解表中成药具有发汗、解表、透疹等作用，在临床上广泛用于治疗表证。解表中成药制剂品种繁多、工艺各异，一些处方相同、功效相近的解表中成药，在制法和质量标准上却存在较大差异，这必然对其功效有一定的影响。从《新编国家中成药》第2版和《中国药典》2010年版中含挥发油的解表类中成药的情况、制备工艺及质量控制现状，通过文献研究，分析挥发油对解表药解表功效的重要性、制法对解表作用的重要影响，并在中医药“方-证-剂”对应的中药制剂指导思想基础上，进一步提出“方-证-制-剂-质”对应指导中成药组方、制备和质量控制的指导思想，以期对现代中成药复方制剂的研究、开发和再评价具有一定的启示。

Traditional Chinese patent medicines (TCPM) with relieving exterior syndrome function were widely used in clinic to relieve exterior syndrome by diaphoresis and promoting eruption. There are a huge number of relieving exterior syndrome functional drugs in market, which are different in prescription and preparation process. However, some of them are in the same prescription and have the same efficacy, but significantly different in process and quality control, which will result in some influence on drug efficacy. Following New Edition of National Traditional Chinese Patent Medicines (2nd edition) and Chinese Pharmacopoeia (2010 Edition), we focused on the current clinical application, preparation process, and quality control of the relieving exterior syndrome functional TCPM containing volatile oil. After summarizing and analyzing the literature, we figured out the importance of volatile oil as well as the preparation process and quality control for the efficacy of relieving exterior syndrome functional TCPM. On the basis of corresponding thinking of "Prescription-Syndrome-Agent", we put forward a new opinion of "Prescription-Syndrome-Procession- Agent-Quality" and mentioned its importance for composing a new prescription, preparation processing, and quality control. We hope all these will stimulate some new ideas or methods in the development of a new TCPM and re-evaluation of modern TCPD compound preparation as well.

江西中医药大学校级科研课题（2012FC004）