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Ibutilide fumarate injection and preparation method thereof

A technology of ibutilide fumarate and injection, which is applied in the field of injection and can solve problems such as poor thermal stability

Active Publication Date: 2010-03-10
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The purpose of this invention is to provide a kind of ibutilide fumarate injection, to solve the problem of poor thermal stability of the injection of the prior art, ensure that the injection can still be in a stable state after autoclaving, both It can improve the level of sterility assurance, thereby improving clinical safety and ensuring its quality stability

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  • Ibutilide fumarate injection and preparation method thereof
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  • Ibutilide fumarate injection and preparation method thereof

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Embodiment 1

[0039] The ibutilide fumarate injection of the present invention is prepared from the following components: 1000 mg of ibutilide fumarate; 2000 mg of sodium bicarbonate; 5000 mg of sodium bisulfite; 80000 mg of sodium chloride; add water for injection to 10000 ml.

[0040] Its preparation method is as follows:

[0041] 1) Solvent pretreatment: put about 5,000 ml of water for injection into the No. 1 preparation tank, cool to room temperature, and inject CO 2 About 15 to 30 minutes to saturation, measure the pH value, about 6.0.

[0042] 2) Injection preparation: ①Weigh the prescribed amount of sodium bicarbonate, sodium bisulfite, sodium chloride plus about 2000 ml of water for injection, stir slightly to dissolve, and obtain the auxiliary material solution; ②Weigh the prescribed amount of yi fumarate Bullitt, add about 1000 ml of water for injection, stir to dissolve completely, and obtain the raw material solution; ③Add the auxiliary material solution and the raw material s...

Embodiment 2

[0053] Ibutilide fumarate injection of the present invention is made of following raw materials: 1000 mg of ibutilide fumarate; 10000 mg of sodium bicarbonate; 20000 mg of sodium bisulfite; 70000 mg of sodium chloride; 10000ml.

[0054] Its preparation method is as follows:

[0055] 1) Solvent pretreatment: put about 5,000 ml of water for injection into the No. 1 preparation tank, cool to room temperature, and inject CO 2 About 15 to 30 minutes to saturation, measure the pH value, about 6.0.

[0056] 2) Injection preparation: ①Weigh the prescribed amount of sodium bicarbonate, sodium bisulfite, sodium chloride plus about 2000 ml of water for injection, stir slightly to dissolve, and obtain the auxiliary material solution; ②Weigh the prescribed amount of yi fumarate Bullite, add about 1000 ml of water for injection, stir to dissolve completely, and obtain the raw material solution; ③ add the auxiliary material solution and the raw material solution to the No. Evenly, adjust ...

Embodiment 3

[0066] Ibutilide fumarate injection of the present invention is made of following raw materials: 1000 mg of ibutilide fumarate; 5000 mg of sodium bicarbonate; 10000 mg of sodium bisulfite; 75000 mg of sodium chloride; 10000ml.

[0067] Its preparation method is as follows:

[0068] 1) Solvent pretreatment: put about 5000 ml of water for injection into the concentrated preparation tank, cool to room temperature, and inject CO 2 About 15 to 30 minutes to saturation, measure the pH value, about 6.0.

[0069] 2) Injection preparation: ①Weigh the prescribed amount of sodium bicarbonate, sodium bisulfite, sodium chloride plus about 1000 ml of water for injection, stir slightly to dissolve, and obtain the auxiliary material solution; ②Weigh the prescribed amount of idyl fumarate Bullite, add about 1000 ml of water for injection, stir to dissolve completely, and obtain the raw material solution; ③ Add the auxiliary material solution and the raw material solution to the No. 1 prepara...

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Abstract

The invention relates to ibutilide fumarate injection which comprises the following components by weight percent in volume (mg / ml): 0.093-0.107 ibutilide fumarate, 0.2-1.0 sodium bicarbonate, 0.5-2.0 sodium bisulfite and 6.0-9.0 sodium chloride, wherein, water for injection is used for constant volume. The ibutilide fumarate injection of the invention has good thermostability; and the injection can be still in a stable status after hot pressing sterilization, thus improving sterility assurance level, clinical safety and quality stability.

Description

technical field [0001] The invention relates to an injection, in particular to an ibutilide fumarate injection and a preparation method thereof. Background technique [0002] Ibutilide fumarate, molecular formula: C 20 h 36 N 2 o 3 S 1 / 2C 4 h 4 o 4 ; Molecular weight: 442.62, its structural formula is as follows: [0003] [0004] Molecular structure of ibutilide fumarate [0005] Ibutilide fumarate is a new class III antiarrhythmic drug with ion channel activity. Its main indication is the conversion of atrial fibrillation or atrial flutter that occurred recently (duration ≤ 90 days). It is clinically used for the recent onset of atrial fibrillation or atrial flutter to reverse into sinus rhythm. [0006] Ibutilide fumarate is generally unstable after being sterilized above 100°C in aqueous solution. Currently, the production process of Ibutilide Fumarate Injection (Ibutilide Fumarate Injection) is as follows: dissolution of raw materials and excipients - prepar...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/18A61K47/02A61P9/06
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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