中成药和中药材添加化学物质补充检验方法分析

中成药添加相似或相同治疗功效的化学物质、中药材添加化工染料是中药掺杂掺假的主要手段。补充检验方法是认定有掺杂掺假嫌疑药品的技术依据。自2003至2013年，共有135个针对中成药和中药材添加化学物质的补充检验方法获得国家药品监管部门批准。本文通过对近10年批准的方法进行分析，一方面，梳理出易被添加化学物质的中成药和中药材品种及添加物的种类。对于中成药，主要是降糖类和补肾壮阳类，添加物分别是具有降糖功效的格列和双胍类以及具有抗疲劳功效的那非类；对于中药材，主要是红花和血竭等类，添加物是具有相似或相同颜色的化工染料；以降血糖和补肾壮阳类中成药和染色类中药材为例，分析得出添加物呈现数量增加和种类翻新的趋势。另一方面，归纳出常用的初筛技术和确证技术，如物理化学鉴别法、薄层色谱法、高效液相色谱法和液相色谱质谱联用法等。为更有效地建立识别添加物的补充检验方法，提议要“建立添加物负面清单”、“对已批准方法整合”和“重新认识方法所需对照品”。

Addition of chemical substances with similar or the same therapeutic functions to traditional Chinese medicine preparations(TCMPs)and chemical dyestuff to Chinese herbal medicines(CHMs)are the main approaches for adulteration of traditional Chinese medicines(TCMs).The supplementary testing methods and items(STMIs)were developed as the technical reference to detect medicines suspected of adulteration.From 2003 to 2013,135 STMIs were approved by the national drug regulatory authority for the detection of adulterated TCMPs and CHMs.This paper analyzed the approved STMIs over past ten years.On one hand,those traditional medicines vulnerable to adulteration and the illegally added chemical substances were listed.For TCMPs(mainly for lowering blood sugar and invigorating the kidney and strengthening vigor),additives were glinides and biguanides for lowering blood sugar and nafils for anti-fatigue.For CHMs(mainly for safflower and Sanguis Draconis),additives were chemical dyestuff with similar or the same colors.With examples of TCMPs for lowering blood sugar and invigorating the kidney and strengthening vigor and dyed TCMs,the analysis showed additives had a tendency of increasing quantity and renovated varieties.On the other hand,this paper summarized the techniques in supplementary testing methods for preliminary screening and verification,such as physic-chemical identification, TLC,HPLC and LC-MS.Based on the review above,this paper proposed three practical suggestions,i.e.,publishing the negative list of commonly used chemical substances,integrating approved methods and rethinking the role of reference substances,which could contribute to the effective establishment of supplementary testing methods to detect TCMPs and CHMs with adulterated chemical substances.