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Preparation method of piracetam freeze-dried powder injection for injection

A technology of piracetam and piracetam, applied in the field of medicine, can solve problems affecting the efficacy of piracetam, adverse reactions, etc., and achieve the effect of simple and easy to control preparation method, easy reconstitution, and good stability

Inactive Publication Date: 2020-11-06
广东鼎信医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the piracetam freeze-dried powder injection will inevitably be exposed to light and other environments during the preparation process. Existing studies have shown that: piracetam will be degraded during the placement process, and the by-products generated by the degradation are likely to affect the piracetam. The efficacy of Tantan, and even the risk of adverse reactions

Method used

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  • Preparation method of piracetam freeze-dried powder injection for injection
  • Preparation method of piracetam freeze-dried powder injection for injection
  • Preparation method of piracetam freeze-dried powder injection for injection

Examples

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Effect test

Embodiment 1

[0024] Example 1. Preparation method of piracetam freeze-dried powder for injection

[0025] It includes the following steps:

[0026] S1) Take 60% of the total volume of the water for injection and place it in the batching tank, add piracetam under stirring, and after it is fully dissolved, add the remaining volume of the water for injection and stir, and add L-arginine to the batching tank Stir the hydrochloride, adjust the pH to 7.1, add the needle and stir with activated carbon, filter and remove the carbon, continue to stir, filter through a 0.22μm sterile filter, fill it in a vial and stopper half;

[0027] S2) Pre-freeze the vial of step S1 below -50°C for 5 hours; turn on the condenser, and when the condenser temperature drops below -40°C, turn on the vacuum pump to reduce the vacuum to 1.5×10 -1 Below mbar, raise the temperature to -18°C and keep it for 21h until the waterline disappears; continue to raise the temperature to 35°C and keep it for 1.5h, evacuate the air, fill ...

Embodiment 2

[0031] Example 2. Preparation method of piracetam freeze-dried powder for injection

[0032] It includes the following steps:

[0033] S1) Take 60% of the total volume of the water for injection and place it in the batching tank, add piracetam under stirring, and after it is fully dissolved, add the remaining volume of the water for injection and stir, and add L-arginine to the batching tank Stir the hydrochloride, adjust the pH to 7.2, add the needle and stir with activated carbon, filter and remove the carbon, continue to stir, filter through a 0.22μm sterile filter, fill it in a vial and stopper half;

[0034] S2) Pre-freeze the vial of step S1 below -50°C for 6 hours; turn on the condenser, and when the condenser temperature drops below -40°C, turn on the vacuum pump to reduce the vacuum to 1.5×10 -1 Below mbar, raise the temperature to -18°C and keep it for 20h until the waterline disappears; continue to raise the temperature to 35°C and keep it for 2h, evacuate the air, fill i...

Embodiment 3

[0038] Example 3, a preparation method of piracetam freeze-dried powder for injection

[0039] It includes the following steps:

[0040] S1) Take 60% of the total volume of the water for injection and place it in the batching tank, add piracetam under stirring, and after it is fully dissolved, add the remaining volume of the water for injection and stir, and add L-arginine to the batching tank Stir the hydrochloride, adjust the pH to 7.2, add the needle and stir with activated carbon, filter and remove the carbon, continue to stir, filter through a 0.22μm sterile filter, fill it in a vial and stopper half;

[0041] S2) Pre-freeze the vial of step S1 below -50°C for 5 hours; turn on the condenser, and when the condenser temperature drops below -40°C, turn on the vacuum pump to reduce the vacuum to 1.5×10 -1 Below mbar, raise the temperature to -18°C and keep it for 22h until the waterline disappears; continue to raise the temperature to 35°C and keep it for 1h, evacuate the air, fill...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a preparation method of a piracetam freeze-dried powder injection for injection. The preparation method of the piracetam freeze-dried powder injection for injection comprises the following steps: (1) putting 60% of water for injection based on the total volume into a mixing tank, adding piracetam in a stirring state, fully dissolving, adding the rest volume of water for injection, stirring, regulating the pH value, adding activated carbon for injection, stirring, filtering, decarbonizing, and continuously stirring, finely filtering, filling into a penicillin bottle, and performing semi-corking; S2) performing pre-freezing on the penicillin bottle in the step S1, starting a condenser, starting a vacuum pump when the temperature of the condenser is reduced to -40 DEG C or below, increasing the temperature to -18 DEG C, and keeping the temperature until the water line disappears; continuously raising the temperature to 35 DEG C, keeping the temperature, pumping out air, filling high-purity nitrogen, and pressing a penicillin bottle plug; and S3) rolling an aluminum-plastic cover, carrying out lightinspection, and packaging to obtain the injection. The piracetam freeze-dried powder injection for injection disclosed by the invention has the advantages that the appearance conforms to the specification, the redissolution is easy, the impurities are few, and the quality is stable.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation method of a piracetam freeze-dried powder injection for injection. Background technique [0002] Piracetam is a derivative of γ-aminobutyric acid, which has a wide range of pharmacological and physiological effects of activating, protecting and repairing brain nerve cells, as well as improving the comprehensive functions of the brain, so that it can effectively improve the memory and emotional disorders of patients. [0003] At present, the preparation types of piracetam include tablets, capsules, granules, oral preparations, injections, and freeze-dried powder injections. The freeze-dried powder injections are obtained by low-temperature freezing-vacuum drying. The specific preparation process is : First dissolve each material with a solvent (water for injection) to prepare a solution, then freeze the solution at a low temperature, and then vacuum, sublimate, ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61K47/18A61P25/28
CPCA61K9/19A61K9/0019A61K31/4015A61K47/183A61P25/28
Inventor 钱锦花忻蓉张明
Owner 广东鼎信医药科技有限公司
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