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Prepn and product of oxiracetam powder for injection

A freeze-dried powder injection and low-temperature freeze-drying technology, which is applied in the field of pharmaceutical preparations, can solve the problems of unsatisfactory forming results, slow dissolution of finished products, and difficulty in forming, and achieves advantages of long-term storage and long-distance transportation, simple preparation process, and good stability. Effect

Inactive Publication Date: 2004-04-07
HARBIN SANLIAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method is prone to spray bottle phenomenon when freeze-drying, not easy to form and easy to appear hole-like, umbrella-shaped bad shape, forming result is not ideal, and sticking bottle phenomenon easily occurs when freeze-drying, the finished product dissolves slowly in water for injection, in addition , the content of related substances is large

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: Taking the preparation of 100 bottles of oxiracetam freeze-dried powder injection products as an example, the specific preparation method is to weigh 1000g oxiracetam and 250g sorbitol in a sterile compounding room and put them into a sterile container, add Water for injection 4000ml, after dissolving, add 0.02% (W / V) active carbon for needles 1g to the solution, heat to 60°C, stir for 15 minutes, filter and decarbonize to obtain the filtrate; then add water for injection to the filtrate to 5000ml, Adjust the pH value to 4.8, then fine filter with a 0.22 μm microporous membrane to obtain the filtrate, check the clarity and pH value of the filtrate, and measure the content of oxiracetam. Bottle 5ml, freeze-dry in a freeze dryer, first lower the temperature of the freeze-drying box of the freeze-drying machine (model GLZY-513) to -40°C (the eutectic point of this product is -3.5°C), and then put the product into the freeze-drying box The pre-freezing time is...

Embodiment 2

[0017] Embodiment 2: Taking the preparation of 100 bottles of oxiracetam freeze-dried powder injection products as an example, the specific preparation method is to weigh 1000g oxiracetam and 300g lactobionic acid in a sterile compounding room and put them into a sterile container, add Water for injection 4000ml, after dissolving, add 0.02% (W / V) active carbon for needles 1g to the solution, heat to 60°C, stir for 15 minutes, filter and decarbonize to obtain the filtrate; then add water for injection to the filtrate to 5000ml, Adjust the pH value to 4.8, then fine filter with a 0.22 μm microporous membrane to obtain the filtrate, check the clarity and pH value of the filtrate, and measure the content of oxiracetam. Bottle of 5ml, freeze-dried in a freeze dryer, first lower the temperature of the freeze-drying box of the freeze-drying machine (model GLZY-513) to -42°C (the eutectic point of this product is -3.5°C), and then put the product into the freeze-drying box The pre-fre...

Embodiment 3

[0018] Example 3: Taking the preparation of 100 bottles of oxiracetam freeze-dried powder injection as an example, the specific preparation method is to weigh 1000g of oxiracetam and 300g of sodium citrate in a sterile compounding room and put them into a sterile container Add water for injection 4000ml, add 0.02% (W / V) active carbon for needles 1g in the dissolving liquid again after dissolving, be heated to 60 ℃, stir for 15 minutes, filter decarbonization, obtain filtrate; Add water for injection in filtrate then to 5000ml, adjust the pH value to 4.8, and then use a 0.22μm microporous membrane filter to obtain the filtrate, check the clarity and pH value of the filtrate, and measure the content of oxiracetam. , 5ml per bottle, freeze-dried in a freeze-dryer, first lower the temperature of the freeze-dryer (model GLZY-513) to -42°C (the eutectic point of this product is -3.5°C), and then put the product into the freezer Pre-freeze in the dry box. The pre-freezing time is 4.5...

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PUM

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Abstract

The present invention provides one kind of Oxiracetam freeze dried powder for injection and its preparation and product. It is prepared with Oxiracetam, sorbic alcohol or citric acid or lactobionic acid or sodium lactobionate, and water in the weight ratio of 1 to 0.1-2.0 to 1-10 and through weighing Oxiracetam and sorbic alcohol or citric acid or lactobionic acid or sodium lactobionate, dissolving in some container, adding active carbon, heating, filtering to eliminate carbon, regulating pH value, microfiltering, bottling in bacteria-free glass bottle, low temperature freeze drying and sealing.

Description

technical field [0001] The invention relates to pharmaceutical preparations, more specifically to a preparation method and product of oxiracetam freeze-dried powder injection. Background technique [0002] Oxiracetam (Oxiracetam, CAS62613-82-5), developed by ISF Company in Italy, is an anti-hypoxic nootropic drug. It is a new GABOB cyclic derivative that can promote the synthesis of phosphorylcholine and phosphorylethanolamine. Promote brain metabolism, pass through the blood-brain barrier, have a stimulating effect on specific central nervous channels, and improve intelligence and memory. This product has extremely low toxicity, no mutagenic, carcinogenic and reproductive toxicity. Oxiracetam injection was launched in Italy for the first time in December 1987, and it has been widely used clinically in foreign countries. In my country, as the aging population continues to accelerate, the market demand for this product will increase significantly. The "Tenth Five-Year Plan" ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4015A61P25/00
Inventor 诸葛华明诸葛国民
Owner HARBIN SANLIAN PHARMA CO LTD
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