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Lomefloxacin hydrochloride injection and preparation method thereof

A technology of lomefloxacin hydrochloride and injections, which is applied in the direction of medical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Dosage and other issues, to achieve the effect of convenient and quick administration, reduced volume, and improved solubility

Active Publication Date: 2016-04-13
HUBEI XINGHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The commercially available lomefloxacin hydrochloride injection is an acidic solution with a pH value of about 4.5 and a solubility of about 1%, but the preparation of a small volume of liquid medicine cannot reach the clinical dosage unless the volume of the liquid medicine is large enough, such as a dose of 100mg per tube Use 10ml, 100ml or larger volumes
Each injection uses such a large volume of liquid medicine, which will inevitably increase the production cost, transportation cost and difficulty of administration

Method used

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  • Lomefloxacin hydrochloride injection and preparation method thereof
  • Lomefloxacin hydrochloride injection and preparation method thereof
  • Lomefloxacin hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A lomefloxacin hydrochloride injection is prepared from the following raw materials:

[0026]

[0027] The preparation method of this lomefloxacin hydrochloride injection, its steps are:

[0028] 1) Weigh or measure each raw material, and prepare sodium hydroxide solution with water for injection into a sodium hydroxide solution with a mass percentage concentration of 10%.

[0029] 2) first add lomefloxacin hydrochloride to the remaining water for injection, then add sodium hydroxide solution, continue stirring until lomefloxacin hydrochloride is completely dissolved, then add glycerol and disodium hydrogen phosphate, after stirring, the system is The pH value is 10.3, then add activated carbon, stir evenly and let stand for 30 minutes, then filter (remove activated carbon), fill, fill with nitrogen, seal, and finally sterilize at 115 ° C for 30 minutes.

[0030] The following table shows the solubility of lomefloxacin hydrochloride at different pH values ​​at room ...

Embodiment 2

[0040] A lomefloxacin hydrochloride injection is prepared from the following raw materials by mass percentage:

[0041]

[0042] The preparation method of this lomefloxacin hydrochloride injection, its steps are:

[0043] 1) Weighing or measuring each raw material, the sodium hydroxide is made into a solution with a mass percentage concentration of 15% with water for injection.

[0044] 2) First add lomefloxacin hydrochloride into water for injection, then add sodium hydroxide solution, continue stirring until lomefloxacin hydrochloride is completely dissolved, then add propylene glycol and sodium dihydrogen phosphate, after stirring, the pH value of the adjustment system is 10.4 , and then add activated carbon, stir evenly, let it stand for 32 minutes, remove the activated carbon, filter, fill, fill with nitrogen, seal, and finally sterilize at 117 ° C for 25 minutes.

Embodiment 3

[0046] A lomefloxacin hydrochloride injection is prepared from the following raw materials by mass percentage:

[0047]

[0048] The preparation method of this lomefloxacin hydrochloride injection, its steps are:

[0049] 1) Weigh or measure each raw material, and prepare sodium hydroxide with water for injection into a sodium hydroxide solution with a mass percentage concentration of 8%.

[0050] 2) first add lomefloxacin hydrochloride to the remaining water for injection, then add sodium hydroxide solution, continue stirring until lomefloxacin hydrochloride is completely dissolved, then add propylene glycol and sodium dihydrogen phosphate, after stirring, adjust the pH of the system The value is 10.2, then add activated carbon, stir evenly, let it stand for 28 minutes, remove the activated carbon, filter, fill, fill with nitrogen, seal, and finally sterilize at 113 ° C for 35 minutes.

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Abstract

The invention discloses a lomefloxacin hydrochloride injection and a preparation method thereof. The lomefloxacin hydrochloride injection is prepared from lomefloxacin hydrochloride, salt-forming agents, cosolvents, stabilizing agents, adsorbing agents and water for injection according to a specific proportion. The preparation method includes 1), weighing all the raw materials according to the specific proportion, and preparing a specific concentration of salt-forming agent solution from the salt-forming agents by the water for injection; 2), adding the lomefloxacin hydrochloride into the residual water for injection, then adding the salt-forming agent solution, continuously stirring till the lomefloxacin hydrochloride dissolves completely, adding the cosolvents and the stabilizing agents, uniformly stirring to reach a pH (potential of hydrogen) value of 10.2-10.4, adding the adsorbing agents, standing for 28-32 minutes after uniform stirring, filtering, filling, filling nitrogen, sealing and sterilizing at the temperature of 113-117 DEG C for 25-35 minutes. The lomefloxacin hydrochloride injection has the advantages of convenience and rapidity in administration, high stability, small preparation volume, convenience in transporting and low cost. The preparation method is simple in technological process, high in operability and applicable to large-batch industrial production.

Description

technical field [0001] The invention belongs to the technical field of clinical antibiotic preparations, in particular to a lomefloxacin hydrochloride injection and a preparation method of the lomefloxacin hydrochloride injection. Background technique [0002] Lomefloxacin hydrochloride (lomefloxacinhydrochloride) is a third-generation quinolone broad-spectrum antibacterial drug, effective against Gram-positive bacteria, Gram-negative bacteria including Pseudomonas aeruginosa, and some anaerobic bacteria. Clinically, lomefloxacin hydrochloride is widely used in the treatment of infections of the respiratory urogenital system, gastrointestinal tract, skin and soft tissues caused by sensitive bacteria. However, lomefloxacin hydrochloride is very slightly soluble in water, almost insoluble in methanol and ethanol, slightly soluble in dilute hydrochloric acid, and easily soluble in sodium hydroxide solution. Under normal temperature conditions, when the pH value is 7, the solub...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/02A61K47/10A61P31/04
CPCA61K9/0019A61K9/08A61K31/496A61K47/02A61K47/10
Inventor 张小刚
Owner HUBEI XINGHUA PHARMA CO LTD
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