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目的对冻干血小板FDP用于动物创面愈合的治疗做初步安全性评价。方法 FDP单次皮肤刺激试验选择10只SD大鼠,采用自身对照,背部左侧皮肤为实验组:用棉签涂抹0.6 m L复水化FDP;右侧为空白对照组:涂抹0.6 m L生理盐水;于涂抹后1、24、48及72 h观察2组大鼠涂敷区皮肤是否出现红斑、水肿等刺激反应。重复给药毒性试验选择32只新西兰白兔建立皮损模型,随机均分为实验组与空白对照组,前者每天涂抹复水化FDP 0.6 m L/次,后者每天涂抹生理盐水0.6 m L/次,连续涂抹28 d,观察1次/d,测体重1次/周,于涂敷前及涂敷d7、d14、d21、d28分别采集动物血样检测血常规和相关生化指标,并取涂敷区皮肤组织行组织病理学检查。结果单次皮肤刺激试验:2组大鼠皮肤均未出现水肿、红斑等刺激反应。重复给药毒性试验:试验周期中2组动物均未出现体重减轻、一般行为异常及死亡,体重、血常规及生化指标检测结果相近(P>0.05),FDP组动物在实验d7 d14、d21及d28的WBC(×109/L)分别为12.20±1.28 vs 8.63±1.71 vs 6.90±1.21 vs 7.60±1.36(P<0.05);2组动物组内不同时间点的Cr波动明显(P<0.01)。组织病理学检查:2组受试动物涂敷区局部皮肤未见明显组织病理学改变。结论FDP对实验动物没有明显的刺激反应,对动物局部损伤皮肤连续涂敷28 d未见明显毒性反应,其作为外敷生物制剂的初步安全性评价合格。
Objective To evaluate the safety of freeze-dried platelet FDP in the treatment of animal wound healing. Methods FDP single skin irritation test to select 10 SD rats with self-control, the back of the left skin as the experimental group: cotton swab 0.6 m L coated rehydration FDP; the right blank control group: 0.6 m L saline At 1, 24, 48 and 72 h after application, the irritation of erythema and edema was observed in the skin of the two groups. Repeated dose toxicity test 32 New Zealand white rabbits were selected to establish the skin lesion model and randomly divided into experimental group and blank control group. The former was given a daily rehydration FDP 0.6 m L / time, and the latter daily smeared saline 0.6 m L / Times, continuous smear 28 d, observed 1 time / d, measured body weight 1 time / week before application and coating d7, d14, d21, d28 blood samples were collected to detect blood and related biochemical indicators, and take coated District skin tissue histopathological examination. Results A single skin irritation test: no skin edema, erythema and other irritation in the two groups of rats. Repeated dose toxicity test: No weight loss was found in the two groups of animals in the experimental period. The general behavior abnormalities and the results of death, weight, blood and biochemical indexes were similar (P> 0.05) The WBC (× 109 / L) of d28 was 12.20 ± 1.28 vs 8.63 ± 1.71 vs 6.90 ± 1.21 vs 7.60 ± 1.36, respectively (P <0.05). Cr in the two groups was significantly increased at different time points (P <0.01). Histopathological examination: No significant histopathological changes were found in the topical skin of the two groups of test animals. Conclusion FDP had no obvious irritant response to the experimental animals. No obvious toxic reaction was observed on the skin of animals for 28 days. The preliminary safety evaluation of FDP as external application of biological agents was satisfactory.