复方火炭母浸膏家兔阴道给药长期毒性试验的研究  

Study on Long-term Toxicity Test of Rabbits with Compound Polygonum Chinense Linn Extract by Vaginal Administration

作　　者：宋清清 方云涛 胡慧[2] 王海梅 SONG Qingqing;FANG Yuntao;HU Hui;WANG Haimei(Jiangsu Center for Safety Evaluation of Drugs,Jiangsu Pharmaceutical Research Institute Co.,Ltd,Nanjing Tech University,Nanjing Jiangsu 211800,China;China Pharmaceutical University,Nanjing Jiangsu 211100,China)

机构地区：[1]江苏省药物安全性评价中心,江苏省药物研究所有限公司,南京工业大学,江苏南京211800 [2]中国药科大学,江苏南京211100

出　　处：《药品评价》2024年第10期1200-1204,共5页Drug Evaluation

摘　　要：目的观察长期阴道注入复方火炭母浸膏对家兔的影响,为人用安全剂量提供参考。方法将60只家兔随机分成空白对照组,复方火炭母浸膏低、中、高剂量组。阴道给药,每天1次,连续给药13周。观察指标为兔一般状况、摄食量、体重、脏器重量及系数、血液学及血生化指标及组织病理学。停药后继续进行可逆性观察4周。结果连续给药13周后,中剂量组体质量增加,与空白对照组相比差异有统计学意义(P<0.05);除此之外,其他各项指标与对照组相比,均差异无统计学意义(P>0.05)。结论家兔每天1次,连续13周阴道给药,复方火炭母浸膏高剂量组(相当于5倍临床浓度)没有发现明显毒性反应。Objective To observe the effects of long-term vaginal injection of compound Polygonum chinense Linn extract on rabbits and provide reference for safe dosage for human use.Methods Sixty rabbits were randomly divided into blank control group and a low,medium,and high dose groups of compound Polygonum chinense Linn extract.The drug was given vaginally once daily for 13 weeks.The observation indexes were general condition,food intake,body weight,organ weight and coefficient,hematology and blood biochemical indexes and histopathology of the rabbits.Reversibility observation was continued for 4 weeks after withdrawal.Results After 13 weeks of continuous administration,the body weight of the medium dose group increased significantly compared to the blank control group(P<0.05).In addition,there was no statistical significance in other indexes compared with the blank control group(P>0.05).Conclusion Rabbits were given vaginal administration once a day for 13 weeks,and no obvious toxic reaction was found in the high dose group(equivalent to 5 times the clinical concentration)of compound Polygonum chinense Linn extract.

关 键 词：复方火炭母浸膏 长期毒性试验 宫颈癌 阴道给药 

分 类 号：R285.5[医药卫生—中药学]