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L-oxiracetam sterile powder with good stability and preparation method thereof

A sterile powder and stability technology, which is applied in powder delivery, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. and other problems to achieve the effect of reducing adverse drug reactions, consistent upper and lower properties, and good product uniformity

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 no fixed shape, is not easy to form a skeleton, is prone to dry shrinkage and bubbling, poor product uniformity, inconsistent properties of the upper and lower layers, poor stability, short shelf life, and sterile Issues such as unqualified inspection

Method used

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  • L-oxiracetam sterile powder with good stability and preparation method thereof
  • L-oxiracetam sterile powder with good stability and preparation method thereof
  • L-oxiracetam sterile powder with good stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A kind of levoxiracetam sterile powder with good stability is prepared according to the following steps:

[0022] Element Dosage Levoxiracetam 100g L-serine 38g Mannitol 41g polyethylene glycol 2000 5g phenol 0.5g

[0023] Makes 1000 bottles

[0024] Preparation process:

[0025] 1. Concentrated preparation: put the prescribed amount of levoxiracetam and excipients in a container, add 5 times the weight of levoxiracetam and sterilized water for injection to stir, after dissolving, add 0.5% by mass fraction of the needle 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 and fill it in In a s...

Embodiment 2

[0030] A kind of levoxiracetam sterile powder with good stability is prepared according to the following steps:

[0031] Element Dosage Levoxiracetam 100g L-serine 31g Mannitol 39g polyethylene glycol 2000 5g phenol 0.5

[0032] Makes 1000 bottles

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

Embodiment 3

[0035] A kind of levoxiracetam sterile powder with good stability is prepared according to the following steps:

[0036] Element Dosage Levoxiracetam 100g L-serine 35g Mannitol 42g polyethylene glycol 2000 4g phenol 0.6g

[0037] Makes 1000 bottles

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

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Abstract

An L-oxiracetam sterile powder with good stability is characterized by being prepared from raw materials and auxiliary materials including L-oxiracetam, L-serine, mannitol, polyethylene glycol and phenol through steps of concentration, dilution, freeze-drying and capping. By the preparation method, the prepared L-oxiracetam sterile powder for injection and with good stability has a fixed shape, has no dry shrinkage or bubbling phenomenon during the freeze-drying preparation process, has good product homogeneity with consistent characteristics of the upper and lower layers, meets the requirements of sterility test, and has less impurity with total impurity of lower than 0.21%. The preparation method is beneficial to raise drug use safety and reduce adverse drug reaction. By the preparation method, product stability is good and shelf life reaches a length of 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam sterile powder with good stability and a preparation method thereof. Background technique [0002] Oxiracetam (S-oxiracetam) is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was synthesized for the first time in 1974 by the Italian company ISFS.P.A. Oxygen nootropic drug (compound disclosed in US411...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61K47/16A61K47/10A61K47/34A61P25/00A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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