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Multi-component content detection of ginkgo armillaria mellea oral solution and construction of a fingerprint spectrum method of the ginkgo armillaria mellea oral solution

A detection method and oral solution technology, which is applied in the directions of measuring devices, material separation, and analysis of materials, can solve problems such as difficult to satisfy samples, inability to comprehensively reflect the quality of oral preparations, complex chemical components, etc., and achieve simple operation and easy sample addition Good recovery effect

Active Publication Date: 2021-10-29
QIONGLAI TIANYIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing standards lack research on the simultaneous detection of multiple components in Ginkgo honey ring oral solution, which cannot comprehensively reflect the product quality of the oral preparation, and are difficult to meet the needs of testing a large number of samples in production
[0004] However, due to the complexity of the chemical components contained in Ginkgo Honey Ring Oral Solution and the limitations of the above-mentioned prior art detection methods, it is impossible to fully evaluate the overall internal content of Ginkgo Honey Ring Oral Solution quality

Method used

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  • Multi-component content detection of ginkgo armillaria mellea oral solution and construction of a fingerprint spectrum method of the ginkgo armillaria mellea oral solution
  • Multi-component content detection of ginkgo armillaria mellea oral solution and construction of a fingerprint spectrum method of the ginkgo armillaria mellea oral solution
  • Multi-component content detection of ginkgo armillaria mellea oral solution and construction of a fingerprint spectrum method of the ginkgo armillaria mellea oral solution

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 of the present invention provides a method for detecting the content of multiple components of ginkgo honey ring oral solution.

[0035] Instrument: Waters ACQUITY UPLC H Class plus, PDA detector;

[0036] The chromatographic conditions are as follows: Chromatographic column: ACQUITY HSS T3 (2.1×100mm, 1.8μm),

[0037] Column temperature: 50°, injection volume: 2μL, detection wavelength: 254nm, flow rate: 0.3mL / min;

[0038] Mobile phase: Phase A is 0.2% formic acid aqueous solution, phase B is methanol; gradient elution, the elution procedure is as follows:

[0039] Table 1 The mobile phase gradient elution program is as follows

[0040]

[0041] Specifically include the following steps:

[0042] The preparation of step a, need testing solution

[0043] Precisely measure 1mL of Ginkgo honey ring oral solution, put it in a 5mL volumetric flask, dilute to the mark with 10% aqueous methanol (v / v), shake well, take an appropriate amount and centrifuge...

Embodiment 2

[0097] Embodiment 2 of the present invention provides the application of a multi-component quantitative analysis method of ginkgo honey ring oral solution in detecting the content of different batches of ginkgo honey ring oral solution.

[0098] (1) Preparation of reference substance solution

[0099] According to " preparation of reference substance solution " method among the same embodiment 1.

[0100] (2) preparation of need testing solution

[0101] Get 22 batches of ginkgo honey ring oral solution products (B1-B22) produced in 2020 within the validity period, and prepare the test solution according to the "preparation of the test solution" method in Example 1.

[0102] (3) adopt ultra-high performance liquid chromatography to detect above-mentioned reference substance solution and need testing solution, and utilize the external standard method in embodiment 1 step c to calculate the content of target component in need testing solution, chromatographic condition is the s...

Embodiment 3

[0109] Embodiment 3 of the present invention provides a method for constructing the UPLC fingerprint of ginkgo honey ring oral solution.

[0110] Instrument: Waters ACQUITY UPLC H Class plus, PDA detector;

[0111] UPLC chromatographic detection conditions are as follows: Chromatographic column: ACQUITY HSS T3 (2.1×100mm, 1.8μm), column temperature: 50℃, sample volume: 2μL, detection wavelength: 254nm, detection flow rate: 0.3mL / min; mobile phase: A phase is 0.2% formic acid aqueous solution, B phase is Methanol; gradient elution, the elution procedure is as follows: 0 ~ 3min, the volume percentage of mobile phase A decreased from 94% to 86% at a constant speed, and the volume percentage of mobile phase B increased from 6% to 14% at a constant speed; 3 ~ 6min mobile phase The volume percentage of A decreased from 86% to 77% at a constant speed, and the volume percentage of mobile phase B increased from 14% to 23% at a constant speed; in 6 to 8.3 minutes, the volume percentag...

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Abstract

The invention relates to multi-component content detection of a ginkgo armillaria mellea oral solution and construction of a fingerprint spectrum method of the ginkgo armillaria mellea oral solution. The content detection analysis method established by the invention is good in precision, reproducibility, stability and sample recovery rate. Therefore, the content detection method is simple and convenient to operate, accurate and reliable, and can be used for determining the content of the gingko armillaria mellea oral solution. According to the fingerprint spectrum detection method, 19 characteristic fingerprint peaks in the gingko armillaria mellea oral solution can be detected at the same time, and 15 fingerprint peaks, namely uridine, adenosine, guanosine, acesulfame potassium, 5-hydroxymethylfurfural, protocatechuic acid, p-hydroxybenzoic acid, sodium benzoate, rutin, isoquercitrin and the like, are identified through a liquid chromatography-mass spectrometry technology and comparison of a reference substance. The detection method can be used for controlling the quality of the gingko armillaria mellea oral solution.

Description

technical field [0001] The present invention relates to the technical field of traditional Chinese medicine analysis, and in particular relates to the detection of multi-component content of ginkgo honey ring oral solution and the construction of its fingerprint method. Background technique [0002] Ginkgo honey ring oral solution is a light brownish red to brownish red clear liquid made from ginkgo leaf extract and Gastrodia elata powder using modern preparation technology. It tastes sweet and slightly bitter. National Standard Volume 16, Standard Number: WS1-XG-004-2001). The oral liquid has the effects of lowering blood fat, lowering blood pressure and improving heart and brain ischemia, and is widely used clinically in the treatment of coronary heart disease, angina pectoris and ischemic cerebrovascular disease. [0003] Ginkgo honey ring oral solution has remarkable clinical curative effect, but the quality detection method is not perfect yet. In the national drug wes...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
CPCG01N30/482G01N2030/484G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/8686G01N2030/065G01N2030/3007G01N2030/324G01N2030/047
Inventor 王益民杨静薛根赫少清张建柴欣于卉娟崔英王丹妮王跃飞
Owner QIONGLAI TIANYIN PHARM CO LTD
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