宫炎平片对SD大鼠生殖毒性研究

Reproductive Toxicity of Gongyanping Tablets in SD Rats

目的检测宫炎平片(GYP)对亲代动物生育能力与早期胚胎发育及胚胎-胎仔发育影响,为其临床安全性应用提供依据。方法(1) SD大鼠生育能力与早期胚胎发育毒性实验:随机分组,对雌鼠在交配前和妊娠期灌胃给药21 d,于妊娠15 d处死,观察临床表现及病理变化,统计各剂量组雄鼠生育率、雌鼠性周期、妊娠率、孕鼠死亡率和死胎率。(2)胚胎-胎仔发育毒性实验:随机分组,对妊娠后大鼠进行灌胃给予溶媒对照品和宫炎平片药液,于妊娠20 d(GD20)处死母鼠,取出胎仔,检查黄体数、着床数、活胎数、死胎数等。结果(1) SD大鼠生育能力与早期胚胎发育毒性实验:各组妊娠大鼠体重、雌鼠及孕鼠摄食量与溶媒对照组比较均无统计学意义(P>0.05);各组雌性大鼠动情周期、交配率、妊娠率等与溶媒对照组比较均无统计学意义(P>0.05)。(2)胚胎-胎仔发育毒性实验:各组大鼠妊娠期增重、摄食量、孕鼠GD20黄体数、着床数、活胎数等与溶媒对照组比较均无统计学意义(P>0.05),大鼠胎仔外观畸形率、内脏畸形率、骨骼畸形率及骨骼发育情况与溶媒对照组比较也均无统计学差异(P>0.05)。结论宫炎平片对亲代动物生育力与早期胚胎发育及胚胎-胎仔发育无毒性影响,对SD大鼠母体无毒性,对胎仔无致畸作用。

OBJECTIVE To investigate the toxicity of Gongyanping( GYP) on SD rat fertility and early embryonic development and embryo-seed development,in order to provide useful data for clinical drug safety. METHODS( 1) Toxicity of GYP on SD rat fertility and early embryonic development. SD rats were randomly divided into 4 groups,solvent control group and GYP low,medium,high dose groups.Female rats were administered intragastrically for 21 days before mating and until to day 7 of gestation( GD7).Pregnant rats were sacrificed at GD15.The clinical manifestations and pathological changes were observed. The fertility rate,female sex cycle,pregnancy rate,pregnancy mortality and stillbirth rate of male rats in each dose group were counted.( 2) Experiment of GYP on SD rats embryo-seed developmental toxicity.Pregnant rats were randomly divided into 4 groups,a solvent control group,GYP,low,medium,high dose groups. Rats were administered intragastrically for 10 days. Pregnant rats were sacrificed at GD20,removed rats embryo-seed checked and the number of corpus luteum,implantations,live births,stillbirths,etc were counted. RESULTS( 1) Compared with solvent control group,there was neither significant difference in body weight of pregnant rats,food intake of female and pregnant rats among each dose( P>0.5).Nor effect on mating rate,pregnancy rate,etc. in female rats( P> 0.5).( 2) Compared with solvent control group,the experimental results showed that GYP had no effect on body weight gain, food intake, corpus luteum, number of implantation,and live fetuses of pregnant rats( P > 0. 5),neither had effect on appearance deformity rate,visceral deformity rate,skeletal deformity rate and bone development,etc( P > 0. 5). CONCLUSION GYP has no toxic effect on SD rat fertility,early embryonic development and embryo-seed development.