Abstract: Objective To analyze the problems existing in the package inserts of Chinese patent drug for suggestion of its revise and for references of rational drug use in the clinic． Methods 86 package inserts of Chinese patent drug from our hospital were analyzed． Results The common problems existing in the package inserts of Chinese patent drug were characterized by absence of important items such as pharmacokinetics, medication of children and elder patients, medication of pregnant and lactation women, adverse drug reactions, drug interaction, contraindication, precautions, pharmacology and toxicity, etc, meanwhile the descriptions of some items were unclear thus hard to understand． Conclusion It is urgent to standardize the package inserts of Chinese patent drug．

Key words: drug package insert, Chinese patent drug, survey, analysis