Study On Quality Control Of The Substance Benchmarks Of The Classical Famous Prescription Wenjing Decoction

The classical famous prescription Wenjing Decoction is derived from Chen Ziming’s《Complete Effective Prescriptions for Women’s Diseases》in the Southern Song Dynasty.It is an important prescription for regulating menstruation in gynecology and has good development value.The research and development of the substance benchmarks of the classical famous prescription is in the core position in the development of the classical famous prescription preparations.Therefore,this topic centered on the substance benchmarks of the classical famous prescription,carried out the research on the preparation technology of the substance benchmarks of Wenjing Decoction,the research on the spectrum-effect relationship and the research on the quality standard,to control the quality of the substance benchmarks of Wenjing Decoction.Firstly,the preparation technology of Wenjing Decoction was studied.Based on the research results of Wenjing Decoction published in《Key Information Table of Ancient Classical Famous Prescriptions(7 Prescriptions)》,the contents of cinnamaldehyde,ginsenoside Rg1+ginsenoside Re,ferulic acid,ligustilide,paeoniflorin,paeonol,liquiritin,glycyrrhizic acid and the extraction rate were used as evaluation indexes.The decocting process(crushing particle size,soaking time,decocting equipment,decocting firepower,filtering process),concentration process(atmospheric concentration,the reduced pressure concentration)and drying process(spray drying,vacuum drying,freeze drying)were examined.The results of the preparation process of the substance benchmarks of Wenjing Decoction were as follows:1 times the prescription amount of decoction pieces were placed in the ceramic decoction pot,added 450 mL water,soaked for 0.5 h,boiled by high heat(2000 W)and slow fire after boiling(400 W).The decoction was decocted to 240 mL,filtered by 100 mesh(No.6 sieve),and the filtrate was mixed evenly and then freeze-dried(T=-80℃,0.012 mBar),which was the substance benchmarks of Wenjing Decoction.Secondly,the spectrum-effect relationship of Wenjing Decoction was studied.Based on the established substance benchmarks preparation technology,10 batches of freeze-dried powder of Wenjing Decoction were prepared.The HPLC fingerprint of Wenjing Decoction was established,and the results of methodological investigation were good.A total of 24 common peaks were calibrated and 14 peaks were identified,and the similarity was above 0.9.At the same time,the pharmacodynamics of Wenjing Decoction in the treatment of dysmenorrhea of cold coagulation and blood stasis type in rats was studied.The dysmenorrhea model of cold coagulation and blood stasis type in rats was prepared by estradiol benzoate+ice water bath+oxytocin,and Wenjing Decoction was given for intervention treatment.The writhing response,whole blood viscosity,plasma viscosity,PGF2α,PGE2,6-keto-PGF1α,TXB2 and β-EP were used as pharmacodynamic indexes.The results showed that Wenjing Decoction could significantly improve the dysmenorrhea symptoms of dysmenorrhea model rats with cold coagulation and blood stasis,reduce the whole blood viscosity and plasma viscosity,reduce the content of PGF2α in uterine homogenate and TXB2 in serum,and increase the content of PGE2 in uterine homogenate and the content of 6-keto-PGF1α and β-EP in serum.There were some differences between different batches.Finally,the spectrum-effect relationship between each chromatographic peak in the HPLC fingerprint of Wenjing Decoction and each single pharmacodynamic index and total pharmacodynamic index was established by the grey correlation degree method.The results showed that the correlation degree of ≥21 chromatographic peaks on each efficacy index was>0.6,indicating that the treatment of dysmenorrhea with cold coagulation and blood stasis by Wenjing Decoction was the result of the combined action of chemical constituents.In terms of the overall results of the correlation degree of the total pharmacodynamic index,the correlation degree was>0.8,indicating that there were 15 chromatographic peaks with high correlation,and the correlation degree was Peak 10>peak 15(paeonol)>peak 18(ligustilide)>peak 4(β-ecdysterone)>peak 19(ginsenoside Rg1)>peak 7(ferulic acid)>peak 23>peak 17(senkyunolide A)>peak 20(ginsenoside Re)>peak 8>peak 3(paeoniflorin)>peak 14(glycyrrhizic acid)>peak 24>peak 9>peak 12(cinnamaldehyde).Finally,the quality standard of Wenjing Decoction was preliminarily studied.The TLC identification method was established for all the 9 medicines in the prescription,and the specificity and method verification were carried out.The HPLC fingerprints of 10 batches of Wenjing Decoction and ginseng were established.The results of methodological investigation were good,the similarity was above 0.9,and the common peaks were assigned.Cinnamaldehyde,ferulic acid,paeoniflorin,paeonol,ligustilide,liquiritin,glycyrrhizic acid,ginsenoside Rgl and ginsenoside Re were selected as the content determination components,and the methodological investigation and multi-batch content determination were carried out.The methodological investigation was good.Through the establishment of TLC identification,HPLC fingerprint,multi-component content determination methods,to characterize the quality control of each traditional chinese medicine.