Quality and safety evaluation of multi-compound determination of Sojae Semen Pra-eparartum from homemade and different origins
Objective The characteristics,color identification and multi-compound determination of 12 Sojae Semen Praeparar-tum(SSP)from homemade and different origins are carried out to provide a reference basis for improving the quality and safety e-valuation 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 provi-sions 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,respec-tively.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.
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