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Gatifloxacin freeze-dried powder injection and preparing method thereof

A technology of freeze-dried powder injection and gatifloxacin, which is applied in the field of medicine, and can solve the problem of poor clarity and stability of freeze-dried powder injection of gatifloxacin, poor clarity of freeze-dried powder injection, and low content of main ingredients, etc. problems, to achieve the effect of good appearance, solve the problem of dissolution, and low water content

Active Publication Date: 2009-07-01
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The prior art shows that gatifloxacin is slightly soluble in water, so the preparation of freeze-dried powder injection usually adds Injection water, add lactic acid solution, stir evenly, so that gatifloxacin is easy to dissolve, and then add sodium hydroxide The pH value of the solution is adjusted, which makes the process cumbersome. First, lactic acid is used to dissolve gatifloxacin, and then hydrogen is added. The sodium chloride solution is adjusted to the required pH value, and the clarity and stability of the prepared gatifloxacin freeze-dried powder injection are not stable. Well, the clarity of the freeze-dried powder injection is not good, and the main drug content is low, while the content of related substances is high, In order to improve the above-mentioned properties of gatifloxacin freeze-dried powder injection, researchers of the present invention, through long-term experimental research, research The researchers found that under the conditions of 70-80°C water for injection and a certain concentration of lactic acid solution, the solubility of gatifloxacin Good performance, combined with an appropriate freeze-drying process, the performance of the prepared freeze-dried powder injection is good, and the preparation method is simple, Therefore, the present invention is proposed

Method used

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  • Gatifloxacin freeze-dried powder injection and preparing method thereof
  • Gatifloxacin freeze-dried powder injection and preparing method thereof
  • Gatifloxacin freeze-dried powder injection and preparing method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0056] 1. Formula composition: prescription (1000 pieces)

[0057] Gatifloxacin 200.0g

[0058] Mannitol 40.0g

[0059] Add water for injection to 3000ml

[0060] 2. Preparation process

[0061] Weigh the formulated amount of gatifloxacin and mannitol into a sterile container, add an appropriate amount of water for injection at 70°C, dissolve, keep warm and stir for 30 minutes, then adjust the pH value to 4.0 with 0.05mol / L lactic acid solution, and stir well; Use charcoal (0.1%), keep warm and stir at 80°C for 15 minutes, let it stand, filter and decarbonize, take the filtrate, then dilute the filtrate to 3000mL with water for injection, stir evenly, measure the intermediate, pass 0.45μm, 0.22μm composite microporous membrane filter, aseptically put in 10ml vials, 3ml per bottle, cover the bottle and keep the air outlet, and then freeze-dry: first lower the drug from room temperature to -18.6°C, and keep it warm for 20 minutes Finally, pre-freeze at -40°C for 3 hours; the...

Embodiment 2

[0063] 1. Prescription composition: prescription (1000 pieces)

[0064] Gatifloxacin 400.0g

[0065] Mannitol 80.0g

[0066] Add water for injection to 6000ml

[0067] 2. Preparation process

[0068] Weigh the formulated amount of gatifloxacin and mannitol into a sterile container, add an appropriate amount of water for injection at 80°C, dissolve, keep warm and stir for 15 minutes, then adjust the pH value to 4.5 with 0.15mol / L lactic acid solution, and stir well; Use charcoal (0.1%), heat and stir at 60°C for 20 minutes, filter and decarbonize, take the filtrate, then dilute the filtrate with water for injection to 6000mL, stir well, measure the intermediate, pass the 0.45μm, 0.22μm composite micro Pore ​​membrane filtration, aseptic filling in 10ml vials, 3ml per bottle, stopper and keep the air outlet, and then freeze-dry: first lower the medicine from room temperature to -18.6°C, keep warm for 40 minutes, continue Cool down to -40°C and pre-freeze for 4 hours, then he...

Embodiment 3

[0070] 1. Prescription composition

[0071] Gatifloxacin 100.0g

[0072] Mannitol 20.0g

[0073] Add water for injection to 1500ml

[0074] 2. Preparation process

[0075] Weigh gatifloxacin and mannitol into a sterile container, add an appropriate amount of water for injection at 75°C, dissolve, stir, adjust the pH value to 3.5 with 0.15mol / L lactic acid solution, and stir well; add charcoal for needles (0.1%), Insulate and stir at 70°C for 30 minutes, filter and decarbonize, take the filtrate, then dilute it with water for injection to 1500mL, stir evenly, measure the intermediate, pass through 0.45μm, 0.22μm composite microporous filter membrane after passing, sterile Fill in 10ml vials, 3ml per bottle, cover the cork and keep the air outlet, and then freeze-dry: first lower the drug from room temperature to -18.6°C, keep it warm for 30 minutes, and then continue to cool down to -40°C Pre-freeze for 2 hours under the same conditions, then heat the drug from -40°C to -23...

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Abstract

The invention provides a gatifloxacin freeze-dried powder injection and a preparation method thereof. The method includes weighing the raw and auxiliary materials according to the formula and placing them in a sterile container, adding water for injection at a temperature of 70-80°C, keeping warm and stirring evenly, and then adding lactic acid solution, and mixing the raw and auxiliary materials to obtain a pH value of 4.0±0.5 after stirring solution; then add activated carbon for needles, stir evenly and let it stand, then filter for decarbonization to obtain the filtrate after decarbonization; dilute the decarbonized filtrate with water for injection to the configured amount, stir well and pass through 0.45 μm, 0.22 μm Composite microporous membrane filtration, the obtained filtrate is bottled and the gas outlet is reserved; the obtained filtrate in the bottle is freeze-dried: first pre-freeze at -40°C for 2-4 hours, and then freeze at -40°C ~ 10 Dry under reduced pressure and vacuum for 24-28 hours under the condition of ℃, and finally dry at 35 ℃ and high temperature for 6-8 hours.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation method of gatifloxacin freeze-dried powder for injection. Background technique [0002] Gatifloxacin (Gatifloxacin) is a newly synthesized fourth-generation quinolone antibacterial drug, which was researched and developed by Japan's Kyorin Company. At present, the U.S. company Bristol-Myers Squibb has obtained the drug in Canada and Brazil. , Mexico, Argentina and other countries. In June 1999, the application for the marketing of oral and intravenous injection preparations of this product was submitted to the US FDA in June 1999, and it was approved in December 1999. It is clinically used to treat bacterial infections of the respiratory system, urinary system and gynecological diseases. The clinical dosage is 400mg / d orally or intravenously. This product has a different structure from quinolone antibacterial drugs such as ciprofloxacin and ofloxacin. The C7 positi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/496A61K47/10A61P31/04
Inventor 刘保起李明华冯长运
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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