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Levorotatory oxiracetam aseptic powder injection and preparation method thereof

A technology of sterile powder and injection, applied in powder delivery, pharmaceutical formulations, nervous system diseases, etc., can solve the problems of difficult skeleton formation, poor product stability, inconsistent upper and lower layers, etc., to achieve good patient compliance and product stability. Good, good product uniformity

Inactive Publication Date: 2017-10-24
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 levoxiracetam sterile powder for injection mainly has no fixed shape, is not easy to form a skeleton, and is prone to dry shrinkage and bubbling. The product injection process is painful, the patient's compliance is poor, the product stability is poor, and the shelf life is short. The uniformity of the product is not good, and the properties of the upper and lower layers are inconsistent, etc.

Method used

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  • Levorotatory oxiracetam aseptic powder injection and preparation method thereof
  • Levorotatory oxiracetam aseptic powder injection and preparation method thereof
  • Levorotatory oxiracetam aseptic powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0022]

[0023] Preparation process:

[0024] 1. Concentrated preparation: put the raw and auxiliary materials of the prescribed amount in a container, add 5 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 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 Packed in sterile glass bottles for later use;

[0026] 3. Freeze-drying: quickly freeze the temperature of the heat transfer oil to -40°C, keep it at a constant temper...

Embodiment 2

[0056] A kind of levoxiracetam sterile powder injection, prepared according to the following steps:

[0057]

[0058] Preparation process: prepared according to the preparation process of Example 1.

[0059] 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 results of the mouse writhing method to observe the pain during the injection showed that the pain of the sample of Example 2 was significantly weaker than that of the control sample during the injection.

Embodiment 3

[0061] A kind of levoxiracetam sterile powder injection, prepared according to the following steps:

[0062]

[0063] Preparation process: prepared according to the preparation process of Example 1.

[0064] 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 results of the mouse writhing method to observe the pain during the injection showed that the pain of the sample of Example 3 was significantly weaker than that of the control sample during the injection.

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Abstract

A levorotatory oxiracetam aseptic powder injection is prepared from the following raw and auxiliary materials by weight percentage: 55-62% of levorotatory oxiracetam, 18-23% of L-serine, 12-19% of mannitol, 3-8% of polyethylene glycol 2000 and 1-3% of benzyl alcohol through the steps of concentration, dilution, freeze-drying and capping. The prepared levorotatory oxiracetam aseptic powder injection has a fixed shape, and is free from drying shrinkage and bubbling in a freeze-drying preparation process, good in uniformity, low in impurity level and good in stability; characters of an upper layer and a lower layer are consistent; the total impurity level is less than 0.27%; 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 sterile 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 dextro-o...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61K47/18A61K47/26A61K47/10A61P25/28
CPCA61K9/0019A61K9/19A61K31/4015A61K47/10A61K47/183A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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