| Purpose: The provisions of this experiment is in the hospital prescription on the basis of the formula ratio of screening and optimization,the quality control of the granules of methodology and standards to conduct a comprehensive,optimizing the best extraction and preparation technology.Method:Adopting efficient uniform experimental design method(equal level constraints)statistical calculations to determine the formula ratio;According to the different nature of the differences of effective components using the extraction methods of science,modern,high feasibility scheme is determined,the alcohol reflux extraction and alcohol soluble compounds,water vapor distillation to extract the volatile oil composition,decocting method to extract the water-soluble components,etc.Method L9(34)orthogonal design to determine the best extraction conditions;Careful study of preparation process each link.According to the characteristics of the effective components uses the classic,reliable and accurate HPLC method,UV ultraviolet spectrophotometry and thin layer chromatography and TLC to detect the quality of the active ingredients.Result: 1.The comprehensive method of uniform design and LARS regression formula screening will eventually determine the formula of medicinal materials and the formula is:angelica 15 g,including 15 g,safflower 12 g,mulberry parasitism 8 g,kudzuvine root 5 g,honeysuckle 5 g.2.All kinds of effective components of the best experimental conditions for:alcohol soluble active ingredients by ethanol heating reflux extraction,with best solution for ten times the amount of 80% ethanol extract twice,each time 2 h;Water vapor distillation extract volatile components with 10 times the amount of water extraction efficiency is highest,after the extraction time is 4 h,the amount of volatile oil reached the maximum value,no longer increases with the extension of time,the volatile oil extraction quantity of about 0.41 ml;Water-soluble component from former medicine bibulous rate is 2 times the amount,soak 30 min,the final process conditions were determined for the first time to join12 times the amount of water,soaking 0.5 h,extract 1.5 h,the separation of liquid,in the liquid to the second ten times the amount of water,extracting 1.5 h,a total of extract twice.3.preparation aspect to determine the best inclusion process conditions for volatile oil,volatile oil,beta cricoid dextrin was 1:6,distilled water,beta cricoid dextrin 3:1,milling time is 90 minutes.using the reduced pressure concentration method will be condensed water decoction to concentrate after the relative density of about 1.10,concentrate on spray drying,spray drying set the inlet temperature of 170 ℃,material flow rate of 450 ml/h.Conclusion: This experiment through the established methodology,find the accurate and stable detection means,formula was determined by the formula screening of volume ratio,through the process optimization to find the optimal extraction process and the preparation process,through quality standards makes the preparation quality and content is verified,all inspection and test results are in accordance with the relevant requirement of the latest edition of Chinese pharmacopoeia 2015,on the basis of conform to the theory of traditional Chinese medicine drug laws made use of the advantages of modern technology,has strong research significance and realistic feasibility. |
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