Theopolyphenol composition for injection and its preparing process

A technology of polyphenol composition and tea polyphenol, which is applied in the field of preparation of tea polyphenol composition injection, can solve the problems of poor clarity and stability, restricting the industrial development of tea polyphenol clinical efficacy, etc., and achieve easy promotion, Enhanced stability and improved water solubility

Inactive Publication Date: 2003-02-12
NANJING NORMAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All of these lead to poor clarity and stability of products using conventional technology and prescriptions during preparation or short-term storage, and it is not feasible to use conventional technology and prescriptions for injections
The stability of this component has become a major obstacle to the development and marketing of pharmaceutical preparations, especially liquid preparations, which seriously restricts the clinical efficacy and industrial development of tea polyphenols.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Prescription Tea Polyphenols 20gHP 2 -β-CD 80g Sodium Chloride 4.3g Water for Injection Add to 1000ml

[0024] Take tea polyphenol raw materials (including catechins, flavonoids and flavonols, anthocyanins and anthocyanins, phenols and phenolic acids), dissolve in 70% alcohol, filter, concentrate, add 10 liters of pure water, and stir Evenly, filter, pass through a macroporous adsorption resin column, elute with PH4.8 acetic acid solution, filter through a microporous membrane, concentrate under reduced pressure at 50°C to a specific gravity of 1.03, add 20% (w / v) HP-b-CD solution and other Excipients, stir at 60°C for 1 hour, stir at 10-20°C for 3 hours, then mix according to the specified content, G 3 No. vertical fusion filter ball coarse filtration, 0.8um microporous membrane fine filtration. Filling and sealing. Sterilize with flowing steam at 100°C for 30 minutes.

Embodiment 2

[0025] Example 2 Prescription Tea Polyphenols 20gHP 2 -β-CD 80g polyvinylpyrrolidone (PVP), 5.7g sodium chloride 4.3g water for injection, add to 1000ml

[0026] Take tea polyphenol raw material, dissolve in 70% ethanol, filter, concentrate, add 10 liters of pure water, stir evenly, filter, pass through a macroporous adsorption resin column, elute with pH4.8 acetic acid solution, filter with microporous membrane, 10K ultra- Membrane filtration, concentration under reduced pressure at 50°C to a specific gravity of 1.03, adding 20% ​​(w / v) HP-b-CD solution and polyvinylpyrrolidone (PVP), stirring at 60°C for 1 hour, and stirring at 10-20°C for 3 hours, Dosing according to the specified content, G 3 No. vertical fusion filter ball coarse filtration, 0.8um microporous membrane fine filtration. Filling and sealing. Sterilize with flowing steam at 100°C for 30 minutes.

Embodiment 3

[0027] Example 3 Prescription Tea Polyphenols 20gHP 2 -β-CD 80g Sodium Chloride 4.3g Mannitol 3.9g Water for Injection Add to 1000ml

[0028] Take tea polyphenol raw material, dissolve in 70% ethanol, filter, concentrate, add 10 liters of pure water, stir evenly, filter, pass through a macroporous adsorption resin column, elute with pH4.8 acetic acid solution, filter with microporous membrane, 10K ultra- Membrane filtration, concentrated under reduced pressure at 50°C to a specific gravity of 1.03, added 20% (w / v) HP-b-CD solution and other auxiliary materials, stirred at 60°C for 1 hour, and after stirring at 10-20°C for 3 hours, formulated according to the specified content Liquid, G 3No. vertical fusion filter ball coarse filtration, 0.8um microporous membrane fine filtration. Filling, filling. Freeze-dry for 28 hours, press the stopper, and seal it.

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PUM

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Abstract

A theopolyphenol injection is prepared from hydroxypropyl cyclo dextrin or sulfobutylether cyclo dextrin and theopolyphenol or theapigment through refining the theopolyphenol extract by ion exchange to obtain the raw material for injection, preparing composition for injection from the said material, the said tyclo dextrin and additive, and preparing liquid injection or powder injection.

Description

technical field [0001] The invention relates to a tea polyphenol composition for injection or a molecular microcapsule called tea polyphenol and water-soluble cyclodextrin derivatives, and a preparation method of the tea polyphenol composition (or molecular microcapsule) injection . Background technique [0002] Tea polyphenols (Tea polyphenol TP) are polyphenolic compounds extracted from tea leaves. According to its chemical structure, it is divided into four categories, including catechins, flavonoids and flavonols, anthocyanins and anthocyanins, phenols and phenolic acids. Among them, the most important components are various catechins of flavanols, accounting for about 60% to 80% of the total TP. The research on tea polyphenols began in the 1980s, reached a climax in the 1990s, and is still in the ascendant. A lot of work has been done on the mechanism of action, clinical pharmacology, and active ingredients of tea polyphenols at home and abroad. Studies have shown th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/353A61P9/10A61P29/00A61P35/00A61P39/06
Inventor 杨星昊任勇龚祝南
Owner NANJING NORMAL UNIVERSITY
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