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Method for preparing sotalol hydrochloride of injection

A technology for sotalol hydrochloride and injection, which is applied in the direction of freeze-drying delivery, cardiovascular system diseases, active ingredients of amides, etc., can solve the problems of increasing the workload of doctors and nurses, inconvenience of popularization and application, and the increase of related substances, and achieves Wide range of applications, strong effects, and few side effects

Inactive Publication Date: 2004-03-17
吉林市卓怡康纳制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinical practice has shown that the oral dosage form of sotalol hydrochloride tablets has a relatively slow onset of effect and is not suitable for rescuing critically ill patients; although the injection type of sotalol hydrochloride injection has a rapid onset of effect, due to the need for After high-temperature sterilization, the product will be partially degraded during the storage period, resulting in the increase of related substances. At the same time, because it is administered by intravenous injection during use, it is inconvenient to take medicine and increases the work of doctors and nurses. amount, which brings a lot of inconvenience to the popularization and application of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0160] The proportioning of each raw material is:

[0161] Sotalol Hydrochloride 20g

[0162] Dextran 40 100g

[0163] Add water for injection to 1200ml to make 1000 bottles

[0164] The preparation method is as follows: measure 960 milliliters of water for injection, heat to boiling, add 100 grams of dextran 40, stir to dissolve, add 1.2 grams of activated carbon for needles, and stir evenly; weigh 20 grams of sotalol hydrochloride and add to the above solution, Add water for injection to 1200 ml, stir to dissolve, absorb for 20 minutes, pour into dilute tank after decarburization; adjust pH value to 4.5 with 10% hydrochloric acid solution or 4% sodium hydroxide solution, After filtering through a microporous membrane of 0.22 μm, it was sterilized and filtered through a microporous membrane of 0.22 μm, then bottled, half stoppered, and freeze-dried for 23 hours, including: pre-freezing temperature -40 ° C, freezing for 2 hours; primary sublimation: when dry When the vacuum...

Embodiment 2

[0167] The proportioning of each raw material is:

[0168] Sotalol Hydrochloride 40g

[0169] Sodium chloride 80 grams

[0170] Add water for injection to 2000ml to make 1000 bottles

[0171] The preparation method is as follows: measure 1600 milliliters of water for injection, add 80 grams of sodium chloride, stir to dissolve, add 2 grams of activated carbon for needles, and stir evenly; weigh 40 grams of sotalol hydrochloride and add it to the above solution, and add additional injection Water to 2000 ml, stir to dissolve, absorb for 20 minutes, pour into dilute tank after decarburization; use 10% hydrochloric acid solution or 4% sodium hydroxide solution to adjust the pH value to 4.5, and pass through 0.45μm micropores Filtered by filter membrane, then sterilized and filtered by 0.22μm microporous filter membrane, bottled, half stoppered, and freeze-dried for 23 hours, including: pre-freezing temperature -40°C, freezing for 2 hours; primary sublimation: when the vacuum de...

Embodiment 3

[0173] The proportioning of each raw material is:

[0174] Sotalol Hydrochloride 60g

[0175] Mannitol 80g

[0176] Add water for injection to 2400ml to make 1000 bottles

[0177] The preparation method is basically the same as Example 2 except that the raw materials and consumption are different.

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PUM

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Abstract

The freeze dried sotalol hydrochloride for injection contains sotalol hydrochloride 20-80 g and excipient 40-100 g in each 1000 ampules. As freeze dried preparation for injection, the present invention has the advantages of fast absorption and action and high stability in the preservation period. It may be administrated via intravenous transfusion to further raise the medicine stability. The present invention is suitable for ventricular fast arythmia, etc.

Description

technical field [0001] The invention relates to a freeze-dried sotalol hydrochloride for injection, which belongs to a pharmaceutical preparation. 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 can prolong the effective refractory period of the atrium and ventricle, slow down atrioventricular conduction, and block the forward and reverse conduction of atrioventricular bypass. Supraventricular tachycardia is effective, and its β-blocking effect can slow down the supraventricular tachycardia. It is clinically applicable to various life-threatening ventricular tachyarrhythmias. [0003] Sotalol hydrochloride tablets and sota...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/18A61P9/06
Inventor 赵国华李建英
Owner 吉林市卓怡康纳制药有限公司
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