目的 評(píng)價(jià)注射用帕瑞昔布鈉的安全性。方法 全身主動(dòng)過(guò)敏實(shí)驗(yàn)：豚鼠隔日ip注射用帕瑞昔布鈉（供試品，20 mg/mL）、原研對(duì)照、生理鹽水或人血清白蛋白3次，于末次致敏后第14、21天進(jìn)行激發(fā)，觀察激發(fā)后30 min內(nèi)動(dòng)物反應(yīng)；被動(dòng)皮膚過(guò)敏實(shí)驗(yàn)：在豚鼠背部分別sc不同稀釋度的抗體血清0.1 mL進(jìn)行被動(dòng)致敏，24 h后iv激發(fā)，30 min后處死，測(cè)量皮膚內(nèi)層的藍(lán)斑大小；家兔血管刺激性實(shí)驗(yàn)：連續(xù)耳iv供試品5 d后，于給藥結(jié)束及恢復(fù)期取雙耳進(jìn)行HE染色，觀察其對(duì)注射部位血管的刺激性；體外溶血實(shí)驗(yàn)觀察供試品3 h內(nèi)有無(wú)溶血現(xiàn)象。結(jié)果 20 mg/mL注射用帕瑞昔布鈉無(wú)豚鼠全身過(guò)敏現(xiàn)象及被動(dòng)皮膚過(guò)敏反應(yīng)，未見(jiàn)血管刺激性；未見(jiàn)溶血現(xiàn)象發(fā)生。結(jié)論 20 mg/mL注射用帕瑞昔布鈉無(wú)明顯過(guò)敏反應(yīng)、刺激性、溶血現(xiàn)象，是安全的。

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.