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Preparation method of vitamin B6 granule for direct tablet forming

A vitamin and granule technology, which is applied in the field of preparation of vitamin B6 granules, can solve the problems of easy splitting, large weight difference of single-piece granules, lack of fluidity and compressibility, etc., and achieves good stability, good mixing, and good combination. Effects of Sexuality and Compressibility

Active Publication Date: 2009-07-08
江西天新药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These tablets are generally composed of vitamin B 6 The powder is directly compressed, but the vitamin B 6 The powder lacks the fluidity and compressibility required for tableting, and the powder is directly pressed into tablets, which has problems such as large difference in the weight of single-tablet particles and easy cracking.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Put 25 kg of vitamin B in wet granulation equipment 6 Powder and 50 kg of pregelatinized starch in wet granulator. Adjust to a suitable stirring and chopping speed, and mix for 10-20 minutes, for example, 13 minutes. Then slowly add 20 kg of pre-prepared 2% hydroxypropyl cellulose solution, and after adding, continue stirring and granulating for 10-30 minutes, for example, stirring for 15 minutes. After the granulation is completed, the prepared vitamin B will be 6 The wet particles are transferred to the boiling dryer, and the fan is turned on for boiling drying. When the temperature of the material reaches 60-80° C., the drying is completed, for example, when it reaches 65° C., the temperature is kept for another 10-30 minutes, for example, the temperature is kept for 15 minutes. After the heat preservation is completed, it can be cooled to below 40 °C and discharged to obtain vitamin B. 6 Particles (weight percent).

Embodiment 2

[0016] Put 50 kg of vitamin powder and 0.75 kg of methyl cellulose into the wet granulation equipment, and open the wet granulator. Adjust to a suitable stirring and chopping speed, and mix for 10-20 minutes, for example, 18 minutes. Then slowly add 4 kg of the pre-prepared 1.5% methylcellulose solution, and after the addition is completed, continue stirring and granulating for 10-30 minutes, for example, stirring for 25 minutes. After the granulation is completed, the prepared vitamin B will be 6 The wet granules are pumped into the boiling dryer, and the fan is turned on for boiling drying. When the temperature of the material reaches 60-80°C, the drying is completed, for example, when it reaches 75°C, the temperature is kept for another 10-30 minutes, such as for 25 minutes. After the heat preservation is completed, it is cooled, and the vitamin B can be obtained after cooling to below 40 °C. 6 Particles (weight percent).

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Abstract

The invention relates to a method for preparing a vitamin B6 granule used for direct tablet compressing. The method comprises the following steps: 30-98% of vitamin B6 powder and 1-65% of filling agent are thrown into a wet type granulator for mixing; 1-5% of 1-20% adhesive solution is added 5-20 minutes later; wet vitamin B6 granules are obtained by stirring and mixing for 10-30 minutes; the prepared wet vitamin B6 granules are removed to an ebullated dryer for drying till the temperature reaches 60-90 DEG C; heat preservation is carried out for 10-30 minutes; cooling is carried out and discharging is carried out until the temperature is lower than 40 DEG C, and the vitamin B6 granules are obtained by drying (weight percentage). The vitamin B6 prepared by the invention has the advantages that the granules have good fluidity and associative property and has condensability.

Description

technical field [0001] The present invention relates to a kind of preparation method of chemical medicine, more particularly, relate to a kind of vitamin B used for direct compression 6 Preparation method of granules. Background technique [0002] Vitamin B 6 It is a component of certain coenzymes in the human body, which are involved in various chemical reactions involving amino acid metabolism. Long-term vitamin B deficiency 6 , will lead to skin, central nervous system and hematopoietic damage. Clinical application of vitamin B 6 Preparations for the prevention and treatment of vomiting of pregnancy and radiation sickness. Vitamin B 6 It can be taken alone or with other vitamins to make a multivitamin, usually in tablet form. This tablet generally consists of vitamin B 6 Powder direct compression, but vitamin B 6 The powder lacks the fluidity and compressibility required for tableting, and the powder is directly compressed, and there are problems such as a large ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K31/4415A61K47/38A61P3/02
Inventor 范卫东章根宝徐勇智洪丰庆
Owner 江西天新药业股份有限公司
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