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Formula and preparation process of aztreonam for injection

A preparation process and technology of aztreonam, applied in the field of aztreonam for injection formulation and preparation process thereof, can solve the problem of different clarity, pH and irritation, large difference in the ratio of aztreonam and arginine, high water content, etc. problems, to achieve the effect of shortening the time of removing moisture, good appearance and quality, proportion and content uniformity

Active Publication Date: 2011-01-26
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Secondly, after mixing aztreonam and arginine, they are aseptically subpackaged. It is difficult to mix the two evenly, and the vibration during the subpackaging process will easily lead to the separation of the two, which makes the ratio of aztreonam and arginine in each bottle different. Large, with varying clarity, pH, and irritation from bottle to bottle
In addition, the vibration during storage, transportation and sub-packaging will easily lead to the separation of the two, uneven mixing, aztreonam and arginine cannot be fully contacted and protected, resulting in the solubility and dissolution rate of aztreonam between each bottle , stability and other inconsistencies
[0008] In addition, aztreonam and arginine are required to be sterile materials, which requires high cleanliness of materials, thus increasing the cost of the product
[0009] Third, the method of recrystallization after aztreonam and arginine is salified has the disadvantage of using lossy and toxic organic solvents, which not only may cause harmful effects on the health of production personnel, but also is not friendly to the environment
However, if the temperature of the product exceeds its glass transition temperature during primary drying, the product will have an unpleasant appearance such as shrinkage, melting, and delamination, as well as undesirable qualities such as excessive moisture, increased impurities, and poor stability. Often unacceptable for therapeutic drugs
It is for this reason that the vacuum freeze-drying process of many products has to control the temperature of the product during a drying period below its glass transition temperature, resulting in a rather long vacuum freeze-drying cycle, such as up to a week, and Therefore, huge energy consumption is generated, which increases the cost of the product

Method used

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  • Formula and preparation process of aztreonam for injection
  • Formula and preparation process of aztreonam for injection
  • Formula and preparation process of aztreonam for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A kind of prescription of aztreonam for injection is as follows:

[0038] Aztreonam (in C 13 h 17 N 5 o 8 S 2 meter) 500g

[0039] Arginine 400g

[0040] Water for injection 2000g

[0041] A preparation process of aztreonam for injection, the preparation steps are as follows:

[0042] 1. Weighing: first weigh 2000 parts by weight of water for injection and put it in the container, then add 400 parts by weight of arginine to the above container and stir to dissolve, then add 500 parts by weight of aztreonam to the above container Stir to dissolve;

[0043] 2. Pyrogen removal: add 0.1% activated carbon for needles to the above container, stir and absorb for 20 minutes, and filter for decarbonization;

[0044] 3. Sterilization: within 8 hours, filter and sterilize the prepared medicinal solution through a 0.22μm filter membrane;

[0045] 4. Filling: fill the sterilized medicinal solution into vials within 8 hours;

[0046]5. Freeze-drying: transfer the vial cont...

Embodiment 2

[0049] A kind of prescription of aztreonam for injection is as follows:

[0050] Aztreonam (in C 13 h 17 N 5 o 8 S 2 meter) 500g

[0051] Arginine 400g

[0052] Water for injection 2000g

[0053] A preparation process of aztreonam for injection, the preparation steps are as follows:

[0054] 1. Weighing: first weigh 2000 parts by weight of water for injection and put it in the container, then add 400 parts by weight of arginine to the above container and stir to dissolve, then add 500 parts by weight of aztreonam to the above container Stir to dissolve;

[0055] 2. Pyrogen removal: add 0.1% activated carbon for needles to the above container, stir and absorb for 20 minutes, and filter for decarbonization;

[0056] 3. Sterilization: within 8 hours, filter and sterilize the prepared medicinal solution through a 0.22μm filter membrane;

[0057] 4. Filling: fill the sterilized medicinal solution into vials within 8 hours;

[0058] 5. Freeze-drying: Transfer the vial con...

Embodiment 3

[0061] A kind of prescription of aztreonam for injection is as follows:

[0062] Aztreonam (in C 13 h 17 N 5 o 8 S 2 meter) 500g

[0063] Arginine 400g

[0064] Water for injection 2000g

[0065] A preparation process of aztreonam for injection, the preparation steps are as follows:

[0066] 1. Weighing: first weigh 2000 parts by weight of water for injection and put it in the container, then add 400 parts by weight of arginine to the above container and stir to dissolve, then add 500 parts by weight of aztreonam to the above container Stir to dissolve;

[0067] 2. Pyrogen removal: add 0.1% activated carbon for needles to the above container, stir and absorb for 20 minutes, and filter for decarbonization;

[0068] 3. Sterilization: within 8 hours, filter and sterilize the prepared medicinal solution through a 0.22μm filter membrane;

[0069] 4. Filling: fill the sterilized medicinal solution into vials within 8 hours;

[0070] 5. Freeze-drying: transfer the vial con...

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Abstract

The invention relates to a formula and a preparation process of aztreonam for injection. The preparation process comprises the following steps of: preparing; removing pyrogen; degerming, namely, filtering a prepared liquid medicament with a 0.22 mu m grade filter membrane within 8 hours for degerming; filling, namely, filling the degermed liquid medicament into a small bottle within 8 hours; performing freeze drying, namely, transferring the small bottle filled with the liquid medicament onto a shelf board of a freeze dryer, pre-freezing at the temperature of 40 DEG C below zero for 2 to 3 hours, setting the temperature of the shelf board to be between 0 and 8 DEG C at a primary drying stage, setting the vacuum degree to be between 5 and 15 Pa and drying for about 19 hours until the temperature of the product is close to the set temperature; and setting the temperature of the shelf board to be between 30 and 40 DEG C at a secondary drying stage, setting the vacuum degree to be between5 and 15 Pa, drying for 3 to 5 hours until the temperature of the product is more than 25 DEG C, restoring the pressure of a freeze drying box to atmospheric pressure, compressing a bottle plug and removing the small bottle from the freeze drier. The preparation process has the advantages of short period, low energy consumption and the like.

Description

technical field [0001] The invention relates to a formulation of aztreonam for injection and a preparation process thereof. Background technique [0002] Aztreonam (Aztreonam) is the first monocyclic β-lactam antibiotic developed by Bristol-Myers Squibb for clinical application. It was launched in Italy in 1984 and has strong antibacterial activity against Gram-negative bacilli. Lactamase is stable. In recent years, with the wide application of antibacterial drugs, the proportion of Gram-negative bacilli infection has increased significantly, and the drug-resistant strains have also increased significantly, making the clinical efficacy of cephalosporin antibiotics far worse than before. However, because of its unique structure, aztreonam makes bacteria sensitive to it, so it is widely used clinically with definite curative effect, and has become a rare good medicine. [0003] Aztreonam is almost not absorbed (less than 1%) when taken orally, absorbed rapidly and completely...

Claims

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Application Information

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IPC IPC(8): A61K31/427A61K9/08A61K9/19A61P31/04
Inventor 翁为华张宝隆
Owner HAINAN HAILING CHEMIPHARMA CORP
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