摘要
目的:研究十二烷基硫酸钠(SDS)纯度对坎地沙坦酯溶出的影响,揭示SDS自身纯度及含有混合物的比例对药物溶出度检验结果的影响。方法:在SDS中加入0.5 mol·L-1硫酸溶液25m L回流后用乙醚提取,将SDS转化为十二烷醇,采用GC法进行测定。GC法:色谱柱HP-5(30 mm×0.53 mm,2.65μm),进样口温度270℃,FID检测器温度300℃,载气为高纯氮,流速3.0 m L·min-1,分流比10∶1,升温程序(起始温度80℃,保持1 min后,以10℃·min-1的升温速率升至260℃,保持3 min),进样1μL。结果:选取具有代表性的4批SDS配制溶液,对坎地沙坦酯的过饱和溶液进行了测定,质量浓度分别为6.28×10-3、11.59×10-3、6.17×10-3和23.36×10-3mg·m L-1。结论:SDS的助溶能力与自身纯度及含有混合物碳链的长短有关;不同企业生产的SDS自身纯度相同时,含有混合物的碳链越长,助溶能力增加,溶出效果相对更好。
Objective： To study the effect of sodium dodecyl sulfate（ SDS） purity on dissolution testing results of candesartan cilexetil,so as to reveal the influence of the SDS purity and the proportion of mixed substances on the test result of dissolution. Methods： SDS was converted to dodecyl alcohol by refluxing with 25 m L of 0. 5mol·L^-1sulfuric acid solution and extracting with diethyl ether. Resulting dodecyl alcohol was determined by GC method. For the GC method,the HP- 5 column（ 30 mm × 0. 53 mm,2. 65 μm） was adopted with the inlet temperature of 270 ℃,the FID detector temperature of 300 ℃,and nitrogen as the carrier gas. The flow rate was 3. 0 m L·min- 1,the split ratio 10∶ 1 with temperature programming starting at 80 ℃ kept for 1 min then increased to 260 ℃ at a speed of 10 ℃ · min- 1maintained for 3 min. The injection volume was 1 μL. Results： Four batches of SDS were prepared as the dissolution testing media. In the four media,the concentration of saturated candesartan cilexetil solution was determined as 6. 28 × 10- 3mg · m L- 1,11. 59 ×10- 3mg·m L^-16. 17 × 10- 3mg·m L^-1nd 23. 36 × 10- 3mg·m L^-1respectively. Conclusion： The ability of SDS to promote solubilization is related with its purity and the length of the carbon chain of the mixed substances. At the same purity level of SDS produced by different manufacturers,the solubility and the dissolution would be better with longer carbon chain.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2015年第4期742-746,共5页
Chinese Journal of Pharmaceutical Analysis
基金
国家重大新药创制专项(2011ZX09303-001)
国家质检总局公益专项(2012104008-1-14)
关键词
坎地沙坦酯
十二烷基硫酸钠
十二烷醇
溶出介质
纯度
助溶作用
溶出度影响
气相色谱法
candesartan
sodium dodecyl sulfate
dodecyl alcohol
dissolution medium
purity
solubilization
influence on dissolution
gas chromatography
