摘要
目的:建立五子补肾胶囊的HPLC指纹图谱,为其质量的研究提供依据。方法:采用Dimonsil C18(2)(4.6 mm×250mm,5μm)色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速:1.0 ml·min-1,检测波长:210 nm,柱温:35℃,进样量:10μl。通过相似度评价对10批次的五子补肾胶囊指纹图谱进行质量评价。结果:10批五子补肾胶囊指纹图谱有20个共有峰,通过与对照品比较确认其为淫羊藿苷(14号峰),利用相似度软件对10批样品指纹图谱进行分析,各批次样品相似度均在0.96以上。结论:所建立的五子补肾胶囊指纹图谱方法灵敏度高、专属性强,可为五子补肾胶囊的质量标准的制定提供科学依据。
Objective: To establish a specific HPLC method and a standard fingerprint for the quality control of Wuzi Bushen capsules. Methods: The samples were separated on a Dimonsil C18( 2) column( 4.6 mm×250 mm,5 μm) with gradient elution at the flow rate of 1.0 ml·min-1 by acetonitrile and 0.1% aqueous formic acid as the mobile phase. The detection wavelength was 210 nm,the column temperature was 30℃ and the sample size was 10 μl. The fingerprint evaluation software for Chinese materia medica( CMM)was used to evaluate the similarity of 10 batches of samples. Results: There were 20 characteristic peaks identified in the characteristic spectra of Wuzi Bushen capsules,and peak 14 was icariin. The similarities of the 10 batches of Wuzi Bushen capsules were proved to be higher than 0.96. Conclusion: The method is available with high sensitivity and specificity,which can control the quality of the preparation effectively.
作者
梁学政
唐勇琛
甄汉深
丘琴
黄晓玉
范秀春
Liang Xuezheng;Tang Yongchen;Zhen Hanshen;Qiu Qin;Huang Xiaoyu;Fan Xiuchun(Traditional Medical Hospital of Liuzhou,Guangxi Liuzhou 545001,China;Guangxi University of Chinese Medicine)
出处
《中国药师》
CAS
2019年第7期1265-1267,1274,共4页
China Pharmacist
基金
广西壮族自治区卫生厅中医药医院制剂类课题(编号:GZYZ-10-36)
