摘要
分析中成药质量标准、说明书"规格"项的现状及存在问题,从药品规格的认识出发,提出以下建议:中成药质量标准、说明书的"规格"项在标明单位制剂的质量、装量等的同时,标明单位制剂所含药物的理论量;以单位制剂所含药物的理论量作为确定药品规格以及药品零售指导价格的依据;取消按辅料差异划分规格的方式,不以中药制剂含糖与否或包衣与否作为区分规格的依据,无糖颗粒、薄膜衣片等的变更申请可按辅料变更处理。
The status and problems on the quality standard and statement for the specification of Chinese patent medicines （CPM） were analyzed and some suggestions were put forward in this article. The specification in the statement and quality standard of CPM should indicate the amount of unit preparartions, the loading amount of the product in proper packaging, and the active ingredient amount in theory as well; The drug specification and the retail price must be determined according to the active ingredient amount in theory. To abolish the way of dividing the drug specification by the adjuvants difference of the same drugs and not to distinguish the drug specification according to whether sugar or thin film contains or not; The application for the alternation of sucrose-free granule or thin film tablet could be handled in the way of changing adjuvants.
出处
《中草药》
CAS
CSCD
北大核心
2012年第2期216-219,共4页
Chinese Traditional and Herbal Drugs
关键词
规格
中成药
质量标准
表述
辅料
specification
Chinese patent medicines （CPM）
quality standard
statement
adjuvant
