摘要
目的:采用高效液相色谱(HPLC)法建立侧柏叶配方颗粒的指纹图谱,旨在为其质量研究评价提供实验依据。方法:样品经20%甲醇超声处理后,采用Agilent ZORBAX SB-C_(18)(4.6 mm×250 mm,5μm)色谱柱,以乙腈(A)-1%冰醋酸(B)为流动相,梯度洗脱,检测波长254 nm,流速1.0 mL·min^(-1),柱温30℃,对照品进样量10μL,供试品进样量20μL,记录时间50 min。结果:侧柏叶配方颗粒精密度、稳定性和重复性试验的RSD分别为0.03%、0.06%、0.21%,均不大于2.0%(n=6)。采用梯度洗脱得到的色谱图各色谱峰分离效果好,达到指纹图谱的要求。与侧柏叶药材、饮片及汤剂的指纹图谱进行系统比较,结果发现各批次样品的相似度较高,均一性较好,均呈现出13个共有峰,各共有峰相对保留时间稳定,具有专属性。结论:该方法准确可靠,重复性好,可为侧柏叶配方颗粒质量控制提供参考。
Objective:To establish an HPLC fingerprint spectrum of formula granule of Cacumen Platycladi,to provide experimental evidence for its quality research evaluation.Methods:Take 20%methanol extract of Cacumen Platycladi formula granules as sample by ultrasonic processing.HPLC analysis was carried out on Agilent ZORBAX SB-C_(18)(4.6 mm×250 mm,5μm)chromatographic column with mobile phase of acetonitrile-1%glacial acetic acid,gradient elution with a flow at 1.0 mL·min^(-1),an ultraviolet detection wavelength at 254 nm,the column temperature at 30℃.The injection volume of reference substance was 10μL,the injection volume of test substance was 20μL,and the recording time was 50 min.Results:The RSD of the precision,stability and repeatability test of Cacumen Platycladi formula granules were 0.03%,0.06%,0.21%,all of which were not more than 2.0%(n=6).The chromatograms obtained by gradient elution have good separation results and meet the requirements of fingerprints spectrums.A systematic comparison with the fingerprints spectrums of Cacumen Platycladi crude drug,decoction pieces and decoction showed that the similarity of each batch of samples was high,and the uniformity was good.All showed 13 common peaks,and the relative retention time of each common peak was stable.Conclusion:The method is accurate,credible with good repeatability,which it can provide reference evidence for quality control of Cacumen Platycladi formula granules.
作者
肖毓
施嘉辉
黄琪
姚俊霞
赵淑淑
XIAO Yu;SHI Jiahui;HUANG Qi;YAO Junxia;ZHAO Shushu(Zhejiang Jolly Pharmaceutical Co.,Ltd,Zhejiang Deqing 313200,China)
出处
《中国医药导刊》
2022年第7期698-701,共4页
Chinese Journal of Medicinal Guide
基金
浙江省中医药管理局中药配方颗粒科研专项(项目编号:浙中医药[〔2017〕11号]
项目名称:中药配方颗粒产业化及临床应用关键技术研究)。
作者简介
肖毓,女,工程师,研究方向:药物制剂及临床药学。E-mail:ling20081103@sina.com;通讯作者:赵淑淑,女,硕士,工程师,研究方向:药物分析研究。E-mail:tracy2937@163.com。
