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L-oxiracetam injection and preparation method thereof

An injection and injection technology, applied in the field of levooxiracetam, can solve the problems of lack of sterility and cannot guarantee the clinical safety of levooxiracetam injection, and achieve stable product quality, guaranteed effectiveness and high quality. The effect of safety and simple production process

Inactive Publication Date: 2017-12-15
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the current Chinese market, drug hazards of injections frequently occur, most of which are caused by lack of sterility, so the non-terminal sterilization process cannot guarantee the clinical safety of levoxiracetam injection

Method used

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  • L-oxiracetam injection and preparation method thereof
  • L-oxiracetam injection and preparation method thereof
  • L-oxiracetam injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Levoxiracetam injection is prepared according to the following steps:

[0042] Element

Dosage

Levoxiracetam

100g

Sodium Calcium EDTA

0.3g

ascorbic acid

0.3g

Thimerosal

0.2g

Sterile water for injection

Add to 1000ml

[0043] 1. Concentrated formulation: Dissolve calcium sodium edetate, ascorbic acid and thimerosal with sterile water for injection of 50%-70% of the prescription amount, then add levoxiracetam and stir to dissolve;

[0044] 2. Dilute formulation: take the concentrated formulation, add citric acid-sodium citrate solution (citrate ion concentration is 30mmol / L), adjust the pH to 5.5, stir, mix well, add sterile water for injection to the prescribed amount;

[0045] 3. Potting and sealing: use 0.22μm acetate membrane material microporous membrane to filter, fill and seal;

[0046] 4. Sterilization: Send the filled ampoule into a steam sterilizer for sterilization at 121°C for 15 minutes. S...

Embodiment 2

[0049] Stability Test of Levoxiracetam Injection

[0050] Experimental Materials:

[0051] Oxiracetam sample for injection: prepared for Example 1.

[0052] Accelerated test method: the oxiracetam for injection prepared in Example 1 is packaged according to the market, placed in an accelerated test box, and samples are taken for a certain period of time, and the investigation items are inspected.

[0053] Accelerated experiment temperature: 40±2℃

[0054] Humidity: RH75%±5%

[0055] Inspection time: 0, 1, 2, 3, 6 months

[0056] Inspection indicators: traits, visible foreign matter, clarity, pH, related substances (impurity A is S-4 hydroxy-2-oxo-1-pyrrolidine acetic acid), content, sterility test

[0057] Accelerated test stability records:

[0058]

[0059]

[0060] The results of the accelerated test show that the quality of the test indicators of the sample in June and the sample in 0 month is equivalent, indicating that the quality of this product remains stabl...

Embodiment 3

[0070] Levoxiracetam injection is prepared according to the following steps:

[0071] Element

Dosage

Levoxiracetam

60g

Sodium Calcium EDTA

0.2g

ascorbic acid

0.2g

Thimerosal

0.2g

Sterile water for injection

Add to 1000ml

[0072] Preparation process:

[0073] 1. Concentrated formulation: Dissolve calcium sodium edetate, ascorbic acid and thimerosal with sterile water for injection of 50%-70% of the prescription amount, then add levoxiracetam and stir to dissolve;

[0074] 2. Dilute formulation: take the concentrated formulation, add citric acid-sodium citrate solution (citrate ion concentration is 15mmol / L), adjust the pH to 4.8, stir, mix well, add sterile water for injection to the prescribed amount;

[0075] 3. Potting and sealing: use 0.22μm acetate membrane material microporous membrane to filter, fill and seal;

[0076] 4. Sterilization: Send the filled ampoule into a steam sterilizer for sterilizat...

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Abstract

An L-oxiracetam injection includes L-oxiracetam injection, ascorbic acid, sodium calcium ethylene diamine tetracetate, thiomersal and injection water used as an injection solvent. In a preparation process, a step of adding active carbon for adsorption and pyrogen removal is not required, and produced bacterial endotoxin of the L-oxiracetam injection meets the quality requirement, so that potential safety risk due to leak or residual of active carbon is prevented. The method is simple in production technology, stable in product quality, and suitable for commercial production.

Description

technical field [0001] The invention relates to levo-oxiracetam, in particular to levo-oxiracetam injection and a preparation method thereof. Background technique [0002] Levooxiracetam (S-Oxiracetam), the chemical name is (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide, can promote the synthesis of phosphorylcholine and phosphorylethanolamine, and promote brain metabolism, Through the blood-brain barrier, it has a stimulating effect on the specific central nervous system, and has a significant effect on the recovery of the patient's neurological function. The curative effect is definite and the safety is good. Its structure is as follows: [0003] [0004] Levoxiracetam [0005] As we all know, oral administration is not suitable for dementia and mental retardation patients with symptoms such as dizziness, dysphagia, and choking and coughing when eating. Especially for patients with acute symptoms of cerebrovascular disease and brain injury, intravenous drip is often used...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/22A61K47/20A61K47/12A61K31/4015A61P25/28A61P25/00
CPCA61K9/0019A61K9/08A61K31/4015A61K47/12A61K47/183A61K47/20A61K47/22
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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