Study On Yu Zhangdan For Protecting Liver Injury And Its Preparation Process

Objective:(1)To optimize the extraction process of Yu Zhangdan.(2)To study protective effect of Yu Zhangdan extract on mice with acute and chronic liver injury by CCl4.(3)To optimize the preparation process of Yu Zhangdan granules.(4)To establish the quality standard for Yu Zhangdan granules.Metheds:(1)L9(34)Orthogonal test was used to investigate the ethanol concentration,amount of alcohol,extraction time and times with the content offerulic acid as an index.L9(34)Orthogonal test was used to investigate the amount of water,extraction times and extraction time with the content of polydatin as an index.Use the content of polydatin and solid content as index to optimize the purification process.(2)0.125%CCl4(10 mL·kg-1 intraperitoneal injection)-induced acute liver injury model was established in mice,evaluate the protective of Yu Zhangdan extract by the AST and ALT in serum.The chronic hepatic model was built by hypodermic injection of 20%CCl4,5 days one time for 8 weeks,in order to observe the protective of Yu Zhangdan extract by the AST and ALT in serum,pathological change of liver.(3)Select the best excipient and dosage for Yu Zhangdan granules by the evaluation indexs of angle of repose,bulk density,ratio of briquetting,melting rate,moisture rate.(4)Identify of Polygonum cuspidatum,Centella asiatica,Rhizoma Chuanxiong,Curcumae radix in Yu Zhangdan granules by TLC,while the content of polydatin was determined by HPLC.Results:(1)The best extraction process of Rhizoma Chuanxiong and Curcumae radix is using 5 times of 70%ethanol,extract once time for 1.5 hour.The best extraction process of Polygonum cuspidatum et al is using 10 times of water,extract 3 times for 1.0 hour;the best purification process of water extraction is merging all the water extraction together and concentrating to a relative density of 1.10-1.15(60℃),adding ethanol to make sure the concentration is 60%,standing 24 hours and recovering the ethanol.(2)The high dose group of Yu Zhangdan extract can significantly decrease the level of ALT and AST in acute hepatic mice reduced by CCl4(p<0.05).All groups of Yu Zhangdan extract can significantly decrease the level of ALT and AST in chronic hepatic mice reduced by CC14(p<0.05),reduce the liver pathological damage degree.(3)The optimal preparation process of Yu Zhangdan granules:extract powder and mixed excipient(lactose:dextrin:starch =1:1:1)was 1:2.(4)The obtained TLC spots of test sample occurred at the corresponding positions compared to the reference of asiaticoside,frangulic,Rhizoma Chuanxiong,radix curcumae,Negative without interference.The linear range of polydatin was 3.3～44μg·mL-1(r=0.9995),and the average recovery rate was 99.11%,(RSD=1.11%),Moisture,solubility,particle size are in line with the "Chinese pharmacopoeia" 2010 version of the relevant requirements under granule.Conclusions:(1)The optimum extraction process of Yu Zhangdan is simple,high rate extraction of active ingredients and good stability.(2)Yu Zhangdan extract has protective effects on the acute and chronic hepatic injury induced by CC14 in mice.(3)The molding process of Yu Zhangdan is stable and feasible.(4)The TLC and HPLC can be used for the quality control of Yu Zhangdan granules.