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Bupropion hydrochloride sustained release tablets and preparation method thereof

A technology of bupropion hydrochloride and sustained-release tablets, which is applied to medical preparations with non-active ingredients, pharmaceutical formulas, and medical preparations containing active ingredients, etc. It can solve the problem of large differences between product batches and easy-to-corrosion production equipment , Unfavorable for industrialized production and other issues, to achieve the effect of easy identification, no pollution to the environment, and conducive to industrialized production

Active Publication Date: 2010-10-27
SHANGHAI ANBISON LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the difficulty of making existing bupropion hydrochloride sustained-release tablets, poor stability, large differences between product batches, easy pollution of the environment in the production process, easy corrosion of production equipment, and unfavorable industrialization. Production and other defects, a new bupropion hydrochloride sustained-release tablet is provided, which uses micropowdered silica gel as an acidic environment regulator, thereby overcoming the above-mentioned defects

Method used

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  • Bupropion hydrochloride sustained release tablets and preparation method thereof
  • Bupropion hydrochloride sustained release tablets and preparation method thereof
  • Bupropion hydrochloride sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 prepares the sustained-release tablet containing 100mg bupropion hydrochloride

[0028] Table 1

[0029]

[0030] *Removable after drying

[0031] Take by weighing bupropion hydrochloride, hypromellose, microcrystalline cellulose, polyvinylpyrrolidone, acidic environment modifier micropowder silica gel (10mg / sheet, accounting for 3.7% of the sustained-release tablet weight) according to Table 1, after mixing , Use an appropriate amount of water to make granules. After the wet granules are dried and sized, add glyceryl behenate and glidant micropowder silica gel (0.8 mg / tablet, accounting for 0.3% of the weight of the sustained-release tablet), mix well, and press into tablets to obtain the product. Coat the plain tablets with a film, increase the weight to 2%-3%, and pack them separately.

Embodiment 2

[0032] Example 2 Preparation of sustained-release tablets containing 100mg bupropion hydrochloride

[0033] Table 2

[0034]

[0035] *Removable after drying

[0036] Take by weighing bupropion hydrochloride, hypromellose, microcrystalline cellulose, polyvinylpyrrolidone, acidic environment modifier micropowder silica gel (10mg / sheet, accounting for 3.7% of the sustained-release tablet weight) according to Table 2, after mixing , Use an appropriate amount of water to make granules. After the wet granules are dried and sized, add glyceryl behenate and glidant micropowder silica gel (0.8 mg / tablet, accounting for 0.3% of the weight of the sustained-release tablet), mix well, and press into tablets to obtain the product. Coat the plain tablets with a film, increase the weight to 2%-3%, and pack them separately.

Embodiment 3

[0037] Example 3 Preparation of sustained-release tablets containing 150mg bupropion hydrochloride

[0038] table 3

[0039]

[0040]

[0041] *Removable after drying

[0042] Take by weighing bupropion hydrochloride, hypromellose, microcrystalline cellulose, polyvinylpyrrolidone, acidic environment modifier micropowder silica gel (22.275mg / sheet, accounting for 5.5% of the sustained-release tablet weight) according to Table 3, and mix well Finally, make granules with appropriate amount of water. After the wet granules are dried and sized, add glyceryl behenate and glidant micropowder silica gel (2.025 mg / tablet, accounting for 0.5% of the weight of the sustained-release tablet), mix well, and press into tablets. Coat the plain tablets with a film, increase the weight to 2%-3%, and pack them separately.

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Abstract

The invention relates to bupropion hydrochloride sustained release tablets, which contain the following components: bupropion hydrochloride, a sustained release framework material, an acid environment regulator, a diluent, a bonding agent, a flow aid and a lubricant. The sustained release tablets are characterized in that: the acid environment regulator is aerosil. The invention also provides a method for preparing the bupropion hydrochloride sustained release tablets. The invention overcomes the defects of large tabletting difficulty, large difference among product batches, easy environmental pollution in the production process, easy corrosion on production equipment, no contribution to industrial production and the like of the conventional bupropion hydrochloride sustained release tablets, and provides new bupropion hydrochloride sustained release tablets which use the aerosil as the acid environment regulator so as to overcome the defects. The sustained release tablets can at least keep 90 percent labeled amount of bupropion hydrochloride after being stored for one year at room temperature under the condition that the relative humidity (RH) is 35 to 60 percent.

Description

technical field [0001] The invention relates to a bupropion hydrochloride sustained-release tablet, and also relates to a preparation method of the bupropion hydrochloride sustained-release tablet. Background technique [0002] The chemical name of bupropion hydrochloride is 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone, and its listed immediate-release tablets and sustained-release tablets For the treatment of depression. The bupropion hydrochloride sustained-release tablet with a specification of 150 mg can also be used as a smoking cessation preparation. Compared with tricyclic antidepressants, bupropion hydrochloride is a blocker of nerve uptake of serotonin and non-catechol, and inhibits the reuptake of dopamine by nerves to a certain extent. However, relevant clinical studies have shown that the incidence of depression in its immediate-release preparation is relatively high, and when the daily dose is 450 mg, the incidence can reach 0.4% (4 / 1000). The ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/137A61K47/04A61K47/38A61P25/24
Inventor 雷继峰许英爱施钰文姜兴金荣根王砾
Owner SHANGHAI ANBISON LAB
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