柏子养心片药理、毒理学实验研究

Experimental Study on Pharmacology and Toxicology of Baizi Yangxin Pian

柏子养心片是《药典》柏子养心丸的剂型改革,属四类中药新药。根据《新药审批办法》的要求进行药效、急性毒性和长期毒性的实验观察。证实本药具有镇静安神的药效作用,其药效作用一定程度上优于柏子养心丸,本药小鼠LD_(50)>37.5g/kg;大鼠长期给药9g/kg、4.5g/kg、3g/kg无明显毒性作用。

Baizi Yangxin Pian is a reformed preparation of Baizi Yangxin Wan (bolus) listed in the Pharmacopoeia of People's Republic of China and is considered as a new drug of 4th class. According to the requirement of Regulations for New Drug Approval, its pharmacodynamics and acute and long-term toxicity tests were observed. It was shown that this preparation has a tranquilizing effect which is stronger than Baizi Yahgxin W an. LD_(50) is greater than 37.5g/kg. No toxic effect is revealed in rats after its long-term administration (9g/kg, 4.5g/kg and 3g/kg).