發(fā)布時間：2018-05-29 06:37

  本文選題：杜仲注射液 + 制備工藝　； 參考：《黑龍江八一農(nóng)墾大學》2015年碩士論文

【摘要】：為了研制杜仲注射液，并確定其對奶牛乳房炎四種常見病原菌的抑菌效果。本試驗采用單因素方法確定藥用附加劑以及pH值的最適范圍，通過L9(3)3正交試驗方法確定最佳附加劑用量和pH值；應用單因素試驗對藥用活性炭用量、吸附溫度、吸附時間進行確定，篩選出最佳的吸附條件；根據(jù)《中國獸藥典》（2010版）相關規(guī)定，對杜仲注射液進行性狀檢查、可見異物檢查、相關物質(zhì)檢查、鑒別試驗以及綠原酸含量測定等質(zhì)量檢查，并對其安全性和穩(wěn)定性進行評價；通過試管二倍稀釋法和打孔法研究杜仲注射液對大腸桿菌、金黃色葡萄球菌、乳房鏈球菌以及停乳鏈球菌的抑菌效果。 試驗結(jié)果表明，杜仲注射液最適附加劑添加量范圍為：亞硫酸氫鈉（W/V）最適用量范圍為0.14%～0.16%，吐溫-80為（V/V）為0.05%～0.06%，，最適pH值范圍為5～6，而亞硫酸氫鈉最佳用量為0.14%，吐溫-80為0.05%，最適pH值為5；最佳制備工藝為：在預先處理的杜仲葉提取物中加入0.14%亞硫酸氫鈉和0.05%吐溫-80，調(diào)節(jié)pH值為5，0.2%藥用活性炭（W/V），45℃吸附25min，0.45μm微孔濾膜粗濾，0.22μm微孔濾膜精濾，分裝，灌封。質(zhì)量檢查結(jié)果顯示，杜仲注射液為澄清透明的棕黃色液體，無可見異物、蛋白質(zhì)、鞣質(zhì)以及樹脂等相關物質(zhì)，杜仲注射液中杜仲葉提取物含量應為1g/mL，有效成分綠原酸含量不得低于8mg/mL，符合《中國獸藥典》（2010版）中的熱原檢查、異常毒性檢查、過敏檢查以及溶血檢查等安全性試驗的相關規(guī)定；強光照射試驗、高溫試驗及高濕試驗結(jié)果顯示，光照和高溫會引起杜仲注射液中綠原酸含量降低，杜仲注射液應室溫避光保存，加速試驗以及長期試驗結(jié)果表明，杜仲注射液質(zhì)量穩(wěn)定，無菌、無可見異物或相關物質(zhì)，符合《中國獸藥典》（2010版）穩(wěn)定性考察標準。杜仲注射液對金黃色葡萄球菌高敏，對大腸桿菌、乳房鏈球菌、停乳鏈球菌中敏，最小抑菌濃度均為0.125g/mL；金黃色葡萄球菌最小殺菌濃度為0.125g/mL，其余三種細菌為0.25g/mL；抑菌圈大小分別為18.42mm、14.21mm、12.01mm、12.89mm。 綜上所述，杜仲注射液制備工藝可靠，安全穩(wěn)定，質(zhì)量可控，對奶牛乳房炎四種常見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

本文編號：1949873