(S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder and preparation method thereof

A pyrrolidine acetamide, sterile powder technology, applied in powder delivery, freeze-dried delivery, nervous system diseases, etc., can solve the problems of poor patient compliance, difficult to form a skeleton, poor stability, etc., and achieve light pain and patient compliance. Good performance and stability

Inactive Publication Date: 2017-10-24
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 Phenomena, poor stability, short shelf life, obvious pain during product injection, poor patient compliance, etc.

Method used

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  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder and preparation method thereof
  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder and preparation method thereof
  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder and preparation method thereof

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 excipients in a container, add (S)-4-hydroxy-2-oxo-1 - Stir 10 times the weight of pyrrolidineacetamide with sterile water for injection, after dissolving, add 0.1% mass fraction of activated carbon for needles, stir for 30 minutes, then filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;

[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;

[0027] 3. Freeze-drying: Put ...

Embodiment 2

[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, the result of the sample stability test in embodiment 2 shows that the sample quality is stable in accelerating June, and the quality is stable in 24 months for a long time, so this product is valid for at least 24 months; Squirt bottle phenomenon occurs. 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 requirements. The results of the mouse writhing method to observe the pain during the injection showed that the pain of the sample of Example 2 was significantly weaker than that of the control sample during the injection.

Embodiment 3

[0076] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide aseptic powder is prepared according to the following steps:

[0077]

[0078] Preparation process: prepared according to the preparation process of Example 1.

[0079] By the test method of embodiment 1, the sample stability test result of embodiment 3 shows that accelerated June sample quality is stable, and long-term 24 months are stable in quality, so this product is valid for at least 24 months; Squirt bottle phenomenon occurs. 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. The results of the mouse writhing method to observe the pain during the injection showed that the pain of the sample of Example 3 was significantly weaker than that of the control sample during the injection.

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Abstract

(S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder is prepared from the following raw materials and auxiliary materials in percentage by weight: 36 to 43 percent of (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide, 22 to 26 percent of L-serine, 18 to 25 percent of mannitol, 8 to 15 percent of sodium glutamate, 3 to 9 percent of methionine and 1 to 3 percent of benzyl alcohol; and the (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide freeze-dried sterile powder prepared according to the invention has the advantages that the increasing amount of the impurities is small in the preparation process and is only 0.03 percent, the product has a fixed shape and avoids spray bottle phenomenon in the freeze-drying preparation process, the product has few impurities, the total impurities are less than 0.28 percent, the product has high stability, the shelf life is up to 24 months, the pain of a patient in the injection process is less, and the patient compliance is high.

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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/18A61K47/26A61K47/20A61K31/4015A61P25/00A61P25/28
CPCA61K9/19A61K31/4015A61K47/183A61K47/20A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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