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Levofloxacin lactate liposome sodium chloride injection and preparation method thereof

A technology of levofloxacin lactate and levofloxacin lactate is applied in the field of medicine and can solve the problems of unqualified clarity and insoluble particles of levofloxacin lactate injection, and the color of the solution turns yellow, so as to improve the therapeutic index of the drug, stabilize the product quality, and reduce the side effects of the drug. Effect

Inactive Publication Date: 2010-02-10
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the problem that the clarity and insoluble particles of levofloxacin lactate injection in the prior art are unqualified, and the color of the solution turns yellow, the object of the present invention is to provide a stable, long-term-placeable levofloxacin lactate liposomal sodium chloride injection, specifically Said, by specific adjuvant and the ratio of raw and adjuvant materials, the levofloxacin lactate liposomal sodium chloride injection of the present invention is made by the reverse phase evaporation method, and the above-mentioned problems of existence are solved

Method used

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  • Levofloxacin lactate liposome sodium chloride injection and preparation method thereof
  • Levofloxacin lactate liposome sodium chloride injection and preparation method thereof
  • Levofloxacin lactate liposome sodium chloride injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] Example 1 Preparation of Levofloxacin Lactate Liposomal Sodium Chloride Injection

[0034] Prescription (100 bottles): Levofloxacin Lactate 10g

[0035] Soy Lecithin 60g

[0036]Cholesterol 5g

[0037] Sodium deoxycholate 15g

[0038] Ascorbyl Palmitate 10g

[0039] Sodium chloride 90g

[0040] Preparation Process

[0041] (1) 60g soybean lecithin, 5g cholesterol, 15g sodium deoxycholate and 10g ascorbyl palmitate are dissolved in the ethanol of 500ml;

[0042] (2) levofloxacin lactate 10g and sodium chloride 90g are dissolved in the potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution of 8000mlpH value 5.0;

[0043] (3) Mix the two and stir to form a W / O emulsion, heat and stir to evaporate, when the mixture reaches a viscous state, add 2000ml of phosphate buffer with a pH value of 5.0, continue to heat and stir to evaporate to remove residual ethanol, and ultrasonic for 30min , transferred to a high-speed homogeneous mixer, stirred a...

Embodiment 2

[0055] Example 2 Preparation of Levofloxacin Lactate Liposomal Sodium Chloride Injection

[0056] Prescription (100 bottles): Levofloxacin Lactate 20g

[0057] Phosphatidylglycerol Distearate 200g

[0058] Cholesterol 20g

[0059] Sodium deoxycholate 40g

[0060] Sodium bisulfite 20g

[0061] Sodium chloride 90g

[0062] Preparation Process

[0063] (1) Dissolve 200g phosphatidylglycerol distearate, 20g cholesterol, 40g sodium deoxycholate and 20g sodium bisulfite in isopropanol of 2000ml;

[0064] (2) levofloxacin lactate 20g and sodium chloride 90g are dissolved in 8000ml water;

[0065] (3) Mix the two, stir to form a W / O emulsion, heat and stir to evaporate, when the mixture reaches a viscous state, add 2000ml of acetic acid-sodium acetate buffer solution with a pH value of 4.6, continue to heat and stir to evaporate to remove residual isopropyl Alcohol, ultrasonic 30min, transferred to a high-speed homogeneous mixer, stirred homogeneously for 30min, to obtain l...

Embodiment 3

[0077] Example 3 Preparation of Levofloxacin Lactate Liposomal Sodium Chloride Injection

[0078] Prescription (100 bottles): Levofloxacin Lactate 30g

[0079] Egg Yolk Phosphatidylserine 400g

[0080] Cholesterol 30g

[0081] Sodium deoxycholate 25g

[0082] Vitamin E 15g

[0083] Sodium chloride 90g

[0084] Preparation Process

[0085] (1) 400g egg yolk phosphatidylserine, 30g cholesterol, 25g sodium deoxycholate and 15g vitamin E are dissolved in 2000ml of benzyl alcohol;

[0086] (2) levofloxacin lactate 30g and sodium chloride 90g are dissolved in the citric acid-sodium citrate buffer solution of 8000mlpH value 4.8;

[0087] (3) Mix the two and stir to form a W / O emulsion, heat and stir to evaporate, when the mixture reaches a viscous state, add 2000ml of water, continue to heat and stir to evaporate to remove residual benzyl alcohol, ultrasonic 30min, transfer to a high-speed uniform In a mass m...

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Abstract

The invention provides a levofloxacin lactate liposome sodium chloride injection and a preparation method thereof. The levofloxacin lactate liposome sodium chloride injection is characterized by beingprepared with the following components according to parts by weight: 1 part of levofloxacin lactate, 5-15 parts of phospholipid, 0.5-1.5 parts of cholesterol, 0.5-2 parts of deoxycholate, 2-10 partsof sodium chloride and 0.5-1.5 parts of antioxidant. The invention adopts specific auxiliary materials to proportion with the original auxiliary materials and adopts the reverse phase evaporation method to prepare the levofloxacin lactate liposome sodium chloride injection of the invention, solving problems of unqualified levofloxacin lactate injection clarity and insoluble particles, and yellowing of solution color in the prior art. The invention provides a stable levofloxacin lactate liposome sodium chloride injection featuring long-time laying aside.

Description

technical field [0001] The invention relates to a liposome preparation, in particular to levofloxacin lactate liposome sodium chloride injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Levofloxacin lactate, chemical name: (-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl) -7-Oxo-7h-pyrido[1,2,3,-de]-[1,4]benzoxazine-6-carboxylic acid lactate hemihydrate, molecular formula: C 18 h 20 FN 3 o 4 ·C 3 h 6 o 3 1 / 2H 2 O, molecular weight: 460.41, structural formula: [0003] [0004] Levofloxacin lactate is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit bacterial DNA gyrase activity and bacterial DNA replication. It has the characteristics of broad antibacterial spectrum and strong antibacterial effect. It is effective against most Enterobacteriaceae bacteria, such as Klebsiella pneumoniae, ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/5383A61K47/28A61K47/02A61P31/04
Inventor 邓菊娟
Owner HAINAN YONGTIAN PHARMA INST
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