目的阐明葛根素及其注射剂标准提高的思路与过程,为制定良好的植物提取来源药品标准提供参考。方法对葛根素、葛根素注射液、葛根素氯化钠注射液、葛根素葡萄糖注射液以及注射用葛根素标准药典收载及标准修订过程进行解析。结果葛根素及其注射剂标准增加安全性检查并修订已有检查方法,可以有效的对产品质量进行控制并保证用药安全。结论现有标准可提高产品质量可控性和安全性。 Objective To clarify the idea and process of raising the standard of puerarin and its injection, and to provide a reference for establishing a good standard of medicine for plant extraction. Methods The puerarin, puerarin injection, puerarin sodium chloride injection, puerarin glucose injection and puerarin injection standard pharmacopoeia were collected and the standard revision process was analyzed. Results Puerarin and its injection standard increased safety inspection and revision of existing inspection methods, which can effectively control product quality and ensure drug safety. Conclusion Existing standards can improve product quality controllability and safety.