注射用帕瑞昔布钠特殊安全性评价.PDFVIP

• 1090 • Drug Evaluation Research 第40 卷 第8 期 2017 年8 月 注射用帕瑞昔布钠特殊安全性评价 * 黄凤娇 ，吴 森，王平慧，张 菊，周大庆 湖北省食品药品监督检验研究院，湖北 武汉 430054 摘要：目的 评价注射用帕瑞昔布钠的安全性。方法 全身主动过敏实验：豚鼠隔日 ip 注射用帕瑞昔布钠 （供试品，20 mg/mL ）、原研对照、生理盐水或人血清白蛋白3 次，于末次致敏后第14、21 天进行激发，观察激发后30 min 内动物反应； 被动皮肤过敏实验：在豚鼠背部分别sc 不同稀释度的抗体血清0.1 mL 进行被动致敏，24 h 后iv 激发，30 min 后处死，测 量皮肤内层的蓝斑大小；家兔血管刺激性实验：连续耳iv 供试品5 d 后，于给药结束及恢复期取双耳进行HE 染色，观察其 对注射部位血管的刺激性；体外溶血实验观察供试品3 h 内有无溶血现象。结果 20 mg/mL 注射用帕瑞昔布钠无豚鼠全身 过敏现象及被动皮肤过敏反应，未见血管刺激性；未见溶血现象发生。结论 20 mg/mL 注射用帕瑞昔布钠无明显过敏反应、 刺激性、溶血现象，是安全的。 关键词：注射用帕瑞昔布钠；安全性评价；过敏；刺激；溶血 中图分类号：R994.2 文献标志码：A 文章编号：1674 - 6376(2017)08 - 1090 - 04 DOI: 10.7501/j.issn.1674-6376.2017.08.010 Safety evaluation of Parecoxib Sodium for Injection HUANG Feng-jiao, WU Sen, WANG Ping-hui, ZHANG Ju, ZHOU Da-qing Hubei Institute for Food and Drug Control, Wuhan 430054, China Abstract: Objective To evaluate the safety of Parecoxib Sodium for Injection. Methods Systemic active anaphylaxis test: Guinea pigs were injected respectively with Parecoxib Sodium for Injection (test sample, 20 mg/mL), primary control, sodium chloride injection or human serum albumin, once every other day, continuously for three times. After 14 and 21 d from the end time of sensitization, to stimulation and to observe whether allergic reactions occurred within 30 mins. Passive cutaneous anaphylaxis test: Guinea pigs were received 0.1 mL antiserum injection for inducing passive sensitization, after 24 h of that we stimulated the guinea pigs, and the guinea pigs were sacrificed after 30 mins to examine the diameter of blue spots. Blood vessel irritation test: After continuous ear IV test sample for 5 d, HE staining was performed at the end of the administration and recovery period, and the stimulation of