Study On Preparation Process And Quality Standard Of Cuyun Granules

Objective: Cuyun granules is based on traditional Chinese medicine theory and a good deal of clinical practice experience.It is made up of Cornus officinalis Sieb.et Zucc.,Rechmannia glutinosa Libosch.,Cuscuta australis R.Br.,Astragalus complanatus R.Br.,Anemarrhena asphodeloides Bge.,Angelica sinensis(Oliv.)Diels,Paeonia lactiflora Pall.,Lycium barbarum L.,Paeonia suffruticosa Andr.,Cyperus rotundus L.and Glycyrrhiza uralensis Fisch.with the effect of nourishing kidney and liver,tonifying Chong and Ren,for the treatment of infertility caused by endometrium receptivity,and curative effect is good.This topic is based on the clinical application and previous research of the original prescription,combined with modern technology,extract the original prescription herbal medicine by water decoction method,dry and powder the extract,add a certain amount of excipients make into granules by wet process,formulate quality standard and investigate of stability Cuyun Granules,in order to develop a new preparation of effective,stable and convenient.Methods:(1)Study on the extraction process: Taking the content of morroniside and loganin and dry extract yield as evaluation index,using single factor experiment method to screen the extraction process of extraction time,water volume and other factors,and then through central composite design-response surface methodology to optimize the best extraction and purification process parameters.(2)Study on the forming process: Taking granulating conditions,solubility,water content,fluidity,granularity and hygroscopicity as the evaluation index,using single factor experiment method to screen the diluent,wetting agent,drying time and other factors of the Cuyun granule,and then through central composite design-response surface methodology to optimize optimum molding process condition.(3)Study on the quality standard of preparation: According to the granules requirements of “general principles of preparation” in the four part of the 2015 edition of People’s Republic of China Pharmacopoeia,for the identification of compounds in traditional Chinese medicine preparations by TLC;the properties,particle size,moisture,solubility and loading difference of the granules were inspected;determine the main effective components of morroniside and loganin content by HPLC method,and conduct the methodological investigation,which provide a feasible and reliable method for the quality control of this preparation.(4)Stability of the preparations: conduct stability test of Cuyun granules,according to the four part of the 2015 edition of People’s Republic of China Pharmacopoeia,investigate the properties,identification,inspection and content of Cuyun granules under the conditions of high temperature test,high humidity test,strong light test,accelerated test and long-run test.Results:(1)The extraction process of Cuyun granules was determined.The optimum extraction process was taking the medicine by prescription,adding15 times amount of water,decocting 2 times,120 minutes per time,with the filtrate,namely.(2)The forming process of Cuyun granules was determined.The optimum forming process was According to the optimum conditions of the extraction process of preparing extract,concentrated and dryed into dry extract powder by microwave vacuum,then powder,mix dry paste powder with diluent(dextrin: lactose=1:4)in a ratio of 1:0.65,sprayed with 80%ethanol solution to make soft material,14 mesh granulating,drying at 70℃for about 1 hours,14 mesh screen the granules,i.e..(3)The quality standard of preparation(Draft)was established.The TLC method was established for the qualitative identification of Cornus officinalis Sieb.et Zucc.,Cuscuta australis R.Br.,Astragalus complanatus R.Br.,and Angelica sinensis(Oliv.)Diels was established.The relevant inspection items of particles were checked and the results were in accordance with the regulations.The mononoside and marcidin were used as the quality control indexes of the granules,and the content limits were specified and the method was reliable,stable and feasible.(4)The stability of Cuyun granules was good.During the test period,all inspection items met the quality standards and relevant requirements under the general rules of granules(Draft)of the 2015 edition of People’s Republic of China Pharmacopoeia,indicating that the properties of granules were stable.Conclusion: This topic studies the preparation process,quality standards and stability of Cuyun granules,establishes a stable and feasible extraction and molding process and quality standards(draft),provides a strong basis for ensuring the quality of dietary supplement.