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Stabilizer of lyophilized powder injection for azithromycin injection

A kind of freeze-dried powder injection, azithromycin technology

Inactive Publication Date: 2012-07-11
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above technologies have done some research on the stability of the freeze-dried agent, but the content of the relevant impurities has not been effectively controlled. Through the market sampling test, the best domestic quality test results are: the single impurity is less than 0.90%, and the total impurity reaches 1.72%.

Method used

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  • Stabilizer of lyophilized powder injection for azithromycin injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Prescription content: Azithromycin: 26.935g

[0034] Citric acid: 8.269g

[0035] Sodium hydroxide: 1.753g

[0036] Preparation process: Dissolve 26.935g of azithromycin, 8.2769g of citric acid, and 1.753g of sodium hydroxide in water, stir, filter, and freeze-dry.

[0037] Stability test results:

[0038] Test sample Red mold (A)% Archie GX% Archie B% Simple% Total Miscellaneous% raw material 0.078 0.000 0.273 0.128 0.78 finished product 0.052 0.000 0.278 0.181 0.76 5 days 0.062 0.02 0.281 0.214 1.01 10 days 0.066 0.024 0.303 0.140 1.16 plus 1 0.065 0.027 0.309 0.133 1.02 plus 2 0.078 0.028 0.299 0.126 1.04 plus 3 0.080 0.021 0.298 0.154 1.12 plus 6 0.110 0.026 0.304 0.191 1.48 cool 1 0.045 0.025 0.285 0.154 0.73 cool 2 0.054 0.021 0.343 0.115 0.81 cool 3 0.054 0.022 0.352 0.176 0.94 cool 6 0.067 0...

Embodiment 2

[0040] Prescription content: Azithromycin: 26.924g

[0041] Citric acid: 17.607g

[0042] Sodium hydroxide: 7.228g

[0043] Preparation process: Weigh 26.924g of azithromycin, 17.607g of citric acid, and 7.228g of sodium hydroxide, dissolve them in water, stir, filter, and freeze-dry.

[0044] Stability test results:

[0045] Test sample Red mold (A)% Archie GX% Archie B% Simple% Total Miscellaneous% raw material 0.078 0.000 0.273 0.128 0.78 finished product 0.048 0.011 0.319 0.131 0.70 5 days 0.065 0.020 0.267 0.182 0.91 10 days 0.103 0.022 0.303 0.151 1.21 plus 1 0.066 0.032 0.299 0.145 1.02 plus 2 0.068 0.033 0.310 0.133 1.01 plus 3 0.079 0.021 0.322 0.157 1.16 plus 6 0.119 0.023 0.314 0.216 1.47 cool 1 0.051 0.028 0.310 0.133 0.74 cool 2 0.056 0.021 0.289 0.113 0.78 cool 3 0.058 0.024 0.346 0.161 0.87 coo...

Embodiment 3

[0047] Prescription content: Azithromycin: 26.934g

[0048] Citric acid: 21.475g

[0049] Sodium hydroxide: 9.517g

[0050] Preparation process: Weigh 26.934g of the main ingredient, 21.475g of citric acid, and 9.517g of sodium hydroxide, dissolve them in water, stir, filter, and freeze-dry.

[0051] Stability test results:

[0052] Test sample Red mold (A)% Archie GX% Archie B% Simple% Total Miscellaneous% raw material 0.078 0.000 0.273 0.128 0.78 finished product 0.074 0.000 0.268 0.161 0.79 5 days 0.074 0.000 0.287 0.176 0.91 10 days 0.107 0.022 0.264 0.150 1.11 plus 1 0.072 0.029 0.288 0.147 0.97 plus 2 0.085 0.026 0.326 0.120 1.02 plus 3 0.089 0.023 0.333 0.143 1.07 plus 6 0.115 0.023 0.310 0.193 1.43 cool 1 0.063 0.021 0.298 0.116 0.74 cool 2 0.065 0.020 0.294 0.111 0.79 cool 3 0.065 0.024 0.301 0.142 0.85 ...

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Abstract

The invention belongs to the field of chemical drugs, and specifically relates to a stabilizer of a lyophilized powder injection for azithromycin injection. The stabilizer is characterized in that the stabilizer is prepared by mixing citric acid and sodium hydroxide, and a mass ratio of the main medicine to the stabilizer is 41-73%:26-59%. With the stabilizer of the present invention, the impurity content in the lyophilized powder injection for azithromycin injection can be effectively reduced, the drug stability can be improved, and the drug use safety can be ensured.

Description

technical field [0001] The invention belongs to the field of chemical medicines, in particular to a stabilizer for azithromycin injection freeze-dried powder. Background technique [0002] Azithromycin is a macrolide anti-infective drug developed and produced in recent years, and it is a broad-spectrum antibiotic. As a first-line antibiotic drug, azithromycin has a short action cycle and is effective against most common pathogenic bacteria. It is the first and only single-dose antibiotic that can treat urethritis and cervicitis caused by chlamydia and is effective against gonorrhea. Its mechanism of action is to inhibit the synthesis of bacterial proteins by binding to the subunit of the 50S ribosome of sensitive microorganisms. Compared with erythromycin, the antibacterial spectrum of azithromycin antibiotics has been expanded and the antibacterial activity has been enhanced. Because of its wide distribution in vivo, high tissue concentration, long half-life, and good aft...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K9/19A61K31/7052A61P31/04A61K47/02
Inventor 张建礼李洁李后涛牛海岗崔晓双白臣生
Owner SHANDONG QIDU PHARMA
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