茯苓药材和饮片质量标准研究

完善茯苓药材和饮片的质量标准,为《中国药典》2020年版茯苓药材和饮片质量标准的修订提出建议。采用薄层色谱法,建立了以茯苓酸、去氢土莫酸对照品及茯苓对照药材同时对照的薄层鉴别方法;参照2015年版《中国药典》四部通则,对茯苓药材及饮片的水分、总灰分、农药残留、重金属及有害元素、真菌毒素、二氧化硫残留和醇溶性浸出物进行测定;采用高效液相色谱法,以茯苓酸和去氢茯苓酸为指标,建立了茯苓三萜的含量测定方法;采用分光光度法,以无水葡萄糖为指标,建立了茯苓多糖的含量测定方法。基于不同批次药材和饮片的测定结果,建立了茯苓药材和饮片的质量标准。该质量标准相比2015年版《中国药典》,新增了茯苓的【含量测定】项,修订了其【薄层鉴别】和【检查】项,方法简便、专属性强、重复性好,可有效用于茯苓药材和饮片的质量控制。

Studies on quality standards of Poria

In order to provide scientific recommendations for the revision of the quality standards of Poria in Chinese Pharmacopoeia(Ch. P) 2020 edition, a series of experiments were carried out to improve the quality standards of Poria. TLC methods were established to identify Poria by using pachymic acid, dehydrotumulosic acid and reference herbs as reference substances. The contents of water, total ash, pesticide residues, heavy metals and deleterious element, mycotoxins, sulfur dioxide residues and ethanol-soluble extract of herbal materials and decoction pieces of Poria were determined according to the methods recorded in the volume Ⅳ of Ch. P 2015 edition. An HPLC method was developed for the determination of pachymic acid and dehydropachymic acid. The contents of polysaccharide were determined by spectrophotometry using D-glucose as reference substance. The quality standards were established on the basis of the research results, in which the assay] were added, and the identification] and tests] were revised when compared with Ch. P 2015 edition. The established methods are simple, specific, repeatable, and suitable for the quality evaluation of Poria.