[ SYSTEM 4000]

——  全自動流通池法系統(tǒng)  ——

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本研究主要圍繞二十碳五烯酸乙酯軟膠囊展開，該藥物是原研于美國、2023年5月中國獲批進口的心血管高危預防用藥，核心成分EPA有抗炎、調血脂等作用。由于其水溶性差，現行多國藥典及進口標準僅查崩解時限、無溶出度檢查，故研究通過對比溶出裝置、介質和行為，建立了該膠囊的溶出度檢查方法，為其處方工藝、質量控制和生物等效性研究提供參考。

The paddle method (settling basket) was used with a rotation speed of 75 r·min-1 , and 900 mL of hydrochloric acid solution （pH1.2） containing 4% Triton X-100 was used as the dissolution medium. The dissolution rate at 60 minutes should not be less than 80%, which was determined by highperformance liquid chromatography using a Welch Xtimate C18 (4.6 mm × 150 mm, 3.5 μm) chromatographic column with acetonitrile-water (85∶15) as mobile phase. The flow rate was 2.0 mL per minute, the column temperature was 30℃, the detection wavelength was 215 nm, and the injection volume was 10 μL.

Blank excipients did not interfere; icosapent ethyl showed good linearity (r > 0.999) within the concentration range of 0.2 to 1.4 mg·mL-1 the recovery rate in the medium was 98.0% - 102.0% (n = 9), with RSD < 2.0% and good accuracy. Both imitation and original soft capsules achieved dissolution rates over 80% within 60 minutes.

The established method is suitable for the dissolution determination of Icosapent ethyl soft capsules and can provide reference for their quality control. 

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