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Preparation method for pazufloxacin mesilate for injection

A technology for pazufloxacin mesylate and injection, which is applied in the field of preparation of pazufloxacin mesylate for injection, can solve the problems of long sublimation time and excessive cost waste in the freeze-drying process, and achieves the freeze-drying process. The effect of shortened process time, reduced production costs and high quality inspection of finished products

Active Publication Date: 2015-07-08
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, in the production process of pazufloxacin mesylate for injection, the sublimation time of the freeze-drying process is too long and the cost is wasted too much

Method used

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  • Preparation method for pazufloxacin mesilate for injection
  • Preparation method for pazufloxacin mesilate for injection
  • Preparation method for pazufloxacin mesilate for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1: the preparation method of pazufloxacin mesylate for injection, its prescription is as follows:

[0048] Pazufloxacin mesylate (calculated as Pazufloxacin): 390.6g

[0049] Mannitol: 60g

[0050] 0.1mol / L hydrochloric acid pH adjustment to 3.0~4.0

[0051] Add water for injection to 2000ml

[0052]

[0053] A total of 1000 bottles were made

[0054] Its preparation method is as follows:

[0055] 1. Precisely weigh 390.6g of the main drug pazufloxacin mesylate, add 2000ml of water for injection and stir to dissolve.

[0056] 2. Add the prescribed amount of 60g mannitol and stir to dissolve;

[0057] 3. Use 0.1mol / L HCl solution to adjust the pH value of the liquid to between 3.0 and 4.0, and add water for injection to the full amount;

[0058] 4. Add an appropriate amount of activated carbon for needles, heat to 70-80°C and stir for 15 minutes to decolorize, and filter to remove carbon;

[0059] 5. Sterilize by filtration with a 0.22 μm microporous...

Embodiment 2

[0066] Embodiment 2: the preparation method of pazufloxacin mesylate for injection, its prescription is as follows:

[0067] Pazufloxacin mesylate (calculated as Pazufloxacin): 390.6g

[0068] Mannitol: 60g

[0069] 0.1mol / L hydrochloric acid pH adjustment to 3.0~4.0

[0070] Add water for injection to 2000ml

[0071]

[0072] A total of 1000 bottles were made

[0073] Its preparation method is as follows:

[0074] 1. Precisely weigh 390.6g of the main drug pazufloxacin mesylate, add 2000ml of water for injection and stir to dissolve.

[0075] 2. Add the prescribed amount of 60g mannitol and stir to dissolve;

[0076] 3. Use 0.1mol / L HCl solution to adjust the pH value of the liquid to between 3.0 and 4.0, and add water for injection to the full amount;

[0077] 4. Add an appropriate amount of activated carbon for needles, heat to 70-80°C and stir for 20 minutes to decolorize, and filter to remove carbon;

[0078] 5. Sterilize by filtration with a 0.22 μm microporous...

Embodiment 3

[0085] Embodiment 3: the preparation method of pazufloxacin mesylate for injection, its prescription is as follows:

[0086] Pazufloxacin mesylate (calculated as Pazufloxacin): 390.6g

[0087] Mannitol: 60g

[0088] 0.1mol / L hydrochloric acid pH adjustment to 3.0~4.0

[0089] Add water for injection to 2000ml

[0090]

[0091] A total of 1000 bottles were made

[0092] Its preparation method is as follows:

[0093] 1. Precisely weigh 390.6g of the main drug pazufloxacin mesylate, add 2000ml of water for injection and stir to dissolve.

[0094] 2. Add the prescribed amount of 60g mannitol and stir to dissolve;

[0095] 3. Use 0.1mol / L HCl solution to adjust the pH value of the liquid to between 3.0 and 4.0, and add water for injection to the full amount;

[0096] 4. Add an appropriate amount of activated carbon for needles, heat to 70-80°C and stir for 18 minutes to decolorize, and filter to remove carbon;

[0097] 5. Sterilize by filtration with a 0.22 μm microporous...

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Abstract

The invention provides a preparation method for pazufloxacin mesilate for injection. The preparation method comprises the following steps of: preparing the pazufloxacin mesilate and mannitol according to a prescription, and regulating pH values to be 3.0-4.0; adding a proper amount of needle active carbon, heating the mixture to be 70-80 DEG C, and carrying out decoloring after stirring for 15-20 minutes; putting an encapsulated semi-finished product into a freezing vacuum drier, controlling the temperature to be below -30 DEG C and carrying out prefreezing for 1-1.5 hours; when the temperature of a cold trap of the drier is lower than -40 DEG C, vacuumizing until the pressure is 20 Pa, and carrying out constant-temperature drying for 0.5-1 hour; raising the temperature of a separation board of the drier to be -10 DEG C, carrying out the constant-temperature drying for 0.5-1 hour; and raising the temperature of the separation board to be 0 DEG C, carrying out the constant-temperature drying until the waterline of the product reaches the bottom, raising the temperature to be 10 DEG C in a temperature manner, after carrying out the constant-temperature drying until the temperature of the product approximates to 0 DEG C, raising the temperature of the separation board to be 35 DEG C, and judging that the product is qualified after carrying out the constant-temperature drying until reaching the end point. The preparation method has the advantages that the production cost is lowered and the product quality is improved and is more suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy and relates to a preparation method of pazufloxacin mesylate for injection. Background technique [0002] Pazufloxacin mesylate is the fourth-generation quinolone antibacterial drug, widely used in respiratory tract infection, genitourinary system infection, surgical infection, etc. Clinical studies of pazufloxacin mesylate have shown that its curative effect is superior to that of levofloxacin, ofloxacin and ciprofloxacin currently on the domestic market. Compared with the quinolone antibacterial drugs commonly used in domestic clinical practice, the drug resistance and safety are improved, and the clinical application prospect is very broad. [0003] The chemical structure of Pazufloxacin Mesilate for Injection is as follows: [0004] . [0005] The sterile freeze-dried powder of pazufloxacin mesylate for injection is not easily oxidized and is good for long-term storage, and has ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/5383A61P31/04
Inventor 朱义王一茜梁臻
Owner SICHUAN BAILI PHARM CO LTD
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