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Nicorandil freeze-dried powder injection and preparation method thereof

A technology for freeze-dried powder injection and nicorandil, which is applied in the field of nicorandil freeze-dried powder injection for injection and its preparation, can solve problems such as instability, and achieves improved stability, delayed degradation speed, and improved product quality. quality effect

Inactive Publication Date: 2018-05-29
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nicorandil is a thermally unstable drug, even if it is prepared as a freeze-dried powder injection, it will be unstable due to different storage conditions or preparation processes

Method used

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  • Nicorandil freeze-dried powder injection and preparation method thereof
  • Nicorandil freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1ml

[0022] Preparation:

[0023] 1. Preparation of preparation solution: Dissolve mannitol and nicorandil sequentially in 80% of the prescribed amount of water for injection. After dissolving, adjust the pH to 7.0-8.0 with sodium citrate solution, and dilute to volume with water for injection.

[0024] 2 The preparation solution is sterilized by filtration, filled with a filling volume of 1 ml, half-stoppered, and placed in a freeze dryer for freeze-drying.

[0025] 3 Freeze-dry according to the following drying procedure: pre-freezing stage: cool down the plate layer to -40°C, maintain for 3h, then raise the temperature to -3°C, maintain for 1h, then cool down to -40°C, maintain for 1h, and then raise the temperature to -3°C , maintain for 1h, then cool down to -40°C, maintain for 1h, and enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20°C, maintain for 10h, then raise the temperature to -10°C, maintain for 3h...

Embodiment 2

2ml

[0043] Preparation:

[0044] 1. Preparation of preparation: Dissolve mannitol and nicorandil sequentially in 80% of the prescribed amount of water for injection. After dissolving, adjust the pH of the sodium citrate solution to 7.0-8.0, and dilute the water for injection.

[0045] 2 The preparation solution is sterilized by filtration, filled with a filling volume of 2 ml, half-stoppered, and placed in a freeze dryer for freeze-drying.

[0046] 3 Freeze-dry according to the following drying procedure: pre-freezing stage: cool down the plate layer to -40°C, maintain for 3h, then raise the temperature to -3°C, maintain for 4h, then cool down to -40°C, maintain for 1h, then raise the temperature to -3°C , maintain for 4 hours, then cool down to -40°C, maintain for 1h, and enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20°C, maintain for 10h, then raise the temperature to -10°C, maintain for 3h, and then raise ...

Embodiment 3

8ml

[0050] Preparation:

[0051] 1. Preparation of preparation solution: Dissolve mannitol and nicorandil sequentially in 80% of the prescribed amount of water for injection. After dissolving, adjust the pH to 7.0-8.0 with sodium citrate solution, and dilute to volume with water for injection.

[0052] 2 The preparation solution is sterilized by filtration, filled with a filling volume of 8 ml, half-stoppered, and placed in a freeze dryer for freeze-drying.

[0053] 3 Freeze-dry according to the following drying procedure: pre-freezing stage: cool down the plate layer to -40°C, maintain for 3h, then raise the temperature to -3°C, maintain for 4h, then cool down to -40°C, maintain for 1h, then raise the temperature to -3°C , maintain for 4 hours, then cool down to -40°C, maintain for 1h, and enter the sublimation stage; the vacuum degree of sublimation is 200ubar, the sublimation temperature is -20°C, maintain for 10h, then raise the temperature to -10°C, maintain for 3...

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Abstract

The invention provides a stable Nicorandil freeze-dried powder injection, and further discloses a preparation method of the freeze-dried powder injection. The preparation method includes: performing afreeze drying process, wherein an annealing process is used in the freeze drying process. By the preparation method, the degradation speed of the Nicorandil freeze-dried powder injection can be greatly reduced, the stability of the Nicorandil freeze-dried powder injection is improved, impurities are decreased, product quality is improved, adverse reaction is decreased favorably, and medication safety of patients is ensured.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a nicorandil freeze-dried powder for injection and a preparation method thereof. Background technique [0002] The chemical name of Nicorandil is N-(2-hydroxyethyl) nicotinamide nitrate, which belongs to nitrate ester compounds, and its molecular formula is C 8 h 9 N 3 o 4 , is the first ATP-sensitive potassium channel opener for clinical use. This product has the functions of preventing intracellular calcium ion dissociation, increasing the permeability of the cell membrane to potassium ions, dilating coronary vessels, continuously increasing coronary blood flow, and inhibiting coronary spasm. When dilating coronary vessels, it does not affect blood pressure, Heart rate, myocardial contractility, and myocardial oxygen consumption. This product also has the effect of inhibiting platelet aggregation and preventing thrombus formation. Clinical studies ha...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/455A61K47/26A61K47/12A61P9/10A61P7/02
CPCA61K9/19A61K9/0019A61K31/455A61K47/12A61K47/26
Inventor 于红霞陈东卫聪聪鲁银录
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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