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Quality detection method of pharmaceutical composition injection

A quality inspection method and technology of the inspection method, applied in the direction of measuring device, color/spectral characteristic measurement, instrument, etc.

Active Publication Date: 2013-05-15
CHANGBAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] High-performance liquid chromatography (HPLC) technology is the main method to construct the fingerprint of traditional Chinese medicine, which plays an important role in the quality control of traditional Chinese medicine; however, the research on fingerprint of traditional Chinese medicine is still in the research stage, and there are still some problems that need to be continuously explored, such as fingerprint The standardization and standardization of spectrum research needs to be strengthened. Due to the influence of the instruments and chromatographic columns used, the reproducibility of fingerprints needs to be improved, and the analysis and evaluation methods of fingerprints need to be improved.

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Examples

Experimental program
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Effect test

experiment example 1

[0071] Experimental Example 1 HPLC-ESI-Iontrap analysis and identification of chemical components in the pharmaceutical composition injection of the present invention

[0072] 1 Instrument and chromatography mass spectrometry conditions

[0073] 1.1 Instruments and materials

[0074] High performance liquid chromatography-mass spectrometry:

[0075] HPLC: Agilent 1200 series; mass spectrometry: Bruker HCT Iontrap (three-dimensional ion trap mass spectrometer)

[0076] Chromatographically pure acetonitrile (Acetonitrile): HPLC grade, Fisher Scientific

[0077] Chromatographically pure methanol (Methanol): HPLC grade, Tianjin Jizhun Chemicals

[0078] Ultrapure water (Water): ultra-pure water

[0079] Solid phase extraction (SPE): Tianjin Shuangji chromatography scientific

[0080] 1.2 Chromatographic conditions

[0081] Analytical chromatographic column: Agilent XDB-C18 150×4.6mm 5μm

[0082] Detection wavelength: 205nm, column temperature: 30°C, flow rate: 0.8ml / min

...

experiment example 2

[0187] Experimental example 2 UHPLC-ESI-QTOF analysis and identification of chemical components in the pharmaceutical composition injection of the present invention

[0188] 1 Instrument and chromatography mass spectrometry conditions

[0189] 1.1 Instrument

[0190] Ultra-high pressure high performance liquid chromatography (UHPLC): Agilent 1290 series-DAD UV-Detection

[0191] Mass spectrometry: Agilent 6520 QTOF (quadrupole-time-of-flight tandem mass spectrometer)

[0192] Acetonitrile: HPLC grade, Fisher Scientific

[0193] Methanol: HPLC grade, Tianjin Jizhun Chemicals

[0194] Ultra-pure water

[0195] Solid phase extraction (SPE): Tianjin Shuangji chromatography scientific

[0196] 1.2 Chromatographic conditions

[0197] Analytical column: Agilent XDB-C18 150×4.6mm 5μm (in order to correspond to the chromatogram of the above ion trap mass spectrometry analysis, the same chromatographic column is selected and analyzed by the mass spectrometer detector in a split fl...

experiment example 3

[0280] Experimental Example 3 Precision Experiment

[0281] Instruments and materials: HPLC: Agilent 1200 series, Acetonitrile: HPLC grade, Fisher Scientific, Methanol: HPLC grade, Tianjin Jizhun Chemicals, Water: ultra-pure water , Solid Phase Extraction (SPE): Tianjin Shuangji chromatography scientific

[0282] Chromatographic conditions: analytical chromatographic column: Agilent XDB-C18 150×4.6mm 5μm, detection wavelength: 205nm, column temperature: 30°C, flow rate: 0.8ml / min, the number of theoretical plates should not be less than 200,000 based on the peak of ginsenoside Rf

[0283] Time table:

[0284]

[0285] Preparation of test solution: accurately measure 10ml of the pharmaceutical composition injection of the present invention, evaporate to dryness in a water bath, add 2ml of 1% glacial acetic acid aqueous solution to the residue to dissolve, and put it on a solid phase extraction column (C-18, 500mg; Wash with 5ml of anhydrous methanol, and then rinse with 5m...

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Abstract

The invention discloses a quality detection method of a pharmaceutical composition injection. An analysis chromatographic column for the chromatographic fingerprint quality detection method is as below: Agilent XDB-C18 150*4.6mm 5 mum, detection wavelength of 205nm, column temperature of 30 DEG C, and flow rate of 0.8ml / min. Preparation of a sample solution comprises steps of: taking a pharmaceutical composition injection; evaporating to dryness by water bath; dissolving residue in an acetic acid aqueous solution; separating on a solid phase extraction column; conducting gradient elution; adding methanol to dissolve the residue; transferring the solution to a 2 ml measuring flask; adding methanol to a scale; shaking uniformly; filtering with a 0.45 mum microporous membrane; and introducing 10 muL of the sample for analysis to obtain a sample fingerprint (see figure 40). The invention also provides a method for determining content of total saponins and 9, 10-dimethoxy pterocarpan-3-o-beta-D-glucoside in the pharmaceutical composition injection.

Description

technical field [0001] The present invention relates to a quality detection method of injection, in particular to the fingerprint quality detection method of the pharmaceutical composition injection of the present invention and the total saponins and 9,10-dimethoxy pterostane-3-O- Determination method of β-D-glucoside content. Background technique [0002] The pharmaceutical composition injection of the present invention is composed of astragalus, ginseng and matrine, and is a traditional Chinese medicine injection refined by modern extraction and separation technology. Treatment of primary liver cancer, rectal cancer, malignant lymphoma, gynecological tumors, leukopenia and leukopenia caused by various reasons and chronic hepatitis B. [0003] High-performance liquid chromatography (HPLC) technology is the main method to construct the fingerprint of traditional Chinese medicine, which plays an important role in the quality control of traditional Chinese medicine; however, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/31G01N30/02G01N30/86
Inventor 段宏泉翁红张子安李颖杨玲
Owner CHANGBAISHAN PHARMA
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