基于《中华人民共和国药典》2015年版拟修订的无硫山药饮片质量标准初步构建

Initially constructs the revised quality standard of Sulfur-free Rhizoma Dioscoreae pieces based on the 2015 Edition of Pharmacopoeia of the People’s Republic of China

《中华人民共和国药典》2015年版规范了中药饮片质量的基本标准,但由于现行标准与市场实情不符,拟修订的需求越来越多。国内外对硫残量限定的要求反映了市场对安全产品的重视,硫残量是关键的安全问题隐患;研究无硫中药饮片质量标准,有利于保障中医临床用药安全。文章以道地药材怀山药为研究对象,基于无硫加工技术,以现行《中华人民共和国药典》2015年版通则项为参照,更新检查标准,提高中药饮片质量检查要求,初步构建无硫山药饮片质量标准,为无硫优质中药饮片质量标准的研究奠定坚实基础。

Pharmacopoeia of the People’s Republic of China(2015 Edition)has standardized the basic standards for the quality of Chinese herbal pieces,but due to the discrepancy between the current standards and the market facts,the demand for revising standard is increasing.The domestic and international requirements for sulfur residual limits reflect the market’s emphasis on safety products,the sulfur residuals are the key safety problems;research on the quality standard of traditional Chinese medicine without sulfur helps to ensure the safety of Chinese medicine clinical use.In this paper,genuine regional Rhizoma Dioscoreae as the research object,based on sulfur-free processing technology,and the current Pharmacopoeia of the People’s Republic of China as a reference,updating standards to improve the quality of Chinese herbal pieces inspection requirements,initially construction of sulfur-free pieces quality standards for sulfur-free high-quality Rhizoma Dioscoreae pieces lay a solid foundation for the study.