目的:制备盐酸氮卓斯汀(AH)滴眼液,建立其质量控制方法并考察其稳定性。方法:以AH为主药、β-环糊精等为辅料制备滴眼液;按照《中国药典》相关规定进行性状、鉴别、检查等质量考察,采用高效液相色谱法测定滴眼液的含量及有关物质;通过影响因素、恒温加速和长期试验考察其稳定性。结果:制备的滴眼液各项质量考察指标均符合规定;稳定性试验中各项指标均未见明显改变。结论:该制剂处方合理,工艺简便可行;建立的含量测定方法简便、专属性强、灵敏度高;制剂质量可控,稳定性好。 Objective: To prepare azelastine hydrochloride (AH) eye drops and establish its quality control method and investigate its stability. Methods: Taking AH as the main drug and β-cyclodextrin as the excipients, the eye drops were prepared. According to the relevant regulations of Chinese Pharmacopoeia, traits such as traits, identification and inspection were investigated. The content of eye drops was determined by HPLC And related substances; investigate its stability through influencing factors, accelerated temperature and long-term tests. Results: The quality of the eye drops prepared by the inspection indicators are in line with the provisions of the stability test in the indicators did not change significantly. Conclusion: The preparation prescription is reasonable and the process is simple and feasible. The method for determination of content is simple, specific and sensitive, and the preparation quality is controlled and the stability is good.