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Levo-oxiracetam sterile powder and preparation method thereof

A technology for aseptic powder and prescription, applied in powder delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve the problems of poor stability, short shelf life, easy to spray bottles, etc. Good product stability and the effect of improving safety

Inactive Publication Date: 2017-05-24
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing levo-oxiracetam sterile powder mainly has problems such as no fixed shape, difficult to form a skeleton, easy to spray bottle phenomenon during the freeze-drying process, poor stability, and short shelf life.

Method used

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  • Levo-oxiracetam sterile powder and preparation method thereof
  • Levo-oxiracetam sterile powder and preparation method thereof
  • Levo-oxiracetam sterile powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A kind of sterile powder of levoxiracetam, prepared according to the following steps:

[0022] Element Dosage Levoxiracetam 100g L-serine 55g Mannitol 52g sodium glutamate 15g

[0023] Makes 1000 bottles

[0024] Preparation process:

[0025] 1. Concentrated preparation: put the prescribed amount of levoxiracetam and excipients in a container, add 10 times the weight of levoxiracetam and sterilized water for injection to stir, after dissolving, add 0.1% injection Stir with activated carbon for 30 minutes, then filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;

[0026] 2. Dilute preparation: add sterile water for injection to the filtrate to the prescribed amount, adjust the pH to 7.0 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22-micron microporous membrane, take the filtrate to pass the inspection and fill it for sub-packaging In a sterile glass bottle, set a...

Embodiment 2

[0030] A kind of sterile powder of levoxiracetam, prepared according to the following steps:

[0031] Element Dosage Levoxiracetam 100g L-serine 44g Mannitol 40g sodium glutamate 16g

[0032] Makes 1000 bottles

[0033] Preparation process: prepared according to the preparation process of Example 1.

Embodiment 3

[0035] A kind of sterile powder of levoxiracetam, prepared according to the following steps:

[0036] Element Dosage Levoxiracetam 100g L-serine 52g Mannitol 45g sodium glutamate 11g

[0037] Makes 1000 bottles

[0038] Preparation process: prepared according to the preparation process of Example 1.

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PUM

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Abstract

A levo-oxiracetam sterile powder is characterized by being prepared from the following raw and auxiliary materials by the weight percentage: 35%-60% of levo-oxiracetam, and 40%-65% of an excipient, wherein the excipient is a composition of L-serine, mannitol and sodium glutamate. The levo-oxiracetam sterile powder for injection prepared by the preparation method has a fixed shape and has no bottle spraying phenomenon in a freeze-drying preparation process; the product has fewer impurities, has the total impurity content less than 0.22%, is conducive to improvement of the safety of drug use, reduces drug adverse reactions, has good product stability, and has the shelf life as long as 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a sterile levoxiracetam injection powder and a preparation method thereof. Background technique [0002] Nootropic drug, also known as brain activator, is a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs are required to selectively act on the cerebral cortex, and have the characteristics of selectively activating, protecting and promoting the recovery of damaged nerve cell functions. The difference from other neurological drugs is that their above-mentioned effects do not pass through the reticular system or the olfactory bulb, but directly act on the cortex. It neither affects behavior nor has sedative and exciting effects, so this class of drugs has attracted widespread attention and interest, and the demand for this class of drugs is also increasing day by day. [0003] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/18A61K47/26A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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