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Preparation method of emulsion containing oleum fructus bruceae

A technology for guts and emulsions, applied in the field of medicine, can solve the problems of high proportion of large particles, high safety risks, inability to pass through sterilization-grade filters, etc., and achieve the effect of reducing the Ke value and improving the stability of the emulsion.

Active Publication Date: 2021-06-18
沈阳药大雷允上药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current production process has a high proportion of large particles in the Brucea javanica oil emulsion injection product, which cannot pass through a 0.22 μm sterilizing grade filter, which makes it impossible to achieve sterility of Brucea javanica oil emulsion injection by adding filter sterilization steps level, making Brucea javanica oil emulsion injection have a high safety risk in clinical use

Method used

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  • Preparation method of emulsion containing oleum fructus bruceae
  • Preparation method of emulsion containing oleum fructus bruceae
  • Preparation method of emulsion containing oleum fructus bruceae

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Preparation of Brucea javanica oil emulsion (sample 1)

[0100] (1) Add 150 g of emulsifier soybean lecithin into the emulsification shear tank, add 3000 g of water for injection at 50 ° C, and carry out a 40-minute circulation emulsification shear to the emulsifier and water for injection by the emulsification shear tank and pipeline shear Cut to mix well. Then add 600g of 80°C glycerol aqueous solution (wherein glycerol and water for injection are uniformly mixed in a mass ratio of 1:1), and continue to carry out circulation emulsification and shearing of the gained mixture by the emulsification shear tank and the pipeline shearer for 3 times, the first time 20 minutes, 20 minutes the second time, 10 minutes the third time.

[0101] (2) Heat 1000ml of javanica javanica oil to 80°C, slowly add it to the pipeline shearer, and mix it with the mixture described in step (1) in the pipeline shearer to obtain an oil-water mixture , the oil-water mixture material is made to...

Embodiment 2

[0107] Preparation of Brucea javanica oil emulsion (sample 2)

[0108] (1) Put a total of 250g of emulsifier (egg yolk lecithin and poloxamer in a mass ratio of 1:1) into the emulsification shear tank, add 3750g of water for injection at 90°C, and shear through the emulsification shear tank and pipeline The emulsifier and water for injection were subjected to an 80-minute cycle of emulsification shear to make them fully mixed. Add the homogeneous mixed solution (wherein, the mass ratio of propylene glycol, mannitol and water for injection of 375g 100 ℃ of propylene glycol, mannitol and water for injection is 2: 1: 1.5), continue to pass through the emulsification shearing tank and pipeline shearing device The resulting mixture was subjected to cyclic emulsification shearing 4 times, 10 minutes each time.

[0109] (2) Heat 3000ml of javanica javanica oil to 100°C, slowly add it to the pipeline shear, and mix it with the mixture in step (1) in the pipeline shear to obtain an oi...

Embodiment 3

[0115] Preparation of Brucea javanica oil emulsion (sample 3)

[0116] (1) Add 120 g of the emulsifier soybean lecithin into the emulsification shear tank, add 600 g of water for injection at 40 ° C, and carry out a 10-minute circulation emulsification of the emulsifier and water for injection through the emulsification shear tank and pipeline shear Cut to mix well. Then add 1750ml of 50°C water for injection, and continue to carry out circulation emulsification and shearing of the resulting mixture twice, each time for 60 minutes, through the emulsification shear tank and the pipeline shearer.

[0117] (2) Heat 500ml of javanica javanica oil to 50°C, slowly add it into the pipeline cutter, and mix it with the mixture described in step (1) in the pipeline cutter to obtain an oil-water mixture , the oil-water mixture material is made to flow in the emulsified and sheared circulation channel, and the emulsified and sheared circulation is carried out by the pipeline shearer and ...

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Abstract

The invention provides a preparation method of an emulsion containing oleum fructus bruceae. The preparation method of the emulsion containing the oleum fructus bruceae comprises the following steps: firstly, performing circular emulsifying and shearing on a water-phase material and an oil-phase material to form a primary emulsion; and then, performing circular homogenizing on the primary emulsion to obtain a uniform emulsion which can be filtered by a sterilization filter. More specifically, the step of performing circular emulsifying and shearing means to perform circular shearing on the materials in an emulsifying and shearing tank and a pipeline shearing device. The emulsion containing the oleum fructus bruceae prepared by the preparation method has obviously reduced particle size, so that the emulsion can be filtered through a sterilization-grade filter so as to meet sterile test requirement; and moreover, the emulsion also has greatly improved stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of an emulsion containing javanica javanica oil. Background technique [0002] Brucea javanica (L.) Merr, a traditional Chinese medicine, is the dried ripe fruit of Brucea javanica (L.) Merr. Harvest when the fruit is ripe in autumn, remove impurities and dry in the sun. Brucea javanica was first recorded in "Supplements to Compendium of Materia Medica" written by Zhao Xuemin in the Qing Dynasty. The efficacy recorded in "Pharmacopoeia of the People's Republic of China" is clearing away heat and detoxification, cutting off malaria, stopping dysentery, and corroding warts. For dysentery, malaria, external treatment of warts, corns. [0003] The organic component of Brucea javanica contains water-soluble component and oil-soluble component, and its toxic component exists in the water-soluble bitter component; while the oil-soluble component, ie Brucea javan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/24A61K47/26A61K36/185A61P35/00
CPCA61K9/107A61K47/24A61K47/26A61K36/185A61P35/00Y02A50/30
Inventor 张宇周浩罗岩姚立龙高玥媛刘晓庆杨颖李薇薛春梅
Owner 沈阳药大雷允上药业有限责任公司
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