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A kind of amikacin sulfate freeze-dried preparation and preparation method thereof

A technology of amikacin sulfate and freeze-dried preparations, which is applied in the field of medicine, can solve problems such as unstable product quality, loose dosage forms, and high production costs, and achieve the effects of shortening freeze-drying time, reducing energy consumption, and increasing production capacity

Active Publication Date: 2018-04-17
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the production process of traditional amikacin sulfate lyophilized preparations, it is first prepared into an aqueous solution, and then filled to freeze-drying. The shorter the time of amikacin sulfate in a non-dry state, the more stable the product quality: It is not easy to form during the freeze-drying process, and the appearance of the dosage form is loose; at the same time, the freeze-drying time exceeds 25 hours during the freeze-drying process, the longer the freeze-drying time, the longer the amikacin sulfate is in a non-dried state, and the product quality is more unstable; at the same time The longer the freeze-drying time, the greater the energy consumption and the higher the production cost

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  • A kind of amikacin sulfate freeze-dried preparation and preparation method thereof
  • A kind of amikacin sulfate freeze-dried preparation and preparation method thereof
  • A kind of amikacin sulfate freeze-dried preparation and preparation method thereof

Examples

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Embodiment 1

[0029] The present embodiment provides a freeze-dried preparation of amikacin sulfate with a batch number of 140601 and an output of 10,000 bottles; it is prepared from the following raw materials:

[0030] Amikacin sulfate 100mg; sodium bisulfite 10g; edetate disodium 100mg; mannitol 200g; water for injection was added to 10000ml.

[0031] The present embodiment also provides the preparation method of described amikacin sulfate freeze-dried preparation, specifically:

[0032] (1) Preparation of medicinal liquid: get about 60% water for injection of the total volume of the prepared amount, pass CO 2 After 15 to 30 minutes to the saturated state (pH 4.0), add the prescribed amount of amikacin sulfate into water for injection to dissolve, then add the prescribed amount of anhydrous sodium sulfite and disodium edetate, and dissolve to obtain a solution ①; weigh the prescribed amount Dissolve mannitol in an appropriate amount of water for injection to obtain solution ②; combine s...

Embodiment 2

[0043] The present embodiment provides a freeze-dried preparation of amikacin sulfate with a batch number of 140603 and an output of 10,000 bottles; it is prepared from the following raw materials:

[0044] Amikacin sulfate 120mg; sodium bisulfite 12g; edetate disodium 120mg; mannitol 250g; water for injection was added to 10000ml.

[0045] The present embodiment also provides the preparation method of described amikacin sulfate freeze-dried preparation, specifically:

[0046] (1) Preparation of medicinal liquid: get about 60% water for injection of the total volume of the prepared amount, pass CO 2 After 15 to 30 minutes to the saturated state (pH 4.0), add the prescribed amount of amikacin sulfate into water for injection to dissolve, then add the prescribed amount of anhydrous sodium sulfite and disodium edetate, and dissolve to obtain a solution ①; weigh the prescribed amount Dissolve mannitol in an appropriate amount of water for injection to obtain solution ②; combine s...

Embodiment 3

[0056] This embodiment provides a batch number of 140605, 10000 bottles of amikacin sulfate freeze-dried preparation; it is prepared from the following raw materials:

[0057] Amikacin sulfate 150mg; sodium bisulfite 15g; edetate disodium 150mg; mannitol 300g; water for injection was added to 20000ml.

[0058] The present embodiment also provides the preparation method of described amikacin sulfate freeze-dried preparation, specifically:

[0059] (1) Preparation of medicinal liquid: get about 60% water for injection of the total volume of the prepared amount, pass CO 2 After 15 to 30 minutes to the saturated state (pH 4.0), add the prescribed amount of amikacin sulfate into water for injection to dissolve, then add the prescribed amount of anhydrous sodium sulfite and disodium edetate, and dissolve to obtain a solution ①; weigh the prescribed amount Dissolve mannitol in an appropriate amount of water for injection to obtain solution ②; combine solution ① and solution ②, add 0...

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Abstract

The invention relates to an amikacin sulfate freeze-drying preparation. The freeze-drying preparation is prepared from, by weight, 0.1-0.2 part of amikacin sulfate, 0.1-0.2 part of edetate disodium, 10-20 parts of sodium bisulfite and 200-400 parts of mannitol. The invention further provides a preparing method of the amikacin sulfate freeze-drying preparation. According to the formula and the preparing method, freeze-drying time can be shortened, and thus the stability of amikacin sulfate is ensured; meanwhile, energy consumption is reduced, the unit time production yield is increased, and production cost is reduced.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a drug freeze-dried preparation of amikacin sulfate and a preparation method thereof. Background technique [0002] Amikacin, chemical name: O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α -D-glucopyranosyl-(1→4)]-N-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-D-streptavidin sulfate, which is kanapenicillin a A semi-synthetic derivative of sulfate, white or off-white crystalline powder, almost odorless and tasteless. This product is soluble in water, almost insoluble in ethanol. [0003] Amikacin sulfate belongs to the aminoglycoside antibiotics. This product has good effects on most Enterobacteriaceae bacteria, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, etc. Genus, Alcaligenes, etc. also have good effects; Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Yersinia, Campylobacter fetalis, Mycobacterium tuberculosis and some non-tubercul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7036A61K47/02A61K47/18A61K47/26A61P31/04
CPCA61K9/19A61K31/7036A61K47/02A61K47/183A61K47/26
Inventor 尹双青刘甜甜黄莹
Owner MAANSHAN BBCA PHARMA