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Medicinal composition containing sotalol hydrochloride and preparing method of composition

A technology of sotalol hydrochloride and composition, which is applied in the field of medicinal compositions containing sotalol hydrochloride and its preparation field, can solve potential safety hazards of patients, increase the workload of medical workers, and increase the size of insoluble particles, etc. problems, to achieve the effect of reducing security risks

Inactive Publication Date: 2018-09-14
王美娟 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The inventor found in the test that after the sotalol hydrochloride freeze-dried composition for injection was reconstituted with 5% glucose injection, the insoluble particles became larger as the storage time prolonged, which virtually brought safety to patients. Hidden dangers, while increasing the workload of medical workers, the inventors have tested the current method, but can not solve this problem

Method used

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  • Medicinal composition containing sotalol hydrochloride and preparing method of composition
  • Medicinal composition containing sotalol hydrochloride and preparing method of composition
  • Medicinal composition containing sotalol hydrochloride and preparing method of composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027]

[0028] Preparation Process

[0029] The mannitol, sodium bisulfite and sotalol hydrochloride of the prescribed amount are dissolved in water for injection accounting for 80% of the total volume, stirred and mixed evenly; the pH value is adjusted with an appropriate amount of pH value, and the volume is adjusted to the total volume with water for injection. Measure, stir and mix evenly; filter, fill in neutral borosilicate glass injection bottles according to 4ml / bottle, stopper halfway, freeze-dry, and visually inspect to get the finished product.

[0030] Freeze-drying curve:

[0031] 1). Pre-freezing stage: place the filled and semi-stoppered semi-finished product on the partition in the freeze-drying cabinet for pre-freezing, and make the semi-finished product reach the pre-freezing temperature -45°C in the shortest possible time. 150min;

[0032] 2). Sublimation drying stage: the vacuum degree in the drying oven reaches 100mTorr; the main drying temperature i...

Embodiment 2

[0035] prescription

[0036]

[0037] Preparation Process

[0038] The mannitol, sodium bisulfite and sotalol hydrochloride of the prescribed amount are dissolved in water for injection accounting for 80% of the total volume, stirred and mixed evenly; the pH value is adjusted with an appropriate amount of pH value, and the volume is adjusted to the total volume with water for injection. Measure, stir and mix evenly; filter, fill in neutral borosilicate glass injection bottles according to 4ml / bottle, stopper halfway, freeze-dry, and visually inspect to get the finished product.

[0039] Freeze-drying curve:

[0040] 1). Pre-freezing stage: place the filled and semi-stoppered semi-finished product on the partition in the freeze-drying cabinet for pre-freezing, and make the semi-finished product reach the pre-freezing temperature -48°C in the shortest possible time, the time is 120min ;

[0041] 2). Sublimation drying stage: When the vacuum degree in the drying oven reache...

Embodiment 3

[0044] prescription

[0045]

[0046] Preparation Process:

[0047] The mannitol, sodium bisulfite and sotalol hydrochloride of the prescribed amount are dissolved in water for injection accounting for 80% of the total volume, stirred and mixed evenly; the pH value is adjusted with an appropriate amount of pH value, and the volume is adjusted to the total volume with water for injection. Measure, stir and mix evenly; filter, fill in neutral borosilicate glass injection bottles according to 4ml / bottle, stopper halfway, freeze-dry, and visually inspect to get the finished product.

[0048] Freeze-drying curve:

[0049] 1). Pre-freezing stage: place the filled and semi-stoppered semi-finished product on the partition in the freeze-drying cabinet for pre-freezing, and make the semi-finished product reach the pre-freezing temperature in the shortest possible time. The pre-freezing temperature range is - 42℃, the time is 180min;

[0050] 2). Sublimation drying stage: When the ...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a medicinal composition containing sotalol hydrochloride and a preparing method of the composition. The medicinalcomposition containing sotalol hydrochloride is mainly composed of active components of sotalol hydrochloride, mannitol, sodium hydrogen sulfite and a pH value regulator. After a sotalol hydrochloridefreeze-drying composition for injection and 5% glucose injection are redissolved, insoluble particles of the freeze-drying composition are not obviously changed, and hidden safety hazards brought toa patient due to enlargement of the insoluble particles are greatly reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing sotalol hydrochloride and a preparation method thereof. Background technique [0002] Ventricular arrhythmia is a heart rhythm disorder originating in the ventricles. It is a common arrhythmia, including premature ventricular contractions (ventricular premature beats), ventricular tachycardia (ventricular tachycardia), and ventricular fibrillation (ventricular fibrillation). Ventricular tachycardia is an arrhythmia that can lead to serious consequences such as ventricular fibrillation and sudden death. It is necessary to make a clear diagnosis in time, judge the cause, inducement and impact on prognosis of ventricular tachycardia and deal with it in time. Sotalol hydrochloride is a drug suitable for the treatment of ventricular and supraventricular arrhythmias, hypertension, angina pectoris and myocardial infarction, especially...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/18A61K47/26A61K47/20A61P9/06
CPCA61K9/0019A61K9/19A61K31/18A61K47/20A61K47/26A61P9/06
Inventor 王美娟杜婷
Owner 王美娟
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