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A kind of methylcobalamin tablet and preparation method thereof

A technology of methylcobalamin tablets and methylcobalamin, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve problems affecting product quality control, interference with methylcobalamin detection, Liver and kidney function effects and other issues can be achieved to save coating materials, improve product stability, and have good reflective properties

Active Publication Date: 2021-09-28
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, carmine and other pigments are chemically synthesized pigments. Excessive consumption or long-term consumption will cause great harm to the human body, affect liver and kidney functions, and may cause cancer in serious cases.
Methylcobalamin tablets are long-term medications, so it is not suitable to add such pigments, and carmine will also interfere with the detection of related substances of methylcobalamin, affecting product quality control
[0004] It can be seen that the existing technology is not only complicated in process, but also has various problems. At present, there is no simple and reliable method that can simultaneously solve the stability of methylcobalamin tablets and the uniformity of active ingredients.

Method used

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  • A kind of methylcobalamin tablet and preparation method thereof
  • A kind of methylcobalamin tablet and preparation method thereof
  • A kind of methylcobalamin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Vegetarian Tablet Recipe:

[0056]

[0057] Preparation method (the following steps are carried out under a red light with a wavelength greater than 600nm):

[0058] (1) Methylcobalamin raw material is micronized to control the particle size D of the raw material 50 ≤10μm, pass methylcobalamin through a 100-mesh sieve (to remove lumps), pass the granular lactose through a 120-mesh sieve, take the part above the sieve, and weigh each raw and auxiliary material according to the prescription amount;

[0059] (2) Add granulated lactose and methylcobalamin into the high-speed mixing granulator in sequence, stirring at 120rpm / min, cutting knife at 1000rpm / min, and time of 10min;

[0060] (3) Add microcrystalline cellulose and croscarmellose sodium into the high-speed mixing granulator in turn, stir at 180rpm / min, and cut at 1000rpm / min for 3min;

[0061] (4) Add calcium stearate into the high-speed stirring mixing granulator, stirring at 120rpm / min, cutting knife at 1000...

Embodiment 2

[0064] Vegetarian Tablet Recipe:

[0065]

[0066] Preparation method (the following steps are carried out under a red light with a wavelength greater than 600nm):

[0067] (1) Methylcobalamin raw material is micronized to control the particle size D of the raw material 50 ≤10μm, pass methylcobalamin through a 100-mesh sieve (to remove lumps), pass the granular lactose through a 120-mesh sieve, take the part above the sieve, and weigh each raw and auxiliary material according to the prescription amount;

[0068] (2) Add granulated lactose and methylcobalamin into the high-speed mixing granulator in sequence, stirring at 120rpm / min, cutting knife at 1000rpm / min, and time of 10min;

[0069] (3) Add microcrystalline cellulose and croscarmellose sodium into the high-speed mixing granulator in turn, stir at 180rpm / min, and cut at 1000rpm / min for 3min;

[0070] (4) Add calcium stearate into the high-speed stirring mixing granulator, stirring at 120rpm / min, cutting knife at 1000...

Embodiment 3

[0073] Vegetarian Tablet Recipe:

[0074]

[0075] Preparation method (the following steps are carried out under a red light with a wavelength greater than 600nm):

[0076] (1) Methylcobalamin raw material is micronized to control the particle size D of the raw material 50 ≤10μm, pass methylcobalamin through a 100-mesh sieve (to remove lumps), pass the granular lactose through a 120-mesh sieve, take the part above the sieve, and weigh each raw and auxiliary material according to the prescription amount;

[0077] (2) Add granulated lactose and methylcobalamin into the high-speed mixing granulator in sequence, stirring at 120rpm / min, cutting knife at 1000rpm / min, and time of 10min;

[0078] (3) Add microcrystalline cellulose and croscarmellose sodium into the high-speed mixing granulator in turn, stir at 180rpm / min, and cut at 1000rpm / min for 3min;

[0079] (4) Add calcium stearate into the high-speed mixing granulator, stir at 120rpm / min, cutter at 1000rpm / min, and time fo...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a methylcobalamin tablet and a preparation method thereof. The methylcobalamin tablet provided by the present invention includes a plain tablet and a coating; wherein, the plain tablet is composed of methylcobalamin, granulated lactose for direct compression, microcrystalline cellulose, croscarmellose sodium and calcium stearate , under the appropriate selection and proportion of auxiliary materials, the tablet can have good uniformity of active ingredients, and the materials and preparation process are reasonable, so that the product is stable and the growth of related substances is slow.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a methylcobalamin tablet and a preparation method thereof. Background technique [0002] Methylcobalamin is an endogenous coenzyme B 12 , participate in the one-carbon unit cycle, play an important role in the transmethylation reaction process of synthesizing methionine from homocysteine, and can be used for vitamin B 12 Megaloblastic anemia caused by deficiency has also been reported in the literature to reduce the incidence of neural tube defects. [0003] Methylcobalamin is photosensitive and easily decomposes when exposed to light. Therefore, how to maintain the stability of methylcobalamin is a technical difficulty in the field of pharmacy, and it is also a research hotspot. For example, in the patent application with application number 200510105797.2, the method of operating under light-shielding conditions is used to prevent methylcobalamin from degr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/714A61K47/38A61K47/26A61P7/06
CPCA61K9/2018A61K9/2054A61K9/2853A61K9/2866A61K31/714A61P7/06
Inventor 蔡正军白杰张正全罗丽莲肖艳皎韩雅慧易斌
Owner 北京斯利安药业有限公司
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