Study On The Quality Control And Pharmacodynamics For Compound Gentamycin Sulfate Granules

In this study,gentamicin and baicalin were used to made compound gentamicin granules by traditional manual wet method.And the quality control of compound gentamicin granules,in vitro antibacterial activity,acute toxicity and baicalin on the antagonism of gentamicin toxicity and other related projects of the study,in order to provide a reference for the clinical application of compound gentamicin granules.1.In vitro antibacterial test of gentamicin and baicalin and combined drug susceptibility test.The minimum inhibitory concentration(MIC)and minimum bactericidal concentration(MBC)of gentamicin and baicalin on Pasteurella multocida,Streptococcus agalactiae,Salmonella,Escherichia coli and Staphylococcus aureus were determined by the classical double tube dilution method.The inhibitory concentration of gentamicin and baicalin was determined by the checkerboard method,and the FIC index was calculated.The MIC of gentamicin on five kinds of bacteria were: 975.2,487.6,121.9,1950.5,487.6 ?g/mL;and the MBC of the five strains were: 975.2,975.2,121.9,1950.5,121.9 ?g/mL respectivel;the MIC of baicalin on five kinds of bacteria were: 61.0,121.9,30.5,121.9 and 30.5 mg/mL;MBC were: 61.0,121.9,30.5,121.9 and 30.5 mg/mL.The results of combination of gentamicin and baicalin showed that,gentamicin and baicalin in combination with the above-mentioned bacteria have additive or synergistic effect.2.Preparation and Quality Control of Compound Gentamicin GranulesThe best proportion of gentamicin and baicalin was determined by in vitro antibacterial test,and the ratio of gentamicin granules was 10%,baicalin 2.5%,?-cyclodextrin 87.5%.According to the composition of the above formula,through the traditional manual wet granulation,made of compound gentamicin granules.The particle size,solubility,dry weight loss and other indexes of compound gentamicin granules were investigated,the content of gentamicin in compound gentamicin granules was determined by optical rotation method,the content of baicalin in the compound preparation was determined by ultraviolet spectrophotometry.The results showed that the particle size,solubility,dry weight loss and other related items of the compound gentamicin granules were in accordance with the relevant provisions of the Chinese veterinary pharmacopoeia for granules;the average content of gentamicin was 24.00 mg/g,96% of the indicated amount,and the average content of baicalin was 24.30 mg/g,which was 97.2% of the indicated amount,which accorded with the relevant regulations.3.In vitro antibacterial test of compound gentamicin granulesThe minimum inhibitory concentration(MIC)and minimum bactericidal concentration(MBC)of compound gentamicin granules on Pasteurella multocida,Streptococcus agalactiae,Salmonella,Escherichia coli and Staphylococcus aureus were determined by the classical double tube dilution method.The MIC of compound gentamicin granules on five kinds of bacteria were:121.9,243.8,61.0,121.9,61.0 ?g/mL,and MBC were: 243.8,243.8,61.0,243.8 and 61.0 ?g/mL respectively.The results showed that the compound gentamicin granules had a significant effect on the antibacterial effect of the above five kinds of bacteria.4.Acute toxicity test of compound gentamicin granulesThe toxicity of gentamicin,compound gentamicin granules to mice and the maximum dosage of baicalin were determined by simplified method.The test results show that,the LD50 of gentamicin to mice was 1378 mg/kg,the maximum dose of baicalin was 16000 mg/kg,the LD50 of compound gentamicin granules was 3675 mg/kg.The effect of baicalin on the toxicity of gentamicin reduced the toxicity of gentamicin to a certain extent.The compound gentamicin granules are low toxicity drugs.