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Citron acid Azithromycin frozen-dried preparation for injection and preparation method thereof

A technology of azithromycin citrate and freeze-dried preparations, which is applied in the field of freeze-dried preparations of azithromycin citrate for injection and its preparation, which can solve problems such as instability, and achieve the effect of good shape, high stability, and loose appearance

Active Publication Date: 2006-08-02
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But azithromycin is almost insoluble in water, only soluble in polyols such as polyethylene glycol, glycerol, etc., but unstable, so only its oral preparations are currently available

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The prescription consists of:

[0040] (a) Azithromycin 62.5mg / ml

[0041] (b) Citric acid 45mg / ml

[0042] (c) Sodium hydroxide 20mg / ml

[0043] (d) Mannitol 45mg / ml

[0044] (e) Water for injection 1ml

[0045] Taking the preparation of 100 bottles of azithromycin citrate products for injection as an example, the specific preparation method is to weigh the prescribed amount of sodium hydroxide and place it in a sterilized beaker, add an appropriate amount of water for injection, stir, and dissolve; acid, put it in a sterilized beaker, add 150ml of water for injection, stir to dissolve, add the above sodium hydroxide solution to it, and stir well; weigh the prescribed amount of azithromycin, add it, stir to dissolve; add the prescribed amount of Mannitol, stir to dissolve, add water for injection to 200ml, adjust pH value to 6.5, add 0.04% activated carbon for needles, stir at 70°C for 20min, decarbonize and sterilize with sterilized No. 6 sand core and 0.22μm filt...

Embodiment 2

[0046] Example 2: Effects of Different pH Values ​​of Solutions on the Stability of Azithromycin Citrate for Injection.

[0047] The solution was made into azithromycin citrate for injection containing 62.5 mg / ml of the main drug according to the similar procedures described in Example 1. The results are shown in Table 1.

[0048] pH value

Embodiment 3

[0049] Example 3: The influence of different citric acid concentrations in the preparation process on azithromycin citrate preparations for injection.

[0050] The solution was prepared according to the similar procedure described in Example 1, containing five different concentrations of azithromycin citrate for injection in the range of citric acid 45*(1±10%) mg / ml. The results are shown in Table 2.

[0051] Citric acid concentration (mg / ml)

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PUM

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Abstract

The invention provides a citron acid azithromycin frozen-dried preparation for injection and preparation method, wherein the preparation is prepared from the following raw materials, azithromycin 1 weight part, acidum citricum 0.64-0.80 weight part, sodium hydroxide 0.32 weight part, mannitol 0.57-0.87 weight part, and water for injection 14-18 weight parts.

Description

technical field [0001] The invention relates to an injection preparation of azithromycin and a preparation method thereof. Background technique [0002] Azithromycin is a third-generation macrolide antibacterial drug, the chemical name is (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3 -C-methyl-3-O-methyl-α-L-ribose-hexapyranose ring)oxidation]-2-ethyl-3,4,10-trihydroxy-3,5,6,8, 10,12,14-Heptylmethyl-11-[[3,4,6,-trideoxy-3-(dimethylamine)-β-D-xyl-hexapyranose ring]oxidation]-1-oxo -6-Pentadecane-15-one kills bacteria by hindering bacterial transpeptidation process and inhibiting bacterial protein synthesis. It has a strong antibacterial effect on Gram-positive bacteria, some Gram-negative bacteria, anaerobic bacteria, mycoplasma, spirochete and chlamydia, and has a significant effect on respiratory tract infections. Azithromycin also has some effect on non-communicable diseases (see WO02087596). Azithromycin has high bioavailability, strong antibacteria...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7052A61K9/19A61P31/04
Inventor 张仓滕再进
Owner NANJING SANHOME PHARMACEUTICAL CO LTD