ABSTRACT
There are only 22 varieties of pediatric drugs in National Essential Drug Catalogue (2018 Edition), including five chemicals and 17 Chinese patent medicines (13 prescriptions). Chinese patent medicines are widely used to treat pediatric diseases. The formulations of Chinese patent medicines are mostly derived from ancient classic prescriptions, based on the theory of syndrome differentiation and treatment of traditional Chinese medicine. The instruction of Chinese patent medicine as a document to guide the use of medicines, the specification and integrity of it directly affects whether Chinese patent medicine is used safely and effectively. This paper investigates the instructions of pediatric Chinese patent medicines in National Essential Drug Catalogue (2018 Edition) comparing with the relevant requirements of the United States and Japan, analyzes the toxicity and contraindication of Chinese patent medicines for pediatrics, summarizes the problems existing in these instructions, and puts forward some suggestions. The result shows that there are few kinds of proprietary Chinese patent medicines for pediatrics. There exist common shortcomings in the instructions of Chinese patent medicines for pediatrics, such as unlabeled contents, unnormalized indications, unclear usage and dosage, unknown contraindications and unclear precautions. This study provides a basis for further perfecting the instructions of Chinese patent medicines, and it is helpful to promote the safe and rational use of medicines for children.