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Sustained-release preparation of 5-methyltetrahydrofolic acid and preparation method thereof

A technology of methyltetrahydrofolate and methyltetrahydrofolate, which is applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., can solve the problems affecting male fertility and the like, To achieve the effect of reducing the frequency of medication and improving the applicability

Active Publication Date: 2019-06-11
SHENZHEN AUSA PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, stevioside is prohibited from being used in pharmaceutical preparations in many countries due to its influence on male fertility and other unsafe factors

Method used

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  • Sustained-release preparation of 5-methyltetrahydrofolic acid and preparation method thereof
  • Sustained-release preparation of 5-methyltetrahydrofolic acid and preparation method thereof
  • Sustained-release preparation of 5-methyltetrahydrofolic acid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1—direct compression method

[0030] The composition of the prescription is as follows:

[0031]

[0032]

[0033] 1) Weigh (6S)-5-methyltetrahydrofolate calcium, microcrystalline cellulose (MCC) PH102, hydroxypropylmethylcellulose (HPMC) K100M, hydroxypropylcellulose, magnesium stearate according to the prescription, Pass through 80-mesh sieve respectively, set aside;

[0034] 2) Mix (6S)-calcium 5-methyltetrahydrofolate and lactose in equal amounts, and sieve;

[0035] 3) Add hydroxypropyl methylcellulose and hydroxypropyl cellulose to the mixture in step 2), and mix well;

[0036] 4) Magnesium stearate is added to the mixture in step 3), and mixed uniformly;

[0037] 5) Tablet pressing, the hardness is controlled at 70-100N.

Embodiment 2

[0038] Embodiment 2—direct compression method

[0039] The composition of the prescription is as follows:

[0040]

[0041] The preparation method is the same as in Example 1.

Embodiment 3

[0042] Embodiment 3—direct compression method

[0043] The composition of the prescription is as follows:

[0044]

[0045]

[0046] The preparation method is the same as in Example 1.

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Abstract

The present invention relates to a sustained-release preparation of 5-methyltetrahydrofolic acid or salt thereof. Glyceryl behenate and a hydrophilic gel framework material are mainly combined for useso as to achieve the purpose that the 5-methyltetrahydrofolic acid is slowly and stably released for a long time to exert the drug effect for a long time. The 5-methyltetrahydrofolic acid is freely soluble in water, and the sustained-release preparation prepared from medicines with good water solubility is apt to generate initial burst release phenomenon in vivo. The glyceryl behenate is a novelauxiliary material, is used as a material resisting initial burst release, can reduce the dosage of the hydrophilic framework material, and meanwhile, can prevent the medicines from initial burst release under severe conditions.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to sustained-release preparations containing 5-methyltetrahydrofolate. Background technique [0002] 5-Methyltetrahydrofolate (5-MTHF) is a naturally occurring salt-forming methyl derivative of folic acid. 5-MTHF is also known as L-methylfolate. It is the most biologically active and functional form of folic acid. Plain folic acid is more easily absorbed. Ordinary folic acid must be converted into (6S)-5-methyltetrahydrofolate (ie: L-5-methyltetrahydrofolate) to participate in two main metabolic pathways: methylation process and DNA synthesis. 5-Methyltetrahydrofolate does not require metabolism and does not depend on MTHFR enzyme activity. It directly participates in the metabolism of homocysteine ​​(Hcy) in the body, and the effect of reducing Hcy is more obvious, especially for TT in the MTHFR C677T gene polymorphism. Genotype population will play a better role in cli...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/14A61K47/38A61K31/519A61P9/00A61P9/10
CPCY02A50/30
Inventor 徐希平陈平梁胜群陈亚宁于多
Owner SHENZHEN AUSA PHARM CO LTD
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