CAJ | 학술논문

目的：考察静注人免疫球蛋白(pH4)的稳定性。方法对三批静注人免疫球蛋白(pH4)进行2~8℃条件下为期3年的长期稳定性试验，对考察的制品依照《中华人民共和国药典》2005年版二部中附录XIX C药物稳定性试验指导原则及《中华人民共和国药典》2010年版二部中附录XIX C原料药及药物制剂稳定性试验指导原则进行检测。结果在长期稳定性试验过程中，可见异物，纯度、pH值、IgG含量、蛋白质含量、分子大小分布等均无明显的变化趋势。结论静注人免疫球蛋白(pH4)稳定性良好，在进行3年长期稳定性试验后，其质量仍符合《中华人民共和国药典》2010年版三部的要求。
목적：고찰정주인면역구단백(pH4)적은정성。방법대삼비정주인면역구단백(pH4)진행2~8℃조건하위기3년적장기은정성시험，대고찰적제품의조《중화인민공화국약전》2005년판이부중부록XIX C약물은정성시험지도원칙급《중화인민공화국약전》2010년판이부중부록XIX C원료약급약물제제은정성시험지도원칙진행검측。결과재장기은정성시험과정중，가견이물，순도、pH치、IgG함량、단백질함량、분자대소분포등균무명현적변화추세。결론정주인면역구단백(pH4)은정성량호，재진행3년장기은정성시험후，기질량잉부합《중화인민공화국약전》2010년판삼부적요구。
Objective Investigate the stability of human immunoglobulin (pH4) for intravenous injection. Methods The three batch of human immunoglobulin(pH4) for intravenous injection were carried on the long term stability test of 3 years in 2~8℃. Tested the inspection product in accordance with the“drug stability test guiding principle”of the Chinese Pharmacopeia(Volume Ⅱ , 2005 edition)in appendix XIX C and“stability principle of raw material medicine and drug"of the Chinese Pharmacopeia(VolumeⅡ, 2010 edition)in appendix XIX C. Results In the long term stability of the test process, visible foreign matter, purity, pH value, IgG content, protein content, molecular size distribution have no obvious variation trend. Conclusion Human immunoglobulin (pH4) for intravenous injection has good stability, after 3 years of long term stability test, the quality is still in accordance with the requirements of Chinese Pharmacopeia(VolumeⅢ, 2010 edition).