Ginkgo biloba leaf extract injection quality control method based on quantitative analysis of multi-components by single marker and fingerprint spectrum

A measurement method and injection technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effect of fast measurement method, high precision and good stability

Inactive Publication Date: 2017-08-18
HEILONGJIANG ZBD PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the research on the quality standard of flavonol glycosides in Shuxuening injection only stays in acid hydrolysis to determine the three contents of quercetin, kaempferol and isorhamnetin, which are converted into the content of total flavonol glycosides In terms of the method, the control for the prototype components of flavonol glycosides is blank

Method used

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  • Ginkgo biloba leaf extract injection quality control method based on quantitative analysis of multi-components by single marker and fingerprint spectrum
  • Ginkgo biloba leaf extract injection quality control method based on quantitative analysis of multi-components by single marker and fingerprint spectrum
  • Ginkgo biloba leaf extract injection quality control method based on quantitative analysis of multi-components by single marker and fingerprint spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Determination method of flavonol glycosides in Shuxuening injection

[0058] (1) Preparation of the reference substance solution: respectively accurately weigh rutin (Rutin), kaempferol-3-O-rutinoside (KGR), isorhamnetin-3-O-rutinoside (IGR), kaempferol Phenol-3-O-rhamnose-2-glucoside (KRG), quercetin-3-O-rhamnose-2-O-(6-OL-p-hydroxytrans-cinnamoyl)-glucoside ( QRcG), kaempferol-3-O-rhamnose-2-O-(6-O-p-hydroxytrans-cinnamoyl)-glucoside (KRcG) appropriate amount of reference substance, add methanol to make each 1mL containing 75μg respectively , 70μg, 60μg, 35μg, 75μg, 75μg solutions, as the reference solution;

[0059] (2) High-performance liquid chromatography detection: 10 μL each of Shuxuening injection and reference solution were accurately drawn, and injected into the high-performance liquid chromatography;

[0060] Wherein, the conditions for the liquid chromatography detection are: using octadecylsilane bonded silica gel as filler, acetonitrile as mobile phase ...

Embodiment 2

[0062] Determination method of flavonol glycosides in Shuxuening injection

[0063] (1) Preparation of the reference substance solution: respectively accurately weigh rutin (Rutin), kaempferol-3-O-rutinoside (KGR), isorhamnetin-3-O-rutinoside (IGR), kaempferol Phenol-3-O-rhamnose-2-glucoside (KRG), quercetin-3-O-rhamnose-2-O-(6-OL-p-hydroxytrans-cinnamoyl)-glucoside ( QRcG), kaempferol-3-O-rhamnose-2-O-(6-O-p-hydroxytrans-cinnamoyl)-glucoside (KRcG) appropriate amount of reference substance, add methanol to make each 1mL containing 75μg respectively , 70μg, 60μg, 35μg, 75μg, 75μg solutions, as the reference solution;

[0064] (2) High-performance liquid chromatography detection: 25 μL each of Shuxuening injection and reference solution were accurately drawn, and injected into high-performance liquid chromatography;

[0065] Wherein, the conditions for the liquid chromatography detection are: using octadecylsilane bonded silica gel as filler, acetonitrile as mobile phase A, a...

experiment example 1

[0067] Shuxuening Injection Fingerprint Detection Method Test Results

[0068] Using the detection method in Example 2, the similarity of 13 batches of samples was measured, and the results all met the limit specified in the current standard. See Table 1, fingerprints see image 3 .

[0069] Table 1 Fingerprint Spectrum Determination Results

[0070]

[0071]

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Abstract

The invention relate to a ginkgo biloba leaf extract injection quality control method based on quantitative analysis of multi-components by a single marker and a fingerprint spectrum. The method comprises the steps that rutin is adopted as a reference sample, flavonols kaempferol-3-O-rutinoside, isorhamnetin-3-O-rutinoside, kaempferol-3-O-rhamnose-2-glucoside, quercetin-3-O-rhamnose-2-O-(6-O-p-hydroxy cinnamoyl) glucosyl and kaempferol-3-O-rhamnose-9-O-6-O-(p-hydroxy cinnamoyl) glucosyl are quantified through quantitative analysis of multi-components by a single marker, and the ginkgo biloba leaf extract injection batched quality stability is controlled through the fingerprint spectrum. The problem that ginkgo biloba leaf extract injection multi-component quantification and multi-index quality control lack reference samples is solved, and the quality of the ginkgo biloba leaf extract injection is ensured while the product batched quality stability is controlled through the fingerprint spectrum.

Description

technical field [0001] The invention relates to a method for controlling the quality of Shuxuening injection based on a one-measurement-multiple-assessment method and a fingerprint. Background technique [0002] Shuxuening Injection dilates blood vessels and improves microcirculation. For ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism, cerebral vasospasm, etc. The raw material is Ginkgo biloba, and the excipients are glucose and ethanol. Every 2 mL of Shuxuening injection contains 7.0 mg of Ginkgo biloba extract, which contains 1.68 mg of total flavonol glycosides and 0.28 mg of ginkgo biloba lactone. [0003] The fingerprint of traditional Chinese medicine refers to the chromatogram or spectrum of a certain type or several types of components that are common in certain Chinese medicinal materials or Chinese patent medicines. At the present stage, when most of the active ingredients of traditional Chinese me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86
CPCG01N30/8686
Inventor 方同华许照芹项彦华席桂才
Owner HEILONGJIANG ZBD PHARMA
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