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High safety polyene phosphatidyl choline for injection and preparation method thereof

A technology of polyene phosphatidylcholine and phosphatidylcholine, which is applied in the field of polyene phosphatidylcholine for injection with high safety and its preparation, can solve problems such as difficulties in the freeze-drying process, achieve improved safety, reduce dosage, Guaranteed effect of resolubility

Inactive Publication Date: 2011-01-12
北京中海康医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Too little amount of solubilizer will affect the reconstitution of freeze-dried products, but deoxycholic acid (or cholic acid) salts are hemolytic, too much solubilizer will cause irritation and other adverse reactions, and with the increase of solubilizer The increase in dosage brings difficulties to the freeze-drying process

Method used

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  • High safety polyene phosphatidyl choline for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] prescription:

[0022] Polyene Phosphatidylcholine 250g

[0023] Vitamin B 6 2.5g

[0024] Vitamin B 12 0.01g

[0025] Niacinamide 25g

[0026] Sodium pantothenate 1.5g

[0027] Deoxycholic acid 100g

[0028] Mannitol 150g

[0029] Appropriate amount of pH adjuster

[0030] Appropriate amount of water for injection

[0031]

[0032] Made 1000 pieces

[0033] crafting process:

[0034] (1) Solution preparation: take an appropriate amount of water for injection, add the prescribed amount of polyene phosphatidylcholine, vitamin B 6 , Vitamin B 12 , niacinamide, sodium pantothenate, deoxycholic acid, mannitol, stir well, and adjust the pH value to 7.5-9.5 with sodium hydroxide or hydrochloric acid solution;

[0035] (2) Sterilization and depyrogenation: Add 0.05-0.3% of the above volume of activated carbon, stir for 15-30 minutes, filter to remove carbon, add water for injection to a sufficient amount,...

Embodiment 2

[0040] prescription:

[0041] Polyene Phosphatidylcholine 250g

[0042] Vitamin B 6 2.5g

[0043] Vitamin B 12 0.01g

[0044] Niacinamide 25g

[0045] Sodium pantothenate 1.5g

[0046] Deoxycholic acid 150g

[0047] Sucrose 250g

[0048] Appropriate amount of pH adjuster

[0049] Appropriate amount of water for injection

[0050]

[0051] Made 1000 pieces

[0052] crafting process:

[0053] (1) Solution preparation: take an appropriate amount of water for injection, add the prescribed amount of polyene phosphatidylcholine, vitamin B 6 , Vitamin B 12 , niacinamide, sodium pantothenate, deoxycholic acid, sucrose, stir well, and adjust the pH value to 7.5-9.5 with sodium hydroxide or hydrochloric acid solution;

[0054] (2) Sterilization and depyrogenation: Add 0.05-0.3% of the above volume of activated carbon, stir for 15-30 minutes, filter to remove carbon, add water for injection to a suffi...

Embodiment 3

[0059] prescription:

[0060] Polyene Phosphatidylcholine 250g

[0061] Vitamin B 6 2.5g

[0062] Vitamin B 12 0.01g

[0063] Niacinamide 25g

[0064] Sodium pantothenate 1.5g

[0065] Deoxycholic acid 125g

[0066] Lactose 125g

[0067] Appropriate amount of pH adjuster

[0068] Appropriate amount of water for injection

[0069]

[0070] Made 1000 pieces

[0071] crafting process:

[0072] (1) Solution preparation: take an appropriate amount of water for injection, add the prescribed amount of polyene phosphatidylcholine, vitamin B 6 , Vitamin B 12 , niacinamide, sodium pantothenate, deoxycholic acid, lactose, stir well, and adjust the pH value to 7.5-9.5 with sodium hydroxide or hydrochloric acid solution;

[0073] (2) Sterilization and depyrogenation: Add 0.05-0.3% of the above volume of activated carbon, stir for 15-30 minutes, filter to remove carbon, add water for injection to a sufficient amo...

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Abstract

The invention provides high safety polyene phosphatidyl choline for injection and a preparation method thereof. Each injection contains the polyene phosphatidyl choline, vitamin B6, vitamin B12, nicotinamide, sodium pantothenate, a solubilizer and cryoprotectant. The injection is characterized in that the weight ratio of the solubilizer to the polyene phosphatidyl choline is 0.4-0.6:1, and is 0.5:1 preferably. The dosage of the solubilizer is reduced, the potential safety problem is reduced, the problem of re-dissolution is solved by optimizing the formula and the process, and the excellent re-dissolution is maintained on the premise of reducing the dosage of the solubilizer.

Description

technical field [0001] The invention relates to a polyene phosphatidylcholine for injection with high safety and a preparation method thereof. Background technique [0002] Polyene Phosphatidylcholine (Polyene Phosphatidylcholine) is an essential phospholipid that cannot be synthesized in the human body. It contains a large amount of unsaturated fatty acids (mainly linoleic acid, linolenic acid and oleic acid, etc.), which have a good protective effect on the liver and It can repair and regenerate damaged liver cells, and is a liver cell membrane protective agent. When suffering from liver disease, the metabolic activity of the liver is severely impaired. Polyene phosphatidylcholine injection can provide high doses of high-energy polyene phosphatidylcholines that are easily absorbed and utilized. These polyene phosphatidylcholines are chemically consistent with important endogenous phospholipids and are superior in function to the latter. They mainly enter into liver cell...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K31/685A61K31/455A61K31/4415A61K31/197A61K9/19A61P1/16
Inventor 黄海宋华先张占军马红萍程宇刘启悦
Owner 北京中海康医药科技发展有限公司
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