Study On The Preparation Technology And Quality Standard Of Hand And Foot Clearing Suppositorie

Hand foot and mouth disease(HFMD)was found widely in the children,caused by enterovirus,especially by coxsackie virus A16(CVA16)and enterovirus 71(EV71).In the mainland of China,vaccine is available for the EV71 by which most of the case with serious complications were caused.However,the vaccine is not effective for the ordinary HFMD caused by other type of virus.So,it’s an important task to develop new effective drugs.Objective:Shouzuqing Formula is a clinical prescription,consisted of Scutellariae Radix,Garadeniae Fructus and other herbs,which is effective for the ordinary HFMD.The formula can clear heat,expel damp,cool blood and remove stasis.The formula was used in the form of enemain clinics.So,the children patients can only be given the drugs by the doctors and nurses.Considering that suppository is easier to carry and use,and more acceptable for the children patients,the formula was prepared into suppository,using the modern medicine preparation techniques to optimize the extraction,purification,concentration,drying and forming process.Methods:This study mainly contains research on extraction,purification,concentration and drying process,forming process and quality standards of Shouzuqing Suppository.The specific methods are as follows:(1)Study on the extraction,purification,and drying process:Adopted single factor test to study the quantity of water during the extraction and concentration process with the extraction rate of baicalin.Referring to the method of Scutellariae Radix in Shuanghuanglian Suppository,extracted and purified the Scutellariae Radix.Adopted orthogonal test to optimize the water extraction process and single factor test to investigate the alcohol precipitation,concentration and drying process with the extraction rate of geniposide.(2)Study on the forming process:Investigated the hygroscopicity and RCH of the extract powder;selected the kind of suppository base;investigated the rate between drug and suppository base;chose proper temperature for preparation and time for cooling;investigated the proper concentration of Tween 80 with the dissolution rate of indecatice components.(3)Study on quality standard:Detected the weight difference and melting time of Shouzuqing suppository,referring to the methods under Suppository of General principle 0107 in the Chinese Pharmaceutical of 2015 edition.Identified the four herbs in Shouzuqing suppository with the method of TLC.Determined the content of baicalin and geniposide with the method of HPLC and the content of patchouli alcohol with the method of GC.Results:(1)The extraction,purification,and drying process:Extract Scutellariae Radix with 8 times water,and concentrate the filtrate with the temperature below 60℃.Optimization of water extraction and purification process:Extract the herbs with 12 times of water for 3times,and 1.5h for each time.Concentrat the filtrate to the relative density of 1.10-1.15 below 80℃,cool the concentration to room temperature and add alcohol to attain the alcohol concentration of 70%,and stand for 12h at 4℃.Concentrated the filtrate below 80℃.Add the extractive of Scutellariae Radix into the water extractive,adjust the PH to 7.0-7.5,concentrat and dry the mixture below 60℃.(2)Forming process:Select mixed fatty acid ester 36 as the suppository base.Make each formula into 3 grain of suppository.Add the extractive powder,patchouli oil and with Tween-80 into the melted base at 45℃,stir the mixture,pour it into the mould,cool at 0℃ for more than 10min.Take out the mould and clip off the drug overflowed the mould,open the mould and take out the suppository.(3)Quality standard:The suppository has low weight difference and proper melting time.The TLC methods for the herbs are accurate.The methods for the determination of content are reliable and stable.The content of baicalin(C21H18O11)shall not be less than 89 mg per gram,geniposide(C17H24O10)shall not be less than 23 mg per gram,and patchouli alcohol(C15H6O)shall not be less than 9 mg per gram.Conclusion:After the research of extraction,concentration,drying and forming pocess,a stable and reliable preparation process was established.Through the study on it’s quality standard,quality and quantity methods were established,and all of them are accurate and stable,and can be used to control the quality of Shouzuqing suppository.