Ginkgo leaf powder for injection and its preparation

A technology of ginkgo leaf powder and ginkgo biloba, which is applied in the direction of pharmaceutical formula, powder delivery, medical preparations containing active ingredients, etc., can solve the problems of large difference in quality of preparations, unstable mutual transformation, difficult to remove, etc., to improve safety and stability, increasing uniformity and stability, and avoiding open-loop variations

Inactive Publication Date: 2005-12-28
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are many kinds of ginkgo biloba preparations, and the ginkgo biloba extract freeze-dried powder injection has the following main disadvantages: the drug solution before freeze-drying is adjusted to be alkaline, the ring-opening and dissolution of ginkgolide is made, and the flavonoids are salted
After the liquid is adjusted to be alkaline, the ring-opening of ginkgolides will cause the inter-transformation and instability of the lactone components, and the flavonoids will also be easily oxidized after forming a salt, which will cause a large difference in the quality of the preparation
The ginkgo leaf freeze-dried powder injection does not use ultrafiltration technology, and the impurities (macromolecules, pyrogens, particles, microorganisms, etc.) in the ginkgo leaf extract that affect the safety of the preparation are difficult to remove, which will affect the safety of the injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Example 1 Preparation of Ginkgo Leaf Freeze-dried Powder Injection

[0011] Get the ginkgo biloba coarse powder, add 8 times the concentration of 60% (weight) ethanol solution, soak at 60-70 DEG C for 3 hours, and filter. Add 7 times the amount of 60% ethanol solution to the filter residue, warm soak at 60-70°C for 2 hours, and filter. Combine the above two filtrates, dry the filtrate under reduced pressure, concentrate the material to one-third of the original volume, and recover ethanol. The concentrated material was diluted with water to twice the original volume, left for 24 hours, and filtered. The filtrate is adsorbed by a macroporous adsorption resin, washed with distilled water until the effluent is colorless, eluted with an ethanol solution with a concentration of 80% as a solvent, collected the eluate, dried under reduced pressure to recover ethanol, and refined until the water is removed to obtain Ginkgo biloba leaf extract.

[0012] Take 88g of Ginkgo bil...

Embodiment 2

[0013] Example 2 Preparation of Ginkgo Leaf Spray Dry Powder Injection

[0014] Adopt the same method of embodiment 1 to obtain the ultrafiltrate, add water for injection to 5000ml in the ultrafiltrate, then aseptically spray dry to obtain spray-dried powder, spray-dried powder is aseptically subpackaged in vials, 268 mg per bottle, stoppered, Press the cap to obtain the ginkgo leaf spray-dried powder injection of the present invention.

Embodiment 3

[0015] The selection of embodiment three ginkgo leaf freeze-dried powder auxiliary materials

[0016] Obtain ginkgo leaf extract by the technique of embodiment one, get three groups of ginkgo leaf extracts, every group 88mg, three groups of ginkgo leaf extracts add hydroxypropyl beta-cyclodextrin by 1.5, 2.0, 2.5 times respectively, and use Meglumine adjusts the pH value to 6-7, and the remaining steps are the same as the powder injection process in Example 1. Divide the ultrafiltration solution into 4ml and 6ml bottles, freeze-dry (first freeze at -15°C for 2 hours, then pre-freeze at -40°C for 3 hours after freezing, and freeze-dry in a small freeze dryer for 48 hours) , observe the moldability of powder injection, see Table 1.

[0017] Liquid volume

[0018] It can be seen from Table 1 that different additions of the auxiliary material hydroxypropyl beta cyclodextrin have different effects on the moldability of the powder injection. A group of 2 times the amount...

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PUM

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Abstract

The invention relates to a ginkgo leaf extract powder injection, which contains 1 weight part of ginkgo leaf extract, 1-4 weight parts of hydroxypropyl beta cyclodextrin, and 0.02- 0.08 parts by weight. Its preparation method is: take ginkgo biloba extract, add hydroxypropyl beta cyclodextrin and mix in proportion, add acid-base regulator, filter, and the filtrate is ultrafiltered through a 50000-150000 Dalton ultrafiltration membrane, ultrafiltration The liquid is directly aseptically freeze-dried or aseptically spray-dried to form a powder for injection. On the basis of fully retaining the active ingredients, the preparation effectively removes impurities such as macromolecules, pyrogens, particles (including resin exfoliation), microorganisms, etc. in the original extract, and the safety and stability of the preparation are significantly improved.

Description

(technical field) [0001] The invention relates to a ginkgo leaf extract powder injection and a preparation method of the ginkgo leaf extract powder injection, belonging to the field of traditional Chinese medicines. (Background technique) [0002] Ginkgo biloba is the leaf of Ginkgo biloba L. Ginkgo biloba is a specialty plant in my country and one of the existing ancient relic plants. The extract of Ginkgo biloba has a certain effect on the treatment of coronary atherosclerotic heart disease, myocardial infarction, expansion of cerebral blood vessels, increase of cerebral blood flow, and treatment of ischemic encephalopathy. Modern medical research has proved that ginkgo leaves and other parts contain various active chemical components such as flavonoids and terpenoids, which have various physiological activities. According to reports, the main flavonoids quercetin, kaempferol and isorhamnetin in Ginkgo biloba have good effects on improving heart and brain blood circulati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61P9/10
Inventor 彭国平李旭东戴军平
Owner YANGTZE RIVER PHARM GRP CO LTD
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