加米霉素注射液的过敏性试验研究

Sensitization test of gamithromycin injection

为科学、客观地评价加米霉素注射液的过敏性反应,本试验分别选用FMMU豚鼠和SD大鼠进行加米霉素注射液的全身主动过敏性试验和被动皮肤过敏性试验。试验均随机分为阴性对照组、阳性对照组、加米霉素注射液低剂量试验组(6 mg/kg BW)和高剂量试验组(18 mg/kg BW),在常规饲养条件下按照试验方法进行致敏和激发,观察各试验组全身主动过敏反应发生程度和被动皮肤过敏反应等级。结果显示,加米霉素注射液低剂量试验组和高剂量试验组的全身主动过敏反应和被动皮肤过敏反应均为阴性。试验表明加米霉素注射液不引起豚鼠全身主动过敏反应和大鼠被动皮肤过敏反应。

In order to evaluate the sensitization of gamithromycin injection scientifically,the FMMU guinea pigs and SD rats were used to conduct active systemic anaphylaxis test and passive cutaneous anaphylaxis test of gamithromycin injection respectively. The animals were randomly divided into negative control group,positive control group,low-dose test group(6 mg/kg b.w.)and high-dose test group(18 mg/kg b.w.). Under the conditions of conventional breeding,the active allergic reaction degree of guinea pigs and passive allergic reaction degree of rats in each group were observe after being sensitized and stimulated according to the test method. The results showed that the active systemic anaphylaxis and passive cutaneous anaphylaxis reaction degree of low-dose test group and high-dose test group were negative,which indicated that Gamithromycin injection cause neither active systemic anaphylaxis in guinea pigs,nor passive cutaneous anaphylaxis in rats.