Kanamycin sulfate injection and preparation method thereof

Abstract

The invention discloses a kanamycin sulfate injection and a preparation method thereof. The injection is prepared from kanamycin sulfate, an antioxidant, a metal ion complexing agent, a pH value stabilizing agent and water for injection. After the antioxidant, the metal ion complexing agent and the pH value stabilizing agent are added into a prescription of the kanamycin sulfate, the kanamycin sulfate can withstand high-temperature sterilization at the temperature of 115 DEG C for 30 minutes under the synergistic actions of the antioxidant, the metal ion complexing agent and the pH value stabilizing agent, the sterility assurance level of the injection is raised, and clinical use safety is ensured.

Description

technical field

[0001] The invention relates to a kanamycin sulfate injection and a preparation method thereof, in particular to a kanamycin sulfate injection added with an antioxidant, a metal ion complexing agent and a pH stabilizer and a preparation method thereof. Background technique

[0002] Kanamycin sulfate is an aminoglycoside antibiotic. After its injection is sterilized by high temperature, it is easy to cause the degradation of kanamycin sulfate, which will lead to the darkening of the solution. Generally, the method of lowering the sterilization temperature (such as less than 110°C) is used. way to prevent degradation, but reduces the sterility assurance level of injections and increases the risk of clinical use. Contents of the invention

[0003] The object of the present invention is to provide a kind of kanamycin sulfate injection preparation.

[0004] Another object of the present invention is to provide a kind of preparation method of kanamycin sulfate i...

Examples

Embodiment 1

[0049] Kanamycin Sulfate 25kg

[0050] Sodium bisulfite 0.2kg

[0051] Edetate Calcium Sodium 0.01kg

[0052] Sodium citrate 0.8kg

[0053] Water for injection 100kg

[0054] Take kanamycin sulfate, add 50% water for injection, add 15kg of 6 molar concentration under constant stirring to make it dissolve, then add sodium bisulfite, calcium sodium edetate and sodium citrate and fully stir until dissolved, Use 6 molar concentration of sulfuric acid to adjust the pH value to 5.0-7.0, then add 0.01kg of activated carbon and stir for 45 minutes, filter and decarburize, finally add the remaining water for injection, filter until clear, fill, seal, and extinguish at 115°C Bacteria for 30 minutes, that is.

Embodiment 2

[0056] Kanamycin Sulfate 35kg

[0057] Sodium metabisulfite 0.15kg

[0058] Disodium Edetate 0.013kg

[0059] Disodium hydrogen phosphate 0.6kg

[0060] Water for injection 130kg

[0061] Take kanamycin sulfate, add 50% water for injection, add 20 kg of sulfuric acid with a concentration of 5 moles under constant stirring to dissolve it, then add sodium metabisulfite, disodium edetate and disodium hydrogen phosphate in the prescribed amount, and stir thoroughly until dissolved, adjust the pH value to 5.0-7.0 with 5 molar concentration of sulfuric acid, then add 0.02 kg of activated carbon and stir for 55 minutes, filter, decarburize, and finally add the remaining water for injection, filter until clear, fill, seal, and store at 115 ℃ sterilization for 30 minutes, that is.

Embodiment 3

[0063] Kanamycin Sulfate: 15kg

[0064] Sodium sulfite: 0.25kg

[0065] Edetate disodium 0.002kg

[0066] Edetate Calcium Sodium: 0.005kg

[0067] Sodium dihydrogen phosphate: 1.0kg

[0068] Water for injection 70kg

[0069]Get kanamycin sulfate, add 50% water for injection, add 10 kg of sulfuric acid of 7 molar concentration under constant stirring to make it dissolve, then add sodium sulfite, edetate disodium, edetate calcium sodium and sodium dihydrogen phosphate, Fully stir until dissolved, adjust the pH value to 5.0-7.0 with 7 molar concentration of sulfuric acid, then add 0.006kg of activated carbon and stir for 35 minutes, filter and decarburize, finally add the remaining water for injection, filter until clear, fill, seal, Sterilize at 115° C. for 30 minutes to obtain the kanamycin sulfate injection of the present invention.

technical field

[0001] The invention relates to a kanamycin sulfate injection and a preparation method thereof, in particular to a kanamycin sulfate injection added with an antioxidant, a metal ion complexing agent and a pH stabilizer and a preparation method thereof. Background technique

[0002] Kanamycin sulfate is an aminoglycoside antibiotic. After its injection is sterilized by high temperature, it is easy to cause the degradation of kanamycin sulfate, which will lead to the darkening of the solution. Generally, the method of lowering the sterilization temperature (such as less than 110°C) is used. way to prevent degradation, but reduces the sterility assurance level of injections and increases the risk of clinical use. Contents of the invention

[0003] The object of the present invention is to provide a kind of kanamycin sulfate injection preparation.

[0004] Another object of the present invention is to provide a kind of preparation method of kanamycin sulfate i...

Examples

Embodiment 1

[0049] Kanamycin Sulfate 25kg

[0050] Sodium bisulfite 0.2kg

[0051] Edetate Calcium Sodium 0.01kg

[0052] Sodium citrate 0.8kg

[0053] Water for injection 100kg

[0054] Take kanamycin sulfate, add 50% water for injection, add 15kg of 6 molar concentration under constant stirring to make it dissolve, then add sodium bisulfite, calcium sodium edetate and sodium citrate and fully stir until dissolved, Use 6 molar concentration of sulfuric acid to adjust the pH value to 5.0-7.0, then add 0.01kg of activated carbon and stir for 45 minutes, filter and decarburize, finally add the remaining water for injection, filter until clear, fill, seal, and extinguish at 115°C Bacteria for 30 minutes, that is.

Embodiment 2

[0056] Kanamycin Sulfate 35kg

[0057] Sodium metabisulfite 0.15kg

[0058] Disodium Edetate 0.013kg

[0059] Disodium hydrogen phosphate 0.6kg

[0060] Water for injection 130kg

[0061] Take kanamycin sulfate, add 50% water for injection, add 20 kg of sulfuric acid with a concentration of 5 moles under constant stirring to dissolve it, then add sodium metabisulfite, disodium edetate and disodium hydrogen phosphate in the prescribed amount, and stir thoroughly until dissolved, adjust the pH value to 5.0-7.0 with 5 molar concentration of sulfuric acid, then add 0.02 kg of activated carbon and stir for 55 minutes, filter, decarburize, and finally add the remaining water for injection, filter until clear, fill, seal, and store at 115 ℃ sterilization for 30 minutes, that is.

Embodiment 3

[0063] Kanamycin Sulfate: 15kg

[0064] Sodium sulfite: 0.25kg

[0065] Edetate disodium 0.002kg

[0066] Edetate Calcium Sodium: 0.005kg

[0067] Sodium dihydrogen phosphate: 1.0kg

[0068] Water for injection 70kg

[0069]Get kanamycin sulfate, add 50% water for injection, add 10 kg of sulfuric acid of 7 molar concentration under constant stirring to make it dissolve, then add sodium sulfite, edetate disodium, edetate calcium sodium and sodium dihydrogen phosphate, Fully stir until dissolved, adjust the pH value to 5.0-7.0 with 7 molar concentration of sulfuric acid, then add 0.006kg of activated carbon and stir for 35 minutes, filter and decarburize, finally add the remaining water for injection, filter until clear, fill, seal, Sterilize at 115° C. for 30 minutes to obtain the kanamycin sulfate injection of the present invention.

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