Composition containing ibutilide fumarate and preparation method and application thereof

A technology of ibutilide fumarate and its composition, which is applied in the direction of drug combination, medical preparation of non-active ingredients, drug delivery, etc., can solve the problems of increased impurities and decreased content of active ingredients, and achieves the reduction of impurities and the improvement of Sterility and the effect of improving the safety of clinical medication

Active Publication Date: 2011-09-07
JIANGSU JIUXU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to solve the above existing problems in the prior art that the effective components of the injection solution are degraded after sterilization, the impurities increase, and the content of the active components decreases greatly within the validity period, the present invention provides a combination compound containing ibutilide fumarate substances and their preparation methods and applications

Method used

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  • Composition containing ibutilide fumarate and preparation method and application thereof
  • Composition containing ibutilide fumarate and preparation method and application thereof
  • Composition containing ibutilide fumarate and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5、 comparative example 1～5

[0019] Weigh ibutilide fumarate and sodium acetate according to the dosage shown in Table 1, and dissolve in water to obtain solution 1.

[0020] Weigh sodium chloride according to the amount shown in Table 1, dissolve it in water and add activated carbon to adsorb for 30 minutes, then filter it with a microporous filter (0.45 μm first, then 0.22 μm, the same below), take the filtrate and mix it with the solution, and adjust it to The total volume was 100ml, and solution 2 was obtained.

[0021] The pH value of solution 2 was adjusted to the pH value shown in Table 1 with the pH regulator shown in Table 1 to obtain the composition containing ibutilide fumarate.

[0022] Then, the compositions containing ibutilide fumarate obtained in Examples 1 to 5 and Comparative Examples 1 to 5 were subjected to an oversterilization experiment at 121°C and F0≥12 in a autoclaved steam sterilizer, and the sterilizer showed The pressure is 0.12mpa, and the sterilization time is 7 minutes.

...

Embodiment 6～25、 comparative example 6～15

[0036] Weigh ibutilide fumarate and sodium acetate according to the dosage shown in Table 2, and dissolve in water to obtain solution 1.

[0037] Weigh sodium chloride according to the dosage shown in Table 2, dissolve it in water and add activated carbon to adsorb for 30 minutes, then filter with a microporous filter, mix the filtrate with solution one, adjust to a total volume of 100ml with water, and obtain solution two.

[0038] The pH value of solution 2 was adjusted to the pH value shown in Table 2 with the pH regulator shown in Table 2 to obtain a composition containing ibutilide fumarate.

[0039] Then the compositions containing ibutilide fumarate obtained in Examples 6 to 25 and Comparative Examples 6 to 15 were carried out in an autoclaved steam sterilizer for an oversterilization experiment at 121° C., F0≥12, and the sterilizer The display pressure is 0.12mpa, and the sterilization time is 7 minutes.

[0040] Then, the changes of various indexes of the ibutilide f...

Embodiment 26～37、 comparative example 16～21

[0046] Weigh ibutilide fumarate and sodium acetate according to the dosage shown in Table 3, and dissolve in water to obtain solution 1.

[0047] Weigh sodium chloride according to the dosage shown in Table 3, dissolve it in water and add activated carbon to adsorb for 30 minutes, then filter with a microporous filter, mix the filtrate with solution one, adjust to a total volume of 20000ml with water, and obtain solution two.

[0048] Adjust the pH value of Solution 2 to the pH value shown in Table 3 with the pH regulator shown in Table 3, and pot it to obtain ibutilide fumarate injection.

[0049] Then the ibutilide fumarate injection obtained in Examples 26 to 37 and Comparative Examples 16 to 21 was subjected to an oversterilization experiment at 121°C and F0≥12 in a steam autoclave, and the sterilizer showed pressure 0.12mpa, sterilization time is 7 minutes.

[0050] Then, the contents of the active ingredient ibutilide fumarate and impurities were detected by high perfor...

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Abstract

The invention discloses a composition containing ibutilide fumarate and a preparation method and application thereof. The pH value of the composition containing ibutilide fumarate is smaller than 4.0. The preparation method comprises the step of adjusting the pH value of the composition to a set pH value by utilizing a pH regulating agent. The application refers to the application of the composition containing ibutililde fumarate in preparing antiarrhythmic drugs. The composition containing ibutilide fumarate has good thermal stability and has little change on the content of the ibutilide fumarate and reduction of impurities after sterilized.

Description

technical field [0001] The invention relates to a composition containing ibutilide fumarate, a preparation method and application thereof. Background technique [0002] Ibutilide fumarate (Ibutilide Fumarate) is a fast-acting and safe antiarrhythmic drug, which has the effect of rapidly terminating atrial flutter (atrial flutter) and atrial fibrillation (atrial fibrillation). One of the important drugs for rapid turnover. The pH value of the ibutilide fumarate injection sold in the domestic and foreign markets is all controlled above 4.0, and the ibutilide fumarate injection of this pH causes the degradation of active ingredient after sterilization, and the impurity increases, and During the validity period, the content of active ingredients has dropped significantly, and the relevant substances may exceed the maximum limit of 1.0% required by the quality standard. When this product is used for cardiac emergency, it may reduce the curative effect and increase the safety ri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/18A61K47/12A61K47/02A61K9/08A61P9/06
Inventor 刘新红李宏岳昌林于自勋
Owner JIANGSU JIUXU PHARMA
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