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A kind of levoxiracetam injection with few impurities and preparation method thereof

A technology with less impurities for injections, applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve problems such as large pH changes in solutions, poor stability, and increased impurities in products, and achieve Simple and feasible preparation process, good solubility and good clarity

Active Publication Date: 2020-08-11
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing levoxiracetam injection mainly has problems such as large changes in pH of the solution during product sterilization, obvious increase in product impurities, poor stability, poor solubility of the main drug, and poor clarity.

Method used

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  • A kind of levoxiracetam injection with few impurities and preparation method thereof
  • A kind of levoxiracetam injection with few impurities and preparation method thereof
  • A kind of levoxiracetam injection with few impurities and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A levoxiracetam injection with few impurities is prepared according to the following steps:

[0022] Element Dosage Levoxiracetam 100g glycerin 38g Glycine 29g Vitamin C 8g Ethylenediaminetetraacetic acid 6g Sterile water for injection Add to 1000ml

[0023] Made of 500

[0024] Preparation process:

[0025] 1. Concentrated preparation: Add the 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 preparation;

[0026] 2. Dilute preparation: take the concentrated preparation, add sodium phosphate salt buffer solution (accurately 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 volume , to obtain) adjust the pH to 6.8, add chitosan with a total volume of 0.2% to 0.6% mass volume ratio to ...

Embodiment 2

[0078] A levoxiracetam injection with few impurities is prepared according to the following steps:

[0079] Element Dosage Levoxiracetam 100g glycerin 30g Glycine 20g Vitamin C 7g Ethylenediaminetetraacetic acid 5g Sterile water for injection Add to 1000ml

[0080] Made of 500

[0081] Preparation process: prepared according to the preparation process of Example 1.

[0082] By the test method of embodiment 1, the sample stability test result of embodiment 2 shows that the sample quality is stable in accelerated June, and the quality is stable in long-term 18 months, so this product is valid for at least 18 months. The test results of the effect of sterilization process on the increase of impurities show that the prescription of Example 2, combined with a specific sterilization process, increases the related substances significantly better than that of the control sample. Clarity comparative test results show that the sample...

Embodiment 3

[0084] A levoxiracetam injection with few impurities is prepared according to the following steps:

[0085]

[0086]

[0087] Made of 500

[0088] Preparation process: prepared according to the preparation process of Example 1.

[0089] By the test method of embodiment 1, the sample stability test result of embodiment 3 shows that the sample quality is stable in accelerated June, and the long-term quality is stable in 18 months, so this product is valid for at least 18 months. The test results of the effect of sterilization process on the increase of impurities show that the prescription of Example 3, combined with a specific sterilization process, has significantly better increase of related substances than the control sample. Clarity comparative test results show that the sample clarity produced by Example 3 is less than No. 0.5 standard turbidity liquid, and this product has good clarity. Experiments on the influence of different pH regulators on the pH of the solut...

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Abstract

The invention relates to a levo s-oxiracetam injection with few impurity. The levo s-oxiracetam injection is prepared with levo s-oxiracetam, glycerin, glycine, vitamin C and ethylenediamine tetraacetic acid as the raw and auxiliary materials through the steps of concentrated preparation, dilute distribution, filling and sealing, sterilizing, inspection and packaging. Specifically, the weight percentage of the raw and auxiliary materials is shown as the following: 50%-68% of levo s-oxiracetam, 15%-25% of glycerin, 10%-20% of glycine, 3%-8% of vitamin C, and 2%-5% of ethylenediamine tetraacetic acid. According to the levo s-oxiracetam injection obtained by the method provided by the invention, the pH of the solution almost has no change, the impurity increase amount during sterilization is only 0.03%, the injection is not easily oxidized in the storage process, has good stability and a valid period up to 18 months or above, and has few impurity within the valid period, and a total impurity content of less than 0.27%. The product has good clarity, which is lower than the No. 0.5 standard turbidity solution, the product main drug has good solubility, insoluble particles are less than 25 micrometers, and the preparation process is simple and feasible, thus being worthy of market promotion.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam injection with few impurities 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 (S-oxiracetam) is a synthetic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4015A61K47/10A61K47/18A61K47/22A61P25/28
CPCA61K9/0019A61K9/08A61K31/4015A61K47/10A61K47/183A61K47/22
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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