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Nicorandil freeze-drying powder preparation method

A technology of nicorandil and freeze-dried powder, which is applied in the field of pharmaceutical injection preparation to achieve the effects of ensuring safety, reducing the generation of harmful impurities and improving stability

Active Publication Date: 2008-09-10
XIAN LIBANG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The result of the novelty search is: there is no relevant report on the preparation of nicorandil freeze-dried powder with amino acids as excipients in the relevant literature at home and abroad

Method used

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  • Nicorandil freeze-drying powder preparation method
  • Nicorandil freeze-drying powder preparation method
  • Nicorandil freeze-drying powder preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1: Nicorandil dosage is 6.1%, the preparation of the Nicorandil for injection that excipient is L-serine

[0014] prescription:

[0015]

[0016] Preparation method: Weigh each component according to the prescription amount, add an appropriate amount of water for injection to dissolve, add water for injection to 1000ml, fill with 1ml per bottle, freeze-dry, and cap to get ready. Each bottle contains nicorandil 2mg.

Embodiment 2

[0017] Embodiment 2: Nicorandil dosage is 3.8%, the preparation of the Nicorandil for injection that excipient is L-serine

[0018] prescription:

[0019]

[0020] Preparation method: Weigh each component according to the prescription amount, add appropriate amount of water for injection to dissolve, then add water for injection to 1000ml, sterilize and filter according to the conventional method, fill in 1ml per bottle, freeze-dry, and cap to get ready. Each bottle contains nicorandil 2mg.

Embodiment 3

[0021] Embodiment 3: Nicorandil dosage is 7.4%, the preparation of the Nicorandil for injection that excipient is L-serine

[0022] prescription:

[0023]

[0024] Preparation method: Weigh each component according to the prescription amount, add appropriate amount of water for injection to dissolve, then add water for injection to 1000ml, sterilize and filter according to the conventional method, fill in 1ml per bottle, freeze-dry, and cap to get ready. Each bottle contains nicorandil 12mg.

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PUM

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Abstract

The invention discloses a process for preparing Nicorandil freeze-dried powder, which consists of charging 0.1-50.0 wt% of Nicorandil into water for injection, dissolving excipient simultaneously, degerming and filtering, loading, and finally freeze drying.

Description

technical field [0001] The present invention relates to a kind of preparation method of the injection of medicine, especially the preparation method of nicorandil freeze-dried powder, this method uses amino acid substance as excipient, adopts freeze-drying technology to prepare the freeze-dried powder of nicorandil, can be Intravenous injection avoids the degradation of nicorandil into other substances with toxic and side effects in water, and ensures the safety of medication for patients. The product has good resolubility, and it can be used directly after being dissolved in sterile water for injection, normal saline, glucose injection, etc. when used clinically. Background technique [0002] Nicorandil, also known as Nicotinate and Nicotinate, belongs to nitrate ester compounds, and is the only drug for the treatment of coronary heart disease and angina pectoris with a dual mechanism of action among the currently marketed cardiovascular system drugs. It not only has the e...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/455A61K9/19A61P9/10A61P7/02
Inventor 胡忍乐耿宏斌王九成党晓怡
Owner XIAN LIBANG PHARMA TECH
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