Study On The Quality Standard Of Compound Preparations Of Traditional Chinese And Western Medicine Gansukang Tablets

With the development of the combination between Chinese and Western medicine, many new patents of Chinese and Western combined to prevent and cure disease are becoming more and more popular,and compound preparations of traditional Chinese and Western medicine is brought to more attention.At present,the quality standard of compound preparations of traditional Chinese and Western medicine has become hot spot. Each component has respective feature,coupled with diversity and complexity of Chinese composition,all those have brought great difficulties to establish the quality evaluation criterion.For this reason,researching the quality standard has significant meaning to ensure product safe and stable.This thesis take Gansukang tablets as model medicine,was about integrated quality assessment,and the results were provide basis for quality evaluation of compound preparations of traditional Chinese medicine and Western medicine.The main contents and conclusions were as follows:(1) Qualitative analysis and Quantitative analysis of Gansukang tabletsThe TLC methods were used to identify the folium isatidis,flos lonicerae,radix sophorae tonkinensis,acetaminophen and chlorpheniramine maleate of praeparatum,the methods were easy,sensitive,and the reproducibility was well.A HPLC method was developed to simultaneously determine the two marker ingredients adenosine and caffeotannic acid in Gansukang tablets.Mobile phase consisted of Colonial spirit-0.5%glacial acetic acid(0～18min 8:92,18～40min 25:75) with wave length of 257nm.Assay was linear over the range(μg/mL)4.83-48.30 for adenosine, 31.12-186.72 for caffeotannic acid,the two correlation coefficient was all 0.9995.The method was easy,accurate,the reaction rate was accurate,so this method could control the quality of folium isatidis and flos lonicerae effectually in Gansukang Tablets.A HPLC method was developed to assay sophocarpidine in Gansukang tablets. Mobile phase consisted of acetonitrile-absolute alcohol-0.2%triethylamine(8:2:90, pH=3.0 with H₃PO₄) with wave length of 220nm.The method showed good linear relationship in the range of 0.14-1.41μg,the correlation coefficient was 0.9994.The method was easy,accurate,the reaction rate was accurate,so this method could control the quality of radix sophorae tonkinensis effectually in Gansukang tablets. A HPLC method was developed to assay acetaminophen in Gansukang tablets. Mobile phase consisted of Colonial spirit-aquafer- glacial acetic acid(20:80:0.5) with wave length of 245nm.The method showed good linear relationship in the range of 30.66-183.96μg/mL,the correlation coefficient was 0.9997.The method was easy,accurate,the reaction rate was accurate,so this method could control the content of acetaminophen in Gansukang tablets.A HPLC method was developed to assay chlorpheniramine maleate in Gansukang tablets.Mobile phase consisted of acetonitrile-aquafer-triethylamine(15:85:1.5,pH=2.2 with H₃PO₄) with wave length of 264nm.The method showed good linear relationship in the range of 2.39-83.61μg/mL,the correlation coefficient was 0.9999.The method was easy,accurate,the reaction rate was accurate,so this method could control the content of chlorpheniramine maleate in Gansukang tablets.A HPLC method was developed to assay vitamin C in Gansukang tablets.Mobile phase consisted of 0.02mol/mL KDP solution-acetonitrile(90:10) with wave length of 244nm.The method showed good linear relationship in the range of 8.45-84.52μg/mL, the correlation coefficient was 0.9999.The method was easy,accurate,the reaction rate was accurate,so this method could control the content of vitamin C in Gansukang tablets.(2) Appreciation of dissolution in acetaminophen of Gansukang tablets.A method was developed to determine dissolution of acetaminophen in Gansukang tablets.One-factor analysis of variance was used in T₅₀,T_d,m of different batches of sample.The result showed that the difference of dissolution was significant in different batches of Gansukang tablets,and the quality control in process of production should be better.A correlation test was used between disintegration time and T₅₀ of acetaminophen.The result showed that detecting disintegration time can not control the product quality,so inspection of dissolution should be adde.(3) An analytical method of capillary gas chromatography was described for the determination of alcohol residue in five compound preparations of traditional Chinese and Western medicine.The result showed that the five medicine were all consistent with ICH,the method was convenient,sensitive,fast,could be used for the determination of alcohol residue.