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Genistein injection and preparation method thereof

A technology for genistein and injections, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the risk of increasing adverse reactions, limit the types of preparations, Increase the cost of drugs and other issues, achieve good prevention and treatment effects, improve bioavailability, and facilitate industrial production.

Inactive Publication Date: 2012-01-04
李荣立
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Genistein is almost insoluble in water, and its poor water solubility makes it difficult for the preparations prepared by traditional preparation methods to achieve the bioavailability required for treating diseases after oral administration, which also greatly limits the production of preparations. Type, such as dosage forms such as soluble powders or intravenous formulations
In addition, the content of genistein in the preparation is low, and in order to achieve the therapeutic drug concentration, the curative effect can only be improved by increasing the dosage of the preparation, but this increases the risk of adverse reactions to a certain extent, It also increases the cost of medication

Method used

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  • Genistein injection and preparation method thereof
  • Genistein injection and preparation method thereof
  • Genistein injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0059] Example 1: Preparation of genistein freeze-dried powder for injection

[0060] Weigh 2.0g of genistein, 60.0g of hydroxypropyl-β-cyclodextrin, and 126g of mannitol, first dissolve genistein in 130ml of ethanol, stir to dissolve, then add hydroxypropyl-β-cyclodextrin Refining, magnetic stirring for 2 hours, temperature 50°C, after clathrate, remove ethanol under reduced pressure, add mannitol and water for injection 1000ml and stir to dissolve, add water for injection to 2000ml full amount, adjust pH to 3.3 with citric acid, add drug Stir and adsorb with activated carbon for 15 minutes, the amount of medicinal carbon used is 0.03%, filter, the filtrate is divided into vials, freeze-dried, vacuum-pressed and taken out, and the aluminum-pressed cap is labeled to obtain the freeze-dried product.

Embodiment 2

[0061] Embodiment 2: Preparation of Genistein Sodium Chloride Injection

[0062] Weigh 40.0g of hydroxypropyl-β-cyclodextrin, 1.0g of genistein and 9.0g of sodium chloride for injection, add genistein to 60ml of ethanol, stir to dissolve and add hydroxypropyl -β-cyclodextrin and sodium chloride for injection, magnetically stirred for 1 hour (control the speed so that the liquid does not splash outwards), temperature 60°C, observed to obtain clear and transparent genistein hydroxypropyl-β-cyclodextrin clathrate solution. Remove ethanol under reduced pressure, add water for injection to 600ml and stir, add water for injection to 1000ml full amount, adjust pH to 3.8 with tartaric acid, add medicinal active carbon and stir for adsorption for 20 minutes, the amount of medicinal carbon used is 0.03%, filter, press The predetermined dose is divided into infusion bottles and sterilized by autoclaving at 115°C for 30 minutes.

Embodiment 3

[0063] Embodiment 3: Preparation of Genistein Glucose Injection

[0064] Weigh 50.0g of hydroxypropyl-β-cyclodextrin, 2.0g of genistein, and 50g of glucose for injection, add genistein to 150ml of ethanol, stir and dissolve, then add hydroxypropyl-β- Cyclodextrin, stirred by magnetic force for 1 hour (the speed is controlled so that the liquid does not splash outside), the temperature is 55° C., and a clear and transparent genistein hydroxypropyl-β-cyclodextrin inclusion complex solution is obtained. Ethanol was removed under reduced pressure. After glucose for injection and 100ml of water for injection are stirred and dissolved, the glucose solution is poured into the clathrate, replenished to 800ml, adjusted to pH 3.8 with tartaric acid, added with medicinal activated carbon and stirred and adsorbed for 20 minutes. The amount of medicinal carbon used is 0.03%, filtered, divided into infusion bottles according to the predetermined dose, and sterilized at 115°C for 30 minutes...

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Abstract

The invention discloses a genistein injection and a preparation method thereof. The injection disclosed by the invention comprises genistein-cyclodextrin or cyclodextrin derivant clathrate. The preparation method comprises the following steps: preparing a water solution of the genistein clathrate into a water injection through sterilization; adding an appropriate amount of an osmotic pressure regulator, and carrying out autoclave sterilization to prepare medicine-carrying injection; and adding an appropriate amount of an excipient, and freezing and drying to prepare a freeze-dried injection powder. The injection disclosed by the invention acts rapidly and has stable quality, and has excellent prevention and treatment effects for diseases, such as osteoporosis, women menopause syndrome, tumor, cardiovascular and cerebrovascular diseases and the like.

Description

technical field [0001] The invention relates to a genistein injection and a preparation method thereof, in particular to an injection containing a genistein inclusion compound and a preparation method thereof. It belongs to the field of medicine. Background technique [0002] Genistein is soluble in DMSO and ethanol, almost insoluble in water, the structure is as follows: [0003] [0004] Genistein is an isoflavone compound derived from legumes and dentate plants, and its chemical name is 4',5,7-trihydroxyisoflavone. It is the main active ingredient of soybean isoflavones, which has estrogen-like effects in the metabolism in the body, and is called phytoestrogens. Genistein has a variety of pharmacological effects and biological activities such as preventing early atherosclerosis and chronic vascular diseases, anti-tumor, and women's climacteric syndrome. Genistein is a powerful inhibitor of tyrosine protein kinase and topoisomerase, through the regulation of oncogene...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/352A61K47/48A61P35/00A61P35/02A61P19/10A61P15/12A61P9/00
Inventor 李荣立赵素芬
Owner 李荣立
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