中国生化药物杂志2017,Vol.37Issue(11) :10-11.DOI:10.3969/j.issn.1005-1678.2017.11.004

泮托拉唑钠静注后在胃溃疡大鼠体内的药代动力学特点分析

Pharmacokinetic characteristics of pantoprazole sodium in rats with gastric ulcer after intravenous injection

倪斌 杨晶晶 叶卫林
中国生化药物杂志2017,Vol.37Issue(11) :10-11.DOI:10.3969/j.issn.1005-1678.2017.11.004

泮托拉唑钠静注后在胃溃疡大鼠体内的药代动力学特点分析

Pharmacokinetic characteristics of pantoprazole sodium in rats with gastric ulcer after intravenous injection

倪斌 1杨晶晶 2叶卫林1
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作者信息

  • 1. 杭州市第一人民医院 药学部,浙江 杭州 310006
  • 2. 杭州市第三人民医院 药学部,浙江 杭州 310009
  • 折叠

摘要

目的 研究分析泮托拉唑钠静注后在胃溃疡大鼠体内的药代动力学特点.方法 选取15只SD雄性大鼠,随机分为3组,分别为模型组、假手术组及对照组,每组大鼠各为5只.对照组大鼠不进行任何处理,仅起对照作用.假手术组进行开腹操作,但不造模.模型组大鼠进行胃溃疡大鼠造模.3组大鼠均经尾静注10 mg/kg泮托拉唑钠,在给药后与给药前取大鼠眼静脉丛血,进行分离操作,分析计算相关药代动力学特点,方法为HPLC-UV法,并验证所得的稳定性和精密度等指标.结果 3组大鼠在经尾静注10 mg/kg泮托拉唑钠后,CLz、AUC(0-t)、MRT(0-t)等药代动力学参数情况比较,差异无统计学意义.在0.1~50.0 mg/L范围内,紫外线响应与药物浓度呈现良好的线形关系,HPLC-UV法回收率均在90.0%以上,符合生物样品分析的要求.泮托拉唑钠样品分析准确度范围为86.0%~116.0%左右,符合要求.在不同的条件下,泮托拉唑钠药物浓度的理论值与实测值相比,差异无统计学意义,稳定性符合要求.结论 泮托拉唑钠静注后在胃溃疡大鼠体内的药代动力学与正常大鼠并无显著差异,可应用HPLC-UV法进行分析.

Abstract

Objective To investigate the pharmacokinetic characteristics of pantoprazole sodium in rats with gastric ulcer after intravenous injection. Methods 15 SD male rats were randomly divided into three groups: the model group, the sham operation group and the control group, 5 rats for each group. Rats in the control group did not take any treatment, but only served as a control group.The sham operation group performed laparotomy, but not the model. Rats in model group were made for gastric ulcer model. Three groups of rats were treated by tail intravenous injection of 10 mg/kg pantoprazole sodium, eye venous plexus blood of rats were separated before and after medication. Relevant pharmacokinetic characteristics were analyzed and calculated with the HPLC-UV method, and the stability and precision were verified. Results There was no statistical significance in pharmacokinetic parameters of CLz, AUC (0-t) and MRT (0-t) after intravenous injection of 10 mg/kg pantoprazole sodium in the three groups. In the range from 0.1 to 50.0 mg/L, the UV response showed a good pre correlation with the drug concentration, and the recovery rate of HPLC-UV was over 90.0%, which met the requirements of biological sample analysis. The analytical accuracy of pantoprazole sodium sample ranged from 86.0% to 116.0%, which met the requirements. Under different conditions, the theoretical value of pantoprazole sodium concentration is not significantly different from the measured value, and the stability met the requirements. Conclusion The pharmacokinetics of pantoprazole sodium in gastric ulcer rats is not significantly different from that in normal rats, and could be analyzed by HPLC-UV method.

关键词

泮托拉唑钠/胃溃疡大鼠/药代动力学特点/静注

Key words

pantoprazole sodium/gastric ulcer in rats/pharmacokinetic characteristics/intravenous injection

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出版年

2017
中国生化药物杂志
南京生物化学制药研究所,全国生化制药情报中心站,中国生化制药工业协会,中国药品生物制品检定所

中国生化药物杂志

ISSN:1005-1678
参考文献量6
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