Preparation Of ZiQi Granules And Its Effect On Mouse's Immune Function

Astragalus,a kind of invigorating vital energy herb,which have the function of invigorating Qi for strengthening superficies and can enhance immunity function strikingly;Echinacean purpurea is the health product,which has been commonly used in American and Europe for prevention and treatment of upper respiratory infection.This study combined the Chinese materia medica and the western herbal medicine based on their effectiveness and prepared ZiQi granules for clinical application,perfected the preparation technology of ZiQi granules,detected qualitatively and quantitatively on the common quality and active component,and had the acceleration stability test to make the standardization of the quality control of ZiQi granules and the perfect preparation technology,and had the acute toxicity experiment on ZiQi granules that compared with the YuPingFeng granules to research the effect of ZiQi granules on the immune function of the immune suppression mice.According to the requirement of preparation technology of Traditional Chinese medicine granules,orthogonal experiment was designed for the preparation technology of ZiQi granules,the percentage of drugs and adjuvants,the quantum of the adjuvant,the kind of adjuvant(the different percentage of cane suger and starch),alcohol concentration,the dose of alcohol were all the investigation factors.Base the uniformity on the investigation index of granules to design 3 levels to have(L₉3⁴)orthogonal experiment.The result showed that the best preparation technology of ZiQi granules was medicne:adjuvant=1:1,cane sugei:starch =1:9,the concentration of alcohol was 90%, the volume of ues of the alcohol is 20%.Taking the best preparation technology to make 3 batches of ZiQi granules,the average uniformity(92.6%) and relative standard deviation(1.6792) all indicated that the technology condition is stable.According to the requirement of Drug granules in the veterinary Pharmacopeia of People's Republic of China,2005 edition,the routine quality detection on ZiQi granules showed that the moisture content,grade size,dissolubility and the difference of content are all accord with the requirement of the veterinary Pharmacopeia,the bulk density,angle of repose and hydroscopicity all can meet the requirement of the granules production.According to the regulation of the People's Republic of China veterinary Pharmacopeia, lamellar detection was taken to assay the active component and the content of chicoric acid in ZiQi granules to make a standardization of quality control to meet the company production.The results showed that the separation effect is good to detect Astragalus mongholicus with trichloromethane:methanol:water(13:7:2) as developing agent and to detect Echinacean purpurea with methylbenzene:acetidin:methanoic acid(5:4:2) as developing agent,to establish the determination methods of the chicoric acid from ZiQi granules with HPLC,acetonitrile: 0.2%phosphoric acid(25:75)was used as the mobile phase,the standard curve regression equation wss:Y=75142960X-439842(R=0.9998),the results showed that:when the concentration of chicoric acid between 0.020～0.10mg/mL,linear correlation is very good;the sample is stability within 24h while RSD%is 2.73;the average recovery is 97.9563%,RSD%is 1.5312;the content of the chicoric acid from ZiQi granules is≥3.0 mg/g.The 6 months accelerated test showed that ZiQi granules was accord with the regulation of the veterinary Pharmacopeia in 2 years,the character,the content of chicoric acid,grade size,moisture content,dissolubility,the difference of content and lamellar detection all suited with the requirement on the ZiQi granules in the People's Republic of China veterinary Pharmacopeia.The acute toxicity testing on mice indicated that the maximum dose(160g/kg) of ZiQi granules in a day was 123 times that of the recommended dose(0.026g/day).There were no difference between experiment group and control group in spirit,appetite and pathological change of organs, the results showed that ZiQi granules had a broad medical safety margin of is and a little toxicity in clinics.The mice model with immune suppression made by injecting 75μg/g CORT were divided into 3 groups and respectively given different dosage of ZiQi granules,YuPingFeng granules,Echinacean purpurea granules by intragastric administration to research the effect on the immune suppression mice.The result showed that the ZiQi granules can strikingly enhance the immune function of the mice and have a better effect on immune suppression mice to strengthen their phagocytose function of peritoneal macrophage than YuPingFeng granules,have a corresponding effect with Echinacean purpurea granules and YuPingFeng granules on the function of lymphocyte,and have an obvious effect than Echinacean purpurea granules and YuPingFeng granules on boosting blood serum erythrocytolysin of immune suppression mice.The little dose ZIQi granules have a corresponding function with Echinacean purpurea granules and YuPingFeng granules on enhancing spleen index of immunosuppression mice.