Emulsified pharmaceutical composition containing oleum fructus bruceae and processes for producing same

A technology of javanica javanica oil emulsion and javanica javanica oil, applied in the direction of drug combination, medical preparations containing active ingredients, pharmaceutical formulas, etc., to achieve the effect of improving product quality and good physical stability

Inactive Publication Date: 2008-02-27
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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  • Emulsified pharmaceutical composition containing oleum fructus bruceae and processes for producing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The emulsified pharmaceutical composition containing brucea javanica oil is prepared by the following method: take 5ml brucea javanica oil, 10g egg yolk lecithin, 1ml glycerin, add water to 100ml, homogenize and emulsify until the diameter of the milk particles is ≤15um, and then make one An emulsified pharmaceutical composition containing Brucea javanica oil.

[0044] The brucea javanica oil used in each embodiment of the present invention can be brucea javanica oil obtained from commercial sources, or it can be obtained by conventional methods and equipment for extracting brucea javanica oil known in the art, for example, taking brucea javanica and pressing, Take the squeezed oil, let it stand, and filter; or take the Brucea javanica, crush it, add filter extracts, filter and extract, combine the filtrate extracts, and recover the solvent. The total acid content of the brucea javanica oil is calculated based on oleic acid, not less than 85 %

[0045] The egg yolk lecithin u...

Embodiment 2

[0047] The emulsified pharmaceutical composition containing brucea javanica oil is prepared by the following method: take 30ml brucea javanica oil, 1885g poloxamer, 10ml glycerin, add water to 100ml, homogenize and emulsify until the diameter of the milk particles is less than 15um, and it is prepared. An emulsified pharmaceutical composition containing Brucea javanica oil. Poloxamer's chemical name is: polyoxyethylene-polyoxypropylene copolymer. Poloxamer 188 is a polyoxyethylene-polyoxypropylene copolymer with a molecular weight in the range of 7680-9510.

Embodiment 3

[0049] The emulsified pharmaceutical composition containing brucea javanica oil is prepared by the following method: take 8ml brucea javanica oil, 1.8g egg yolk lecithin E-80, 2ml glycerin, add water to 100ml, homogenize and emulsify until the diameter of the milk particles is ≤15um, That is, an emulsified pharmaceutical composition containing Brucea javanica oil is prepared.

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Abstract

The invention discloses an emulsifying drug composition with oleum fructus bruceae and making method, which comprises the following parts: at least one of among oleum fructus bruceae, yolk lecithine and mooring luoshamu, glycerol with added water to 100ml to be homogeneous emulsification with grain diameter<=15um. The making method comprises the following steps: (1) adding at least one of yolk lecithine and mooring luoshamu into oleum fructus bruceae to shear-mix uniformly; (2) mixing glycerol and water; (3) adding liquid in step (1) into liquid in step (2) slowly at stirring state to add water of 100ml total amount and adjusting pressure of high-pressure homogeneity machine to adopt method of two-step emulsification to cycle 3-6 times continuously to form product. The invention discloses an injection of oleum fructus bruceae with good stability and without hemolysis in security, which facilitates spreading application of clinic.

Description

Technical field [0001] The invention relates to a pharmaceutical composition containing brucea javanica oil, a preparation method and a brucea javanica oil emulsion injection. Background technique [0002] Brucea javanica is a commonly used traditional Chinese medicine, which is the seed of the plant Brucea javanica, which has anti-tumor, anti-peptic ulcer, blood-lowering effects and other pharmacological effects. The commercially available brucea javanica oil emulsions are mainly injections and oral liquids, and are mainly used clinically to treat lung cancer, lung cancer brain metastases, gastrointestinal tumors, etc. The early product preparation process was unreasonable, and there were many adverse reactions. Chinese Patent: ZL03156023.7 discloses "a low-toxic Brucea javanica oil emulsion injection and its preparation method". This invention improves the production process of the emulsion and reduces the diameter of the milk particles. The finished milk particles are uniform,...

Claims

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Application Information

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