摘要
目的观察新西兰兔重复给予乳酸菌阴道胶囊后产生的毒性反应、量效关系及主要靶器官毒性严重程度,考察乳酸菌阴道胶囊的安全性及毒性,为临床用药安全提供参考。方法健康未孕雌性新西兰兔30只,随机分为5组(n=6),分别为阴性对照组(给予医用凡士林),赋形剂对照组(给予仅含辅料的胶囊),乳酸菌阴道胶囊小、中、大剂量组(分别给予乳酸菌阴道胶囊0.1、0.2、0.4 g·kg^(-1))。乳酸菌阴道胶囊小、中剂量组每天给药1次,大剂量每天给药2次,均连续给药4周,末次给药后恢复4周。赋形剂对照组和阴性对照组给药次数及恢复期同大剂量组。结果新西兰兔连续4周阴道最高给予乳酸菌阴道胶囊0.4 g·kg^(-1),一般症状、眼科检查、脏器系数、尿液、血清生化、电解质、凝血指标、心电图、体温、阴道分泌物检查及骨髓细胞计数均无明显异常;血液学个别指标在各组间虽有差异,但无明显的时间-反应趋势及剂量-反应趋势。阴性对照组、赋形剂对照组和乳酸菌阴道胶囊组动物少量脏器见极轻度/轻度病理学改变,病变数量和病变程度未见明显的组别相关性和剂量依赖性。结论新西兰兔连续4周阴道给予乳酸菌阴道胶囊后,主要组织器官及子宫、卵巢、阴道黏膜无病理性损害,一般生理功能指标无明显影响或明显毒性作用。
Objective To observe the toxic reactions,dose-response relationship,and severity of toxicity to the main target organs after repeated administration of lactobacillus vaginal capsules in New Zealand rabbits,and to investigate the safety and toxicity of lactobacillus vaginal capsules,providing a reference for clinical medication safety.Methods Thirty healthy non-pregnant female New Zealand rabbits were randomly divided into five groups(n=6):a negative control group(treated with medical vaseline),an excipient control group(treated with capsules containing only excipients),and small,medium,and high-doses of lactobacillus vaginal capsules(treated with 0.1,0.2,and 0.4 g·kg^(-1) lactobacillus vaginal capsules,respectively).The low and medium-dose groups of lactobacillus vaginal capsules were administered once a day,while the high-dose group was administered twice a day,both for 4 consecutive weeks.After the last administration,the recovery period was 4 weeks.The administration frequency and recovery period of the excipient control and negative control group were the same as those of the high-dose group.Results New Zealand rabbits were given a maximum of 0.4 g·kg^(-1) lactobacillus vaginal capsule for 4 consecutive weeks.There were no significant abnormalities in general clinical symptoms,ophthalmic examination,organ coefficient,urine,serum biochemistry,electrolytes,coagulation,electrocardiogram,body temperature,vaginal secretion examination,and bone marrow cell count.Although there were differences in individual hematological indicators among the groups,there was no significant time-response trend or dose-response trend.A small number of organs in the negative control group,vehicle control group,and lactobacillus vaginal capsule group showed extremely mild/mild pathological changes,and there was no significant group correlation or dose-dependent relationship in the number and severity of lesions.Conclusion After 4 consecutive weeks of vaginal administration of lactobacillus vaginal capsules to New Zealand rabbits,there was no pathological damage to the main tissues,organs,uterus,ovaries,and vaginal mucosa,and there was no significant impact or toxic effect on general physiological function indicators.
作者
李聪
牛婷婷
王启艳
皮娜
韩雪花
刘栋
杨金玲
张才星
江勤芳
李云
楼牧梦
范胜涛
LI Cong;NIU Tingting;WANG Qiyan;PI Na;HAN Xuehua;LIU Dong;YANG Jinling;ZHANG Caixing;JIANG Qinfang;LI Yun;LOU Mumeng;FAN Shengtao(Center for Drug Safety Evaluation,Research Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650118,China;Marketing Department of Xi'an Zhenghao Biopharmaceutical Co.,Ltd,Xi'an 610119,China)
出处
《医药导报》
北大核心
2026年第1期22-30,共9页
Herald of Medicine
关键词
乳酸菌阴道胶囊
毒性实验
阴道炎
Lactobacillus vaginal capsules
Toxic experiment
Vaginitis
