| The recipe of "Jiangtang Tongmai”is based on the national health guru Zhongying Zhou’s many years clinical practice.It uses the method of Yiqiyangyin and Qingyure to treat Qiyinliangxu and Shireyuzu for diabetes and kidney.The recipe of "Jiangtang tongmai" includes ten herbs such as Euonymus alatus,Whitmania pigra Whitman,C,uscuta chinensis,Anemarrhena asphodeloides et al.The paper according to the policy requirements of national drug regulatory and technical requirements for drug research to carrying out the study on Chinese herbal compound granule for "Jiangtang Tongmai".In addition,esTab.lishment of the criteria of quality control for the king herb Euonymus alatus of the recipe was determined according to Chinese Pharmacopoeia(Ed.2010)methods.Research work will be summarized as follows:1.Study on Extraction processThe paper used single factor experiments to study the relationship between the rate of paeonol extraction from Paeonia suffruticosa and the amount of distillate by single factor experiments.Observed three indicators that the color of the distillate,FeCl3 reaction and the weight of Paeonol.When 15-fold distillate was collected the rate of Paeonol extraction can reach 99%.Then orthogonal design to optimize the process of water extraction for the residue of Paeonia suffruticosa and other nine herbs.Test the transfer rate of Hyperoside and Mangiferin and the extract rate of water extract.Comprehensive evaluation to measure four factors that water multiples,boiling time,soaking,boiling number.The results show that better process was extracted twice.The first,add 10-fold water of the total weight of herbs(including 2-fold Herbs absorbent),soaking for 30 minutes,boiling for 60 minutes.The second,add 8-fold water,boiling for 60 minutes.The extracts were combined.And then three validation batches proved that the process was sTab.le.2.Study on purification processTest the retention rate of Hyperoside and Mangiferin and the extract rate of ethanol precipitation solution to determine three factors that ethanol concentration,extraction solution concentration before ethanol precipitation.The results show that the extract solution was concentrated to the relative density about 1.16～1.17(50 C).Then medicinal alcohol was added slowly.So that ethanol content of 60%.And kept 18 hours at 4℃.The resulting solution was filtered and distilled under vacuum at 50～60 C.And then three validation batches proved that the process was sTab.le.3.Study on molding processUsed dry granulation and selected orthogonal experiment L9(34)to evaluation molding process based on the composite score of forming rate,angle of repose,moisture absorption,bulk density and melting properties.The results show that the purification solution distilled to the relative density about 1.30(50 C).Add 1 times the amount of,add 1-fold dextrin of the total weight of purification solution(Rd≈1.30)The resulting mixture is stirred and dried under vacuum at 60℃.Then dry granulation.And then three validation batches proved that the process was sTab.le.However,it was need to add paeonol in the actual production.Therefore,Dextrin should be less than 1-fold(about 90%).Then dried and pulverized,and add paeonol and the right amount of dextrin to deploy the total dose.4.The criteria of quality control for Jiangtang Tongmai GranulesThrough examination of the three batches of test particles in moisture,granularity,melting resistance,microbial limits and heavy metals(arsenic salt).The test results show that three batches of granules were in line with regulations of Chinese Pharmacopoeia(Ed.2010).Meanwhile,the paper esTab.lished a HPLC method for the content of hyperoside and mangiferin.Hyperoside contained not less than 1.9 mg per bag,mangiferin not less than 10 mg.TLC identification of Whitmania pigra Whitman,Astragalus,Paeonia suffruticosa,Rheum palmatum,Scrophularia ningpoensis.Negative control without interference and specificity.It can be used as the criteria of quality control for Jiangtang Tongmai Granules5.The criteria of quality control for Euonymus alatusFocusing on 10 different sources of Euonymus alatus,the paraffin section and photomicrographic techniques were used to describe microscopic characters.The contents of moisture,ash,solvent extract were determined according to Chinese Pharmacopoeia(Ed.2010)methods.The results show that the microscopic characters of ten different sources of Euonymus alatus were basically the same pattern without striking differences.The contents of moisture were 13.8%±0,9%,aqueous extracts 9.3%±1.2%,alcoholic extracts 7.3%±0.9%,total ash 8.4%%±1.8%,and acid-insoluble ash 2.9%±1.0%.The developed TLC spots were quite clear,and a red spot obtained with the given samples all corresponded in position and color to the spot obtained with the reference naringenin in the chromatogram.The contents of total flavonoids were 2.8%11.0%,and naringenin 0.006%±0.005%.All these data mentioned above can be used as the reference standards for evaluating quality of Euonymus alatus. |
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