Studies On Preparation Process And Quality Of Fufang Shuangjinqingdan Capsules

Fufang Shuangjinqingdan prescription is the experience prescription from our hospital digestive experts,the famous old Chinese medicine Tang Xiyu director.The composition is Herb lysimachiae,Flos Honeysuckle,Bupleurum,Citrus aurantium,Peony,white peony,Coptis,rhubarb,Coix seed and scutellaria twelve herbs.It has a good effect in right upper quadrant pain,mouth pain,fever,vomiting and other symptoms caused by cholecystitis and cholelithiasis.The prescription is effective,stable and safety.In order to facilitate the use of our hospital,prepared as a capsule,but because of weak basic research,the complexity of traditional Chinese medicine compound,lack of qualitative qualitative and quantitative indicators.The key purpose of this study is to set up the quality and standard of the capsules by studying the preparation technology and stability of Fufang Shuangjinqingdan capsule.Objective:To choose the prepartion process for Fufang Shuangjinqingdan Cspsules,establish its quality control method and investigate its stability.Methods:By means of chlorogenic acid for evalution,the Orthogonal design was used to study the effect of water extracting for acid,by means of dry extract rate for evalution,the orthogonal design was used to study the effect of water extracting;taking the impurity removal rate as the index,the Single factor investigation was carried out to extract the temperature and rotation speed of centrifugation todetermine.The best impurity removal process of the extract;Optimization of the excipients and the best molding process by comparison,the Index of hygroscopicity,flowability,bulk density and relative critical humidity;Used TLC to indentify qualitative identification;Applied HPLC method prescribed to the determination of chlorogenic acid;investigated preparation stability by longterm test and accelerated test.Results:The best extraction process is the use of twelve times the amount of water extraction twice,each extraction for two hours;the optimum centrifugal process was concentrate sample solution to 0.8g per ml,under 25 degrees celsius 5000 round per minute to centriugal separation;take the compound double Jinqing bile capsule dry extract powder by drug ratio(3:1)add dextrin,mix well,rinse with the right amount of 95% ethanol,make soft material,squeeze the 14 mesh sieve,after drying with 14 mesh sieve,packing,filling.The relative humidity of the production environment should be controlled below 74%.TLC was used to analyze the compounds of Coptis chinensis,Scutellaria baicalensis and Rhubarb,and the chromatographic spots were clear and the specificity was good.The HPLC method for the determination 0f chlorogenic acid showed a good linear relationship in the range of 3.426?g~342.6?g(r2=0.9997)and its average recoverywas 98.8 %,RSD was 1.2 %;long-term test(6 months)and accelerated test(6 months)showed that the granules has good stability.Conclusions:The optimum process is feasible,the quality contral methods can effectively control the quality of Fu Fang Shuangjinqingdan capsules.