以人参和三七为例浅析品质中药材质量标准现状

Analysis on the present situation of the qualitative standards of quality Chinese medicinal materials as examples of Panax ginseng and Panax notoginseng

当前,中药材品质参差不齐的现状严重影响中药质量的安全性、有效性及稳定性,制约中药产业的发展。本文以人参和三七为例,阐述了现有中药材标准的现状,并通过对药材来源及生产过程、反映内在品质的控制指标及外源性污染物限量指标的规定,制定了品质中药材系列标准的质控指标。依据现有中药材质量标准,品质中药材来源于其道地产区及主产区,生产过程管理严格按照GAP、GACP等管理规定,并依据具体品种类型按照最佳采收期进行采制,采用得当的产地加工方式生产而成。现有质量标准表明,反映品质中药材内在品质的控制指标包含性状、检查、浸出物、含量等。在此基础上,品质人参规定醇溶性浸出物不低于10.0%,且干燥品含人参皂苷Rg1和人参皂苷Re总量不低于0.35%;品质三七醇溶性浸出物不低于17.0%,且干燥品含人参皂苷Rg1、人参皂苷Rb1及三七皂苷R1总量不低于6.5%,均高于现行标准。品质中药材外源性污染物及内源性毒性有害物质的控制指标包含了农残限量指标、重金属及有害元素限量指标、真菌毒素限量指标及内源性毒性有害物质等限量指标。其中品质中药材、品质人参及品质三七规定了236种农药残留、5种重金属及有害元素的最大限量指标,检出限低于国内外标准,保障中药临床的安全性。品质中药材系列标准是对现行质量标准补充和完善,为中药材优质优价的发展方向提供判定依据,保障中药材品质提升。

At present,the uneven quality of traditional Chinese medicine(TCM)influences the safety,effectiveness and stability seriously,and thus restricts the development of the TCM industry.In this paper,the qualitative standards of quality Panax ginseng and quality Panax notoginseng were taken as examples,the current situation of existing standards for Chinese herbal medicines were described,and the quality control indexes of quality standard series of Chinese medicinal materials were expounded through the source and the process of production,the control index reflecting internal quality and the determination of the limit index of exogenous pollutants.According to the existing quality standards for TCM,the quality Chinese medicinal materials are high-quality medicinal materials,which were from their genuine or main production area,strictly in accordance with GAP,GACP and other management regulations in the management of production process,harvested according to the specific variety type and the best harvest time,as well as processed and produced in an appropriate way.The existing quality standards indicate that the control indexes reflecting the internal quality of TCM materials include character,inspection,extract,content and other indexes.On this basis,the alcohol soluble extract of high-quality Panax ginseng should be not be less than 10.0%,and the total amount of Ginsenoside Rg1 and Ginsenoside Re in the dried product of high-quality Panax ginseng should be not be less than 0.35%;the alcohol soluble extract of high-quality Panax notoginseng should be not be less than 17.0%,and the total amount of Ginsenoside Rg1,Ginsenoside Rb1 and Notoginsenoside R1 in the dried product of high-quality Panax notoginseng should be not be less than 6.5%,which is higher than the existing standard.The control indexes of exogenous pollutants as well as endogenous toxic and harmful substances of quality Chinese medicinal materials include the limit of agricultural residue,heavy metals and harmful elements,mycotoxins,endogenous toxic and harmful substances and other limits.The maximum limit indexes of 236 pesticide residues,5 heavy metals and harmful elements are set for quality Chinese medicinal materials,quality Panax ginseng and quality Panax notoginseng,which are lower than the domestic and foreign standards to ensure the clinical safety of TCM.The series standards of quality Chinese medicinal materials supplement and perfect the current quality standards,which will provide a basis for determining the development direction of high-qualityand affordable Chinese medicinal materials,and ensure the quality improvement of it.