匹多莫德水溶液稳定性研究  

Study on Stability of Pidotimod Aqueous Solution

作　　者：于士龙[1] 罗胜男 徐菁阳 崔思娇 汪宇[1] Yu Shilongl;Luo Shengnan;Xu Jingyangl;Cui Sijiaol;Wang Yu(N0.463 Hospital of PLA,Shenyang,Liaoning,China 110042;Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110000)

机构地区：[1]中国人民解放军第463医院,辽宁沈阳110042 [2]沈阳药科大学,辽宁沈阳110000

出　　处：《中国药业》2018年第21期12-14,共3页China Pharmaceuticals

摘　　要：目的探讨不同条件下匹多莫德水溶液的稳定性,为其相关制剂质量标准的制订提供依据。方法配制不同pH的匹多莫德水溶液样品,采用高效液相色谱(HPLC)法分别对室温普通光照、60℃光照、室温强光(4 500 lx)3种条件下匹多莫德的含量进行测定,考察其稳定性。结果匹多莫德水溶液含量前后变化趋势基本相同,pH在6～8范围内最稳定;室温普通光照下稳定性最好,60℃光照稳定性最差。结论匹多莫德水溶液应调节pH为6～8,在室温、避光条件下可保持最佳稳定性。Objective To investigate the stability of pidotimod aqueous solution under difierent conditions, and to provide a basis for the formulation of quality standards of related preparations. Method Pidotimod aqueous samples with difierent pH were made up, and the content of pidotimod samples were determined by HPLC under three conditions： room temperature and normal light, 60 ℃ and normal light, room temperature and hard light（4 500 lx）, and its stability was inspected. Results Under the three kinds of conditions, the content of pidotimod aqueous solution had the same change trend, its most stable pH range was 6- 8. According to content change degree, the stability of room temperature and normal light was the best and the stability of 60 ℃ and normal light was the worst. Conclusion Pidotimod queous solution can maintain the best stability at room temperature without light and its pH should be adjusted to 6- 8.

关 键 词：匹多莫德 高效液相色谱法 稳定性 PH 光照试验 

分 类 号：R927.11[医药卫生—药学] TQ460.6[化学工程—制药化工]