Study On The Preparation Technology And Quality Standard Of Liushenqu Dispensing Granules

Objective:Liushenqu is a traditional kind of Chinese medicine for removing food,which is made from wheat bran,flour,bitter almond,red bean,Artemisia annua,Xanthium sibiricum,Polygonum hydropiper fermentation by a certain percentage.It can be used to strengthen the spleen and stomach,help stimulate appetite and digestion.But the material base and the medicinal mechanism are not clear.Throughout the history,different areas of formula standards are not uniform,cause its sales market be very confusing and quality difference is extremely significant.All those influenced its safety and effectiveness of clinical medication.This thesis project to establish the quality standard of Liushenqu by research,on the basis of which can be used to establish the preparation technology and quality standard of the formula granules.Finally,this study can provide a reference for the quality control of Liushenqu.Method:Selected Liushenqu which was produced by sichuan Qianfang Traditional Chinese Medicine Co.Ltd as experimental object.The experiment was divided into three parts.The first part was to establish the quality standard of Liushenqu.Taking the National standard “GB/T 5521-2008”(Inspection of grain and oils—Determination of alpha-amylase activity in cereal and cereal products—Colorimetric method)as the determination method of enzyme activity of ?-Amylase,which had been confirmed stably and feasibly.Besides,the research found that artemisinin was existed in Liushenqu,and can be used for TLC identification and content detection.So both of them were established.Meanwhile,in order to control the overall quality of Liushenqu,the research established the HPLC fingerprint analysis method.The second part was to study the dispensing granules of Liushenqu.Taking enzyme activity of ?-Amylase,yield of solid extracts as indexes,orthogonal test was enployed for optimize the extraction parameters.The temperature of vacuum concentration was screened by enzyme activity of?-Amylase.Taking enzyme activity of ?-Amylase and extract powder yield to screen the parameters of spry drying technology.The parameters of dry granulation were screened by granules property and granules yield.The last part was to establish the quality standard of Liushenqu Dispensing Granules.Results:The quality standard of Liushenqu was established including the prescription,preparation method,character,identification,moisture,determination of content(Amylase and artemisinin),extractum and HPLC fingerprint.Among them,tentatively fix that the moisture should not exceed 10.6%,enzyme activity of Amylase should not be less than 14 U,artemisinin content shall not be less than 46 ppm,water soluble extract shall not be less than 11.1%,alcohol soluble extract shall not be less than 12.0%.In the second part,the optimal preparation technology of Liushenqu dispensing granules was as follows as in bath at 40 ?,adding 10 folds water,extracting for 3 times,lasting for 1.0h each time;vacuum concentration temperature 50 ? and relative concentration density 1.08(50?);powdered extract prepared by spray drying method,and mixed with appropriate excipient to prepare granules by dry granulation.The last part the quality standard of Liushenqu Dispensing Granule was established.Conclusion:This thesis establishes the quality analysis method of Liushenqu,select the optimum preparation technology which is reasonable and feasible.In addition,the draft quality standards are established initially,which provide a reference for the quality control of Liushenqu and its formula particles' industrial production.