摘要
目的:建立了以龙胆苦苷、黄芩苷和栀子苷为指标成分,测定龙胆泻肝丸(龙胆、黄芩、栀子等)溶出度的方法。方法:照中国药典2005版(二部)溶出度测定法中的小杯法,以100 mL 0.5%的十二烷基硫酸钠水溶液为溶出介质,转速100 r/m in。取样后,采用高效液相色谱法测定,色谱柱:Krom asil C18(250 mm×4.6 mm,5.0μm),流动相:A为乙腈;流动相B为1%的冰醋酸水溶液,梯度洗脱,检测波长254 nm,流速1.0 mL/m in,以外标法计算龙胆泻肝丸3种有效成分的溶出度。结果:三批样品4 h时龙胆苦苷、黄芩苷和栀子苷的溶出百分数均超过了75%。结论:该方法准确、可靠,可作龙胆泻肝丸溶出度测定的方法,用以控制中药复方质量。
AIM： To determine the dissolution of Longdan Xiegan Pills （Radix et Rhizoma Gentianae, Radix Scutellariae, Fructus Gardeniae, etc. ） on the basis of markers such as gentiopicroside, baicalin and geniposide. METHODS ： According to Appendix X C Ill of Chinese Pharmacopoeia 2005 edition Vol 11 , dissolution medium was 100 mL 0.5% SDS aqueous solution and rotating speed was 100 r/min. The dissolution solution of pill was taken and analyzed by HPLC method. A column of Kromasil C18 （4.6 mm×250 mm,5μm） was used. The mobile phase composed of A acetonitrile, B 1% glacial acetic acid aqueous solution, gradient eluation. The flow rate was 1.0 mL/min with the detection wavelength at 254 nm. RESULTS ： The average dissolution of three batches of gentiopicroside, baicalin and geniposide exceeded the marker amount by factor of 0.75 time in 4 h. CONCLUSION ： A reliable and qualitative method is established with good reproducibility for determination of dissolution of Longdan Xiegan Pills.
出处
《中成药》
CAS
CSCD
北大核心
2006年第11期1578-1581,共4页
Chinese Traditional Patent Medicine
