Detection method of ginkgo dipyridamole injection preparation

A technology of injection preparations and detection methods, which is applied in the field of medicines and can solve problems such as non-incorporation

Active Publication Date: 2020-11-24
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, it has not been included in the national standard of this product, and with the development of society, the requirements for the quality control of drugs are getting higher and higher, and the detection indicators such as the identification and content determination of active ingredients need to be clarified gradually. The demand for fast, convenient and controllable detection methods is becoming more and more urgent, and the State Foo

Method used

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  • Detection method of ginkgo dipyridamole injection preparation
  • Detection method of ginkgo dipyridamole injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0315] Detection method of Ginkgo Damo injection:

[0316] traits:

[0317] This product is yellow to brown yellow transparent liquid;

[0318] Identification:

[0319] (1) Take 2 ml of this product, add a little magnesium powder, add a few drops of concentrated hydrochloric acid, and it will gradually turn red after standing;

[0320] (2) Take 2 ml of this product, add 10 ml of ethanol, it will show green fluorescence, and the fluorescence will disappear after adding dilute hydrochloric acid;

[0321] (3) In the chromatograms recorded under the content determination items of dipyridamole, total flavonol glycosides, and terpene lactones, the retention time of the peak of the test product should be the same as that of the peak of the corresponding reference substance and the peak of the total ginkgo lactone control extract. The retention time is the same;

[0322] (4) Take 25ml of this product, pass it through a D201 macroporous adsorption resin column (inner diameter 2cm, ...

Embodiment 2

[0390] Detection method of Ginkgo Damo injection:

[0391] traits:

[0392] This product is yellow to brown yellow transparent liquid;

[0393] Identification:

[0394] (1) Take 2 ml of this product, add a little magnesium powder, add a few drops of concentrated hydrochloric acid, and it will gradually turn red after standing;

[0395] (2) Take 2 ml of this product, add 10 ml of ethanol, it will show green fluorescence, and the fluorescence will disappear after adding dilute hydrochloric acid;

[0396] (3) In the chromatograms recorded under the content determination items of dipyridamole, total flavonol glycosides, and terpene lactones, the retention time of the peak of the test product should be the same as that of the peak of the corresponding reference substance and the peak of the total ginkgo lactone control extract. The retention time is the same;

[0397] (4) Take 50ml of this product, pass it through a D101 macroporous adsorption resin column (inner diameter 2cm, ...

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Abstract

The invention provides a detection method of a ginkgo dipyridamole injection preparation. The ginkgo dipyridamole injection preparation is prepared from a ginkgo leaf extract and dipyridamole, and thedetection method comprises the items of character, identification, inspection, fingerprint spectrum and content determination. Compared with the prior art, a thin-layer chromatography identificationmethod of the ginkgo biloba extract, limited quantity inspection of 5-hydroxymethylfurfural, total ginkgolic acid and the like, inspection of injection related substances, fingerprint detection and the method for determining the content of rutin, kaempferol-3-O-rutinoside, narcissoside and terpene lactones are additionally arranged, the method for determining the content of the total flavonol glycosides is optimized, the requirement for product quality detection is improved, and the method is more suitable for quality control of drugs in the future and is more beneficial to guaranteeing the drug quality and clinical efficacy.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a detection method for ginkgo damole injection preparation. Background technique [0002] Cardiovascular and cerebrovascular diseases such as coronary heart disease, cerebral thrombosis, hypertension, and cerebral infarction are among the most common and harmful diseases in the world today. One of the reasons; according to reports, the incidence rate has been increasing year by year in recent years, and the number of middle-aged and young patients is increasing. Ginkgo Damole Injection is made from Ginkgo biloba extract and dipyridamole. It is recorded in National Standards for Local Standards of Chemical Drugs (Volume 1), Standard Number: WS-10001-(HD-0087)- 2002. This product can resist platelet aggregation and belongs to coronary artery dilator, which is suitable for the prevention and treatment of coronary heart disease and thromboembolic diseases. Ginkgo biloba extract...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74G01N30/86G01N30/90
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N30/8679G01N30/8686G01N30/90G01N2030/047G01N2030/062
Inventor 窦啟玲杨青波陆煜玫段毅
Owner GUIZHOU YIBAI PHARMA CO LTD
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