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Study On Standardization Of Hot - Pressing Steaming Process In

Posted on:2016-05-02Degree:MasterType:Thesis
Country:ChinaCandidate:S L FeiFull Text:PDF
GTID:2134330461492970Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
ObjectiveRadix Aconiti was a big poisonous traditional Chinese medicine,it must processing attenuated then use for clinical. Currently, State pharmacopoeia and local processing Radix Aconiti process for common atmospheric process.not contains hot steamed stir-baked Radix Aconiti,hot steamed Radix Aconiti was used as modern proces sing technology, it has been applied to certain pharmaceutical factory production,but the process of optimizing the evaluation index is different,lead to select the best processing parameters are obviously different. This research intend to studies on standardization of hot pressing Radix Aconiti technology,and conduct a comprehensive legal system of quality comparison between the hot pressing Radix Aconiti slices compare with pharmacopoeia Radix Aconiti, provide scientific basis for its application in the pilot production and collection standards at all levels.Methods And ResultsFirstly, we roundly refered to the ancient and modern literature,sorting Radix Aconiti’s chemical composition, processing technology and quality standards, lay the foundation for the research of carrying out experiments.Secondly, with YX-280-a type of portable pressure steam sterilizer do some little experiments, compare the appearance,three kind of diester and three single ester content, consumption time,choose the suitable method to infiltrate(saturated steam, steam soak slice, wet steaming) and hot-pressing steamed time(0.5h、1h、1.5h、2h). ZYZ500 intelligent extrusion cooking machine to carry out the pilot research, through the pilot running in, finally determine the pilot production process removing stem, soaking to no dry heart, steamed 1h at thermal pressure 0.125MPa (121 ℃), sixty percent dry and then slice,60℃ dry;With pilot ZYZ1200 hot-pressing intelligent cooking machine equipment preparation two origi (jiangyou, hanzhong) 10 batch of pilot sample,checked the shape-property quality, calculate 6 kinds of alkaloids contents by HPLC, results:10 in the batch manufacture have no differences between the traditional quality of Radix Aconiti,6 kinds of alkaloid content have no significant difference (P> 0.05),three system of 10 batches of Radix Aconiti monoester type range at 0.0824%~0.1486% in total alkaloids,consistent with the provisions in the 2010 edition pharmacopeia 0.070%~0.15%,three double ester scope of total alkaloids was range at 0.0020% ~0.0042%,consistent with the provisions in the 2010 edition pharmacopeia is less than 0.04%,so set up SOP for hot steaming Radix Aconiti;Test 5-HMF content on different hot pressing steamed time radix aconiti sample,fond that no such compositions in raw Radix Aconiti,such component content increases with hot-pressing steamed time,and such components increase deepen Radix Aconiti color.Secondly,study testing samples on quality standards,macroscopic observation character color,using machine vision technology to determine pilot slices color,result:two origin of Radix Aconiti products has no significantly difference between the H,S,V, Hot steamed scope of radix aconiti H20.93-21.60,S0.40~0.42,V0.13-0.15,steaming hot pressing products and in the 2010 edition pharmacopeia atmospheric products consistent appearance requirement,machine vision technique can be applied to objective description slices appearance color. make fingerprint research at two origin pilot sample which included raw and processed products. Observed the two origin Radix Aconiti 4 batch system slices for six months on traditional quality and amount of the 6 kinds of alkaloids,examine slices stability,0 to 6 months, pilot 4 batch processed products appearance no difference,three single ester type alkaloid content range at 0.081%~0.147%,moisture content are within the scope of the pharmacopoeia that is lower than 11%,with SPSS17.0,analyzed three single ester type alkaloid content and three pairs of ester type alkaloid content in 6 months,P>0.05,prove four processed products of six kinds of alkaloids from batch to batch has no difference and the pilot process of radix aconiti slices quality is stable;Use 2 origin(jiangyou, hanzhong) 10 batch of pilot sample raw products, result:fingerprint results are the same with clustering analysis,after processing,different origin of Radix Aconiti similarity rising from 98% to 99%,it prove that pilot hot steamed is scientific and practical.Lastly,Comparing the pharmacopoeia atmospheric steaming and hot steamed Radix Aconiti by using 6 kinds of alkaloid contents, traditional character indexes,HPLC fingerprint and mass spectrum methods,result:Hot pressing system of Radix Aconiti internal composition and pharmacopoeia Radix Aconiti are basically identical,the hot pressing process can ensure the quality of system stability;Mass analysis,result:atmospheric pressure steamed Radix Aconiti has 37 peaks, the known composition peak is 20,the unknown is 17,hot steamed Radix Aconiti has 43 peaks,the known composition peak is 21,the unknown is 22. The two common peak is 35. The components has identified,10-OH aconitine is characteristic in atmospheric pressure steaming Radix Aconiti, Hot steaming Radix Aconiti characteristic ingredients is 14-benzoyldeoxyaconine.ConclusionThrough literature study, small experiment and pilot test,we at last determined hot steaming Radix Aconiti process:removing stem, soaking to no dry heart, steamed 1h at thermal pressure 0.125MPa (121 ℃), sixty percent dry and then slice,60℃ dry.The processing technology we choose for Radix Aconiti can make it’s quality basically stable,so we establish a hot pressing steamed Radix Aconiti SOP.Raw Radix Aconiti don’t contain 5-HMF,the higher the component content in Radix Aconiti,the deeper the slices color will be.Atmospheric pressure steaming Radix Aconiti and hot-pressing steaming Radix Aconiti has no significant difference in traditional appearance,6 kinds of alkaloid content and in fingerprint comparison, it provided scientific basis for production, recommended to be included in Pharmacopoeia.
Keywords/Search Tags:Radix Aconiti, Processing, Alkaloid, Standardization
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