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Nasal medicine composition enclosing fluticasone propionate by cyclodextrin

A technology of fluticasone propionate and composition, which is applied in the field of nasal pharmaceutical composition, can solve the problems of poor stability, undisclosed, poor stability of nasal spray, etc., and achieve the effect of stable content, good stability and good water solubility

Inactive Publication Date: 2010-06-30
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Chinese patent application 97195225.6 discloses a nasal spray containing intranasal corticosteroids and antihistamines. In the application specification, it is believed that the combination of intranasal corticosteroids and antihistamines can take effect quickly and last, and reduce The dosage required by antihistamines, thereby reducing potential side effects such as drowsiness, however, the application does not disclose any specific pharmacological experimental data to prove the above effects, and we found that the nasal drug disclosed in the application The stability of the composition is poor and cannot meet the requirements for stability in the current Pharmacopoeia
[0011] Chinese patent application 03819170 discloses a compound preparation of azelastine hydrochloride and glucocorticoid, and discloses that the compound of azelastine hydrochloride and glucocorticoid is made into dosage forms such as nasal spray, aerosol, powder spray, etc. Through our experiments, we found that the nasal spray disclosed in this application has poor stability and cannot meet the stability requirements in the current Pharmacopoeia.

Method used

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  • Nasal medicine composition enclosing fluticasone propionate by cyclodextrin
  • Nasal medicine composition enclosing fluticasone propionate by cyclodextrin
  • Nasal medicine composition enclosing fluticasone propionate by cyclodextrin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Dissolve 2 g of 3-hydroxypropyl β-cyclodextrin in 15 ml of 95% ethanol at room temperature, add 0.2 g of fluticasone propionate, stir to dissolve, stir for another 30 minutes, filter through a microporous membrane (220 nm), add 8 ml of water for injection , stirred for 5 minutes, concentrated under reduced pressure, and evaporated to remove ethanol to obtain an aqueous solution of fluticasone propionate / 3-hydroxypropyl β-cyclodextrin inclusion complex, which was set aside.

Embodiment 2

[0051] Dissolve 2g of 2-hydroxypropyl-β-cyclodextrin in 20ml of acetone at 40±2°C, add 0.5g of fluticasone propionate, stir to dissolve, stir for another 30 minutes, filter through a microporous membrane (220nm), add 3mL The water for injection was stirred for 5 minutes, and concentrated under reduced pressure. During the concentration process, 4ml water for injection was added twice to remove the acetone to obtain the dexamethasone acetate / 2-hydroxypropyl-β-cyclodextrin inclusion aqueous solution. spare.

Embodiment 3

[0053] Dissolve 7g of 2-hydroxyethyl-β-cyclodextrin in 20ml of absolute ethanol at room temperature, add 0.5g of fluticasone propionate, stir to dissolve, stir for another 30 minutes, filter through a microporous membrane (220nm), and stir for 5 minutes , concentrated under reduced pressure, during the concentration process, 3.5ml of water for injection was added three times, and the ethanol was evaporated to obtain the fluticasone propionate / 2-hydroxyethyl-β-cyclodextrin inclusion complex aqueous solution, which was set aside.

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Abstract

The invention relates to a nasal medicine composition enclosing fluticasone propionate by cyclodextrin, which contains the fluticasone propionate and one or more auxiliary material medicine compositions acceptable in pharmacy. The nasal medicine composition is characterized that the fluticasone propionate contained in the medicine composition and used as an active component is enclosed by the cyclodextrin and / or derivatives thereof. The medicine composition is used for treating the allergic rhinitis of human or mammals.

Description

Technical field: [0001] The invention relates to a nasal drug composition containing corticosteroid inclusion compound. Background technique: [0002] Allergic rhinitis, also known as allergic rhinitis, is an allergic disease of the nasal mucosa and can cause various complications. Allergic rhinitis can occur at any age, both men and women, and it is easy to see in young people. The main reasons are: [0003] (1) Inhalational allergens: such as indoor and outdoor dust, dust mites, fungi, animal fur, feathers, cotton wadding, etc., often cause perennial attacks; plant pollen causes mostly seasonal attacks. [0004] (2) Food allergens: such as fish and shrimp, eggs, milk, flour, peanuts, soybeans, etc. Especially certain drugs, such as sulfonamides, quinine, antibiotics, etc. can cause disease. [0005] (3) Contact objects such as cosmetics, gasoline, paint, alcohol, etc. [0006] Others may be certain bacteria and their toxins, physical factors (such as changes in cold an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K31/56A61K47/40A61P11/02A61P37/08A61K47/69
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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