Mecobalamine dispersion delayed release tablet and preparation method thereof

A technology of methylcobalamin and dispersible tablets, applied in the field of medicine, can solve the problems of high production costs, unstable product quality, and complicated processes, so as to reduce the probability of adverse reactions, solve high production costs, and optimize the preparation process. Effect

Active Publication Date: 2018-07-13
JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention overcomes the disadvantages in the prior art such as cumbersome process, low efficiency, unstable product quality and easy product scrapping, high production cost, etc., and improves the light-shielding property and reduces the packaging cost

Method used

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  • Mecobalamine dispersion delayed release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The preparation method of the methylcobalamin dispersible delayed-release tablet provided in this example includes two steps of preparing dispersed particles and preparing a dispersible tablet;

[0029] The preparation of dispersed particles refers to the following operations under dark conditions:

[0030] (1) 20g of fumed silica with a particle size of 100-120nm is uniformly dispersed in 100g of solvent through ultrasonic treatment, and the solvent is a mixed solution of absolute ethanol / acetone, wherein the volume ratio of absolute ethanol to acetone is 1 :0.1;

[0031] (2) Add 2 g of cellulose acetate phthalate CAP to the mixture obtained in step (1), then add 3 g of polyvinyl acetal diethylamine acetate AEA; mix uniformly under ultrasonic treatment;

[0032] (3) Pass the methylcobalamin raw material through a 400-mesh sieve, take 20 g and add it to the mixture obtained in step (2) and mix uniformly; then add ethyl cellulose EC with a concentration of 1 g, and mix ...

Embodiment 2

[0039] The preparation method of the methylcobalamin dispersible delayed-release tablet provided in this example includes two steps of preparing dispersed particles and preparing a dispersible tablet;

[0040] The preparation of dispersed particles refers to the following operations under dark conditions:

[0041] (1) 30g of fumed silica with a particle diameter of 120 to 130nm is uniformly dispersed in 100g of solvent through ultrasonic treatment, and the solvent is a mixed solution of absolute ethanol / acetone, wherein the volume ratio of absolute ethanol to acetone is 1 :0.1~0.2;

[0042] (2) Add 3g of cellulose acetate phthalate CAP to the mixture obtained in step (1), then add 4g of polyvinyl acetal diethylamine acetate AEA; mix uniformly under ultrasonic treatment;

[0043] (3) Pass the methylcobalamin raw material through a 325 mesh sieve, take 25g and add it to the mixture obtained in step (2) and mix uniformly; then add ethyl cellulose EC with a concentration of 2g, a...

Embodiment 3

[0050] The preparation method of the methylcobalamin dispersible delayed-release tablet provided in this example includes two steps of preparing dispersed particles and preparing a dispersible tablet;

[0051] The preparation of dispersed particles refers to the following operations under dark conditions:

[0052] (1) 35g of fumed silica with a particle diameter of 130 to 150nm is uniformly dispersed in 100g of solvent through ultrasonic treatment, and the solvent is a mixed solution of absolute ethanol / acetone, wherein the volume ratio of absolute ethanol to acetone is 1 :0.1~0.2;

[0053] (2) Add 5 g of cellulose acetate phthalate CAP to the mixture obtained in step (1), then add 5 g of polyvinyl acetal diethylamine acetate AEA; mix uniformly under ultrasonic treatment;

[0054] (3) Pass the methylcobalamin raw material through a 300-mesh sieve, take 30g and add it to the mixture obtained in step (2) and mix uniformly; then add ethyl cellulose EC with a concentration of 3g,...

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Abstract

The invention provides a mecobalamine dispersion delayed release tablet and a preparation method thereof. The preparation method comprises two steps, namely preparing dispersion micro granules, and preparing dispersion tablets, wherein the step of preparing the dispersion micro granules is mixing mecobalamine with fumed silica and a coating material under a light shielding condition to as to prepare coated granules; the step of preparing the dispersion tablet is uniformly mixing auxiliary materials with the dispersion micro granules according to an equivalent increase principle, and carrying out pelletizing and tabletting in a dry-method pelletizer. According to the mecobalamine dispersion delayed release tablet, the defects that in the prior art a process is tedious, the efficiency is low, the product quality is not stable, product discard can be easily caused, the production cost cannot be reduced, and the like can be overcome; in addition, the light shielding property can be improved, and the packaging cost can be reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a methylcobalamin dispersible delayed-release tablet and a preparation method thereof. Background technique [0002] Dispersible tablets are tablets that disintegrate rapidly and disperse evenly in water. Compared with solid preparations such as ordinary tablets and capsules, dispersible tablets have the characteristics of convenient administration, rapid disintegration, rapid absorption and high bioavailability. Dispersible tablets are suitable for young children, the elderly and other people who have difficulty swallowing, and are an essential dosage form. [0003] Mecobalamin (Mecobalamin) is an endogenous vitamin B12, which exists in blood and spinal fluid. Compared with vitamin B12, it has a good effect on improving the conduction of neurons, and can promote nucleic acid-protein- Fat metabolism, as a coenzyme of methionine synthase, can convert homocysteine ​​into methion...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/04A61K47/26A61K47/32A61K31/714A61P25/00
CPCA61K9/2009A61K9/2018A61K9/2027A61K9/2054A61K9/2886A61K31/714
Inventor 江永红刘红沈振宇袁菊凤丁月萍
Owner JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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