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A kind of sotalol hydrochloride preparation and preparation method thereof

一种洛尔片剂、盐酸的技术，应用在盐酸索他洛尔制剂及其制备领域，能够解决水包油型药物药效无法得到充分利用、不能解决病人病变、使用麻烦等问题，达到溶出速率快、增加附着面积、提高溶出度的效果

Inactive Publication Date: 2018-11-23
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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  • A kind of sotalol hydrochloride preparation and preparation method thereof
  • A kind of sotalol hydrochloride preparation and preparation method thereof
  • A kind of sotalol hydrochloride preparation and preparation method thereof

Examples

Experimental program
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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 medicine, and in particular relates to a sotalol preparation and a preparation method thereof. Sotalol tablet of the present invention is made up of tablet core and coating layer, and the composition of tablet core comprises sotalol hydrochloride, filler, disintegrant, binding agent, lubricant; The composition of coating layer comprises formazan Acrylic Polymer, Triacetin and Talc. The dissolution effect of the sotalol hydrochloride tablet prepared by the invention is good, and the content of related substances is relatively low. The invention shortens the preparation process of the sotalol hydrochloride tablet, reduces the production cycle of the product, and solves the problem of pressing The problem of sticking and punching in the process of tableting has been greatly improved, and the production efficiency of medicines has been greatly improved, and the quality of products has been further 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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K31/18A61K47/26A61K47/38A61K47/10A61P9/06
CPCA61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K9/2813A61K9/282A61K9/284A61K31/18A61P9/06
Inventor 安宁李梅
Owner 安宁
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