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A lyophilized powder injection of polyene phosphatidylcholine and preparation method thereof

A polyene phosphatidylcholine, freeze-dried powder injection technology, applied in freeze-dried delivery, powder delivery, digestive system and other directions, can solve the problems of product failure, prone to oxidative degradation, content drop, etc., and achieve good stability Effect

Inactive Publication Date: 2006-12-20
四川思达康药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since polyene phosphatidylcholine contains multiple unsaturated double bonds, it is very unstable in the solution state at room temperature, and is prone to oxidative degradation, resulting in a decrease in content
Therefore, the product requires a low-temperature environment during transportation, and its storage temperature should be controlled below 8°C, which will inevitably increase the difficulty and cost of transportation
At the same time, if the storage method is a little careless, it is easy to make the product invalid, seriously affect the curative effect of the product, and endanger the health of the drug patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0026] Preparation of Reference Substance Solution Take about 25 mg of 3-Sn-phosphatidylcholine reference substance, accurately weigh it, put it in a 25ml volumetric flask, add chloroform-methanol solution (2:1) to dissolve and dilute to the mark, shake well to obtain .

[0027] Preparation of the test solution Precisely measure 1ml of this product, put it in a 50m measuring bottle, add chloroform-methanol solution (2:1) to dissolve and dilute to the mark, shake well, and you get it.

[0028] Determination method Take the reference substance solution and the test solution respectively 10μl, inject the liquid chromatograph, record the chromatogram, calculate the peak area according to the external standard method, that is.

Embodiment 1

[0030] Polyene Phosphatidylcholine 93g

[0031] Sodium Glycocholate 180g

[0032] Mannitol 80g

[0033] Add water for injection to 1000ml

[0034] Preparation method: Take the prescribed amount of polyene phosphatidylcholine, sodium glycocholate, mannitol and appropriate amount of water for injection, stir evenly under the protection of nitrogen, and add water to 1000ml. Finely filter with a 0.22um microporous membrane, pack in vials, freeze-dry, and crimp the cap to pack.

[0035] In the preparation, the weight percentage of polyene phosphatidylcholine in the freeze-dried preparation is 25.3%-31.3% (moisture is removed by vacuum drying, and the water content of the final product is about 1%-5%).

Embodiment 2

[0037] Polyene Phosphatidylcholine 93g

[0038] Sodium deoxycholate 90g

[0039] Glucose 50g

[0040] Add water for injection to 1000ml

[0041] Preparation method: Take the prescribed amount of polyene phosphatidylcholine, sodium deoxycholate, glucose and an appropriate amount of water for injection, stir evenly under nitrogen protection, and add water to 1000ml. Finely filter with a 0.22um microporous membrane, pack in vials, freeze-dry, and crimp the cap to pack.

[0042] In the preparation, the weight percentage of the polyene phosphatidylcholine in the finished product of the freeze-dried preparation is 38.9-44.9% (the water content is about 1%-5%).

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PUM

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Abstract

The invention relates to a phosphatidyl choline freeze powder injection and relative preparation, wherein said formula is formed by phosphatidyl choline, solubilizer, support agent and other additive components; the phosphatidyl choline content is 10-60%; the solubilizer can colalin, glycocholic acid, cholaic acid, deoxycholic acid, anthrodsoxycholic acid, or taurodeoxycholic acid and relative salt, loxapine and tween; the support agent can be freeze protector. The invention has high stability, which can be stored for 1 year at normal temperature, without allergic and excitation.

Description

technical field [0001] The invention relates to a polyene phosphatidylcholine freeze-dried powder injection and a preparation method thereof. Background technique [0002] Polyene phosphatidylcholine is a liver cell membrane protective agent, which is used to treat various types of liver diseases, such as hepatitis, chronic hepatitis, liver necrosis, liver cirrhosis, hepatic coma, fatty liver, bile obstruction, recurrence of gallstones, etc. It can also be used in the treatment before and after hepatobiliary surgery. Its main component is a high-purity soybean oil phospholipid extracted from soybean lecithin, which is an "essential" phospholipid for the human body. Because it is rich in polyunsaturated fatty acid phosphatidylcholine, it is also called polyene phosphatidylcholine, and the polyunsaturated fatty acids are mainly linoleic acid (about 70%), linolenic acid and oleic acid. [0003] When the human body suffers from liver disease, the metabolic activity of the live...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/6615A61K9/19A61P1/16A61P31/14
Inventor 杨磊
Owner 四川思达康药业有限公司
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