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Preparation method for tinidazole sodium chloride injection

A technology of nitrazole sodium chloride and injection, which is applied in the field of medicine, can solve problems such as poor stability, achieve the effects of reducing product content loss, avoiding the incidence of adverse reactions, and reducing operation steps

Inactive Publication Date: 2017-09-08
兰西哈三联制药有限公司
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0007] The present invention solves the shortcoming of poor stability in the traditional preparation of nidazole sodium chloride injection; and provides a preparation method of tinidazole sodium chloride injection

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  • Preparation method for tinidazole sodium chloride injection

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specific Embodiment approach 1

[0022] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A method for preparing tinidazole sodium chloride injection in the present invention, said injection is mainly made of tinidazole, sodium chloride, water for injection, specifically carried out according to the following steps :

[0023] Step 1, in the concentrated mixing tank, first add water for injection, under stirring, slowly add sodium chloride, make sodium chloride dissolve completely, be mixed with the solution of concentration 20% (mass), drop into gac [0.2% (W / V)] after the stirring process, then decarbonize and filter through a 20 micron titanium rod filter, then filter through a 0.45 micron polypropylene filter element, and the filtrate is poured into a dilute tank to obtain solution A;

[0024] Step 2. Rinse the concentrated preparation tank, add water for injection with 20% (mass) of the total amount of water for injection in the concentrated preparation tank, boil for 15 minutes, add tinidazole after cool...

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Abstract

The invention discloses a preparation method for tinidazole sodium chloride injection, and belongs to the technical field of medicines. The method provided by the invention comprises the steps of slowly adding sodium chloride into water for injection for completely dissolving the sodium chloride, adding active carbon, stirring, decarbonizing and filtering with a polypropylene filter element; adding tinidazole into the water for injection and stirring for completely dissolving, passing through a carbon layer, and filtering with the polypropylene filter element; refilling the water for injection until full dose, stirring and reflowing, adjusting a pH value by using a PH regulator, filtering, filling, pressing plug, capping, sterilizing to acquire the injection. According to the method provided by the invention, filtering time of the tinidazole sodium chloride injection can be effectively reduced by changing a decarbonization mode during a preparation process, impurities in material can be better removed, the situation that related substances are generated due to the fact that the tinidazole cannot be completely dissolved or is long in reaction time under a high temperature condition can also be avoided, improved on stability and safety of products is facilitated. The preparation method provided by the invention is simple in technology, and is applicable to large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a preparation method of tinidazole sodium chloride injection. Background technique [0002] The chemical name of tinidazole is 2~methyl~1~[2~(ethylsulfonyl)ethyl]~5~nitro~1H imidazole. Tinidazole and metronidazole belong to the same class of nitroimidazoles. It has good activity against protozoa (Amoeba histolytica, Trichomonas vaginalis, etc.) and anaerobic bacteria. The effect on amoeba and Giardia lamblia is better than that of metronidazole. Gram-positive anaerobic bacteria (Peptococcus, Peptostreptococcus, Lactobacillus), Clostridium and Clostridium difficile are all sensitive to this product; this product is sensitive to Bacteroides fragilis, Fusobacterium and Fischeri Gram-negative anaerobic bacteria such as cocci are slightly more effective than metronidazole, and Campylobacter jejuni is moderately sensitive to this product. Actinomycetes and Propionibacterium are resis...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K31/4164A61P31/04
Inventor 俞洪涛王学安永刚贾瑞艳柳丽艳王萍萍姚烁
Owner 兰西哈三联制药有限公司
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