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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, which can solve the problems of unstable quality of flucloxacillin sodium, improve bioavailability and increase safety and stability, avoiding the effect of phase separation

Inactive Publication Date: 2010-05-05
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) Add 200g of polyvinyl alcohol and 50g of cholesterol into 1600ml of water for injection, then add 50g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 80°C until molten;

[0041] (2) Keeping the above liquid at 70-90°C for 10 minutes with a tissue masher to shear and stir at a speed of 15,000 r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0042] (3) Add 66.7g of mannitol and 133.3g of trehalose to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain flucloxacillin sodium suspension powder injection.

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) Add 640g of polyvinyl alcohol and 160g of cholesterol into 10000ml of water for injection, then add 100g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 90°C until molten;

[0060] (2) Keeping the above liquid at 70-90°C for 20 minutes with a tissue masher to shear and stir at a speed of 10,000 r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 4 times to obtain an emulsion;

[0061] (3) Add 600g of mannitol sugar and 600g of glucose to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain flucloxacillin sodium suspension powder injection.

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) Add 260g of polyvinyl alcohol and 65g of cholesterol into 3500ml of water for injection, then add 50g of flucloxacillin sodium and mix evenly, heat and stir in a water bath at 70°C until molten;

[0079] (2) The above liquid was kept warm at 70-90°C and was sheared and stirred for 20 minutes with a tissue masher at a speed of 13000r / min to obtain a primary emulsion, which was then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0080] (3) Add 300 g of sorbitol and 100 g of lactose to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain flucloxacillin sodium suspension powder injection.

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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 suspension powder injection of flucloxacillin sodium and a preparation method thereof, and a new application of the preparation in treating Pityrosporum folliculitis. Background technique [0002] Pityrosporum trichotillomania is a kind of folliculitis caused by Malassezia saccharosa. The primary skin lesions are erythema, papules, and pustules around the hair follicles, with a diameter of 2-3 mm and scattered distribution. Diabetes and antibiotics and glucocorticoids can trigger the disease. Malassezia is deeply hidden in the hair follicles, and the resulting folliculitis is more stubborn. The age of onset of the disease is mostly around 30 years old, and women are more than men, and it is prone to occur in the back, chest, neck, face and shoulders. Treatment options include topical and systemic treatments. [0003] Flucloxacillin sodium, chemical name: (2S, 5R,...

Claims

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Application Information

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