| 摘要: |
| 【目的】制备复方盐酸土霉素注射液，并对其质量浓度进行测定。【方法】通过预试验，确定复方盐酸土霉素注射液的配方组分及其大致用量。以焦亚硫酸钠、MgCl2、乙醇胺和复合有机溶媒为影响因素，以灭菌前后盐酸土霉素和甲硝唑质量浓度变化为考察指标，利用L9(34)正交试验确定复方注射液的最优配方。利用紫外分光光度法对注射液中甲硝唑和盐酸土霉素的质量浓度进行考察，并计算其回收率和精密度。【结果】复方盐酸土霉素注射液的最优配方为：每100 mL注射液中含有2.5 g甲硝唑、5.0 g 盐酸土霉素、3 g 氯化镁、0.2 g焦亚硫酸钠、40 mL复合有机溶媒(由N,N-二甲基甲酰胺和聚乙二醇 400组成，体积比为2∶1)、4 mL乙醇胺，其余为注射用水。甲硝唑和盐酸土霉素在1～30 μg/mL质量浓度时与吸光度呈现良好的线性关系。制备的复方盐酸土霉素注射液中甲硝唑的平均回收率为(99.22±1.48)%，变异系数为1.49%；盐酸土霉素的平均回收率为(98.22±1.24)%，变异系数为1.26%。注射液中甲硝唑和盐酸土霉素的日内、日间精密度测定结果为：平均质量浓度较高，相对标准偏差较小，且不大于 2.00%。【结论】确定的复方盐酸土霉素注射液配方合理，甲硝唑和盐酸土霉素稳定性好，且回收率高。 |
| 关键词: 盐酸土霉素 甲硝唑 正交试验 紫外分光光度计法 |
| DOI： |
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| 基金项目:西北农林科技大学大学生科技创新项目（2201110712040） |
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| Preparation of compound oxytetracycline hydrochloride injection |
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| Abstract: |
| 【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. |
| Key words: metronidazole oxytetracycline hydrochloride orthogonal UV |
