扁咽口服液生产过程中黄芩苷转移率的研究.pdfVIP

药学实践杂志 2012 年 7 月 25 日第 30 卷第 4 期 Joumal of Pharmaceutical Practi时， VoI. 30 ， No.4 ,July 25 ,2012 289 扁咽口服液生产过程中黄苓昔转移率的研究 李 翔，刘饭阳，马建丽，王晓肯，高 磊，张清哲(解放军总医院第一附属医院药剂药理科，北京 100037 ) [摘要] 目的 建立高效液相色谱法测定扁咽口服液中黄苓昔的含量，对其在生产过程中的转移率进行评价。方法 色谱桂:Agilent Zorbax Eclipse XDß-C 18 (4.6 mm x 150 mm ， 5μm) ;流动相:甲醇-0.5% 冰醋酸溶被(45 : 55) ;流速: 1. 0 mll min; 检测波长:277 nm; 柱温:30 c ;进样量 :10μl。结果 黄苓昔浓度在1. 064 - 106.4μg/ml 范围内与其峰面积线性关系良 好(r=0.999 9) ，平均回收率(n =6) 为 10 1. 26% ,RSD 为1. 929毛。黄苓音由药材到中|同品及由中间品到成品的转移率分别为 17.2% -19.0% 和 78.7% -79.4% 。结论 该方法快速、简便、准确，可用于扁咽口服液的质量控制和生产工艺评价p [关键词] 扁咽口服液;黄苓音;含量;转移率;高效液相色谱法 [中图分类号] R917 [文献标志码] A [文章编号] 1006 - 0111 (2012) 04 - 0289 - 03 [DOI] 10. 3969/j. issn. 1006 - 0111.2012.04.012 Research on the transfer rate of baicalin in preparation of Bianyan oral solution LI Xiang , LIU Gui-yang , AM Jian-li , WANG Xiao-qing , GAO Lei , ZHANG Qin-zhe (Department of Pharmacy , First Affiliated Hos- pital , General Hospital of PLA , Beijing 100037 , China) [ Abstract 1 Objective To establish the HPLC method for det阳t忧erm口nll川llna川ation of haica剖lin in Bian盯yan oral so叫lu川t transfer rat怆e in process of production. Methods The Agilenl Zorhax Eclipse XDB-C (4.6 mm x 150 mm , 5μm) was used , the mohile phase consisted of methanol-O. 5% acetic acid (45 : 55) , the flow rale was 1.0 mllmin , the detection wavelength was at 277 nm , the column temperature was at 30 C , the inject volume was 10μ1. Resu Its A good linear correlation of baicalin was observed within the range of 1. 064 - 106.4μg/ml (r =O. 9999). The average recovery was 10 1. 26% with RSD 1. 929毛 ( n =6). The trans- fer rates from Radix Scutellariae to intεrmediate sample and 10 Bianyan oral solution were 17. 2 % - 19. 09也 and 78.7% - 79. 4%. Conclusions The method was rapid , sîmple and acc