Evaluation Of The Substance Benchmarks Standard Quality Of Classical Material Medica Prescription Danggui Buxue Decoction And Preliminary Study On Preparation Process

Objective:1.The identification and inspection of Astragalus membranaceus and Angelica sinensis,as well as the determination of the relevant active ingredients,ensure the quality of the original herbal medicines,and provide a guarantee for the stability and uniformity of the material standard of the classic Danggui Buxue Decoction2.Establish the effective ingredient content determination and fingerprint method of the classic famous Danggui Buxue Decoction decoction,and formulate the effective ingredient transfer rate and ointment rate in the substance reference,which will provide a reference for the subsequent classic Mingfang Danggui Buxue decoction preparation technology research.3.Based on the pharmacological parameters of Danggui Buxue Decoction as the criterion,the technological research of the classic prescription Danggui Buxue Decoction preparation was determined to ensure the safety and effectiveness of modern preparations in clinical use.Method:1.Quality standard of Astragalus and Angelica decoction: Astragalus and Angelica decoction were obtained according to the processing regulations,according to the provisions of the 2015 edition of "Chinese Pharmacopoeia",the quality control of Astragalus and Angelica were carried out to prepare Danggui Buxue Decoction Reference material provided.2.Danggui Buxue Decoction Substance Standard Quality Standard: Inquire about ancient books,conduct herbal research on medicinal materials,and confirm the preparation process of Danggui Buxue Decoction.Establish high-performance liquid active ingredient content determination,fingerprint analysis method,and study the 15 batches of Danggui Buxue decoction standard decoction creaming rate,effective ingredient transfer rate and material group value transfer analysis to study.3.Based on the standard quality control of Danggui Buxue Decoction,through the static and dynamic decoction pieces water absorption rate,extraction process,concentration temperature and drying process,preliminary confirmation Danggui Buxue Decoction preparation process.Result:1.According to the quality standards of Astragalus and Angelica in 15 batches of different origins,the requirements of the 2015 edition of "Chinese Pharmacopoeia" are complied with.The identification,inspection,extract and content determination are all in line with the requirements.2.In the 15 batches of Danggui Buxue Decoction,the astragaloside content ranged from 0.0108% to 0.0133%,the effective component transfer rate was 26.72% to 32.23%,and the isoflavone glucoside content ranged from 0.0120% to 0.0180%,the active component was transferred.The rate is 30.45% ~ 48.61%;the ferulic acid content is0.0046% ~ 0.0069%,and the active ingredient transfer rate is 30.43%~52.21%.The standard decoction substance reference lyophilized powder paste extraction rate range is19.59 ~ 36.37%.3.The similarity results of 15 batches of Astragalus membranaceus and Angelica decoction and their corresponding control maps are in the range of 0.946~0.992,0.947~0.988.The similarity results of 15 batches of Danggui Buxue Decoction substance reference and corresponding control maps are all in 0.964~0.998.4.The Dangguibuxuetang substance standard identified 6 peaks for the characteristic peaks,which were chlorogenic acid,ferulic acid,mullein isoflavone glucoside,formononetin,mullein isoflavone,and formononetin.The effective substance group identification rate was 31.58 %5.Preliminary study on the preparation process of Danggui Buxue Decoction granules: take 30 g of Astragalus root and 6 g of Angelica root,soak for 30 min,and cook twice..The concentration temperature should be less than 80?,and the duration should not exceed 10 hours;the drying parameters of the extract(the temperature in the first zone: 100? ~ 120?;the temperature in the second zone: 80? ~ 100?;the temperature in the third zone: 25?~30?)Conclusion:The quality control of Astragalus and Danggui TCM decoction pieces are in compliance with the requirements under the 2015 edition of the Chinese Pharmacopoeia;the established classic recipe Danggui Buxue Decoction has a stable substance preparation process,content determination and fingerprint method,It can provide a reference for the subsequent research on the quality standards of related preparations.