Study On Preparation Process And Quality Standard Of Xiaoer Gehuang Zhixie Granules

Objective: Xiaoer Gehuang Zhixie Granules,composed of Pueraria lobata(Willd.)Ohwi,Coptis chinensis Franch,Scutellaria baicalensis Georgi,Aucklandia lappa Decne,Fried Atractylodes macrocephala Koidz,Glycyrrhiza uralensis Fisch six kinds of medicinalherbs,is a Traditional Chinese medicine classic prescription Gegen Qilian Soup combined clinical experience and added Aucklandia lappa,Atractylodes macrocephala to evolve empirical Chineseherbal medicine compoundpreparation which hasthe function of removing detoxification and clearing heat,stopping diarrhea and Stop dysentery and clinically treat damp-heat type diarrhea in children.According to the requirements of Chinese medicine and natural medicine of6.1 categories new drug registration classification,the preparation process and quality standard of Xiaoer Gehuang Zhixie Granules are studied experimentally on system by applying modern science and technology,with the guidance of traditional Chinese Medicine theory,to ensure the scientific and reasonable preparation process and the quality is stable and controllable.Methods:1.The extraction process: With the dry extract rate and the transfer rate of main active components puerarin,baicalin,berberine hydrochloride,costunolide and dehydrocostuslactone were used as the evaluation index.By preliminary test and pharmacodynamic test effect and combined orthogonal design test results,finally determined the extraction process of Xiaoer Gehuang Zhixie Granules.2.Preparation forming process:Through the researching the influence of the different excipients,wetting agents,flavoring agent and their dosage to the granulation and by a number of small tests and three batches of scale-up pilot,finally,the forming process ofXiaoer Gehuang Zhixie Granules was determinedas 3.Study on quality standard: TLC was adopted for the qualitative identification of Pueraria lobata,Coptis chinensis,Scutellaria baicalensis,Aucklandia lappa,Fried Atractylodes macrocephala,Glycyrrhiza uralensis in Xiaoer Gehuang Zhixie Granules and the specificity and durability were investigated.The content of Puerarin,which exists in Pueraria lobata and the content of Berberine hydrochloride,which exists in Coptis chinensis of Xiaoer Gehuang Zhixie Granules was studied by high performance liquid chromatography(HPLC)..Results: 1.The extraction process: Add water in the Pueraria lobata,Scutellaria baicalensis,Aucklandia lappa,Atractylodes macrocepha,Glycyrrhiza uralensis to boil and reflux for three times,each time for 1 hour.Add 12 times the amount of water for the first time,after the decoction boiled,added the Scutellaria baicalensis immediately.Then add 8 times the amount water for the next two times,filtered,combined filtrate,concentrated under reduced pressure to medicinal herbs and the extract ratio 1:1 at 80 ℃(the relative density of 1.20~1.23(50℃)),cooled,add 95% ethanol alcohol precipitation,containing alcohol amounted to 50%,for 12 hours,filtered,and the filtrate was concentrated under reduced pressure to medicinal herbs and the extract ratio 3:1 thick paste at 80℃,dried under reduced pressure into a dry paste at 80℃.Take Coptis chinensis Rhizoma,add 6 times the amount of60% ethanol reflux extraction 2 times,each time 1.5 hour,combined filtrate,80℃ concentrated under reduced pressure to medicinal herbs and the extract ratio 2.7:1(the relative density of 1.25~1.29(60℃))thick paste,dried under reduced pressure into a dry paste at 80℃.Combine with the alcohol precipitated dry pasteand and the alcohol extracted dry paste eventually.2.Preparation forming process: the dry paste powder(80 mesh),1% sucralose,1.5%~2% aspartame and the appropriate amount of sugar powder was mixed,then added the appropriate amount of 95% ethanol alcohol,made into soft material,palletized by 14 mesh,50℃dried,sieved by 16 mesh,add 1%~1.5%solid mint flavor powder,mix well,bagged,that is.3.Study on quality standard: The results show that the sample displays the same spots or fluorescent spots with reference drug or standard drug in the corresponding position,has no negative interference and has good specificity and durability.Through multiple sets of tests and ten batch of pilot study to determine the content of Puerarin in the finished product is not less than 24.0 mg in each bag(4g/bag),the content of Berberine hydrochloride in the finished product isnot less than 35.0 mg in each bag(4g/bag).At the same time,the speciality and durability are good.Conclusion: The preparation method of this product is reasonable,stable and feasible,which provides experimental basis for the production of Xiaoer Gehuang Zhixie Granules.At the same time,the quality standard method is simple and reliable,strong specificity,good repeatability,and can effectively control the quality of the preparation.