Flucloxacillin sodium suspension and new application thereof

A technology of flucloxacillin sodium and powder injection, which is applied in the field of a new dosage form of flucloxacillin sodium, can solve the problems of unstable quality and unstable quality of flucloxacillin sodium, and achieve increased safety and stability, and improved Bioavailability, the effect of reducing drug toxicity

Inactive Publication Date: 2011-11-09
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] After a long period of earnest research, the inventor has unexpectedly found that the application of emulsified suspension technology to make powder injection by freeze-drying can not only solve the problem of unstable quality of flucloxacillin sodium, but also be more conducive to the treatment of pityrosporum folliculitis. The present invention has thus been accomplished
[0009] The purpose of the present invention is to provide a stable flucloxacillin sodium powder injection, specifically, through the combination of a certain amount of surfactant, lyophilized support agent and active components, the fluorocloxacillin sodium powder of the present invention is prepared by emulsification and suspension technology. Cloxacillin Sodium Suspension Powder Injection solved the problem of unstable quality and achieved satisfactory technical results

Method used

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  • Flucloxacillin sodium suspension and new application thereof
  • Flucloxacillin sodium suspension and new application thereof
  • Flucloxacillin sodium suspension and new application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of embodiment 1 flucloxacillin sodium suspension powder injection

[0033] Prescription (100 bottles):

[0034] Flucloxacillin Sodium 50g

[0035] Polyvinyl alcohol 200g

[0036] Cholesterol 50g

[0037] Mannitol 66.7g

[0038] Trehalose 133.3g

[0039] Preparation Process:

[0040] (1) 200g of polyvinyl alcohol and 50g of cholesterol were added to 1600ml of water for injection, then 50g of flucloxacillin sodium was added and mixed evenly, heated and stirred in a water bath at 80°C to a molten state;

[0041] (2) adopting the tissue masher to shear and stir for 10min under the condition of keeping the above-mentioned liquid at 70-90°C, the rotating speed is 15000r / min, to obtain the primary emulsion, and then circulate emulsification through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0042] (3) 66.7g of mannitol and 133.3g of trehalose were added to the emulsio...

Embodiment 2

[0051] The preparation of embodiment 2 flucloxacillin sodium suspension powder injection

[0052] Prescription (100 bottles):

[0053] Flucloxacillin Sodium 100g

[0054] Polyvinyl Alcohol 640g

[0055] Cholesterol 160g

[0056] Mannitol 600g

[0057] Glucose 600g

[0058] Preparation Process

[0059] (1) 640g of polyvinyl alcohol and 160g of cholesterol were added to 10000ml of water for injection, then 100g of flucloxacillin sodium was added and mixed evenly, heated and stirred in a 90°C water bath to a molten state;

[0060] (2) adopting tissue masher to shear and stir for 20min under the condition of thermal insulation 70-90℃, rotating speed 10000r / min to obtain primary emulsion, and then circulate emulsification by high pressure homogenizer for 4 times to obtain emulsion;

[0061] (3) adding 600g mannitol sugar and 600g glucose to the emulsion, dissolving, filtering and packaging, freeze-drying, to ...

Embodiment 3

[0070] The preparation of embodiment 3 flucloxacillin sodium suspension powder injection

[0071] Prescription (100 bottles):

[0072] Flucloxacillin Sodium 50g

[0073] Polyvinyl Alcohol 260g

[0074] Cholesterol 65g

[0075] Sorbitol 300g

[0076] Lactose 100g

[0077] Preparation Process

[0078] (1) 260g of polyvinyl alcohol and 65g of cholesterol were added to 3500ml of water for injection, then 50g of flucloxacillin sodium was added and mixed evenly, heated and stirred in a water bath at 70°C to a molten state;

[0079] (2) adopting the tissue masher to shear and stir for 20min under the condition of thermal insulation 70-90 ℃ of the above-mentioned liquid, and the rotating speed is 13000r / min, to obtain the primary emulsion, and then circulate and emulsify 5 times through the high-pressure homogenizer to obtain the emulsion;

[0080] (3) adding 300 g of sorbitol and 100 g of lactose to the emulsio...

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Abstract

The invention relates to a flucloxacillin sodium suspension and a new application thereof. The invention provides the flucloxacillin sodium suspension containing 1 part by weight of flucloxacillin sodium, 3-14 parts by weight of surfactant and 2-20 parts by weight of freeze-drying support agent. The invention further discloses the new application of the flucloxacillin sodium suspension in the preparation of drugs for treating pityrosporum folliculitis.

Description

technical field [0001] The invention relates to a new dosage form of flucloxacillin sodium, in particular to a flucloxacillin sodium suspension powder injection and a preparation method thereof, and a new application of the preparation in the treatment of Pityrosporum folliculitis. Background technique [0002] Pityrosporum folliculitis is a kind of folliculitis caused by Malassezia sugar. The primary skin lesions are erythema, papules and pustules around the hair follicle, with a diameter of 2-3mm and scattered distribution. Diabetes and antibiotics and glucocorticoids can promote the disease. Malassezia is deeply hidden in the hair follicle, causing more stubborn folliculitis. The age of onset of the disease is mostly around 30 years old, more women than men, and it is more common in the back, chest, neck, face and shoulders. Treatment methods include local therapy and systemic therapy. [0003] Flucloxacillin sodium, chemical name: (2S,5R,6R)-6-[[3-(2-chloro-6-fluoroph...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/431A61P17/00A61P31/10
Inventor 陶灵刚
Owner HAINAN MEILAN SMITH KLINE PHARMA
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