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Polyenic phosphatide acylcholine freeze-dried powder injecta medicine

A technology of polyene phosphatidylcholine and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, drug combination, powder delivery, etc., which can solve the problems of increased transportation difficulty and transportation costs, decreased content of the main drug, and allergic reactions in patients

Active Publication Date: 2006-03-08
SICHUAN KELUN PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The obvious defects of this injection product are that the main drug in the aqueous solution is unstable, easily degraded during storage, and has a short validity period. It needs to be stored below 8°C, so it must be protected by ice packs during transportation, which increases the difficulty of transportation and transportation. The cost also increases the economic burden of the patient, and will inevitably cause the decline of the content of the main drug, which will affect the curative effect of the product; the second is that benzyl alcohol needs to be added as a preservative in the aqueous solution of its water injection preparation, so the In addition to not being used for neonates and premature infants, the product can also cause allergic reactions in patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Composition: Polyene Phosphatidylcholine 5.0g

[0020] Sodium Glycocholate 9g

[0021] Mannitol 4g

[0022] Add water for injection to 100ml

[0023] Preparation method: Add 5.0 g of polyene phosphatidylcholine and 9 g of sodium glycocholate in the prescribed amount into an appropriate amount of water for injection at 60°C under nitrogen gas, stir to obtain a clear liquid, then add mannitol to dissolve, Adjust the pH to 6.5-8.0 with NaoH, and add water to 100ml. The solution was filtered with a 0.2 μm microporous membrane, distributed into vials, cooled to -35°C to -40°C in a freeze dryer, then heated to -20°C to -5°C, vacuum (0.1-0.5 kPa) dry. Raise the temperature at 5°C / hour to 30°C for an hour, stopper, crimp and pack.

Embodiment 2

[0025] Composition: Polyene Phosphatidylcholine 4.65g

[0026] Sodium deoxycholate 10g

[0027] Vitamin E 0.05g

[0028] Sucrose 5g

[0029] Preparation method: Add 4.65g of polyene phosphatidylcholine, 10g of sodium deoxycholate, and 0.05g of vitamin E into an appropriate amount of water for injection at 60°C under the condition of nitrogen gas, stir to obtain a clear liquid, and then add sucrose After the alcohol is dissolved, adjust the pH to 6.5-8.0 with NaoH, and add water to 100ml. The solution was filtered with a 0.2 μm microporous membrane, distributed into vials, cooled to -35°C to -40°C in a freeze dryer, then heated to -20°C to -5°C, vacuum (0.1-0.5 kPa) dry. Raise the temperature at 5°C / hour to 30°C for an hour, stopper, crimp and pack.

Embodiment 3

[0031] Composition: Polyene Phosphatidylcholine 4.65g

[0032] Poloxamer 2g

[0033] Vitamin E 0.05g

[0034] Sucrose 5g

[0035] Add water for injection to 100ml

[0036] Preparation method: Add 4.65g of polyene phosphatidylcholine, 2g of poloxamer, and 0.05g of vitamin H into an appropriate amount of water for injection at 60°C under the condition of nitrogen gas, stir to obtain a clear liquid, and then add sucrose After dissolving, adjust the pH to 6.5-8.0 with NaoH, and add water to 100ml. The solution was filtered with a 0.2 μm microporous membrane, distributed into vials, cooled to -35°C to -40°C in a freeze dryer, then heated to -20°C to -5°C, vacuum (0.1-0.5 kPa) dry. Raise the temperature at 5°C / hour to 30°C for an hour, stopper, crimp and pack.

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Abstract

The present invention relates to a polyene phosphatidylcholine freeze-dried powder injection. It is formed from polyene phosphatidylcholine as effective medicinal component and auxiliary component including necessary solubiliser and freeze-drying protective agent. Its weight composition includes 0.1-1.5 portions of polyene phosphatidylcholine, the weight ratio of solubilizer and polyene phosphatidylcholine is 0.1-2.5:1 and the weight ratio of freeze-drying protective agent and polyene phosphatidylcholine is 0.1-10:1. According to the requirement the pharmaceutically-acceptable vitamin as other auxiliary component also can be added.

Description

technical field [0001] The invention relates to a polyene phosphatidylcholine freeze-dried powder injection medicine which can be used as a liver cell membrane protective agent. Background technique [0002] Polyene phosphatidylcholine, as a liver cell membrane protective component, has been used in the treatment of various types of acute and chronic liver diseases, and is currently the most effective hepatoprotective drug. In liver diseases, irrespective of the etiology, damage to hepatic parenchymal cells and organelles, accompanied by loss of phospholipids, inevitably occurs. Polyene phosphatidylcholine can supplement human exogenous phospholipids and bind to the cell membrane or organelle membrane, which plays a very important role in the regeneration and reconstruction of liver cells, and can significantly improve the transmembrane process of nutrients and electrolytes, Increase the activity of phospholipid-dependent enzymes to repair the damaged membrane structure. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/6615A61K9/19A61P1/16
Inventor 郁东梅欧苏梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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