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Long-circulating ligustrazine composite injection and preparation method thereof

A technology of ligustrazine and composition, applied in the field of composition injection and preparation thereof, can solve the problems of ligustrazine drug treatment effect that is not very satisfactory to patients, low bioavailability, frequent administration and the like, so as to prolong the action time of the drug , Increase targeting function, reduce lipid deposition effect

Active Publication Date: 2010-07-28
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent CN 1430963A, in order to solve the shortcomings of Ligustrazine common preparations such as rapid excretion, frequent administration, and obvious peak-valley phenomenon, prepared a Ligustrazine Phosphate Sustained-release Tablet to prolong the action time, reduce the frequency of administration, and improve patient compliance. However, the sustained-release tablet is still an oral preparation, with slow onset, low bioavailability, and unavoidable impact on the stomach
[0005] Through clinical experiments, the therapeutic effect of the Ligustrazine drug prepared by the prior art is not very satisfactory to the patients, so after a long period of research, we have invented a Ligustrazine preparation with a good therapeutic effect and solved the problems existing in the prior art

Method used

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  • Long-circulating ligustrazine composite injection and preparation method thereof
  • Long-circulating ligustrazine composite injection and preparation method thereof
  • Long-circulating ligustrazine composite injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: 0.1% long-circulation ligustrazine composition injection preparation

[0038] prescription:

[0039]

[0040] method:

[0041] Take 10g of linseed oil, add 0.5g egg yolk lecithin, 0.1g polyethylene glycol-phospholipid (PEG 2000 -DSPE), under the protection of nitrogen, heat to 75°C, stir for about 10min to fully dissolve the added lipid compounds, then add 0.1g ligustrazine, 1g vitamin E and 0.03g selenium, dissolve and mix. Take another 80ml of water for injection, add 1g of glycerol, 0.5g of fructose, and 0.01g of EDTA. Under the protection of nitrogen, the oil solution containing ligustrazine is added to the glycerin aqueous solution under shearing and stirring conditions to prepare colostrum, and the total amount is adjusted to 100ml. The high-pressure homogenizer homogenizes 5-8 times, the homogenization pressure is about 100MPa, to the particle size range of 150nm-200nm, adjusts the pH 7.0-8.0, filters, divides, and seals. Rotate sterilize at 115°C for 30mi...

Embodiment 2

[0042] Example 2: 4% long-circulation ligustrazine composition injection preparation

[0043] prescription:

[0044]

[0045] method:

[0046] Take 10g of linseed oil, add 0.5g egg yolk lecithin, 0.1g polyethylene glycol-phospholipid (PEG 2000 -DSPE), under the protection of nitrogen, heat to 75°C, stir for about 10min to fully dissolve the added lipid compounds, then add 4g ligustrazine, 1g vitamin E and 0.03g selenium, dissolve and mix. Take another 80ml of water for injection, add 1g of glycerol, 0.5g of fructose, and 0.01g of EDTA. Under the protection of nitrogen, the oil solution containing ligustrazine is added to the glycerin aqueous solution under shearing and stirring conditions to prepare colostrum, and the total amount is adjusted to 100ml. The high-pressure homogenizer homogenizes 5-8 times, the homogenization pressure is about 100MPa, to the particle size range of 150nm-200nm, adjusts the pH 7.0-8.0, filters, divides, and seals. Rotate sterilize at 115°C for 30min. A...

Embodiment 3

[0047] Example 3: 0.1% long-circulating fat-soluble ligustrazine derivative composition injection preparation

[0048] prescription:

[0049]

[0050]

[0051] method:

[0052] Take 10g of linseed oil, add 0.5g egg yolk lecithin, 0.1g polyethylene glycol-phospholipid (PEG 2000 -DSPE), under the protection of nitrogen, heat to 75℃, stir for about 10min to fully dissolve the added lipid compounds, then add 0.1g of fat-soluble ligustrazine derivatives, 1g of vitamin E and 0.03g of selenium to dissolve Mix well. Take another 80ml of water for injection, add 1g of glycerol, 0.5g of fructose, and 0.01g of EDTA. Under the protection of nitrogen, the oil solution containing ligustrazine is added to the glycerin aqueous solution under shearing and stirring conditions to prepare colostrum, and the total amount is adjusted to 100ml. The high-pressure homogenizer homogenizes 5-8 times, the homogenization pressure is about 100MPa, to the particle size range of 150nm-200nm, adjusts the pH 7.0-8...

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Abstract

The invention relates to a long-circulating ligustrazine composite injection and a preparation method thereof, wherein the preparation contains the following ingredients: ligustrazine compounds, polyunsaturated acid-enriched oil for injection, emulsifier of natural product, polyglycol derivative, vitamin E, micro element selenium, glycerol, fructose, complexing agent EDTA, a proper amount of pH value regulator and water for injection as the rest. The preparation according to the invention enhances the effect of ligustrazine compounds in preventing and treating cardiovascular diseases.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to a composition injection with ligustrazine as the main active ingredient of the medicine and a preparation method thereof. technical background [0002] Ligustrazine is the effective ingredient of the traditional Chinese medicine Ligusticum chuanxiong, which is an alkaloid. Pharmacological studies and clinical observations have shown that the drug has anti-platelet aggregation effects, and has the effects of expanding blood vessels, increasing coronary blood flow, improving microcirculation and increasing cerebral blood flow. In addition, it has the effect of protecting vascular endothelial cells. It is clinically suitable for the treatment of coronary atherosclerotic diseases and ischemic cardiovascular and cerebrovascular diseases, such as coronary heart disease, angina, cerebral insufficiency, cerebral thrombosis, and cerebral embolism. However, the pharmacokinetic studies of ligu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/04A61K36/064A61K38/00A61K9/10A61K31/4965A61K47/34A61K47/44A61P9/10A61P7/02A61K31/355A61K47/24
Inventor 王汝涛陈涛胡惠静
Owner XIAN LIBANG PHARMA
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