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Low-toxicity Ginkgo biloba extract composition and preparations thereof

A technology of ginkgo ketone ester and ginkgo ketone ester tablet, which is applied in the field of low-toxic ginkgo ketone ester composition and preparation, can solve the problems of reduced content range, unfavorable and accurate drug use, etc., and achieves reduced content of toxic components and accurate content range of effective components and stable, low solvent residue content

Inactive Publication Date: 2018-12-18
SPH XING LING SCI & TECH PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, Ginkgo biloba extract also contains ginkgolic acid, a toxic component, and its content range needs to be further reduced to minimize the harm to patients. Moreover, the content range of active ingredients in Ginkgo biloba extract in the current applicable standards is too wide, which is not conducive to accurate Therefore, it is necessary to conduct in-depth research on ginkgo ketone esters to solve the problems of existing products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] The present embodiment relates to a kind of low toxicity ginkgo ketone ester composition, comprises following component by weight percent: total flavonoids, 44-55%; Bilobalide (C 15 h 18 o 8 ), greater than 2.6%; rutin, less than 4%; quercetin, less than or equal to 0.4%; total ginkgolic acid, less than or equal to 4ppm; moisture, less than 5%; cyclohexane residue, less than or equal to 0.002%.

[0021] Optionally, the following components are also included: total flavonol glycosides 24-35%; terpenoid lactones and bilobalide (C 15 h 18 o 8 ), ginkgolide A (C 20 h 24 o 9 ), ginkgolide B (C 20 h 24 o 10 ) and ginkgolide C (C 20 h 24 o 11 ) in the total amount of 6-12%.

[0022] In the existing standard, ginkgolic acid is determined by TLC scanning method, which has low sensitivity; in the technical solution of the present invention, ginkgolic acid is determined by liquid chromatography-mass spectrometry, which has high sensitivity and more accurate measuremen...

Embodiment 2

[0026] This embodiment relates to a ginkgo ketone ester tablet, which contains the low-toxic ginkgo ketone ester composition of Example 1.

[0027] Optionally, the ginkgo ketone ester tablet includes the following components in parts by weight: 30-45 parts of low-toxicity ginkgo ketone ester composition, 40-55 parts of dextrin, 75-100 parts of starch, hydroxypropyl cellulose 35-40 parts, microcrystalline cellulose 15-20 parts, carboxymethyl starch sodium 10-15 parts, magnesium stearate 1-3 parts.

[0028] Preferably, the ginkgo ketone ester tablet includes the following components in parts by weight: 40 parts of low-toxic ginkgo ketone ester composition, 50 parts of dextrin, 90 parts of starch, 37.5 parts of hydroxypropyl cellulose, microcrystalline cellulose 17.5 parts, sodium starch glycolate 12.5 parts, magnesium stearate 2.5 parts.

[0029] Preparation method: Take the low-toxic ginkgo ketone ester composition of Example 1, add dextrin, starch, hydroxypropyl cellulose, mi...

Embodiment 3

[0031] This embodiment relates to ginkgo ketone ester granules, which contain the low-toxicity ginkgo ketone ester composition described in Example 1.

[0032] Optionally, the ginkgo ketone ester granules include the following components in parts by weight: 30-45 parts of low-toxicity ginkgo ketone ester composition, 450-500 parts of dextrin, 420-450 parts of sucrose powder, 10-30 parts of starch 10-30 parts of low-substituted hydroxypropyl cellulose, 5-10 parts of aspartame.

[0033] Preferably, the ginkgo ketone ester granules include the following components in parts by weight: 40 parts of low-toxic ginkgo ketone ester composition, 480 parts of dextrin, 433 parts of sucrose powder, 20 parts of starch, low-substituted hydroxypropyl cellulose 20 servings, 7 servings of aspartame.

[0034] Preparation method: take the low-toxicity ginkgo ketone ester composition of Example 1, add corresponding contents of dextrin, sucrose powder, starch, low-substituted hydroxypropyl cellulos...

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Abstract

The invention relates to a low-toxicity Ginkgo biloba extract composition and preparations thereof. The composition comprises, by weight, 44-55% of general flavones, above 2.6% of bilobalide (C15H18O8), below 4% of rutin, 0.4% or less of quercetin, 4 ppm or less of total ginkgolic acids, below 5% of water and 0.002% or less of a cyclohexane residue. The low-toxicity Ginkgo biloba extract composition can be processed to prepare a tablet, a granule and a capsule. The low-toxicity Ginkgo biloba extract composition and the preparations thereof have the advantages of further reduction of the content of toxic components, low content of the solvent residue, stable content of the effective components, and great improvement of the administration safety.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine, and mainly relates to a low-toxic ginkgo ketone ester composition and preparation. Background technique [0002] Ginkgo biloba is a kind of medicine with exact curative effect and wide application. The main effective components of its extract are flavonoids (Flavonoids) and terpene lactones. The former is mainly quercetin, kaempferol, isorhamnetin and its glycosides. The latter is mainly based on Ginkgolides and Bilobalide. Clinical verification of ginkgo biloba extract is quite satisfactory for the curative effect of heart, cerebrovascular and peripheral vascular circulation disorders. At present, it is mainly used for the treatment of ischemic cerebrovascular disease and the dizziness caused by it, hearing impairment, senile dementia, diabetic neuropathy, cor pulmonale and epilepsy, such as ginkgo ketone ester raw materials and its preparations. [0003] However, Ginkgo b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/20A61K9/16A61K9/48A61K47/36A61K47/38A61P9/10A61P25/28A61P25/08
CPCA61K9/1652A61K9/2054A61K9/2059A61K9/4866A61K36/16A61P9/10A61P25/08A61P25/28
Inventor 沈琴高崎王军王挚豪高勇张曙平
Owner SPH XING LING SCI & TECH PHARM CO LTD
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