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A kind of oxiracetam for injection and preparation method thereof

A technology of water for injection and control bottles, which is applied in the direction of freeze-drying transportation, neurological diseases, powder transportation, etc. It can solve the problems of long freeze-drying cycle, unfavorable drying, slow drying, etc., and achieve low moisture content, low impurity level and high quality. stable effect

Active Publication Date: 2018-04-17
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, for freeze-dried products with excessive solute concentration (greater than 20% (W / V)), it is easy to accumulate solutes in the surface frozen layer during the freezing process, forming a hard shell, which is not conducive to later drying, and it is easy to cause the product to shrink, melt and burn. A series of problems such as difficult reconstitution
Oxiracetam injection has been listed with a specification of 1.0 / bottle, filled with 5ml, and its solute concentration is 20%. Freeze-drying is carried out in different ways, and the drying is slow due to the formation of a freeze-concentrated layer on the surface. As a result, the freeze-drying cycle is very long, and a hard film is formed on the surface of the product, and it needs to be shaken vigorously to dissolve completely when reconstituted.

Method used

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  • A kind of oxiracetam for injection and preparation method thereof
  • A kind of oxiracetam for injection and preparation method thereof
  • A kind of oxiracetam for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Prepare oxiracetam solution at a concentration of 50%, add ethanol of 0%, 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2.0% and 2.2% (V / V) of the total volume respectively, observe the oxiracetam Dissolution of Piracetam. The results are shown in Table 1:

[0052] Ethanol concentration (V / V)

[0053] From the above experimental results, it can be seen that when the amount of ethanol is greater than 2.0%, oxiracetam cannot be completely dissolved, and its solubility decreases. Therefore, during the preparation of this product, the amount of ethanol should not exceed 2.0%.

Embodiment 2

[0055] On the basis of Example 1, store the completely dissolved drug solution at 60°C for 24 hours, and take a sample at the specified time to detect the amount of impurity (oxiracetam acid). The results are shown in Table 2:

[0056] Table 2 The impurity levels of oxiracetam in solutions containing different amounts of ethanol

[0057]

[0058] From the above experimental results, it can be seen that the amount of oxiracetam acid increases with time, and the amount of increase is related to the amount of ethanol in the solution. The more the amount of ethanol, the less the amount of increase. When the amount of ethanol is greater than or equal to 1.4%, the amount of increase is the least, and oxiracetam is the most stable.

Embodiment 3

[0060] On the basis of Example 1, carry out terminal filtration and sterilization of the completely dissolved medicinal liquid through a 0.22 μm microporous membrane to obtain a filtrate, fill the filtrate into a control bottle at 5.0 ml / bottle, stopper, and use ordinary pre-freezing Freeze-drying is carried out after the method, and the freeze-drying program is shown in Table 3:

[0061] pre-freeze

[0062] Statistically obtain the ratio of frozen concentrated layer samples in each batch of samples, the results are shown in Table 4:

[0063] Ethanol concentration (V / V)

[0064] From the above experimental results, it can be seen that all the samples without ethanol have freeze-concentrated layers. For samples containing ethanol, as the amount of ethanol increases, the proportion of samples with frozen concentrate layer decreases. When the amount of ethanol is greater than or equal to 1.4%, the proportion of samples with frozen concentrated layer is small....

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Abstract

The invention discloses an oxiracetam freeze-dried powder injection and a preparation method thereof. The oxiracetam freeze-dried powder injection is prepared by dissolving oxiracetam in water for injection, and then adding 1.2% to 2.0% (V / V) ethanol of the total volume to prepare 200 to 500 mg / ml of oxiracetam Racetam solution, obtained by lyophilization. The oxiracetam freeze-dried powder injection is prepared by adding an appropriate amount of ethanol and combined with a special freeze-drying process, especially a special pre-freezing method, and formulates the pre-freezing process parameters so that the surface of the solution crystallizes first, avoiding the surface Solute accumulation. The oxiracetam freeze-dried powder injection prepared by the invention basically does not contain auxiliary materials, has rapid reconstitution, good quality and stable storage.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically, to an oxiracetam for injection and a preparation method thereof. Background technique [0002] Oxiracetam, the chemical name is: 4-hydroxy-2-oxo-1-pyrrolidineacetamide, the structural formula is: [0003] [0004] Oxiracetam is a pyrrolidone derivative first synthesized by the Italian ISF company, and it is a new generation of brain metabolism improving drug. This product can promote the synthesis of phosphorylcholine and phosphorylethanolamine, increase the utilization of oxygen and glucose in the brain and the ratio of ATP / ADP, increase the synthesis of protein and nucleic acid in the brain; act on glutamate-promoting receptors, Prevent neurotoxicity caused by glutamate; can improve memory and learning functions of patients with memory and intellectual disabilities. This product is suitable for memory and intelligence disorders caused by mild to moderate vascul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4015A61P25/28
Inventor 喻義王小霞
Owner YAOPHARMA CO LTD
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