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Cefmenoxime hydrochloride/anhydrous sodium carbonate pharmaceutical composition liposome injection

A technology of cefmenoxime hydrochloride and anhydrous sodium carbonate, applied in the field of medicine, can solve the problems of light, heat sensitivity, influence drug safety, poor stability, etc., achieve short production cycle, increase in vitro stability, and improve drug safety Effect

Inactive Publication Date: 2012-06-27
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the marketed preparations of cefmenoxime hydrochloride are all sterile subpackaged powder injections, which are sensitive to light and heat and have poor stability. Long-term storage leads to a significant increase in related substances, which affects the safety of the drug.

Method used

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  • Cefmenoxime hydrochloride/anhydrous sodium carbonate pharmaceutical composition liposome injection
  • Cefmenoxime hydrochloride/anhydrous sodium carbonate pharmaceutical composition liposome injection
  • Cefmenoxime hydrochloride/anhydrous sodium carbonate pharmaceutical composition liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment one cefmenoxime hydrochloride liposome injection

[0031] Prescription (specification 0.05g)

[0032] Cefmenoxime Hydrochloride 5g

[0033] Anhydrous sodium carbonate 2g

[0034] Soy Lecithin 20g

[0035] Cholesterol 20g

[0036] Tween 80 10g

[0037] Isopropanol 300ml

[0038] Lactose 7g

[0039] Sodium sulfite 3g

[0040] Phosphate buffer 200ml

[0041] Preparation Process:

[0042] (1) 20g phospholipids, 20g cholesterol, 10g Tween 80 and 3g sodium sulfite are dissolved in 300ml isopropanol, mix uniformly, and remove the organic solvent under reduced pressure on a rotary thin film evaporator to obtain a phospholipid film;

[0043] (2) Add 200ml of sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution with a pH value of 6.3 to the prepared phospholipid film, shake and stir to completely hydrate the phospholipid film, high-speed homogeneous emulsification, 0.45 μm microporous membrane Filter to obtain a blank lip...

Embodiment 2

[0062] The preparation of embodiment two cefmenoxime hydrochloride liposome injection

[0063] Prescription (specification 0.1g)

[0064] Cefmenoxime Hydrochloride 10g

[0065] Anhydrous sodium carbonate 3.6g

[0066] Egg yolk lecithin 35g

[0067] Cholesterol 7g

[0068] Tween 80 28g

[0069] Ethanol 300ml

[0070] Mannitol 10g

[0071] Vitamin E 8g

[0072] Citrate buffer 200ml

[0073] Preparation Process:

[0074] (1) 35g egg yolk lecithin, 7g cholesterol, 28g Tween 80 and 8g vitamin E are dissolved in 300ml ethanol, mix uniformly, remove the organic solvent under reduced pressure on a rotary thin film evaporator, and obtain a phospholipid film;

[0075] (2) Add 200ml of citric acid-sodium citrate buffer solution with a pH value of 7 to the prepared phospholipid film, shake and stir to completely hydrate the phospholipid film, high-speed homogeneous emulsification, and filter with a 0.45um microporous membrane , to prepare a blank liposome suspension;

[0076] (...

Embodiment 3

[0078] The preparation of embodiment three cefmenoxime hydrochloride liposome injection

[0079] Prescription (specification 0.2g)

[0080] Cefmenoxime Hydrochloride 20g

[0081] Anhydrous sodium carbonate 8.8g

[0082] Soy Lecithin 18g

[0083] Cholesterol 27g

[0084] Tween 80 3.6g

[0085] Ethanol 200ml

[0086] Mannitol 10g

[0087] Sodium bisulfite 6g

[0088] Phosphate buffer 200ml

[0089] Preparation Process:

[0090] (1) 18g soybean lecithin, 27g cholesterol, 3.6g Tween 80 and 6g sodium bisulfite are dissolved in 200ml ethanol, mix uniformly, remove the organic solvent under reduced pressure on a rotary thin film evaporator, and obtain a phospholipid film;

[0091] (2) Add sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution with a pH value of 5.0 to the prepared phospholipid film, shake and stir to completely hydrate the phospholipid film, high-speed homogeneous emulsification, and filter with a 0.45um microporous membrane , to prepare a ...

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Abstract

The invention provides a cefmenoxime hydrochloride / anhydrous sodium carbonate pharmaceutical composition liposome injection and a preparation method thereof. The cefmenoxime hydrochloride / anhydrous sodium carbonate pharmaceutical composition comprises the following components according to parts by weight: 1 part of cefmenoxime hydrochloride, 0.36-0.44 part of anhydrous sodium carbonate, 1-3 partsof liposome matrix and 0-1 part of additive. The prepared preparation has better stability and ensures medication safety.

Description

technical field [0001] The invention relates to an antibiotic drug cefmenoxime hydrochloride / anhydrous sodium carbonate pharmaceutical composition preparation, in particular to a cefmenoxime hydrochloride liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefmenoxime hydrochloride, its chemical name is: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[[ 1-Methyl-1H-tetrazol-5-yl)-thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-metha Hydrochloride (2:1), molecular formula: C 16 h 17 N 9 o 5 S 3 1 / 2HCl, molecular weight: 529.79, structural formula: [0003] [0004] Cefmenoxime hydrochloride is the third-generation cephalosporin developed by Takeda Corporation of Japan. It was first listed in Japan in 1983. It is a broad-spectrum antibiotic. It achieves bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. The strong antibacterial effect is ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K31/546A61K47/02A61P31/04
Inventor 王洪胜
Owner HAINAN LINGKANG PHARMA CO LTD
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