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Ginkgo leaf extract and quality control method and application thereof

A technology of extract and ginkgo biloba, which is applied in the field of ginkgo biloba extract and its quality control, can solve problems such as obstacles, uneven product quality, and artificial additions that cannot be completely avoided

Active Publication Date: 2019-02-26
弘和制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] my country is a country with abundant resources of Ginkgo biloba. The preparation of Ginkgo biloba extract has a long history, but the composition of the extract is complex. The traditional method of quality control using a single component as an indicator is increasingly unable to meet the current quality control requirements of traditional Chinese medicine.
The current quality testing standards for extracts of traditional Chinese medicine cannot truly reflect the inherent quality of ginkgo biloba extract products, thus resulting in uneven quality of many products
[0003] The main active ingredients in Ginkgo biloba extract are flavonoids and terpenoid lactones, but the current quality standards only control the lower limit of the content of these two types of substances, and it is still impossible to completely avoid illegal phenomena such as artificial addition
[0004] In addition, my country's current Pharmacopoeia standard limits the content of total ginkgolic acid in ginkgo leaf extract to 10mg / kg, which is higher than the international general standard of 5mg / kg, which has become a major obstacle restricting the export of ginkgo leaf extract in my country

Method used

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  • Ginkgo leaf extract and quality control method and application thereof
  • Ginkgo leaf extract and quality control method and application thereof
  • Ginkgo leaf extract and quality control method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0050] Preparation of reference substance solution: Accurately weigh an appropriate amount of rutin reference substance, add 80% methanol to make a solution containing 30μg per 1ml, and obtain it.

[0051] Preparation of the control extract solution: accurately weigh 40 mg of the Ginkgo biloba control extract, accurately add 20 ml of 80% methanol, ultrasonicate (power 250 W, frequency 33 kHz) for 10 minutes, filter, and take the subsequent filtrate to obtain final product.

[0052] Preparation of the test solution: accurately weigh 40 mg of the Ginkgo biloba extract of the present invention, and prepare the test solution in the same way as the reference extract solution.

[0053] Determination method: Accurately draw 10 μl (method 1) or 1 μl (method 2) of each of the reference substance solution, the control extract solution and the test solution respectively, inject it into the liquid chromatography for determination, and record for 70 minutes (method 1) or 15 minutes ( The c...

Embodiment 1

[0057] Preparation and determination of embodiment 1 Ginkgo biloba extract

[0058] (I) Preparation

[0059] Take ginkgo biloba decoction pieces, heat and reflux with 70% to 80% ethanol to extract twice, the first time is 2 hours, and the second time is 1 hour. Filter the extract, concentrate it to a clear paste with a relative density of 1.05-1.25 (60±2°C), sink it in water for more than 8 hours, filter it, pass the filtrate through a macroporous adsorption resin column with a particle size of 0.12mm, and then water and 30-80 % ethanol solution for elution, discard the washing solution, elute with 30-80% ethanol solution, pass the eluent through another macroporous adsorption resin column, collect the effluent, concentrate to an appropriate amount, refrigerate, filter, and add the filtrate to the third Put it on a macroporous adsorption resin column, wash with water, discard the washing solution, elute with 30-80% ethanol solution, collect the eluate, concentrate to an appro...

Embodiment 2

[0103] Determination of the content range of total flavonol glycosides in the Ginkgo biloba extract of embodiment 2

[0104] According to the method described in Example 1 (II-i), the content of total flavonol glycosides in multi-batch ginkgo leaves and ginkgo leaf extracts is measured, and it is found that the content range of total flavonoids in natural ginkgo leaf extracts is 24.5~41.4 %, with an average of 33.5%.

[0105] In addition, according to the method described in Example 1 (V), the fingerprints of the Ginkgo biloba extract with a total flavonol glycoside content of 41.04% and the Ginkgo biloba extract with a total flavonol glycoside content of 30.90% were measured respectively. The results are as follows: image 3 with Figure 4 shown. The fingerprint similarity evaluation results show that the similarity between the fingerprint of the Ginkgo biloba leaf extract with a total flavonol glycoside content of 41.04% and the control fingerprint is reduced to a level of...

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Abstract

The invention relates to a ginkgo leaf extract and a quality control method and application thereof. The ginkgo leaf extract, on a dry weight basis, comprises 24.0%-37.0% of total ginkgo flavone glycosides and 6.0%-12.0% of terpene lactone, preferably, the content of rutin in the ginkgo leaf extract does not exceed 4.0%, the content of free quercetin does not exceed 0.4%, more preferably, the content of total ginkgolic acid in the ginkgo leaf extract does not exceed 2 mg / kg, and further preferably, the contents of heavy metals in the ginkgo leaf extract are as follows: lead does not exceed 5 mg / kg, cadmium does not exceed 0.3 mg / kg, arsenic does not exceed 2 mg / kg, mercury does not exceed 0.2 mg / kg, and copper does not exceed 20 mg / kg. The ginkgo leaf extract can be used for preparing food, health-care products, drugs or cosmetics and the like.

Description

technical field [0001] The invention relates to a ginkgo leaf extract and a quality control method thereof. Background technique [0002] my country is a country with abundant Ginkgo biloba resources. The preparation of Ginkgo biloba extract has a long history, but the components of the extract are complex. The traditional method of quality control using a single component as an indicator cannot meet the current quality control requirements of traditional Chinese medicine. At present, the existing quality testing standards for extracts of traditional Chinese medicine cannot truly reflect the inherent quality of Ginkgo biloba extract products, thus resulting in uneven quality of many products. [0003] The main active ingredients in Ginkgo biloba extract are flavonoids and terpenoid lactones, but the current quality standards only control the lower limit of the content of these two types of substances, and it is still impossible to completely avoid illegal phenomena such as a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/08A61K8/9771A61Q19/00A23L33/105G01N30/02G01N30/86A61K127/00A61K31/4965
CPCA23V2002/00A61K9/0019A61K9/08A61K31/4965A61K36/16A61Q19/00A23L33/105A61K8/9771G01N30/02G01N30/8686A61K2300/00A23V2200/30A23V2250/2122
Inventor 郑建勇田慧龚静胡金劳芳
Owner 弘和制药有限公司