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Oxymetazoline hydrochloride nasal spray and preparation method thereof

A technology of oxymetazoline hydrochloride and nasal spray, which is applied in the field of medicine, can solve the problems of lack of high stability and low irritation of nasal mucosa, and achieve the effect of low irritation of nasal mucosa, small side effects and improved stability

Active Publication Date: 2017-11-21
深圳大佛药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Still lack a kind of oxymetazoline hydrochloride nasal spray with high preparation stability and low nasal mucosal irritation in the prior art

Method used

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  • Oxymetazoline hydrochloride nasal spray and preparation method thereof
  • Oxymetazoline hydrochloride nasal spray and preparation method thereof
  • Oxymetazoline hydrochloride nasal spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of embodiment 1 bletilla striata polysaccharide zinc

[0037] (1) Take Bletilla striata, crush it to 40-60 mesh, add purified water 20 times its weight, treat it with microwave for 10 minutes under the condition of microwave power of 250W, and ultrasonically extract it under the condition of temperature of 80°C and ultrasonic frequency of 25kHz 2 times, 15 min each time, filter, combine the filtrate, concentrate the filtrate under reduced pressure to 1 / 3 of the volume of the original filtrate, add 3 times the volume of ethanol with a volume fraction of 90%, stir and mix, and stand at 4°C for 10 h , centrifuged to take the precipitate, and dried under reduced pressure to obtain the crude polysaccharide of Bletilla striata;

[0038] (2) adding purified water to the crude polysaccharide of Bletilla striata described in step (1) to form a 3% crude polysaccharide solution, adding papain at a weight ratio of 5 mg / g to the crude polysaccharide of Bletilla stria...

Embodiment 2～4、 comparative example 1

[0041] Embodiment 2~4, the preparation of comparative example 1~3 oxymetazoline hydrochloride nasal spray

[0042] formula:

[0043]

[0044] Preparation:

[0045] S1: Take oxymetazoline hydrochloride, Bletilla striata polysaccharide zinc, povidone K30, and osmotic pressure regulator, add appropriate amount of purified water to completely dissolve, add buffer, adjust pH, and obtain a mixed solution;

[0046] S2: Add purified water to adjust the volume of the mixed liquid described in step S1 to 10000 mL, filter and sterilize with a 0.22 μm filter membrane, subpackage, fill, and pack to obtain the product.

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Abstract

The invention belongs to the technical field of medicines, and provides an oxymetazoline hydrochloride nasal spray and a preparation method thereof. The nasal spray comprises the following components by weight: 2.5-5g of oxymetazoline hydrochloride, 50-100g of blettila striata polysaccharide zinc, 50-80g of povidone K30, 15-400g of an osmotic pressure regulating agent, a proper amount of a buffer agent, and the balance of purified water till 10,000 mL. The pH value of the nasal spray provided by the invention is 5.5-6.5. Due to mutual action of the components of the oxymetazoline hydrochloride nasal spray provided by the invention, the stability of medicinal active component, namely the oxymetazoline hydrochloride, but also the stability a medicinal preparation are improved, and meanwhile the nasal mucosa irritation of the preparation is alleviated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an oxymetazoline hydrochloride nasal spray and a preparation method thereof. Background technique [0002] Oxymetazoline hydrochloride is an imidazole derivative and an α-adrenergic receptor agonist, which can directly stimulate blood vessel α 2 receptors to cause vasoconstriction, thereby reducing congestion and edema caused by inflammation. Oxymetazoline hydrochloride is highly selective for constricting nasal mucosal blood vessels, and can significantly inhibit the release of histamine. Because it can be used to treat nasal cavity inflammatory diseases, it is mainly used in clinical formulations such as nasal drops and sprays for acute and chronic rhinitis, Treatment of sinusitis and allergic rhinitis. [0003] The drug is absorbed through the nasal mucosa in the nasal cavity and exerts systemic or local therapeutic effects. It is called a nasal drug delivery sy...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K47/36A61K47/32A61K31/4174A61P11/02A61P37/08
CPCA61K9/0043A61K9/12A61K31/4174A61K47/32A61K47/36
Inventor 杨瑞雄肖仰
Owner 深圳大佛药业股份有限公司
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