中国药房2018，Vol.29Issue(20)：2747-2751,5.DOI:10.6039/j.issn.1001-0408.2018.20.03
HPLC指纹图谱法评价知柏地黄丸(浓缩丸)的质量
Quality Evaluation of Zhibai Dihuang Pills(Concentrated Pills)by HPLC Fingerprint
摘要
Abstract
OBJECTIVE:To establish the HPLC fingerprint of Zhibai dihuang pills(concentrated pills),and to evaluate its quality. METHODS:The determination was performed on Dikma Diamonsil C18column with mobile phase consisted of 0.1%acetic acid solution-methanol(gradient elution)at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm,and column temperature was 30 ℃. The sample size was 10 μL. Using paeonol as reference,HPLC chromatograms of samples from A, B,C manufacturers within validity period and samples from manufacturer A within validity period and out of validity period were drawn. The similarity of HPLC chromatogram for samples from A,B and C manufacturers and samples from A manufacturer within validity period and out of validity period was evaluated by TCM Chromatogram Fingerprint Similarity Evaluation System (2004 A). Common peaks of HPLC chromatogram for 3 manufacturers sample within validity period were confirmed. RESULTS:There were 24,29 and 32 common peaks in HPLC chromatograms for each 10 batches of samples from manufacturer A,B and C within validity period,respectively. The similarity of corresponding HPLC chromatograms of samples from manufacturer A,B and C compared with control HPLC chromatography were all higher than 0.94 with good agreement. HPLC chromatograms of sample from A manufacturer within validity period had good agreement with that from A manufacturer out of validity period. CONCLUSIONS:Established HPLC fingerprint analysis method can represent the quality of Zhibai dihuang pills (concentrated pills),but cannot effectively identify the expired samples.关键词
高效液相色谱法/指纹图谱/知柏地黄丸(浓缩丸)/有效期Key words
HPLC/Fingerprint/Zhibai dihuang pills(concentrated pills)/Validity period分类
医药卫生引用本文复制引用
李雅静,王丰青,谢彩侠,谢惠英,张苗,雷敬卫..HPLC指纹图谱法评价知柏地黄丸(浓缩丸)的质量[J].中国药房,2018,29(20):2747-2751,5.基金项目
国家自然科学基金资助项目(No.81473299) （No.81473299）
河南省科技攻关项目(No.182102311156) （No.182102311156）
