Pharmaceutical composition containing mecobalamin and preparation method thereof

A technology of methylcobalamin and composition, which is applied in the field of pharmaceutical composition containing methylcobalamin and its preparation, can solve the problems of many preparation steps and the quality impact of methylcobalamin tablets, achieve uniform content, reduce degradation problems, reduce cost effect

Active Publication Date: 2016-12-21
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are many preparation steps and the presence of damp and heat factors will affect the quality of methylcobalamin tablets

Method used

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  • Pharmaceutical composition containing mecobalamin and preparation method thereof
  • Pharmaceutical composition containing mecobalamin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The pharmaceutical composition containing methylcobalamin of this embodiment, according to the mass percentage, the content of each component is: 0.67% methylcobalamin with a particle diameter D90 of 36 μm, 5% stabilizer sodium carbonate, 87.33% diluent, 6% disintegration agent pregelatinized starch, 1% lubricant magnesium stearate.

[0036] The preparation method of the pharmaceutical composition containing methylcobalamin of the present embodiment is carried out according to the following steps:

[0037] (1) mixing: by mass percentage 0.67% methylcobalamin, 5% stabilizer sodium carbonate, 87.33% diluent, 6% disintegrant pregelatinized starch, after 1% lubricant magnesium stearate takes each raw material, Mix methylcobalamin raw material and spray-dried lactose in a three-dimensional mixer for 10 minutes, then add stabilizer sodium carbonate, diluent microcrystalline cellulose and disintegrant pregelatinized starch, continue mixing for 10 minutes, and finally add lubri...

Embodiment 2

[0066] The pharmaceutical composition containing methylcobalamin of this embodiment is composed of raw materials and auxiliary materials. According to the mass percentage, the content of each component is: 0.67% methylcobalamin whose particle size D90 is 36 μm, 5% stabilizer magnesium oxide, and 87.33% diluent , 6% disintegrant croscarmellose sodium, 1% lubricant magnesium stearate.

[0067] The preparation method of the pharmaceutical composition containing methylcobalamin of the present embodiment is carried out according to the following steps:

[0068] (1) Mixing: 0.67% methylcobalamin by mass percentage, 5% stabilizer magnesium oxide, 87.33% diluent, 6% disintegrant croscarmellose sodium, 1% lubricant magnesium stearate After each raw material, put methylcobalamin raw material and spray-dried lactose in a three-dimensional mixer and mix for 10 minutes, then add stabilizer magnesium oxide, diluent microcrystalline cellulose and disintegrant croscarmellose sodium, continue ...

Embodiment 3

[0073] The pharmaceutical composition containing methylcobalamin of this embodiment is composed of raw materials and auxiliary materials. According to the mass percentage, the content of each component is: 0.67% methylcobalamin whose particle size D90 is 36 μm, 5% stabilizer potassium carbonate, and 87.33% diluent , 6% disintegrant low-substituted hydroxypropyl cellulose, 1% lubricant magnesium stearate.

[0074] The preparation method of the pharmaceutical composition containing methylcobalamin of the present embodiment is carried out according to the following steps:

[0075] (1) Mixing: 0.67% methylcobalamin by mass percentage, 5% stabilizer potassium carbonate, 87.33% diluent, 6% disintegrating agent low-substituted hydroxypropyl cellulose, 1% lubricant magnesium stearate to weigh each raw material Finally, put the methylcobalamin raw material and spray-dried lactose in a three-dimensional mixer and mix for 10 minutes, then add the stabilizer potassium carbonate, the dilue...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing mecobalamin and a preparation method thereof. The pharmaceutical composition containing mecobalamin is composed of, by mass percentage, 0.01-1% of methylcobalamin, 1%-10% of a stabilizer, 40-95% of a diluent, 0-20% of a disintegrant, and 0.1-10% of a lubricant. The preparation method consists of: premixing mecobalamine and part of the diluents, then mixing the pre-mixture with the stabilizer, the diluent and the disintegrant to obtain mixed powder, mixing the mixed powder with the lubricant for a certain period of time to obtain mixed raw material powder, and subjecting the mixed raw material powder to direct tabletting and coating. The method provided by the invention adopts a dry granulation process, involves fewer steps, avoids the influence of moisture and heat to the main drug, further improves the quality of mecobalamin tablets, lowers the cost, and is beneficial to industrial production.

Description

technical field [0001] The technical field of pharmaceutical preparations of the present invention particularly relates to a pharmaceutical composition containing methylcobalamin and a preparation method thereof. Background technique [0002] With the development of society and the continuous improvement of the living standard of our people, the incidence of diabetes is gradually increasing. Peripheral neuropathy is one of the most common serious complications of diabetes, and the incidence rate can reach about 80%. Diabetic peripheral neuropathy will cause limb numbness in patients, and in severe cases, limb ulcers, muscle atrophy and severe pain will occur, and even necrosis of limbs will occur, resulting in disability. [0003] Methylcobalamin is a drug for the treatment of peripheral neuropathy and belongs to vitamin B 12 class, alias methyl vitamin B 12 , it exists in blood and spinal fluid, and repairs damaged peripheral nerves by promoting the synthesis of nucleic ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K47/02A61K31/714A61P25/02
CPCA61K9/2009A61K9/2095A61K9/28A61K31/714
Inventor 吴问辙王嬿钧刘杨丁菲贾树田
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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