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Pazufloxacin mesilate for injection and preparation method

A technology of pazufloxacin mesylate and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as hypoglycemia, electrolyte disturbance, and poor water solubility, and achieve the effects of reducing hypoglycemia, reducing electrolyte disturbance, and avoiding precipitation

Inactive Publication Date: 2020-02-18
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, pazufloxacins have poor water solubility, and crystallization occurs at lower temperatures, and when the pH value is higher, the solution tends to become turbid, and the color of the solution will change when it is exposed to light under long-term storage, causing related problems. substance elevation
In addition, pazufloxacin mesylate may have gastrointestinal reactions, leading to diarrhea and electrolyte disturbance, and there is also a risk of hypoglycemia

Method used

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  • Pazufloxacin mesilate for injection and preparation method
  • Pazufloxacin mesilate for injection and preparation method
  • Pazufloxacin mesilate for injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: the preparation of pazufloxacin mesylate for injection comprises the following steps:

[0023] S1: Weigh 350mL of water for injection, cool to below 70°C, add 30g of glucose and 15g of mannitol, and stir to dissolve;

[0024] S2: Weigh 350mL water for injection, cool to below 55°C, add 0.6g sodium chloride, 0.5g potassium chloride, 0.2g magnesium chloride, and stir evenly;

[0025] S3: Combine the injections in steps S1 and S2, add 4g of pazufloxacin mesylate, stir well, add methanesulfonic acid, adjust the pH to 3.3-4.1, add water for injection to 1000mL, filter with activated carbon for injection Post-potting encapsulation;

[0026] S4: The filtered injection is freeze-dried in a freeze-drying machine to obtain a freeze-dried powder, which is subpackaged, boxed, and packaged.

Embodiment 2

[0027] Embodiment 2: the preparation of pazufloxacin mesylate for injection comprises the following steps:

[0028] S1: Weigh 350mL of water for injection, cool to below 70°C, add 43g of glucose and 28g of mannitol, stir to dissolve;

[0029] S2: Weigh 350mL water for injection, cool to below 55°C, add 0.8g sodium chloride, 0.7g potassium chloride, 0.3g magnesium chloride, and stir evenly;

[0030] S3: Combine the injections in steps S1 and S2, add 6g of pazufloxacin mesylate, stir well, add methanesulfonic acid, adjust the pH to 3.3-4.1, add water for injection to 1000mL, filter with activated carbon for injection ;

[0031] S4: The filtered injection is freeze-dried in a freeze-drying machine to obtain a freeze-dried powder, which is subpackaged, boxed, and packaged.

Embodiment 3

[0032] Embodiment 3: the preparation of pazufloxacin mesylate for injection comprises the following steps:

[0033] S1: Weigh 350mL of water for injection, cool to below 70°C, add 37g of glucose and 22g of mannitol, stir to dissolve;

[0034] S2: Weigh 350mL water for injection, cool to below 55°C, add 0.7g sodium chloride, 0.6g potassium chloride, 0.2g magnesium chloride, and stir evenly;

[0035] S3: Combine the injections in steps S1 and S2, add 5g of pazufloxacin mesylate, stir well, add methanesulfonic acid, adjust the pH to 3.3-4.1, add water for injection to 1000mL, filter with activated carbon for injection ;

[0036] S4: The filtered injection is freeze-dried in a freeze-drying machine to obtain a freeze-dried powder, which is subpackaged, boxed, and packaged.

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Abstract

The invention relates to pazufloxacin mesilate for injection. The pazufloxacin mesilate comprises the following components as shown in the description, further eletrolyte comprises the following components in parts by weight of 0.6-0.8g of sodium chloride, 0.5-0.7g of potassium chloride and 0.2-0.3 of magnesium chloride. An injection agent can avoid separation of effective components, can preventturbidity in the long-term storage process, and can reduce the appearance of situations of electrolyte disturbance and hypoglycemia after medication. The invention further provides a preparation method of the pazufloxacin mesilate for injection.

Description

technical field [0001] The invention relates to pazufloxacin mesylate for injection, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Pazufloxacin mesylate is one of the fourth-generation quinolones. It is a quinolone antibiotic first researched and developed by Toyama Chemical Corporation in Japan. It was first approved for marketing in Japan in April 2002. This product is suitable for the following infections caused by sensitive bacteria: secondary infection of chronic respiratory diseases, such as chronic bronchitis, diffuse bronchiolitis, bronchiectasis, emphysema, pulmonary interstitial fibrosis, bronchial asthma, old tuberculosis, Pneumonia, lung abscess, etc.; pyelonephritis, complicated cystitis, prostatitis; burn wound infection, surgical wound infection; cholecystitis, cholangitis, liver abscess; intra-abdominal abscess, peritonitis; meningitis, pelvic inflammatory disease. [0003] Currently, the commonly used do...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/5383A61P31/04
CPCA61K9/0019A61K9/19A61K31/5383A61K47/26A61P31/04
Inventor 史志迅
Owner NANJING CHENGONG PHARM CO LTD
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