摘要
目的对靶向生物大分子药物PM01单抗进行处方研究。方法对多种缓冲液、pH、蛋白保护剂、表面活性剂等进行筛选,采用差示扫描量热法检测蛋白熔解温度,采用体积排阻色谱法检测蛋白纯度,采用毛细管电泳-十二烷基硫酸钠法检测聚合物含量,确定适用于PM01单抗的制剂处方,并进行36个月的验证试验,考察蛋白的稳定性。结果优选制剂处方组成为质量浓度为20 mg/mL的PM01单抗,缓冲液为25 mmol/L琥珀酸,pH为5.5,蛋白保护剂为质量浓度为75 mg/mL的海藻糖,表面活性剂为质量浓度为0.40 mg/mL的聚山梨酯20。按此处方制备PM01单抗制剂,放置36个月后的外观、pH、蛋白质含量、蛋白纯度、聚合物含量均符合规定。结论该制剂处方对PM01单抗有较好的保护作用,可保证PM01单抗长期储存的稳定性,为PM01单抗的临床应用提供了基础。
Objective To study the formulation of the targeted biomacromolecule drug PM01 monoclonal antibody.Methods A screen was conducted on the multiple buffer systems,pH,protein stabilizer,surfactants and so on.The differential scanning calorimetry was used to detect protein melting temperature,the volume exclusion chromatography method was used to detect protein purity,the capillary electrophoresis sodium dodecyl sulfate method was used to detect polymer content,in order to determine the formulation suitable for PM01 monoclonal antibody.A 36-month validation test was conducted to investigate the stability of the protein.Results The optimal formulation was as follows:20 mg/mL PM01 monoclonal antibody,buffer solution of 25 mmol/L succinic acid,pH of 5.5,protein protectant of 75 mg/mL trehalose,and surfactant of 0.40 mg/mL polysorbate 20.The appearance,pH,protein content,protein purity,and polymer content of PM01 monoclonal antibody preparation prepared according to the above formulation after 36 months of storage all complied with the regulations.Conclusion The formulation of this preparation has a good protective effect on PM01 monoclonal antibody,which can ensure the stability of long-term storage of PM01 monoclonal antibody,and provide a basis for the clinical application of PM01 monoclonal antibody.
作者
杨天一
秦梦贝
陈小春
唐浩
YANG Tianyi;QIN Mengbei;CHEN Xiaochun;TANG Hao(Jiangsu Pacific Meinuoke Bio-Pharmaceutical Co.,Ltd.,Changzhou,Jiangsu 213000,China)
出处
《中国药业》
2026年第1期62-67,共6页
China Pharmaceuticals
基金
国家科技重大专项子课题[2014ZX09508001004]。
关键词
PM01单抗
制剂处方
海藻糖
琥珀酸
聚山梨酯20
靶向生物大分子
PM01 monoclonal antibody
formulation prescription
trehalose
succinic acid
polysorbate 20
targeting biomolecules
