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Ornithine aspartate liposome injection

A technology of ornithine-aspartate and ornithine-aspartate, which is applied in the field of ornithine-aspartate liposome injection and liposome injection, can solve the problem that the quality cannot reach the expiration date Requirements, ornithine aspartic acid solution is easy to deteriorate, product quality is unstable, etc., to achieve the effect of improving bioavailability, ensuring product quality, and low cost

Inactive Publication Date: 2011-02-02
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, ornithine aspartic acid injection and freeze-dried powder injection are on the market, but the quality of the product is very unstable and cannot meet the quality requirements of the expiration date
Chinese patent CN1679610A discloses a preparation method of a compound aspartic acid ornithine pharmaceutical composition. It does not adopt a special method for protection, but a commonly used production process. The prepared preparation has poor stability and deteriorates after long-term storage. affecting the quality of medicines
[0005] Aiming at the problem that the current aspartic acid ornithine solution is easy to deteriorate and has poor stability after long-term storage, the inventors have found through long-term and serious research that the aspartic acid ornithine is encapsulated with liposomes by the pH value gradient method, Solve the above-mentioned existing problems, obtain the very good injection of stability, thus complete the present invention

Method used

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  • Ornithine aspartate liposome injection
  • Ornithine aspartate liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Preparation of ornithine-aspartate liposome injection

[0027] Prescription (100 bottles):

[0028] Component Content

[0029] Ornithine Aspartate 50g

[0030] Dipalmitoylphosphatidylglycerol 150g

[0031] Cholesterol 90g

[0032] tert-Butyl-p-Hydroxyanisole 2.5g

[0033] Glycerin 80g

[0034] Preparation Process:

[0035] (1) Dissolve 150g of dipalmitoylphosphatidylglycerol, 90g of cholesterol and 2.5g of tert-butyl p-hydroxyanisole in 1300ml of a mixed solvent of ether and n-hexane with a volume ratio of 4:1, and slowly inject 0.01mol / L under stirring 1300ml of ammonium sulfate solution, heated and stirred to distill off the mixed solvent, put it in an ice bath and ultrasonically for 10min, to obtain blank liposomes;

[0036] (2) Blank liposome is placed in the dialysis bag, seals, and the dialysis bag is placed in the solution 2000ml that contains 80g glycerol and dialyzes for 20 hours, removes the ammonium sulfate in the liposome external phase;

...

Embodiment 2

[0038] The preparation of embodiment 2 aspartic acid ornithine liposome injection

[0039] Prescription (100 bottles):

[0040] Component Dosage

[0041] Ornithine Aspartate 100g

[0042] Dipalmitoylphosphatidylglycerol 500g

[0043] Cholesterol 240g

[0044] Sodium formaldehyde bisulfite 8g

[0045] Sorbitol 350g

[0046] Preparation Process:

[0047](1) Dissolve 500g of dipalmitoylphosphatidylglycerol, 240g of cholesterol and 8g of sodium formaldehyde bisulfite in 5000ml of tert-butanol and acetone mixed solvent with a volume ratio of 2:1, slowly inject 0.2mol / L ammonium sulfate under stirring Solution 2500ml, heated and stirred to evaporate the mixed solvent, placed in an ice bath and ultrasonicated for 5 minutes to obtain blank liposomes;

[0048] (2) Blank liposome is placed in the dialysis bag, seals, and the dialysis bag is placed and contains 350g sorbitol solution 3000ml and dialyzes 22 hours, removes the ammonium sulfate in the liposome external phase;

[004...

Embodiment 3

[0050] Example 3 Preparation of ornithine-aspartate liposome injection

[0051] Prescription (100 bottles):

[0052] Component Dosage

[0053] Ornithine Aspartate 50g

[0054] Dipalmitoylphosphatidylglycerol 650g

[0055] Cholesterol 300g

[0056] Ascorbyl Palmitate 5g

[0057] Sodium chloride 540g

[0058] Preparation Process:

[0059] (1) Dissolve 650g dipalmitoylphosphatidylglycerol, 300g cholesterol and 5g ascorbyl palmitate in 7000ml of chloroform and n-butanol mixed solvent with a volume ratio of 1:2, slowly inject 5000ml of 0.1mol / L ammonium sulfate solution under stirring , heated and stirred to distill off the mixed solvent, placed in an ice bath and sonicated for 10 minutes to obtain blank liposomes;

[0060] (2) blank liposome is placed in the dialysis bag, seals, and the dialysis bag is placed in containing 540g sodium chloride solution 6000ml and dialyzes 18 hours, removes the ammonium sulfate in the liposome external phase;

[0061] (3) Insulate the dialy...

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Abstract

The invention discloses an ornithine aspartate liposome injection. The injection mainly comprises the following active ingredients: ornithine aspartate, dipalmitoyl phosphatidyl glycerol, cholesterol and antioxidant in part by weight of 1:3-20:1.8-12:0.05-0.2. The stability of the ornithine aspartate is improved; the valid period is prolonged; and the quality of the product is guaranteed. Because the liposome carriers, namely the dipalmitoyl phosphatidyl glycerol and the cholesterol, are degradable in bodies, the bioavailability is improved and the toxic and side effects are reduced. The injection has the advantages of simple production process, easy operation, low cost, high yield and suitability for mass production.

Description

technical field [0001] The invention relates to a liposome injection, in particular to an aspartate ornithine liposome injection, and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ornithine aspartate is an essential substance for the synthesis of urea and glutamine. Glutamine is the detoxification product of ammonia, and it is also the storage and transportation form of ammonia; under physiological and pathological conditions, the synthesis of urea and the synthesis of glutamine will be affected by ornithine, aspartic acid and other dicarboxylic compounds. influences. Ornithine is almost involved in the activation of urea cycle and the whole process of ammonia detoxification. In the process, arginine is formed, which in turn splits off urea to form ornithine. Aspartic acid participates in the synthesis of nucleic acid in liver cells to facilitate the repair of damaged liver cells. In addition, due to the indirec...

Claims

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Application Information

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IPC IPC(8): A61P1/16A61P25/28A61K47/24A61P3/00A61K31/205A61K9/127A61K47/28
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA
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