Research on the HPLC Fingerprint of Zishen Tablet and the Content Detection of Five Chemical Compone

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ObjectiveTo establish the analysis method for the HPLC fingerprint of Zishen tablet,to detect the contents of ligustilide,n-butylene( n-butene) phthalide,tanshinoneⅠ,cryptotanshinone and tanshinoneⅡA in Zishen tablet,and to provide references for the quality control of Zishen tablet. MethodsHPLC was adopted; chromatographic column was Ultimate XB C 18 column( 250 mm × 4. 6 mm,5 μm) ; mobile phase was acetonitrile 0. 3% phosphoric acid solution; and detection wavelength was 260 nm. According to the HPLC of Zishen tablets,tanshinone ⅡA was taken as the control substance. The RSD values of the relative retention time and relative peak area of the chromatographic peak of tanshinoneⅡA were analyzed. Similarity analysis of the 10 batches of Zishen tablets was carried out based on the similarity evaluation system for chromatographic fingerprint of TCM ( Version 2004A) . By using the external standard method,contents of ligustilide,n-butylene( n-butene) phthalide,tanshinoneⅠ,cryptotanshinone and tanshinoneⅡA were detected in 10 batches of Zishen tablets. ResultsUnder the selected conditions,32 peaks together constituted the fingerprint characteristics of Zishen tablets; and sample in each batch had the same characteristics; the relative contents of characteristic peaks had basically the same distribution. The corresponding retention time of the chromatographic peak of tanshinone ⅡA was the same in different batches; RSD values of the relative retention time and the relative peak area of the chromatographic peaks of tanshinone ⅡA in different batches all met the requirements of fingerprint detection. The similarity degrees of the fingerprints of 10 batches of samples were all greater than 0. 940; and 5 chemical components had basically the same contents in the 10 batches. ConclusionsHPLC fingerprint and the detection method of 5 components in Zishen tablet were accurate,stable and simple,and the two methods could be used for the quality control of Zishen tablet. ObjectiveTo establish the analysis method for the HPLC fingerprint of Zishen tablet, to detect the contents of ligustilide, n-butylene (n-butene) phthalide, tanshinone I, cryptotanshinone and tanshinone IIA in Zishen tablet, and to provide references for the quality control of Zishen tablet . HPLC was was; chromatographic column was Ultimate XB C 18 column (250 mm × 4.6 mm, 5 μm); mobile phase was acetonitrile 0.3% phosphoric acid solution; and detection wavelength was 260 nm. According to the HPLC of Zishen tablets, tanshinone IIA was taken as the control substance. The RSD values ​​of the relative retention time and relative peak area of ​​the chromatographic peak of tanshinone IIA were analyzed. Similarity analysis of the 10 batches of Zishen tablets was carried out based on the similarity evaluation system for chromatographic fingerprint of TCM (Version 2004A). By using the external standard method, contents of ligustilide, n-butylene (n-butene) phthalide, tanshinone I, crypto ResultsUnder the selected conditions, 32 peaks together constitute the fingerprint characteristics of Zishen tablets; and sample in each batch had the same characteristics; the relative contents of characteristic peaks had basically the same distribution. The corresponding retention time of the chromatographic peak of tanshinone IIA was the same in different batches; RSD values ​​of the relative retention time and the relative peak area of ​​the chromatographic peaks of tanshinone IIA in different batches all met the requirements of fingerprint detection. degrees of the fingerprints of 10 batches of samples were all greater than 0. 940; and 5 chemical components had basically the same contents in the 10 batches. Conclusions HPLC finger and the detection method of 5 components in Zishen tablets were accurate, stable and simple, and the two methods could be used for the quality control of Zishen ta blet.
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