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Levo oxiracetam lyophilized powder for injection and preparation method thereof

A technology of freeze-dried powder injection and freeze-drying, which is applied in the direction of freeze-drying transportation, powder transportation, and pharmaceutical formulations. It can solve the problems of inconsistent properties of the upper and lower layers, poor product uniformity, and difficulty in forming a skeleton, and achieve consistent properties of the upper and lower layers. , Reduce adverse drug reactions, good product stability

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 levoracetam freeze-dried powder injection mainly has no fixed shape, is not easy to form a skeleton, and is prone to spray bottle phenomenon during the freeze-drying process. The product has poor stability, short shelf life, poor product uniformity, and inconsistent properties of the upper and lower layers. And other issues

Method used

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  • Levo oxiracetam lyophilized powder for injection and preparation method thereof
  • Levo oxiracetam lyophilized powder for injection and preparation method thereof
  • Levo oxiracetam lyophilized powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0023] Element Dosage Levoxiracetam 100g L-serine 70g Mannitol 85g sodium glutamate 15g

[0024] Makes 1000 bottles

[0025] Preparation process:

[0026] 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;

[0027] 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 sterile glass bottle, spare;

[0028] 3....

Embodiment 2

[0031] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0032] Element Dosage Levoxiracetam 100g L-serine 55g Mannitol 72g sodium glutamate 12g

[0033] Makes 1000 bottles

[0034] Preparation process: prepared according to the preparation process of Example 1.

Embodiment 3

[0036] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0037] Element Dosage Levoxiracetam 100g L-serine 60g

[0038] Mannitol 75g sodium glutamate 15g

[0039] Makes 1000 bottles

[0040] Preparation process: prepared according to the preparation process of Example 1.

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Abstract

The invention relates to a levo oxiracetam lyophilized powder for injection. The levo oxiracetam lyophilized powder for injection is characterized by being prepared from levo oxiracetam, L-serine, mannitol and sodium glutamate as the raw materials by the steps of concentrated blending, diluted blending, freeze drying and capping. The levo oxiracetam lyophilized powder for injection prepared according to method provided by the invention has the characteristics of fixed shape, no bottle eruption phenomenon in the freeze drying preparation process, good product homogeneity, consistent upper layer and lower layer characters, few impurities, and a total impurity content of less than 0.24%, and is conducive to improving the drug use safety and reducing adverse drug reactions, the product has good stability, and the shelf life is up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam freeze-dried powder injection and a preparation method thereof. Background technique [0002] The chemical name of levo-oxiracetam is: S-(-)-4-hydroxy-2-oxopyrrolidine-N-acetamide. It 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 as follows: [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 103735545 A that levoxiracetam has an obvious wake-promoting effect on coma caused by alcoholism, while dex...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/18A61K47/10A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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