药物熔点测定方法的等效性研究  

Equivalence Studies of Different Methods for Drug Melting Point Determination

作　　者：熊婧[1] 吴建敏[1] 王嗣岑[2] 刘新社[2] 项新华[1] 赵海山 宁保明[1] 何兰[1] XIONG Jin;WU Jian-min;WANG Si-cen;LIU Xin-she;XIANG Xin-hua;ZHAO Hai-shan;NING Bao-ming;HE Lan(National Institutes for Food and Drug Control,Beijing 102629,China;School of Pharmacy,Xi＇an Jiaotong University,Xi＇an 710061,China;Tianda Tianfa Technology Co.,Ltd.,Tianjin 300072,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]西安交通大学药学院,西安710061 [3]天津市天大天发科技有限公司,天津300072

出　　处：《中国药学杂志》2018年第21期1861-1868,共8页Chinese Pharmaceutical Journal

基　　金：中国食品药品检定研究院学科带头人培养基金项目资助(2017X4)

摘　　要：目的评价药物熔点测定传温液加热法分别通过玻璃液体温度计(A1)和数字温度显示(A2)读取熔点值以及电热块空气加热法(B) 3种方法的熔点测定结果是否存在差异。方法选择5个不同熔点值的化学药品作为目标药物,采用不同品牌的熔点仪测定熔点,结合中国食品药品检定研究院2015～2016年组织实施的化学药品熔点测定能力验证项目的数据,采用等效性检验分析评估A1、A2和B法的熔点测定结果。结果 A1、A2和B法是等效的,三者测定的熔点值不存在显著差异。结论 2015年版《中国药典》"熔点测定法"A法和B法的熔点测定结果无显著差异,A法通过数字温度显示与玻璃液体温度计读取的熔点值无显著差异,本实验为《中国药典》"熔点测定法"中的传温液加热法增加通过熔点仪数字温度显示读取熔点值的相关内容提供了数据支持。OBJECTIVE To evaluate the equivalence among three different methods for drug melting point determination：（1） method A1 by glass liquid thermometer, （2）method A2 by digital display, and （3） method B by instrumental method. METHODS Five chemical reference substances with different melting points were selected as the target drugs, and different brands of melting point apparatus were used to determine melting point. The apparatus used by method A consists of a glass container for a liquid bath and fitted with a suitable means of heating. The obtained results of the melting point by method A1, A2 and B were evaluated by equivalence testing referring to the data of Proficiency Testing Scheme for the melting point determination of chemical drugs organized by NIFDC in 2015 and 2016. RESULTS Method A1, A2 and B were equivalent,and no significant difference were observed for the melting point values determined by the three methods. CONCLUSION There is no significant difference between the melting point determination method A and method B in the Chinese Pharmacopoeia（ Ch. P）, and the obtained melting point values are equivalent either by glass liquid thermometer or digital display while using method A. This experiment provides scientific data support for potential adoption of digital display in melting point apparatus by Ch. P.

关 键 词：熔点 差示扫描量热法 方差分析 等效性检验 

分 类 号：R917[医药卫生—药物分析学]