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Preparation method of mecobalamin dispersible tablets

A technology of methylcobalamin and dispersible tablets, applied in the field of medicinal chemistry, can solve problems such as instability, and achieve the effects of high production efficiency, high purity and risk reduction

Pending Publication Date: 2020-10-09
ZHUOHE PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing preparation process adopts the method of adding equal amounts for mixing, which needs to be weighed many times, mixed for no less than 6 times, and then wet granulated. It takes about 2 hours to prepare 600,000 pieces of granules. The raw material of methylcobalamin is being processed Contact with water during wet granulation, the product is unstable in dissolved state, and related substances will increase

Method used

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  • Preparation method of mecobalamin dispersible tablets
  • Preparation method of mecobalamin dispersible tablets
  • Preparation method of mecobalamin dispersible tablets

Examples

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Embodiment 1

[0031] This embodiment discloses a preparation method of methylcobalamin dispersible tablets, comprising the following steps:

[0032] Step 1: Prepare the following materials for later use: methylcobalamin raw material, microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate. Among them, 0.5g of methylcobalamin raw material, 88.9g of microcrystalline cellulose, 28.8g of lactose, 1.2g of croscarmellose sodium, and 0.6g of magnesium stearate were weighed under the condition that the ambient humidity was 40%. the above materials.

[0033] Step 2: pass the raw material of methylcobalamin through a standard sieve, the standard sieve is a 60-mesh sieve; divide the microcrystalline cellulose into two parts, the first part of microcrystalline cellulose is 13.3g, and the second part of microcrystalline cellulose is 75.6g.

[0034] Step 3: Add the first part of microcrystalline cellulose into the three-dimensional mixer under the condition of avoiding light t...

Embodiment 2

[0039] This embodiment discloses a preparation method of methylcobalamin dispersible tablets, comprising the following steps:

[0040] Step 1: Prepare the following materials for later use: methylcobalamin raw material, microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate. Among them, 0.5g of methylcobalamin raw material, 88g of microcrystalline cellulose, 28g of lactose, 2.5g of croscarmellose sodium, and 1g of magnesium stearate were weighed under the condition that the ambient humidity was 35%.

[0041] Step 2: pass the methylcobalamin raw material through a standard sieve, which is a 40-mesh sieve; divide the microcrystalline cellulose into two parts, the first part of microcrystalline cellulose is 15g, and the second part of microcrystalline cellulose is 73g.

[0042] Step 3: Add the first part of microcrystalline cellulose into the three-dimensional mixer under the condition of avoiding light throughout the process, then add the methylcobala...

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Abstract

The invention provides a preparation method of mecobalamin dispersible tablets, which comprises the following steps: adding a part of microcrystalline cellulose into a three-dimensional mixer, addinga mecobalamin raw material, and mixing to obtain a mixture I; rinsing the tank body of the three-dimensional mixer with lactose, adding the rinsed lactose and the mixture I into the multi-dimensionalmixer, adding croscarmellose sodium and the other part of microcrystalline cellulose into the multi-dimensional mixer, and mixing to obtain a mixture II. The invention provides a preparation method ofmecobalamin dispersible tablets. A direct tabletting method is adopted; links such as granulation, size stabilization and drying are omitted; the method has the characteristics of short process route, high production efficiency, low energy consumption and few degradation impurities; the materials are fully and uniformly mixed by three steps, the mecobalamin raw material can be uniformly distributed in the dispersible tablet, and the obtained mecobalamin dispersible tablet has much lower impurity content and higher purity than the mecobalamin dispersible tablet prepared by the existing wet granulation process.

Description

technical field [0001] The invention relates to the technical field of medicinal chemistry, in particular to a method for preparing methylcobalamin dispersible tablets. Background technique [0002] Methylcobalamin drugs are used for the treatment of peripheral nerve diseases and megaloblastic anemia caused by vitamin B12 deficiency. Compared with other vitamin B12 drugs, methylcobalamin has better transmission in the nervous system and can promote the metabolism of nucleic acid, protein and fat. Pharmacologically, it repairs damaged peripheral nerves by promoting the synthesis of nucleic acid, protein and nerve myelin sheath in nerve cells. Clinically, methylcobalamin drugs have obvious effects on peripheral nerve diseases such as diabetic neuropathy and multiple neuritis, especially on numbness, pain and paralysis. They are currently effective drugs for clinical treatment of such diseases with minimal side effects. In addition, studies have shown that methylcobalamin is ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/714A61P25/02A61P7/06A61P25/16A61P25/28A61P25/00A61P21/00
CPCA61K9/2095A61K9/2054A61K31/714A61P25/02A61P7/06A61P25/16A61P25/28A61P25/00A61P21/00
Inventor 丁月萍江永红刘红陶冬梅
Owner ZHUOHE PHARM GRP CO LTD
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