Study On Preparation Technology And Quality Of Qufeng Huoxue Granule Based On Classical Prescription

Since the reform of new drugs for more than 10 years,China has made great efforts to develop traditional Chinese medicine and emphasized the complementarity and synergy be-tween traditional Chinese medicine and Western medicine.The ancient classical formula was established on the basis of definite clinical efficacy and is a precious treasure left by Chinese history.It is an urgent problem to solve on the road of modernization of Traditional Chinese medicine that how to make the traditional classical decoction glow with the help of modern preparation technology.In this study,based on the addition and subtraction of the ancient jing-fang formula,combining the advantages of traditional dosage forms and modern dosage forms,the modern preparation process was studied,and the quantity transfer relationship of 7 char-acteristic components in the process of granule preparation was combined to ensure the sta-bility of the production process.The specific research work is as follows:（1）To establish a content determination method for hesperidin in Schizonepeta schi-zonepeta ear,a traditional Chinese medicine of Qufeng Huoxue Prescription,so that it can be used as an indicator component to describe the process of component transfer.The results showed that the morphology and thin layer identification of 15 batches of Schizonepeta pa-niculata conformed to the relevant description of the People’s Republic of China Pharmaco-poeia 2020 edition.Acid insoluble ash,total ash,extract content and humenone content all met the relevant provisions,indicating that the quality of 15 batches of medicinal materials was qualified.Subsequently,a method for the determination of hesperidin in Schizonepeta schi-zonepeta spike was established and investigated.The results showed that the method had good precision,reproducibility,accuracy and stability.The content of hesperidin in schizonepeta schizonepeta ear from different producing areas was determined,and the quality difference between anguo,Xinle and Luoyang of Hebei province was compared.It was determined that Schizonepeta schizonepeta ear from Xinle of Hebei province was the best producing area,and the content of Hesperidin(C₂₈H₃₄O₁₅)in schizonepeta schizonepeta ear from xinle of Hebei Province should not be less than 0.24%to ensure the quality of medicinal materials.（2）HPLC fingerprint chromatographic conditions of Qufeng Huoxue Fang granules were established.The method was verified to be accurate and effective.Methods Seven characteristic components were identified as ammonium glycyrrhizinate,paeoniflorin,stil-bene glycoside,hesperidin,cognetin,5-O-methylvisamitol glycoside and ferulic acid.（3）To establish the preparation process of Qufeng Huoxue granules.The extraction pro-cess was investigated,and the quality relationship between the production extract extracted by using multi-function extraction tank and the laboratory decocted solution was verified.The results showed that there was no obvious difference,and the large-scale production process transformation could be realized.The types and dosage of pelleting excipients were investi-gated,and soluble starch was used as excipient in granulation,and the dosage of excipient and extract（density not less than 1.2）was 1:1 for granulation.（4）Study on the quality standard of three batches of qufenghuoxue granules prepared.The particle size,moisture,dry weight loss,solubility,fluidity and moisture absorption of the trial-produced qufenghuoxue granules were examined under the item 0104 granules of Gen-eral Rules of Three parts of Pharmacopoeia of the People’s Republic of China（2020 edition）.A TLC method was established for the identification of 6 kinds of radix Angelica,ligusticum chuanxiong,Radix paeoniae paeoniae,Polygonum multiflorum,radix parsnip and liquorice.The content of three batches of granules was determined,and the content of each indicator component in granules should not be less than 70%of the average value,that is,ferulic acid(C₁₀H₁₀O₄)should not be less than 0.12%,ammonium glycyrrhizinate(C₄₂H₆₅NO₁₆)should not be less than 0.50%.The content of paeoniflorin(C₂₃H₂₈O₁₁)should not be less than 0.89%,hesperidin(C₂₈H₃₄O₁₅)should not be less than 0.41%,cocimine(C₂₂H₂₈O₁₁)should not be less than 0.09%,5-O-methylvisamitol(C₂₂H₂₈O₁₀)should not be less than 0.10%,The content of stilbene glycoside(C₂₀H₂₂O₉)shall not be less than 0.21%.