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扑热息痛在PEG400中溶解量达180mg/ml(25℃),在80%PEG400-水共溶媒中溶解量约300mg/ml;35～40%PEG400-水共溶媒是扑热息痛注射液理想的溶剂系统。PEG400的存在可增强扑热息痛在水中的化学稳定性,抗氧剂可阻止扑热息痛水解物对氨酚的氧化而改善注射液色泽。注射液稳定pH值范围为4.5～6.5,预测室温贮藏期t_(0.95)~(25℃)至少3.5年。质量考察证实处方工艺合理,质量稳定。小鼠LD_(50)(ip)为473±42mg/kg(p=0.95),刺激性和溶血性试验均为阴性。
Paracetamol dissolved in PEG400 at 180mg / ml (25 ℃), dissolved in 80% PEG400-water co-solvent about 300mg / ml; 35 ~ 40% PEG400-water co-solvent is the ideal solvent system for paracetamol injection. The presence of PEG400 enhances the chemical stability of paracetamol in water, and antioxidants prevent the paracetamol hydrolyzate from oxidizing paracetamol and improving the color of the injection. The stability of the injection ranged from 4.5 to 6.5, and the storage time at room temperature was estimated to be at least 3.5 years at t 0.95 to 25 ℃. Quality inspection confirmed the prescription process is reasonable, quality and stability. Mice LD_ (50) (ip) of 473 ± 42mg / kg (p = 0.95), irritation and hemolytic tests were negative.