羟乙基淀粉40氯化钠注射液过敏实验研究

Experimental Study on Anaphylactoid Reactions of Hydroxyethyl Starch 40 Sodium Chloride Injection

目的评价羟乙基淀粉40氯化钠注射液过敏安全性。方法进行了主动全身过敏反应试验、体内过敏指标测定与筛查及被动皮肤过敏反应试验的方法,考察样品的过敏安全性。结果我们对3个企业45批羟乙基淀粉40氯化钠注射液进行了豚鼠全身过敏反应和被动皮肤过敏试验,均未发生过敏反应。通过对血浆中过敏性指标,组胺(HIS)、Ig G、Ig M和Ig E进行测定和比较,发现Ig M和Ig E在各组间均无明显变化;组胺及Ig G阳性组与阴性组及样品组间均有差异。结论建议羟乙基淀粉40氯化钠注射液安全性评价应包括过敏反应,还可在羟乙基淀粉临床应用时进行组胺及Ig G这两项过敏指标的监测。

Objective To evaluate the sensitizations of Hydroxyethyl Starch 40 Sodium Chloride Injection. Methods Active systemic anaphylaxis （ASA） test, internal sensitive index＇ s determination and screening and Passive Cutaneous Anaphylaxis（PCA） test are carried out. Observe the allergy safety of the samples. Results We use guinea pigs to carry on ASA test and PCA test with Hydroxyethyl Starch 40 Sodium Chloride Injection from 45 batches of 3 companies and no changes have occurred. Measuring and comparing the sensitive index of HIS, IgG, IgM and IgE in plasma, IgM and IgE are not obvious variation; HIS and IgG positive group and negative group and sample groups are different. Conclusions It is suggestion that Hydroxyethyl Starch 40 Sodium Chloride Injection satety evaluation should include allergic reactions, HIS and lgG sensitive index monitoring in clinical application of hydroxyethyl starch.