关于中药蜜丸加蜜量的思考及相关问题探讨  

Reflection on Amount of Honey Added to Honeyed Pills and Discussion on Related Problems

作　　者：周跃华 张彤[2] 周刚 ZHOU Yue-hua;ZHANG Tong;ZHOU Gang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]上海中医药大学,上海201203

出　　处：《中国现代中药》2022年第12期2522-2528,共7页Modern Chinese Medicine

摘　　要：中药蜜丸为临床应用广泛的传统剂型,由于其制备时大多加蜜量不固定,在一定程度上影响了不同批次药品质量的一致性、给药剂量的准确性及药品规格表述的规范性。对《中华人民共和国药典》2020年版(一部)收载的中药蜜丸加蜜量进行了总结,分析了蜜丸加蜜量的影响因素。认为随着科学技术的发展,目前已具备固定蜜丸加蜜量及制成总量的条件。建议:1)固定中药蜜丸的加蜜量及制成总量,提高蜜丸质量的稳定性。2)加强相关研究,控制药粉质量、炼蜜程度、生产的温湿度等条件,保证固定加蜜量后蜜丸顺利生产。3)规范蜜丸规格表述,标明单位制剂蜜丸所相当的饮片量,指导规范用药。4)采用碳-4植物糖检查法,提高蜂蜜检验的专属性。Honeyed pill is a traditional dosage form widely used in Chinese medicine in clinic.The variable amount of honey added during the preparation of honeyed pills affects the quality consistency of different batches of drugs,the accuracy of dosage,and the standard description of drug specifications.This paper summarized the amount of honey added to honey pills included in Chinese Pharmacopoeia(2020 edition),and analyzed the factors influencing the amount of honey added.Additionally,the paper put forward that with the development of science and technology,the conditions for fixing the amount of honey added to honeyed pills and the theoretical total yield have been met.Suggestions were proposed:1)fix the amount of honey added to honeyed pills and the theoretical total yield,to improve the quality stability of honeyed pills.2)Strengthen relevant research and control the conditions such as powder quality,honey refining degree,temperature and humidity,to ensure the smooth production of honey pills after fixed amount of honey added.3)Standardize the specification description of honeyed pills and indicate the amount of per honeyed pill equivalent to the amount of decoction pieces,to guide standard prescription.4)Improve the specificity of honey test by C-4 sugar testing.

关 键 词：蜜丸 药品规格 蜜丸加蜜量 

分 类 号：R286[医药卫生—中药学]