摘要
目的评价国产盐酸奥洛他定滴眼剂的质量。方法采用现行法定标准结合风险控制的理念开展了国产制剂与原研制剂的对比研究,通过杂质谱研究、抑菌剂及抑菌效力研究、毒性元素研究、包材研究,评价国产制剂质量。结果研究结果表明,国产制剂质量标准需要提升。但国产制剂抑菌剂、毒性元素、塑化剂等研究结果均与原研制剂一致。结论国产盐酸奥洛他定滴眼剂质量与原研制剂一致。
Objective To evaluate the quality of domestic olopatadine hydrochloride eye drops.Methods Based on the current legal standards and the risk-based control approach,the comparative study of domestic preparation and original preparation was carried out.The quality of domestic preparation was evaluated through the study of impurity spectrum,antibacterial agent and antibacterial effectiveness,toxic elements and packaging materials.Results The quality standards of domestic preparations need to be improved.However,the results of antibacterial agents,toxic elements and plasticizers of domestic preparations were consistent with those of the original preparation.Conclusion The quality of domestic olotatidine hydrochloride eye drops is the same as that of the original preparation.
作者
董双涛
李宝霞
沈丹丹
赵丽元
张春泓
马郑
DONG Shuang-tao(Shanxi Pharmaceutical Vocational College,Taiyuan 030031,China)
出处
《牡丹江医学院学报》
2021年第2期100-105,共6页
Journal of Mudanjiang Medical University
关键词
盐酸奥洛他定滴眼液
质量评价
风险控制理念
olopatadine hydrochloride eye drops
quality evaluation
risk-based control approach
