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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. Methods: According to statutory methods combined with exploratory studies, the samples were tested, the test results were statistically analyzed and the quality status of tropicamide eye drops was evaluated. Results: The statutory test showed that 79 batches of 119 batches of samples were qualified and 40 batches of unqualified samples were unqualified. Exploratory studies showed that the osmotic pressure of some producers was significantly lower than that of the 2010 edition of Chinese Pharmacopoeia Limits, the control of bacteriostatic agents is not strict enough, can not be fully consistent with the “Chinese Pharmacopoeia” 2010 edition of the eye drops in the bacteriostatic content of the provisions of the limits. Conclusion: tropicamide eye drops by the statutory test, the overall pass rate is better, but there are still some problems. Through exploratory research, manufacturers are suggested to improve production technology, improve quality standards, further control osmotic pressure and antibacterial agents, and improve product quality.