Establishment method and application of uplc fingerprint of Xintong Granules

A technique of fingerprinting and establishing methods, which is applied in the field of analysis of traditional Chinese medicine preparations, achieves good stability and repeatability, saves time and material costs, and overcomes the effects of single detection indicators

Active Publication Date: 2022-05-13
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no patent publication or literature report on the fingerprint analysis of Xintong Granules by UPLC method.

Method used

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  • Establishment method and application of uplc fingerprint of Xintong Granules
  • Establishment method and application of uplc fingerprint of Xintong Granules
  • Establishment method and application of uplc fingerprint of Xintong Granules

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The establishment of embodiment 1 Xintong granule UPLC standard fingerprint

[0050] 1 Instruments and reagents

[0051] 1.1 Instrument

[0052] Waters Acquity Arc high performance liquid chromatography (USA); 2998PDA detector; Quaternary ultra-high pressure gradient pump; Empower chromatography workstation.

[0053] 1.2 Reagent

[0054] Xintong 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 the rest of the reagents were analytically pure.

[0055] Table 1 Xintong Granule Test Sample Batch Number

[0056]

[0057]

[0058] 2 Methods and results

[0059] 2.1 Chromatographic conditions: Chromatographic column: C18 (4.6×50mm, 2.7μm) column; mobile phase: acetonitrile as mobile phase A, 0.1% phosphoric acid aqueous solution as mobile phase B, detection wavelength: 280nm; column temperature: 30°C; injection volume :...

Embodiment 2

[0089] The establishment of embodiment 2 Xintong granules UPLC standard fingerprint

[0090] 1 Instruments and reagents

[0091] 1.1 Instrument

[0092] Waters Acquity Arc high performance liquid chromatography (USA); 2998PDA detector; Quaternary ultra-high pressure gradient pump; Empower chromatography workstation.

[0093] 1.2 Reagent

[0094] Xintong 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 other reagents were analytically pure.

[0095] Table 4 Xintong Granule Test Sample Batch Number

[0096]

[0097] 2 Methods and results

[0098] 2.1 UPLC chromatographic conditions: Chromatographic column: C18 (4.6×50mm, 2.7μm) column; mobile phase: acetonitrile as mobile phase A, 0.06% phosphoric acid aqueous solution as mobile phase B; detection wavelength: 275nm; column temperature: 28°C; injection volume : 2 μl.

[009...

Embodiment 3

[0105] The establishment of embodiment 3 Xintong granules UPLC standard fingerprint

[0106] 1 Instruments and reagents

[0107] 1.1 Instrument

[0108] Waters Acquity Arc high-performance liquid chromatography (USA): 2998PDA detector; quaternary ultra-high pressure gradient pump; Empower chromatography workstation.

[0109] 1.2 Reagent

[0110] Xintong 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.

[0111] Table 5 Xintong Granule Test Sample Batch Number

[0112]

[0113]

[0114] 2 Methods and results

[0115] 2.1 Chromatographic conditions: Chromatographic column: C18 (4.6×50mm, 2.7μm) column; mobile phase: acetonitrile as mobile phase A, and 0.08% phosphoric acid aqueous solution as mobile phase B; detection wavelength: 277nm; column temperature: 29°C; injection volume : 2 ...

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Abstract

The invention belongs to the field of analysis of traditional Chinese medicine preparations, and specifically discloses a method for establishing UPLC fingerprints of Xintong granules, including preparation of test sample solutions, determination of UPLC chromatographic conditions and preparation of UPLC standard fingerprints. The invention simultaneously discloses the UPLC standard fingerprint of Xintong Granule obtained by the method, and the obtained fingerprint has 41 common peaks. The method of the present invention is easy to operate, high in stability and good in reproducibility, and the obtained spectrum has many characteristic peaks. By comparing with the common peaks in the standard fingerprint spectrum, the quality of Xintong Granules can be comprehensively evaluated and controlled, which is conducive to stabilizing the product Quality, to ensure the uniformity and stability of its inherent quality, and improve the safety and effectiveness of clinical medication.

Description

technical field [0001] The invention belongs to the field of analysis of traditional Chinese medicine preparations, and in particular relates to a method for establishing the UPLC fingerprint of Xintong granule, the fingerprint and its application. Background technique [0002] Xintong granule is recorded in the national ministerial standards, and is composed of thirteen traditional Chinese medicine raw materials such as astragalus, Codonopsis radix, Ophiopogon japonicus, Polygoni multiflorum, Epimedium, Pueraria lobata, Angelica, Salvia miltiorrhiza, Saponaria thorn, seaweed, kelp, oyster, and Citrus aurantium. , has the effect of replenishing qi and activating blood, resolving phlegm and dredging collaterals. It is used for chest obstruction caused by deficiency of both qi and yin, phlegm and blood stasis, such as coronary heart disease and angina pectoris. The clinical effect is remarkable. [0003] At present, the current inspection items for Xintong Granules in the nat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74
Inventor 张贵民庄会芳金凤
Owner LUNAN PHARMA GROUP CORPORATION
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