《新药审批办法》第二章第四条指出了中药新药范围,其中第二类改变中药传统给药途径的新制剂;第三类新的中药制剂;第四类改变剂型但不改变给药途径的中成药,以上均包含着研制中药新制剂新剂型。中药新药的研制是在中医药理论指导下,突出中药特色,利用现代科学技术方法,在继承基础上不断 Article 4 of Chapter 2 of the “Approval Methods for New Drugs” pointed out the scope of new Chinese medicines, of which the second type changed the traditional preparations of traditional Chinese medicines; the third type of new Chinese medicine preparations; the fourth type changed dosage forms but did not change the route of administration. The Chinese patent medicines, all of which contain new preparations for the preparation of new Chinese medicine formulations. The development of new Chinese medicines is based on the theory of Chinese medicine, highlighting the characteristics of Chinese medicine, using modern scientific and technological methods, and continuing to develop on the basis of inheritance.