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.
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
Keywords
HPLCFingerprintZhibai dihuang pills (concentrated pills)Validity period