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Levofloxacin hydrochloride composition packaged by plastic ampoule

A technology of levofloxacin hydrochloride and a composition, which is applied in the field of pharmaceutical preparation, can solve the problems of increasing insoluble particles and deepening color, and achieves the effect of solving the increase of insoluble particles

Inactive Publication Date: 2019-05-31
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the above-mentioned technical problems, the present invention provides a levofloxacin hydrochloride injection drug packaged in plastic ampoules to overcome the problems of the existing levofloxacin hydrochloride injection, which are prone to color deepening and insoluble particles during long-term storage.

Method used

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  • Levofloxacin hydrochloride composition packaged by plastic ampoule
  • Levofloxacin hydrochloride composition packaged by plastic ampoule
  • Levofloxacin hydrochloride composition packaged by plastic ampoule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription:

[0018]

[0019] Its preparation method is:

[0020] Take 80% of the prescribed amount of water for injection, lower the temperature to 35°C, add the prescribed amount of edetate disodium, sodium metabisulfite, gargaronic acid B, and levofloxacin hydrochloride and stir to dissolve; adjust with 0.1mol / L sodium hydroxide solution When the pH value reaches 3.8, add the prescribed amount of activated carbon to stir and absorb, and filter with a 0.5 μm titanium rod and a 0.22 μm microporous filter respectively. The first equipment makes plastic PP bottles, fills, seals, and sterilizes at 121°C for 15 minutes.

Embodiment 2

[0022] prescription:

[0023]

[0024] crafting process:

[0025] Its preparation method is:

[0026] Take 80% water for injection of prescription quantity, temperature drops to 40 ℃, add disodium edetate, sodium pyrosulfite, levofloxacin hydrochloride of prescription quantity and stir to dissolve; adjust pH value to 4.3 with 0.1mol / L sodium hydroxide solution, add The prescription amount of activated carbon is stirred and adsorbed, filtered with a 0.5μm titanium rod and a 0.22μm microporous filter element respectively, after sampling and testing the semi-finished product is qualified, the final 0.22μm microporous filter element is filtered until the visible foreign matter is qualified, and a plastic PP bottle is made with a three-in-one equipment , filling, sealing, and sterilization at 121°C for 15 minutes.

Embodiment 1

[0028] prescription:

[0029]

[0030] Its preparation method is:

[0031] Take 80% of the prescribed amount of water for injection, the temperature drops to 40°C, add the prescribed amount of levofloxacin hydrochloride and stir to dissolve; adjust the pH value to 4.3 with 0.1mol / L sodium hydroxide solution, add the prescribed amount of activated carbon and stir for adsorption, and use 0.5 μm titanium rod and 0.22μm microporous filter element to filter. After sampling and testing the semi-finished product is qualified, the terminal 0.22μm microporous filter element is filtered until the visible foreign matter is qualified, and the three-in-one equipment is used to make plastic PP bottles, fill, seal, and extinguish at 121°C. Bacteria for 15 minutes.

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PUM

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Abstract

The invention belongs to the technical field of medicine preparation and particularly relates to a levofloxacin hydrochloride composition packaged by a plastic ampoule. The composition comprises levofloxacin hydrochloride, an anti-discoloration composition and sodium hydroxide. The anti-discoloration composition accounts for 0.01%-0.5% of levofloxacin hydrochloride injection by weight. Compared with the prior art, the levofloxacin hydrochloride injection medicine packaged by the plastic ampoule can solve the problem that the color of the levofloxacin hydrochloride injection is deepened in theplacing process by adding the anti-discoloring composition into the prescription. The plastic ampoule can well solve the problem that the insoluble particles of the levofloxacin hydrochloride injection are increased, and the effect far exceeding the effect of traditional glass bottle packaging is obtained.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a levofloxacin hydrochloride composition packaged in a plastic ampoule. Background technique [0002] Levofloxacin is the optically active levorotatory form of the racemate ofloxacin. It is a fully synthetic quinolone antibacterial drug. Its antibacterial spectrum is the same as that of ofloxacin, but its antibacterial activity is twice that of ofloxacin. Injections with levofloxacin as the active ingredient are widely used clinically to treat severe infections of the respiratory system, urinary system, reproductive system, skin and soft tissues, and intestinal tract caused by sensitive bacteria. [0003] Levofloxacin hydrochloride is off-white to light yellow crystal or crystalline powder; this product is easily soluble in water, slightly soluble in methanol, slightly soluble in ethanol, almost insoluble in chloroform, ether or petroleum ether. The mole...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5383A61K47/02A61K47/12A61K47/18A61P31/04A61J1/06
Inventor 王飞魏东法刘新刚
Owner CISEN PHARMA
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