Preparation method of oral solid preparation containing polyene phosphatidyl choline

A technology of polyene phosphatidylcholine and solid preparation, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, etc., to facilitate the detection of finished product loading, improve the yield of finished products and the accuracy of quality. , the effect of facilitating the intermediate quantitative control

Inactive Publication Date: 2011-08-31
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of the present invention is to overcome the unfavorable physical properties of polyene phosphatidylcholine raw materials and the deficiencies of existing preparation technology, improve the fluidity of phospholipid materials, so as to facilitate the large-scale and popularized production and preparation of its related oral solid preparations, for The clinical use of this type of drug provides safer and more appropriate oral solid preparation options, and is a corresponding preparation preparation with stronger production operability, better quality controllability, improved finished product processing rate, and safety and effectiveness. method

Method used

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  • Preparation method of oral solid preparation containing polyene phosphatidyl choline
  • Preparation method of oral solid preparation containing polyene phosphatidyl choline
  • Preparation method of oral solid preparation containing polyene phosphatidyl choline

Examples

Experimental program
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Effect test

Embodiment 1

[0020] Dosage form: drop pills, specification 76mg / grain (calculated as polyene phosphatidylcholine)

[0021] Put the polyene phosphatidylcholine in a low-temperature pulverizer, pulverize it to 100 mesh at a temperature of -60°C to -70°C, and sieve it; take 326g of polyene phosphatidylcholine and 33g of folic acid, and then granulate it under nitrogen. granules, dried under reduced pressure at 15°C and 0.01MPa; take the dry matter and add it to molten 977g stearic acid, stir quickly until the mixture is uniform, drip, cool, and wash the pills to obtain 3000 drop pills, each drop pill Contents weigh approximately 0.45g.

Embodiment 2

[0023] Dosage form: capsule, specification: 57mg / capsule (calculated as polyene phosphatidylcholine)

[0024] Put the polyene phosphatidylcholine in a low-temperature pulverizer, grind it to 100 mesh at a temperature of -40°C to -50°C, and sieve it; take 326g of polyene phosphatidylcholine and mix it with 33g of vitamin C, and then mix it with 1629g of starch, Microcrystalline cellulose 1303g, mix in equal increments, detect the content of intermediates, measure the bulk density, pack in capsules or enteric-coated capsules, make 4000 capsules in total, and the content of each capsule weighs about 0.8g.

Embodiment 3

[0026] Dosage form: tablet, specification: 76mg / tablet (calculated as polyene phosphatidylcholine)

[0027] Put the polyene phosphatidylcholine in a low-temperature pulverizer, pulverize it to 100 mesh at a temperature of -70~-80°C, and sieve it; take 326g of polyene phosphatidylcholine and 33g of folic acid, and mix them with 977g of pregelatinized starch And carboxymethyl starch sodium 326g, mix by equal increment method, granulate, granulate, 20 ℃, 0.08MPa decompression drying 3 hours, tabletting, film-coating, make 3000 tablets altogether. Each piece weighs about 0.56g.

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Abstract

The invention relates to an oral solid preparation containing polyene phosphatidyl choline and a preparation method thereof. The oral solid preparation comprises polyene phosphatidyl choline as a raw material, antioxidants and related accessories necessary for corresponding forming of the preparation. The procedure is as follows: cryogenically comminuting and sieving the polyene phosphatidyl choline, and then pelletizing, granulating and drying under reduced pressure; then adding accessories for the corresponding preparation, thereby obtaining the corresponding oral solid preparation according to the procedure for corresponding forming of the preparation. The finished preparation is convenient for clinical using and has good material liquidity for production and preparation, which leads to an easy operated forming process of corresponding preparation formation with good quality control.

Description

technical field [0001] The invention relates to oral solid preparations (including tablets, capsules, granules, dripping pills, soft capsules, etc.) with polyene phosphatidylcholine as the main raw material, especially a kind of polyene phosphatidylcholine with good fluidity Granular material and its preparation method. Background technique [0002] Polyene Phosphatidylcholine is a soybean extract, a further extract of soybean phospholipids, chemically identical to important endogenous phospholipids. [0003] Modern pharmacological studies have shown that polyene phosphatidylcholine can reduce fat infiltration of liver cells; reduce inflammation; promote liver cell regeneration by increasing RNA and protein synthesis and glycogen content; inhibit collagen production and reduce collagen / DNA ratio and liver hydroxyproline to reduce connective tissue formation; polyene phosphatidylcholine can protect liver sinusoidal endothelial cells and liver cell biofilm from damage, repair...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K31/685A61K47/22A61P1/16
Inventor 安英张玲玲张慧英
Owner 北京瑞伊人科技发展有限公司
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