Sodium fusidate lipidosome injection

A technology of sodium fusidate and injection, applied in the field of pharmaceutical preparations, can solve the problems of easy aggregation, fusion, and leakage of encapsulated drugs of liposomes, and achieve the effects of improving bioavailability, delaying release, and improving stability

Inactive Publication Date: 2014-09-10
海南路易丹尼生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The stability of liposomes has long been an important problem that has limited the wide application of liposomes. Liposomes are generally prone to aggregation and fusion, resulting in leakage of encapsulated drugs. Therefore, the industrial preparation of pharmaceutical liposomes that meet the stability requirements It is not easy, and those skilled in the field of pharmaceuticals with general experience clearly know that they face various difficulties in the preparation of pharmaceutical liposomes, all of which are by no means expected to be solved by existing theories, and many difficulties need to be overcome

Method used

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  • Sodium fusidate lipidosome injection
  • Sodium fusidate lipidosome injection
  • Sodium fusidate lipidosome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] The preparation of embodiment 1 sodium fusidate liposome injection

[0060] Prescription: (100 bottles)

[0061]

[0062] making process:

[0063] (1) Dissolve 12.5g of sodium fusidate in 5000ml of phosphate buffer solution with a pH of 7.8, add 50g of povidone, and stir evenly to obtain an aqueous phase;

[0064] (2) Dissolve 200g of soybean lecithin, 50g of cholesterol succinate and 25g of poloxamer 188 in 500ml of a mixed organic solvent of tert-butanol and isopropanol with a volume ratio of 3:1, stir to dissolve; The solution is placed in an eggplant-shaped bottle, and the organic solvent is removed under reduced pressure in a 45°C water bath to form a uniform transparent film on the wall of the bottle;

[0065] (3) Under the protection of nitrogen, add the water phase of step 1 into the bottle; stir to elute the phospholipid film and fully swell and hydrate it, then do gradient homogenization at 300bar to 600bar for 5 times, filter with a 0.22μm microporous ...

Embodiment 2

[0067] The preparation of embodiment 2 sodium fusidate liposome injection

[0068] Prescription: (100 bottles)

[0069]

[0070] making process:

[0071](1) Dissolve 25g of sodium fusidate in 5000ml of phosphate buffer solution with a pH of 7.8, add 75g of povidone, and stir evenly to obtain an aqueous phase;

[0072] (2) Dissolve 350g of soybean lecithin, 87.5g of cholesterol succinate and 50g of poloxamer 188 in 800ml of a mixed organic solvent of tert-butanol and isopropanol with a volume ratio of 3:1, stir to dissolve; The above solution is placed in an eggplant-shaped bottle, and the organic solvent is removed under reduced pressure in a water bath at 45°C to form a uniform transparent film on the wall of the bottle;

[0073] (3) Under the protection of nitrogen, add the water phase of step 1 into the bottle; stir to elute the phospholipid film and fully swell and hydrate it, then perform gradient homogenization at 300bar to 600bar for 4 times, filter with a 0.22μm...

Embodiment 3

[0075] The preparation of embodiment 3 sodium fusidate liposome injection

[0076] Prescription: (100 bottles)

[0077]

[0078] making process:

[0079] (1) Dissolve 50g of sodium fusidate in 10,000ml of phosphate buffer solution with a pH of 7.8, add 100g of povidone, and stir evenly to obtain an aqueous phase;

[0080] (2) Dissolve 600g of soybean lecithin, 150g of cholesterol succinate and 100g of poloxamer 188 in 1200ml of a mixed organic solvent of tert-butanol and isopropanol with a volume ratio of 3:1, stir to dissolve; The solution is placed in an eggplant-shaped bottle, and the organic solvent is removed under reduced pressure in a 45°C water bath to form a uniform transparent film on the wall of the bottle;

[0081] (3) Under the protection of nitrogen, add the water phase of step 1 into the bottle; stir to elute the phospholipid film and fully swell and hydrate it, then do gradient homogenization at 300bar to 600bar for 6 times, filter with a 0.22μm micropor...

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Abstract

The invention discloses sodium fusidate lipidosome injection and a preparation method thereof. The lipidosome injection is prepared from sodium fusidate, soya bean lecithin, cholesteryl succinate, poloxamer188, povidone and mannitol. The lipidosome injection has the advantages of small particle size and even distribution of lipidosome, excellent stability of preparation, good encapsulation efficiency and lower leakage rate, reduces the impurities and the toxic and side effects, and improves the product quality and the curative effect.

Description

technical field [0001] The invention relates to a liposome injection and a preparation method thereof, in particular to a sodium fusidate liposome injection and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Sodium fusidate, its chemical name is: 16α-acetoxy-3β, 11β-dihydroxy-4β, 8β, 14α-trimethyl-18-nor-5β, 10α-cholesteric-(17Z)- 17(20), sodium 24-dien-21-ate, molecular formula: C 31 h 47 NaO 6 , molecular weight: 538.70, its structural formula is as follows: [0003] [0004] Fusidic acid is a colorless needle crystal, soluble in organic solvents such as ethanol, acetone, chloroform and pyridine, but insoluble in water. Sodium fusidate is a white crystalline powder, easily soluble in water, well absorbed by intravenous injection, and has strong penetrability to tissues and body fluids. Sodium fusidate has a bactericidal effect by inhibiting bacterial protein synthesis, and has a strong ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/19A61K31/56A61K47/32A61K47/34A61P31/04
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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