Stable pharmaceutical composition of (6S)-5-methyl-calcium tetrahydrofolate

A technology of calcium tetrahydrofolate and composition, applied in the field of medicine, can solve the problem that the harm of JK12A cannot be fundamentally avoided

Active Publication Date: 2018-03-20
LIANYUNGANG JINKANG HEXIN PHARMA CO LTD
View PDF10 Cites 5 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Although the above technology slows down the oxidation process of 5‐methyltetrahydrofolate, it cannot fundamentally avoid the harm of JK12A

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Stable pharmaceutical composition of (6S)-5-methyl-calcium tetrahydrofolate
  • Stable pharmaceutical composition of (6S)-5-methyl-calcium tetrahydrofolate
  • Stable pharmaceutical composition of (6S)-5-methyl-calcium tetrahydrofolate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Example 1-Direct compression:

[0089] The prescription composition is as follows: 80mg / tablet

[0090]

[0091] The preparation method is as follows:

[0092] 1. Pass (6S)-5-methyltetrahydrofolate calcium, lactose T80, microcrystalline cellulose PH112, hypromellose, and croscarmellose sodium through a 60 mesh sieve; Magnesium goes through 80 mesh sieve;

[0093] 2. Mix the above raw and auxiliary materials except magnesium stearate according to the multiple dilution method to make the mixing uniform;

[0094] 3. Add the prescription amount of magnesium stearate to the mixture obtained in the above 2 to make the mixture uniform and avoid excessive lubrication.

[0095] 4. Press the theoretical tablet weight 80mg / tablet, control the tablet weight difference not to exceed 10%, the disintegration time limit is less than 15 minutes, and the friability is less than 1.0%.

[0096] 5.15% Opadry solution is film-coated, the temperature of the tablet bed is not higher than 50℃, and the wei...

Embodiment 2

[0097] Example 2-Direct compression:

[0098] The prescription composition is as follows: 80mg / tablet

[0099]

[0100] Preparation:

[0101] 1. Pass (6S)-5-methyltetrahydrofolate calcium, vitamin C, pregelatinized starch PC-10, microcrystalline cellulose PH112, and sodium starch glycolate respectively through 60 mesh sieve; pass magnesium stearate through 80 mesh sieve;

[0102] 2. Mix the above raw and auxiliary materials except magnesium stearate according to the multiple dilution method to make the mixing uniform;

[0103] 3. Add the prescription amount of magnesium stearate to the mixture obtained in the above 2 to make the mixture uniform and avoid excessive lubrication.

[0104] 4. Press the theoretical tablet weight 80mg / tablet, control the tablet weight difference not to exceed 10%, the disintegration time limit is less than 15 minutes, and the friability is less than 1.0%.

[0105] The 15.5% Opadry solution is film-coated, and the temperature of the tablet bed does not exceed 5...

Embodiment 3

[0106] Example 3-Direct compression method

[0107] The prescription composition is as follows: 80mg / tablet

[0108]

[0109]

[0110] Preparation method: Refer to Example 1 and Example 2.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
wavelengthaaaaaaaaaa
Login to view more

Abstract

The invention discloses a stable pharmaceutical composition. The stable pharmaceutical composition contains (6S)-5-methyl-calcium tetrahydrofolate crystal and / or pharmacologically acceptable reducingsubstances as well as pharmacologically acceptable auxiliaries, wherein the reducing substances can protect (6S)-5-methyl-tetrahydrofolic acid and a salt thereof from being oxidized, and are selectedfrom vitamin C and a salt thereof, iso-vitamin C and a salt thereof, mercaptoethanol, cysteine, mercaptoethyl sulfoacid, dithiothreitol, reduced glutathione and thioctic acid. The stable pharmaceutical composition provided by the invention has good stability during processing and storage, avoids drug use risk caused by degradation, and ensures quick and reliable release of (6S)-5-methyl-tetrahydrofolic acid in the composition.

Description

[0001] This application is a divisional application for a Chinese invention patent for a stable pharmaceutical composition with an application date of 2014.09.04, an application number of 201410449805.4, and an invention title of (6S)-5-methyltetrahydrofolate calcium salt. Technical field [0002] The present invention belongs to the field of medicine. Specifically, the present invention relates to a stable pharmaceutical composition of type C (6S)-5-methyltetrahydrofolate calcium salt. Background technique [0003] (6S)-5-Methyltetrahydrofolate is the natural active form of folic acid, which can directly cross the blood-brain barrier without any metabolism in the body. More importantly, taking (6S)-5-methyltetrahydrofolate can avoid the major risks of vitamin B12 deficiency masking caused by folic acid alone. [0004] It is well known that 5-methyltetrahydrofolate products are very unstable and easily degraded, especially highly sensitive to oxygen and moisture (A.L. Fitzhugh, Pter...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/519A61K31/567A61K31/566A61K31/565A61P15/18A61P3/02A61K47/22A61K47/20A61K47/26A61K47/18A61K31/585
CPCA61K31/519A61K31/565A61K31/566A61K31/567A61K31/585A61K45/06A61K47/183A61K47/20A61K47/22A61K47/26A61K2300/00
Inventor 成永之成志
Owner LIANYUNGANG JINKANG HEXIN PHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap