US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA.
J Pharm Biomed Anal. 2010 Nov 2;53(3):295-301. doi: 10.1016/j.jpba.2010.03.036. Epub 2010 Apr 1.
A dissolution test method and an analytical procedure by HPLC were developed and validated for evaluation of the dissolution behavior of dietary supplements tablets containing vitamin A in the forms of retinyl acetate or retinyl palmitate. Seven different commercially available products containing retinyl acetate or retinyl palmitate were selected for this study. A dissolution medium containing 1% (w/v) Octoxynol 9 (Triton X-100) and 1% (w/v) (+)-sodium alpha-ascorbate in 0.05 M phosphate buffer, pH 6.8, was found suitable to ensure sink conditions and chemical stability for both retinyl acetate and retinyl palmitate. Two rotation speeds, 50 and 75 rpm, were evaluated with USP Apparatus 2 and 900 ml dissolution medium. Dissolution profiles were generated over 120 min. Dissolution samples were analyzed with a reversed-phase HPLC method with UV detection at 325 nm. Each product was also assayed for vitamin A content according to USP 32-NF 27. The results from 45 min to the last time point of the dissolution tests performed at 75 rpm were consistent with the Assay results. The dissolution test described here could be proposed as a pharmacopeial standard to assess the performance of tablet formulations containing vitamin A as retinyl esters.
建立并验证了一种高效液相色谱分析程序和溶出度测试方法，用于评估以醋酸视黄酯或棕榈酸视黄酯形式存在的维生素 A 的膳食补充片剂的溶出行为。选择了七种不同的市售含有醋酸视黄酯或棕榈酸视黄酯的产品进行这项研究。发现含有 1%（w/v）辛基苯酚聚氧乙烯醚 9（曲通 X-100）和 1%（w/v）（+）-抗坏血酸钠的 0.05 M 磷酸盐缓冲液，pH 值 6.8，是确保醋酸视黄酯和棕榈酸视黄酯均处于溶出度测试所需的均一稳定的溶解环境的合适介质。采用 USP 溶出仪 2 和 900ml 溶出介质，评估了两种转速，50 和 75rpm。在 120 分钟内生成溶出曲线。采用反相高效液相色谱法，在 325nm 处进行紫外检测，对溶出样品进行分析。根据 USP 32-NF 27，每个产品均进行维生素 A 含量测定。在 75rpm 下进行的溶出试验的 45 分钟至最后时间点的结果与含量测定结果一致。此处描述的溶出度测试可以作为评估含有维生素 A 作为视黄酯的片剂制剂的性能的药典标准。
