Primary Research On The Process And Quality Control Of Xangqin Zhili Tablets For Animals

The diarrhea of dogs and cats is one of the common clinical diseases in pets.If pets with diarrhea are not treated in time,they can suffer from severe dehydration,electrolyte imbalance,stunted growth and even death.Xiangqin Zhili tablets for treating dampness-heat diarrhea syndrome are made up of Natrii Sulfas Exsiccatus,Pogostemonis Herba,Scutellaria baicalensis Geogi,Rheum officinale Bai.l in a certain proportion by our laboratory,belonging to tablets made of Chinese medicine semi-extract.According to prevoius work of our laboratory,Xiangqin Zhili tablets have a good clinical efefct on the treatment of dampnessheat diarrhea syndrome in dogs,chickens and other animals.Thus,in this thesis the preparation process and quality control research of tablets were mainly optimized,with the optimization of the preparation process in tablet apperance,quality diference,friability,disintegration time and costs,and a qualitative indentification and content determination method using baicalin as an inductor component.At the same time,a method for checking the microbial limit of tablets was established,in order to provide a certain theoretical basis for clinical applications.This thesis mainly was carried out the following tests on tablets:Test Ⅰ Optimization of the preparation process of Xiang Qin Zhi Li tabletsAccording to the preparation process of semi-extract tablets of traditional Chinese medicine,tablets are prepared by wet granulation and compression method.Firstly,the Rheum officinale Bail.and Pogostemonis Herba are pulverized,mixed with Natrii Sulfas Exsiccatus;Scutellaria baicalensis Geogi etc.are decocted and concentrated;the powder is mixed with the decoction to prepare a soft material,wet granulated and dried,and finally compressed.The productivity and angle of response obtained from the granules prepared by soft materials are used to evaluate the fluidity of granules.Then,the appearance of the tablet after compression,the differences in tablet weight,friability,disintegration time and price are used as the evaluation indicators to comprehensively evaluate the quality of the tablet.The experiment results show that granules rate made from soft materials with or without fillers is about 80%,and the angle of repose is all < 40°.Weight variation of tablets meets standards of Pharmacopoeia of the People’s Republic of China in each group,the disintegration time is about 20 min,and the friability is less than 1%.It is finally determined that the volume of decoction is 1000 m L,the amount of remaining drug powder is 1000 g,the amount of corn starch is 125 g,and the quantity of carboxymethyl cellulose sodium is200 g in the prescription of tablets.These resuluts have shown that all the properties and indices of tablets prepared under this prescription process meet the quality requirements of Chinese medicine semi-extract tablets stipulated in the Chinese Pharmacopoeia,and the price is relatively low.Test Ⅱ Optimization of qualitative and quantitative detection method of baicalin in Xiangqin Zhili tabletsIn order to effectively determine the quality of Xiangqin Zhili tablets,this thesis uses the index component of the mian drug of Scutellaria baicalenesis Georgi as an indicator to establish a method for qualitative and quantitative monitoring of tablet quality by Thin-Layer Chromatography and High Performance Liquid Chromatography methods.In the volume ratio of ethyl acetate: 2-butanone: formic acid: water =5:3:1:1,8 μL spot sample quantity,4℃ developed and 80℃ dried under the condition of Fe Cl3 colour development reagent,the baicalin in 1.0000 g tablets powder can be effectively indentify.Under the HPLC conditions of acetonitrile~0.1% phosphoric acid as the mobile phase,a single injection 10 μL,a flow rate 1.0 m L/min,a column temperature 25℃ and the UV detection wavelength 280 nm,the content of baicalin can be determined in each 1.0000 g tablet is between 63.1~76.0 mg fast and stably.Test Ⅲ The detection of microbical limit tests of Xiangqin Zhili tabletsAccording to and improving the two common limit tests methods(the pour-plate method and the membrane filtration method)in the fourth part of the 2015 edition of Pharmacopoeia of the People’s Republic of China,the recovery rate of bacterial colony of qualified preparations is specified to be 50%~200%.In order to check whether the content of common microorganisms(Staphylococcus aureus,Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans,Aspergillus niger)in Xiangqin Zhili tablets meets requirements,we determined the recovery rate of bacterial colony in tablets.The results show that the recovery rate of the bacterial colony required is between 80% and 130% by using the pour-plate method;the recovery rate of bacteria of the membrane filtration method can be counted except Aspergillus niger,and the rest of bacterial recovery rate is 100%~130%.No bacteria were detected in the negative control group throughout the experiment.Because when the surface area of filter membrane is very small,it is very inconvenient to use membrane filtration method to count the spores of Aspergillus niger during the growth process.Combined with the actual application effect,it can be obtained that the pour-plate method is more effective because it has the advantages of simple operation.