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Levorotatory oxiracetam injection and preparation method thereof

A technology for injections and injections, which is applied in the field of levo-oxiracetam, can solve the problems that the clinical safety of levo-oxiracetam injection cannot be guaranteed, and the sterility is not achieved, so as to ensure the effectiveness and safety, avoid Good effect of discoloration and stability

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Levoxiracetam injection is prepared according to the following steps:

[0041]

[0042]

[0043] 1. Concentrated formulation: Dissolve edetate calcium sodium, cysteine ​​and thimerosal with 50%-70% of the prescription amount of sterile water for injection, 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 5.4, stir, mix well, add sterilized water for injection to the prescribed amount ;

[0045] 3. Potting: use 0.22μm polycarbonate membrane material microporous filter 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. Sterilization procedure: 10°C / min, rise to 121°C, keep at 121°C for 15 minutes; compressed air blast Wind cooling at 3-5°C / min, cooling to 70-80°C in 8-12 minutes, cooling with cooling water...

Embodiment 2

[0049] Levoxiracetam injection is prepared according to the following steps:

[0050] Element

Dosage

Levoxiracetam

80g

Sodium Calcium EDTA

0.2g

cysteine

0.1g

Thimerosal

0.1g

Sterile water for injection

Add to 1000ml

[0051] Preparation process:

[0052] 1. Concentrated formulation: Dissolve edetate calcium sodium, cysteine ​​and thimerosal with 50%-70% of the prescription amount of sterile water for injection, then add levoxiracetam and stir to dissolve;

[0053] 2. Dilute formulation: Take the concentrated formulation, add citric acid-sodium citrate solution (citrate ion concentration is 15mmol / L), adjust the pH to 5.4, stir, mix well, add sterilized water for injection to the prescribed amount ;

[0054] 3. Potting: use 0.22μm polycarbonate membrane material microporous filter membrane to filter, fill and seal;

[0055] 4. Sterilization: Send the filled ampoule into a steam sterilizer for sterilizatio...

Embodiment 3

[0058] Levoxiracetam injection is prepared according to the following steps:

[0059] Element

Dosage

Levoxiracetam

240g

Sodium Calcium EDTA

0.4g

cysteine

0.3g

Thimerosal

0.3g

Sterile water for injection

Add to 1000ml

[0060] Preparation process:

[0061] 1. Concentrated formulation: Dissolve edetate calcium sodium, cysteine ​​and thimerosal with 50%-70% of the prescription amount of sterile water for injection, then add levoxiracetam and stir to dissolve;

[0062] 2. Dilute formulation: take concentrated formulation, add citric acid-sodium citrate solution (citrate ion concentration is 50mmol / L), adjust pH to 6.8, stir, mix well, add sterilized water for injection to the prescribed amount ;

[0063] 3. Potting: use 0.22μm polycarbonate membrane material microporous filter membrane to filter, fill and seal;

[0064] 4. Sterilization: Send the filled ampoule into a steam sterilizer for sterilization, and ...

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Abstract

The invention discloses a levorotatory oxiracetam injection. The levorotatory oxiracetam injection comprises levorotatory oxiracetam, cysteine, calcium sodium ethylenediaminetetraacetate, thiomersalate and injection water as an injection solvent. Through combination with specific amounts of cysteine, calcium sodium ethylenediaminetetraacetate and thiomersalate, pH of the levorotatory oxiracetam solution is strictly controlled through citric acid-sodium citrate. Through synergism of raw materials, increasing of glycine anhydride content of the injection is avoided, the influence caused by discoloration and related substances exceeding standards on injection quality is avoided, the levorotatory oxiracetam injection tolerates the final sterilization process, stability is good and the effectiveness and safety of drugs are effectively ensured.

Description

technical field [0001] The invention relates to levo-oxiracetam, in particular to a 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] 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 clinically Note the ...

Claims

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Application Information

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