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Single herb medicine, intermediate and its injection liquid finger-print atlas quality testing method

A technology of fingerprint spectrum and quality control method, which is applied in the field of fingerprint quality detection of unique medicinal materials, intermediates and their injections, and can solve the problems of not reflecting fingerprint characteristics and the like.

Inactive Publication Date: 2007-04-18
SICHUAN HENGKANG DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In No. 200410083678.7 patent application, although the relevant technical content of the unique fingerprint is also involved, this patent application introduces macroporous adsorption resin for pretreatment in the preparation process of medicinal materials, intermediates and injection test samples, which may affect the The final result causes at least two influences: one is that the macroporous adsorption resin will inevitably introduce new substances in the process of adsorption and elution; the other is that the macroporous adsorption resin will supply Adsorption of related substances in the test sample
Can not reflect the real fingerprint characteristics

Method used

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  • Single herb medicine, intermediate and its injection liquid finger-print atlas quality testing method
  • Single herb medicine, intermediate and its injection liquid finger-print atlas quality testing method
  • Single herb medicine, intermediate and its injection liquid finger-print atlas quality testing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Example 1: Fingerprint quality detection method of unique medicinal materials

[0118] Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as filler; flow rate: 1ml / min; detection wavelength at 254nm; column temperature: 30°C; analysis time: 1 hour; gradient elution:

[0119] Time (min)

Acetonitrile (%)

0.2% phosphoric acid aqueous solution (%)

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[0120] Preparation of the reference solution: take an appropriate amount of quercetin reference substance, add methanol to make a 40μg / ml solution, as the reference solution;

[0121]Preparation of test solution: Take 5g of medicinal powder that has been crushed and passed through a sieve with an inner diameter of 5mm, put it in a flask, add 100ml of water, reflux for extraction for 2 hours, filter, evaporate the water to dryness, and dissolve the residue with ...

Embodiment 2

[0124] Example 2: Fingerprint quality detection method of Duyiwei intermediate

[0125] Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as filler; flow rate: 1ml / min; detection wavelength at 254nm; column temperature: 30°C; analysis time: 1 hour; gradient elution:

[0126] Time (min)

Acetonitrile (%)

0.2% phosphoric acid aqueous solution (%)

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[0127] Preparation of the reference solution: take an appropriate amount of quercetin reference substance, add methanol to make a 40μg / ml solution, as the reference solution;

[0128] Preparation of the test solution: Take 1ml of the unique injection intermediate, put it in a 10ml volumetric flask, add 1ml of the reference solution precisely, dilute to the mark with methanol, shake well, filter with a 0.45μm microporous membrane, and take the filtrate , That is;

[0...

Embodiment 3

[0131] Example 3: Fingerprint quality detection method of Duyiwei injection

[0132] Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as filler; flow rate: 1ml / min; detection wavelength at 254nm; column temperature: 30°C; analysis time: 1 hour; gradient elution:

[0133] Time (min)

Acetonitrile (%)

0.2% phosphoric acid aqueous solution (%)

0

10

40

50

60

10

15

30

40

40

90

85

70

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[0134] Preparation of the reference solution: take an appropriate amount of quercetin reference substance, add methanol to make a 40μg / ml solution, as the reference solution;

[0135] Preparation of test solution: Take 1ml of unique flavor injection, put it in a 10ml volumetric flask, add 1ml of reference solution, dilute to the mark with methanol, shake well, filter with 0.45μm microporous membrane, take the filtrate, and get it;

[0136] Determination method: draw 10μ...

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PUM

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Abstract

A fingerprint method for testing the quality of common lamiophlomis, its intermediate and its injection includes such steps as preparing the reference solution from quercetin, preparing three solutions of common lamiophlomis, its intermediate and its injection, filling the reference solution and one solution to be tested into liquid-phase chromatograph, and testing the similarity between their fingerprints, which must be greater than 0.90.

Description

Technical field [0001] The invention relates to a quality detection method for traditional Chinese medicinal materials, intermediates and injections thereof, and particularly relates to a fingerprint spectrum quality detection method for unique medicinal materials, intermediates and injections thereof. Background technique [0002] The main chemical components in Duyiwei mainly include flavonoids, iridoids and some fatty acids. Flavonoids mainly include luteolin, luteolin-7-o-glucoside, quercetin, quercetin-3-o-arabinoside, and apigenin. At present, the quality standards of traditional Chinese medicine are very irregular and perfect, and the methods of quality analysis and evaluation are still very backward, which cannot accurately reflect the quality status of existing traditional Chinese medicine materials and finished products. The fingerprint of traditional Chinese medicine is based on the concept of fingerprint identification in forensic medicine. After proper processing, a ...

Claims

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Application Information

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IPC IPC(8): A61K36/53G01N30/02
Inventor 阙文彬李育飞
Owner SICHUAN HENGKANG DEV
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