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Preparation method for (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection

A pyrrolidine acetamide and injection technology, which is applied in the fields of pharmaceutical formulations, nervous system diseases, drug combinations, etc., can solve the problems of unqualified foreign matter in products, poor product clarity, and reduced product yield, so as to reduce the pain of injection , Patient compliance is good, the effect of improving clarity

Inactive Publication Date: 2017-10-31
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] But existing (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection is prone to foam in the filling process, adopts ampoule bottle filling, and medicinal liquid will stick to the bottle mouth, in The carbonization of the liquid medicine during the melting and sealing of the ampoule bottle makes the product unqualified for visible foreign matter, reduces the product yield, and also increases the unknown safety of the patient's medication; when the vial is used for filling, the solution sticks to the bottle mouth, which is prone to plugging. The situation also reduces the product yield
In addition, the existing (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection still has problems such as poor product clarity, obvious pain during the injection process, and poor patient compliance.

Method used

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  • Preparation method for (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection
  • Preparation method for (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection
  • Preparation method for (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The prescription of (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 1 is shown in the table below:

[0025]

[0026] The preparation method of the (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 1 comprises the following steps:

[0027] (1) Weigh (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide, edetate disodium, methylparaben, meglumine and benzyl alcohol into the water for injection, Stir and dissolve to obtain concentrated liquid; the process of concentrated liquid needs to be treated with nitrogen, and the nitrogen flow rate is 0.03-0.08L / min;

[0028] (2) Take the concentrated solution obtained in step (1), add 0.1mol / L sodium hydroxide solution to adjust the pH value to 6.5;

[0029] (3) add the chitosan of 2g / L in the solution that step (2) obtains, stir and mix, after leaving standstill 50min, filter with the filter membrane of 0.8 μm;

[0030] (4) In the solution that step (3) obtains, add the gac of 1g / L, filter with the...

Embodiment 2

[0039] The prescription of (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 2 is shown in the table below:

[0040]

[0041] The preparation method of the (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 2 comprises the following steps:

[0042] (1) Weigh (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide, edetate disodium, methylparaben, meglumine and benzyl alcohol into the water for injection, Stir and dissolve to obtain concentrated liquid; the process of concentrated liquid needs to be treated with nitrogen, and the nitrogen flow rate is 0.03-0.08L / min;

[0043] (2) Take the concentrated solution obtained in step (1), add 0.3mol / L sodium hydroxide solution to adjust the pH value to 6.8;

[0044] (3) add the chitosan of 4g / L in the solution that step (2) obtains, stir and mix, after leaving standstill 40min, filter with the filter membrane of 0.8 μm;

[0045] (4) in the solution that step (3) obtains, add the gac of 2g / L, filter with the...

Embodiment 3

[0054] The prescription of (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 3 is shown in the following table:

[0055]

[0056] The preparation method of the (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide injection of embodiment 3 comprises the following steps:

[0057] (1) Weigh (S)-4-hydroxyl-2-oxo-1-pyrrolidineacetamide, edetate disodium, methylparaben, meglumine and benzyl alcohol into the water for injection, Stir and dissolve to obtain concentrated liquid; the process of concentrated liquid needs to be treated with nitrogen, and the nitrogen flow rate is 0.03-0.08L / min;

[0058] (2) Take the concentrated solution obtained in step (1), add 0.5mol / L sodium hydroxide solution to adjust the pH value to 7.0;

[0059] (3) add the chitosan of 6g / L in the solution that step (2) obtains, stir and mix, after standing 30min, filter with the filter membrane of 0.8 μ m;

[0060] (4) Add the gac of 3g / L in the solution that step (3) obtains, filter with the filte...

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Abstract

The invention discloses a preparation method for a (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection. 1ml of injection contains the following raw ingredients: 180-220mg of (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide, 0.01-0.1mg of edetate disodium, 4-5mg of methylparaben, 10-16mg of meglumine and 1-3mg of benzyl alcohol. In the preparation process, 0.1-0.5mol / L of sodium hydroxide solution is added for regulating pH value to 6.5-7.0 and 2-6g / L of chitosan is added for processing. The (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide injection prepared according to the invention does not form foams, is free from liquor adhesion problem, is high in product yield, is capable of obviously increasing the clarity of the injection, is high in product stability, is capable of relieving the injection pain of the patient and has high patient compliance.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide injection. Background technique [0002] The chemical name of levo-oxiracetam is: (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide, which is a white microcrystalline powder with a melting point of 135-136°C and an optical rotation of -36° (C= 1.00in water), the solubility of levoxiracetam is obviously better than that of racemate. The chemical structural formula is shown in the following formula: [0003] [0004] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei et al. mentioned in the patent publication No. CN 103735545A that levoxiracetam has an obvious effect of promoting awakening on the coma caus...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4015A61K47/14A61K47/18A61K47/36A61P25/28
CPCA61K9/0019A61K9/08A61K31/4015A61K47/14A61K47/183A61K47/36
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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