The Pharmaceutical Research Of Huang Bai Granules

Bacillary dysentery caused by Shigella dysenteriae is an intestinal infectious disease,with popular range,fast transmission,widespread population susceptibility,and easy to repeated infection.Its morbidity and mortality are among the top of the infectious diarrhea.Treatment of diarrhea using Traditional Chinese Medicine can address both the symptoms and root causes with syndrome differentiation and have less adverse reaction.Huang Bai Granules are based on clinical experience with the research and development into traditional Chinese medicine compound preparations.The particles are composed of rhizoma coptidis,radix pulsatillae,radix paeoniae alba,cortex fraxini,costustoot and combination of appropriate excipients.Huang Bai Granules are customized medicine for children and have small side effects with the treatment of bacillary dysentery to ensure children's safety.This thesis mainly studied the preparation process,quality control,stability and pharmacodynamics of the Huang Bai Granules,the results are as follows:The best alcohol extraction process was chosen through single factor test and orthogonal test with using berberine extraction rate as the index and granular molding process were determined through the formulation research.The optimum extraction process was determined as follows: ethanol concentration was 60%,solvent dosage was 6 Times,extraction time was 2h,and extraction times were 3 times.The filtrate was condensed and dried into paste powder,which was mixed with pharmaceutical excipients according to the 1:1.The mixture was made of particles with 90% ethanol,and the particles were dried in 40?,then sorted and packed.The preparation process is stable and high yield,indicating that we can enlarge the production.Establishing the identification method of rhizoma coptidis,cortex fraxini and costustoot by TLC and setting up the method of content of berberine hydrochloride in Huang Bai Granules by HPLC and validating the method.The results showed that TLC method was simple and specific;HPLC method was high sensitivity and good separation effect,which had good linearity,specificity,repeatability and recovery,etc.So the two methods can be included in quality standards of Huang Bai Granules.The preliminary stability research of Huang Bai Granules showed that the stability of the product was good,but the content of berberine would be slightly lower under the condition of high temperature,high humidity,and light.So the product should be stored in a cool,dry,and out of the light place.The result of pharmacodynamics research of the diarrhea caused by castor oil in mice proved that Huang Bai Granules had anti-diarrhea effect,and the effect was better than the traditional decoction.