中药现代化论坛· 中药制剂含量均匀度的测定方法 - 天津中草药杂志社.pdf

中草药 Chinese Traditional and Herbal Drugs 第45 卷 第15 期 2014 年8 月 ·2125 · ·中药现代化论坛· 中药制剂含量均匀度的测定方法初探 1 1* 1 1 1 1, 2 韩 丽 ，张 芳 ，张定 ，唐宜轩 ，杨迎光 ，杨 明 1. 成都中医药大学药学院，四川 成都 611137 2. 江西中医药大学 现代中药制剂教育部重点实验室，江西 南昌 330004 摘 要：以中药制剂含量均匀度研究的必要性为切入点，归纳总结了可用于中药制剂含量均匀度的测定与评估方法，并对机 器视觉技术与红外光谱指纹图谱进行了阐述，旨在提升中药制剂品质，保证临床用药的安全、有效，推动适合中药制剂含量 均匀度评价体系的建立。 关键词：中药制剂；含量均匀度；红外指纹图谱；机器视觉技术；质量控制 中图分类号：R286.02 文献标志码：A 文章编号：0253 - 2670(2014)15 - 2125 - 07 DOI: 10.7501/j.issn.0253-2670.2014.15.001 Determination methods of content uniformity in preparations of Chinese materia medica 1 1 1 1 1 1, 2 HAN Li , ZHANG Fang , ZHANG Ding-kun , TANG Yi-xuan , YANG Ying-guang , YANG Ming 1. College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China 2. Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China Abstract: In this paper, the essentiality of content uniformity of Chinese materia medica (CMM) is taken as a breakthrough point, the determination and assessment methods which may be used for the content uniformity of CMM are summarized, and the measures respected by author of IR fingerprint and machine vision technology are elaborated, in order to enhance the quality of CMM preparations, strengthen the safety and effectiveness of clinical medicine, and promote the establishment of content uniformity evaluation system suitable for CMM preparations. Key words: Chinese materia medica preparation; content uniformity; IR fingerprint; machine vision technology; quality control 含量均匀度（content uniformity ）是保障药物制 1