摘要
为了建立八味健骨片临床药物动力学研究方法,通过分析组方成分、临床前药学研究结果,估算血药浓度,并经实验证明,地高辛免疫反应药物监测系统可以检出口服八味健骨片、香加皮提取物的动物血清中的强心苷响应值,与给予地高辛片的检出结果一致；在Ⅰ期临床耐受性试验受试者血清中也检出响应值,检测值大小与给药时间、给药剂量相关；临床阴性对照显示,该反应具有特异性。结果提示,可以用地高辛免疫反应临床药物监测系统对杠柳毒苷的交叉反应进行以毒性成分为目标的药物动力学研究。
Objective To establish the clinical pharmacokinetics research method for Bawei Jiangu Tablet . Methods Drug blood concentration was estimated through analyzing the ingredients and preclinical pharmaceutical research results of Bawei Jiangu Tablet . Results Corresponding cardiac glycoside value in serum of animals treated with oral use of Bawei Jiangu Tablets and cortex periplocae extracts can be detected by drug monitor system of digoxin immunoreaction, which was similar to that in animals treated with digoxin. Corresponding cardiac glycoside value had also been detetected in serum of subjects in phase I clinical tolerance trial, which was related to the time and dosage of administration. Clinical negative control trial showed that the reaction was specific. Conclusion Pharmacokinetics study on target of toxic components with cross - reaction of periplocoside is feasible through drug monitor system of digoxin immunoreaction.
出处
《中药新药与临床药理》
CAS
CSCD
2006年第6期436-439,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
科技部国家高技术研究发展计划项目(863项目)"临床试验关键技术及平台研究"(2002AA22341M)。
