摘要
目的考察滤器(滤膜)与人粒细胞巨噬细胞刺激因子(rhGM-CSF)药液的相互作用。方法对滤器的吸附性、可提取物、兼容性等各项目进行试验,确认其符合广州白云山拜迪生物医药有限公司产品质量要求。结果活性药物成分rhGM-CSF过滤前后无明显吸附;每个Millipak 20滤器可提取不挥发物总量为0.5 mg,总有机碳为0.3 mg,可提取物经傅里叶变换红外光谱(FTIR)和反向高效液相色谱(RP-HPLC)分析鉴定为聚丙烯酸酯,无生物毒害;膜片和滤器均表明不存在兼容性问题。结论采用的过滤器及滤膜符合药品质量要求,可为进一步评估过滤工艺提供数据支持。
Objective To investigate the interaction between the filter(filter membrane)and Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF)liquid.Methods The adsorptivity,extractablility and compatibility of the filter were tested to confirm that it met the Guangzhou Baiyunshan Baidi Biopharmaceutical Co.,Ltd.quality requirements.Results The active drug ingredient rhGM-CSF had no obvious adsorption before and after filtration.Each Millipak 20 filter could extract a total of 0.5 mg of non-volatile matter,and 0.3 mg organic carbon in total.The extracts were identified as polyacrylate by Fourier transform infrared spectroscopy(FTIR)and reversed phase-high performance liquid chromatography(RP-HPLC)analysis without biological toxicity.Both the membrane and filter showed no compatibility.Conclusion The filters and membranes used meet the drug quality requirements and can provide data support for further evaluation of the filtration process.
作者
魏荣华
孔雯雯
周茂德
王维唯
WEI Rong-hua;KONG Wen-wen;ZHOU Mao-de;WANG Wei-wei(Department of Production,Guangzhou Baiyunshan Baidi Biopharmaceutical Co.,Ltd.,Guangdong Province,Guangzhou511495,China)
出处
《中国当代医药》
2020年第36期13-16,共4页
China Modern Medicine
关键词
人粒细胞巨噬细胞刺激因子
过滤
兼容性
可提取物
吸附
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor
Filtration
Compatibility
Extracts
Absorption
