Levo-oxiracetam freeze-dried powder for injection

A technology for freeze-dried powder and injection, which is applied in the field of freeze-dried powder of Levo-Oxiracetam for injection, can solve the problems of low sublimation temperature, content drop, scattering, etc., achieve qualified sterility inspection, shorten production cycle, and improve sublimation. effect of temperature

Inactive Publication Date: 2018-01-05
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, during the preparation process of the existing levoxiracetam freeze-dried powder for injection, the inventors found that in the secondary drying stage, the sublimation temperature is low, and the temperature cannot be higher than 20°C, which greatly prolongs the production cycle of the preparation. , if the temperature in the secondary drying stage is increased, powder scattering will occur in the formulation, its content will drop significantly, and the product clarity will be unqualified
In addition, the existing levoxiracetam freeze-dried powder for injection has relatively poor antibacterial properties, which may easily lead to unqualified sterility tests

Method used

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  • Levo-oxiracetam freeze-dried powder for injection
  • Levo-oxiracetam freeze-dried powder for injection
  • Levo-oxiracetam freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The prescription of the L-Oxiracetam lyophilized powder for injection of Example 1 is shown in the following table:

[0018] prescription

Weight percentage

L-Oxiracetam

200g

Methionine

100g

lactose

140g

Triethanolamine

60g

Tween 80

2g

phenol

4g

Water for Injection

Add to 1000mL

[0019] The preparation method of L-Oxiracetam lyophilized powder for injection of Example 1 includes the following steps:

[0020] Dissolve the prescription amount of L-Oxiracetam, methionine, lactose, triethanolamine, Tween 80 and phenol in water for injection, adjust the pH to 5.5 with 0.1 mol / L hydrochloric acid solution, and then freeze dry according to the following steps :

[0021] (1) Pre-freezing stage: freeze the temperature to -15°C within 10 minutes; then increase the temperature to -10°C with a heating time of 40 minutes; again freeze the temperature to -35°C within 10 minutes; then increase the temperature to -25°C and increase the temperature The time is 100min; finally t...

Embodiment 2

[0025] The prescription of the lyophilized L-Oxiracetam powder for injection of Example 2 is shown in the following table:

[0026] prescription

Weight percentage

L-Oxiracetam

200g

Methionine

80g

lactose

100g

Triethanolamine

40g

Tween 80

3g

phenol

2g

Water for Injection

Add to 1000mL

[0027] The preparation method of L-Oxiracetam lyophilized powder for injection of Example 2 includes the following steps:

[0028] Dissolve the prescription amount of L-Oxiracetam, methionine, lactose, triethanolamine, Tween 80 and phenol in water for injection, adjust the pH to 5.5 with 0.1 mol / L hydrochloric acid solution, and then freeze-dry according to the following steps :

[0029] (1) Pre-freezing stage: freeze the temperature to -15°C within 5 minutes; then increase the temperature to -9°C, and the heating time is 30 minutes; again freeze the temperature to -32°C within 5 minutes; then increase the temperature to -20°C and increase the temperature The time is 90min; finally the ...

Embodiment 3

[0033] The prescription of Levoxiracetam lyophilized powder for injection in Example 3 is shown in the following table:

[0034] prescription

Weight percentage

L-Oxiracetam

200g

Methionine

120g

lactose

180g

Triethanolamine

80g

Tween 80

4g

phenol

6g

Water for Injection

Add to 1000mL

[0035] The preparation method of L-Oxiracetam lyophilized powder for injection of Example 3 includes the following steps:

[0036] Dissolve the prescription amount of L-Oxiracetam, methionine, lactose, triethanolamine, Tween 80 and phenol in water for injection, adjust the pH to 5.5 with 0.1 mol / L hydrochloric acid solution, and then freeze-dry according to the following steps :

[0037] (1) Pre-freezing stage: freeze the temperature to -18°C within 15 minutes; then heat up to -8°C with a heating time of 60 minutes; freeze the temperature again within 15 minutes to -36°C; then heat up to -26°C, and then heat up The time is 120min; finally, the temperature is frozen to -46℃ again within 15...

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PUM

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Abstract

The invention discloses a levo-oxiracetam freeze-dried powder for injection. The freeze-dried powder contains the following raw and auxiliary materials by mass: 1 part of levo-oxiracetam, 0.4-0.6 partof methionine, 0.5-0.9 part of lactose, 0.2-0.4 part of triethanolamine, 0.01-0.02 part of Tween 80, and 0.01-0.03 part of phenol. The invention utilizes specific excipient combination and freeze-drying curve, the sublimation temperature of a secondary drying stage is raised, the preparation production cycle is shortened, powder scattering phenomenon does not occur, the content and other indicators all meet the requirements, the product has good clarity that is lower than a 0.5# standard turbidity solution, also has strong antibacterial properties, and is qualified in aseptic inspection.

Description

Technical field [0001] The invention belongs to the field of pharmacy, and specifically relates to a lyophilized L-Oxiracetam powder for injection. Background technique [0002] Nootropics, also known as brain activators, are a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs require selective action on the cerebral cortex and have the characteristics of selective activation, protection and promotion of the functional recovery of damaged nerve cells. The difference from other neuropharmaceuticals is that their above-mentioned effects do not pass through the reticular system or olfactory bulb, but directly act on the cortex. Neither affects behavior, nor does it have a sedative and excitatory effect. Therefore, this type of drug has attracted widespread attention and interest, and the demand for this type of drug is also increasing. [0003] Oxiracetam (CAS No.: 62613-82-5) is chemically named 4-hydroxy-2-oxo-1-pyrrolidine acetami...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/20A61K47/26A61K47/18A61K47/10A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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