将2种聚酯酸酐(P(SA∶RA 20∶80),P(SA∶RA 30∶70))分别与伊维菌素溶于三氯甲烷中作为有机相,以聚乙烯醇水溶液为水相,用乳化溶剂挥发法制备出2种伊维菌素聚酯酸酐微球.采用光学显微镜考察所制备微球的形态及粒径,紫外分光光度法测定载药量和包封率.结果显示,制备出的P(SA∶RA 30∶70)/IVM微球的平均粒径为(72.240±24.747) μm,载药量为19.67％,包封率为87.70％.P(SA∶RA 20∶80)/IVM微球的平均粒径为(64.18±26.14) μm,载药量为17.72％,包封率为87.27％.这表明采用乳化溶剂挥发法成功制备出2种伊维菌素聚酯酸酐微球.

【Objective】 The study was conducted to prepare compound oxytetracycline hydrochloride injection and determine its mass concentration.【Method】 The formula components and approximate dosage of the compound oxytetracycline hydrochloride injection were determined through pre-test.We used sodium metabisulfite,magnesium chloride,ethanolamine and complex organic solvent as effecting factors,and took changes of the mass concentration of metronidazole and oxytetracycline hydrochloride as the selection standard.Finally the optimal formula of compound oxytetracycline hydrochloride injection was determined using orthogonal experiment L9(34).We also determined the mass concentrations of metronidazole and oxytetracycline hydrochloride in the compound injection by UV spectrophotometry,and calculated the recovery percent and the precision.【Result】 The optimized formula of compound oxytetracycline hydrochloride injection(in 100 mL Volume) was composed of metronidazole 2.5 g,oxytetracycline hydrochloride 5.0 g,magnesium chloride 3 g,sodium Pyrosulfite 0.2 g,complex organic solvent(composed of N,N-dimethyl formamide and polyethy leneglycol 400 with a volume ratio of 2∶1) 40 mL,ethanolamine 4 mL,and water for injection.There was fine linear relationship between the mass concentration and absorbance when metronidazole and oxytetracycline hydrochloride was 1-30 μg/mL.The average recovery of metronidazole was(99.22±1.48)%,and its coefficient of variation was 1.49%.The average recovery of oxytetracycline hy-drochloride was(98.22±1.24)%,and its coefficient of variation was 1.26%.By measuring the daily precision and the day to day precision,the average concentration of metronidazole and oxytetracycline hydrochloride was high,and the relative standard deviation was low and no greater than 2.00%.【Conclusion】 The production of injection formula was reasonable and practical for stable potency with high recovery percent of metronidazole and oxytetracycline hydrochloride.