Preparation method for quick-release tablet cores of bupropion hydrochloride enteric-coated and sustained-release tablets

A technology of bupropion hydrochloride and sustained-release tablets, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, coatings, etc., to achieve the effects of high application value, reduced material loss, and reduced time consumption

Inactive Publication Date: 2018-07-10
SHANGHAI SUNTECH PHARMA
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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 above-mentioned deficiencies, research and design the preparation is simple, reduce the production cost, reduce the consumption of time, manpower and materials in the production process, and improve the preparation of bupropion hydrochloride enteric-coated sustained-release tablets Preparation method of immediate-release tablet core

Method used

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  • Preparation method for quick-release tablet cores of bupropion hydrochloride enteric-coated and sustained-release tablets
  • Preparation method for quick-release tablet cores of bupropion hydrochloride enteric-coated and sustained-release tablets
  • Preparation method for quick-release tablet cores of bupropion hydrochloride enteric-coated and sustained-release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Formulation 1000 tablets in Table 1

[0023]

[0024] *Remove after drying

[0025] Dissolve polyvinyl alcohol in water to form a 20% concentration binder, place bupropion hydrochloride in a high-shear wet granulator (Mini-CG-1 / 10), add 20% binder Polyvinyl alcohol, stirred and cut evenly to make granules, sieved wet granules (1mm sieve), dried (dried in oven at 60°C for 1 hour), granulated, added micro-powdered silica gel and mixed for 20 minutes, then added glyceryl behenate, mixed evenly, and pressed into tablets 600 immediate-release cores of bupropion hydrochloride sustained-release tablets were prepared, with a tablet weight of 320mg±3%

[0026] Formulation 500 tablets in Table 2

[0027]

[0028]

[0029] Get each raw and auxiliary material according to Table 2, add ethyl cellulose and hydroxypropyl cellulose in ethanol under stirring state, be made into coating solution, then make the immediate release of bupropion hydrochloride sustained-release tabl...

Embodiment 2

[0033] Embodiment 2: prepare 1000 tablets

[0034] Table 4

[0035]

[0036] *Remove after drying

[0037] Take the raw and auxiliary materials according to Table 4, place bupropion hydrochloride in a high-shear wet granulator, add 20% binder polyvinyl alcohol, stir to make granules, and sieve the wet granules (1mm sieve) After drying (drying in an oven at 60° C. for 1 hour), glyceryl behenate was added and mixed evenly, and tableted to obtain 600 tablet cores with a tablet weight of 320 mg±3%. The core of the tablet is coated with a slow-release layer, and the weight gain of the coating is 4%-7%, and the sustained-release tablet is further coated with an enteric layer to obtain a bupropion hydrochloride sustained-release tablet, and the weight gain of the coating is 1.5%-3.5%.

Embodiment 3

[0039] table 5

[0040]

[0041] *Remove after drying

[0042] Weigh raw and auxiliary materials according to Table 5, place bupropion hydrochloride in a high-shear wet granulator, add 20% binder polyvinyl alcohol, stir to make granules, and sieve the wet granules (1mm sieve) After drying (drying in an oven at 60° C. for 1 hour), glyceryl behenate was added and mixed evenly, and tableted to obtain 600 tablet cores with a tablet weight of 320 mg±3%. The core of the tablet is coated with a slow-release layer, and the weight gain of the coating is 4%-7%, and the sustained-release tablet is further coated with an enteric layer to obtain a bupropion hydrochloride sustained-release tablet, and the weight gain of the coating is 1.5%-3.5%.

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Abstract

The invention provides a preparation method for quick-release tablet cores of bupropion hydrochloride enteric-coated and sustained-release tablets. The preparation method comprises the following steps: dissolving polyvinyl alcohol in water to prepare 20% of a concentration adhesive; placing bupropion hydrochloride in a high-shear wet-process granulator; adding 20% of adhesive polyvinyl alcohol; stirring and cutting uniformly to obtain particles; sieving the wet particles by using a 1 mm sieve; after drying, granulating, adding superfine silica powder and mixing for 20 min; and adding glycerylbehenate and mixing uniformly, and carrying out tabletting to obtain the quick-release tablet cores of the bupropion hydrochloride enteric-coated and sustained-release tablets. High-shear wet-processgranulating is carried out, the process is simple and easy to operate, the production time is greatly shortened, loss of crude drugs is reduced, the yield is improved, and preparation stability is improved. The method is suitable for industrial production, and has high application value.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a preparation method for drug sustained-release tablets, in particular to a preparation method for an immediate-release tablet core of bupropion hydrochloride enteric-coated sustained-release tablets. Background technique [0002] Bupropion is an antidepressant drug, the molecular formula of bupropion hydrochloride is C 13 h 18 ClNO HCl, CAS No. 31677-93-7, chemical name (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone . The molecular weight is 276.2. Bupropion hydrochloride is a white crystalline powder, soluble in water, soluble in methanol, ethanol, acetone, ether and benzene, has good solubility in various solvents, the solubility in water is 312mg / ml, and the solubility in ethanol It is 193mg / ml, and its solubility in 0.1N HCl is 333mg / ml. It is stable under acidic conditions and unstable under alkaline conditions. Bupropion hydrochloride crude drug melting ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/30A61K31/137A61P25/24
CPCA61K9/0002A61K9/282A61K9/2866A61K9/2886A61K31/137
Inventor 刘学军赵海伟许英爱牛国琴
Owner SHANGHAI SUNTECH PHARMA
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