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可见异物具体指存在于注射剂、滴眼剂药物当中,且在规定条件下可通过肉眼观测的不溶性物质,也即是指长度与粒径均大于50μm玻璃碎屑、金属屑、纤维及白块等等。可见异物的存在,直接对滴眼剂与注射剂质量水平造成巨大的影响,严重危害到病人的身体健康。因此为了提高制剂类药物的用药安全性,2005年版的《中国药典》直接增加了对可见异物的检查项目。但是在实际的可见异物检查当中仍然存在一些问题,本文针对此类问题进行探讨。
Visible foreign body specifically refers to the presence of injections, eye drops, drugs, and under the specified conditions can be observed by the naked eye insoluble material, that is, both the length and particle size greater than 50μm glass chips, metal shavings, fibers and white blocks Wait. Visible foreign body exists directly on the quality of eye drops and injections caused a huge impact on the quality of the serious endanger the patient’s health. Therefore, in order to improve the drug safety of preparation drugs, the 2005 edition of “Chinese Pharmacopoeia” directly increased the inspection of visible foreign objects. However, there are still some problems in the actual inspection of foreign bodies, this paper discusses the problems.