National Institute for Public Health and the Environment, P.O. Box 1, 3721 MA, Bilthoven, The Netherlands.
Division of Food, Medicines and Consumer Safety, Section Medicines and Healthcare Products, Scientific Institute of Public Health (WIV-ISP), Brussels, Belgium.
J Pharm Biomed Anal. 2018 Sep 10;159:173-178. doi: 10.1016/j.jpba.2018.06.066. Epub 2018 Jul 2.
Facial treatments with dermal fillers for medical or esthetic purposes occasionally give rise to adverse effects, ranging from temporary effects such as reddening of the skin, to long term effects such as hardening of tissue. There appears to be a relationship between the lifetime of the filler product and the risk for adverse effects. The lifetime of hyaluronic acid-based fillers is dependent on the presence and amount of crosslinking agents such as 1,4-butanediol diglycidyl ether (BDDE). It would therefore make sense to establish methodology to analyze the crosslinking grade of HA-based filler products on a routine basis. To this end, an analytical method was developed and validated to identify HA-BDDE-based fillers and to quantify their modification and crosslinking grade. The method was subsequently applied to products from the legal supply chain and the illegal market. It was found that the product Hyacorp H 1000, previously taken from the market, indeed contains a high modification grade and crosslinking grade, as was the assumed reason for the increased risk for adverse effects of this product. However, it was also shown that the Hyacorp products are highly unreliable in relation to their product composition in general. In this study, authentic products could not be distinguished from the illegal market products based on their modification and crosslinking grade.
出于医疗或美容目的而进行的面部皮肤填充治疗偶尔会引起不良反应，从皮肤发红等暂时的影响到组织变硬等长期影响都有可能出现。填充剂产品的寿命似乎与不良反应的风险之间存在一定的关系。基于透明质酸的填充剂的寿命取决于交联剂（如 1,4-丁二醇二缩水甘油醚（BDDE））的存在和数量。因此，有必要建立一种常规分析基于 HA 的填充剂产品的交联程度的方法。为此，开发并验证了一种分析方法，以鉴定基于 HA-BDDE 的填充剂并定量其修饰和交联程度。该方法随后应用于合法供应链和非法市场的产品。结果发现，先前从市场上撤出的产品 Hyacorp H 1000 确实含有较高的修饰和交联程度，这也是该产品不良反应风险增加的原因。然而，研究还表明，Hyacorp 产品在其产品组成方面普遍不可靠。在这项研究中，无法根据其修饰和交联程度将正品产品与非法市场产品区分开来。
