摘要
筛选长效土霉素注射液的最优配方,制备长效土霉素注射液,并对土霉素质量浓度进行测定。通过预试验,确定长效土霉素注射液的各组分及其大致范围,以质量浓度变化量为检测指标,利用正交试验确定长效土霉素注射液的最优配方。制备长效土霉素注射液,并利用紫外分光光度法对土霉素有效质量浓度进行考察,计算其回收率。长效土霉素注射液的最优配方为,每100 mL长效土霉素注射液中含有30 g盐酸土霉素、6 g MgCl2、0.6 g甲醛合次硫酸氢钠、60 mL复合有机溶媒（由甘油甲缩醛和聚乙二醇200按照适当比例配制）、7.5 g聚乙烯吡咯烷酮K175、.4 mL单乙醇胺、其余为注射用水。所制备的长效土霉素注射液在5~30mg/L时呈现良好线性关系,平均回收率为97.86%,RSD为1.15%。该长效土霉素注射液的配方合理,土霉素效价稳定,产品回收率高。
The study was done to select the optimal formula,prepare and determine the mass concentration of long-acting oxytetracycline injection.The mass concentration of the approximate range in the oxytetracycline injection was determined through pre-test.The optimal formula of long-acting oxytetracycline injection is determined by using of orthogonal experiment.Prepare long-acting oxytetracycline injection and determine the mass concentration of long-acting oxytetracycline injection by UV spectrophotometry.The results showed that,the optimized formula of long-acting oxytetracycline injection（in 100 mL Volume） was composed of oxytetracycline hydrochloride 30 g,magnesium chloride 6g,sodium formaldehyde sulfoxylate 0.6g,complex organic solvent（composed by A glycerol acetaland polyethylene glycol 200）60 mL,polyvinylpyrrolidone（PVP） K17 7.5 g,ethanolamine 5.4 mL and water for injection.There is fine linear relationship for the mass concentration range which oxytetracycline hydrochloride unit is 5～30 mg/L.The average recovery was 97.86% and coefficient of variation was 1.15%.In conclusion,the production of long-acting oxytetracycline injection formula is reasonable and practical for stable potency and high recovery rate of oxytetracycline hydrochloride.
出处
《西北农业学报》
CAS
CSCD
北大核心
2011年第8期35-38,共4页
Acta Agriculturae Boreali-occidentalis Sinica
基金
陕西省重大科技创新专项基金(K332020916)
