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Preparation method of nifedipine tablet

A technology for nifedipine and dipine tablets, applied in the field of nifedipine tablets, can solve the problem that the particle size of nifedipine raw materials is not easy to control, and achieve the effects of improving the dissolution rate and ensuring product quality

Active Publication Date: 2015-06-03
常州康普药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a method for preparing nifedipine tablets in order to overcome the deficiency that the particle size of the nifedipine raw material is not easy to control during the pulverization process in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Prepared per 10,000 pieces

[0017] (1) The raw material nifedipine is ultrafinely pulverized by a jet mill until the particle size D50 is less than 1 μm; other raw and auxiliary materials such as magnesium stearate, microcrystalline cellulose, carboxymethyl starch and compressible starch are pulverized by a universal high-speed pulverizer Pulverize, use vortex vibration sieve after pulverizing to pass through 120 mesh sieves; The raw and auxiliary materials that have been screened are weighed, take raw and auxiliary materials nifedipine 500g; Take magnesium stearate 20g, microcrystalline cellulose 200g, compressible starch 750g, Carboxymethyl starch 570g is standby.

[0018] (2) Prepare adhesive: (every ten thousand pieces): 400ml of 1-3% hydroxypropyl methylcellulose 30% ethanol solution, add 25ml polysorbate-80, add 10g sodium lauryl sulfate as binding agent;

[0019] (3) 500 g of nifedipine is transferred to the fluidized bed, and the fan frequency is set so that ...

Embodiment 2

[0025] Prepared per 10,000 pieces

[0026] (1) The raw material nifedipine is ultrafinely pulverized by a jet mill until the particle size D50 is less than 10 μm; other raw materials such as magnesium stearate, microcrystalline cellulose, carboxymethyl starch and compressible starch are pulverized by a universal high-speed pulverizer Grinding, after crushing, sieve through a 120-mesh sieve with a vortex vibrating sieve; weigh the sieved raw and auxiliary materials, take 500 g of the raw and auxiliary materials nifedipine, and use a jet mill to carry out ultrafine pulverization until the particle size is less than 1-10 μm; take the hard Magnesium fatty acid 20g, microcrystalline cellulose 166.6g, compressible starch 625.05g, carboxymethyl starch 528.35g, set aside;

[0027] (2) Prepare adhesive: (every ten thousand pieces): 800ml of 1-3% hydroxypropyl methylcellulose 30% ethanol solution, add 45ml polysorbate-80, add 30g sodium lauryl sulfate as binding agent;

[0028] (3) 50...

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Abstract

The invention provides a preparation method of a nifedipine tablet. The preparation method comprises the following steps: (1) using raw materials and auxiliary materials comprising nifedipine, carboxymethyl starch, PVP-K 30, lauryl sodium sulfate, microcrystalline cellulose, compressible starch, and ethanol; (2) using a jet mill to grind the nifedipine raw material in a superfine manner, controlling the particle size of the raw material to be 1-10 microns, and respectively crushing the microcrystalline cellulose, the carboxymethyl starch and the compressible starch; (3) adopting an ethanol solution of hydroxypropyl methyl cellulose as a binding agent, and adding PVP-K 30 and the lauryl sodium sulfate; (4) in a fluidized bed, spraying the binding agent onto the nifedipine raw material, and then enabling the raw material to pass through a sieve; (5) adding the raw material processed in the step (4), the carboxymethyl starch, the microcrystalline cellulose and the compressible starch into a granulator, dryly mixing, cutting, and spraying the binding agent to pelletize; (6) drying the prepared wet particles; (7) stabilizing the size of the particles; (8) mixing magnesium stearate with the stabilized particles, tableting, and coating.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to nifedipine tablets. Background technique [0002] Nifedipine is used for the prevention and treatment of angina pectoris caused by coronary heart disease, especially variant angina pectoris and angina pectoris caused by coronary artery spasm. It has no adverse effect on respiratory function, so it is suitable for patients with angina pectoris with obstructive airway diseases, and its curative effect is better than that of beta-receptor antagonists. It is also suitable for various types of hypertension, and has a good effect on intractable and severe hypertension. Because it can reduce afterload, it also has good curative effect on refractory congestive heart failure and is suitable for long-term use. [0003] First, the nifedipine raw material is pulverized, and then the processes such as granulation, tabletting and coating are carried out to prepare tablets. The above processes are mo...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/20A61K31/4422A61P9/10
Inventor 王苏南汤金春
Owner 常州康普药业有限公司
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