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Amikacin sulfate injection and preparation method thereof

A technology of amikacin sulfate and injection, which is used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of yellowish color of samples, non-compliance with standard regulations, etc., and achieves low cost and production. simple craftsmanship

Active Publication Date: 2016-01-06
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the prescription process provided by it, we sterilized it at 115°C for 30 minutes. As a result, the color of the sample turned yellow obviously, which did not meet the standard requirements.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0048] Experimental example 1: Comparative experiment

[0049] (1) A batch of amikacin sulfate injection was prepared according to the prescription and preparation method disclosed in "A preparation method of amikacin sulfate injection" (patent number CN101584658A), batch number: 110801A·S, specification 2ml: 0.2 g, as follows:

[0050] 1. Measure 150ml of water for injection (about 75% of the total preparation), stir and heat to 45°C;

[0051] 2. Weigh 0.18g disodium ethylenediaminetetraacetic acid and 40g amikacin sulfate, add them to the above aqueous solution, stir until completely dissolved; adjust the pH to 5.50 with lactic acid;

[0052] 3. Add water for injection to 80% of the total volume of Amikacin Sulfate Injection, and then adjust the pH to 6.00 with lactic acid;

[0053] 4. Add water for injection to 200ml, while cooling to 20~30℃

[0054] 5. Add 0.1% activated carbon, stir for 20 minutes, and filter;

[0055] 6. Potting and sterilizing at 115℃ for 30 minutes.

[0056] (2) A...

Embodiment 1

[0068] Amikacin Sulfate 100g

[0069] Antioxidant 1.5g

[0070] Complexing agent 0.1g

[0071] Add water for injection to 1000ml

[0072] 1. Take 75% of the water for injection in the dilute mixing tank according to the formula, cool it to 30℃, and saturate it with nitrogen;

[0073] 2. Add the formula amount of calcium sodium edetate, amikacin sulfate, and keep stirring. When it is completely dissolved, add the formula amount of sodium bisulfite to dissolve, and finally add 1000ml of water for injection saturated with nitrogen;

[0074] 3. Add 0.1% (W / V) medicinal charcoal, stir for 30 minutes, adjust the pH to 5.8 with 0.1 mol / L sodium hydroxide;

[0075] 4. Decarburization and fine filtration of the chemical liquid under nitrogen flow until the visible foreign matter is qualified;

[0076] 5. Filling and sealing under nitrogen flow;

[0077] 6. Sterilize at 115℃ for 30 minutes, and it is ready.

Embodiment 2

[0079] Amikacin Sulfate 200g

[0080] Antioxidant 3g

[0081] Complexing agent 0.2g

[0082] Add water for injection to 1000ml

[0083] 1. Take 75% of the water for injection in the dilute mixing tank according to the formula, cool to 20℃, and saturate it with nitrogen;

[0084] 2. Add the formula amount of disodium edetate and amikacin sulfate, stirring constantly, after it is completely dissolved, add the formula amount of sodium metabisulfite to dissolve, and finally add 1000ml of water for injection saturated with nitrogen;

[0085] 3. Add 0.1% (W / V) medicinal charcoal, stir for 30 minutes, adjust the pH to 5.8 with 0.1 mol / L sodium hydroxide;

[0086] 4. Decarburization and fine filtration of the chemical liquid under nitrogen flow until the visible foreign matter is qualified;

[0087] 5. Filling and sealing under nitrogen flow;

[0088] 6. Sterilize at 115℃ for 30 minutes, and it is ready.

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Abstract

The invention discloses amikacin sulfate injection and a preparation method thereof. Antioxidants, complexing agents and injection water are added into amikacin sulfate. The amikacin sulfate injection and the preparation method thereof have the advantages that production technology is simple, cost is low, the problem that existing amikacin sulfate injection cannot meet the terminal sterilization requirement is solved, shortcomings of the prior art are overcome, and the preparation method is applicable to modernized production.

Description

Technical field [0001] The invention relates to an injection of amikacin sulfate and a preparation method thereof. Background technique [0002] Amikacin Sulfate Injection is a semi-synthetic aminoglycoside antibiotic, stable to most aminoglycoside inactivating enzymes, so it is especially suitable for treating gram-negative bacilli that are resistant to kanamycin, gentamicin or tobramycin Severe infections caused by drug strains have been widely used clinically. [0003] In the existing patents and literature, the amikacin sulfate injection reported by CN101584658A is a veterinary drug, and its prescription only adds edetate disodium, and the sterilization conditions are unclear. According to the prescription process we provided, we sterilized it at 115°C for 30 minutes. As a result, the color of the sample became obviously yellow, which did not meet the standard. In order for Amikacin Sulfate Injection to meet terminal sterilization, its prescription process must be improved. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7036A61P31/04
Inventor 林丽洋谢绍鹏杨志洪吉孟媛
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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