食蟹猴连续皮下注射YKY-011毒性试验血清Ⅰ型胶原交联氨基末端肽含量的检测  

Determination of the serum NTx in toxicity of YKY-011 to cynomolgus monkey via subcutaneous injection

作　　者：陈凯 马玉奎 刘天斌 贾庆文 

机构地区：[1]山东省药学科学院,山东省生物药物重点实验室,山东济南250101

出　　处：《药学研究》2018年第1期16-18,共3页Journal of Pharmaceutical Research

基　　金：山东省创新公共服务平台项目(No.2015CXPT0001);山东省自然科学基金

摘　　要：目的建立食蟹猴血清Ⅰ型胶原交联氨基末端肽(NTx)的含量检测方法,用以评估YKY-011重复给予食蟹猴毒性试验中Ⅰ型胶原交联氨基末端肽的含量变化。方法采用竞争酶联免疫吸附测定(ELISA)法检测,验证考察了检测方法的线性范围、精密度和准确性,并对YKY-011重复给药毒性试验中食蟹猴的血清Ⅰ型胶原交联氨基末端肽含量进行了检测。结果建立并验证了灵敏度高、稳定性良好的检测猴血清中Ⅰ型胶原交联氨基末端肽的酶联免疫吸附测定方法;食蟹猴连续皮下注射YKY011在给药2周后较给药前血清Ⅰ型胶原交联氨基末端肽开始下降,且与同剂量市售对照组下降幅度相当。结论该酶联免疫吸附测定方法可用于食蟹猴血清Ⅰ型胶原交联氨基末端肽的检测,YKY-011可有效降低食蟹猴血清中Ⅰ型胶原交联氨基末端肽水平,并与市售对照品降低幅度类似。Objective To establish the method for the determination of serum NTx in cynomolgus monkey,and evaluate the changes of NTx in the toxicity of YKY-011 to cynomolgus monkeys.Methods The linear range,precision and accuracy of the detection method were examined by competitive ELISA.The serum NTx of cynomolgus monkeys in YKY-011 repeated toxicity was detected.Results The ELISA method for detecting NTx in monkey serum with high sensitivity and good stability was established and validated.The serum NTx was decreased after repeated administration via subcutaneous for 2 weeks,and compared with the same dose of commercial control group the decline was similar.Conclusion The ELISA method can be used for the detection of serum NTx in cynomolgus monkey.YKY-011 can effectively reduce the level of NTx in cynomolgus monkey and the effect was similar to the commercial reference substance.

关 键 词：酶联免疫吸附测定法 Ⅰ型胶原交联氨基末端肽 骨质疏松 食蟹猴 血清 

分 类 号：R994.39[医药卫生—毒理学]