摘要
目的：制备盐酸格拉司琼注射液并考察其稳定性。方法：以外观色泽、澄明度、有关物质、含量、pH为指标，筛选处方，考察3批样品的稳定性。结果：最佳处方关键因素为pH5．0～7.0，加入辅料聚乙烯吡咯烷酮（PVP）0.2％；以该处方制备的3批样品在市售包装条件下经加速、室温留样考察，质量稳定。结论：该处方设计合理，注射液质量稳定。
OBJECTIVE： To prepare granisetron hydrochloride injection（GHI） and study its stability.METHODS： The formula of GHI was optimized with appearances and color, clarity, the related substances, contents and pH value as indexes,and the stabilities of 3 batches of samples were investigated.RESULTS：The key factors in optimized formula was the following ： the pH was 5.0-7.0,and the dosage ratio of the added adjuvant - polyvinyl pyrrolidone（PVP）was 0.2% .The 3 batches of samples prepared in this formula were stable in quality in the accelerated, room temperature storage test under the condition of commercial packing.CONCLUSION：The formula is reasonable in design and the injection is stable in quality.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第19期1462-1464,共3页
China Pharmacy
关键词
盐酸格拉司琼注射液
制备
稳定性
Granisetron hydrochloride injection
Preparation
Stability
