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Pharmaceutical composition containing deslanoside injection liquid and preparation method thereof

A technology of deacetylated lanatosides and compositions, applied in the field of pharmaceutical compositions and preparations containing deacetylated lanatosides, capable of solving problems such as the instability of deacetylated lanatosides, achieving a high level of sterility assurance and stable quality , Ease of large-scale production

Pending Publication Date: 2021-08-03
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Aiming at the instability of deacetylated lanatosides, the inventors researched and found a composition of deacetylated lanatosides injection, which can avoid the use of non-aqueous solvents such as ethanol and glycerin, and withstand terminal sterilization conditions of 121°C to obtain After the stability of the injection is retained, the pH is stable and the level of degraded impurities is good

Method used

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  • Pharmaceutical composition containing deslanoside injection liquid and preparation method thereof
  • Pharmaceutical composition containing deslanoside injection liquid and preparation method thereof
  • Pharmaceutical composition containing deslanoside injection liquid and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Material name Dosage ( g )

[0035] Add water for injection, polyoxyethylene castor oil, and lecithin with 95% of the prescription amount in sequence in the liquid preparation tank, stir until dissolved and clarified, add sodium dihydrogen phosphate and disodium hydrogen phosphate, add water for injection to a sufficient amount, and stir until dissolved and clarified , 0.22μm filter, ampoules filled and sealed, autoclaved at 121°C for 12 minutes.

Embodiment 2

[0037] Material name Dosage ( g )

[0038] Add water for injection, polyoxyethylene castor oil, and lecithin with 95% of the prescription amount in sequence in the liquid preparation tank, stir until dissolved and clarified, add sodium dihydrogen phosphate and disodium hydrogen phosphate, add water for injection to a sufficient amount, and stir until dissolved and clarified , 0.22μm filter, ampoules filled and sealed, autoclaved at 121°C for 12 minutes.

Embodiment 3

[0040] Material name Dosage ( g )

[0041] Add water for injection, polyoxyethylene castor oil, and lecithin with 95% of the prescription amount in sequence in the liquid preparation tank, stir until dissolved and clarified, add sodium dihydrogen phosphate and disodium hydrogen phosphate, add water for injection to a sufficient amount, and stir until dissolved and clarified , 0.22μm filter, ampoules filled and sealed, autoclaved at 121°C for 12 minutes.

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Abstract

The invention discloses a pharmaceutical composition containing a deslanoside injection liquid. A prescription of the pharmaceutical composition consists of deslanoside, polyoxyethylated castor oil and water for injection. The pharmaceutical composition containing deslanoside which is prepared by the composition and the process disclosed by the invention, does not contain solvents such as ethanol, glycerol and the like, has stable quality, can tolerate thermocompression sterilization, has a high sterility assurance level, has an F0 value of more than or equal to 12, has controllable quality and is simple, convenient and efficient in process.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing deacetyllanatoside and a preparation method. Background technique [0002] Deacetyl lanatoside is a cardiac glycoside, also known as positive inotrope, it is mainly used clinically to treat heart failure, especially for patients with acute cardiac insufficiency or exacerbated chronic cardiac insufficiency, and can also be used to control Ventricular rate in patients with atrial flutter, atrial fibrillation with rapid ventricular rate, etc. [0003] Globally, the active ingredient deacetyllanatoside is only available in the form of injections. It was launched in 1986, with a specification of 2ml: 0.4mg. According to the listing data, the prescription consists of deacetyllanatoside, ethanol, glycerin and water for injection, of which ethanol And glycerol is mainly used to solubilize the active ingredient deacetyllanatoside, and the...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7048A61K47/24A61K47/44A61P9/04A61P9/06
CPCA61K9/0019A61K9/08A61K31/7048A61K47/24A61K47/44A61P9/04A61P9/06
Inventor 朱亚芳沈舒胡雄林贺涵
Owner 南京泽恒医药技术开发有限公司
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