| Xiaoer Chaigui tuire granules (XCTG), a prescription traditional chinese medicine, is composed of Radix Bupleuri, Rumulus Ginnamomi, Radix Paeoniae Alba, Radix Puerariae, Radix Scutellariae, Herba Spirodelae, Periostracum Cicadae, each of them containing many active compounds, e.g. puerarin, peoniflorin, daidzin, baicalin, daidzein, cinnamaldehyde, baicalein, wogonin. It has the function of promoting sweating to release the exterior and reducing interior heat. Consequently, it was effective in the treatment of many diseases including common cold, acute upper respiratory infection and hand-foot-mouth disease in children. Analysis the content of puerarin using thin-layer chromatography in Chinese pharmacopoeia2010versions was different to overall evaluate the quality of XCTG. Nowadays, fingerprint technique, a integrative and quantization method, have now been widely used in the quality control of TCM. The chromatographic fingerprints to assess the batch-to-batch consistency of chemical constituents and the determination of the contents of those bioactive compounds are widely applied both home and abroad. One precondition for international TCM composite preparation is the application of fingerprint technique. Therefore, the content of8major compounds including puerarin, peoniflorin, daidzin, baicalin, daidzein, cinnamaldehyde, baicalein, wogonin was simutinious determined, and then the HPLC fingerprint of12batches of XCTG was investigated. This study established a comprehensive analysis method for internal quality control of XCTG. Experiments as follow were accomplished(1) High performance liquid chromatography was employed for simultaneous determination of eight principle components in XCTG. Baseline separation was performed on an Agilent Zorbax XDB-C18Column with gradient elution of acetonitrile and0.1%(v/v) phosphoric acid. The results indicated that eight principle components (puerarin, peoniflorin, daidzin, baicalin, daidzein, cinnamaldehyde, baicalein, wogonin) were separated well under the analytical condition. The linear correlation, precision, stability, reproducibility and recovery were very well.(2) High performance liquid chromatography with diode array detector was employed for specific chromatograms analysis of XCTG with an Agilent Zorbax XDB-C18 Column and a gradient elution of acetonitrile-water (containing0.1%phosphoric acid) as mobile phase. Twenty-four common peaks were selected as the specific chromatograms of XCTG with baicalin as the reference peak. It was subsequently compared with the chromatograms from12batches of XCTG to generate the similarity values which were all above0.90, indicating a good consistency among samples in qualitative evaluation. Additionally, the similarity of B manufacturer was better than A manufacturer. Principle component analysis (PCA) demonstrated that peaks3、4、5、8and18had more significance on the separation between the two manufacturers.(3) The similarity of XCTG was evaluated by cosine of angle, correlation coefficient and cosine of angle of peak ratio. The distribution of the principle components in different batches was assessed using the Grubbs’ test. Hierarchical cluster analysis indicated the difference between chromatographic fingerprint analysis and simultaneous determination of the principle components. They should be both employed for the quality control of XCTG. |
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