复方鱼腥草颗粒剂的质量控制及药效学研究

发布时间：2018-04-23 09:53

本文选题：鱼腥草 + 质量控制　；参考：《西北农林科技大学》2017年硕士论文

【摘要】：根据中兽医学辨证论治的基本理论及中药的功能主治,制备复方鱼腥草颗粒剂,并进行体外抑菌试验以及急性毒性试验来确定其抑菌效果及安全性,为临床的应用提供参考依据。1.单药和复方的体外抑菌试验采用二倍管稀释法测定了鱼腥草、黄芪、连翘、金银花以及复方鱼腥草对金黄色葡萄球菌、无乳链球菌、大肠埃希菌、沙门菌、多杀性巴氏杆菌的最小抑菌浓度(MIC)和最小杀菌浓度(MBC)。结果显示,复方鱼腥草的抑菌效果大于各单药。2.复方鱼腥草颗粒剂的制备与质量控制试验将鱼腥草、黄芪、连翘和金银花按42%、9%、4.5%和4.5%以及β-环糊精40%的比例,以手工湿法制备复方鱼腥草颗粒剂。颗粒剂的粒径介于200μm~2000μm之间,颜色为棕褐色。考察复方鱼腥草颗粒剂的粒度、干燥失重、溶化性等指标,并用紫外分光光度含量分析方法测定了复方鱼腥草颗粒剂中总黄酮和多糖的含量。结果显示,复方鱼腥草颗粒剂的粒度、干燥失重、溶化性等指标均符合兽药典规定;总黄酮的平均含量为39.1 mg/g,多糖的平均含量为281.9 mg/g,分别为标示量的97.8%、94.0%,符合药物制剂的要求。3.复方鱼腥草颗粒剂的体外抑菌试验采用二倍管稀释法测定了复方鱼腥草颗粒剂对金黄色葡萄球菌、无乳链球菌、大肠埃希菌、沙门菌、多杀性巴氏杆菌的最小抑菌浓度(MIC)和最小杀菌浓度(MBC),结果显示,复方鱼腥草颗粒剂对以上5种细菌的MIC(mg/mL)分别为45.71、45.71、182.86、365.71、182.86;MBC(mg/mL)分别为45.71、91.43、365.71、731.43、365.71。与复方鱼腥草煎液的体外抑菌试验结果比较可以发现,将复方鱼腥草煎液制成颗粒剂对抑菌和杀菌效果没有影响。4.复方鱼腥草颗粒剂的急性毒性试验根据急性毒性试验对复方鱼腥草颗粒剂进行安全性评价,测得LD50大于10000mg/kg。根据WHO规定,如果LD50在5000~15000 mg/kg,为实际无毒药物。故复方鱼腥草颗粒剂安全性良好,属于实际无毒药物,临床使用安全可靠。
[Abstract]:According to the basic theory of Chinese veterinary medicine and the function of traditional Chinese medicine, compound Houttuynia cordata granules were prepared, and the bacteriostatic test and acute toxicity test in vitro were carried out to determine the bacteriostatic effect and safety of compound Houttuynia cordata granules. To provide reference basis for clinical application. 1. In vitro bacteriostatic tests of single drug and compound were used to determine the effects of Houttuynia cordata, Astragalus membranaceus, Forsythia suspensa, Flos Lonicerae and compound Houttuynia on Staphylococcus aureus, Streptococcus alacinus, Escherichia coli and Salmonella. Minimal inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) of Pasteurella multocida. The results showed that the bacteriostatic effect of compound Houttuynia cordata was higher than that of each single drug. Preparation and quality control test of compound Houttuynia granules compound Houttuynia granules were prepared by manual wet method with the ratio of 42Houttuynia, Astragalus membranaceus, Forsythia Forsythia and Flos Lonicerae at the ratio of 4.5% and 4.5% and 40% of 尾 -cyclodextrin. The particle size was between 200 渭 m and 2000 渭 m, and the color was brown. The granularity, dry weight loss and solubility of compound Houttuynia cordata granules were investigated. The contents of total flavonoids and polysaccharides in compound Houttuynia cordata granules were determined by UV spectrophotometry. The results showed that the granularity, dry weight loss and dissolution of compound Houttuynia granules were in accordance with the requirements of the Veterinary Pharmacopoeia, the average content of total flavonoids was 39.1 mg / g, and the average content of polysaccharides was 281.9 mg / g, respectively, which was 97.8% and 94.0% of the marked amount, which was in line with the requirements of drug preparation. In vitro bacteriostatic test of compound Houttuynia cordata granules the effects of compound Houttuynia granules on Staphylococcus aureus, Streptococcus lactococcus, Escherichia coli and Salmonella were determined by double tube dilution method. The minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBCL) of Pasteurella multocida were respectively 45.71and 45.71182.86MBCmg / mL, respectively. The results showed that the MICM / mLs of compound Houttuynia cordata granules against the above five bacteria were 45.71and 365.1182.86MBCmg / mL, respectively, and 45.71C / mL91.43365.71,731.43365.71, respectively. Compared with compound decoction of Houttuynia houttuyniae in vitro, it was found that the preparation of compound decoction of Houttuynia cordata had no effect on bacteriostatic and bactericidal effect. Acute toxicity test of compound Houttuynia cordata granules according to acute toxicity test the safety of compound Houttuynia cordata granules was evaluated and the LD50 was measured to be more than 10 000 mg / kg. According to WHO, if LD50 is at 5, 000 g / kg, it is actually non-toxic. Therefore, compound Houttuynia granules are safe and safe in clinical use.
【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

【相似文献】