Dexamethasone acetate oral tablet and preparation method thereof

Abstract

The invention provides a dexamethasone acetate oral tablet, which comprises a drug-containing adhesive layer and a water-insoluble protective layer; wherein a plasticizer in the water-insoluble protective layer adopts triethyl citrate. The invention also provides the preparation method of the dexamethasone acetate oral tablet, which comprises the following steps: 1) dexamethasone acetate is dissolved after added with absolute ethyl alcohol and then added and mixed with dextrin and part of carbomer for granulation, and drug-loading particles are obtained after drying and rounding; 2) the rest of carbomer is drily pressed for granulation, so as to obtain carbomer particles; 3) the drug-loading particles obtained from the step (1) and the carbomer particles obtained in the step (2) are mixedwith magnesium stearate for being pressed into tablets; and 4) spray coating liquid containing polyacrylic resin II, the triethyl citrate, titanium dioxide and a coloring matter is sprayed on the surfaces of the tablets. The dexamethasone acetate oral tablet prepared by the invention is good in uniformity among different batches and low in fragility, thereby improving the stability of the tablet quality.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dexamethasone acetate oral patch and a preparation method thereof. Background technique

[0002] Oral patch refers to a tablet that sticks to the oral cavity and acts locally or systemically after being absorbed by the oral mucosa. The common oral patch is mostly a double-layer structure, which is an adhesive layer containing drugs and a waterproof protective layer. Because it can maintain a continuous effective concentration of the drug in the local area, the oral patch is especially suitable for local oral diseases such as oral ulcers and cold sores.

[0003] Dexamethasone acetate is a glucocorticoid with anti-inflammatory and anti-allergic effects. The dexamethasone acetate oral patch can maintain the local drug concentration of the ulcer with a relatively small total dose, and reduce the side effects and adverse reactions caused by human body absorpt...

Examples

Embodiment 1

[0069] Embodiment 1: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0070] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 35mg, and each tablet contains 0.1mg of dexamethasone acetate) are prescribed as follows:

[0071]

[0072] Prepared by:

[0073] 1) Preparation of drug-loaded particles

[0074] a. Dissolution of raw materials: add 90g of dexamethasone acetate to 2500ml of absolute ethanol, put it in a water bath at 50-60°C with constant temperature and stir to dissolve, take it out after complete dissolution, let it cool to room temperature, and obtain the solution of dexamethasone acetate in absolute ethanol, which is ready for use .

[0075] B, granulation: dextrin 20kg, carbomer 0.57kg (5%) put in the high-speed mixer, add 75-80% (v / v) ethanol aqueous solution 3500ml and stir, add the described dexamethasone acetate that step a obtains Anhydrous ethanol solution, mix evenly, dis...

Embodiment 2

[0086] Embodiment 2: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0087] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 38mg, and each tablet contains 02mg of dexamethasone acetate) are prescribed as follows:

[0088]

[0089] Prepared by:

[0090] 1) Preparation of drug-loaded particles

[0091] a. Dissolution of raw material medicine: add 180g dexamethasone acetate to 4000ml absolute ethanol, put it in a water bath at 50-60°C with constant temperature and stir to dissolve, take it out after complete dissolution, let it cool to room temperature, and obtain dexamethasone acetate absolute ethanol solution, set aside .

[0092] B, granulation: dextrin 33kg, carbomer 0.225kg (5%) put in the high-speed mixer, add 75-80% ethanol aqueous solution 2500ml and stir, add the described dexamethasone acetate dehydrated alcohol solution that step a obtains, Mix evenly, discharge according to the c...

Embodiment 3

[0103] Embodiment 3: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0104] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 50 mg, each tablet contains 0.3 mg of dexamethasone acetate) are prescribed as follows:

[0105]

[0106] Prepared by:

[0107] 1) Preparation of drug-loaded particles

[0108] a, raw material drug dissolution: add 280.8g dexamethasone acetate to 4500ml dehydrated ethanol, put in 50-60 ℃ water bath constant temperature and stir to dissolve, take out after completely dissolving, let cool to room temperature, obtain dexamethasone acetate dehydrated alcohol solution, spare.

[0109] B, granulation: dextrin 33kg, carbomer 0.57kg (5%) put in the high-speed mixer, add 75-80% (v / v) ethanol aqueous solution 3500ml to stir, add the described dexamethasone acetate that step a obtains Anhydrous ethanol solution, mix evenly, discharge depending on the condition of the soft mater...

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dexamethasone acetate oral patch and a preparation method thereof. Background technique

[0002] Oral patch refers to a tablet that sticks to the oral cavity and acts locally or systemically after being absorbed by the oral mucosa. The common oral patch is mostly a double-layer structure, which is an adhesive layer containing drugs and a waterproof protective layer. Because it can maintain a continuous effective concentration of the drug in the local area, the oral patch is especially suitable for local oral diseases such as oral ulcers and cold sores.

[0003] Dexamethasone acetate is a glucocorticoid with anti-inflammatory and anti-allergic effects. The dexamethasone acetate oral patch can maintain the local drug concentration of the ulcer with a relatively small total dose, and reduce the side effects and adverse reactions caused by human body absorpt...

Examples

Embodiment 1

[0069] Embodiment 1: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0070] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 35mg, and each tablet contains 0.1mg of dexamethasone acetate) are prescribed as follows:

[0071]

[0072] Prepared by:

[0073] 1) Preparation of drug-loaded particles

[0074] a. Dissolution of raw materials: add 90g of dexamethasone acetate to 2500ml of absolute ethanol, put it in a water bath at 50-60°C with constant temperature and stir to dissolve, take it out after complete dissolution, let it cool to room temperature, and obtain the solution of dexamethasone acetate in absolute ethanol, which is ready for use .

[0075] B, granulation: dextrin 20kg, carbomer 0.57kg (5%) put in the high-speed mixer, add 75-80% (v / v) ethanol aqueous solution 3500ml and stir, add the described dexamethasone acetate that step a obtains Anhydrous ethanol solution, mix evenly, dis...

Embodiment 2

[0086] Embodiment 2: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0087] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 38mg, and each tablet contains 02mg of dexamethasone acetate) are prescribed as follows:

[0088]

[0089] Prepared by:

[0090] 1) Preparation of drug-loaded particles

[0091] a. Dissolution of raw material medicine: add 180g dexamethasone acetate to 4000ml absolute ethanol, put it in a water bath at 50-60°C with constant temperature and stir to dissolve, take it out after complete dissolution, let it cool to room temperature, and obtain dexamethasone acetate absolute ethanol solution, set aside .

[0092] B, granulation: dextrin 33kg, carbomer 0.225kg (5%) put in the high-speed mixer, add 75-80% ethanol aqueous solution 2500ml and stir, add the described dexamethasone acetate dehydrated alcohol solution that step a obtains, Mix evenly, discharge according to the c...

Embodiment 3

[0103] Embodiment 3: dexamethasone acetate oral adhesive tablet (900,000 pieces) and preparation method thereof

[0104] 900,000 dexamethasone acetate oral adhesive tablets (specification: each tablet weighs 50 mg, each tablet contains 0.3 mg of dexamethasone acetate) are prescribed as follows:

[0105]

[0106] Prepared by:

[0107] 1) Preparation of drug-loaded particles

[0108] a, raw material drug dissolution: add 280.8g dexamethasone acetate to 4500ml dehydrated ethanol, put in 50-60 ℃ water bath constant temperature and stir to dissolve, take out after completely dissolving, let cool to room temperature, obtain dexamethasone acetate dehydrated alcohol solution, spare.

[0109] B, granulation: dextrin 33kg, carbomer 0.57kg (5%) put in the high-speed mixer, add 75-80% (v / v) ethanol aqueous solution 3500ml to stir, add the described dexamethasone acetate that step a obtains Anhydrous ethanol solution, mix evenly, discharge depending on the condition of the soft mater...

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