Preparation method of levo-oxiracetam lyophilized powder

A freeze-dried powder and drying technology, which is applied in the field of preparation of levooxiracetam freeze-dried powder, can solve the problems of poor product uniformity, inconsistent properties of upper and lower layers, poor product stability, etc. Consistent layer properties and good product stability

Inactive Publication Date: 2017-11-28
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] However, the existing levoxiracetam freeze-dried powder for injection has problems such as no fixed shape, difficulty in forming a skeleton, easy drying shrinkage and bubbling, poor product uniformity, inconsistent properties of the upper and lower layers, and poor product stability. Before clinical use, it needs to be dissolved in 100-250ml of 5% glucose injection or 0.9% sodium chloride injection to prepare

Method used

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  • Preparation method of levo-oxiracetam lyophilized powder
  • Preparation method of levo-oxiracetam lyophilized powder
  • Preparation method of levo-oxiracetam lyophilized powder

Examples

Experimental program
Comparison scheme
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Example Embodiment

[0014] Example 1

[0015] The prescription of the lyophilized L-Oxiracetam powder of Example 1 is shown in the following table:

[0016] prescription

[0017] The preparation method of the lyophilized L-Oxiracetam powder of Example 1 includes the following steps:

[0018] (1) Concentration: Place the prescription amount of raw and auxiliary materials in a container, add 10 times parts by weight of L-Oxiracetam and stir with sterile water for injection. After dissolving, add 0.1% mass fraction of activated carbon for needles and stir for 30 minutes. Then filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;

[0019] (2) Dilute formulation: add sterile water for injection to the filtrate to 1000 times the volume of the filtrate, adjust the pH to 3.2-3.6 with 0.1 mol / L hydrochloric acid or 0.1 mol / L sodium hydroxide, and then use 0.22 micron Sterilize and filter through microporous membrane, fill the qualified filtrate into sterile glass bottles for lat...

Example Embodiment

[0022] Example 2

[0023] The prescription of the lyophilized L-Oxiracetam powder of Example 2 is shown in the following table:

[0024] prescription

[0025] The preparation method of the lyophilized L-Oxiracetam powder of Example 2 is the same as that of Example 1.

Example Embodiment

[0026] Example 3

[0027] The prescription of the lyophilized L-Oxiracetam powder of Example 3 is shown in the following table:

[0028] prescription

[0029] The preparation method of the lyophilized L-Oxiracetam powder of Example 3 is the same as that of Example 1.

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Abstract

The invention discloses a preparation method of levo-oxiracetam lyophilized powder. The levo-oxiracetam lyophilized powder is prepared from the following raw materials and auxiliary materials in percentage by weight: 50-59% of levo-oxiracetam, 20-25% of L-serine, 10-17% of mannitol, 5-7% of polyethylene glycol 2000, 5-10% of sodium hydrogen sulfite and 0.1-0.5% of phenol; and the levo-oxiracetam lyophilized powder is obtained by carrying out the steps of thick mixing, dilute mixing, freeze drying and capping. The preparation method disclosed by the invention has the advantages that specific excipient combination is utilized, and then a specific freeze drying technology is combined, so that the prepared levo-oxiracetam lyophilized powder has fixed geometry, no phenomena such as dry shrinkage and bubbling are caused in a freeze drying preparation process, product uniformity is good, upper and lower layers are consistent in character, antibacterial property is strong, sterility test is qualified, product stability is good, and insoluble particles are obviously reduced.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of levoxiracetam freeze-dried powder. Background technique [0002] Oxiracetam is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and can activate, protect or promote the functional recovery of nerve cells , to improve the memory and learning function of patients with mental retardation, and the drug itself has no direct vasoactive activity, nor does it have a central excitatory effect, and the effect on learning and memory ability is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/18A61K47/26A61K47/10A61K47/02A61K31/4015A61P25/00
CPCA61K9/19A61K31/4015A61K47/02A61K47/10A61K47/183A61K47/26
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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