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Budesonide nasal spray and preparation method thereof

A nasal spray and surfactant technology, applied in the field of pharmaceutical preparations, can solve problems such as inability to detect spray characteristics, achieve good spray effect, simple preparation method, and good storage stability

Pending Publication Date: 2022-04-15
湖南醇健制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the patent CN112516087A, a nasal cavity model spray test was carried out to determine the distribution of nasal spray in the nasal cavity, but this method requires the sample to stand for 1 hour after spraying, and cannot detect the spray characteristics in the dynamic process, and this method is subjective. sex

Method used

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  • Budesonide nasal spray and preparation method thereof
  • Budesonide nasal spray and preparation method thereof
  • Budesonide nasal spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Preparation of Bugnadi Nasal Spray

[0050] This embodiment provides a method of preparation of a Budnad nasal spray, and its raw material formulation is shown in Table 1:

[0051] Table 1

[0052] name Prescription composition (g) Budesonide 0.64 Avicel 12.5 Waterless glucose 47.5 Polyshanate 80 0.16 Disodium 0.01 Potassium sorbate 1.20 purified water 937.99, with other components to 1000g

[0053] The preparation of micronized Bud Nida: Using the air current pulverizer to smash the Band Nidal to the particle size below 10 μm or less, to get a micronized Budnad;

[0054] Preparation of A liquid: 47.5 g of water-free glucose, 1.2 g of sorbate, 0.01 g of sorbate, dissolved, spare;

[0055] Preparation of B liquid: Take 50 ml of purified water, add 0.16 g of polysorbate 80, completely dissolve, add 0.64 g of micronized Budnad, stirred and dispersed.

[0056] Preparation of C liquid: Take 200 ml of purified water, add 1...

Embodiment 2

[0058] Example 2 Preparation of Bugnadi Nasal Spray

[0059] This example provides a method of preparation of a Budnad nasal spray, and its raw material formulation is shown in Table 2:

[0060] Table 2

[0061] name Prescription composition (g) Budesonide 0.64 Avicel 12.5 Waterless glucose 47.5 Polyshanate 80 0.16 Disodium 0.01 Potassium sorbate 1.20 purified water 937.99, with other components to 1000g

[0062] The preparation of micronized Bud Nida: Using the air current pulverizer to smash the Band Nidal to the particle size below 10 μm or less, to get a micronized Budnad;

[0063] Preparation of A liquid: 47.5 g of water-free glucose, 1.2 g of sorbate, 0.01 g of sorbate, dissolved, spare;

[0064] Preparation of B liquid: Take 50 ml of purified water, add 0.16 g of polysorbate 80, completely dissolve, add 0.64 g of micronized Budnad, stirred and dispersed.

[0065] Preparation of the C liquid: Take 200 ml of purified water, ad...

Embodiment 3

[0067] Example 3 Preparation of Budnad Nasal Spray

[0068] This embodiment provides a method of preparation of a Budnad nasal spray, and its raw material formulation is shown in Table 3:

[0069] table 3

[0070] name Prescription composition (g) Budesonide 1.28 Avicel 12.5 Waterless glucose 47.5 Polyshanate 80 0.16 Disodium 0.01 Potassium sorbate 1.20 purified water 937.35, with other components to 1000g

[0071] The preparation of micronized Bud Nida: Using the air current pulverizer to smash the Band Nidal to the particle size below 10 μm or less, to get a micronized Budnad;

[0072] Preparation of A liquid: 47.5 g of water-free glucose, 1.20g sorbate, 0.01 g of sorbate, 0.01 g and sodium, 0.01 g of sodium water, 0.01 g and sodium, 0.01 g.

[0073] Preparation of B liquid: Take 50 mL of purified water, add 0.16 g of polysorberry 80, completely dissolved, add 1.28 g of micronized Budnad, stirred and dispersed;

[0074] Preparatio...

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Abstract

The invention provides budesonide nasal spray and a preparation method thereof. The preparation method of the budesonide nasal spray comprises the following steps: S1, dissolving auxiliary materials in water to obtain an auxiliary material solution; s2, a compound Avicel of microcrystalline cellulose and sodium carboxymethyl cellulose is dispersed in water and subjected to first shearing, an Avicel suspension is obtained, the rotating speed of first shearing ranges from 4000 rpm to 9000 rpm, and the shearing time ranges from 10 min to 30 min; s3, dissolving a surfactant in water, adding the micronized budesonide, and then dispersing, so as to obtain a budesonide suspension I; and S4, sequentially adding the auxiliary material solution and the budesonide suspension I into the Avicel suspension, adding water to fix the weight to 100%, and shearing for the second time to obtain a budesonide suspension II, thereby obtaining the budesonide nasal spray.

Description

Technical field [0001] The present invention belongs to the field of pharmaceutical preparations, and in particular to the Bud Narad nasal spray and the preparation method thereof. Background technique [0002] Budesonide Nasal Spray is a first-line drug and preferred therapy for treating all-year ache, with powerful anti-inflammatory effects and anti-edema, which can effectively improve the drainage of airway ventilation and sinus. Clinically mainly for children and adults in 6 years old to treat allergic rhinitis and nasal polyps. [0003] At present, the Pakistani-nasal spray original developer prescription has been disclosed by Patent CN1168450C, which is made of micronized Budnad, anhydrous glucose, microcrystalline cellulose and carboxymethylcellulose (Avicel), polysorbate 80, sodium sodium sour, potassium sorbate, hydrochloric acid and purified water, but the preparation method of this patent did not disclose the fabric nasal spray. [0004] The composition of the Budney's...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K47/38A61K31/58A61P11/02A61P37/08
Inventor 李龙陈国普许诗豪吴四清
Owner 湖南醇健制药科技有限公司
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