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[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。
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[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 the blood vessel at the site of injection was observed. Hemolysis or agglutination of Parecoxib Sodium for Injection was examined by in vitro methods. Results Under the dosage of 20 mg/mL, guinea pigs showed no systemic allergy and passive skin allergy, and no hemolysis, agglutination, and irritation of vascular was observed. Conclusion Under the present experimental conditions, 20 mg/mL Parecoxib Sodium for Injection shows no obvious allergic reactions, irritation and hemolysis, is safe.
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