Propranolol hydrochloride tablets and preparation method thereof

A technology of propranolol hydrochloride tablets and propranolol hydrochloride, applied in pill delivery, cardiovascular system diseases, antineoplastic drugs, etc., can solve the unsatisfactory content uniformity and dissolution rate of ordinary propranolol hydrochloride tablets and other issues, to achieve the effect of improving bioavailability, good compressibility, and ensuring product uniformity

Active Publication Date: 2014-05-21
常州康普药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims to solve the technical problem that the content uniformity and dissolution rate of ordinary propranolol hydrochloride tablets are not ideal, adopts PEG6000 as carrier to prepare propranolol hydrochloride solid dispersion, and then prepares solid dispersion type tablet, obtained propranolol hydrochloride The content uniformity of naphthalene tablets is good, and the dissolution rate can reach more than 90% of the labeled amount, which improves the bioavailability of the drug and ensures the quality of the drug

Method used

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  • Propranolol hydrochloride tablets and preparation method thereof
  • Propranolol hydrochloride tablets and preparation method thereof
  • Propranolol hydrochloride tablets and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1 preparation method of propranolol hydrochloride sheet

[0020] 1), Preparation of solid dispersion carrier: Weigh 200g of PEG6000 and add 300mL of 95% (ml / ml) ethanol until the PEG6000 is completely dissolved to obtain an auxiliary material solution; 100g of propranolol hydrochloride is dissolved in 300ml of 95% (ml / ml) ethanol to obtain drug solution; uniformly mix the auxiliary material solution and the main drug solution to obtain a mixed solution; vacuum-dry the mixed solution for 12 hours, the vacuum degree is less than 10Pa, the temperature is 35°C, and the moisture content is controlled to be less than 1%;

[0021] 2), tablet preparation: crush the material obtained in step 1), and pass through a 100-mesh standard sieve to obtain a solid dispersion powder; put the obtained solid dispersion powder and 430 g of dextrin into a granulator, dry mix for 5 minutes, and add an appropriate amount of 40% Wet with ethanol, set the frequency of the shear knife t...

Embodiment 2

[0024] Embodiment 2 preparation method of propranolol hydrochloride sheet

[0025] 1), preparation of solid dispersion carrier: Weigh 200g of PEG6000 and add 400ml 95% (ml / ml) ethanol until PEG6000 is completely dissolved to obtain adjuvant solution; 100g propranolol hydrochloride is dissolved in 400ml 95% (ml / ml) ethanol to obtain drug solution; uniformly mix the auxiliary material solution and the main drug solution to obtain a mixed solution; vacuum-dry the mixed solution for 24 hours, the vacuum degree is less than 10Pa, the temperature is 55°C, and the moisture content is controlled to be less than 1%;

[0026] 2), tablet preparation: crush the material obtained in step 1), and sieve through a 120-mesh standard sieve to obtain a solid dispersion powder; put the obtained solid dispersion powder and 430 g of dextrin into a granulator, dry mix for 10 minutes, and add an appropriate amount of 50% Wet with ethanol, set the frequency of the shear knife to 30Hz, and shear and gr...

Embodiment 3

[0030] Embodiment 3 tablet quality inspection

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Abstract

The invention relates to a preparation method for propranolol hydrochloride tablets. The method comprises the following steps of: 1) preparing a carrier for solid dispersoid, namely weighing 200 grams of polyethylene glycol (PEG) 6000, dissolving the PEG 6000 in 95 percent (ml / ml) ethanol to obtain an auxiliary material solution, dissolving 100 grams of propranolol hydrochloride in 95 percent (ml / ml) ethanol to obtain a main medicine solution, mixing the auxiliary material solution and the main medicine solution uniformly to obtain a mixed solution, and drying the mixed solution at temperature of between 35 and 55 DEG C under the vacuum with the vacuum degree of less than 10 Pa for 12 to 24 hours; 2) preparing tablets, namely crushing the materials obtained in the step 1), and sieving to obtain solid dispersoid powder; adding a formula dose of dextrin into the solid dispersoid powder, and putting the mixture into a granulator, performing dry mixing for 5 to 10 minutes, adding 40 to 50 percent ethanol serving as an adhesive, and granulating; sieving the materials with a 20-to-30-mesh sieve, granulating in the wet state, and transferring to a fluidized drying machine for drying until the moisture is 5 to 8 percent; and sieving the dried granules with a 20-to-30-mesh sieve, granulating, and mixing the obtained granules and a lubricating agent in a formula uniformly for tabletting.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a method for preparing propranolol hydrochloride tablets. Background technique [0002] Propranolol hydrochloride is a β-receptor blocking drug, which blocks myocardial β receptors, slows down the heart rate, inhibits cardiac contractility and conduction, reduces circulating blood volume, and reduces myocardial oxygen consumption. Clinically, it is mainly used to treat arrhythmia caused by various reasons, and it can also be used for angina pectoris and hypertensive pheochromocytoma (preparation before surgery). [0003] The content uniformity of ordinary propranolol hydrochloride tablets is measured according to the method of Appendix XE of the Chinese Pharmacopoeia. Although it meets the requirements of the Pharmacopoeia, the absolute value A of the difference between the labeled amount and the mean value specified in Appendix XE is often larger, and A+1.80S...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/138A61K47/36A61K47/34A61P9/06A61P9/12A61P9/10A61P35/00
Inventor 王苏南汤金春周云飞
Owner 常州康普药业有限公司
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