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Preparation method of oral high-density lipoprotein liposome

A high-density lipoprotein, liposome technology, used in liposome delivery, peptide/protein components, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2014-06-18
国药集团贵州血液制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, high-density lipoprotein is mainly used as a physiological indicator in clinical practice, and there are few researches on separation technology and products of high-density lipoprotein

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] [Embodiment 1] Preparation of oral high-density lipoprotein liposomes by injection method.

[0034] (1) Prepare ethanol solution.

[0035] (1.1) Weigh 15ml of vitamin E, 5g of cholesterol, and 25g of phospholipids in the same container according to the prescribed amount.

[0036] (1.2) Measure 60ml of 95% ethanol or absolute ethanol of the prescription amount, and pour it into the container of 2.1.

[0037] (1.3) Under the condition of 20~80℃ water bath, stir the mixture in the container to dissolve into a transparent and uniform solution.

[0038] (1.4) Use a 0.22 micron sterile filter membrane or filter to filter the solution of 1.3, and carry out the bacterial count culture of the filtrate, which should be less than 10CFU / 10ml, and the filtrate should be used within 8 hours if it is sealed for use.

[0039] (2) Prepare buffer.

[0040] (2.1) Weigh 8 g of disodium hydrogen phosphate, 1.2 g of sodium dihydrogen phosphate, 30 g of sorbitol, 20 g of β-cyclodextrin, and 14 g of lacto...

Embodiment 2

[0050] [Embodiment 2] Oral HDL liposomes were prepared by homogenization method.

[0051] (1) Prepare ethanol solution.

[0052] (1.1) Weigh 18ml of vitamin E, 7g of cholesterol, and 35g of phospholipids in the same container according to the prescribed amount.

[0053] (1.2) Measure 70ml of 95% ethanol or absolute ethanol of the prescribed amount and pour it into the container of 2.1.

[0054] (1.3) Under the condition of 20~80℃ water bath, stir the mixture in the container to dissolve into a transparent and uniform solution.

[0055] (1.4) Use a 0.22 micron sterile filter membrane or filter to filter the solution of 1.3, and carry out the bacterial count culture of the filtrate, which should be less than 10CFU / 10ml, and the filtrate should be used within 8 hours if it is sealed for use.

[0056] (2) Prepare buffer.

[0057] (2.1) Weigh 9 g of disodium hydrogen phosphate, 1.2 g of sodium dihydrogen phosphate, 36 g of sorbitol, 27 g of β-cyclodextrin, and 18 g of lactose in the same conta...

Embodiment 3

[0067] [Example 3] Preparation of oral high-density lipoprotein liposomes by film dispersion method.

[0068] (1) Prepare ethanol solution.

[0069] (1.1) According to the prescription, weigh 25ml of vitamin E, 5g of cholesterol, and 35g of phospholipids in the same container.

[0070] (1.2) Measure 70ml of 95% ethanol or absolute ethanol of the prescribed amount and pour it into the container of 2.1.

[0071] (1.3) Under the condition of 20~80℃ water bath, stir the mixture in the container to dissolve into a transparent and uniform solution.

[0072] (1.4) Use a 0.22 micron sterile filter membrane or filter to filter the solution of 1.3, and carry out the bacterial count culture of the filtrate, which should be less than 10CFU / 10ml, and the filtrate should be used within 8 hours if it is sealed for use.

[0073] (2) Prepare buffer.

[0074] (2.1) Weigh 18 g of disodium hydrogen phosphate, 1.2 g of sodium dihydrogen phosphate, 38 g of sorbitol, 20 g of β-cyclodextrin, and 19 g of lactose ...

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Abstract

The invention provides a preparation method of oral high-density lipoprotein liposome. The oral high-density lipoprotein is prepared from the components (calculated according to 1000ml) of: 20-400 ml of high-density lipoprotein solution, 20-150g of sorbitol, 2-50g of beta-cyclodextrin, 2-50g of PEG (Polyethylene Glycol) (2000-8000), 2-15g of disodium hydrogen phosphate (12 H2O), 0.2-2g of disodium hydrogen phosphate (2 H2O), 2-60g of polyvinyl alcohol, 15-90g of soybean phospholipid, 2-20g of vitamin E, 0.5-20g of cholesterol and suitable amount of ethyl alcohol. The prepared oral high-density lipoprotein liposome has the characteristics that the oral high-density lipoprotein liposome can tolerate the conventional moist heat sterilization, can also keep the stability for more than 2-5 hours in the strong acid environment with a pH value smaller than 2 and is also insensitive to the attenuation treatment, and the stability of the oral high-density lipoprotein liposome is greatly improved compared with that of the conventional liposome.

Description

technical field [0001] The invention belongs to pharmaceutical preparations for the cardiovascular system, and provides a preparation method for oral high-density lipoprotein oral liquid. Background technique [0002] High-density lipoprotein (high density lipoprotein, HDL) has anti-atherosclerotic effect, and plasma high-density lipoprotein and cholesterol concentrations are risk factors for coronary heart disease. Therefore, the research on HDL has increasingly become a hot spot that people pay attention to. [0003] HDL is one of the serum proteins. Also known as a1 lipoprotein. Relatively rich in phospholipids, the content in serum is about 300mg / dl. The protein part, A-I is about 75%, and A-II is about 20%. Since it can export cholesterol and promote the metabolism of cholesterol, it is now being valued as an arteriosclerosis preventive factor. High-density lipoprotein carries cholesterol in the surrounding tissue, and then converted into bile acid or directly excr...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K38/17A61K47/40A61P9/10
Inventor 孔维权张庭喜王连群石正国朱瑞芳张帆侯彩霞吕绍玉
Owner 国药集团贵州血液制品有限公司
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