| Objective:Frist,to study the preparation technology and quality standard on Qingfei Huatan granule and to make the preliminary study on stability.Second, to discuss the therapeutic effect and drug safety of Qingfei Huatan granule through pharmacodynamic study with antitussive and expectorant experiment index on Qingfei Huatan granule.Methods:Frist,to study the preparation process stability and pilot on Qingfei Huatan granule which have been preparated by the method of water extracting.To investigate The appearance of the character, water soluble, load difference and hygiene of the granule,while using the method of thin layer chromatography to identificate the component on Qingfei Huatan granule include Lonicera Japonicaã€Forsythia suspensaã€Glycyrrhizaeã€Coelogyne fimbriata for the purpose of establish the quality standard of those drugs.During the stability study we take accelerated test and and sample observation method at room temperature.Second,using aqueous ammonia, phenol red, endotoxin, mouse ear swelling and bacteriostatic ring to anlyse Qingfei Huatan Granule on antitussive expectorant, antipyretic, anti-inflammatory, antibacterial action respectively.Third, to take intragastric administration on mouse for seven days with the maximum dosage.To observe the diet, activity and the survival rate of mouse. To observate mouse organs weather have pathological changes through Anatomy.Results:Frist,the preparation process to Qingfei Huatan granule is below: adding8times amount of water extracting for2times, each time for1.5hours, filtering, merging two extracted liquid, concentrated to a relative density of1.15to1.25(80degrees measured) clear paste, vacuum drying, crushing into fine powder, dry extract powder adding dextrin, Steviosin amount, mixing, granulation, drying, made of1000g, that is. Second,quality standards,This product is light brown granules; micro gas, sweet, bitter, good water-solubility, effective ingredients content standards. Mould content per gram of not more than20, were not detected in Escherichia coli, living, Escherichia coli, Staphylococcus, Pseudomonas aeruginosa per gram of not more than10.3, the experimental results show that the drug stability, appearance character identification, inspection, hygiene and other indicators within three months were not significantly changed.4, pharmacodynamic experiment shows, Qingfei Huatan granule can effectively reduce the experimental animal cough frequency and number of times, increased respiratory phenol red excretion, decreased by endotoxin caused by elevated body temperature, inhibit the ear swelling of mice induced by xylene in two, against Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus has, certain antibacterial effect.5, Qingfei Huatan Granule on mouse stomach lavaging of maximum dose of62.29g/kg, equivalent to181.67times the amount of clinical adult, and dosing during murine normal activities, the water eating normal color luster, no abnormal phenomenon.Conclusion:Frist, Qingfei Huatan Granula in the test research shows that the medicine preparation process, good stability, quality inspection in full compliance with national standards. Qingfei Huatan granule stability test results consistent with preclinical drug quality standard requirements, the preparation in the quality of basic stability during storage, storage period is tentatively scheduled for24months.Second, Qingfei Huatan granule can effectively to cold caused by coughing, sputum, fever, inflammation, and has good inhibition. Thrid, acute toxicity test, experimental animal abnormal behavior, and the dosage is much higher than that of clinical dosage, Qingfei Huatan granule clinical medication safety. |