不同产地淡豆豉多指标成分含量测定的质量和安全性评价

Quality and safety evaluation of multi-compound determination of Sojae Semen Praeparartum from homemade and different origins

目的对自制和不同产地来源的12个淡豆豉样品进行性状、显色鉴别和多指标成分含量测定,为完善淡豆豉药材质量和安全性评价提供参考。方法根据2020年版《中国药典》淡豆豉项下的性状、显色鉴别方法对淡豆豉进行鉴别,用高效液相色谱法(High Performance Liquid Chromatography,HPLC)和超高效液相色谱-串联质谱法(Ultra Performance Liquid Chromatography Mass Spectrometry,UPLC-MS/MS)测定各样品中大豆苷元、染料木素、γ-氨基丁酸(GABA)、谷氨酸(GLu)和黄曲霉毒素(AFTs)含量。结果12个淡豆豉样品性状均符合药典标准,显色鉴别中9个样品显紫红色反应,3个不符合药典规定。不同产地淡豆豉的大豆苷元、染料木素、GABA和GLu含量差异较大,大豆苷元、染料木素总量依次是安徽3(SSP6)>江西3(SSP3)>自制淡豆豉(SSP0),分别为1.992、1.713 mg/g和1.673 mg/g;GABA含量依次为自制淡豆豉(SSP0)>安徽3(SSP6)>四川(SSP10),分别为7.940、5.336 mg/g和2.145 mg/g,另有4个样品的大豆苷元、染料木素总量不符合药典规定,且它们的GABA含量很低;有6个样品检测出AFTs,其中2个样品超出药典限量标准,分别为安徽1(SSP4)和安徽3(SSP6),SSP4的AFB1、AFB2含量最高分别为6.48,0.63μg/kg。结论各产地淡豆豉品质良莠不齐,存在一定安全隐患。新引入的活性成分GABA和AFTs含量测定可作为淡豆豉质量优劣和安全性评价的指标。

Objective The characteristics,color identification and multi-compound determination of 12 Sojae Semen Praeparartum(SSP)from homemade and different origins are carried out to provide a reference basis for improving the quality and safety evaluation of SSP medicinal materials.Methods According to the 2020 edition of the Chinese Pharmacopoeia,the characteristics and color identification methods of SSP are identified.High Performance Liquid Chromatography(HPLC)and Ultra Performance Liquid Chromatography Mass Spectrometry(UPLC-MS/MS)were used to determine the glycine,genistein,γ-aminobutyric acid(γ-amino butyric acid,GABA),glutamic acid(GLu)and aflatoxin(AFTs)content.Results The traits of 12 samples comply with the provisions of the Pharmacopoeia,9 samples of SSP have purple-red reactions,3 samples do not meet the provisions of the pharmacopoeia.The contents of daidzein,genistein,GABA and GLu in SSP from different origins are quite different.Among them,the total amount of daidzein and genistein was in the order of Anhui 3(SSP6)>Jiangxi 3(SSP3)>homemade SSP(SSP0),which were 1.992 mg/g,1.713 mg/g and 1.673 mg/g,respectively.The content of GABA was in the order of homemade SSP(SSP0)>Anhui 3(SSP6)>Sichuan 10(SSP10),which were 7.940 mg/g,5.336 mg/g and 2.145 mg/g,respectively.Another 4 samples of SSP did not meet the requirements of the pharmacopoeia for daidzein and genistein content,and their GABA content was quite low.Aflatoxin was detected in 6 samples,and 2 samples exceeded the pharmacopoeia limit standards,namely Anhui 1(SSP4)and Anhui 3(SSP6),and the AFB1 and AFB2 content of SSP4 were up to 6.48 ug/kg and 0.63 ug/kg respectively.Conclusion The quality of SSP from different origins was uneven,and there were still certain safety risks.The newly introduced active ingredients GABA and AFTs content determination can be used as a reference index for evaluating the quality of SSP.