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Method for establishing UPLC fingerprint spectrum of Xintong granules, fingerprint spectrum of Xintong granules and application of fingerprint spectrum

A technique for fingerprinting and establishing methods, applied in the field of analysis of traditional Chinese medicine preparations

Active Publication Date: 2021-09-14
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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  • Method for establishing UPLC fingerprint spectrum of Xintong granules, fingerprint spectrum of Xintong granules and application of fingerprint spectrum
  • Method for establishing UPLC fingerprint spectrum of Xintong granules, fingerprint spectrum of Xintong granules and application of fingerprint spectrum
  • Method for establishing UPLC fingerprint spectrum of Xintong granules, fingerprint spectrum of Xintong granules and application of fingerprint spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Establishment of UPLC Standard Fingerprint of Xintong Granules

[0050] 1 Instruments and reagents

[0051] 1.1 Instruments

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

[0053] 1.2 Reagents

[0054] Xintong granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the batch numbers of the samples are shown in Table 1; acetonitrile was chromatographically pure, water was double-distilled water, and the rest of the reagents were of analytical grade.

[0055] Table 1 Xintong Granules Test Sample Lot 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 vo...

Embodiment 2

[0089] Example 2 Establishment of UPLC Standard Fingerprint of Xintong Granules

[0090] 1 Instruments and reagents

[0091] 1.1 Instruments

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

[0093] 1.2 Reagents

[0094] Xintong granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the sample batch numbers are shown in Table 4. Acetonitrile is of chromatographic grade, water is of double distilled water, and other reagents are of analytical grade.

[0095] Table 4 Xintong Granules Test Sample Lot 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, and 0.06% phosphoric acid aqueous solution as mobile phase B; detection wavelength: 275nm; column temperature: 28°C; injection volume : 2 μl.

[0...

Embodiment 3

[0105] Example 3 Establishment of UPLC Standard Fingerprint of Xintong Granules

[0106] 1 Instruments and reagents

[0107] 1.1 Instruments

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

[0109] 1.2 Reagents

[0110] Xintong granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., and the batch numbers of the samples are shown in Table 5. Acetonitrile is of chromatographic grade, water is of double distilled water, and other reagents are of analytical grade.

[0111] Table 5 Xintong Granules Test Sample Lot 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...

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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 a UPLC fingerprint spectrum of Xintong granules. The method comprises the steps of preparation of a test solution, determination of UPLC chromatographic conditions and preparation of a UPLC standard fingerprint spectrum. The invention also discloses a Xintong granule UPLC standard fingerprint spectrum obtained by the method, wherein the obtained fingerprint spectrum has 41 common peaks. According to the invention, the method is simple and convenient to operate, high in stability and good in reproducibility, the obtained spectrum has multiple characteristic peaks, the quality of the Xintong granules can be comprehensively evaluated and controlled by comparing the characteristic peaks with common peaks in a standard fingerprint spectrum, the stability of the product quality is facilitated, the uniformity and the stability of the internal quality of the Xintong granules are ensured, and the safety and the effectiveness of clinical medication are improved.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparation analysis, and in particular relates to a method for establishing a UPLC fingerprint of Xintong granules, a fingerprint and application thereof. Background technique [0002] Xintong Granules are included in the standards issued by the national ministries. It has the effect of nourishing qi and promoting blood circulation, resolving phlegm and dredging collaterals. It is used for chest pain caused by deficiency of qi and yin and obstruction of phlegm and blood stasis, such as coronary heart disease, angina pectoris, and symptoms such as heartache, chest tightness, shortness of breath, nausea, nausea, and anorexia. The clinical effect is remarkable. [0003] At present, the current inspection items for Xintong Granules in the national ministerial standard YBZ16392009-2017 mainly include the thin-layer identification of Astragalus, Polygonum multiflorum, Epimedium and Salvia m...

Claims

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Application Information

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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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