我国上市药品规格的标准化表达方法研究

Study on Standardized Expression of Listed Drug Specifications in China

目的:对现有格式不统一、表达方式多样的药品规格进行标准化,使规格数据表达更完整、简洁,以便更高效、合理地利用。方法:针对现有药品说明书及其他药品信息中药品规格的具体表达情况,总结并制订药品规格标准化表达的流程及一系列规则,包括药品规格标准化表达的基本原则以及化学药品、生物制品、中成药、特殊制剂规格4种类别药品规格标准化原则及规则。结果与结论:统一药品规格标准化表达后可减少规格数据的冗余和缺省,保证了数据的完整性、简洁性;标准化表达后的规格数据较少且格式统一,可更高效地创建索引和排序,利于各种查询和统计分析。

OBJECTIVE： To standardize the present drug specifications which have no uniform formats and various expression approaches to make the data of drug specifications more complete and simple, then could be used more efficiently and reasonably. METHODS： Combined with the specification expression of present package inserts and other drug information, processes and a se- ries of rules of drug specifications standardization were summarized and established, including the basic principles of drug specifica- tions standardization and rules of four drugs categories such as chemicals, biological products, Chinese patent medicine and special preparations specifications. RESULTS ＆ CONCLUSIONS： Drug specifications standardization reduces date redundancy and default to make the data more complete and simple. After standardization the data has less amount and uniform formats which make index and sorting more efficient to optimize various query and statistical analysis.