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A kind of sotalol hydrochloride tablet and preparation method thereof

A technology of lol tablets and hydrochloric acid, applied in the field of medicine, can solve the problems of safe drug use, slow dissolution rate of tablets, unsatisfactory effects, etc., and achieves the effects of low content of related substances, fast dissolution, and simple preparation process

Active Publication Date: 2021-05-11
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the existing sotalol hydrochloride preparations, the dissolution rate of the tablet is slow, which cannot satisfy the effect, and brings great safety hazards to safe drug use

Method used

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  • A kind of sotalol hydrochloride tablet and preparation method thereof
  • A kind of sotalol hydrochloride tablet and preparation method thereof
  • A kind of sotalol hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: the prescription of 1000 tablets:

[0028]

[0029] The prescription of coating solution is:

[0030] Hydroxypropyl methylcellulose 4g, titanium dioxide 0.55g, talcum powder 1g.

[0031] The preparation method is as follows: dissolving hydroxypropyl methylcellulose and titanium dioxide in 5% pure water, and then adding talcum powder to obtain a coating solution.

[0032] 1000 tablets Preparation method:

[0033] (1) Crushing the raw materials through a 100-mesh sieve, dissolving in citric acid-sodium citrate buffer solution, adjusting the pH value to 5.0-6.0, and obtaining the mixture by rotary evaporation;

[0034] (2) Mix the mixture obtained in step (1) with microcrystalline cellulose, lactose, and low-substituted hypromellose, add 4% hypromellose to granulate, pass through a 20-mesh sieve, and dry at 60°C for 4 hours , after adding magnesium stearate and mixing, pressing into tablets;

[0035] (3) Dissolving hydroxypropyl methylcellulose and tit...

Embodiment 2

[0037] Embodiment 2: the prescription of 1000 tablets

[0038]

[0039] The prescription of coating solution is:

[0040] Hydroxypropyl methylcellulose 2g, titanium dioxide 0.1g, talcum powder 1g.

[0041] The preparation method is as follows: dissolving hydroxypropyl methylcellulose and titanium dioxide in 5% pure water, and then adding talcum powder to obtain a coating solution.

[0042] 1000 tablets of preparation method: coating weight gain 1%, other with embodiment 1.

Embodiment 3

[0043] Embodiment 3: the prescription of 1000 tablets

[0044]

[0045] The prescription of coating solution is:

[0046] Hydroxypropyl methylcellulose 6g, titanium dioxide 1g, talcum powder 1g.

[0047] The preparation method is as follows: dissolving hydroxypropyl methylcellulose and titanium dioxide in 5% pure water, and then adding talcum powder to obtain a coating solution.

[0048] 1000 pieces of preparation method: coating weight gain 5%, other is the same as embodiment 1.

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Abstract

The invention relates to the field of medicine, in particular to a sotalol hydrochloride tablet and a preparation method thereof, wherein the tablet is obtained by adding sotalol hydrochloride raw materials into a buffer solution, stirring and dissolving, and rotary evaporation to obtain the mixture; and then It is prepared by mixing it with pharmaceutically acceptable auxiliary materials, compressing into tablets, and then coating. Compared with the prior art, the sotalol hydrochloride tablet has low content of related substances, rapid dissolution and simple preparation process.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a sotalol hydrochloride tablet and a preparation method thereof. Background technique [0002] The chemical name of sotalol hydrochloride is: (RS)·4·(1·hydroxy·2·isopropylaminoethyl) methanesulfonanilide hydrochloride. It belongs to class II antiarrhythmic drugs (β-adrenergic receptor blockers), and also has the effect of class III antiarrhythmic drugs (drugs that prolong the action potential duration). Side effects are small, sotalol has the advantages of prolonging atrial and ventricular refractory periods, slowing down atrioventricular conduction, and blocking the forward and reverse conduction of atrioventricular bypass. Supraventricular tachycardia is effective, and its β-blocker effect can slow down the supraventricular tachycardia. It is clinically applicable to various life-threatening ventricular tachyarrhythmias. [0003] Currently, preparations using sotalol hydrochloride as ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/18A61P9/06
CPCA61K9/2054A61K9/2866A61K31/18
Inventor 柳春娣秦启飞杨本官
Owner SHANDONG NEWTIME PHARMA
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