杜仲注射液的研制及其体外抑菌效果的研究

发布时间：2018-05-29 06:37

  本文选题：杜仲注射液 + 制备工艺　； 参考：《黑龙江八一农垦大学》2015年硕士论文

【摘要】：为了研制杜仲注射液，并确定其对奶牛乳房炎四种常见病原菌的抑菌效果。本试验采用单因素方法确定药用附加剂以及pH值的最适范围，通过L9(3)3正交试验方法确定最佳附加剂用量和pH值；应用单因素试验对药用活性炭用量、吸附温度、吸附时间进行确定，筛选出最佳的吸附条件；根据《中国兽药典》（2010版）相关规定，对杜仲注射液进行性状检查、可见异物检查、相关物质检查、鉴别试验以及绿原酸含量测定等质量检查，并对其安全性和稳定性进行评价；通过试管二倍稀释法和打孔法研究杜仲注射液对大肠杆菌、金黄色葡萄球菌、乳房链球菌以及停乳链球菌的抑菌效果。 试验结果表明，杜仲注射液最适附加剂添加量范围为：亚硫酸氢钠（W/V）最适用量范围为0.14%～0.16%，吐温-80为（V/V）为0.05%～0.06%，，最适pH值范围为5～6，而亚硫酸氢钠最佳用量为0.14%，吐温-80为0.05%，最适pH值为5；最佳制备工艺为：在预先处理的杜仲叶提取物中加入0.14%亚硫酸氢钠和0.05%吐温-80，调节pH值为5，0.2%药用活性炭（W/V），45℃吸附25min，0.45μm微孔滤膜粗滤，0.22μm微孔滤膜精滤，分装，灌封。质量检查结果显示，杜仲注射液为澄清透明的棕黄色液体，无可见异物、蛋白质、鞣质以及树脂等相关物质，杜仲注射液中杜仲叶提取物含量应为1g/mL，有效成分绿原酸含量不得低于8mg/mL，符合《中国兽药典》（2010版）中的热原检查、异常毒性检查、过敏检查以及溶血检查等安全性试验的相关规定；强光照射试验、高温试验及高湿试验结果显示，光照和高温会引起杜仲注射液中绿原酸含量降低，杜仲注射液应室温避光保存，加速试验以及长期试验结果表明，杜仲注射液质量稳定，无菌、无可见异物或相关物质，符合《中国兽药典》（2010版）稳定性考察标准。杜仲注射液对金黄色葡萄球菌高敏，对大肠杆菌、乳房链球菌、停乳链球菌中敏，最小抑菌浓度均为0.125g/mL；金黄色葡萄球菌最小杀菌浓度为0.125g/mL，其余三种细菌为0.25g/mL；抑菌圈大小分别为18.42mm、14.21mm、12.01mm、12.89mm。 综上所述，杜仲注射液制备工艺可靠，安全稳定，质量可控，对奶牛乳房炎四种常见病原菌有很好的抑制效果。
[Abstract]:In order to develop Eucommia ulmoides injection and determine its bacteriostatic effect on four common pathogens of dairy cow mastitis. In this experiment, the optimum range of medicinal additive and pH value was determined by single factor method, the optimum dosage and pH value of additive was determined by L9 / 3 orthogonal test, and the adsorption temperature was determined by single factor test. According to the relevant regulations of "China Veterinary Pharmacopoeia" (2010), the characteristics of Eucommia injection were checked, and the foreign bodies and related substances were examined. The safety and stability of Eucommia ulmoides injection against Escherichia coli and Staphylococcus aureus were studied by double dilution method and perforation method. Antimicrobial effect of Streptococcus Breast and Streptococcus Breast. The results show that The optimum addition amount range of Eucommia ulmoides injection is as follows: sodium bisulfite (W / V), Tween -80 (V / V), Tween -80 (V / V) 0.05g 0.06, optimum pH value 5 ~ 6, and sodium bisulfite 0.14, Tween -80 0.05 and optimum pH 5, respectively, and the optimal dosage of sodium bisulfite is 0.14, Tween -80 is 0.05, and the optimum pH is 5; The optimum preparation process was as follows: 0.14% sodium bisulfite and 0.05% Tween-80 were added to the pre-treated extract of Eucommia ulmoides leaves, and the pH value was adjusted to 50.2wt% of the medicinal activated carbon (W/ V), which was adsorbed at 45 鈩

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