盐酸氮卓斯汀滴眼液的制备及质量控制

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。

Preparation and Quality Control ofAzelastine Hydrochloride Eye Drops

OBJECTIVE： To prepare Azelastine hydrochloride （AH） eye drops, and to establish its quality control method and determine its stability. METHODS ： AH eye drops were prepared with AH as main component using β-cyclodextrin and other materi- als as excipients. The character, identification and examination were tested in accordance with Chinese Pharmacopeia. The content of eye drops and its related substances were determined by HPLC. Influencing factor test, accelerated test and long-term test were done to study its stability. RESULTS： Prepared eye drops were in line with quality control index; no obvious changes were ob- served in stability test. CONCLUSION： The preparation is reasonable in formulation, simple and convenient in preparation tech- nique. The HPLC method is simple, specific and sensitive. The product is controllable in quality and stable.