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Nimodipine venous preparation and preparation method thereof

A technology of nimodipine and nimodi, which is applied in the field of medicine, can solve the problems of unseen content reports, etc., and achieve the effect of remarkable drug effect, good solubility and stability, and concise prescription composition

Inactive Publication Date: 2009-11-11
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In a word, according to the search results of related patents and prior art documents, there is no report of the same content of the present invention

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription:

[0024] Sodium chloride 8.9g

[0025] Nimodipine 0.2g

[0026]

[0027] 1000ml (10ml / piece)

[0028] Process: Dissolve the prescribed amount of sodium chloride in 2 / 3 of the prescribed amount of water for injection, keep warm at 60°C until constant temperature, add the prescribed amount of nimodipine and stir for 40 minutes to fully dissolve, and then keep warm for 3 hours. Then, adjust the pH value to 6.0 with hydrochloric acid, measure the content, and add water for injection to constant volume. Filter through a 0.22 μm filter membrane, fill in a brown ampoule, melt the seal, sterilize at 115°C for 30 minutes, and check for leaks to obtain the aqueous injection preparation.

Embodiment 2

[0030] prescription:

[0031] Sodium chloride 8.8g

[0032] Nimodipine 0.2g

[0033]

[0034] 1000ml (10ml / piece)

[0035] Process: dissolve the prescribed amount of sodium chloride in 2 / 3 of the prescribed amount of water for injection, keep warm at 70°C until constant temperature, add the prescribed amount of nimodipine and stir for 40 minutes to fully dissolve, and then keep warm for 3 hours. Then, adjust the pH value to 6.5 with sodium hydroxide, measure the content, and add water for injection to constant volume. Filter through a 0.22 μm filter membrane, fill in a brown ampoule, melt the seal, sterilize at 115°C for 30 minutes, and check for leaks to obtain the aqueous injection preparation.

Embodiment 3

[0037] prescription:

[0038] Sodium chloride 8.8g

[0039] Nimodipine 0.2g

[0040]

[0041] 1000ml (100ml / bottle)

[0042] Process: dissolve the prescribed amount of sodium chloride in 2 / 3 of the prescribed amount of water for injection, keep warm at 70°C until constant temperature, add the prescribed amount of nimodipine and stir for 40 minutes to fully dissolve, and then keep warm for 3 hours. Then, adjust the pH value to 6.8 with sodium hydroxide, measure the content, and add water for injection to constant volume. Filter through a 0.22 μm filter membrane, fill in a brown infusion bottle, stopper, cap, sterilize at 115°C for 30 minutes, and check for leaks to obtain an infusion solution.

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PUM

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Abstract

The invention relates to a nimodipine venous preparation (comprising injection and an infusion solution) and a preparation method thereof. The nimodipine venous preparation is characterized in that nimodipine and sodium chloride are raw materials; nimodipine with the amount of a prescription is added in a sodium chloride solution with the right amount of a prescription to be prepared into a concentrated solution for backup, a conventional pH regulator is used for regulating the pH value of the concentrated solution to be 5.5-7.5, water for injection is added in the concentrated solution for constant volume, and the injection or the infusion solution is obtained after the concentrated solution is processed by the processing procedures of filter, encapsulation (or filling, bunging and capping), sterilization, leak detection, and the like. The prepared product has better stability when being stored at low temperature or used clinically and is free from opacity or crystallization.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an intravenous preparation for antihypertensive medicine and a preparation method thereof. Background technique [0002] Nimodipine is a dihydropyridine calcium antagonist. Normally, the contraction of smooth muscle depends on Ca 2 Enters the cell, causing depolarization of the transmembrane current. Nimodipine effectively blocks Ca 2 Enter the cell, inhibit the contraction of smooth muscle, and achieve the purpose of relieving vasospasm. Animal experiments have proved that the effect of nimodipine on cerebral arteries is much stronger than that of arteries in other parts of the body, and because of its high lipophilicity, it can easily penetrate the blood-brain barrier. When used for the treatment of subarachnoid hemorrhage, the concentration in cerebrospinal fluid can reach 12.5ng / ml. It is easy to pass through the blood-brain barrier and act on cerebral blood vessels and ne...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/435A61P9/12
Inventor 安英
Owner 北京瑞伊人科技发展有限公司