易艳++李春英++张宇实++赵雍++王连嵋++潘辰++刘素彦

[摘要]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IgE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YXY3流分中，最后对YXY3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YXY31和YXY32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。

[关键词]舒血宁注射液；过敏反应；类过敏反应；致敏物质

Adverse reaction and screening of sensitizing substance of

Shuxuening injection

YI Yan， LI Chunying， ZHANG Yushi， ZHAO Yong， WANG Lianmei， PAN Chen， LIU Suyan，

TIAN Jingzhuo， HAN Jiayin， LIANG Aihua*

（Key Laboratory of Beijing for Identification and Safety of Chinese Medicine， Institute of Chinese Materia Medica，

China Academy of Chinese Medical Sciences， Beijing 100700， China）

[Abstract]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 IgEmediated 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 dosedependent， 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 YXY3 fractions containing flavonol glycosides By further chemically separating YXY3， we got four chemical components Among these four components， YXY31 and YXY32 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， indepth study in followup experiments should be needed

[Key words]Shuxuening injection； allergic reactions； pseudoallergic reactions； pseudoallergenic substances

舒血寧注射液（Shuxuening injection，SXNI） 是银杏叶或银杏叶提取物经加工制成的灭菌水溶液，有效成分是黄酮和内酯，其主要功效为扩张血管，改善微循环，临床上主要用于缺血性心脑血管疾病，冠心病，心绞痛，脑栓塞，脑血管痉挛等疾病[13]。SXNI目前属于内科使用量第一的中药注射剂，国内有9家获批企业生产SXNI，年销售量逾25亿元，使用人次250余万人，SXNI治疗疾病数量也由2010年138个，增加至2011年154个。随着SXNI在临床的广泛使用，其不良反应发生……