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(S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder and preparation method of same

A technology of pyrrolidine acetamide and sterile powder, which can be used in powder delivery, pharmaceutical formulations, nervous system diseases, etc. It can solve problems such as short shelf life, easy to appear spray bottles, and increased impurities, and achieve good product stability.

Inactive Publication Date: 2017-07-14
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 (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide aseptic powder mainly exists in the preparation process. Impurities increase significantly, have no fixed shape, and are not easy to form a skeleton. The product is prone to spray bottles during the freeze-drying process Phenomenon, poor stability, short shelf life and other issues

Method used

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  • (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder and preparation method of same
  • (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder and preparation method of same
  • (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder and preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide aseptic powder is prepared according to the following steps:

[0023]

[0024] Preparation process:

[0025] 1. Concentrated preparation: put the prescribed amount of (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide and additives in the container, add (S)-4-hydroxy-2-oxo-1- Pyrrolidineacetamide 10 times by weight of sterile water for injection was stirred, after dissolving, adding 0.1% mass fraction of activated carbon for needles, stirred for 30 minutes, then filtered through a 0.45 micron microporous membrane, and the filtrate was collected for subsequent use;

[0026] 2. Dilute preparation: add sterilized water for injection to the filtrate to 1000 times the volume of the filtrate, adjust the pH to 7.0 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22 micron microporous membrane, take the filtrate after passing the inspection and pour Packed in sterile glass bottles, set aside;

[00...

Embodiment 2

[0066] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide aseptic powder is prepared according to the following steps:

[0067]

[0068] Preparation process: prepared according to the preparation process of Example 1.

[0069] Press the test method of embodiment 1, respectively carry out stability test, spray bottle phenomenon statistical experiment and preparation process to the impact experiment of impurity increase in the freeze-drying process, the sample stability test result of embodiment 2 shows that accelerated June sample quality is stable, long-term The quality is stable for 24 months, so the validity period of this product is at least 24 months; the sample of Example 2 did not spray the bottle during the freeze-drying process. Example 2 The influence of the preparation process on the increase of impurities The experimental results show that the increase of product impurities in the preparation process of this product is small, which meets the product requiremen...

Embodiment 3

[0071] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide aseptic powder is prepared according to the following steps:

[0072]

[0073] Preparation process: prepared according to the preparation process of Example 1.

[0074] By the test method of embodiment 1, respectively carry out stability test, spray bottle phenomenon statistical experiment and preparation process to the impact experiment of impurity increase in the freeze-drying process, embodiment 3 sample stability test results show that accelerated June sample quality is stable, long-term The quality is stable for 24 months, so the valid period of this product is at least 24 months; the sample of Example 3 has no bottle spray phenomenon during the freeze-drying process. Example 3 The influence of the preparation process on the increase of impurities The experimental results show that the increase of product impurities in the preparation process of this product is small, which meets the product requirements.

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Abstract

A (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder is prepared from the raw and auxiliary materials including, by weight, 35-45% of (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide, 20-28% of L-serine, 25-38% of mannitol, 3-9% of sodium glutamate and 2-10% of methionine. The preparation process of the (S)-4-hydroxy-2-oxy-1-pyrrolidine acetamide sterile powder is less in increase of impurities, wherein increase amount of the impurities is only 0.02%. The powder has a fixed shape and is free of bottle spraying phenomenon during a freeze-drying preparation process. The sterile powder is low in impurity with total impurity content being lower than 0.26%, has good stability and can reach 24 months in shelf life.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide sterile powder 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, CA...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61K47/26A61K47/18A61P25/28
CPCA61K31/4015A61K9/0019A61K9/19A61K47/183A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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