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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 purity of sodium dodecyl sulfate (SDS) on the dissolution of candesartan cilexetil, and to reveal the effect of the purity of SDS and the ratio of mixture on the dissolution test of drug. Methods: After adding 25 mol of 0.5 mol·L-1 sulfuric acid solution to SDS, the extract was extracted with ether and the SDS was converted to dodecanol. The determination was carried out by GC method. GC method: column HP-5 (30 mm × 0.53 mm, 2.65 μm), inlet temperature of 270 ° C, FID detector temperature of 300 ° C, carrier gas of high purity nitrogen and flow rate of 3.0 m L · min- 10: 1, temperature program (starting temperature of 80 ℃, holding 1 min, heating rate of 10 ℃ · min-1 to 260 ℃ for 3 min). Results: The supersaturated solution of candesartan cilexetil was selected from four batches of SDS preparation solution. The mass concentration of candesartan cilexetil was 6.28 × 10-3, 11.59 × 10-3, 6.17 × 10-3 and 23.36, respectively × 10-3 mg · m L-1. Conclusion: The solubilization ability of SDS is related to its purity and the length of the carbon chain containing the mixture. When the purity of the SDS produced by different enterprises is the same, the longer the carbon chain of the mixture, the more the solubilizing ability is and the better the dissolution effect is.