注射用鼠神经生长因子制备方法的优化  

Optimization of the Preparation Method of Mouse Nerve Growth Factor for Injection

作　　者：钟贞[1] 廖亮亮 扈会平[1] ZHONG Zhen;LIAO Liangliang;HU Huiping(Lizon(Group)Pharmaceutical Factory,Zhuhai,Guangdong 519045,China)

机构地区：[1]丽珠集团丽珠制药厂,广东珠海519045

出　　处：《今日药学》2023年第11期827-830,共4页Pharmacy Today

基　　金：广东省科技计划项目(粤科资字[2022]57号)。

摘　　要：目的优化注射用鼠神经生长因子的制备方法。方法首先对注射用鼠神经生长因子冻干赋形剂的种类进行筛选,根据筛选结果对赋形剂组分比例开展进一步研究,优化冻干工艺,采用经优化的处方、冻干工艺制备注射用鼠神经生长因子样品,并对样品的关键质量属性开展稳定性研究。结果使用单一赋形剂不能达到良好的冻干效果,而当混合使用甘露醇和右旋糖酐40两种赋形剂,且其比例为4∶1时,即使在减少人血白蛋白用量情况下,也能获得冻干时间短且成型良好的冻干产品,且稳定性符合质量标准要求。结论该优化的制备方法有效地缩短了注射用鼠神经生长因子冻干步骤的耗时,提高了生产效率,同时可保证产品的稳定性良好,保障临床用药安全有效。OBJECTIVE To optimize the preparation method of mouse nerve growth factor for injection.METHODS Firstly,the types of lyophilized excipient of mouse nerve growth factor for injection were screened,and the proportion of excipient components was further studied according to the screening results,and the lyophilized process was optimized.The samples of mouse nerve growth factor for injection were prepared using optimized prescription and lyophilized process.The stability of the key quality attributes of the sample was studied.RESULTS A single excipient could not achieve a good freeze-drying effect.When mannitol and dextran 40were mixed and the ratio was 4∶1,a freeze-drying product with short freeze-drying time and good shape could be obtained even when the amount of human blood albumin was reduced,and its stability met the requirements of quality standards.CONCLUSION The optimized preparation method can effectively shorten the time of lyophilization of mouse nerve growth factor for injection,improve the production efficiency,ensure the stability of the product,and ensure the safety and effectiveness of clinical use.

关 键 词：鼠神经生长因子 制备方法 优化 

分 类 号：R943[医药卫生—药剂学]