发酵虫草菌粉类产品质量标准研究进展

随着冬虫夏草资源的日益稀缺,从中分离提取的药用菌株经人工液体深层发酵加工得到的菌粉,即发酵虫草菌粉,已逐渐成为其替代品。现代药理学证明,发酵虫草菌粉与冬虫夏草有效成分类似,具有相似的药理作用。目前,市场上发酵虫草菌粉类产品众多,主要有金水宝胶囊、百令胶囊、心肝宝胶囊、至灵胶囊、宁心宝胶囊五大品种。其中,仅金水宝胶囊和百令胶囊被收载入2015年版《中国药典》,质量标准相对较为全面,而其他产品的质量标准则较为粗放。对于发酵虫草菌粉类产品,目前尚无统一对其产品质量进行全面控制的方法。因此,完善并统一发酵虫草菌粉类产品的质量标准是提升其产品质量标准及保证其产品安全、优质、高效的关键。文章全面综述了发酵虫草菌粉类产品的化学成分及质量标准研究进展,分析了现有发酵虫草菌粉类产品质量标准的不足,提出了建立一个更为科学合理的质量标准新模式以综合评价其质量方法的建议,旨在为发酵虫草菌粉类产品的质量标准提升及规范化生产提供参考。

Chemical Constituents and Quality Control of Products of Fermented Cordyceps sinensis Powder

With the increasing scarcity of Cordyceps sinensis, fermented C.sinensis powder that produced through extraction and separation of medical strains from C.sinensis by artificial fermentation has gradually become the substitutes of C.sinensis.Modern pharmacology had verified that the pharmacological activity of fermented C.sinensis powder is similar to that of C.sinensis, because they have similar active ingredients.Currently, there were numerous products of fermented C.sinensis powder, mainly including Jinshuibao capsule, Bailing capsule, Xinganbao capsule, Zhiling capsule, Ningxinbao capsule.Among them, only Jinshuibao capsule and Bailing capsule have reached comprehensive quality standards and been recorded in the 2015 edition of Chinese Pharmacopoeia,while others have inferiorquality standards.For the product of fermented C.sinensis, the unified quality control method has not been established.Therefore, the establishment of improved and unified quality standards for products of fermented C.sinensis powder is the key to improve its quality standard and ensure its safety, high quality and efficiency.This essay summarized the chemical composition and the progress in quality control by analyzing the deficiency of the quality standard of products of fermented C.sinensis powder, and propose to establish a more scientific and rational model of quality standard for comprehensively evaluating its quality, withthe aim to provide a certain reference for the improvement of quality standard and the standardized production of products of fermented C.sinensis powder.