Study On The Preparation Of The Compound Qinggan Sugar Free Granules

Objective: The Compound Qinggan sugar free granules is an empirical prescription which has been excavated from Guangxi folk and has been applied for many years in Chinese medicine to treat alcoholic liver injury.It is made up of five medicinal materials including Pueraria,red ginseng and angelica.Based on clinical Decoction and the previous studies,the compound Qinggan Decoction was changed into granules,through the analysis of prescription and dosage form of screening,this paper has made a study on the preparation process,quality standard,preliminary stability and anti liver injury effect via the application of new technology of modern pharmaceutical research,in order to develop a new preparation of effective,stable and convenient.Methods:(1)Study on the extraction and purification process: Taking the Puerarin Content and the dry paste rate as the evaluation index,using single factor experiment method to screen the extraction process of extraction time,ratio of material to liquid level and purification process in relative density,the concentration of alcohol,alcohol precipitation time and other factors,and then through the central composite design and response surface method 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 types,dosage of excipients and drying temperature of the sugar free granule,and then through the central composite design and response surface method 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 radix puerariae,radix ginseng,Radix Angelicae sinensis,Flos Sophorae and medlar by TLC;the properties,particle size,moisture,solubility,load difference and dissolution of the granules were inspected;the main effective components of Pueraria prescription,ginsenoside content was determined by HPLC method,and the provisions of the content limits,which provide a feasible and reliable method for the quality control of this preparation.(4)Stability of the preparations: According to the four part of the 2015 edition of People's Republic of China Pharmacopoeia,the influencing factors tests,accelerated tests and long-term tests of the compound Qinggan sugar free granules were carried out to investigate the stability of the preparations.(5)Preliminary study on pharmacodynamics of the preparation:A model of liver injury induced by alcohol was used to investigate the protective effect of the Compound Qinggan sugar free Granules on alcoholic liver injury in mice.Results:(1)The extraction and purification process of the compound Qinggan sugar free granules was determined.The optimum extraction and purification process was as follows: Taking the medicine by prescription,adding 11 times amount of water,the herb soak for 120 minutes,decocting 2 times,each time for 100 minutes,with the filtrate,concentrated to the relative density ratio of 1.10(25 C),adding ethanol to 72% alcohol concentration,the refrigerator for 36 hours,filtering,recovery of alcohol,namely.(2)The forming process of the compound Qinggan sugar free granules was determined.The optimum forming process was as follows: According to the first part of the "2.3" under the optimum conditions of the extraction and purification process of preparing extract,the extract containing fine powder of red ginseng was mixed with 3 times the amount of diluent(dextrin: Lactose =0.8:1),the soft material made with 75% ethanol solution,14 mesh sieve granulation,drying at 65?for about 1 hours,14 mesh screen the granules,packaging,i.e..(3)The quality standard of preparation(Draft)was established.For the identification of compounds in traditional Chinese medicine preparations by TLC,the chromatographic spots were clear;on the characteristics,particle size,moisture,solubility,load difference and dissolution of inspection results in accordance with the relevant provisions;HPLC method of puerarin and ginsenoside were quantitatively analyzed and the method is reliable,stable and feasible.(4)The stability of the compound Qinggan sugar free granules was good.During the six month trial,there was no obvious change in the character,identification,examination and content of the compound liver free sugar free granules,which was in line with the relevant regulations.(5)Low,medium and high dose of the Compound Qinggan sugarless granules could reduce ALT,AST,GT mice,MDA value,the high and middle dose is significant,the difference was statistically significant(P<0.05 or P<0.01);studies in liver pathology,compared with model group,the liver pathological damage of other drug delivery group was reduced.Conclusion:(1)The extraction and purification process and molding process of the compound Qinggan sugar free granules are safe and reliable,and the reproducibility is good.(2)The quality standard of the preparation(Draft)is feasible,quality controllable,and qualitative and quantitative analysis has good separation,high sensitivity and good reproducibility.All the inspection accords with the relevant regulations.(3)The preliminary stability of the preparation provides a theoretical basis for the practical production of the preparation.(4)The compound Qinggan sugar free granules have protective effect on the liver injury of alcoholic mice.