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A kind of sotalol hydrochloride preparation

A technology of sotalol hydrochloride and hydrochloric acid, which is applied in the field of medicine, can solve the problems of untimely treatment of arrhythmia patients, poor dissolution rate and low dissolution rate of sotalol hydrochloride tablets, and facilitate industrialized large-scale production and improve drug production. Good curative effect and stability

Active Publication Date: 2021-05-25
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injection works quickly and is mostly used for the treatment of critically ill patients. However, most of them use intravenous injection, which takes a long time to take medicine, which brings a lot of inconvenience to patients.
Ordinary tablets on the market are easy to carry, but clinical data show that the dissolution rate is low, and the blood concentration can only reach the peak after 2-3 hours after oral administration. It cannot be treated in time for patients with sudden severe arrhythmia
[0005] Therefore, selecting appropriate excipients and rationally optimizing the preparation process to solve the problems of poor dissolution and slow onset of sotalol hydrochloride tablets have positive significance for strengthening the clinical application of the drug

Method used

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  • A kind of sotalol hydrochloride preparation
  • A kind of sotalol hydrochloride preparation
  • A kind of sotalol hydrochloride preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription of 1000 tablets

[0032]

[0033] Preparation:

[0034] 1) Micronize 80g of sotalol hydrochloride and pass through a 100-mesh sieve, mix evenly with 10g of carmellose calcium, 4g of sodium alginate and 120g of filler;

[0035] 2) Mix the binder solution with the mixture in step 1) to make a soft material, pass through a 20-mesh sieve, and dry at 55-65°C for 4 hours;

[0036] 3) Mix the mixture in step 2) with 1.0 g of lubricant and press into tablets to make 1000 tablets.

[0037] 4) Mix hypromellose, povidone, and talcum powder, add purified water, stir for 0.5-1h, and make a suspension;

[0038] 5) Add the plain tablet prepared in step 3) into a multifunctional coating machine, and preheat to 60-65°C;

[0039] 6) Spray the suspension in step 1) evenly on the plain tablet through a peristaltic pump. During the spraying process, control the air inlet temperature to 65-75° C., stop coating after the weight gain is 2.5%, and let it cool to obtain.

Embodiment 2

[0041] 1) Micronize 80g of sotalol hydrochloride and pass through a 100-mesh sieve, mix evenly with 5g of carmellose calcium, 6g of sodium alginate and 120g of filler;

[0042] 2) Mix the binder solution with the mixture in step 1) to make a soft material, pass through a 20-mesh sieve, and dry at 55-65°C for 4 hours;

[0043] 3) Mix the mixture in step 2) with 1.0 g of lubricant and press into tablets to make 1000 tablets.

[0044] 4) Mix hypromellose, povidone, and talcum powder, add purified water, stir for 0.5-1h, and make a suspension;

[0045] 5) Add the plain tablet prepared in step 3) into a multifunctional coating machine, and preheat to 60-65°C;

[0046] 6) The suspension in step 1) is evenly coated on the plain tablet by spraying with a peristaltic pump. During the spraying process, the temperature of the air inlet is controlled to be 65-75° C., and the coating is stopped after the weight gain is 1.0%, and allowed to cool.

Embodiment 3

[0048] 1) Micronize 80g of sotalol hydrochloride and pass through a 100-mesh sieve, mix evenly with 15g of carmellose calcium, 2g of sodium alginate and 120g of filler;

[0049] 2) Mix the binder solution with the mixture in step 1) to make a soft material, pass through a 20-mesh sieve, and dry at 55-65°C for 4 hours;

[0050] 3) Mix the mixture in step 2) with 0.5 g of lubricant and press into tablets to make 1000 tablets.

[0051] 4) Mix hypromellose, povidone, and talcum powder, add purified water, stir for 0.5-1h, and make a suspension;

[0052] 5) Add the plain tablet prepared in step 3) into a multifunctional coating machine, and preheat to 60-65°C;

[0053] 6) Spray the suspension in step 1) evenly on the plain tablet through a peristaltic pump. During the spraying process, control the air inlet temperature to 65-75° C., stop coating after the weight gain is 4.5%, and let it cool to obtain.

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PUM

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Abstract

The invention discloses a sotalol hydrochloride preparation. In the present invention, the active ingredient sotalol hydrochloride is micronized, mixed with carboxymethylcellulose calcium, sodium alginate, fillers and lubricants, granulated, dried, and coated to prepare stomach-soluble tablets, which improves the sotalol hydrochloride The dissolution rate and stability of Lol can be quickly absorbed by patients after taking it, and the time to peak blood drug can be shortened. In the preparation process, few types of auxiliary materials are selected, the toxicity is low, the process is simple, and the industrial production is easy.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a sotalol hydrochloride tablet and a preparation method thereof. Background technique [0002] Sotalol hydrochloride is the only antiarrhythmic drug that has both β-receptor blockade and class III action potential (ADP) prolongation, and can also be used to treat angina pectoris and hypertension. The drug was synthesized for the first time in 1966 and was approved by the FDA for marketing in 1992. Due to its remarkable curative effect, stable drug effect, and few adverse reactions, it has been widely recognized clinically and is used as a first-line drug for the treatment of sinus rhythm and atrial fibrillation. The chemical name of sotalol hydrochloride is (R,S)-4'-(1-hydroxy-2-isopropylaminoethyl)methanesulfonanilide hydrochloride, and its structural formula is as follows: [0003] [0004] At present, the dosage forms of sotalol hydrochloride on the market mainly includ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/18A61K47/36A61K47/38A61P9/06A61P9/12A61P9/10
CPCA61K9/205A61K9/2054A61K9/2866A61K9/2893A61K31/18
Inventor 张贵民秦启飞刘阿利
Owner LUNAN PHARMA GROUP CORPORATION
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