摘要
目的:探讨注射用雷莫司琼的处方组成、测定方法与制备工艺。方法:以甘露醇、山梨醇、右旋糖酐为填充剂,制备了注射用雷莫司琼;采用HPLC测定注射用雷莫司琼的含量及有关物质。结果:最佳处方为甘露醇100 g,雷莫司琼0．3 mg;3批样品的含量分别为100．5％,101．2％,99．6％,有关物质的含量分别为 0．17％,0．17％,0．18％,符合新药申报要求。结论:处方及工艺经中试放大制备的注射用粉针性质稳定;质量可控。
AIM ：To investigate the formula of ramosetron for injection,determination and technique of preparation. METHODS：Ramosetron for injection with mannitol,sorbitol and dextran as stuffing bulking agent was prepared and its content and related substance was detected by HPLC method. RESULTS ：The best formula was composed of mannitol（ 100 g） and ramosetron （0,3 g）. The sample content of three batches were 100.5 %, 101.2 % ,99.6 % ,and related compound were 0.17 % ,0.17 % ,0.18 % ,respectively,fulfilling the declare new drugs. CONCLUSION：The formula and technique of preparation of the ramosetron for injection is legally in quality stable and controllable.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2006年第2期125-127,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
雷莫司琼
注射
色谱法
高压液相
ramosetron
injections
chromatography, high pressure liquid
