| Objective:The main research work of this subject is to carry on the research to the clinical prescription modified allergic granule,to make the granule,to overcome the shortcomings of the traditional decoction,such as the traditional decoction is not easy to be boiled,the dosage is large,the preservation is inconvenient,it is not easy to carry,the taste is poor,etc.To give full play to the advantages of the granule which is easy to carry,easy to preserve and benefit to take,and to provide a certain theoretical basis for the further development and i m p r o v e m e n t o f t h e p r e p a r a t i o n.Methods:1.In the study of the preparation technology of Modified Guomin Decoction,the literature study was carried out on the prescription Chinese medicinal materials.The main active components in the medicinal materials for the treatment of allergic diseases were respectively extracted by alcohol and water according to the different polar sizes.Single factor and orthogonal test were used to select the best process.2.In the aspect of molding technology,the best molding technology is optimized by selecting the type of auxiliary material,determining the amount of flavoring agent,drying temperature,drying time and so on,taking particle forming rate and appearance shape as index.3.In terms of quality control,a thin-layer chromatographic identification method for radix saposhnikoviae,dark plum and schisandra chinensis was established,and the content of polysaccharide andβ-sitosterol was determined by colorimetric method and high performance liquid chromatography.4.In the anti-allergic asthma efficacy experiment,OVA sensitization and challenge BALB/c mice were used to prepare allergic asthma model.By observing the behavioral response during the excitation phase,cell counting and classification counting of BALF precipitation,determination of total Ig E,OVA-s Ig E levels were initially evaluated for the effectiveness of flavored allergy granules in the treatment of asthma.Results:1.The content of total polysaccharide andβ-sitosterol and their obtained ointment were selected in the water extraction group and the alcohol extraction group.The comprehensive evaluation method was used as the evaluation standard,and the single factor and orthogonal test were used to optimize the water extraction.The optimal extraction conditions of the group were added with 16 times of water,soaked for 1 hour,extracted twice for 2.5h each time;the best extraction conditions of the alcohol extraction group were 16 times of 95%ethanol,soaked for 1h,and extracted twice for 2h each time.According to the composition and properties of the thick paste,the thick paste was finally selected:starch:dextrin=1:1:1,and the best granulation effect was obtained by drying in a hot air circulating drying oven at 80℃for 2h.The angle of repose of the finished product is 32°on average,which is in line with the particle packing requirements.3.The auxiliary materials were established by TLC identification method of radix saposhnikoviae,dark plum and schisandra chinensis.The results showed that the chromatogram of the test sample and the reference material of the drug and the reference substance showed the same color spot at the corresponding position,and the negative control solution chromatogram showed no corresponding position.Spot can be used for the identification of Chinese medicinal materials;colorimetric method for polysaccharide content,regression equation Y=0.0085x+0.0604,correlation coefficient R~2=0.9991;HPLC method for determination ofβ-sitosterol content,regression equation:Y=216.34x+84.861,linear coefficient R~2=0.9997.The method is accurate,sensitive and reproducible.4.In the pharmacodynamic study,compared with the model group,the symptoms of sneezing,cough,shortness of breath,restlessness,abdominal breathing,etc.,which were induced by asthma in asthmatic mice in the group of allergic granules were significantly reduced(P<0.01-0.05),the percentage of total leukocytes and eosinophils,neutrophils in the high-dose and middle-dose groups of BALF were significantly lower(P<0.01),and the total number of white blood cells and eosinophils in the low-dose group.The proportion of neutrophils was significantly decreased(P<0.01),lymphocyte changes were not obvious,and serum total Ig E and OVA-s Ig E levels were significantly decreased(P<0.01).Conclusion:This topic has studied the preparation process of flavored allergy granules,established a stable and feasible extraction process and molding process,and carried out quality and drug efficacy test research,basically achieving the purpose of quality control,ensuring safe and effective drug use.Further development and expansion of production provide a theoretical basis. |
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