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Synergistic ofloxacin freeze-dried powder injection and preparing method thereof

A technology of freeze-dried powder injection and ofloxacin, which is applied in the field of chemical pharmaceuticals, can solve problems such as poor stability, and achieve the effects of improving solubility, plump appearance, and novel prescription composition

Active Publication Date: 2012-12-19
SOUTHWEST UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ofloxacin is slightly soluble in water, and gradually changes color when exposed to light, and the stability is not good

Method used

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  • Synergistic ofloxacin freeze-dried powder injection and preparing method thereof
  • Synergistic ofloxacin freeze-dried powder injection and preparing method thereof
  • Synergistic ofloxacin freeze-dried powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1, the preparation of synergistic ofloxacin freeze-dried powder injection

[0017] Prescription: 8g ofloxacin, 20g vitamin C, 0.2g sodium bisulfite, appropriate amount of sodium carbonate, 4g polyethylene glycol 6000, add water to 100ml.

[0018] Preparation method: Dissolve polyethylene glycol 6000 in 20ml of water; in addition, dissolve sodium bisulfite and vitamin C in 50ml of water, add ofloxacin to dissolve completely, adjust the pH to 7.0 with saturated sodium carbonate solution, then add poly Ethylene glycol 6000 aqueous solution, mix well, add water to 100ml, filter, divide the filtrate into 1ml vials, and vacuum freeze-dry to prepare synergistic ofloxacin freeze-dried powder injection;

[0019] The vacuum freeze-drying is carried out according to the following procedures:

[0020] a. Pre-freezing: Freeze the product to -45°C for 85 minutes and keep it warm for 1 hour;

[0021] b. Sublimation: After the pre-freezing is completed, control the vacu...

Embodiment 2

[0023] Embodiment 2, the preparation of synergistic ofloxacin freeze-dried powder injection

[0024] Prescription: 8g ofloxacin, 10g vitamin C, 0.2g sodium bisulfite, appropriate amount of sodium carbonate, 4g polyethylene glycol 6000, add water to 100ml.

[0025] Preparation method: Dissolve polyethylene glycol 6000 in 20ml of water; in addition, dissolve sodium bisulfite and vitamin C in 50ml of water, add ofloxacin to dissolve completely, adjust the pH to 7.0 with saturated sodium carbonate solution, then add poly Ethylene glycol 6000 aqueous solution, mix, add water to 100ml, filter, the filtrate is subpackaged in 1ml medicine bottles, carry out vacuum freeze-drying according to the procedure described in Example 1, promptly make synergistic ofloxacin freeze-dried powder injection .

Embodiment 3

[0026] Embodiment 3, the preparation of synergistic ofloxacin freeze-dried powder injection

[0027] Prescription: 8g ofloxacin, 20g vitamin C, 0.2g sodium bisulfite, appropriate amount of sodium carbonate, 4g polyethylene glycol 6000, add water to 100ml.

[0028] Preparation method: Dissolve polyethylene glycol 6000 in 20ml of water; in addition, dissolve sodium bisulfite and vitamin C in 50ml of water, add ofloxacin to dissolve completely, adjust the pH to 6.5 with saturated sodium carbonate solution, then add poly Ethylene glycol 6000 aqueous solution, mix, add water to 100ml, filter, the filtrate is subpackaged in 1ml medicine bottles, carry out vacuum freeze-drying according to the procedure described in Example 1, promptly make synergistic ofloxacin freeze-dried powder injection .

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Abstract

The invention discloses a synergistic ofloxacin freeze-dried powder injection which is prepared by carrying out vacuum freeze drying on aqueous solution dissolved with 5-20% of ofloxacin, 6-25% of vitamin C, 0.1-0.3% of sodium hydrogensulfite, sodium carbonate and 3-5% of polyethylene glycol 6000 according to mass composition, wherein the pH valve of the solution is regulated to be 6.0-7.5 by the sodium carbonate; the prescription of the freeze-dried powder injection is novel, the vitamin C serves as a cosolvent and a synergist, the sodium hydrogensulfite serves as a stabilizer, the sodium carbonate serves as a pH regulator, the polyethylene glycol 6000 serves as a freeze-dried powder injection framework, the vitamin C not only can improve the dissolubility of ofloxacin in water, but also can generate a synergistic effect on ofloxacin of broad spectrum antibiotic in clinic treatment by virtue of intrinsic antiallergic, liver-protecting, detoxifying, anti-stress and immune-improving functions; and in addition, the freeze-dried powder injection is simple in manufacturing method, and the obtained product is plump in shape and has good redissolving performance and stability.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy and relates to a pharmaceutical preparation and a preparation method thereof. Background technique [0002] Ofloxacin is a synthetic third-generation broad-spectrum fluoroquinolone antibacterial drug, which has obvious inhibitory effects on most Gram-positive bacteria and Gram-negative bacteria, especially for aerobic Gram-negative bacteria. bacilli have high antibacterial activity. Clinically, it is mainly used for acute and chronic bacterial infections of the lower respiratory tract, genitourinary system, digestive system, skin and soft tissues caused by sensitive bacteria, as well as urethritis and cervicitis caused by Neisseria gonorrhoeae and Chlamydia trachomatis. [0003] Ofloxacin is slightly soluble in water, and gradually changes color when exposed to light, and its stability is not good. Ofloxacin preparations currently on the market in China include tablets, capsules, injections, fre...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5383A61K47/34A61P31/04
Inventor 肖国君陈力徐兴然刘倩张焱
Owner SOUTHWEST UNIVERSITY
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