Cary and Chapel Hill, N.C.; and West Lafayette, Ind. From the Cary Skin Center; the Department of Dermatology, University of North Carolina at Chapel Hill; the Department of Chemistry, Purdue University; and Pandion Laboratories, LLC.
Plast Reconstr Surg. 2013 Oct;132(4 Suppl 2):22S-32S. doi: 10.1097/PRS.0b013e31829e88a3.
In this study, the authors sought to determine the molecular weight distribution of three hyaluronic acids-Belotero Balance, Restylane, and Juvéderm Ultra-and their rates of degradation following exposure to hyaluronidase. Lot consistency of Belotero Balance also was analyzed.
Three lots of Belotero Balance were analyzed using liquid chromatography techniques. The product was found to have high-molecular-weight and low-molecular-weight species. One lot of Belotero Balance was compared to one lot each of Juvéderm Ultra and Restylane. Molecular weights of the species were analyzed. The hyaluronic acids were exposed to ovine testicular hyaluronidase at six time points-baseline and 0.5, 1, 2, 6, and 24 hours-to determine degradation rates.
Belotero Balance lots were remarkably consistent. Belotero Balance had the largest high-molecular-weight species, followed by Juvéderm Ultra and Restylane (p < 0.001). Low-molecular-weight differences among all three hyaluronic acids were not statistically significant. Percentages of high-molecular-weight polymer differ among the three materials, with Belotero Balance having the highest fraction of high-molecular-weight polymer. Degradation of the high-molecular-weight species over time showed different molecular weights of the high-molecular-weight fraction. Rates of degradation of the hyaluronic acids following exposure to ovine testicular hyaluronidase were similar. All hyaluronic acids were fully degraded at 24 hours.
Fractions of high-molecular-weight polymer differ across the hyaluronic acids tested. The low-molecular-weight differences are not statistically significant. The high-molecular-weight products have different molecular weights at the 0.5- and 2-hour time points when exposed to ovine testicular hyaluronidase and are not statistically different at 24 hours.
在这项研究中，作者试图确定三种透明质酸——贝洛特平衡、瑞蓝和乔雅登极致——的分子量分布，以及在暴露于透明质酸酶后它们的降解速度。贝洛特平衡的批次一致性也进行了分析。
使用液相色谱技术分析了三种贝洛特平衡批次。结果发现该产品含有高分子量和低分子量物质。将一个贝洛特平衡批次与一个乔雅登极致和瑞蓝批次进行比较。分析了各批次的分子量。将透明质酸暴露于羊睾丸透明质酸酶中，在 0.5、1、2、6 和 24 小时六个时间点进行检测，以确定降解速度。
贝洛特平衡批次非常一致。贝洛特平衡的高分子量物质最大，其次是乔雅登极致和瑞蓝（p<0.001）。三种透明质酸之间的低分子量差异无统计学意义。三种材料的高分子聚合物比例不同，贝洛特平衡的高分子聚合物比例最高。随着时间的推移，高分子量物质的降解显示出不同的高分子量部分的分子量。暴露于羊睾丸透明质酸酶后，透明质酸的降解速度相似。所有透明质酸在 24 小时内完全降解。
测试的透明质酸的高分子聚合物比例不同。低分子量差异无统计学意义。当暴露于羊睾丸透明质酸酶时，高分子量产物在 0.5 和 2 小时时间点具有不同的分子量，但在 24 小时时无统计学差异。
