摘要
目的:制备注射用兰索拉唑,建立其质量控制方法并考察其稳定性。方法:制备注射用兰索拉唑;采用高效液相色谱法测定其含量及有关物质,并对制剂进行稳定性考察。结果:本品处方以每瓶50mg甘露醇作为赋形剂,用0.1mol·L-1氢氧化钠溶液调节pH为11.0;兰索拉唑浓度在20.51～205.1μg·mL-1范围内线性关系良好(r=0.9999,n=5);恒温加速试验6个月及长期留样24个月时主药含量及有关物质未见明显变化。结论:该制剂处方工艺可行,质量可控,稳定性良好;所建立的含量测定方法重复性好,专属性强,结果准确可靠。
Objective： To prepare lansoprazole for injection, establish its quality control and determine its stability. Methods：The type and dosage of the excipients in the formula were optimized the lansoprazole for injec- tion, with its content determined by HPLC. Meanwhile its stability was tested. Results：50 mg per bottle mannitol so- lution was selected with 0. 1 tool ~ L-t sodium hydroxide solution as the major exeipient adjusting pH to 11.0;The linear range of lansoprazole was 20.51 - 205.1 μg· mL- 1, r = 0. 9999 （ n = 5 ） ; No obvious changes were observed at 6 months of an accelerated test or 24 months of long - term storage test. Conclusion ： The preparation is controlla- ble and stable in quality, and the established method is reliable and specific for the quantitation of lansoprazole.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第9期1510-1513,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
注射用兰索拉唑
制备
质量控制
稳定性
lansoprazole for injection
preparation
quality control
stability
