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Sotalol hydrochloride preparation and preparation method thereof

A technology of sotalol hydrochloride and Lol tablets, which is applied in the fields of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve the problem that the efficacy of oil-in-water drugs cannot be fully utilized and cannot solve the problem of patients. Diseases, troublesome use and other problems, to achieve the effect of fast dissolution rate, increase the attachment area, and improve the dissolution rate

Inactive Publication Date: 2018-05-04
安宁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the current sotalol hydrochloride drug injection and powder injection drug use is more troublesome, and the injection is easily degraded by high temperature treatment, and the drug effect of the oil-in-water type drug cannot be fully utilized. Sotalol hydrochloride tablet is currently still available There is no relevant patent report, but sotalol hydrochloride tablets have been disclosed in the existing literature. Most of the currently used sotalol hydrochloride tablets have low dissolution rate and slow onset of action. In the face of some emergencies , in the case of not being able to go to the doctor for emergency treatment in time, the existing tablet cannot solve the disease caused by the arrhythmia of the patient, so there is an urgent need for a tablet with a short dissolution time and high dissolution efficiency

Method used

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  • Sotalol hydrochloride preparation and preparation method thereof
  • Sotalol hydrochloride preparation and preparation method thereof
  • Sotalol hydrochloride preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044]

[0045] Preparation Process:

[0046]Sotalol hydrochloride is pulverized through 80 mesh sieves, and then sotalol hydrochloride is fully mixed with blank pellets made of a mixture of microcrystalline cellulose and lactose and part of 4% hypromellose is added. Completely dissolve in an ethanol solution with a pH value of 5.5, stir for 1.0 h, remove ethanol by rotary evaporation, add disintegrant and remaining binder after drying to granulate, pass through a 20-mesh sieve, dry at 60°C for 4 h, add lubricant and mix After compressing the tablet, add absolute ethanol to the liquid preparation container and stir, and evenly sprinkle the coating powder mixed with the prescribed amount of methacrylic acid polymer, triacetin, and talcum powder into the vortex liquid surface , keep stirring until the coating solution is completely mixed, the obtained solution is sieved, and the prepared tablet core is added to the coating pan, adjust the rotation speed of the coating pan, pr...

Embodiment 2

[0048]

[0049] The components of the auxiliary materials were changed accordingly, the weight of the coating was increased by 1.5%, and the preparation process was the same as in Example 1.

Embodiment 3

[0051]

[0052]

[0053] The components of the auxiliary materials were changed accordingly, the weight of the coating was increased by 4%, and the preparation process was the same as in Example 1.

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Abstract

The invention belongs to the technical field of medicines and in particular relates to a sotalol preparation and a preparation method thereof. A sotalol tablet is prepared from a tablet core and a coating layer; the tablet core is prepared from sotalol hydrochloride, a filling agent, a disintegrating agent, an adhesive and a lubricant; the coating layer is prepared from a methacrylic acid polymer,glycerol triacetate and talcum powder. The sotalol hydrochloride tablet prepared by the preparation method has a good dissolution effect and the content of relative substances is relatively low; a preparation technology flow of the sotalol hydrochloride tablet is shortened and the production period of a product is shortened; a sticking problem in a tabletting process is solved; the production efficiency of the medicines is extremely improved; furthermore, the quality of the product is improved.

Description

Technical field: [0001] The invention relates to a sotalol hydrochloride preparation and a preparation method thereof, belonging to the field of chemical drug preparations. Background technique: [0002] Sotalol hydrochloride, also known as 4'-(1-hydroxy-2-isopropylaminoethyl) methanesulfonanilide hydrochloride, is an antiarrhythmic drug with both β-blocker and potassium channel blocking properties , developed by Bristol-Myers Squibb, was first approved for marketing in the UK in 1974, and was approved by the FDA for marketing in the United States in 1993. Sotalol is the first-line drug for maintaining sinus rhythm in patients with atrial fibrillation without structural heart disease. Moreover, because of its receptor blocking function, it is especially suitable for patients with atrial fibrillation combined with coronary heart disease, and can effectively reduce the ventricular rate and relieve the symptoms of atrial fibrillation. Due to its clear mechanism of action, long...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K31/18A61K47/26A61K47/38A61K47/10A61P9/06
CPCA61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K9/2813A61K9/282A61K9/284A61K31/18A61P9/06
Inventor 李梅
Owner 安宁
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