复方庆大霉素颗粒剂的质量控制及药效学研究

发布时间：2018-03-28 14:11

本文选题：庆大霉素　切入点：黄芩苷　出处：《西北农林科技大学》2017年硕士论文

【摘要】：本研究通过选用庆大霉素与黄芩苷,经一定配比,采用传统手工湿法,制成复方庆大霉素颗粒剂。并对其进行质量控制、体外抑菌活性、急性毒性以及黄芩苷对庆大霉素毒性的拮抗作用等相关项目的考察,以期为复方庆大霉素颗粒剂在临床上应用提供参考依据。1.庆大霉素与黄芩苷的体外抑菌试验及联合药敏试验本试验经经典二倍管稀释法分别测定庆大霉素及黄芩苷对多杀性巴氏杆菌、无乳链球菌、沙门菌、大肠埃希菌和金黄色葡萄球菌的最小抑菌浓度(MIC)和最小杀菌浓度(MBC)。采用棋盘法测定庆大霉素和黄芩苷联合用药时抑菌浓度,并计算FIC指数。结果表明,庆大霉素对5种菌的MIC分别为:975.2、487.6、121.9、1950.5、487.6μg/mL,对5种菌的MBC分别为:975.2、975.2、121.9、1950.5、121.9μg/mL;黄芩苷对5种菌的MIC分别为:61.0、121.9、30.5、121.9、30.5 mg/mL,对5种菌的MBC分别为:61.0、121.9、30.5、121.9、30.5 mg/mL。庆大霉素和黄芩苷联合药敏结果显示,庆大霉素和黄芩苷联合应用对上述细菌有相加或协同作用。2.复方庆大霉素颗粒剂的制备及质量控制研究经体外抑菌试验确定庆大霉素和黄芩苷的最佳比例,并最终确定此复方庆大霉素颗粒剂的组方配比为:庆大霉素10%、黄芩苷2.5%、β-环糊精87.5%。依据上述组方配比,经传统手工湿法制粒,制备复方庆大霉素颗粒剂。对该颗粒剂的粒度、溶化性、干燥失重等指标进行考察,并采用旋光法测定复方庆大霉素颗粒剂中庆大霉素的含量,采用紫外分光光度法测定该复方制剂中黄芩苷的含量。试验结果显示,该复方庆大霉素颗粒剂的粒度、溶化性、干燥失重等均符合中国兽药典中对于颗粒剂相关指标的规定;庆大霉素的平均含量为24.00 mg/g,为标示量的96%,黄芩苷的平均含量为24.30 mg/g,为标示量的97.2%,均符合相关规定。3.复方庆大霉素颗粒剂的体外抑菌试验经经典的二倍管稀释法测定复方庆大霉素颗粒剂分别对多杀性巴氏杆菌、无乳链球菌、沙门菌、大肠埃希菌、金黄色葡萄球菌的MIC和MBC。测得复方庆大霉素颗粒剂对5种菌的MIC分别为:121.9、243.8、61.0、121.9、61.0μg/mL;MBC分别为:243.8、243.8、61.0、243.8、61.0μg/mL。结果表明,该复方制剂对上述5种菌的抗菌效果均有显著提高。4.复方庆大霉素颗粒剂的急性毒性试验经简化寇氏法分别测定庆大霉素、复方庆大霉素颗粒剂对小鼠的毒性及黄芩苷最大给药量。试验结果显示,庆大霉素对小鼠的LD50是1378 mg/kg,黄芩苷最大给药量是16000 mg/kg,复方庆大霉素颗粒剂对小鼠的LD50是3675mg/kg。黄芩苷对庆大霉素毒性的降低作用,在一定程度上降低了庆大霉素的毒性。此复方药为低毒药物。
[Abstract]:In this study, gentamicin and baicalin were selected to prepare compound gentamicin granules by traditional manual wet method, and their quality control and antibacterial activity in vitro were carried out. Acute toxicity and the antagonistic effect of baicalin on gentamicin, The in vitro bacteriostatic test of gentamicin and baicalin and the combined drug sensitivity test this test was used to determine gentamicin and baicalin by classical diploid tube dilution method. Glycoside against Pasteurella multocida, The minimal inhibitory concentrations of Streptococcus lactis, Salmonella, Escherichia coli and Staphylococcus aureus were determined by chessboard method and the FIC index was calculated. The MIC of gentamicin to 5 strains was: 9755.2487.6C121.9A1950.5487.6 渭 g / mL, the MBC of five strains was: 1 975.2975.2121.9A1950.5121.9 渭 g / mL. the MIC of baicalin to 5 strains was respectively 61.0121.90.50121.90.0.5 mg / mL, and the MBC of 5 strains was: 61.0121.930.5121.90.0.5 mg / mL, respectively. The results showed that the drug sensitivity of gentamycin and baicalin was 30.5121.90.5 mg / mL, respectively. Preparation and quality Control of compound Gentamycin granules; the optimal proportion of gentamicin and baicalin was determined by in vitro bacteriostasis test. The formula of compound gentamicin granules was determined as follows: gentamicin 10, baicalin 2.5, 尾 -cyclodextrin 87.5. According to the above formula, compound gentamicin granules were prepared by traditional wet method. The content of gentamicin in compound gentamicin granules and baicalin in compound gentamycin granules were determined by spectrophotometry, and the results showed that the content of baicalin in compound gentamycin granules was determined by UV spectrophotometry. The granularity, dissolution and dry weight loss of the compound gentamicin granules were all in accordance with the provisions of the Chinese Veterinary Pharmacopoeia. The average content of gentamicin was 24.00 mg / g, and the average content of baicalin was 24.30 mg / g for 96 mg / g. The average content of baicalin was 97.2g / g, which was consistent with the relevant regulation .3.The in vitro bacteriostatic test of compound gentamicin granules was determined by the classical diploid tube dilution method. Dingfang gentamicin granules were used to treat Pasteurella multocida, MIC and MBCof Streptococcus lactis, Salmonella, Escherichia coli, Staphylococcus aureus. The MIC of compound gentamicin granules for 5 strains were determined to be: 1: 121.9243.8 / 61.0121.9 / 61.0 渭 g / mL MBC = 243.8243.83.81.061.0243.81.0 渭 g / mL / mL, respectively. The antimicrobial effect of the compound preparation against the above five bacteria was significantly improved. 4. The acute toxicity test of compound gentamicin granules was determined by simplified Kou's method. The toxicity of compound gentamycin granules to mice and the maximum dose of baicalin. The LD50 of gentamicin to mice was 1378 mg / kg, the maximum dose of baicalin was 16000 mg / kg, and the LD50 of compound gentamicin granules was 3 675 mg / kg. To some extent, the toxicity of gentamicin was reduced.
【学位授予单位】：西北农林科技大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：S853.7

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