Dihydroergotamine mesilate nasal spray

A technology of ergotamine nasal and methanesulfonic acid, which is applied in the direction of nebulizer for treatment, packaged food, packaging, etc., can solve the problems of expensive production line, incompatibility of production line, increase waste of medicinal liquid, etc. Equipment requirements, mature processing technology, and cost-saving effects

Inactive Publication Date: 2013-09-11
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages: 1. Inconvenient administration: patients can only go to the hospital for treatment when they have headaches, and it is impossible to inject them by themselves
2. Migraine is a chronic disease, and the route of injection is not suitable for long-term administration
3. There are many adverse reactions, mainly severe and fatal cardiac adverse reactions (coronary artery spasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, ventricular fibrillation, cardiac valve fibrosis, etc.)
[0005] The dihydroergotamine mesylate nasal spray produced by Valeant is filled with liquid medicine in a spray bottle with a volume of about 3.5ml, which is compatible with the conventional spray head, conventional spray bottle and conventional spray bottle of the existing widely used common s...

Method used

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  • Dihydroergotamine mesilate nasal spray
  • Dihydroergotamine mesilate nasal spray
  • Dihydroergotamine mesilate nasal spray

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] 1. Prescription (based on 1000 bottles, 0.5mg / spray)

[0053]

[0054] Second, the preparation process:

[0055] 1. Dosing: Weigh the raw and auxiliary materials of the prescription amount into water of 95% of the prescription amount, stir to dissolve, add water to make up the volume, and get ready.

[0056] 2. Filling: Fill the dihydroergotamine mesylate aqueous solution prepared above into the attached figure 2 In the spray bottles shown, each bottle is filled with 1.0ml, filled with carbon dioxide while filling, and the spray head is tightened (the spray volume is 0.5mg / spray), that is, the final product is shown in the attached Figure 4 .

[0057] 3. Tests of effective spray times, spray uniformity and spray residual rate

[0058] The content of main ingredient per spray: same as comparative example

[0059] The preparation of reference substance solution: with comparative example

[0060] Residual main drug content in the bottle:

[0061] Take out all th...

Embodiment 2

[0073] 1. Prescription (based on 1000 bottles, 0.5mg / spray)

[0074]

[0075] Second, the preparation process:

[0076] 1. Dosing: Weigh the raw and auxiliary materials of the prescription amount into water of 95% of the prescription amount, stir to dissolve, add water to make up the volume, and get ready.

[0077] 2. Filling: Fill the dihydroergotamine mesylate aqueous solution prepared above into the attached image 3 In the spray bottles shown, each bottle is filled with 1ml, filled with carbon dioxide while filling, and the spray head is tightened (the spray volume is 0.5mg / spray), that is, the final product is shown in the attached Figure 5 .

[0078] 3. Tests of effective spray times, spray uniformity and spray residual rate

[0079] The content of main ingredient per spray: same as comparative example

[0080] The preparation of reference substance solution: with comparative example

[0081] Residual main drug content in the bottle:

[0082] Take out all the r...

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PUM

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Abstract

The invention provides a dihydroergotamine mesilate nasal spray. A used spraying device comprises a spray bottle and a spray head, and is characterized in that the spray bottle comprises a casing (1) and a liner (2) with 1.5 ml volume; the liner of the spray bottle is in a shape of a cylinder, the combination of a cylinder and a conoidcone, or the combination of a cylinder, a conoidcone and a cylinder with a smaller diameter; the casing of the spray bottle is provided with the same shape, size and interface part with a spray bottle of a 10 ml spraying agent device sold in the market presently; and the spray head adopts a spray head of the 10 ml spraying agent device sold in the market presently. The dihydroergotamine mesilate nasal spray provided by the invention has the advantages of few residues, high safety and multiple times of effective spraying, the production cost can be reduced, and the medicine waste is prevented.

Description

Technical field: [0001] The invention relates to a dihydroergotamine mesylate nasal spray, in particular to a dihydroergotamine mesylate nasal spray using a spray bottle with a volume of 1.5ml. Background technique: [0002] Dihydroergotamine mesylate is a semi-synthetic ergotamine, which mainly contracts the dilated extracranial arteries through direct contraction of smooth muscle, and may also activate 5-HT receptors on the arterial wall to make cerebral arteries The excessive expansion and pulsation of blood vessels return to normal, thereby reducing headaches. Clinically, it is mainly used for the treatment of migraine. [0003] Dihydroergotamine mesylate was first marketed abroad (1946) in the form of injection, the original manufacturer: Valeant (USA), trade name: D.H.E.45, specification: 1ml: 1mg. Advantages of the injection: rapid onset of action, 70-80% of patients' symptoms were significantly relieved 2 hours after administration. Shortcoming: 1, administration ...

Claims

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Application Information

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IPC IPC(8): A61M11/00A61J1/05
Inventor 姜庆伟衣伟锋唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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