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Polyene phosphatidylcholine capsule and preparation method thereof

A technology of polyene phosphatidylcholine and capsules, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve the instability of polyene phosphatidylcholine and the decrease of polyene phosphatidylcholine content , maintaining the efficacy of polyene phosphatidylcholine capsules, etc., to achieve the effect of facilitating industrial production and simple preparation methods

Active Publication Date: 2014-07-09
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] Polyene phosphatidylcholine is unstable. Phospholipid hydrolysis will occur in different degrees during long-term storage, resulting in a decrease in the content of polyene phosphatidylcholine and an increase in the generation of toxic substance lysophosphatidylcholine, which is not conducive to maintaining polyene phosphatidylcholine. Efficacy of Enene Phosphatidylcholine Capsules

Method used

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  • Polyene phosphatidylcholine capsule and preparation method thereof
  • Polyene phosphatidylcholine capsule and preparation method thereof
  • Polyene phosphatidylcholine capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Taking the preparation of 1000 polyene phosphatidylcholine capsules as an example, add 22.8g medium-chain triglycerides in a disperser (IKA T65, Guangzhou Yike Laboratory Technology Co., Ltd.), so that the cutter head of the disperser is immersed in the liquid Below the surface, start stirring at 7500rpm, slowly add 228g of pulverized polyene phosphatidylcholine in 5 times and stir evenly, control the temperature at 55-65°C, then add 1g of glyceryl monostearate and 0.01gα - Stir the tocopherol evenly, control the temperature at 55-65°C, then take a sample to detect the intermediate, and finally calculate the filling amount according to the content of the intermediate before filling the capsules.

Embodiment 2

[0028] Taking the preparation of 1000 polyene phosphatidylcholine capsules as an example, add 456g medium-chain triglycerides to the disperser (IKA T65, Guangzhou Yike Laboratory Technology Co., Ltd.), so that the cutter head of the disperser is immersed in the liquid surface Next, start stirring at a speed of 7500rpm, slowly add 228g of pulverized polyene phosphatidylcholine in 5 times and stir evenly, control the temperature at 55-65°C, then add 200g of glyceryl monostearate and 10g of α-tocopherol Phenol and stir evenly, control the temperature at 55-65°C, then take a sample to detect the intermediate, and finally calculate the filling amount according to the content of the intermediate before filling the capsules.

Embodiment 3

[0030] Taking the preparation of 1000 polyene phosphatidylcholine capsules as an example, add 45.6g medium-chain triglycerides to the disperser (IKAT65, Guangzhou Yike Laboratory Technology Co., Ltd.), so that the cutter head of the disperser is immersed in the liquid surface Next, start stirring at a speed of 7500rpm, slowly add 228g of pulverized polyene phosphatidylcholine in 5 times and stir evenly, control the temperature at 55-65°C, then add 10g of glyceryl monostearate and 0.05g of α- Stir the tocopherol evenly, control the temperature at 55-65°C, then take a sample to detect the intermediate, and finally calculate the filling amount according to the content of the intermediate before filling the capsules.

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Abstract

The invention relates to a polyene phosphatidylcholine capsule and a preparation method thereof, and belongs to the field of medicine preparations. Polyene phosphatidylcholine has unstable characteristic, different-degree phosphatide hydrolysis is generated during long-term storage of polyene phosphatidylcholine, and leads to content reduction of polyene phosphatidylcholine and generation increase of a toxic substance lysophosphatidylcholine. The invention provides the polyene phosphatidylcholine capsule which comprises polyene phosphatidylcholine and medium-chain triglyceride, and is substantially improved in stability compared with a current marked product Essentiale N. The polyene phosphatidylcholine capsule also comprises one or more pharmaceutically accepted excipient. Additionally, the invention also aims at providing a method for preparing the polyene phosphatidylcholine capsule, and the method is simple in preparation technology and is convenient for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a polyene phosphatidylcholine capsule and a preparation method thereof. Background technique [0002] Polyene phosphatidylcholine is a high-purity phosphatidylcholine extracted from soybean lecithin, which contains a large amount of unsaturated fatty acids, mainly linoleic acid (accounting for about 70%), linolenic acid and oleic acid. Polyene phosphatidylcholine is chemically consistent with important endogenous phospholipids, and has the following physiological functions: restore damaged liver function and enzyme activity, regulate liver energy balance, promote liver tissue regeneration, Converts sexual fats and cholesterol into easily metabolizable forms and stabilizes bile. At present, the listed formulations of polyene phosphatidylcholine include two kinds of injection and capsule, wherein the capsule is polyene phosphatidylcholine capsule with trade n...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/685A61K47/14A61P1/16
Inventor 曾艳玲王艳霞蔡紫阳
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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