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Tinidazole and sodium chloride injection and preparation method thereof

A technology of nidazole sodium chloride and injection, which is applied in the fields of pharmaceutical formula, drug delivery, inorganic non-active ingredients, etc. It can solve the problem of easy crystallization, low pass rate of clarity of tinidazole sodium chloride injection, and influence on the yield of finished products. Problems such as production rate and sales market, to achieve the effect of solving crystallization problems, improving drug stability and clinical drug safety, and solving instability problems

Inactive Publication Date: 2012-07-04
HENAN TIANFANG HUAZHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the production process, it was found that the qualified rate of clarity of tinidazole sodium chloride injection was low, and it was easy to crystallize in winter during storage, which directly affected the yield of finished products and the sales market

Method used

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  • Tinidazole and sodium chloride injection and preparation method thereof
  • Tinidazole and sodium chloride injection and preparation method thereof
  • Tinidazole and sodium chloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]

[0032] Weigh each raw material according to the formula for subsequent use. The sodium chloride of formula quantity is placed in the concentrated preparation tank that is placed in appropriate amount of water for injection, stirs and dissolves, makes sodium chloride become the 20% concentrated solution measured by weight / volume. For the first time, add 0.1 g of activated carbon for needles, stir and mix well, boil for 15 minutes, and let cool to 80°C. Use a titanium rod filter to filter under pressure, circulate it for 10 minutes, and transfer it to a dilute mixing pot.

[0033] Put the prescribed amount of tinidazole into a clean container, add 40ml of water for injection, stir for 15 minutes to fully dissolve it, and then transfer it to a dilute mixing pot. Then put 0.1 g of edetate calcium sodium into the dilute mixing pot, and add water for injection to 80% of the total amount in the dilute mixing pot. Add 0.1 g of activated carbon for needles for the second ...

Embodiment 2

[0043]

[0044] Weigh each raw material according to the formula for subsequent use. The sodium chloride of formula quantity is placed in the concentrated preparation tank that is placed in appropriate amount of water for injection, stirs and dissolves, makes sodium chloride become the 20% concentrated solution measured by weight / volume. For the first time, add 0.1 g of activated carbon for needles, stir and mix well, boil for 15 minutes, and let cool to 80°C. Use a titanium rod filter to filter under pressure, circulate it for 10 minutes, and pump it into the dilute pot.

[0045] Pour the prescribed amount of tinidazole into a clean container, add 40ml of water for injection, stir for 15 minutes to fully dissolve, and then add it to the dilute mixing pot. Then 0.2 g of trisodium citrate is dropped into the dilute mixing pot, and water for injection is added to the full amount of 80% in the dilute mixing pot. Add 0.1 g of activated carbon for needles for the second time, ...

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Abstract

The invention relates to a tinidazole and sodium chloride injection and a preparation method thereof. The injection is prepared from the following raw materials in percentage by weight / volume: 0.4 percent of tinidazole, 0.9 percent of sodium chloride, 0.005 to 0.5 percent of stabilizer, 0.01 to 0.05 percent of activated carbon, a proper amount of pH value regulator (the pH value is 3.5 to 5.5), and the balance of water for injection. The preparation method comprises the following steps of: putting the sodium chloride into a thick mixing tank, stirring the sodium chloride and water and dissolving to form a solution at the concentration of between 20 and 22 percent (g / ml), adding 50 percent of the activated carbon, stirring, boiling, cooling, performing pressure filtration, performing internal circulation for 10 minutes, and transferring into a thin mixing pot; putting the tinidazole into a container, adding water, stirring and dissolving, and transferring into the thin mixing pot; putting the stabilizer into the thin mixing pot, adding water, adding the residual activated carbon, adding water until the mixture reaches certain volume, stirring, refluxing for 15 minutes, and regulating the pH value to be 3.5 to 5.5 by using the pH value regulator; sampling, detecting the sodium chloride and the tinidazole, and cooling to 20 to 40 DEG C after the content of the sodium chloride and the tinidazole is qualified; and sequentially performing four-stage filtration and filling, sterilizing at the temperature of 121 DEG C, and warehousing after the product is proved to be qualified through light inspection. The problems that a tinidazole and sodium chloride injection is low in clarity qualification rate and is easy to crystallize in winter are solved.

Description

1. Technical field [0001] The invention relates to a tinidazole sodium chloride injection and a preparation method thereof. 2. Background technology [0002] Tinidazole is a new generation of nitroimidazole compounds developed by Pfizer Company of the United States in the late 1960s. It is an anti-trichomonad drug developed after metronidazole with high curative effect, short course of treatment and good tolerance. Tinidazole Sodium Chloride Injection can be used for various anaerobic infections, such as sepsis, osteomyelitis, abdominal infection, pelvic infection, pulmonary and bronchial infection, pneumonia, sinusitis, skin cellulitis, oral infection and postoperative wound infection ; Preoperative prophylaxis for colorectal surgery, obstetrics and gynecology surgery, and oral surgery. During the production process, it was found that tinidazole sodium chloride injection has a low qualified rate of clarity and is easy to crystallize in winter during storage, which directly...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/02A61P31/04
Inventor 张清升王桂玲程静黎寇素丽张彦涛齐红强王庆玲王彩霞
Owner HENAN TIANFANG HUAZHONG PHARMA
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