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Nasal composition and preparation method and application thereof

A composition and technology for nasal use, applied in the field of medicine, can solve problems such as aggravation of rhinitis symptoms, affecting treatment of patients, and acupuncture sensation

Active Publication Date: 2021-05-18
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when patients use this type of drug for a long time, the nostril mucosa is prone to burning and tingling sensations, and some patients discontinue the drug due to poor tolerance, which aggravates the symptoms of rhinitis and affects the treatment of patients

Method used

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  • Nasal composition and preparation method and application thereof
  • Nasal composition and preparation method and application thereof
  • Nasal composition and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Preparation of nasal composition

[0027] Add water for injection to prepare a total amount of 70wt% in the preparation tank, and start stirring. At a temperature of 70°C, add ethylparaben (preservative) into the preparation tank and stir to dissolve evenly, then add Xylomezoline hydrochloride, sodium chloride (osmotic pressure regulator), Potassium dihydrogen phosphate and disodium hydrogen phosphate (anhydrous, pH regulator), stirred and dissolved evenly, heated and boiled for 15 minutes, lowered to 60°C, added ethylmenthane carboxamide, and adjusted to the full amount to obtain the nasal A nasal composition of the following composition based on the total weight of the composition:

[0028]

[0029] (2) Quality inspection of nasal spray

[0030] The nasal composition prepared in Example 1 was used as a nasal spray, and the accelerated stability inspection was carried out according to the stability inspection principle of 9001 preparations of the "Chinese Phar...

Embodiment 2

[0043] (1) Preparation of nasal composition

[0044] The preparation method of the nasal composition of this example is the same as that of Example 1, except that the preservative is benzalkonium chloride, the osmotic pressure regulator is potassium chloride, and the pH regulator is borax. Its composition based on the total weight of the nasal composition is as follows:

[0045]

[0046] (2) Quality inspection of nasal spray

[0047] The nasal composition prepared in Example 2 was used as a nasal spray, and the accelerated stability investigation was carried out according to the stability inspection principle of the 9001 preparation of the "Chinese Pharmacopoeia" 2015 edition, and the test was carried out according to the test method described in Example 1. The results are shown in the table 2.

[0048] The nasal composition of table 2 embodiment 2 is as the inspection result of nasal spray

[0049]

[0050]

[0051] It can be seen from Table 2 that the nasal compo...

Embodiment 3

[0053] (1) Preparation of nasal composition

[0054] The preparation method of the nasal composition of this example is the same as that of Example 1, except that the preservative is methylparaben, and the pH regulator is boric acid. Its composition based on the total weight of the nasal composition is as follows:

[0055]

[0056]

[0057] (2) Quality inspection of nasal spray

[0058] The nasal composition prepared in Example 3 was used as a nasal spray, and the accelerated stability investigation was carried out according to the stability investigation principle of the 9001 preparation of the "Chinese Pharmacopoeia" 2015 edition, and the test was carried out according to the test method described in Example 1. The results are shown in the table 3.

[0059] The nasal composition of table 3 embodiment 3 is as the inspection result of nasal spray

[0060]

[0061]It can be seen from Table 3 that the nasal composition prepared in Example 3 of the present invention a...

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Abstract

The invention relates to a nasal composition. The nasal composition comprises celezoline hydrochloride and ethyl menthane formamide, wherein the mass ratio of celezoline hydrochloride to ethyl menthane formamide is (1-3): 1. The invention further relates to a preparation method of the nasal composition. The preparation method comprises the following steps that S1, a preservative is added into water for injection with the temperature higher than or equal to 70 DEG C, and a first mixed solution is obtained; S2, celezoline hydrochloride, an osmotic pressure regulator and a pH regulator are added into the first mixed solution, the mixture is heated to be boiled and then cooled to 50-60 DEG C, and a second mixed solution is obtained; and S3, ethyl menthane formamide and water for injection are added into the second mixed solution, and the nasal composition is obtained. In addition, the invention relates to application of the nasal composition in preparation of medicine for treating rhinitis and / or nasosinusitis. Nasal spray prepared from the nasal composition can relieve nasal mucosa burning sensation, pricking sensation and other uncomfortable symptoms caused when a patient uses celezoline hydrochloride nasal spray for a long time.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a nasal composition and its preparation method and application. Background technique [0002] Xyllozoline hydrochloride is an imidazoline derivative that directly stimulates blood vessels α 1 Receptors, which can cause vasoconstriction, clear blocked nostrils in a short time, effectively improve nostril breathing, and reduce congestion and edema caused by inflammation, so it is widely used in the treatment of chronic rhinitis and sinusitis. However, when patients use this type of drug for a long time, the nostril mucosa is prone to burning and tingling sensations, and some patients discontinue the drug due to poor tolerance, which aggravates the symptoms of rhinitis and affects the treatment of patients. [0003] Therefore, at present, there is an urgent need for a nasal composition and a preparation method and application thereof that relieve patients from using xylometazoline...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K31/167A61K31/4174A61K47/02A61P11/02
CPCA61K31/4174A61K31/167A61K9/0043A61K9/12A61K47/02A61P11/02A61K2300/00Y02A50/30
Inventor 付欢刘晨曦万利鹏延静梁琴尹传忠王超
Owner 湖北远大天天明制药有限公司
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