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Tinidazole injection preparation and preparation method thereof

A technology of tinidazole and injection, which is applied in the field of medicine, can solve the problems affecting the quality of finished products and the pass rate, and the decrease of tinidazole content, and achieve the effects of facilitating mass production, simple prescription, and reducing production costs

Inactive Publication Date: 2013-05-22
YANGZHOU ZHONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, activated carbon has a strong adsorption effect on tinidazole, which will cause the content of tinidazole in the finished product of its infusion solution to decline to varying degrees, thereby seriously affecting the quality of its finished product and the qualified rate.

Method used

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  • Tinidazole injection preparation and preparation method thereof
  • Tinidazole injection preparation and preparation method thereof
  • Tinidazole injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A kind of tinidazole injection preparation, it comprises the component that comprises following percentage by weight:

[0025]

[0026] The production method is as follows:

[0027] (1) Weigh 30% water for injection of the formula and cool to 30°C;

[0028] (2) Weigh the formula amount of osmotic pressure regulator sodium chloride and dissolve it in the cooled fresh water for injection in step (1);

[0029] (3) Weigh 50% of the adsorbent activated carbon of the formula and add it to the solution obtained in step (2), boil and adsorb for 15 minutes, remove the adsorbent, and add water for injection to the full amount;

[0030] (4) Keep the solution obtained in step (3) at 60±1°C, add the prescribed amount of tinidazole, stir to dissolve, measure the pH value, and adjust the pH value to 4.0 with the pH adjusting additive hydrochloric acid (0.1mol / L) ;

[0031] (5) Add 50% of the formula amount of adsorbent activated carbon to the solution obtained in step (4), stir ...

Embodiment 2

[0033] A kind of tinidazole injection preparation, it comprises the component that comprises following percentage by weight:

[0034]

[0035] The production method is as follows:

[0036] (1) Weigh 30% water for injection of the formula and cool to 40°C;

[0037] (2) Weigh the formula amount of osmotic pressure regulator sodium chloride and dissolve it in the cooled fresh water for injection in step (1);

[0038] (3) Weigh 50% of the adsorbent activated carbon of the formula and add it to the solution obtained in step (2), boil and adsorb for 30 minutes, remove the adsorbent, and add water for injection to the full amount;

[0039] (4) Keep the solution obtained in step (3) at 60±1°C, add the prescribed amount of tinidazole, stir to dissolve, measure the pH value, and adjust the pH value to 4.2 with the pH adjusting additive hydrochloric acid (0.1mol / L) ;

[0040] (5) Add 50% of the formula amount of adsorbent activated carbon to the solution obtained in step (4), stir ...

Embodiment 3

[0047] Embodiment 3: the investigation result of finished product rate and raw material consumption rate

[0048] Adopt embodiment 1, 2, comparative example 1, 2, 3 and present conventional process method (conventional method namely, add appropriate amount of water for injection, stir and drop into the sodium chloride of recipe quantity, sodium chloride is mixed with 20% solution, Add 0.3% activated carbon for needles, boil for 10 minutes, decarburize after cooling slightly. Heat the water for injection to the full amount, add the prescribed amount of tinidazole, stir to dissolve, measure the pH value, adjust the pH to 4.0~ with 0.1mol / l hydrochloric acid 4.2, add 0.02% (W / V) 767# activated carbon for needles, take a sample to measure the content of the semi-finished product, pH value, and transport the tinidazole injection (according to 100L volume) to the filling room after the visible foreign matter is qualified. ) product yield and raw material consumption rate are shown i...

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Abstract

The invention discloses a tinidazole injection preparation which consists of the following components by weight percent: 0.3-0.8% of tinidazole, 0.9% of an osmotic pressure regulating agent, 0.25-0.5% of an absorbing agent, and the balance of injection water to achieve 100%, wherein pH value is regulated to be 4.0-4.2 through a pH regulating additive. Furthermore, the invention discloses a preparation method of the tinidazole injection preparation. According to the tinidazole injection preparation and the preparation method thereof, problems of high raw material consumption and low qualification rate of the tinidazole injection in production process can be effectively solved, so that an expected effect is achieved. According to the tinidazole injection preparation and the preparation method, by regulating dosages and percents of the absorbing agent and the osmotic pressure regulating agent in the formula as well as regulating main drug dissolving temperature and two absorbing time limits of the absorbing agent, the quality of a product can effectively guaranteed, and the production cost is reduced. And the tinidazole injection preparation disclosed by the invention is simple in formula, high in yield, and stable and reliable, and can implement industrial mass production conveniently.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tinidazole injection preparation and a preparation method thereof. Background technique [0002] Tinidazole (Tinidazole, TNE) is a nibendazole derivative, the chemical name is: large 2-methyl-1-[2-ethylsulfonyl] ethyl]-5-nitro-1H misazole. Tinidazole injection is commonly used clinically to prevent and treat anaerobic infection. It is an anti-trichomonas drug developed after metronidazole (Metmnjdazole) with high curative effect, short course of treatment and good tolerance. Internationally, tinidazole is highly evaluated. In developed countries, this product has gradually replaced metronidazole as the drug of choice for anti-anaerobic bacteria, and is widely used before and after surgery. Commonly used for oral anaerobic infection (gingivitis, periapical periodontitis, pericoronitis, etc.), Trichomonas vaginalis and non-specific vaginitis, other anaerobic infect...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/02A61K47/12A61P31/04
Inventor 葛海涛唐俊
Owner YANGZHOU ZHONGBAO PHARMA
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