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Metoprolol tartrate sustained-release preparation and preparation method thereof

A technology for metoprolol tartrate and sustained-release tablets, which is applied in the field of metoprolol tartrate sustained-release tablets and their preparation, can solve the problems of affecting the progress of production, decreased production capacity, easy to produce sticking and so on, and achieves release Good speed, good stability and simple operation

Inactive Publication Date: 2014-08-20
SHANGHAI SINE PROMOD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, metoprolol tartrate is extremely hygroscopic, and it is easy to produce sticky punches after traditional wet granulation, which affects the production progress and leads to a decrease in production capacity.

Method used

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  • Metoprolol tartrate sustained-release preparation and preparation method thereof
  • Metoprolol tartrate sustained-release preparation and preparation method thereof
  • Metoprolol tartrate sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) adopt the inventive method:

[0031] Formula for 400,000 tablets: 40kg of metoprolol tartrate, 7.2kg of carboxymethylcellulose, 16kg of hypromellose, 10kg of calcium sulfate, 0.8kg of talc, and 0.8kg of micronized silica gel.

[0032] Pass the metoprolol tartrate, hypromellose, carboxymethylcellulose and calcium sulfate through a 60-mesh sieve for later use. Prepare 36 kg of 80% by weight ethanol solution. Preparation of coating solution: Coating premix commercially available Yicai YCW-E 1.0kg and 8kg of ethanol solution are mixed evenly.

[0033] Mix 40kg of metoprolol tartrate and 7.2kg of carboxymethylcellulose evenly, pour it into the fluidized bed (FL-120D), adjust the inlet air temperature to 35-50°C, and when the temperature of the material rises to 45°C, use the prepared 16kg of wetting liquid was sprayed and granulated. After spraying, the material was cooled to a room temperature of 26° C. and discharged, and the material was passed through a 18-mesh sie...

Embodiment 2

[0045] Formula for 400,000 tablets: 40 kg of metoprolol tartrate, 6 kg of povidone, 20 kg of ethyl cellulose, 12 kg of microcrystalline cellulose, 1.2 kg of polyethylene glycol, and 0.8 kg of talc.

[0046]Metoprolol tartrate, ethyl cellulose, povidone, and microcrystalline cellulose were respectively passed through a 50-mesh sieve. Preparation of wetting solution: the wetting solution is 38 kg of 75% by weight ethanol solution; preparation of coating solution: 2000.6 kg of commercially available Opadry and 7 kg of ethanol solution are evenly mixed.

[0047] Mix 40kg of metoprolol tartrate and 6kg of povidone evenly, pour it into the fluidized bed (FL-120D), adjust the inlet air temperature, and spray with 17kg of the prepared wetting liquid when the temperature of the material rises to 50°C For granulation, after spraying, cool to room temperature 28°C and discharge the material, and pass the material through a 20-mesh sieve to obtain dry granules 1. Mix 20kg of ethyl cellul...

Embodiment 3

[0052] Formula for 400,000 tablets: 40kg of metoprolol tartrate, 16kg of methylcellulose, 8kg of hypromellose, 8kg of starch, 1.2kg of sodium lauryl sulfate, and 0.8kg of talc.

[0053] Metoprolol tartrate, ethyl cellulose, povidone and microcrystalline cellulose were respectively passed through a 60-mesh sieve. Preparation of wetting solution: the wetting solution is 37 kg of 70% by weight ethanol solution; preparation of coating solution: commercially available Opadry 2000.8 kg is mixed with 9 kg of ethanol solution evenly.

[0054] Mix 40kg of metoprolol tartrate and 8kg of hypromellose evenly, pour it into the fluidized bed (FL-120D), adjust the inlet air temperature, and use 15kg of the prepared wetting solution when the temperature of the material rises to 48°C. Spray granulation. After spraying, cool to room temperature 25°C and discharge the material. Pass the material through a 20-mesh sieve to obtain dry granules 1. Mix 16kg of methyl cellulose and 8kg of starch eve...

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Abstract

The invention discloses a metoprolol tartrate sustained-release tablet and a preparation method thereof. The metoprolol tartrate sustained-release tablet is prepared from the following components in percentage by weight: 39-57 percent of metoprolol tartrate, 17-31 percent of retardant, 4-15 percent of adhesive, 9-24 percent of filler, 1-3 percent of lubricant, 1-2 percent of flow aid and 1-4 percent of coating premix. According to the preparation method, a method of twice separately granulating metoprolol tartrate and partial medicinal auxiliaries is adopted, and a fluidized bed is adopted for granulating. Compared with a traditional wet granulation method, the preparation method has the advantages that raw and auxiliary materials are separately granulated by the fluidized bed according to different properties, and play roles in improving particle fluidity, in particular resisting viscosity. The preparation is good in stability, good in releasing rate, and is beneficial to clinical use. The method is easy to operate, is suitable for large-scale industrial production, and has a higher application value.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a metoprolol tartrate slow-release tablet and a preparation method thereof. Background technique [0002] At present, commonly used anti-anginal drugs mainly include calcium antagonists, nitrates and β-blockers. Beta blockers are considered to be one of the most commonly used drugs in the field of cardiovascular disease treatment, and are the first-line drugs for the treatment of major cardiovascular diseases such as heart failure, hypertension, arrhythmia and coronary heart disease. As the world's first selective β1 receptor blocker, metoprolol was successfully developed in Sweden's Hassle laboratory in 1969. Metoprolol has been widely used in the treatment of myocardial infarction, hypertension, hypertrophic cardiomyopathy, angina pectoris, aortic dissection, hyperthyroidism, arrhythmia, etc. . It can not only attenuate the effects of catecholamines related to physical and ment...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/138A61P9/10A61P9/12A61P9/00A61P9/06A61P5/16
Inventor 李丁康巍梅锦平肖志勇孙蓉
Owner SHANGHAI SINE PROMOD PHARMA
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