摘要
目的:评价托吡卡胺滴眼液的质量现状及存在的问题。方法:按照法定方法结合探索性研究进行样品检验,统计分析检验结果并对托吡卡胺滴眼液的质量现状进行评价。结果:法定方法检验显示119批样品79批合格,不合格样品40批,均为可见异物不合格;探索性研究显示,部分生产企业的渗透压测定结果明显低于《中国药典》2010年版规定的限度范围,对抑菌剂的控制不够严格,不能完全符合《中国药典》2010年版中对滴眼液中抑菌剂含量所规定的限度范围。结论:托吡卡胺滴眼液按法定方法检验,总体合格率较好,但还存在一些问题。通过探索性研究建议生产企业改进生产工艺,提高质量标准,进一步控制渗透压及抑菌剂,提高产品质量。
Objective：To evaluate the quality status and existing problems of tropicamide eye drops.Method：The quality of tropicamide eye drops was evaluated by statistical analysis using statutory testing methods combined with the exploratory research.Result： Among 119 batches of tropicamide eye drops,79 batches met the requirements of current specifications,while 40 batches showed visible particles.The exploratory studies showed that the osmotic pressure of the samples from partial companies was lower than the requirements of China pharmacopeia（2010）.The content of antibacterial agents in tropicamide eye drops in some products were lack of strict control and couldn＇t completely meet the requirements of China pharmacopeia（2010）.Conclusion：Most of the product quality of domestic tropicamide eye drops meets the current specifications,while there are still some problems existing in some enterprises.And exploratory research suggests that production enterprises should enhance the preparation process,especially further control the osmotic pressure and the antibacterial agents to improve the product quality.
出处
《中国药师》
CAS
2013年第3期400-402,共3页
China Pharmacist
关键词
托吡卡胺滴眼液
评价性抽验
质量评价
Tropicamide eye drops
Evaluative sample inspection
Quality evaluation
