射干清咳片6种活性成分溶出度比较  

Comparative Studies of Dissolution on Six Active Components of Shegan Qingke Tablet

作　　者：张婧涵[1] 张晓瑞[1] 姜鸿[2] 李国信[2] 邹桂欣[2] 

机构地区：[1]辽宁中医药大学,辽宁沈阳110847 [2]辽宁省中医药研究院,辽宁沈阳110034

出　　处：《辽宁中医药大学学报》2013年第10期37-39,共3页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家重大新药创制资助项目(2009ZX9103-330);国家重大新药临床技术平台资助项目(2012zx09303-017);辽宁省自然基金资助项目(20102117)

摘　　要：目的:研究射干清咳片中6种活性成分的体外溶出特点。方法:《中华人民共和国药典》2010年版二部附录XC第二法,以0.05%磷酸二氢钾(含0.3%十二烷基硫酸钠)水溶液为溶出介质。采用高效液相色谱法,色谱柱:Kromasil C_(18)(250 mm×4.6 mm,5μm);流动相:0.5%磷酸水溶液(A)和乙腈(B),梯度洗脱,检测波长265nm,流速1.0 mL./min,测定射干清咳片中6种活性成分的体外溶出度,计算活性成分的累积溶出率。结果:60 min时鸢尾苷、野鸢尾苷、鸢尾黄素、野鸢尾黄素、次野鸢尾黄素及白射干素的累积溶出率分别为92.45%、92.26%、80.97%、86.21%、80.51%及79.41%。结论:在0.05%磷酸二氢钾(含0.3%十二烷基硫酸钠)水溶液中,射干清咳片中的6种活性成分具有同步性溶出的特点。Objective ： To study the dissolution characteristics of six active components of Shegan Qingke Tablet in vitro. Method： The different dissolution solvents and the dissolution rates in vitro of six kinds active components in Shegan Qingke tablet were investigated.According to Appendix X C III of Chinese Pharmacopoeia 2005 edition Vol II , dissolution medium was 100 mL 0.05% KH2PO4 （ containing 0.3% SDS ） aqueous solution and rotating speed was 100 r/min.The dissolution solution of pill was taken and analyzed by HPLC.A column of Kromasil Cls （4.6 mmx 250 ram,5 m ）was used.The mobile phase composed of A acetonitrile, B 0.5% phosphoric acid solution.The flow rate was 1.0 mL/min with the detection wavelength at 265 nm. Results： The accumulative dissolution percentages were 92.45%,92.26%, 80.97%, 86.21%, 80.51% and 79.41% at 60 rain, respectively. Conclusion： Six active components of Shegan Qingke tablet have the characteristics of synchronicity dissolution in 0.05% KH2PO4 （ containing 0.3% SDS ） actueous solution.

关 键 词：HPLC 射干清咳片 溶出度 

分 类 号：R284[医药卫生—中药学]