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Establishment method of HPLC fingerprint of Mailuoshutong granule and its standard spectrum

A kind of technology of miluoshutong and fingerprint spectrum, applied in the field of traditional Chinese medicine preparation analysis, to achieve the effect of good baseline separation, quality assurance and high precision

Active Publication Date: 2020-05-26
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the quality of Mailuoshutong granules is controlled by fingerprints, and there are no patent publications and literature reports at home and abroad.

Method used

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  • Establishment method of HPLC fingerprint of Mailuoshutong granule and its standard spectrum
  • Establishment method of HPLC fingerprint of Mailuoshutong granule and its standard spectrum
  • Establishment method of HPLC fingerprint of Mailuoshutong granule and its standard spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Establishment of Mailuoshutong Granules HPLC Standard Fingerprint

[0027] 1 Instruments and reagents

[0028] 1.1 Instrument

[0029] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0030] 1.2 Reagent

[0031] Mailuoshutong 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.

[0032] Table 1 Batch numbers of test samples of Mailuoshutong granules

[0033]

[0034] 2 Methods and results

[0035] 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 ...

Embodiment 2

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

[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] Mailuoshutong granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., as shown in Table 4; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0060] Table 4 Batch No. of Mailuoshutong Granules Test Samples

[0061]

[0062]

[0063] 2 Methods and results

[0064] 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:

...

Embodiment 3

[0070] Example 3 Establishment of Mailuoshutong Granules HPLC Standard Fingerprint

[0071] 1 Instruments and reagents

[0072] 1.1 Instrument

[0073] Agilent 1100 high performance liquid chromatography (USA): DAD detector, quaternary low-pressure gradient pump, AgilentOpen Lab chromatography workstation.

[0074] 1.2 Reagent

[0075] Mailuoshutong granules were provided by Lunan Houpu Pharmaceutical Co., Ltd., see Table 5; acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0076] Table 5 Batch No. of Mailuoshutong Granules Test Samples

[0077]

[0078] 2 Methods and results

[0079] 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 the followin...

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Abstract

The invention discloses an establishment method of an HPLC fingerprint atlas of meridian and collateral dredging granules. The establishment method comprises the following steps: preparing a test solution, determining an HPLC chromatographic condition and preparing an HPLC standard fingerprint atlas. The invention further discloses the HPLC standard fingerprint atlas of the meridian and collateraldredging granules, which is obtained by the establishment method. The fingerprint atlas has 25 common peaks. By a quality detection method, the operation is simple, the stability is high, the reproducibility is good, and the obtained atlas has many characteristic peaks; through comparison of the common peaks of the standard fingerprint atlas, the quality of the meridian and collateral dredging granules can be comprehensively evaluated, so that stabilization of the product quality and guarantee of the safety and the effectiveness of clinical medication are facilitated.

Description

technical field [0001] The invention relates to a method for establishing an HPLC fingerprint of a compound traditional Chinese medicine Mailuoshutong granule and an HPLC standard fingerprint thereof, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] The similar products of Mailuoshutong include Mailuoshutong Granules, Mailuoshutong Granules (sugar-free type), Mailuoshutong Pills (Concentrated Pills) and other dosage forms. White peony root, licorice, leech, centipede, and scorpion are refined from twelve traditional Chinese medicines. They have the effects of clearing heat and detoxifying, removing blood stasis and dredging collaterals, removing dampness and reducing swelling. It is mainly used for superficial thrombophlebitis caused by damp heat and blood stasis. , Lower limb swelling, pain, dark red skin color or cord-like objects caused by deep vein thrombosis in the non-acute stage. [0003] The prescriptions...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 刘武占刘向东
Owner LUNAN PHARMA GROUP CORPORATION
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