刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性

doi:10.3969/j.issn.1004-616x.2022.02.013

癌变·畸变·突变 ›› 2022, Vol. 34 ›› Issue (2): 144-148.doi: 10.3969/j.issn.1004-616x.2022.02.013

• 检测研究 • 上一篇

刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性

许文黎¹, 何江², 李曙芳¹, 王新钢¹, 张亚娟¹, 刘欢¹, 岳娟¹, 李建国¹, 杨伟俊^2,

1. 中国辐射防护研究院药物安全性评价中心, 山西太原 030006;
2. 新疆维吾尔自治区药物研究所, 新疆乌鲁木齐 830004)

收稿日期:2021-08-05 修回日期:2021-11-22 发布日期:2022-04-07
通讯作者: 杨伟俊,E-mail:wilfred3106@163.com E-mail:wilfred3106@163.com
作者简介:许文黎,E-mail:xwl1986714@163.com。
基金资助:
重大新药创制科技重大专项(2019ZX09731-002)

Reproductive toxicity of Capparis spinosa fruits pain gel paste in SD rats

XU Wenli¹, HE Jiang², LI Shufang¹, WANG Xingang¹, ZHANG Yajuan¹, LIU Huan¹, YUE Juan¹, LI Jianguo¹, YANG Weijun^2,

1. Drug Safety Evaluation Center in China Institute for Radiation Protection, Taiyuan 030006, Shanxi;
2. Institute of Materia Medica of Xinjiang, Urumqi 830004, Xinjiang, China

Received:2021-08-05 Revised:2021-11-22 Published:2022-04-07

摘要/Abstract

摘要： 目的：评价刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性。方法：SD大鼠随机分为辅料对照组(辅料贴)、阳性对照组(环磷酰胺)和刺山柑果风湿止痛凝胶膏高(117.8g/m2)、中(58.9g/m2)、低(29.5g/m2)剂量组，每组雌、雄鼠各25只。每天经皮外贴给药1次，雄鼠给药4周、雌鼠给药2周后按1∶1合笼交配，雄鼠给药至交配成功，雌鼠给药至妊娠第6天，阳性对照组在大鼠给药第1天单次腹腔注射(0.1g/kg环磷酰胺)。实验期间观察动物的一般状况，体质量、摄食量和交配情况；雄鼠于交配成功当天解剖检查睾丸、附睾及精子情况；雌鼠于妊娠第14天解剖检查子宫、卵巢及胚胎情况。结果：与辅料对照组比较，刺山柑果风湿止痛凝胶膏各剂量组对雄鼠和孕鼠的体质量、饲料消耗量均无明显差异(P>0.05)；对雄鼠交配率、睾丸横径、精子数目的：评价刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性。方法：SD大鼠随机分为辅料对照组(辅料贴)、阳性对照组(环磷酰胺)和刺山柑果风湿止痛凝胶膏高(117.8g/m²)、中(58.9g/m²)、低(29.5g/m²)剂量组，每组雌、雄鼠各25只。每天经皮外贴给药1次，雄鼠给药4周、雌鼠给药2周后按1∶1合笼交配，雄鼠给药至交配成功，雌鼠给药至妊娠第6天，阳性对照组在大鼠给药第1天单次腹腔注射(0.1g/kg环磷酰胺)。实验期间观察动物的一般状况，体质量、摄食量和交配情况；雄鼠于交配成功当天解剖检查睾丸、附睾及精子情况；雌鼠于妊娠第14天解剖检查子宫、卵巢及胚胎情况。结果：与辅料对照组比较，刺山柑果风湿止痛凝胶膏各剂量组对雄鼠和孕鼠的体质量、饲料消耗量均无明显差异(P>0.05)；对雄鼠交配率、睾丸横径、精子数量、精子活动度和畸形率、附睾和睾丸质量均无明显影响(P>0.05)；对雌鼠妊娠率、子宫连胎质量、平均黄体数、平均着床数、平均活胎数、平均死胎数、平均吸收胎数、死胎率、卵巢质量亦均无明显影响(P>0.05)；但刺山柑果风湿止痛凝胶膏117.8g/m²剂量组着床前胚胎丢失率升高(P<0.05)、着床率降低(P<0.05)，29.5g/m²组着床前胚胎丢失率降低(P<0.01)、着床率升高(P<0.01)。结论：刺山柑果风湿止痛凝胶膏对雄鼠的生育力无明显毒性影响，高剂量(117.8g/m²)刺山柑果风湿止痛凝胶膏对雌鼠的生育力存在一定影响，中(58.9g/m²)、低(29.5g/m²)剂量对雌鼠的生育力无明显毒性影响。量、精子活动度和畸形率、附睾和睾丸质量均无明显影响(P>0.05)；对雌鼠妊娠率、子宫连胎质量、平均黄体数、平均着床数、平均活胎数、平均死胎数、平均吸收胎数、死胎率、卵巢质量亦均无明显影响(P>0.05)；但刺山柑果风湿止痛凝胶膏117.8g/m2剂量组着床前胚胎丢失率升高(P<0.05)、着床率降低(P<0.05)，29.5g/m2组着床前胚胎丢失率降低(P<0.01)、着床率升高(P<0.01)。结论：刺山柑果风湿止痛凝胶膏对雄鼠的生育力无明显毒性影响，高剂量(117.8g/m2)刺山柑果风湿止痛凝胶膏对雌鼠的生育力存在一定影响，中(58.9g/m2)、低(29.5g/m2)剂量对雌鼠的生育力无明显毒性影响。

关键词: 刺山柑果风湿止痛凝胶膏, SD大鼠, 一般生殖毒性, 药物安全性评价

Abstract: OBJECTIVE：To evaluate reproductive toxicity Capparis spinosa fruits pain gel paste in SD rats. METHODS： SD rats were randomly divided into five groups： excipient control (excipient)， positive control (cyclophosphamide) and Capparis high-dose (117.8 g/m²)，medium-dose(58.9 g/m²) and low-dose (29.5 g/m²) groups. There were 25 males and 25 females in each group. The rats were given by transdermal delivery once a day. The male rats received administration for 4 weeks before mating. Female rats received administration of 2 weeks before mating to the 6^th days after pregnancy. Positive controls received single intraperitoneal injection (0.1 g/kg cyclophosphamide) on D1 of administration in male and female rats. The rats were observed of the general condition， weight， food intake and mating during the experiment. When the female rats were confirmed to be pregnant，the male rats were executed and their epididymis，testicle and spermatozoa were examined. The female rats were executed on the 14^th day of pregnancy， and the uterus， ovaries and embryos were studied. RESULTS：There was no significant effect on weight and feed consumption of rats and pregnant rats. There were no significant effects on the mating rates，transverse diameters of testes， sperm counts of epididymis，mobility and malformation rates，epididymis and testicular organ weights. There were no significant effects on pregnancy rates， uterine fetal weights， mean corpus luteum numbers， mean implantation numbers， mean live fetus numbers， mean stillbirth numbers， mean absorbed fetus numbers， stillbirth rates and ovarian organ weights. In the high-dose group， the pre-implantation loss rates were increased (P<0.05) and the implantation rates were decreased (P<0.05). In the low- dose group， the pre-implantation loss rates were decreased (P<0.01) and the implantation rates were increased (P<0.01). These had a certain dose- effect relationship. CONCLUSION： Capparis spinosa fruits pain gel had no significant toxic effect on the fertility of male rats， while the high dose (117.8 g/m²) showed some reproductive toxicity in female rats. The medium (58.9 g/m²) and low (29.5 g/m²) doses showed no significant toxicity on female fertility.

Key words: Capparis spinosa fruits pain gel, SD rats, general reproductive toxicity, drug safety evaluation

中图分类号:

R394.6

许文黎, 何江, 李曙芳, 王新钢, 张亚娟, 刘欢, 岳娟, 李建国, 杨伟俊. 刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性[J]. 癌变·畸变·突变, 2022, 34(2): 144-148.

XU Wenli, HE Jiang, LI Shufang, WANG Xingang, ZHANG Yajuan, LIU Huan, YUE Juan, LI Jianguo, YANG Weijun. Reproductive toxicity of Capparis spinosa fruits pain gel paste in SD rats[J]. Carcinogenesis, Teratogenesis & Mutagenesis, 2022, 34(2): 144-148.

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刺山柑果风湿止痛凝胶膏对SD大鼠的一般生殖毒性

Reproductive toxicity of Capparis spinosa fruits pain gel paste in SD rats

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