Study On The Preparation Process And Quality Standard Of Ganzhiqing Granule

Objective: Chinese medicine prescriptions which has been in clinical use for several decades were selected for experimental drugs in the study,developing drugs preparation of liver fat particles for the treatment of fatty liver using modern preparation technology.Its quality control method had been established and its preliminary stability had also been studied.The clinical efficacy and safety was demonstrated by pharmacodynamic test in vitro and related acute toxicity test,which would provide the basis for the formulation development into newChinese medicine.Methods:(1)Preparation Process:(1)Volatile oil extraction process: Supercritical CO2 extraction technology was chose for the extraction of prescription of volatile oil,and the best extraction process was optimized by orthogonal experiment design with naphtha yield as evaluation index.(2)Water extraction process: On the basis of the single factor investigation,extraction process was optimized by using orthogonal experimental design,with baicalin content and extract rate of comprehensive score as evaluation index.(3)Volatile oil inclusion process: With the yield of inclusion compound and volatile oil conversion rate as evaluation index,?-cyclodextrin inclusion volatile oil process was investigated by orthogonal experiment design.(4)Concentrated and dried process: concentrated time and baicalin content evaluation as evaluation index,preferably concentrated condition;baicalin content,dry cream powder melting of control indicators,preferably the best drying method(5)Molding process: Commonly used materials were filtered using single factor experiment,then coupled with star design-response surface method to optimize the liver fat granule molding process.(2)Quality standard research: The rhizoma coptidis,radix scutellariae,acid-insoluble ash,poria,dried tangerine ororange peel,and white chloe,etc.in the anagraph were detected qualitatively by TLC.The study set up a HPLC method to determine the content of baicalin and berberine hydrochloride which is the main effective ingredients in the preparation,and tested the preparation according to the method of granules(general rule 0401)on Edition 2015(4)of Chinese Pharmacopoeia.(3)Preliminary Stability: according to the product quality standard and stability test requirements,examine the long-term stability of the drug in the test conditions director 0,3,6,9,12 months.(4)Acute toxicity studies: by hepatic lipid clear on acute toxicity,and to explore their safety.Results:(1)Preparation Process:(1)Water extraction process: Volatile oil extraction process: The best conditions for supercritical extraction were: pressure of 35 mpa,temperature of 35?,time of 3h,and volatile oil has the highest output.(2)The optimal extraction process was as following: adding 8 times amount of water,extracting 3 times,2 hours each time.(3)Volatile oil inclusion process: the optimal inclusion process was: proportion of cyclodextrin and volatile oil of 35 g/mL,saturated temperature of 40?,saturated time of 3h.(4)Concentrated and dried process: using concentrated under reduced pressurewith 70?to clear liver lipid extract was concentrated,dried and concentrated paste spray dried to give way to dry paste powder.(5)Molding process: the comprehensive score high and economic price of dextrin was chose in the single factor experiment,combined with the star design to optimize the best molding process was: 12% dextrin,90% alcohol for preparation of liver fat particles.(2)Quality standard research: The quality standard for Ganzhiqing granular formulation was preliminarily established,and the method was simple and feasible.(3)Preliminary Stability: The product packaging for 12 months at room temperature,the indicators are in line with regulations,good initial stability.(4)Acute toxicity studies: liver fat Granule show low toxicity,acute toxicity tests by security.Conclusion: The best preparation technology was screened in this study,which was simple,viable and reasonable,and all the index accorded with relevant requirements.Furthermore,the quality standard for Ganzhiqing granular formulation was preliminarily established by a simple and feasible method,and Ganzhiqing granular has a good initial stability,with a significant lipid-lowering effect,and safe non-toxic in the doses applied.