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Method for preparing emulsified medicinal composition containing oleum fructus bruceae

A technology of brucei japonica oil emulsion and composition, which is applied in the directions of drug combination, medical preparation containing active ingredients, pharmaceutical formula, etc., to achieve the effect of improving product quality and good physical stability

Inactive Publication Date: 2010-03-31
ZHEJIANG JIUXU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the hemolysis test is not required in the quality standards of chemical drugs, only traditional Chinese medicine injections require hemolysis test. Therefore, the hemolysis of chemical drugs with phospholipids as emulsifiers has not been reported.

Method used

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  • Method for preparing emulsified medicinal composition containing oleum fructus bruceae
  • Method for preparing emulsified medicinal composition containing oleum fructus bruceae

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The emulsified pharmaceutical composition containing javanica javanica oil is made by the following method: take 5ml of javanica javanica oil, 10g of egg yolk lecithin, 1ml of glycerin, add water to 100ml, and homogeneously emulsify until the diameter of the emulsion particles is ≤15um, and then a An emulsified pharmaceutical composition containing javanica javanica oil.

[0025] The Brucea javanica oil used in each embodiment in the present invention can be the Brucea javanica oil that obtains from commercial source, also can be by the routine method equipment of extracting Brucea javanica oil known in the art, for example, get Brucea javanica, press, Take squeezed oil, let it stand, and filter; or take Brucea javanica, crush it, add filter extractant to filter, combine the filtrate and extract, and recover the solvent. %

[0026] The egg yolk lecithin used in each embodiment of the present invention can be commercially obtained egg yolk lecithin for injection, or can...

Embodiment 2

[0028] The emulsified pharmaceutical composition containing javanica javanica oil is made by the following method: take 30ml of javanica javanica oil, 1885g of poloxamer, 10ml of glycerin, add water to 100ml, homogeneously emulsify until the diameter of the emulsion particles is ≤15um, and then it is made An emulsified pharmaceutical composition containing javanica javanica oil. The chemical name of poloxamer is: polyoxyethylene-polyoxypropylene copolymer. Poloxamer 188 is a polyoxyethylene-polyoxypropylene copolymer with a molecular weight range of 7680-9510.

Embodiment 3

[0030] The emulsified pharmaceutical composition containing javanica javanica oil is made by the following method: take 8ml of javanica javanica oil, 1.8g of egg yolk lecithin E-80, 2ml of glycerin, add water to 100ml, homogeneously emulsify until the diameter of the milk particle is ≤15um, Promptly make a kind of emulsified pharmaceutical composition containing javanica javanica oil.

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Abstract

The invention discloses a method for preparing an emulsified medicinal composition containing oleum fructus bruceae, which comprises the following steps: (1) mixing a proper amount of water and 1 to 10ml of glycerin; (2) adding at least one of yolk lecithin and poloxamer into liquid prepared in step (1), and performing shear mixing uniformly, wherein the yolk lecithin is between 0.5 and 10g, and the poloxamer is between 0.1 and 5g; and (3) slowly adding 5 to 30ml of oleum fructus bruceae into liquid prepared in step (2), adding water to make the total content be 100ml, adjusting the pressure of a high pressure homogenizer, adopting two-step emulsification method, and continuously circulating 3 to 6 times to prepare the emulsified medicinal composition containing the oleum fructus bruceae.The oleum fructus bruceae emulsion injection prepared by the method has good stability, no hemolysis in a period of validity, and safety, and is favorable for clinical promotion and application.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical composition containing javanica javanica oil and a javanica javanica oil emulsion injection. Background technique [0002] Brucea javanica is a commonly used traditional Chinese medicine, which is the seed of Brucea javanica, a plant of the bitter wood family. It has pharmacological effects such as anti-tumor, anti-digestive ulcer, and hypolipidemic. Commercially available Brucea javanica oil emulsions are mainly injections and oral liquids, and are mainly used clinically for the treatment of lung cancer, brain metastases of lung cancer, and gastrointestinal tumors. The early product preparation process was unreasonable, and there were many adverse reactions. Chinese patent: ZL03156023.7 discloses "a low-toxicity javanica javanica oil emulsion injection and its preparation method". This invention improves the production process of the emulsion, reduces the diameter of the emulsion, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/185A61K9/107A61K47/34A61P35/00A61P1/04A61P3/06A61K131/00A61K47/10A61K47/22A61K47/24
Inventor 朱德领李宏岳昌林于自勋
Owner ZHEJIANG JIUXU PHARMA
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