Levorotatory oxiracetam freeze-drying powder injection and preparation method thereof

A freeze-dried powder injection and freeze-drying technology, used in freeze-dried delivery, powder delivery, pharmaceutical formulations, etc., can solve the problems of inconsistent properties of the upper and lower layers, difficult to form a skeleton, and poor product stability, and achieve consistent properties of the upper and lower layers. Good compliance and good product stability

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 levo-oxiracetam freeze-dried powder injection has the main problems that the impurities increase significantly during the preparation process, there is no fixed shape, it is difficult to form a skeleton, and the phenomenon of spraying bottles is easy to appear during the freeze-drying process, the product has poor stability, short shelf life, and uneven product uniformity. Well, the properties of the upper and lower layers are inconsistent, and the product injection process is painful, and the patient's compliance is poor, etc.

Method used

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  • Levorotatory oxiracetam freeze-drying powder injection and preparation method thereof
  • Levorotatory oxiracetam freeze-drying powder injection and preparation method thereof
  • Levorotatory oxiracetam freeze-drying powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0022] Element

[0023] Makes 1000 bottles

[0024] Preparation process:

[0025] 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;

[0026] 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;

[0027] 3. Freeze-drying: quickly freeze the temperature of the heat transfer o...

Embodiment 2

[0073] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0074] Element

Dosage (% by weight)

Levoxiracetam

40％

L-serine

25％

Mannitol

20％

sodium glutamate

8％

Methionine

6％

Benzyl alcohol

1％

[0075] Makes 1000 bottles

[0076] Preparation process: prepared according to the preparation process of Example 1.

[0077] By the test method of embodiment 1, the result of the sample stability test in embodiment 2 shows that the sample quality is stable in accelerating June, and the quality is stable in 24 months for a long time, so this product is valid for at least 24 months; Squirt bottle phenomenon occurs. Example 2 The influence of the preparation process on the increase of impurities The experimental results show that the increase of product impurities in the preparation process of this product is small, which meets the product requirements. The results of the...

Embodiment 3

[0079] A levoxiracetam freeze-dried powder injection, prepared according to the following steps:

[0080] Element

Dosage (% by weight)

Levoxiracetam

38％

L-serine

26％

Mannitol

22％

sodium glutamate

8％

Methionine

5％

Benzyl alcohol

1％

[0081] Makes 1000 bottles

[0082] Preparation process: prepared according to the preparation process of Example 1.

[0083] By the test method of embodiment 1, the sample stability test result of embodiment 3 shows that accelerated June sample quality is stable, and long-term 24 months are stable in quality, so this product is valid for at least 24 months; Squirt bottle phenomenon occurs. Example 3 The influence of the preparation process on the increase of impurities The experimental results show that the increase of product impurities in the preparation process of this product is small, which meets the product requirements. The results of the mouse writhing method t...

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Abstract

A levorotatory oxiracetam freeze-drying powder injection is prepared from the following raw and auxiliary materials by weight percentage: 35-41% of levorotatory oxiracetam, 23-30% of L-serine, 18-28% of mannitol, 5-12% of sodium glutamate, 3-10% of methionine and 1-3% of benzyl alcohol through the steps of concentration, dilution, freeze-drying and capping. According to the prepared levorotatory oxiracetam freeze-drying powder injection, an impurity level is increased less in a preparation process; the impurity level is only increased by 0.03%; the product has a fixed shape; a bottle spraying phenomenon does not occur in a freeze-drying preparation process; the product is good in uniformity and low in impurity level; characters of an upper layer and a lower layer are consistent; the total impurity level of the freeze-drying powder injection is less than 0.28%; 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 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): A61K9/19A61K31/4015A61K47/18A61K47/26A61K47/10A61P25/28
CPCA61K9/0019A61K9/19A61K31/4015A61K47/10A61K47/183A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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