Study On The Preparation Technology And Quality Standard Of Formula Granules Of Erigeron Breviscapus

Erigeron breviscapus(Vant)Hand-Mazz,the whole herb is used as medicine.Because the flowers resemble "Dengzhan" and the roots resemble Xixin,they are also called "Dengzhanxixin".The seeds of Erigeron breviscapus are obtained by soaking,extracting,concentrating,drying and granulating dried breviscapine.It can dispel the cold and dispel the surface,remove wind and dampness,promote blood circulation and relieve pain.It is usually used to treat stroke hemiplegia,chest pain,rheumatoid arthralgia,headache and toothache.Traditional decoctions require large doses,and the quality is not easy to control,so they are made into granules for patients to take.1.Screening of erigeron raw materialsThe source of the collected breviscapus medicinal material was characterized and thin-layered,and the moisture,ash,extract,and content were determined item by item.The results showed that the content of scutellarin in each batch reached 0.3% of the breviscapine item in the Pharmacopoeia.,The average content of the main component of baicalin(Scutellarin)is 7.74mg/g,so Dengzhanhua produced in Honghe County is used as the raw material of its formula granules.2.Preparation process of Erigeron breviscapus extractThis chapter compares the advantages and disadvantages of each process condition with the extraction rate and the content of baicalin as the measurement indicators.Screening of extraction methods,extraction solvents and extraction times;using extraction time,ethanol concentration,liquid-to-mass ratio as research factors,single factor investigation and response surface design,model optimization results are: extraction time 67 min,ethanol concentration 65%,liquid The mass ratio was 6.4m L/g.Under these conditions,the model predicted that the extract of Erigeron breviscapus was 16.67%,and the content of erigeron B was 7.14mg/g.3.Preparation process of Erigeron breviscapus formula particlesAccording to the optimal extraction process conditions of Erigeron breviscapus,the extraction rate and the content of baicalin are used as the control indicators.After extraction,the combined extracts are filtered;after comparing the concentration ratio and concentration method,it is determined that the concentration is reduced to relative pressure at 55℃ and 0.075 MPa under reduced pressure.The density is 1.2,and the flow extract is obtained;four drying methods are used to compare the drying rate and the content of baicalin.Finally,the vacuum freeze-drying is selected: the flow extract is pre-frozen,and the dry powder of Erigeron breviscapus extract is obtained by vacuum freezing;Moisture,moisture absorption,angle of repose,bulk density,etc.are used as indicators.The types of auxiliary materials and the ratio of auxiliary materials are screened to determine the optimal auxiliary material ratio is 1:1.2,fully mixed,using ethanol as the wetting agent,wet granulation,to "light Hold it in a group and disperse it with one touch,sieving and granulating to get the finished product.Measure the moisture absorption rate and draw a moisture absorption balance curve,check its moisture,particle size,angle of repose and bulk density.4.Study on the quality standard of Erigeron breviscapus formula particlesIn this chapter,the quality control indicators of Erigeron breviscapus are systematically studied.Due to its nature,the product is yellow-brown to brown particles,the gas is slightly aromatic,and the bitter taste is slightly astringent.Refer to the "Chinese Pharmacopoeia" 2015 edition(Part 1)granules,mainly by legal identification of thin layer chromatography,HPLC method to determine the content.The thin layer chromatography identification method of Erigeron breviscapus formula particles was determined,and a methodological study was carried out on the content of Erigeron breviscapus by high performance liquid chromatography.Finally,the content was determined according to the measurement results of 10 samples: 1g of formula particles Contains at least 3mg Breviscapine.5.Draft standard of erigeron formula particlesBased on the selection of Dengzhanhua decoction pieces,the preparation process of granules and the research on the quality standard of the granules,the draft standard of Dengzhanhua formula granules was prepared: 1000 g Dengzhanhua granules were obtained by drying the whole plant of Erigeron breviscapus,after extraction,concentration,drying and granulation;Appearance: yellow brown To brown particles,slightly fragrant,bitter and slightly astringent;thin layer identification item,showing the same color spots as baicalin at the same position;moisture not exceeding 5%;failure rate lower than 7%;solubility test,soluble particles It should be completely dissolved or slightly turbid in hot water;the content of the active ingredient is determined,the content of baicalin is not less than 3mg/g;the determination of the extract with 95% ethanol is not less than 15%;the recommended amount is 5g;Take half a bag or 1 bag at a time,either orally or by injection;note that it is not suitable for patients with acute cerebral hemorrhage or bleeding tendency.Some patients have itchy skin and disappear after stopping the drug.This paper establishes the quality analysis method of Erigeron breviscapus,explores the production process of Erigeron breviscapus formula granules,systematically studies the quality standard,formulates the quality standard of Erigeron breviscapus formula granules,provides a theoretical reference for formulating the medicine standard of Erigeron breviscapus granules,and indirectly ensures The effectiveness and safety of clinical medication provides a theoretical reference for the quality control of Erigeron breviscapus and granules.