中国药物警戒 ›› 2013, Vol. 10 ›› Issue (8): 449-451.

• 基础研究 •    下一篇

CASANT抗肿瘤缓释剂Beagle犬肺部植入给药毒性研究

汤连升,贾庆文*   

  1. 山东省医药工业研究所,药物安全性评价实验室,山东济南 250033
  • 收稿日期:2013-01-18 修回日期:2016-03-09 出版日期:2013-08-08 发布日期:2016-03-09
  • 通讯作者: 贾庆文,男,本科,主任药师,药理毒理。 E-mail:jqw1971@163.com
  • 作者简介:汤连升,男,硕士,主管药师,药理毒理。

The Safety Evaluation Study of C ASANT Sustained-release Anti-tumor Agent by Implanted Medication in the Lung of Beagle Dog

TANG Lian -sheng JIA Qing -wen*   

  1. Shandong Institute of Pharmaceutical Industry, Center for Drug Evaluation, Shandong Jinan 250033, China
  • Received:2013-01-18 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

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摘要： 目的 通过Beagle犬肺脏植入CASANT抗肿瘤缓释剂,评价其非临床安全性。方法 采用MyLabTwice超声诊断仪引导定位犬肺脏后,植入低、中和高剂量的受试物,药后连续观察13 周,药后2、4、8 和13 周进行体温、尿常规、标准Ⅱ导联心电图、血液学、血清生化学等指标检测,并于动物实验结束剖检后进行骨髓象检查,对主要脏器组织进行病理组织学检查。结果 实验期间,各给药组动物一般状态、体温、尿常规、标准Ⅱ导联心电图、血液学、血清生化学等临床检测未见明显异常,病理组织学检查未见明显组织损伤。结论 CASANT抗肿瘤缓释剂对Beagle犬的未产生毒性反应。

关键词: 缓释制剂, 植入, 非临床安全性

Abstract: Objective To evaluate the general toxicity of CASANT sustained-release anti-tumor agent by implanted medication in the lung of Beagle dog. Methods The test substance [1,2,4 mg/dog] was implanted into the lung of Beagle dog by using MyLabTwice ultrasonic diagnostic apparatus to guide positioning. After administration, the ani mals were continuously observed. The body temperature, urine, standard lead-ECG, hematology, serum chemistry indicators were detected, and the bone marrow examination, histological examination of major organs and tissues were conducted at 2,4,8,13 wk. Results There were no statistical significance between the test substance groups and control group in above indexes. The histological examination showed no tissue damage. Conclusion The CASANT does not have toxicity on Beagle dog.

Key words: sustained-release agent, implanted, non-clinical safety

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