Butylphthalide fat emulsion injection and preparation process thereof

A technology of butylphthalide fat and emulsion injection, which is applied in the directions of emulsion delivery, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of butylphthalide being insoluble in water, etc. Simple and easy to implement, improve stability, reduce the effect of toxic and side effects

Inactive Publication Date: 2016-07-27
NANJING TIANXIANG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to further improve the clinical applicability of butylphthalide, the object of the present invention is to effectively solve the problem of butylphthalide insoluble in water by screening a large number of emulsifiers, and then provide a kind of emulsifier with high safety and good stability. Butylphthalide fat emulsion injection and preparation process thereof

Method used

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  • Butylphthalide fat emulsion injection and preparation process thereof
  • Butylphthalide fat emulsion injection and preparation process thereof
  • Butylphthalide fat emulsion injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] prescription:

[0038]

[0039] Preparation Process:

[0040] Dissolve refined butylphthalide in soybean oil and mix evenly to obtain an oil phase; dissolve glycerin for injection in 500ml water for injection and mix uniformly to obtain an aqueous phase; add lecithin and poloxamer to water phase, put it in a tissue masher, stir at high speed to a homogeneous liquid, then add the oil phase, stir at high speed to obtain colostrum.

[0041] Mix the colostrum twice under the pressure of 80Mpa through a high-pressure homogenizer, add water for injection to 1000ml, and mix once under the pressure of 70Mpa to obtain an emulsion, filter it through a 0.45μm microporous membrane, and fill it into a 100ml glass bottle In the process, sterilize at 121°C for 15 minutes, and after passing the inspection, the Butylphthalide Fat Emulsion Injection is obtained.

Embodiment 2

[0043] prescription:

[0044]

[0045] Preparation Process:

[0046] Extract refined butylphthalide, dissolve in rapeseed oil, and mix uniformly to obtain an oil phase; dissolve glycerin for injection in 500ml water for injection, and mix uniformly to obtain an aqueous phase; separately take lecithin and poloxamer Add it to the water phase, put it in a tissue grinder, stir at high speed until it becomes a homogeneous liquid, then add the oil phase, stir at high speed to obtain colostrum.

[0047] Mix the colostrum twice under the pressure of 80Mpa through a high-pressure homogenizer, add water for injection to 1000ml, and mix once under the pressure of 70Mpa to obtain an emulsion, filter it through a 0.45μm microporous membrane, and fill it into a 100ml glass bottle In the process, sterilize at 121°C for 15 minutes, and after passing the inspection, the Butylphthalide Fat Emulsion Injection is obtained.

Embodiment 3

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] Extract refined butylphthalide, dissolve it in cottonseed oil for injection, and mix evenly to obtain an oil phase; dissolve sodium chloride in 500ml water for injection, mix evenly, to obtain an aqueous phase; separately take lecithin and poloxa Add the milk to the water phase, put it in a tissue masher, stir at high speed to a homogeneous liquid, then add the oil phase, stir at high speed to obtain colostrum.

[0053] Mix the colostrum twice under the pressure of 80Mpa through a high-pressure homogenizer, add water for injection to 1000ml, and mix once under the pressure of 70Mpa to obtain an emulsion, filter through a 0.45μm microporous membrane, and fill it into a 10ml ampoule medium, 121 ° C high temperature sterilization for 15 minutes, after passing the inspection, the butylphthalide fat emulsion injection (small needle) is obtained.

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Abstract

The invention discloses a butylphthalide fat emulsion injection and a preparation process thereof.The butylphthalide fat emulsion injection is prepared from 0.1-1.0% of refined butylphthalide, 10.0-20.0% of oil for injection, 1.0-5.0% of a compound emulsifier, 0.5-2.5% of an isotonic regulator and the balance water for injection, wherein the grain size of an obtained milk white emulsion solution ranges from 0.1 micrometer to 1.0 micrometer.Butylphthalide is dissolved in an oil phase, a better solubilization effect can be achieved after the oil phase and a water phase are fully emulsified under the action of the compound emulsifier at a specific proportion, the divided dose is accurate, and no solubilizer or cosolvent needs to be added; meanwhile, stability is improved, and the toxic and side effects of the butylphthalide fat emulsion injection are reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to a butylphthalide fat emulsion injection and a preparation process thereof. The active ingredient butylphthalide refers to butylphthalide, L-butylphthalide or D-butylphthalide . Background technique [0002] Butylphthalide is a water-insoluble oily substance with the following structure: [0003] [0004] Since it contains a chiral carbon atom, it has two optical isomers, namely L-butylphthalide and D-butylphthalide. Butylphthalide (NBP for short, also known as apigenin A), can be directly extracted from natural plant celery seed oil, and can also be obtained through synthesis. [0005] In recent years, studies on butylphthalide have shown that compared with the control group in phase II and III clinical trials, the total effective rate of this active ingredient in the treatment of acute ischemic stroke can reach 73.2%, which is safe ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/107A61K31/365A61K47/24A61K47/34A61P9/10
CPCA61K9/0019A61K9/08A61K9/107A61K31/365A61K47/10A61K47/24
Inventor 张爱琴胡长花莫奇萍潘娜娜李正海
Owner NANJING TIANXIANG PHARMA TECH
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