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(S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection and preparation method thereof

A technology of pyrrolidine acetamide and water for injection, which is applied in the field of -4-hydroxy-2-oxo-1-pyrrolidine acetamide water injection for injection and its preparation field, and can solve the problem of obvious pain, easy crystallization, easy oxidation, etc. problems, to achieve the effect of good patient compliance, less product impurities, and not easy to be oxidized

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

[0004] The existing (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide aqueous injection for injection mainly has a large change in pH of the solution during the sterilization process of the product, and the sterilization process is likely to cause the increase of impurities and the stability of the finished product. Not good, easy to oxidize, easy to crystallize during storage, obvious pain during injection, poor compliance, etc.

Method used

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  • (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection and preparation method thereof
  • (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection and preparation method thereof
  • (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide water injection for injection is prepared according to the following steps:

[0022] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 17g Lecithin 27g Vitamin C 7g Ethylenediaminetetraacetic acid 5g Benzyl alcohol 2g Sterile water for injection Add to 2000ml

[0023] Make 1000 pieces

[0024] Preparation process:

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

[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 th...

Embodiment 2

[0073] A (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide water injection for injection is prepared according to the following steps:

[0074] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 13g Lecithin 22g Vitamin C 5g Ethylenediaminetetraacetic acid 5g Benzyl alcohol 2g Sterile water for injection Add to 2000ml

[0075] Make 1000 pieces

[0076] Preparation process: prepared according to the preparation process of Example 1.

[0077] 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 significantl...

Embodiment 3

[0079] A (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide water injection for injection is prepared according to the following steps:

[0080] Element Dosage (S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide 100g Propylene Glycol 15g Lecithin 23g Vitamin C 8g Ethylenediaminetetraacetic acid 5g Benzyl alcohol 3g Sterile water for injection Add to 2000ml

[0081] Make 1000 pieces

[0082] Preparation process: prepared according to the preparation process of Example 1.

[0083] According to 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, increases the related substances si...

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Abstract

(S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection is characterized in that (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide, propylene glycol, lecithin, vitamin C, ethylene diamine tetraacetic acid and benzyl alcohol which are used as raw materials and auxiliary materials undergo steps of concentrated mixing, diluted mixing, encapsulation, sterilization, inspection and packaging to prepare the (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide hydro-acupuncture for injection. During the sterilization process of the (S)-4-hydroxy-2oxo-1-pyrrolidine acetamide injection, pH value of the solution is barely changed, and impurity increasing amount during the sterilization process is only 0.05%. The finished product will not be crystallized during the storage process, is not easy to oxidize, and has good stability. The period of validity is as long as 18 months and above. During the period of validity, the product has less impurity, and the total impurity content is lower than 0.29%. Pains of patients are obviously reduced during the injection process, and patients' compliance is good. The product is worthy of market promotion.

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 aqueous injection 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] Oxiraceta...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61K47/10A61K47/24A61K47/18A61K47/22A61P25/00
CPCA61K9/0019A61K9/08A61K31/4015A61K47/10A61K47/183A61K47/22A61K47/24
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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