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Isosorbide 5-mononitrate nasal drug delivery composition and preparing method thereof

A technology for isosorbide dinitrate and intranasal administration, which is applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problem that the patent or literature of isosorbide mononitrate nasal spray has not been retrieved, and achieves stable and controllable quality , Self-administration, good patient compliance

Active Publication Date: 2010-06-09
BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] No patents or literature on Isosorbide Mononitrate Nasal Spray have been found

Method used

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  • Isosorbide 5-mononitrate nasal drug delivery composition and preparing method thereof
  • Isosorbide 5-mononitrate nasal drug delivery composition and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1 isosorbide mononitrate spray

[0050] Ingredients Dosage

[0051] Isosorbide Mononitrate 10g

[0052] Dimethyl-β-cyclodextrin 2.5g

[0053] Sodium chloride 0.9g

[0054] Paraben ethyl ester 0.05g

[0055] Preparation method: Mix the above amounts of isosorbide mononitrate, dimethyl-β-cyclodextrin, sodium chloride, and ethylparaben thoroughly to dissolve them all in an appropriate amount of distilled water, and finally dilute to 100ml with distilled water. The resulting solution was dispensed into spray pumps, each spraying volume was 100 μl, containing 5 mg of isosorbide mononitrate.

Embodiment 2

[0056] Embodiment 2 isosorbide mononitrate spray

[0057] Ingredients Dosage

[0058] Isosorbide Mononitrate 10g

[0059] Propylene glycol 5g

[0060] Mannitol 0.5g

[0061] Chlorobutanol 0.02g

[0062] Preparation method: fully stir the above-mentioned amount of isosorbide mononitrate, propylene glycol, mannitol, and chlorobutanol to dissolve them all in an appropriate amount of distilled water, and finally use distilled water to set the volume to 100ml, and pack the obtained solution into a spray pump. Each spray volume is 100μl, containing 5mg of isosorbide mononitrate.

Embodiment 3

[0063] Embodiment 3 isosorbide mononitrate spray

[0064] Ingredients Dosage

[0065] Isosorbide Mononitrate 10g

[0066] Laurylazepine 3g

[0067] Sucrose 5g

[0068] Benzalkonium Bromide 0.02g

[0069] Preparation method: fully dissolve the above-mentioned amount of isosorbide mononitrate, laurylazepine, sucrose, and benzalkonium bromide in an appropriate amount of distilled water, and finally use distilled water to make up to 100ml. In the spray pump, each spray volume is 100l, containing 5mg of isosorbide mononitrate.

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Abstract

The invention discloses an isosorbide 5-mononitrate nasal drug delivery composition for treating coronary heart diseases and angina, and a preparing method thereof. The nasal drug delivery composition comprises isosorbide 5-mononitrat, a solvent and a preservative, and optionally comprises an absorption enhancer, an osmotic pressure regulator and other pharmaceutic adjuvants. The composition has simple preparing process and stable and controllable quality, and is suitable for industrial production. The preparation is quickly absorbed, takes effect in 3-5 minutes, achieves the maximum drug effect after 15 minutes, has high bioavailability, convenient use, and good compliance of patients, is especially suitable for delivering drugs to the middle and old patients, dysphagia patients and bedrid patients, is suitable for delivering drugs for patients with coronary heart diseases and angina in acute attach period at the first time, obtains valuable time for rescuing patient lives, and has significant clinical meaning on long-term continuous prevention and maintenance therapy.

Description

technical field [0001] The invention relates to an isosorbide mononitrate pharmaceutical preparation and a preparation method thereof, in particular to a nasal spray composition containing isosorbide mononitrate and a preparation method thereof. The preparation includes isosorbide mononitrate, absorption enhancer, osmotic pressure regulator, antiseptic, solvent or other pharmaceutical auxiliary materials. Background technique [0002] Isosorbide Mononitrate (Isosorbide Mononitrate) is the general name of 1,4:3,6-dianhydro-D-sorbitol-5 mononitrate, also known as 5-Isosorbide Mononitrate, its structure is: [0003] [0004] Molecular formula: C 6 h 9 NO 6 Molecular weight: 191.14 [0005] As the main bioactive metabolite of isosorbide dinitrate, isosorbide mononitrate is a commonly used drug for the treatment of coronary heart disease and angina pectoris. It was first developed by Boehringer Mannheim GmbH.H in Germany and launched in the market in 1981. Afte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/34A61K9/00A61P9/10
Inventor 高永良刘文王晋李劲彤
Owner BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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