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Flucloxacilin sodium liposome injection

A technology of flucloxacillin sodium lipid and flucloxacillin sodium, which is applied in the field of pharmaceutical preparations, can solve the problems such as quality requirements that cannot meet the validity period, low liposome encapsulation rate, unstable quality, etc., and achieves low cost and reduced toxicity. Side effects, the effect of improving product quality

Inactive Publication Date: 2011-07-27
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Flucloxacillin sodium has been included in the 2000 edition of the British Pharmacopoeia. At present, there are injections and oral preparations on the market. There are few domestic manufacturers. Most of them have defects of poor purity and unstable quality, which cannot meet the quality requirements of the expiration date.
[0004] Prior art adopts the technology of liposome encapsulation to the composition of flucloxacillin sodium and amoxicillin sodium, but defective also is obvious, for example the encapsulation rate of liposome is low, and leakage rate is on the high side, and The targeted release of liposomes only has a prominent effect on specific parts

Method used

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  • Flucloxacilin sodium liposome injection
  • Flucloxacilin sodium liposome injection
  • Flucloxacilin sodium liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of embodiment 1 flucloxacillin sodium lipid microsphere injection

[0037] Prescription: (100 bottles)

[0038]

[0039]

[0040] making process:

[0041] (1) Dissolve 50g of flucloxacillin sodium, 100g of glycerin and 25g of sodium chloride in 2000ml of water for injection to obtain an aqueous phase;

[0042] (2) 200g polysorbate 80, 150g gelatin and 25g sodium glycocholate were dissolved in 2000ml volume ratio of n-hexane and isopropanol in a mixed solvent of 1:1 to obtain an oil phase;

[0043] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 3ml / min, stir for 10min after dropping, then transfer to a high-speed homogenizer and stir at a high speed for 3 times at a speed of 12000r / min, each 5min, to obtain a uniform white emulsion;

[0044] (4) Put the white emulsion into the spray dryer, adjust the spray conditions: the inlet temperature is 90°C, the outlet temperature...

Embodiment 2

[0046] The preparation of embodiment 2 flucloxacillin sodium lipid microsphere injection

[0047] Prescription: (100 bottles)

[0048]

[0049] making process:

[0050] (1) 50g flucloxacillin sodium, 450g glycerol and 150g sodium chloride were dissolved in 4000ml water for injection to obtain the aqueous phase;

[0051] (2) 400g polysorbate 80, 500g gelatin and 250g sodium glycocholate are dissolved in 4000ml of mixed solvent of n-hexane and Virahol with a volume ratio of 1:1 to obtain an oil phase;

[0052] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 8ml / min, stir for 30min after dropping, then transfer to a high-speed homogenizer and stir at a high speed for 5 times at a speed of 12000r / min, each 10min, to obtain a uniform white emulsion;

[0053] (4) Put the white emulsion into the spray dryer, adjust the spray conditions: the inlet temperature is 80°C, the outlet temperature is about 50°C...

Embodiment 3

[0055] The preparation of embodiment 3 flucloxacillin sodium lipid microsphere injection

[0056] Prescription: (100 bottles)

[0057]

[0058] making process:

[0059] (1) 100g flucloxacillin sodium, 200g glycerol and 50g sodium chloride are dissolved in 3000ml water for injection to obtain the aqueous phase;

[0060] (2) 400g polysorbate 80, 300g gelatin and 50g sodium glycocholate were dissolved in 3000ml volume ratio of n-hexane and isopropanol in a mixed solvent of 1:1 to obtain an oil phase;

[0061] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 5ml / min, stir for 20min after dropping, then transfer to a high-speed homogenizer and stir at a high speed for 4 times at a speed of 12000r / min, 8min each time, to obtain a uniform white emulsion;

[0062] (4) Put the white emulsion into the spray dryer, adjust the spray conditions: the inlet temperature is 85°C, the outlet temperature is about 50...

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Abstract

The invention discloses a flucloxacilin sodium liposome injection. The flucloxacilin sodium liposome injection is mainly prepared from flucloxacilin sodium, polysorbate 80, gylcocholic acid sodium salt, gelatin, glycerol and sodium chloride; the defect of instability of the flucloxacilin preparation is overcome; and the liposome injection is prepared by protecting flucloxacilin sodium package by using liposome and then performing spray drying and aseptic subpackage, so that the stability of the flucloxacilin sodium is greatly increased, the preparation process is simple, yield is high, and solubility is high. The product quality of the preparation is improved and the toxic and side effects are reduced.

Description

technical field [0001] The invention relates to a novel injection of flucloxacillin sodium, in particular to a lipid microsphere injection of flucloxacillin sodium, belonging to the field of pharmaceutical preparations. Background technique [0002] Flucloxacillin sodium, chemical name: (2S, 5R, 6R)-6-[[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-methanol Acyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt, belonging to the fourth generation of isoxazole penicillins , which is characterized by being not easily destroyed by penicillinase, and has a bactericidal effect on penicillinase-producing drug-resistant Staphylococcus aureus, and is mainly used for penicillin-resistant Staphylococcus infection. It is clinically used to treat severe infections of penicillin-resistant Staphylococcus aureus, respiratory tract infections (such as acute pharyngitis, suppurative tonsillitis), secondary bacterial infections of colds, acute and...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/16A61K31/431A61K47/42A61P31/04
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA
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