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Amikacin sulphate injection and preparation method for same

A technology of amikacin sulfate and injection, which is applied in the direction of medical formula, medical preparations containing active ingredients, drug delivery, etc. It can solve the problems of sample color turning yellow and non-compliance with standard regulations, and achieve low cost and high production efficiency. The effect of simple process

Inactive Publication Date: 2013-07-03
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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  • Amikacin sulphate injection and preparation method for same

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0048] Experimental Example 1: Comparative Experiment

[0049] (1) Prepare 1 batch of amikacin sulfate injection according to the prescription and preparation method disclosed in "A Preparation Method of Amikacin Sulfate Injection" (Patent No. CN101584658A), batch number: 110801A·S, specification 2ml: 0.2 g, as follows:

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

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

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

[0053] 5. Add water for injection to 200ml, and lower the temperature to 20-30°C

[0054] 6. Add 0.1% activated carbon and stir for 20 minutes, then filter;

[0055] 7. Potting, sterilizing at 115°C for 30 minute...

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% water for injection according to the formula in the dilute preparation tank, cool to 30°C, and fill it with nitrogen to make it saturated;

[0073] 2. Add the formula amount of calcium sodium edetate and amikacin sulfate, and stir continuously. After 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 medicinal charcoal in an amount of 0.1% (W / V), stir for 30 minutes, and adjust the pH to 5.8 with 0.1mol / L sodium hydroxide;

[0075] 4. The liquid medicine is decarburized and finely filtered under nitrogen flow until the visible foreign matter is qualified;

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

[0077] 6. Sterilize at 115°C for 30 minutes.

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% water for injection according to the formula in the dilute preparation tank, cool to 20°C, and fill it with nitrogen to make it saturated;

[0084] 2. Add the formula amount of disodium edetate and amikacin sulfate, and stir continuously. After they are 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 medicinal charcoal in an amount of 0.1% (W / V), stir for 30 minutes, and adjust the pH to 5.8 with 0.1mol / L sodium hydroxide;

[0086] 4. The liquid medicine is decarburized and finely filtered under nitrogen flow until the visible foreign matter is qualified;

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

[0088] 6. Sterilize at 115°C for 30 minutes.

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Abstract

The invention discloses an amikacin sulphate injection and a preparation method for the same. According to the preparation method disclosed by the invention, an antioxidant, a complexant and injection water are added in amikacin sulphate. The amikacin sulphate injection and the preparation method for the same disclosed by the invention are simple in production process and low in cost, solve the problem that the amikacin sulphate injection cannot meet the requirement of terminal sterilisation and make up the shortages of the prior art, and are suitable for modern production.

Description

technical field [0001] The invention relates to an amikacin sulfate injection and a preparation method thereof. Background technique [0002] Amikacin sulfate injection belongs to semi-synthetic aminoglycoside antibiotics and is stable to most aminoglycoside inactivating enzymes, so it is especially suitable for the treatment of Gram-negative bacilli resistant to kanamycin, gentamicin or tobramycin. Serious infections caused by drug strains have been widely used clinically. [0003] In existing patents and documents, the amikacin sulfate injection reported in CN101584658A is a veterinary drug, and only disodium edetate is added in its prescription, and the sterilization conditions are not clear. 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. In order to make amikacin sulfate injection meet terminal sterilization, its p...

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