A kind of preparation method of azithromycin freeze-dried powder for injection

A technology of freeze-dried powder injection and azithromycin, which is applied in the field of preparation of azithromycin freeze-dried powder injection to achieve the effect of shortening the freeze-drying cycle, simplifying the process and improving the safety of medication

Active Publication Date: 2012-02-22
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem in the prior art is that the amount of auxiliary materials in the process is generally large
[0003] In addition, the phenomenon that the freeze-drying cycle is generally longer in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Process recipe

[0019] Each injection contains 0.25g of azithromycin, 0.055g of citric acid, 0.04g of mannitol, and water for injection is added to 2ml.

[0020] Preparation process:

[0021] Clean and sterilize the chlorinated butyl rubber stoppers according to conventional methods, dry them and send them to the packing room for later use. The vials are cleaned by an ultrasonic cleaner, sterilized in a tunnel oven at 350°C, and cooled into the packing room.

[0022] Add about 80% pre-prepared volume of water for injection into the batching tank, add the mannitol in the prescribed amount, and stir to make it fully dissolved. Then add citric acid and stir to fully dissolve it. Add the weighed azithromycin raw powder into the above auxiliary material liquid, and stir fully while adding to make it all dissolve. Make up the volume, add 0.2% (g / ml) activated carbon, stir for 30 minutes to decolorize and depyrogenate, and then decarbonize by coarse filtration. During th...

Embodiment 2

[0025] Process formula: each injection contains 0.125g of azithromycin, 0.0275g of citric acid, 0.02g of mannitol, and add water for injection to 1ml

[0026] Preparation Process

[0027] Add about 80% pre-prepared volume of water for injection into the batching tank, add the prescribed amount of mannitol, and stir to make it fully dissolved. Then add citric acid and stir to fully dissolve it. Add the weighed azithromycin raw powder into the above auxiliary material liquid, and stir fully while adding to make it all dissolve. Make up the volume, add 0.1% (g / ml) activated carbon, stir for 30 minutes to decolorize and depyrogenate, and then decarbonize by coarse filtration. Check the pH value to make it between 5.2-7.3. After passing through a 0.22 μm microporous membrane filter to filter the liquid in two stages of sterilization and filtration, it is filled, semi-stoppered, and freeze-dried.

[0028] The freeze-drying curve is:

[0029] When the temperature of the product...

Embodiment 3

[0031] Stability test

[0032] a. Accelerated test

[0033] Get three batches of azithromycin freeze-dried powder for injection produced according to the method of Example 1. Store it for 6 months under the condition of temperature 40±2℃ and relative humidity 75±5%, take samples at the end of 0, 1, 2, 3 and 6 respectively, and conduct inspection according to the key inspection items (according to the current Chinese Pharmacopoeia relevant standard), see Table 1 for details.

[0034] Table 1

[0035] batch time (month) character Clarity PH value relative substance(%) Labeled content (%) Reconstitution speed (s) Appearance shape first batch 0 1 2 3 6 White loose block White loose block White loose block White loose block White loose block clear clear clear clear clear clear 6.58 6.58 6.57 6.55 6.52 1.63 1.64 1.66 1.71 1.76 100.08 100.05 99.92 99.83 99.72 6 Loose and plump second batch 0 1 2 3 ...

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PUM

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Abstract

The invention discloses a preparation method of azithromycin freeze-dried powder for injection. Azithromycin is used as the main drug, 22% of the weight of the main drug is added as citric acid as a co-solvent, and 16% of the weight of the main drug is added as mannitol. The excipients are pre-cooled to -40°C during the freeze-drying process, then gradually heated up to 40°C, kept warm for 2 hours, plugged, taken out of the box, capped, and packaged. The invention has less auxiliary material consumption and short freeze-drying time, and the prepared freeze-dried preparation has beautiful appearance, good resolubility and stable quality.

Description

Technical field: [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of azithromycin freeze-dried powder for injection. Background technique: [0002] Azithromycin is a 15-ring semi-synthetic macrolide antibiotic newly developed in recent years, which has the advantages of broad antibacterial spectrum, strong effect and long half-life. It has good antibacterial activity against most Gram-positive bacteria and some negative bacteria, and also has good antibacterial effect on anaerobic bacteria and sexually transmitted disease microorganisms. Clinically, it is widely used in upper and lower respiratory tract infections caused by sensitive bacteria, skin and soft tissue infections, Chlamydia trachomatis and Neisseria gonorrhoeae infections. Azithromycin for injection has fast onset of action, high bioavailability, definite curative effect, mild adverse reactions, low incidence, and good patient tolerance. It has become one o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7052A61K47/12A61K47/10A61P31/04
Inventor 由春峰王志良张西果赵霞李汉起路玉锋
Owner NORTH CHINA PHARMA COMPANY
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