Nicorandil freeze-dried injection and preparation method thereof

A technology of freeze-dried powder injection and nicorandil, applied in the field of nicorandil freeze-dried powder injection and its preparation, can solve acute clinical consequences and other problems, and achieve the effect of high efficiency, energy saving and drug stability in the preparation process

Active Publication Date: 2011-11-16
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For injections administered by injection, if the active ingredient degrades into undesired products that cause side effects, there will be serious and acute clinical consequences

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Composition (1000 made in total):

[0017] Nicorandil 12g

[0018] Mannitol 18g

[0019] Sodium citrate solution

[0020] Add water for injection to 1500ml

[0021] Preparation Process

[0022] 1. Preparation: Take an appropriate amount of water for injection and add mannitol to dissolve it completely, add activated carbon, absorb for 30 minutes, and filter to remove carbon. Add the prescribed amount of Nicorandil below room temperature to dissolve, adjust the pH to 5.5-7.5 with sodium citrate solution, add water for injection to the full amount to obtain an intermediate solution, test, and sterilize and filter.

[0023] 2. Filling: Determine the filling volume according to the determination result of the intermediate content, carry out filling and half stoppering;

[0024] 3. Freeze-drying: freeze-drying parameters and conditions

[0025] 3.1 Turn on the cooling of the front box to reduce the temperature of the heat transfer oil to below -25°C, keep it for a peri...

Embodiment 2

[0032] Composition (1000 made in total):

[0033] Nicorandil 48g

[0034] Dextran 72g

[0035] Sodium citrate solution

[0036] Add water for injection to 6000ml

[0037] The preparation process is the same as in Example 1, wherein the pH value of the intermediate solution is adjusted to 6.3, and the secondary sublimation temperature is 10°C.

[0038] After testing the intermediate solution and finished product obtained by the above method, the related substances were 0.31% and 0.53% respectively.

Embodiment 3

[0040] Composition (1000 made in total):

[0041] Nicorandil 48g

[0042] Mannitol 50g

[0043] Dextran 22g

[0044] Sodium bicarbonate-sodium carbonate solution Appropriate amount

[0045] Add water for injection to 5000ml

[0046] The preparation process is the same as in Example 1, wherein the pH value of the intermediate solution is adjusted to 6.5, and the secondary sublimation temperature is 10°C.

[0047] After testing the intermediate solution and finished product obtained by the above method, the related substances were 0.28% and 0.54% respectively.

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PUM

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Abstract

The invention relates to a stable freeze-drying nicorandil powder injection and a preparation method thereof. In the process of preparing the freeze-drying nicorandil powder injection, acidifying or alkalizing agent is adopted to regulate the PH value of intermediate solution for the pH value to range from 5.0 to 8.0, and secondary sublimation temperature is controlled in the process of freeze drying for the temperature to range from 5 DEG C to 20 DEG C, and thereby, the medicament content and the stability of related substances are improved. The invention overcomes the deficiencies in the prior art; and a stable freeze-drying nicorandil powder is obtained, and the freeze-drying powder injection has good clinical efficacy.

Description

technical field [0001] The invention relates to a stable nicorandil freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Nicorandil is an antiangina pectoris drug, which belongs to nitrate ester compound. It has the functions of preventing the dissociation of intracellular calcium ions, enhancing the permeability of cell membranes to potassium ions, dilating tubular blood vessels, continuously enhancing coronary blood flow, and inhibiting coronary artery spasm. The role of dilation of tubular blood vessels, does not affect blood pressure, heart rate, myocardial contractility and myocardial oxygen consumption. Nicorandil also has the effect of inhibiting platelet aggregation and preventing thrombosis. Nicorandil is a heat-labile drug. Studies have shown that this product degrades at 25°C, and the degraded substance can reach 5%-8% after 1 hour at 60°C, and more than 10% at 100°C for 1 hour...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/455A61P9/10
Inventor 张建强张建勋曹相林
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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