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A kind of levoxiracetam freeze-dried powder for injection and preparation method thereof

A technology for freeze-dried powder and injection, which is applied in the field of levo-oxiracetam freeze-dried powder for injection and its preparation, can solve the problems of obvious pain, poor stability, short shelf life, etc., and achieves good patient compliance and product clarification Good quality and stability

Active Publication Date: 2020-09-29
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing levoxiracetam freeze-dried powder for 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 clarity is unqualified, the stability is poor, the shelf life is short, and the injection process is painful. , poor patient compliance and other issues

Method used

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  • A kind of levoxiracetam freeze-dried powder for injection and preparation method thereof
  • A kind of levoxiracetam freeze-dried powder for injection and preparation method thereof
  • A kind of levoxiracetam freeze-dried powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A kind of levoxiracetam lyophilized powder for injection, prepared according to the following steps:

[0021] Element Dosage (weight %) Levoxiracetam 32％ L-serine 27％ Mannitol 33％ sodium glutamate 6％ Tween 80 1％ Benzyl alcohol 1％

[0022] Makes 1000 bottles

[0023] Preparation process:

[0024] 1. Concentrated preparation: Put the raw and auxiliary materials of the prescribed amount in a container, add 10 times the weight of levoxiracetam in sterile water for injection and stir, after dissolving, add activated carbon for needles with a mass fraction of 0.5%, stir for 30 minutes, and then Filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;

[0025] 2. Dilute preparation: add sterilized water for injection to the filtrate to 1000 times the volume of the filtrate, adjust the pH to 5.5 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22 micron microporous mem...

Embodiment 2

[0064] A kind of levoxiracetam lyophilized powder for injection, prepared according to the following steps:

[0065] Element Dosage (weight %) Levoxiracetam 35％ L-serine 26％ Mannitol 30％ sodium glutamate 7％ Tween 80 1％ Benzyl alcohol 1％

[0066] Makes 1000 bottles

[0067] Preparation process: prepared according to the preparation process of Example 1.

[0068] According to the test method of embodiment 1, the sample stability test result of embodiment 2 shows that the sample quality is stable in 6 months of acceleration, and the quality is stable in 24 months for a long time, so the validity period of this product is at least 24 months. The statistical results of the bottle spraying phenomenon in the freeze-drying process show that the sample of Example 2 did not spray the bottle phenomenon during the freeze-drying process. The results of the mouse writhing method to observe the pain during the injection showed that the pai...

Embodiment 3

[0070] A kind of levoxiracetam lyophilized powder for injection, prepared according to the following steps:

[0071] Element Dosage (weight %) Levoxiracetam 33％ L-serine 28％ Mannitol 31％ sodium glutamate 6％ Tween 80 1％ Benzyl alcohol 1％

[0072] Makes 1000 bottles

[0073] Preparation process: prepared according to the preparation process of Example 1.

[0074] According to the test method of embodiment 1, the sample stability test result of embodiment 3 shows that the sample quality is stable in accelerated June, and the quality is stable in 24 months for a long time, so the validity period of this product is at least 24 months. The statistical results of the bottle spraying phenomenon during the freeze-drying process show that the sample of Example 3 did not have the bottle spraying phenomenon during the freeze-drying process. The results of the mouse writhing method to observe the pain during the injection showed that the...

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Abstract

Levorotatory oxiracetam freeze-drying powder for injection is prepared from the following raw and auxiliary materials by weight percentage: 30-38% of levorotatory oxiracetam, 25-30% of L-serine, 28-35% of mannitol, 5-12% of sodium glutamate, 1-2% of tween 80 and 1-2% of benzyl alcohol through the steps of concentration, dilution, freeze-drying and capping. The prepared levorotatory oxiracetam freeze-drying powder has a fixed shape; a bottle spraying phenomenon does not occur in a freeze-drying preparation process; an impurity level is low; the total impurity level is less than 0.27%; the clarity of the product is good, and higher than that of a number 0.5 standard turbidity solution; the stability is good; a shelf life is up to 24 months; a pain feeling of a patient is milder in an injection process; and the patient is good in compliance.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam freeze-dried powder for injection 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] 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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/18A61K47/26A61K31/4015A61P25/28
CPCA61K9/0019A61K9/19A61K31/4015A61K47/18A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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