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目的：研究甘氨双唑钠（ＣＭＮａ）的致畸性。方法：采用传统致畸学试验方法，检测了ＣＭＮａ对Ｓｐｒａｇｕｅ－Ｄａｗｌｅｙ孕鼠在致畸敏感期的潜在毒性。试验设１３９．９，２７９．０和１３９９．０ｍｇ／ｋｇ３个剂量组（分别相当于１／２０，１／１０和１／２ＬＤ５０），同时设对照组（生理盐水），采用尾静脉注射给药。结果：孕鼠接受ＣＭＮａ后，母体体重减轻，并随剂量的增大而有剂量－效应关系。高剂量（１３９９．０ｍｇ／ｋｇ）组吸收胎增多，活胎率和平均每窝活胎数降低，并有一定程度的胎鼠畸形，总畸形率达９．４％。同时还显示ＣＭＮａ在２７９．０ｍｇ／ｋｇ剂量时有母体毒性和胚胎毒性，但无致畸作用；在１３９．９ｍｇ／ｋｇ剂量时，仅有母体毒性而无胚胎毒性和致畸作用。结论：该药在临床推荐应用剂量下使用比较安全。
Objective: To study the teratogenicity of glycopyrrolate sodium (CMNa). METHODS: The potential toxicity of CMNa to pregnant rats with Sprague-Dawley during teratogenicity was tested by traditional teratological test. The experimental groups were 139.9, 279.0 and 1399.0 mg / kg3 doses (corresponding to 1/20, 1/10 and 1/2 LD50 respectively), and the control group (normal saline) was administered by tail vein injection . Results: Pregnant mice received CMNa, the mother weight loss, and dose-dependent increase of dose-effect relationship. In the high dose group (1399.0mg / kg), the number of aborted fetuses increased, the percentage of live births and average live litter size decreased, and there was a certain degree of fetal malformations with a total deformity rate of 9.4%. CMNa was also shown to have maternal toxicity and embryotoxicity at 279.0 mg / kg but no teratogenic effects; at 139.9 mg / kg, there was only maternal toxicity without embryotoxicity and teratogenicity. Conclusion: The drug is safe to use in clinical recommended dosage.