Levo oxiracetam for injection and preparation method thereof

A technology for injection and water for injection, which is applied in the field of levoxiracetam for injection and its preparation, which can solve the problems of large pH changes of the solution, poor clarity of the finished product, and many impurities, and achieve less impurities and good clarity of the product , good stability

Inactive Publication Date: 2017-09-01
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 levoxiracetam for injection mainly has problems such as large changes in solution pH during product sterilization, poor clarity of finished products, easy crystallization during storage, and many impurities.

Method used

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  • Levo oxiracetam for injection and preparation method thereof
  • Levo oxiracetam for injection and preparation method thereof
  • Levo oxiracetam for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A kind of levoxiracetam for injection, prepared according to the following steps:

[0023]

[0024] Preparation process:

[0025] 1. Concentrated formulation: Add the above-mentioned raw and auxiliary materials into the batching tank, then add 2 / 3 of the prescription amount of sterile water for injection, stir, dissolve, and obtain a concentrated formulation;

[0026] 2. Dilute preparation: Take the concentrated preparation, add sodium phosphate buffer solution (precisely weigh 65.697g of disodium hydrogen phosphate and 2.346g of sodium dihydrogen phosphate, put it in a 1000ml volumetric flask, add purified water to dissolve, dilute to the scale , to obtain), adjust the pH to 6.5, add chitosan with a total volume of 0.3% to 0.5% (g / ml) to the above solution, stir, mix well, let stand for 35 to 45min, and filter with a 0.8 μm filter membrane Add 0.1% to 0.3% (g / ml) of activated carbon in the total volume, adsorb and decolorize, filter with a 0.45 μm filter membrane, ...

Embodiment 2

[0067] A kind of levoxiracetam for injection, prepared according to the following steps:

[0068]

[0069] Preparation process: prepared according to the preparation process of Example 1.

[0070] Press the test method of embodiment 1, carry out respectively stability test investigation, clarity contrast test and pH adjuster to the influence experiment of solution pH before and after product sterilization, stability test result shows that accelerates 6 months sample quality is stable, long-term 18 months The quality is stable, so this product is valid for at least 18 months; the test results of the clarity comparison test show that the clarity of the sample produced in Example 2 is less than No. 0.5 standard turbidity liquid, and the clarity of this product is good; different pH regulators can sterilize the product The experiment of the influence of solution pH before and after showed that the solution pH of the sample prepared in Example 2 did not change substantially befo...

Embodiment 3

[0072] A kind of levoxiracetam for injection, prepared according to the following steps:

[0073]

[0074] Preparation process: prepared according to the preparation process of Example 1.

[0075] Press the test method of embodiment 1, carry out respectively stability test investigation, clarity contrast test and pH adjuster to the influence experiment of solution pH before and after product sterilization, stability test result shows that accelerates 6 months sample quality is stable, long-term 18 months The quality is stable, so this product is valid for at least 18 months; the test results of the clarity contrast test show that the clarity of the sample produced in Example 3 is less than No. 0.5 standard turbidity liquid, and the clarity of this product is good; different pH regulators can sterilize the product The experiment on the influence of solution pH before and after showed that the solution pH of the sample prepared in Example 3 did not change substantially before...

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PUM

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Abstract

The invention relates to levo oxiracetam for injection. The levo oxiracetam for injection is characterized in that it is prepared from the following raw and auxiliary materials: 58%-65% of levo oxiracetam, 15%-22% of propylene glycol, and 18%-25% of lecithin. The preparation method includes: adding the raw and auxiliary materials into a mixing tank, adding water accounting for 2/3 of a prescription dosage, and conducting stirring and dissolving to obtain a concentrated solution; adding a sodium phosphate buffer solution into the concentrated solution to adjust the pH to 6.5, adding 0.2%-0.6% of chitosan into the solution, carrying out stirring, blending, standing and filtering, adding 0.1%-0.3% of activated carbon, conducting adsorption decolorization, and performing filtration, thus obtaining the levo oxiracetam for injection. According to the levo oxiracetam for injection prepared by the method involved in the invention, the pH of the solution almost has no change during sterilization, the finished product has good clarity that is lower than that of a 0.5# standard turbidity solution, and has good stability, does not produce crystals during storage, has long validity period up to 18 months or above, and few impurities within the validity period, wherein the total impurities are less than 0.32%, and the preparation process is simple and feasible, thus being worthy of promotion.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to levoxiracetam for injection and a preparation method thereof. Background technique [0002] Nootropic drug, also known as brain activator, is a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs are required to selectively act on the cerebral cortex, and have the characteristics of selectively activating, protecting and promoting the recovery of damaged nerve cell functions. The difference from other neurological drugs is that their above-mentioned effects do not pass through the reticular system or the olfactory bulb, but directly act on the cortex. It neither affects behavior nor has sedative and exciting effects, so this class of drugs has attracted widespread attention and interest, and the demand for this class of drugs is also increasing day by day. [0003] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) chemical name...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4015A61K47/10A61K47/24A61P25/28
CPCA61K9/0019A61K9/08A61K31/4015A61K47/10A61K47/24
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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