本文選題：甲磺酸培氟沙星 + 對乙酰氨基酚　； 參考：《西北農(nóng)林科技大學(xué)》2015年碩士論文

【摘要】：目的:本試驗以甲磺酸培氟沙星為主藥,確定了用于治療由培氟沙星敏感菌所導(dǎo)致的各種感染的復(fù)方口服制劑,并且利用紫外分光光度計法建立了測定方法,同時又從其理化性質(zhì)、穩(wěn)定性、體外抑菌效果以及安全性等方面對復(fù)方甲磺酸培氟沙星口服液做了深入的研究,以確定其能否成為一種廣譜的、新型、高效、安全可靠的抗菌解熱藥,從而給以后復(fù)方甲磺酸培氟沙星口服液在獸醫(yī)臨床上的開發(fā)及應(yīng)用提供有效的理論依據(jù)。方法:①根據(jù)口服液自身的特征和各成分的屬性,確定口服液中所用增溶劑、絡(luò)合劑、防腐劑等的最佳組成及其比例。②利用紫外分光光度法,建立含量分析方法。③通過強光照射試驗、高溫和低溫試驗以及加速試驗考察復(fù)方甲磺酸培氟沙星口服液的穩(wěn)定性。④對沙門氏菌、金黃色葡萄球菌、無乳鏈球菌、大腸桿菌這4種細菌MIC試驗確定其體外抑菌濃度。⑤依據(jù)急性毒性試驗對復(fù)方甲磺酸培氟沙星口服液進行安全性評價。結(jié)果:本試驗篩選出來的最佳配方是:甲磺酸培氟沙星2%,對乙酰氨基酚0.2%,絡(luò)合劑EDTA-2Na適量,防腐劑焦亞硫酸鈉適量,增溶劑乙醇和PEG400適量,純化水加至100mL。通過紫外分光光度法,在277 nm和202 nm處分別測定復(fù)方甲磺酸培氟沙星口服液中甲磺酸培氟沙星和對乙酰氨基酚的含量,該分析方法的精密度高,回收率和重復(fù)性好。穩(wěn)定性試驗結(jié)果表明,復(fù)方甲磺酸培氟沙星口服液對光照敏感、對溫度變化不敏感,需要避光保存。該制劑對沙門氏菌、金黃色葡萄球菌、無乳鏈球菌、大腸桿菌這4種細菌的均有抗菌活性,較甲磺酸培氟沙星單藥的抗菌活性有明顯的提高。對雛雞的LD50為1453.3mg/kg,這表明該制劑安全性良好,毒性低,臨床上可以廣泛應(yīng)用。結(jié)論:本試驗確定的復(fù)方甲磺酸培氟沙星口服液,符合質(zhì)量要求,且制備工藝簡單,可以擴大生產(chǎn)應(yīng)用于獸醫(yī)臨床。
[Abstract]:Objective: to determine the compound oral preparation of pefloxacin mesylate for the treatment of various infections caused by pefloxacin sensitive bacteria, and to establish a method for its determination by ultraviolet spectrophotometer.At the same time, the physical and chemical properties, stability, bacteriostatic effect in vitro and safety of compound pefloxacin mesylate oral liquid were studied in order to determine whether it could become a broad spectrum, new type and high efficiency.Safe and reliable antimicrobial and antipyretic drugs, thus providing an effective theoretical basis for the development and application of compound pefloxacin mesylate oral liquid in veterinary clinic.Methods according to the characteristics of oral liquid and the properties of each component, the optimum composition and proportion of solvent, complexing agent and preservative used in oral solution were determined by UV spectrophotometry.A method for content analysis was established. 3 the stability of compound pefloxacin mesylate oral liquid was investigated by high light irradiation test, high temperature and low temperature test and accelerated test. 4 pairs of salmonella, Staphylococcus aureus, streptococcus lactococcus were studied.According to acute toxicity test, the safety of compound pefloxacin mesylate oral liquid was evaluated by MIC test of Escherichia coli.Results: the optimum formula was: pefloxacin mesylate 2, paracetamol 0.2, EDTA-2Na proper, sodium pyrosulfite proper, solvent ethanol and PEG400 appropriate, purified water 100mL.The content of pefloxacin mesylate and paracetamol in compound pefloxacin mesylate oral liquid was determined by UV spectrophotometry at 277 nm and 202 nm, respectively. The precision, recovery and repeatability of the method were high.The results of stability test showed that the compound Pefloxacin Mesylate oral liquid was sensitive to light and not sensitive to temperature change, so it needed to be preserved without light.The antimicrobial activity of this preparation against salmonella, Staphylococcus aureus, streptococcus acidis and Escherichia coli was significantly higher than that of pefloxacin mesylate.The LD50 of chicks was 1453.3 mg / kg, which indicated that the preparation was safe, low toxicity and could be widely used in clinic.Conclusion: the compound pefloxacin mesylate oral liquid can meet the quality requirements, and the preparation process is simple, which can be used in veterinary clinic.
【學(xué)位授予單位】：西北農(nóng)林科技大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：S859.79

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