盐酸格拉司琼鼻腔喷雾剂的制备及质量控制

Preparation and Quality Control of Granisetron Hydrochloride Nasal Spray

目的:制备盐酸格拉司琼鼻腔喷雾剂并建立其质量控制方法。方法:以盐酸格拉司琼为主药制备喷雾剂;采用紫外分光光度法测定其中主药的含量。结果:所制制剂为无色或带淡黄色的澄清液体,检查、鉴别项符合2005年版《中国药典》中的相关规定;盐酸格拉司琼检测浓度的线性范围为105.9～635.4μg·mL-1(r=0.999),平均回收率为100.1%(RSD=0.4%)。结论:该制剂处方工艺简便可行,质量可控。

OBJECTIVE： To prepare granisetron hydrochloride nasal spray and establish a method for its quality control. METHODS： Granisetron hydrochloride nasal spray was prepared using granisetron hydrochloride as chief ingredient and its content was determined by UV spectrophotometry. RESULTS： Spray appeared as colorless or yellowish supernatant liquid and it was up to the standard specified in Chinese Pharmacopeia （2005 edition）. The linear range of granisetron hydrochloride was 105.9--635.4 μg·mL-1 （r = 0.999） and its average recovery rate was 100.1% （RSD = 0.4%） . CONCLUSION： The preparation is simple and feasible in preparation process and its quality is controllable.