HPLC法测定注射用丹香冠心中丹参素钠及原儿茶醛含量.docVIP

HPLC法测定注射用丹香冠心中丹参素钠及原儿茶醛含量摘要：目的建立用HPLC法测定注射用丹香冠心中丹参素钠和原儿茶醛含量的方法。方法ODS为固定相；甲醇-0.5%冰醋酸溶液（12?88）为流动相；检测波长280 nm。结果丹参素钠在42.52~382.68μg/mL浓度范围内线性关系良好（r＝0.999 8），平均回收率为100.54%（RSD＝0.797%）；原儿茶醛在8.14~73.30μg/mL浓度范围内线性关系良好（r＝0.999 6）；平均回收率为98.87%（RSD＝1.282%）；结论此法简便，快速，准确．灵敏度高，重现性好，可用于注射用丹香冠心的质量控制。 关键词：高效液相色谱法；注射用丹香冠心；丹参素钠；原儿茶醛 中图分类号：R972文献标识码：A文章编号：1672-979X(2007)05-0021-03 Quantitative Determination of Tanshinol Sodium and Protocatechualdehyde in Danxiang Guanxin for Injection by HPLC WANG Yu-tuan1, PENG Yan-li1, LI Yong2 (1.Shandong University of Traditional Chinese Medicine, Jinan 250014, China; 2.Guangdong Pharmaceutical University, Guangzhou 510006, China) Abstract：Objective To establish a HPLC method for the quantitative determination of tanshinol sodium and protocatechualdehyde in Danxiang Guanxin for injection. Methods Stationary phase was ODS；mobile phase was composed of methanol-0.5%glacial acetic acid solution (12?88); UV detection wavelength was 280 nm. Results The linear ranges of tanshinol sodium and protocatechualdehyde were 42.52~382.68μg/mL and 8.14~ 73.30μg/mL, respectively; the correlation coefficients were 0.999 8 and 0.999 6, respectively; the average recoveries of spiked sample were 100.54% (RSD=0.797%) and 98.87% (RSD=1.282%) , respectively. Conclusion The method is simple, rapid, accurate, sensitive and reproducible. It is suitable for the determination of tanshinol sodium and protocatechualdehyde in Danxiang Guanxin for injection. Key words：HPLC; Danxiang Guanxin for injection; tanshinol sodium; protocatechuialdehyde 注射用丹香冠心是将丹香冠心注射液制成冻干粉针剂，增加了产品的稳定性，并利于储藏运输。注射用丹香冠心的主要药物为丹参、降香，通过抑制红细胞及血小板聚集，降低血液黏滞度从而改善血液黏稠度；扩张血管，降低血管内压，改善微循环从而改善组织从微循环中提取氧的能力；还具有扩张动脉、增加血流量、降压等作用。临床上多用来治疗脑梗塞[1]、肺心病[2]、心绞痛、流行性出血热（少尿期）[3]等。方中丹参用水提醇沉法提取，以水溶性成分为主。近年研究表明，水溶性成分（包括丹参素钠、原儿茶醛等）在扩张心脑血管，抗血小板聚集，清除氧自由基等方面较二萜醌类作用更强，且水溶性成分是抗心脑缺血的主要成分。我们用高效液相法[4,5]同时考察水溶性的丹参素钠和原儿茶醛2种成分的含量，操作简便，结果可靠，可有效控制此制剂的质量。 1仪器、样品与试剂 1.1仪器 戴安高效液相色谱仪（Dionex Ultimate 3000，美国） 1.2