摘要
目的以正交试验法优化对乙酰氨基酚大容量注射液处方工艺,确定适合大生产的关键工艺参数范围。方法采用正交设计优化影响制剂质量的四个关键因素,即中间产品pH值、药用炭用量、灭菌条件和残氧量,以优选确定的最佳处方工艺参数进行连续三批样品的大生产,并进行影响因素考察。结果对乙酰氨基酚注射液的最优生产工艺条件组合为:pH值控制在5.0左右,加入0.01%(m/v)的活性炭,在121℃,15 min条件下灭菌,充氮控制残氧量为低于4%。60℃高温和光照10 d放置样品的含量、有关物质与0 d相比,几乎无明显变化。结论确定了适合对乙酰氨基酚大容量注射液大生产的关键工艺参数范围,工艺稳固,样品质量稳定可控。
Objective To optimize the prescription of Aeetaminophen Infusion （ AI ） by orthogonal design, and confirm the ranges of critical process parameters that suitable for large - scale production. Methods The four critical factors, con- taining pH values of intermediate product, the amount of medicinal charcoal, sterilization condition and residual oxygen, were optimized by orthogonal design. Three consecutive batches of AI were manufactured to further confirm the ranges of process parameters, and the influencing factors were investigated. Results The optimum formula and process parameters were the pH was about 5.0 ,the amount of medicinal charcoal was 0.01% （m/v） ,the sterilization process parameter was 121 ℃ for 15 min and the residual oxygen was below 4%. From the stress test, AI showed good physical and chemical stability after high temperature of 60 ℃and illumination for 10 d. Conclution The optimized manufacturing process parameters were confirmed and the product showed good quality.
出处
《药学研究》
CAS
2013年第5期277-279,共3页
Journal of Pharmaceutical Research
