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Colistimethate sodium solution used for inhalation, and preparation method of colistimethate sodium solution

A technology of sodium methanesulfonate and polymyxin, which is applied in the field of medicine, can solve the problems of poor stability and inconvenient use, and achieve the effects of good stability, good safety and good reproducibility

Pending Publication Date: 2021-03-26
INCREASEPHARM TIANJIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] At present, there is no polymyxin E sodium mesylate for inhalation on the domestic market. The solution of polymyxin E sodium mesylate for pulmonary inhalation is generally reconstituted from a freeze-dried injection preparation or The pharmacy department of the hospital is self-made. This kind of preparation has many problems such as poor stability and inconvenient use.

Method used

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  • Colistimethate sodium solution used for inhalation, and preparation method of colistimethate sodium solution
  • Colistimethate sodium solution used for inhalation, and preparation method of colistimethate sodium solution
  • Colistimethate sodium solution used for inhalation, and preparation method of colistimethate sodium solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription composition

[0032] name composition Sodium polymyxin E methanesulfonate 40g citric acid 0.02g Sodium citrate 4g Sodium chloride 4g Add water for injection to 1000ml

[0033] Preparation:

[0034] Step 1: Add the prescribed amount of citric acid and sodium citrate into 800ml of water for injection, control the water temperature at 20-30°C, and stir evenly.

[0035] Step 2: Add the prescribed amount of polymyxin E sodium methanesulfonate to the solution in step 1, stir to dissolve.

[0036] Step 3: Add the prescribed amount of sodium chloride and stir evenly.

[0037] Step 4: Add water for injection to the full amount, stir evenly, and filter with a 0.22 μm filter membrane or filter element.

[0038] Step five: filling and sealing.

Embodiment 2

[0040] prescription composition

[0041]

[0042]

[0043] Preparation:

[0044] Step 1: Add the prescribed amount of citric acid and sodium citrate into 700ml of water for injection, control the water temperature at 50-60°C, and stir evenly.

[0045] Step 2: Add the prescribed amount of polymyxin E sodium methanesulfonate to the solution in step 1, stir to dissolve.

[0046] Step 3: Add the prescribed amount of sodium chloride and stir evenly.

[0047] Step 4: Add water for injection to the full amount, stir evenly, and filter with a 0.22 μm filter membrane or filter element.

[0048] Step five: filling and sealing.

Embodiment 3

[0050] prescription composition

[0051] name composition Sodium polymyxin E methanesulfonate 80g sodium bicarbonate 5.3g sodium hydroxide 0.2g Sodium chloride 2.5g Add water for injection to 1000ml

[0052] Preparation:

[0053] Step 1: Add the prescribed amount of sodium bicarbonate and sodium hydroxide into 800ml of water for injection, control the water temperature at 30-40°C, and stir evenly.

[0054] Step 2: Add the prescribed amount of polymyxin E sodium methanesulfonate to the solution in step 1, stir to dissolve.

[0055] Step 3: Add the prescribed amount of sodium chloride and stir evenly.

[0056] Step 4: Add water for injection to the full amount, stir evenly, and filter with a 0.22 μm filter membrane or filter element.

[0057] Step five: filling and sealing.

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PUM

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Abstract

The invention relates to a colistimethate sodium solution used for inhalation, and a preparation method of the colistimethate sodium solution. The solution used for the inhalation comprises an activeingredient, i.e., colistimethate sodium, buffering agent, osmotic pressure conditioning agent and solvent. The colistimethate sodium solution used for the inhalation does not contain preservatives, has good stability, reliable quality and good safety and is easy in large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a polymyxin E sodium methanesulfonate solution for inhalation and a preparation method thereof. Background technique [0002] Pseudomonas aeruginosa (PA) is a Gram-negative bacillus and the most common clinical non-fermenting bacteria. It is widely distributed in nature and can be isolated on the surface of human skin as a normal flora. It can also contaminate medical devices and even disinfectants , leading to hospital-acquired infections, is an important opportunistic pathogenic bacteria for hospital-acquired infections, and has the characteristics of easy colonization, mutation and multi-drug resistance. The "Notice of the General Office of the National Health and Health Commission on Further Strengthening the Prevention and Control of Infection in Medical Institutions" (National Health Office Medical Letter [2019] No. 480) pointed out that the multidrug-resistant bacteria ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K47/12A61K47/02A61K38/12A61P31/04
CPCA61K9/08A61K9/0078A61K47/12A61K47/02A61K38/12A61P31/04
Inventor 胡杰扈靖王永福谢晓飞
Owner INCREASEPHARM TIANJIN INST CO LTD