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目的:考察不同处方布洛芬注射液临床使用稀释液的稳定性。方法:将不同处方布洛芬注射液与0.9%氯化钠注射液和5%葡萄糖注射液配伍,稀释液终质量浓度分别为4,2,1 mg.mL-1,考察其24 h内澄清度、pH值、布洛芬含量和有关物质。结果:精氨酸与布洛芬摩尔比为0.92∶1.00的注射液,用0.9%氯化钠注射液稀释,终质量浓度为4,2 mg.mL-1;用5%葡萄糖注射液稀释终质量浓度为4,2,1 mg.mL-1时均出现不同程度的浑浊。精氨酸与布洛芬摩尔比为1.01∶1.00的注射液,用上述输液稀释,终浓度为4,1 mg.mL-1时,均为澄清溶液,24 h内外观、pH值、布洛芬含量、有关物质基本无变化。结论:精氨酸与布洛芬摩尔比为1.01∶1.00、pH7.9的布洛芬注射液,与上述两种输液配伍,终质量浓度为4,1 mg.mL-1,在室温、24 h内稳定。
Objective: To investigate the stability of different dilutions of clinical ibuprofen injection. Methods: Different formulations of ibuprofen injection and 0.9% sodium chloride injection and 5% glucose injection compatibility, the final dilution of the concentration of 4,2,1 mg.mL-1 were investigated within 24 h of clarification Degree, pH, ibuprofen content and related substances. RESULTS: An injection of arginine with an ibuprofen molar ratio of 0.92: 1.00 was diluted with 0.9% sodium chloride injection to a final concentration of 4,2 mg.mL-1; the final concentration was diluted with 5% dextrose injection At 4,2,1 mg.mL-1, the turbidity appeared in different degrees. Arginine and ibuprofen molar ratio of 1.01: 1.00 injection, diluted with the above infusion, the final concentration of 4,1 mg.mL-1, were clear solution within 24 h appearance, pH, Fen content, the basic changes in the relevant substances. Conclusion: The ibuprofen injection with molar ratio of arginine to ibuprofen of 1.01:1.00 and pH7.9 was compatible with the above two infusions with the final concentration of 4,1 mg.mL-1 at room temperature, 24 h stable.