环扁桃酯胶囊溶出度测定方法的研究

目的: 建立环扁桃酯胶囊溶出度试验的方法。 方法: 参照中国药典2010年版二部附录溶出度测定项下第二法装置,分别采用3台不同型号的溶出度检测仪,以0.5%的十二烷基硫酸钠1000 mL为溶出介质,转速75 r·min^-1测定溶出度。用高效液相色谱法以Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm,5 μm)色谱柱;流动相:乙腈-水(4∶ 1);流速:1.0 mL·min^-1;检测波长228 nm;柱温:30 ℃,进样体积10 μL。 结果: 环扁桃酯在146.7~272.48 μg·mL^-1浓度范围内呈良好的线性关系,r=0.9999。高、中、低3种不同浓度的平均回收率范围为99.8%~99.2%,RSD为1.2%(n=9),溶出度测定结果限度为标示量的75%。 结论: 溶出度和测定方法简便,灵敏,结果准确,可满足环扁桃酯胶囊溶出度质量控制的要求。

Objective: To carry out the dissolution tes tusing 1000 mL of containing 0.5% of sodium laury lsulfate as the dissolution medium,adjust the rotational speed of the paddle to 75 r·min^-1 but three medicine dissolves the meter.To develop an-HPLC for determination of cyclandelate capsules and dissolution. Method: The chromatographic conditions were C₁₈ column (4.6 mm×250 mm,5 μm) ;With the mobile phase:acetonitrile-water ( 4∶ 1 ),the flow rate was 1.0 mL·min^-1 and the detective wavelength was 228 nm,the injection volumn was 20 μL。(The dissolution study was analyzed bythree medicine dissolves the meter,following ChP procedure. Results: The calibration curves were linear over the concentration range of 146.7-272.48 μg·mL^-1and the average recovery was from 99.8% to 99.2% for three diffrernt levely of the added amount of cyclandelate capsules,RSD=1.2%( n=9 )。The minimal detectable concentration of cyclandelate capsules was 0.01 ng. Conclusion: The menthod is convenient,accurate and specific.It can be used for control of dissolution of cyclandelate capsules。