舒血宁注射液不良反应及其致敏物质筛选研究

该研究通过豚鼠主动全身过敏试验和大鼠被动皮肤过敏试验及小鼠类过敏试验初步判定舒血宁注射液(Shuxuening injection,SXNI)的"过敏反应"可能不一定是Ig E介导的真正的过敏反应,而是以类过敏反应为主,并进一步证明SXNI的类过敏反应有一定的批间差异和剂量依赖性,建议建立SXNI类过敏反应检测法,对每批生产的产品进行类过敏反应检测,及时发现并控制产品风险,另外临床使用时应严格控制剂量浓度。接着又对舒血宁注射液中的主要单体成分及银杏提取物的不同流分进行了小鼠类过敏反应检测,结果证明舒血宁注射液中致敏物质可能主要存在于主要含黄酮醇苷的YXY-3流分中,最后对YXY-3进行了进一步化学分离得到4个化学组分,小鼠类过敏试验证明其中YXY-3-1和YXY-3-2是舒血宁注射液中的主要致敏成分,但其具体化学成分还有待后续试验进行深入研究。

Adverse reaction and screening of sensitizing substance of Shuxuening injection

In this study, by the means of the active systemic allergy test in guinea pigs, passive skin allergy test in rats and pseudoallergic test in mice, it was determined that the "allergic reaction" of Shuxuening injection(SXNI) may not be a true IgE-mediated allergic reactions, but mainly of pseudoallergic reaction. Further pseudoallergic test proved that the pseudoallergic reactions of SXNI had difference between batches and showed dose dependence, so it was recommended to establish SXNI pseudoallergic reaction detection method for timely detecting and controlling the product risk of each batch products. In addition, as the pseudoallergic reactions of SXNI were dose-dependent, the dose and concentration of SXNI should be strictly controlled in clinical use. Then the main pseudoallergenic reaction test was conducted for the main monomer components in SXNI and the different fractions of Ginkgo biloba extract in mice, and the results showed that the sensitizing substances may mainly exist in YXY-3 fractions containing flavonol glycosides. By further chemically separating YXY-3, we got four chemical components. Among these four components, YXY-3-1 and YXY-3-2 were testified as the main allergenic components in SXNI through pseudoallergic test in mice. To make sure the specific chemical constituent that is responsible for the pseudoallergic reaction, in-depth study in follow-up experiments should be needed.