摘要
通过赋形剂考察、辅料筛选及不同p H值的考察,确定奥加明的处方组成和制备工艺。采用高效液相色谱法测定其含量及有关物质,并对制剂进行了加速和长期条件稳定性考察。结果表明制备条件以室温为宜,处方中选用甘露醇为赋形剂,用量为50 mg/瓶,依地酸二钠用量为1. 5 mg/瓶,中间体溶液的p H值以11~12为宜;雷贝拉唑钠钠进样量线性范围为0. 010 4~0. 208 mg/m L(r=0. 999 9,n=5);低、中、高浓度平均回收率为99. 83%、99. 56%、99. 42%,RSD=0. 36%。
In order to ascertain the formulation and manufacturing technology, the kind of excipients, the adjuvants used in the formulation and the pH value of the intermediates were investigated. The assay and related substances were determined by high performance liquid chromatography. In addition, the accelerated stability and long-term stability of the rabeprazole injections were also tested. For rabeprazole injections, the appropriate preparation conditions were at room temperature. The optimum amount of mannitol as excipient and edetate disodium was 50 mg and 1.5 mg in each vial, respectively. The appropriate extent of pH value ranged from 11 to 12. A linear relationship between concentration and peak area （r=0.9999,n=5） was found when the concentration of rabeprazole was in the scope of 0.010 4 mg/mL to 0.208 mg/mL. The recovery of low, moderate and high concentrations were 99.83%, 99.56%, 99.42% respectively and the relative standard deviation was 0.36%.
作者
伏世建
刘留成
Fu Shijian;Liu Liucheng(Jiangsu Aosaikang Pharmaceutical Co.Ltd,Jiangsu Nanjing 211112)
出处
《化工时刊》
CAS
2018年第9期4-8,共5页
Chemical Industry Times
关键词
质子泵抑制剂
制备
质量研究
稳定性
proton pump inhibitors（PPI）
preparation
Quality research
stability
