HPLC指纹图谱法评价知柏地黄丸(浓缩丸)的质量
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篇名: HPLC指纹图谱法评价知柏地黄丸(浓缩丸)的质量
TITLE:
摘要: 目的:建立知柏地黄丸(浓缩丸)的高效液相色谱(HPLC)指纹图谱,并评价其质量。方法:色谱柱为Dikma Diamonsil C18,流动相为0.1%醋酸溶液-甲醇(梯度洗脱),流速为1.0 mL/min,检测波长为260 nm,柱温为30 ℃,进样量为10 μL。以丹皮酚为参照,分别绘制A、B、C厂有效期内样品和A厂有效期内与有效期外样品的HPLC图谱。采用《中药色谱指纹图谱相似度评价系统》(2004 A)对A、B、C厂有效期内样品及A厂有效期内与有效期外样品进行相似度评价,分别确定共有峰。结果:A、B、C厂各10批有效期内样品的HPLC图谱分别有24、29、32个共有峰,A、B、C厂样品HPLC图谱与对照指纹图谱的相似度均大于0.94,具有较好的一致性。A厂有效期内样品的HPLC图谱与有效期外样品的HPLC图谱具有较好的一致性。结论:本研究建立的HPLC指纹图谱可为评价知柏地黄丸(浓缩丸)的质量提供参考,但其并不能有效鉴别有效期外的样品。
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 C18 column 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.  
期刊: 2018年第29卷第20期
作者: 李雅静,王丰青,谢彩侠,谢惠英,张苗,雷敬卫
AUTHORS: LI Yajing,WANG Fengqing,XIE Caixia,XIE Huiying,ZHANG Miao,LEI Jingwei
关键字: 高效液相色谱法;指纹图谱;知柏地黄丸(浓缩丸);有效期
KEYWORDS: HPLC; Fingerprint; Zhibai dihuang pills (concentrated pills); Validity period
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