Less-impurity levo oxiracetam sterile powder and preparation method thereof
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A technology with sterile powder and less impurities, which can be used in powder transportation, medical preparations containing active ingredients, etc. problems, achieve the effects of reducing adverse drug reactions, good product uniformity, and improving safety
Inactive Publication Date: 2017-05-24
CHONGQING RUNZE PHARM CO LTD
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Problems solved by technology
[0004] The existing levoxiracetam sterile powder mainly has no fixed shape, is not easy to form a skeleton, is prone to dry shrinkage and bubbling, poor product uniformity, inconsistent properties of the upper and lower layers, unqualified clarity, poor stability, and shelf life. Issues such as short term
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Embodiment 1
[0020] A sterile levoxiracetam powder with few impurities is prepared according to the following steps:
[0025] 1. Concentrated preparation: put the prescribed amount of levoxiracetam and excipients in a container, add 10 times the weight of levoxiracetam and sterilized water for injection to stir, after dissolving, add 0.5% by mass fraction of the needle Stir with activated carbon for 30 minutes, then filter with a 0.45 micron microporous membrane, collect the filtrate, and set aside;
[0026] 2. Dilute preparation: add sterile water for injection to the filtrate to the prescribed amount, adjust the pH to 5.5 with hydrochloric acid or sodium hydroxide, then sterilize and filter with a 0.22-micron microporous membrane, take the filtrate and fill ...
Embodiment 2
[0030] A sterile levoxiracetam powder with few impurities is prepared according to the following steps:
[0038] Preparation process: prepared according to the preparation process of Example 1.
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Abstract
Less-impurity levo oxiracetam sterile powder is characterized in that the less-impurity levo oxiracetam sterile powder is prepared from levo oxiracetam, L-serine, mannitol, polyethylene glycol and Tween 80 as raw and accessory materials by the steps of concentrated distribution, dilute distribution, freeze drying and capping, the less-impurity levo oxiracetam injection sterile powder prepared by the method has a fixed shape, the process of freeze drying preparation is free of dry shrinkage and bubbling phenomenon, product homogeneity is good, lower layer and upper layer characters are consistent, impurities are less, the total impurities are less than 0.23%, the less-impurity levo oxiracetam sterile powder helps to improve the safety of drug use, and reduces adverse drug reactions, the product has good clarity, the turbidity of the product is lower than that of 0.5 # standard turbidity fluid, and has good stability, and the shelf life is up to 24 months.
Description
technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a sterile levoxiracetam powder with few impurities and a preparation method thereof. Background technique [0002] Oxiracetam (S-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 has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory 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 ingredient...
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