占47.5%;15种只规定了采收物候期,占3.0%。222种主要来源于栽培以及51种野生与栽培来源共存的植物药材中,仅11种提及栽培品采收期,且仅银柴胡对野生品及栽培品的采收期标准进行区分描述。不同药用部位植物药材的采收期标准存在一定规律。分析采收期标准存在的问题主要有:(1)13种植物药材无采收期标准;(2)几乎全部人工栽培多年生药材的采收期标准无采收年限;(3)250种植物药材采收期标准没有物候期;(4)栽培品与野生品采收期标准的区分不明确;(5)26种全年均可采收的植物药材采收期标准缺乏依据。建议针对以上问题,加强基础研究,尽快提高完善采收期标准。

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials.The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards.According to the statistical analysis,in 499 types of plant medicinal materials,harvest period standards are recorded under 486 types,accounting for 97.4%,and are lacking in the remaining.Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year.The standards of the harvest season and phenological period are recorded under 233 types,accounting for 46.7%.For 237 types,only harvest season is specified,accounting for 47.5%,and for 15 types,only harvest phenological period is specified,accounting for 3.0%.Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation,only 11 types are recorded with harvest period of cultivated products.Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately.The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow.The main problems about the harvest period standards are discovered.Specifically,no harvest period standards are recorded under 13 types of plant medicinal materials.Almost all perennial cultivated medicinal materials are not recorded with harvest year standard.No phenological period standard is found under 250 types of plant medicinal materials.There is no clear distinction between the harvest period standards of cultivated and wild products.The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient.As a result,it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.