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目的:制备阿昔洛韦眼凝胶剂并建立其质量控制方法。方法:以阿昔洛韦为主药,卡泊姆941为凝胶基质,制备阿昔洛韦眼凝胶;采用HPLC法对样品进行鉴别、含量测定和杂质检测;对样品的粒度、pH、微生物限度等进行检查;在稳定性研究中,对高温、光照及低温条件下样品的外观、含量、pH、杂质进行考察。结果:研究表明,样品标示量在98.93%～100.64%左右,凝胶杂质含量在1%以下,样品的粒度均小于50μm,pH、微生物限度等各项指标均符合中国药典要求;稳定性研究表明,样品对光、低温稳定,在该条件下药物含量、杂质含量没有明显变化;而在高温条件下,凝胶pH升高、药物含量下降,杂质增加,胶体粒度增加。综合考虑阿昔洛韦易氧化破坏及凝胶的特性,推荐本品需密闭,在凉暗处保存。结论:阿昔洛韦眼凝胶性质稳定,质量可控。
Objective: To prepare acyclovir eye gel and to establish its quality control method. Methods: Taking acyclovir as the main drug and kapham 941 as the gel matrix, acyclovir eye gel was prepared. The HPLC method was used to identify, measure and detect the impurities. The particle size, pH, Microbial limits and so on. In the stability study, the appearance, content, pH and impurities of samples under high temperature, light and low temperature were investigated. Results: The results showed that the index of samples was about 98.93% ~ 100.64%, the content of gel impurities was less than 1%, the particle size of samples was less than 50μm, and the indexes such as pH and microorganism limits all met the requirements of Chinese Pharmacopoeia. , The samples were stable to light and low temperature. Under these conditions, the content of drug and impurity did not change obviously. Under high temperature, the gel pH increased, the content of drug decreased, the content of impurities increased and the size of colloidal particles increased. Comprehensive consideration of acyclovir vulnerable to oxidative damage and the characteristics of the gel, it is recommended that this product needs to be closed, preserved in cool dark place. Conclusion: Aciclovir eye gel is stable in quality and controllable in quality.