Objective Taking Shaoyao Gancao Decoction(SGD,芍药甘草汤)as an example,the homogenization feeding process was studied.From the triple links of homogenization decoction pieces,decoction and Chinese patent medicine,combined with multi-component content,characteristic spectrum,value transfer and other data,the whole process of homogenization feeding process of SGD was completed,and the quality range of homogenization feeding process of SGD was discussed and determined,so as to achieve uniform and stable quality between batches.Methods UHPLC method was used to determine the content of multiple batches of Baishao(Paeoniae Radix Alba)and Zhigancao(Glycyrrhizae Radix Preparata).The average value was selected as the standard quality of decoction pieces,which was used as the target quality of normalized standard decoction pieces.Calculate the proportion of homogenization of each batch of decoction pieces,complete the feeding,and prepare the SGD homogenization standard decoction and Chinese patent medicine;the mass concentration range was set,and the characteristic chromatograms of normalized standard decoction and Chinese patent medicine were established.After the decoction pieces were graded,15 batches of homogenized decoctions and Chinese patent medicines were newly prepared to verify the rationality of the mass concentration range and comprehensively evaluate the homogenization process.Results The mass fractions of paeoniflorin,liquiritin and glycyrrhizic acid in normalized standard decoction pieces were 2.236％-2.506％,0.500％-0.680％and 1.870％-2.215％,respectively.The corrected mass concentrations of each component in the normalized standard decoction were 2.014-2.522 mg/mL for paeoniflorin,0.170-0.282 mg/mL for liquiritin,and 0.489-0.718 mg/mL for glycyrrhizic acid,respectively.The corrected mass concentrations of each component in the standard Chinese patent medicine were 1.950-2.391 mg/mL for paeoniflorin,0.159-0.269 mg/mL for liquiritin,and 0.453-0.673 mg/mL for glycyrrhizic acid,respectively.A total of 16 characteristic peaks were matched in the characteristic chromatograms of homogenized standard decoctions and Chinese patent medicines,and eight characteristic peaks were identified by reference substances.The components in the newly prepared homogenized decoction and Chinese patent medicine were within the set mass concentration range.The characteristic chromatograms of each group were compared with the characteristic chromatograms of homogenized standard decoction and Chinese patent medicine,and the similarity was greater than 0.995.Conclusion Taking the standard quality of decoction pieces as the goal,the decoction pieces with uniform quality are obtained by homogenizing the feeding,which reduces the quality fluctuation of the feeding decoction pieces,and finally obtains the SGD and Chinese patent medicine with uniform and stable quality between batches,which provides a feasible scheme for the study of the quality consistency process of Chinese patent medicine.
Chinese patent medicineShaoyao Gancao Decoctionhomogenized feedingquality controlclassic prescriptionfeature mappaeoniflorinliquiritinglycyrrhizic acid
NETL
NSTL
万方数据
