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Method for establishing HPLC fingerprint of Yinzhihuang granule, and standard fingerprint obtained therethrough

A fingerprint and standard fingerprint technology, applied in the field of traditional Chinese medicine preparation analysis, to achieve good baseline separation, accurate evaluation, and good reproducibility.

Active Publication Date: 2018-02-02
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are no patent publications and literature reports at home and abroad to control the quality of Yinzhihuang granules with fingerprints

Method used

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  • Method for establishing HPLC fingerprint of Yinzhihuang granule, and standard fingerprint obtained therethrough
  • Method for establishing HPLC fingerprint of Yinzhihuang granule, and standard fingerprint obtained therethrough
  • Method for establishing HPLC fingerprint of Yinzhihuang granule, and standard fingerprint obtained therethrough

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 Establishment of HPLC Standard Fingerprint of Yinzhihuang Granules

[0022] 1 Instruments and reagents

[0023] 1.1 Instrument

[0024] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0025] 1.2 Reagent

[0026] Yinzhihuang Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., as shown in Table 1; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0027] Table 1 Batch numbers of test samples of Yinzhihuang Granules

[0028]

[0029] 2 Methods and results

[0030] 2.1 Chromatographic conditions: Chromatographic column: Tianjin Turner Kromasil C 18 (4.6x250mm, 5um) column; mobile phase: acetonitrile is used as mobile phase A, and 0.1% phosphoric acid aqueous solution is used as mobile phase B in volume percentage, and the gradient elution is carried out acc...

Embodiment 2

[0054] Example 2 Establishment of HPLC Standard Fingerprint of Yinzhihuang Granules

[0055] 1 Instruments and reagents

[0056] 1.1 Instrument

[0057] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0058] 1.2 Reagent

[0059] Yinzhihuang Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., as shown in Table 1; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0060] Table 1 Batch numbers of test samples of Yinzhihuang Granules

[0061]

[0062] 2 Methods and results

[0063] 2.1 Chromatographic conditions: Chromatographic column: Tianjin Turner Kromasil C 18 (4.6x250mm, 5um) column; mobile phase: acetonitrile is used as mobile phase A, and 0.05% phosphoric acid aqueous solution is used as mobile phase B, and the gradient elution is carried out as follows:

[0064] ...

Embodiment 3

[0069] Example 3 Establishment of HPLC Standard Fingerprint of Yinzhihuang Granules

[0070] 1 Instruments and reagents

[0071] 1.1 Instrument

[0072] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0073] 1.2 Reagent

[0074] Yinzhihuang Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., as shown in Table 1; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0075] Table 1 Batch numbers of test samples of Yinzhihuang Granules

[0076]

[0077] 2 Methods and results

[0078] 2.1 Chromatographic conditions: Chromatographic column: Tianjin Turner Kromasil C 18 (4.6x250mm, 5um) column; mobile phase: acetonitrile is used as mobile phase A, and 0.2% phosphoric acid aqueous solution is used as mobile phase B in volume percentage, and the gradient elution is carried out in ...

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Abstract

The invention discloses a method for establishing the HPLC fingerprint of a Yinzhihuang granule. The method comprises the following steps: preparing a sample solution, determining HPLC chromatographicconditions, and making an HPLC standard fingerprint. The invention also discloses a the HPLC standard fingerprint of the Yinzhihuang granule, obtained through the method. The fingerprint has twenty-nine common peaks, and the relative retention times tR of the common peaks sequentially respectively are 0.079, 0.087, 0.113, 0.341, 0.436, 0.563, 0.648, 0.866, 0.891, 0.905, 0.919, 1.000, 1.089, 1.129, 1.161, 1.197, 1.395, 1.453, 1.496, 1.597, 1.776, 1.808, 1.979, 2.071, 2.136, 2.168, 2.353, 2.396 and 2.440. The method has the advantages of simplicity in operation, high stability, good reproducibility, a large quantity of characteristic peaks in the obtained fingerprint, realization of comprehensive evaluation of the quantity of the Yinzhihuang granule through comparing the common peaks in thestandard fingerprint, facilitation of the stabilization of the product quality, and ensuring the clinical medication safety and effectiveness.

Description

technical field [0001] The invention relates to a method for establishing an HPLC fingerprint of Yinzhihuang granules and an HPLC standard fingerprint thereof, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Yinzhihuang granule is recorded in the first part of the "Chinese Pharmacopoeia" 2015 edition. It is prepared from capillary (Mianyinchen) extract, gardenia extract, scutellaria baicalensis extract, and honeysuckle extract. The function of reducing jaundice is used for jaundice caused by damp heat in the liver and gallbladder. Symptoms include yellow eyes, distending pain in the chest and hypochondrium, nausea and vomiting, yellow and red urine; acute and chronic hepatitis with the above syndromes. It has definite clinical curative effect and has been accepted. Included in the "National Essential Drug List (2012 Edition)". [0003] The quality control methods of Yinzhihuang Granules in the current "Chinese P...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张贵民苏瑞强刘武占范建伟
Owner LUNAN PHARMA GROUP CORPORATION
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