基于近红外光谱判定复方丹参片生产过程中冰片的混合均匀性  

A Method for Analyzing Uniformity of Borneol in Manufactory Process of Compound Danshen Tablets by Near-infrared Spectroscopy

作　　者：匡艳辉[1] 唐海姣 王德勤[1] 刘晓谦[2] 覃仁安[1] 王智民[2] 李楚源[1] KUANG Yan-hui1, TANG Hai-jiao1. , WANG De-qin1, LIU Xiao-qian2, QIN Ren-an1, WANG Zhi-min1, LI Chu-yuan1(1. Guangzhou Baiyun Mountain and Hutchison Whampoa Co. Ltd. , Guangzhou 510515, China; 2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, Chin)

机构地区：[1]广州白云山和记黄埔中药有限公司,广州510515 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2018年第6期7-11,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局中药标准化项目(ZYBZH-C-GD-05)

摘　　要：目的：探索一种近红外光谱用于判定复方丹参片生产过程中微量冰片混合均匀性的方法,为该制剂的质量改进提供参考。方法：收集混合过程中所需原料,按照一定的比例配制成不同的组分,采用研磨和喷雾2种方式将冰片混入干膏粉中,在不同部位均匀取样,所得样品进行近红外光谱扫描并计算其阈值及欧式距离,采用气相色谱法（GC）检验每份样品中冰片的含量,DB-FFAP毛细管柱（0.32 mm×30 m,0.25μm）,柱温110℃,进样口和检测器温度均为200℃,分流比1∶1。结果：当阈值或欧式距离〈0.01时,GC结果显示冰片含量的RSD〈10%,表明冰片混合均匀;当阈值或欧式距离〉0.01时,GC结果显示冰片含量的RSD〉30%,表明冰片混合不均匀。结论：所建立的方法能有效快速判定复方丹参片生产过程中冰片混合的均匀性,建议纳入企业内控或国家标准中。Objective： A near-infrared method for determining the uniformity of micro-borneol in the production process of compound Danshen tablets was investigated. Method： The raw materials required for the mixing process were collected and prepared into different fractions according to a certain ratio,two ways of grinding and spraying were used to mix borneol into the dry extract. Uniform samples were sampled at different locations,the samples were scanned by near-infrared, and their thresholds and Euclidean distance parameters were calculated. The content of borneol in each sample was detected by GC. Result： When the threshold or the Euclidean distance was 0. 01,GC results showed that RSD of borneol content was 10%,indicating that the borneol was uniformly mixed. When the threshold or the Euclidean distance was 0. 01,GC results showed that RSD of borneol content was 30%, indicating that the borneol was mixed unevenly. Conclusion： The established method can effectively and quickly determine the uniformity of borneol mixing in compound Danshen tablets,it is recommended to be incorporated into internal control or national standards.

关 键 词：复方丹参片 冰片 均匀度 阈值 欧氏距离 气相色谱法 近红外光谱 

分 类 号：R22[医药卫生—中医基础理论] R283.6[医药卫生—中医学]