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Polyene phosphatidyl choline capsule and preparation process thereof

A polyene phosphatidylcholine and capsule technology, which is applied in the directions of capsule delivery, oil/fat/wax inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problem of unstable polyene phosphatidylcholine stability, High moisture and oxygen permeability, unfavorable easy oxidative hydrolysis and other problems, to achieve the effect of ensuring safety and effectiveness, high degree of automation, and low cost

Active Publication Date: 2017-05-10
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this prior art provides a new dosage form for clinical practice, soft capsules are unfavorable for easy oxidative hydrolysis and the stability of the extremely unstable polyene phosphatidylcholine due to the significantly higher moisture and oxygen transmission rates. Moreover, it is also prone to dehydration and aging of the rubber, resulting in unqualified disintegration of the product during the storage period, and material migration in the capsule, etc.

Method used

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  • Polyene phosphatidyl choline capsule and preparation process thereof
  • Polyene phosphatidyl choline capsule and preparation process thereof
  • Polyene phosphatidyl choline capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription (based on 1000 capsules):

[0032] polyene phosphatidylcholine 228g Soybean oil 22.8g hard fat 15g hydrogenated castor oil 12g ethanol 30g。

[0033] Preparation Process:

[0034] (1) the polyene phosphatidylcholine of prescription quantity is mixed with soybean oil, ethanol, for subsequent use;

[0035] (2) In a vacuum state, heat (60-90°C) hydrogenated castor oil and hard fat in the prescribed amount and stir until completely melted, then add the polyene phosphatidylcholine-ethanol-da soybean oil mixture, mix well;

[0036] (3) Transfer the material obtained in the above step (2) to the hopper of the capsule filling machine, and carry out capsule filling under the condition of heat preservation at 50-80°C.

Embodiment 2

[0038] Prescription (based on 1000 capsules):

[0039] polyene phosphatidylcholine 228g Soybean oil 228g hard fat 70g

[0040] hydrogenated castor oil 2g。

[0041] Preparation Process:

[0042] (1) the polyene phosphatidylcholine of prescription quantity is mixed with soybean oil, for subsequent use;

[0043] (2) Under vacuum, heat (60-90°C) hydrogenated castor oil and hard fat in the prescribed amount and stir until completely melted, then add the polyene phosphatidylcholine-soybean oil mixture obtained in the above step (1) ,well mixed;

[0044] (3) Transfer the material obtained in the above step (2) to the hopper of the capsule filling machine, and carry out capsule filling under the condition of heat preservation at 50-80°C.

Embodiment 3

[0046] Prescription (based on 1000 capsules):

[0047] polyene phosphatidylcholine 228g Soybean oil 45.6g hard fat 20g hydrogenated castor oil 6g ethanol 10g。

[0048] Preparation Process:

[0049] (1) the polyene phosphatidylcholine of prescription quantity is mixed with soybean oil, ethanol, for subsequent use;

[0050] (2) In a vacuum state, heat (60-90°C) hydrogenated castor oil and hard fat in the prescribed amount and stir until completely melted, then add the polyene phosphatidylcholine-ethanol-da soybean oil mixture, mix well;

[0051](3) Transfer the material obtained in the above step (2) to the hopper of the capsule filling machine, and carry out capsule filling under the condition of heat preservation at 50-80°C.

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Abstract

The present invention belongs to the field of pharmaceutical preparations, and mainly relates to a polyene phosphatidyl choline capsule and a preparation process thereof, wherein the polyene phosphatidyl choline capsule contains polyene phosphatidyl choline and soybean oil, and can further contain other pharmaceutically acceptable excipients. Compared to the polyene phosphatidyl choline capsule in the prior art, the polyene phosphatidyl choline capsule of the present invention has good stability so as to well ensure the medication safety and the medication efficacy, and polyene phosphatidyl choline capsule is produced by using the liquid filling hard capsule technology so as to provide advantages of simple production process, small equipment occupation area, low cost, high automation degree, less impurity, and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and mainly relates to a polyene phosphatidylcholine capsule which is more stable than the prior art and a preparation process thereof. Background technique [0002] Polyene phosphatidylcholine is a multi-component mixture extracted from soybeans, etc. It contains a large number of unsaturated fatty acid groups, mainly linoleic acid [about 70%], linolenic acid and oleic acid. [0003] When suffering from liver disease, the metabolic activity of the liver is severely impaired. Polyene phosphatidylcholines provide high-dose, readily available high-energy polyene phosphatidylcholines whose phospholipids are chemically identical to important endogenous phospholipids. Phospholipids are necessary for the synthesis of lipoproteins by the liver to transport lipids from hepatocytes to peripheral storage. Lack of phospholipids can easily lead to fatty liver due to blocked lipoprotein synthesis. ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/685A61K47/44A61P1/16
Inventor 杨平龚成余悦东冯卫范俊迈
Owner SICHUAN HAISCO PHARMA CO LTD
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