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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,5μm)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10μL。结果:环扁桃酯在146.7～272.48μg.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 establish a method for the dissolution test of Cyclotelide capsule. Methods: According to the second method of dissolution test under the Chinese Pharmacopoeia 2010 edition, three different types of dissolution tester were used, respectively, and 1000 mL of 0.5% sodium dodecyl sulfate was used as dissolution medium. The rotation speed was 75 r.min-1 determination of dissolution. The mobile phase was acetonitrile-water (4: 1), the flow rate was 1.0 mL.min-1, the detection wavelength was 228 nm, Column temperature: 30 ℃, injection volume 10μL. Results: Cyclotapentin had a good linearity in the range of 146.7 ~ 272.48μg.mL-1, r = 0.9999. The average recoveries ranged from 99.8% to 99.2% with RSD of 1.2% (n = 9) for high, medium and low concentrations, and 75% of the standard values for dissolution. Conclusion: The method of dissolution and determination is simple, sensitive and accurate. It can meet the quality control requirements of Cyclotelide capsule.