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绿原酸致敏性的综合研究与评价

Keywords: 绿原酸,致敏性,评价,透析法,大分子

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Abstract:

目的:通过不同纯度绿原酸的致敏试验结果,结合对文献的综合分析,揭示绿原酸的非致敏原性。方法:设定了不同纯度绿原酸提取物组(绿原酸20%~99%)、注射用绿原酸组、不同纯度绿原酸提取物和注射用绿原酸的透析内液组和外液组、过期和降解后的注射用绿原酸组作为受试药物,以豚鼠和大鼠为受试动物,分别采用全身主动过敏试验和皮肤被动过敏试验进行致敏性验证;采用LC-MS法鉴定了透析内液中大分子残留物的相对分子质量范围。结果:质量分数高于92%的绿原酸提取物、注射用绿原酸及其降解物和含小分子的透析外液均未发生过敏反应;质量分数低于40%的绿原酸提取物及其透析内液均被LC-MS鉴定出大分子化合物并且发生明显的过敏反应。结论:根据试验结果和国内外相关文献,均证明了绿原酸没有致敏原性,而低纯度提取物中存在的大分子物质才与致敏反应密切相关。

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