| 黄瑛,郑佳威,肖亚妮,王超,秦超,霍艳.SD大鼠经鼻腔给予神经干细胞方法初探[J].中国药事,2022,36(8):954-959 |
| SD大鼠经鼻腔给予神经干细胞方法初探 |
| Preliminary Study on the Method of Nasal Administration for Neural Stem Cells in SD Rats |
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| DOI：10.16153/j.1002-7777.2022.08.013 |
| 中文关键词: 鼻腔给药 神经干细胞 细胞治疗 脑靶向 SD大鼠 |
| 英文关键词: intranasal administration neural stem cells cell therapy brain target SD rats |
| 基金项目:国家重点研发计划课题“干细胞产品非临床有效性和安全性评价新技术及规范研究”(编号 2021YFA1101602)；中国科学院战略先导科技专项“器官重建与制造类细胞质量控制方法标准化研究”(编号 XDA1604050202) |
| 作者 | 单位 | | 黄瑛 | 中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176 | | 郑佳威 | 上海安集协康生物技术股份有限公司,上海 201203 | | 肖亚妮 | 中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176 | | 王超 | 中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176 | | 秦超 | 中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176 | | 霍艳 | 中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176 |
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| 中文摘要: |
| 目的：采用大鼠鼻腔给药，建立可模拟干细胞给药新途径的临床前给药方法，为开展干细胞临床前安全性评价奠定基础。方法：将32只Sprague Dawley(SD)大鼠，随机分为2组：溶媒对照组、受试物组，每组16只动物，雌雄各半。采用鼻腔给药法，溶媒对照组给予生理盐水，受试物组给予人源神经干细胞(Neural Stem Cells，NSCs)，给药剂量为1×107 cells·kg-1。于给药后24 h和6 d，对大鼠实施麻醉后暴露心脏，完成心脏采血并进行心脏灌流固定，取脑(纹状体、黑质、皮层、海马、小脑)、血、 心、肝、脾、肺、肾、睾丸及附睾(雄性)、卵巢(雌性)，脏器、组织进行固定，取材后进行免疫荧光试验，研究神经干细胞在上述组织器官中的分布情况。结果：大鼠鼻腔给予神经干细胞后24 h和6 d， 脑组织的纹状体、黑质、皮层、海马、小脑部位均可见神经干细胞分布。外周组织心、肝、脾、肺、 肾、睾丸及附睾(雄性)、卵巢(雌性)、外周血均未见有阳性细胞。结论：临床前研究表明，神经干细胞可以通过鼻腔给药方式吸收入脑治疗脑部疾病。 |
| 英文摘要: |
| Objective: To establish a preclinical drug administration method that can simulate a novel route of stem cell administration by intranasal administration in rats, so as to lay a foundation for the preclinical safety evaluation of stem cells. Methods: Thirty-two Sprague Dawley (SD) rats were randomly divided into two groups- solvent control group and administration group, and sixteen animals were included in each group with half females and half males. Saline was administered to the solvent control group and human neural stem cells (NSCs) were administered to the administration group at a dose of 1×107 cells·kg-1. All animals were administrated intranasally once. 24 hours and 6 days after administration, the rats were anesthetized and their hearts were exposed. Blood was collected from the heart, the heart was perfused and fixed, the brain (striatum, substantia nigra, cortex, hippocampus, cerebellum), blood, heart, liver, spleen, lung, kidney, testis and epididymis (male) and ovary (female) were taken, and organs and tissues were fi xed. After taking materials, immunofluorescence experiments were carried out to study the biodistribution of NSCs in the above tissues and organs. Results: 24 hours and 6 days after intranasal administration of NSCs, the distribution of NSCs was observed in striatum, substantia nigra, cortex, hippocampus and cerebellum. No positive cells were found in peripheral tissues, including heart, liver, spleen, lung, kidney, testicle, epididymis (male), ovary (female) and peripheral blood. Conclusion: Our preclinical studies have shown that NSCs can be absorbed into the brain by nasal administration to treat brain diseases. |
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