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Ornidazole injection and preparation method
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An ornidazole injection, ornidazole technology, is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of genotoxic impurities such as growth, and achieve quality improvement, The effect of improving stability and reducing risk
Pending Publication Date: 2020-12-22
KAMP PHARMA
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[0020] In this plan, the pH is controlled by adding acetic acid-sodium acetate aqueous solution to improve the stability of ornidazole, but the introduction of water into the preparation may increase the amount of genotoxic impurities in the preparation after high-temperature sterilization.
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[0042] (1) Add the prescription amount of absolute ethanol and propylene glycol into the container;
[0043] (2) Add molecular sieves of 10% feeding amount, process for 1.0h, filter and remove molecular sieves, and the moisture content of the preparation is 0.06%;
[0044] (3) Add the BHT of prescription quantity, stir and dissolve;
[0045] (4) Add ornidazole raw material, stir and dissolve at 30±5°C;
[0046] (5) The medicinal liquid passes through 0.45 μm and 0.22 μm filters in sequence, and is potted;
[0052] (1) Add the prescription amount of absolute ethanol and propylene glycol into the container;
[0053] (2) Add molecular sieves with 7% feed amount, process for 1.5h, filter to remove molecular sieves, and the moisture content of the preparation is 0.07%;
[0054] (3) Add the BHT of prescription quantity, stir and dissolve;
[0055] (4) Add ornidazole raw material, stir and dissolve at 30±5°C;
[0056] (5) The medicinal liquid passes through 0.45 μm and 0.22 μm filters in sequence, and is potted;
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Abstract
The invention relates to an ornidazole injection and a preparation method. The ornidazole injection comprises the following components by weight of 5-10 parts of ornidazole, 5-20 parts of absolute ethanol and 10-40 parts of propanediol, wherein the weight content of water is lower than 0.1%; and when the weight content of the water is greater than 0.02% and less than 0.1%, the injection further comprises 0.3-1 part of an antioxidant. The preparation method comprises the following steps of 1) weighing a certain amount of the absolute ethanol and the propanediol, adding a molecular sieve which accounts for 5-10% of the total weight of the substances, performing treatment, performing filtering, and controlling the water content of a solution to be lower than 0.1%; 2) adding the antioxidant, and performing uniform stirring; 3) adding the ornidazole, and performing stirring until the ornidazole is completely dissolved; and 4) performing filtering and sterilizing to obtain a torasemide injection. By means of water control, antioxidant addition and the like, the generation of impurities is controlled, the stability of product quality is improved, and the risk of a product is reduced.
Description
technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an ornidazole injection and a preparation method. Background technique [0002] Ornidazole is a systemic anti-infective drug that was first listed in Germany by Hoffmann-LaRocheandCo (Switzerland) in 1977. Its mechanism of action is that ornidazole is reduced by a redoxsystem similar to ferredoxin in bacterial cells. By increasing the absorption, the intracellular concentration becomes larger, and on the other hand, toxic metabolites are produced in the cells, which act on the DNA process of bacteria and promote the death of bacteria. Therefore, ornidazole injection can be widely used in clinical acute treatment and maintenance treatment of infections caused by protozoa and anaerobic bacteria. [0003] Ornidazole is unstable, and impurities will be produced after terminal sterilization and storage, especially carrying warning structures, which ma...
Claims
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