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Method for Establishing Fingerprint of Tingli Dazao Xiefei Granules

A technology of fingerprints and standard fingerprints, applied in the field of establishment of HPLC fingerprints of Tingli Dazao Xiefei Granules, achieving good baseline separation, high resolution, and good peak shape

Active Publication Date: 2022-02-18
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 relevant patent publications and literature reports on the quality control of Tingli Dazao Xiefei Granules by using fingerprints of traditional Chinese medicine at home and abroad

Method used

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  • Method for Establishing Fingerprint of Tingli Dazao Xiefei Granules
  • Method for Establishing Fingerprint of Tingli Dazao Xiefei Granules
  • Method for Establishing Fingerprint of Tingli Dazao Xiefei Granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Establishment of HPLC Standard Fingerprint of Tingli Dazao Xiefei Granules

[0028] 1 Instruments and reagents

[0029] 1.1 Instrument

[0030] Agilent 1260 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0031] 1.2 Reagent

[0032] Tingli Dazao Xiefei Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch numbers are shown in Table 1. Acetonitrile was chromatographically pure, water was double distilled water, and other reagents were analytically pure.

[0033] Table 1 Batch No. of Test Samples of Tingli Dazao Xiefei Granules

[0034]

[0035]

[0036] 2 Methods and Results

[0037] 2.1 Chromatographic conditions: chromatographic column: Agilent ZORBAX SB C18 (4.6×250mm, 5μm) column; mobile phase: acetonitrile as mobile phase A, 0.12% phosphoric acid aqueous solution as mobile phase B, gradient as shown in the table below ...

Embodiment 2

[0056] Example 2 Establishment of HPLC Standard Fingerprint of Tingli Dazao Xiefei Granules

[0057] 1 Instruments and reagents

[0058] 1.1 Instrument

[0059] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0060] 1.2 Reagent

[0061] Tingli Dazao Xiefei Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch numbers are shown in Table 4; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0062] Table 4 Batch numbers of test samples of Tingli Dazao Xiefei Granules

[0063]

[0064] 2 Methods and Results

[0065] 2.1 Chromatographic conditions: Chromatographic column: Agilent ZORBAX SB C18 (4.6×250mm, 5μm) column; mobile phase: acetonitrile as mobile phase A, 0.18% by volume phosphoric acid aqueous solution as mobile phase B, gradient as shown in the ta...

Embodiment 3

[0071] Example 3 Establishment of HPLC Standard Fingerprint of Tingli Dazao Xiefei Granules

[0072] 1 Instruments and reagents

[0073] 1.1 Instrument

[0074] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0075] 1.2 Reagent

[0076] Tingli Dazao Xiefei Granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch numbers are shown in Table 5; acetonitrile was chromatographically pure, water was double distilled water, and other reagents were analytically pure.

[0077] Table 5 Batch numbers of test samples of Tingli Dazao Xiefei Granules

[0078]

[0079] 2 Methods and Results

[0080] 2.1 Chromatographic conditions: chromatographic column: Agilent ZORBAX SB C18 (4.6×250mm, 5μm) column; mobile phase: acetonitrile as mobile phase A, 0.12% phosphoric acid aqueous solution as mobile phase B, gradient as shown in the table below Elution: ...

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Abstract

The invention discloses a method for establishing the HPLC fingerprint of Tingli Dazao Xiefei Granules. The method comprises the preparation of the test solution, the determination of the HPLC chromatographic conditions and the preparation of the HPLC standard fingerprint. The invention also discloses the HPLC standard fingerprint spectrum of the Tinglidazao Xiefei granule obtained by the method, and the fingerprint spectrum has 27 common peaks. The quality detection method of the present invention is easy to operate, has high stability and good reproducibility, and the obtained spectrum has many characteristic peaks. Through the comparison of the common peaks of the standard fingerprint spectrum, the quality of Tingli Dazao Xiefei Granules can be comprehensively evaluated and controlled. It is beneficial to accurately evaluate the internal quality of preparations and ensure the safety and effectiveness of clinical medication.

Description

technical field [0001] The invention discloses a method for establishing an HPLC fingerprint of Tingli Dazao Xiefei Granules, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Tingli Dazao Xiefei Decoction is recorded in "Synopsis of the Golden Chamber" written by Han Zhang Zhongjing, and it is composed of Tinglizi and Dazao. Tinglizizi in the prescription is the main drug, which can relieve lungs and expel water, resolve phlegm and relieve asthma, and it is compatible with jujube to relieve its violent nature, and jujube also has the ability to strengthen the spleen and unblock the body fluid. For the method of purging the lungs without injuring the spleen, it has the effects of purging the lungs and diuresis, lowering the qi and eliminating phlegm. It is clinically used to treat phlegm and salivation, cough and asthma, fullness of the chest and flanks, and inability to lie down; or palpitations, facial edema, mos...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/14G01N30/34G01N30/8679
Inventor 赵丽敏姜佳峰范建伟李倩马云雷佳慧
Owner LUNAN PHARMA GROUP CORPORATION
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