Preparation method of gossypol acetate intravenous injection fatty emulsion

A technology of gossypol acetate and fat emulsion, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problems of reports, preparation methods of fat emulsions without gossypol, etc., and achieve The process is simple, conducive to industrial production, and the effect of good stability

Active Publication Date: 2010-09-15
SHENZHEN ICARBONX INTELLIGENT PEPTIDE PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no report about the preparation method of the fat emulsion of gossypol in the prior art

Method used

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  • Preparation method of gossypol acetate intravenous injection fatty emulsion
  • Preparation method of gossypol acetate intravenous injection fatty emulsion
  • Preparation method of gossypol acetate intravenous injection fatty emulsion

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The preparation of embodiment 1 gossypol acetate intravenous injection fat emulsion

[0022] Party:

[0023] Gossypol Acetate 40g

[0024] Ethyl oleate 207g

[0025] Soy Lecithin 35g

[0026] Absolute ethanol 18g

[0027]

[0028] Sterile water for injection to 1000ml

[0029] preparation:

[0030] Dissolve the prescribed amount of gossypol acetate in ether, then add ethyl oleate, soybean lecithin, and absolute ethanol in a constant temperature water bath at 60°C, and stir while adding. The stirring speed is 1600rpm, stir for 2 hours, and evaporate under reduced pressure to remove the ether , as an oil phase medicinal solution, stored in a constant temperature water bath at 60°C for later use;

[0031] Preserve an appropriate amount of sterilized water for injection in a constant temperature water bath at 60°C as the aqueous phase liquid;

[0032] Slowly drop the oil phase liquid into the water phase liquid at a constant temperature of ...

Embodiment 2

[0034] The preparation of embodiment 2 gossypol acetate intravenous injection fat emulsion

[0035] Party:

[0036] Gossypol Acetate 60g

[0037] Ethyl oleate 220g

[0038] Soy Lecithin 43g

[0039] PEG400 35g

[0040]

[0041] Sterile water for injection to 1000ml

[0042] preparation:

[0043] Dissolve the prescribed amount of gossypol acetate in ether, then add ethyl oleate, soybean lecithin, and PEG400 in a constant temperature water bath at 70°C, and stir while adding, at a stirring speed of 1700rpm, stir for 1.5 hours, and evaporate under reduced pressure to remove the ether, as Oil phase liquid, stored in a constant temperature water bath at 70°C for later use;

[0044] Store an appropriate amount of sterile water for injection in a constant temperature water bath at 70°C as the aqueous phase liquid;

[0045] Slowly drop the oil phase liquid into the water phase liquid at a constant temperature of 70°C, stir while adding, the stirring s...

Embodiment 3

[0047] The preparation of embodiment 3 gossypol acetate intravenous injection fat emulsion

[0048] Party:

[0049] Gossypol Acetate 80g

[0050] Medium-chain fatty acid (C8-C10) triglycerides 297g

[0051] Soy Lecithin 36g

[0052] PEG400 29g

[0053]

[0054] Sterile water for injection to 1000ml

[0055] preparation:

[0056] Dissolve the prescribed amount of gossypol acetate in ether, then add medium-chain fatty acid (C8-C10) triglycerides, soybean lecithin, and PEG400 in a constant temperature water bath at 70°C, and stir while adding. The stirring speed is 1800rpm, and stir for 2 hours , evaporated under reduced pressure to remove ether, used as an oil phase liquid, and stored in a constant temperature water bath at 70°C for later use;

[0057] Store an appropriate amount of sterile water for injection in a constant temperature water bath at 70°C as the aqueous phase liquid;

[0058] Slowly drop the oil phase liquid into t...

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Abstract

The invention discloses a preparation method of gossypol acetate intravenous injection fatty emulsion. In the method, gossypol acetate is used as an active constituent, ethyl oleate or middle-chain fatty acid triglyceride is used as an oil phase, soya bean lecithin is used as a surface active agent, absolute ethyl alcohol or PEG (Polyethylene Glycol) 400 is used as a cosurfactant, and sterilized water for injection is used as a water phase. The method comprises the following steps of: (1) dissolving the gossypol acetate in diethyl ether and then mixing with the oil phase, the surface active agent and the cosurfactant; decompressing and evaporating to remove the diethyl ether and preserving at a constant temperature for later use; (2) heating the sterilized water for injection and preserving at a constant temperature for later use; (3) mixing liquids obtained in the steps (1) and (2) at a constant temperature of 60 or 70 DEG C and stirring until a transparent and homogeneous solution is formed; making the volume constant and then repeatedly homogenizing by using a homogenizer; and filtering by using a millipore filter membrane. Proved by researches, the gossypol acetate intravenous injection fatty emulsion prepared by using the method has good slow release and targeting effects and good stability.

Description

technical field [0001] The invention relates to a preparation method of gossypol acetate pharmaceutical preparation, in particular to a preparation method of gossypol acetate intravenous injection fat emulsion. Background technique [0002] Gossypol, also known as gossypol, is a yellow phenolic compound. Naturally present in the seeds, leaves, stems and roots of cotton, a plant of the Malvaceae family. At room temperature, gossypol is yellow crystal, soluble in ethanol, ether, acetone, chloroform and other organic solvents, also soluble in oil, but insoluble in water, hexane and petroleum ether with low boiling point, most of the organic solvents are It is highly toxic to the human body and is not suitable as a drug carrier. [0003] Gossypol is well known as a male birth control drug. In recent years, its anti-tumor effect has been paid more and more attention. It has a wide range of killing effects on tumor cells, such as uterine fibroids, prostate cancer, colon cancer,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/222A61K47/14A61K47/24A61P35/00
Inventor 厉保秋
Owner SHENZHEN ICARBONX INTELLIGENT PEPTIDE PHARM TECH CO LTD
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