Freeze dried polyene lecithin powder for injection and its prepn

A technology of polyene phosphatidyl choline and freeze-dried powder for injection, which is applied in the field of polyene phosphatidyl choline freeze-dried powder for injection and preparation thereof, can solve the problem of allergic reactions in patients, cannot meet the needs of emergency patients, and is safe for medication hidden dangers and other problems, to achieve good solubilization effect, overcome poor stability, and improve quality stability

Active Publication Date: 2006-05-17
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, polyene phosphatidylcholine has oral dosage forms such as capsules, which are convenient to take but have a slow onset of action. The blood concentration can reach the peak after 6 hours of oral administration, which cannot meet the needs of acute and severe patients.
The Chinese patent with publication number CN1602878A discloses a preparation method of polyene phosphatidylcholine injection. A large amount of bile acid solubilizer and preservative benzyl alcohol are added to the injection, so that this product is prohibited for use in newborns and children. Premature infants, and prone to allergic reactions in patients
On the other hand, polyene phosphatidylcholine injection has poor stability, and the storage temperature must be lower than 8°C, which brings inconvenience to drug storage, transportation, and drug administration, and also brings hidden dangers to drug safety.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The preparation method of single preparation 1000 bottles is as follows:

[0025] 1) Solution preparation (completed under nitrogen protection)

[0026] Add polyene phosphatidylcholine and sodium deoxycholate to the final preparation volume of 4 / 5 water for injection, and fully stir until dissolved and dispersed evenly.

[0027] 2) Removal of pyrogens (completed under nitrogen protection)

[0028] Add 3.5 g of activated carbon and stir for 15 minutes, and then use a suction filter funnel to spread two layers of filter paper to filter and decarbonize. Take the filtrate and add water for injection to a sufficient amount, pass through a 0.22 μm filter membrane to obtain the intermediate.

[0029] 3) Packing (completed under nitrogen protection)

[0030] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0031] 4) freeze-dried

[0032]The eutectic point of the intermediate wa...

Embodiment 2

[0035] The preparation method of single preparation 1000 bottles is as follows:

[0036] 1) Solution preparation (completed under nitrogen protection)

[0037] Add polyene phosphatidylcholine, sodium deoxycholate and lactose to the final preparation amount of 7 / 10 water for injection, and fully stir until dissolved and dispersed evenly.

[0038] 2) Removal of pyrogens (completed under nitrogen protection)

[0039] Add 4g of activated carbon and stir for 20 minutes, then spread two layers of filter paper with a suction funnel to filter and decarbonize. Take the filtrate and add water for injection to a sufficient amount, pass through a 0.22 μm filter membrane to obtain the intermediate.

[0040] 3) Packing (completed under nitrogen protection)

[0041] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0042] 4) freeze-dried

[0043] The eutectic point of the intermediate was mea...

Embodiment 3

[0046] The preparation method of single preparation 1000 bottles is as follows:

[0047] 1) Solution preparation (completed under nitrogen protection)

[0048] Add polyene phosphatidylcholine, sodium cholate and glucose to 3 / 5 of the final preparation amount of water for injection, and fully stir until dissolved and dispersed evenly.

[0049] 2) Removal of pyrogens (completed under nitrogen protection)

[0050] Add 7.2 g of activated carbon and stir for 30 minutes, and use a suction filter funnel to spread two layers of filter paper to filter and decarbonize. Take the filtrate and add water for injection to a sufficient amount, use G 6 Filter through a fused glass filter to obtain the intermediate.

[0051] 3) Packing (completed under nitrogen protection)

[0052] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0053] 4) freeze-drying:

[0054] The measured eutectic point of...

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PUM

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Abstract

The present invention discloses one kind of freeze dried polyene phosphatidylcholine powder for injection and its preparation process. It features that the preparation contains polyene phosphatidylcholine and solubilizer sodium deoxycholate, sodium dehydrocholate or sodium cholate in the weight ratio of 0.5-1.5.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a polyene phosphatidylcholine freeze-dried powder for injection and a preparation method thereof. technical background [0002] Polyene Phosphatidylcholine (Polyene Phosphatidylcholine) is a phosphatidylcholine containing arachidonic acid (AA) and docosahexaenoic acid (DHA) in unsaturated fatty acid bonds on the triglyceride skeleton of lecithin. An essential phospholipid that cannot be synthesized in the human body and contains a large amount of unsaturated fatty acids (mainly linoleic acid, linolenic acid and oleic acid, etc.). It has a good protective effect on the liver and repairs and regenerates damaged liver cells. It is a liver cell membrane protective agent and can treat a variety of liver diseases: such as hepatitis, chronic hepatitis, liver necrosis, cirrhosis, and hepatic coma (including prodromal hepatic coma), fatty liver (also seen in diabetics), etc. Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/6615A61P1/16A61P31/12
Inventor 程艳菊张来芳杨玲
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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