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Nasal pharmaceutical composition adopting cyclodextrin to include methylprednisolone aceponate

A technology of methylprednisolone acetin and composition, which is applied in the field of nasal pharmaceutical composition, can solve the problems of poor stability, affecting compliance, and undisclosed issues, and achieve the effects 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

Chinese patent application CN200710058340.X discloses a pharmaceutical composition containing methylprednisolone acetate for the treatment of allergic rhinitis. However, we have found that the pharmaceutical composition disclosed in this application is easy to get stuck in the throat when it is used. Produce foreign body and odor sensations, especially for children, affecting compliance in use
[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 pharmaceutical composition adopting cyclodextrin to include methylprednisolone aceponate
  • Nasal pharmaceutical composition adopting cyclodextrin to include methylprednisolone aceponate
  • Nasal pharmaceutical composition adopting cyclodextrin to include methylprednisolone aceponate

Examples

Experimental program
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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 methylprednisolone acetate, 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 methylprednisolone acetone / 3-hydroxypropyl β-cyclodextrin inclusion complex, which is set aside.

Embodiment 2

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

Embodiment 3

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

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Abstract

The invention relates to a nasal pharmaceutical composition adopting cyclodextrin to include methylprednisolone aceponate. The nasal pharmaceutical composition comprises methylprednisolone aceponate and one or more pharmaceutically acceptable adjuvant materials, and is characterized in that the methylprednisolone aceponate as an active ingredient in the pharmaceutical composition is included by the cyclodextrin and / or a derivative thereof. The pharmaceutical composition is used for treating allergic rhinitis of humans or mammals.

Description

Technical field: [0001] The invention relates to a nasal medicine composition containing corticosteroid. 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 and heat, tempera...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61K31/573A61K47/40A61P11/02A61P37/08A61K47/61
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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