摘要
目的:研究盐酸格拉司琼鼻腔喷雾剂的稳定性。方法:建立用于盐酸格拉司琼鼻腔喷雾剂稳定性研究的高效液相色谱法。按照国家新药研究的有关规定,通过加速实验和长期留样观察试验研究盐酸格拉司琼鼻腔喷雾剂的稳定性。结果:我们建立的高效液相色谱法精密度高、专属性强,能够用于盐酸格拉司琼鼻腔喷雾剂的稳定性研究。盐酸格拉司琼鼻腔喷雾剂加速实验6个月和长期留样观察试验36个月,样品外观、pH值、主药含量、有关物质等各项检测指标均符合规定。结论:盐酸格拉司琼鼻腔喷雾剂稳定性良好。
Objective： To study the stability of granisetron hydrochloride nasal spray. Methods： To establish an HPLC method for studying the stability of granisetron hydrochloride nasal spray. We studied the stability of nasal spray of granisetron hydrochloride, including accelerated test and long term observation. Results： The HPLC method that we established had high precision and good specialty, which could be used in the stability study on granisetron hydrochloride nasal spray. Results of 6-month accelerated test and 36- month long term observation of granisetron hydrochloride nasal spray demonstrated that all test items including appearance, pH, drug content and related materials were up to specification. Conclusion： The nasal spray of granisetron hydrochloride had good stability.
出处
《中国药物应用与监测》
CAS
2012年第2期81-84,共4页
Chinese Journal of Drug Application and Monitoring
基金
国家高技术研究发展计划(863计划)(2003AA2Z347B)
