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Establishment method of HPLC (High Performance Liquid Chromatography) fingerprint spectrum of negundo

A fingerprint spectrum and a technology for establishing a method are applied to the establishment method of HPLC fingerprint spectrum of Jingfang preparations and the field of fingerprint spectrum, achieving the effects of good reproducibility, high precision and overcoming single detection index.

Inactive Publication Date: 2022-05-24
LUNAN HOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no method to control the quality of Jingfang granules or Jingfang mixture with fingerprints. Therefore, it is urgent to provide a method for establishing the fingerprints of Jingfang preparations, so as to ensure product quality and provide authenticity and internal identification of Jingfang preparations. Quality control provides a reliable basis, and provides a reliable analysis method and technical means to ensure the stability of product quality and the safety and effectiveness of clinical medication

Method used

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  • Establishment method of HPLC (High Performance Liquid Chromatography) fingerprint spectrum of negundo
  • Establishment method of HPLC (High Performance Liquid Chromatography) fingerprint spectrum of negundo
  • Establishment method of HPLC (High Performance Liquid Chromatography) fingerprint spectrum of negundo

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Establishment of a standard fingerprint of the Vitex anti-compound HPLC

[0034] 1 instrument with trial drug

[0035] 1.1 Instruments

[0036] Waters Acquity Arc High Performance Liquid Chromatograph (2998PDA Detector, USA), Quad Ultra High Pressure Gradient Pump, Empower Chromatography Workstation.

[0037] 1.2 Trial drug

[0038] Jing anti-compound agent is provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch number is shown in Table 1. Methanol and acetonitrile are chromatographically pure, the water is ultrapure water, and the rest of the reagents are analytically pure.

[0039] Table 1 Vitex anti-compound test sample batch number

[0040]

[0041] 2 Methods and results

[0042] 2.1 Chromatographic conditions

[0043] Column: Agilent SB-C 18 (4.6×250mm, 5μm) column; mobile phase: methanol:acetonitrile (volume ratio of 2:1) as the mobile phase A, 0.1% trifluoroacetic acid solution as the mobile phase B, gradient elution; detection wavelength...

Embodiment 2

[0069] Example 2 Establishment of a standard fingerprint of the Vitex anti-adjuvant HPLC

[0070] 1 instrument with trial drug

[0071] 1.1 Instruments

[0072] Waters Acquity Arc High Performance Liquid Chromatograph (USA): 2998PDA Detector, Quad Ultra High Pressure Gradient Pump, Empower Chromatography Workstation.

[0073] 1.2 Trial drug

[0074] Jing anti-compound agent is provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch number is shown in Table 1. Methanol and acetonitrile are chromatographically pure, the water is ultrapure water, and the rest of the reagents are analytically pure.

[0075] 2 Methods and results

[0076] 2.1 Chromatographic conditions

[0077] Column: Agilent SB-C 18(4.6×250mm, 5 μm) column; mobile phase: methanol: acetonitrile (volume ratio of 2:1) as the mobile phase A, 0.05% trifluoroacetic acid solution as the mobile phase B, gradient elution; detection wavelength: 280 nm; flow rate: 0.6 mL / min; column temperature: 30 °C; injection ...

Embodiment 3

[0089] Example 3 Establishment of a standard fingerprint of the HPLC of Jing anti-particle

[0090] 1 instrument with trial drug

[0091] 1.1 Instruments

[0092] Waters Acquity Arc High Performance Liquid Chromatograph (USA): 2998PDA Detector, Quad Ultra High Pressure Gradient Pump, Empower Chromatography Workstation.

[0093] 1.2 Trial drug

[0094] Jingfang granules are provided by Lunan Houpu Pharmaceutical Co., Ltd., sample batch number is 0012008044, 0012008047, 0012008048. Methanol and acetonitrile are chromatographically pure, the water is re-distilled water, and the rest of the reagents are analytically pure.

[0095] 2 Methods and results

[0096] 2.1 Chromatographic conditions

[0097] Column: Agilent SB-C 18 (4.6×250mm, 5μm) column; mobile phase: methanol:acetonitrile (volume ratio of 2:1) as the mobile phase A, 0.2% trifluoroacetic acid solution as the mobile phase B, gradient elution; detection wavelength: 320 nm; flow rate: 1.0 mL / min; column temperature: 30 °C; inj...

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Abstract

The invention belongs to the field of analysis of traditional Chinese medicine preparations, and particularly discloses a method for establishing an HPLC (High Performance Liquid Chromatography) fingerprint spectrum of a vitex negundo prevention preparation, which comprises the following steps: preparing reference substance and test solution, determining HPLC chromatographic conditions and establishing an HPLC standard fingerprint spectrum. The invention also discloses the HPLC standard fingerprint spectrum of the vitex negundo prevention preparation obtained by the method, and the fingerprint spectrum has 35 characteristic peaks. The method is easy and convenient to operate, high in stability and good in reproducibility, the quality of the negundo chastetree fruit and plant protection preparation can be comprehensively evaluated and controlled through comparison of characteristic peaks in the standard fingerprint spectrum, the product quality can be stabilized, uniformity and stability of the internal quality of the negundo chastetree fruit and plant protection preparation are guaranteed, and safety and effectiveness of clinical medication are guaranteed.

Description

Technical field [0001] The present invention belongs to the field of traditional Chinese medicine formulation analysis, relates to a method of establishing a fingerprint of the hplc fingerprint of the jing anti-preparation and a fingerprint map thereof. Background [0002] Jing anti-granules and Jing anti-compound are made of Jing mustard, parsnip, Qiang Huo, Du Huo, Chai Hu, Qian Hu, Sichuan Root, Citrus Aurantium, Poria Sativa, Platycodon, Licorice 11 Flavor Chinese Medicine, the formula is derived from the "Taiping Huimin and Agent Bureau Fang" in the ginseng defeat poison dispersion, is the first party in ancient anti-epidemic. Jing anti-preparation has the effect of sweating and dissolving the table, dispersing wind and dampness; used for cold and cold, headache and body pain, cold without sweat, nasal congestion and clear nose, cough and white sputum. Fang Zhongjun medicine Jing mustard, windproof Xin, Wen, the function of the drug sweating, dissolving the table scattered w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634G01N30/8686Y02A50/30
Inventor 张贵民袁晓梅庄会芳
Owner LUNAN HOPE PHARM CO LTD
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