The Preliminary Study On The Preparation Technology And Quality Standard Of Yipi Ruangan Pills

Objective:Liver fibrosis,one kind of clinical common diseases,is the liver wound healing response to liver injury caused by various reasons,which makes patients suffer.Liver fibrosis is the pathological features of most chronic liver diseases.Yipi Ruangan prescription is derived from clinical and good effect in the treatment of liver fibrosis,which is composed of Bupleurum,Angelica,Turtle and other herbs composition.But the traditional one is not convenient for carrying and storing,so it is necessary to prepare the traditional decoction of modern preparations.Chinese medicine concentrated pill has become a trend because of the small dose,easy to take and transport,not easy to mildew,good for storage,safety and effective.Therefore,we prepared Yipi Ruangan Pills for the treatment of liver fibrosis.The preparation process was preferably made into concentrated pellets under the guidance of traditional Chinese medicine theory,combining with pharmacological research of traditional Chinese medicine,and use modern form?lation technology.Thin layer chromatography and high performance liquid chromatography was used to establish qualitative and quantitative analysis methods to provide a basis for clinical safety and effective preparation.Method:1.Preparation processAfter literature query of 12 herbs in the original prescription,the main active composition and physicol-chemical properties were sorted,and the extraction process was classified.The main effective ingredients in Bupleurum,Poria,Atractylodes,turtle,red peony,Citrus aurantium were water soluble ingredients,so water extraction was chosen for this part.In the water extraction process,the amount of water,extraction time,extraction times were taken as investigate times,the content of Paeoniflorin,saikosaponin A and dry extract rate as index;The main effective ingredients in Angelica,capillaris,honeysuckle,turmeric were alcohol soluble ingredients,so ethanol extraction was chosen.In the alcohol extraction process,the amount of alcohol,extraction time an extraction times were taken as investigate times,the content of Fer?lic acid,chlorogenic acid and dry extract rate as index.Orthogonal extraction process L9(3~4)was used to select the best extraction process,and the best extraction process was verificated.Dried white ginseng and pangolin did not extract,powder used as a medicine.Preparation of Yipi Ruangan Pill by plastic molded method.2 Quality standardsThin layer chromatography(TLC)was used to determine the qualitative identification of Bupleurum,Angelica and Ginseng in the prescri ption.The contents of saikosaponin A,paeoniflorin,fer?lic acid and chlorogenic acid in Yipi Ruangan Pill were determined by high performance liquid chromatography(HPLC).And the water content,weight difference and dissolution time of Yipi Ruangan Pill were studied.Res?lts:1.Res?lts of preparation processThe best extraction technology of Yibu Ruangan Pill was screened by the orthogonal experiment.The best water extraction technology was Bupleurum,Poria,Atractylodes,turtle,red peony,Citrus aurantium plus 10 times the amount of water,boiling 3 times,each fry Cook for 3 hours.The best alcohol extraction process was angelica,capillaris,honeysuckle,t?lip plus 8 times the amount of 80%ethanol,reflux extraction 3 times,1.5 hours each time.The alcohol extract was filtered and the ethanol was recovered and concentrated under reduced pressure to a pressure of about 1.10(measured at 80?).The aqueous extract was concentrated under reduced pressure to a density of about 1.10(80?).The extracts were combined in 80?drying,vacuum drying oven dry extract,moisture content<5%,crushed into fine powder,100 mesh sieve.Dried white ginseng and pangolin were crushed into powders,and mixed two fine powder evenly.Preparation of Yipi Ruangan Pill by plastic molded method.2 Quality standardsColor of Yipi Ruangan Pill was black brown and smell was bitter.Bupleurum,Angelica,red peony,raw sun ginseng were identified in Yipi Ruangan.The contents of saikosaponin A,paeoniflorin,fer?lic acid and chlorogenic acid were determined by high performance liquid chromatography.Conclusion:This study established the preparation technology of Yipi Ruangan Pill,which was scientific and reliable and suitable for industrial production.The initial quality standard of Yipi Ruangan Pill was established,and the method was accurate and reliable for controlling the quality of Yipi Ruangan Pill.