头孢噻呋混悬注射液的研制及疗效试验

Preparation and Efficacy of Ceftiofur Suspension Injection

研究了复方头孢噻呋混悬注射液处方、物理稳定性和对临床产超广谱β-内酰胺酶(ESBLs)鸡志贺氏菌感染的疗效.利用试管二倍法筛选出头孢噻呋和他唑巴坦联用(质量比为2∶1)对产ESBLs的鸡志贺氏菌较为敏感,最小抑菌质量浓度(MIC值)为16 mg.L-1,质量分数是头孢噻呋MIC值(>128 mg.L-1)质量比的1/8;复方头孢噻呋混悬液由主药、辅料0.2%羧甲基纤维素钠和1.2%司本-80制备而成,沉降比为0.997,再分散性良好.经过在温度为60℃、湿度为75%环境下加速试验6个月后观察,颜色无变化,无粘壁现象,无颗粒凝结,表明物理稳定性良好;该制剂按20 mg.kg-1肌内注射1次,对产ESBLs鸡志贺氏菌感染的治愈率为77%,有效率为85%.

This paper studied the prescription of compound ceftiofur suspension, physical stability and its efficacy against inducedly ESBLs-producing shigella flexneri infection in chichens. The combination of ceftiofur and tazobactam sodium（m： m = 2：1 ） screened by microdilution method in the experiment is the most susceptive drugs against shigella flexneri among all combinations, its MIC （minimal inhibitory concentration） is 16 mg · L^-1, being one eighth time as susceptive as that（ 〉 128 mg · L^-1） of ceftiofur; the compound ceftiofur suspension injection is made from this screened prescription and subsidiary substances including CMC-Na （0.2%） and sorbitan mono-oleate （ 1.2% ）. Its sediment ratio is 0. 997 and disparity is good. No suspension sticking clump, granule aggregating and color changes were found after the compound had accelerated testing at 60 ℃ temperature and 75% humidity for six months. This result reveals the phsical stability of the prepared suspension is good. The curative rate and the effective rates of this suspension against ESBLs-producing shigella flexneri infection in chicken is 77% and 85% respectively after a single intramuscular injection of 20 mg · kg^-1