Preparation method of tramadol hydrochloride sodium chloride injection

Abstract

The invention discloses a preparation method of tramadol hydrochloride sodium chloride injection, and the method comprises the following steps: weighing tramadol hydrochloride, sodium chloride and activated carbon according to the preparation amount and the amount after drying and purification, adding a proper amount of water for injection into a concentrated preparation tank, adding the weighed sodium chloride, performing stirring until the sodium chloride is uniformly dissolved, adjusting the pH value of the solution in the concentrated preparation tank to 4.5-5.5 by using 10% diluted hydrochloric acid, adding weighed activated carbon into the concentrated preparation tank, performing heating to boil to 95 DEG C or above, standing and adsorbing for 10-20 minutes, circularly performing filtering and decarbonizing into a diluted preparation tank, finally adding weighed tramadol hydrochloride into the diluted preparation tank, fixing the volume, and performing stirring until the tramadol hydrochloride is completely dissolved; and circularly performing filtering to obtain the product tramadol hydrochloride sodium chloride injection. According to the tramadol hydrochloride sodium chloride injection produced by the process, the content of related substances is obviously reduced and can be as low as 0.1% or below, and the content of the related substances is basically kept unchangedin each stage of acceleration test in the later period.

Description

technical field [0001] The invention belongs to the technical field of production of tramadol hydrochloride sodium chloride injection, in particular to a preparation method of tramadol hydrochloride sodium chloride injection. Background technique [0002] Tramadol hydrochloride is a non-opioid central analgesic drug, the drug is synthetic, and is mostly used to treat moderate to severe pain. [0003] The preparation method of the existing tramadol hydrochloride sodium chloride injection is: add appropriate amount of water for injection in the concentrated preparation tank, start stirring, add the tramadol hydrochloride and sodium chloride weighed, after stirring to dissolve completely, add Weighed activated carbon, stirred evenly, boiled, let stand for adsorption, decarbonized, sent the liquid to the dilute tank, adjusted the pH value, constant volume, stirred evenly, obtained the product Tramadol Hydrochloride Sodium Chloride Injection after circulating filtration; In the ...

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Problems solved by technology

[0003] The preparation method of the existing tramadol hydrochloride sodium chloride injection is: add appropriate amount of water for injection in the concentrated preparation tank, start stirring, add the tramadol hydrochloride and sodium chloride weighed, after stirring to dissolve completely, add Weighed activated carbon, stirred evenly, boiled, let stand for adsorption, decarbonized, sent the liquid to the dilute tank, adjusted the pH value, constant volume, stirred evenly, obtained the product Tramadol Hydrochloride Sodium Chloride Injection after circulating filtration; In the existing method, after the preparation of the product is completed, the relevant substances are checked according to the "YBH07422004-2014Z National Drug Standard". Prolonging time is rising trend, and index is close to critical value in three months, very dangerous; In order to solve the above problems, it is necessary to develop a kind of improved Tramadol Hydrochloride Sodium Chloride Injection preparation method

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