Lappaconitine hydrobromide orally disintegrating tablets and preparation method thereof

Abstract

The invention discloses lappaconitine hydrobromide orally disintegrating tablets. The lappaconitine hydrobromide orally disintegrating tablets consist of the following ingredients in part by weight: 5 to 10 parts of lappaconitine hydrobromide, 3 to 10 parts of disintegrating agent, 30 to 100 parts of filling agent, 2 to 10 parts of flavoring agent, 0 to 60 parts of adhesive, 0 to 3 parts of lubricating agent and 0 to 50 parts of stomach-soluble acrylic resin. The lappaconitine hydrobromide orally disintegrating tablets which do not comprise the stomach-soluble acrylic resin in the formula canbe prepared by a wet pelleting tabletting method, a dry pelleting tabletting method or a direct tabletting method; and the lappaconitine hydrobromide orally disintegrating tablets which comprise the stomach-soluble acrylic resin in the formula are prepared by the steps of preparing the lappaconitine hydrobromide into smell concealing particles by using the stomach-soluble acrylic resin and then preparing the orally disintegrating tablets by the wet pelleting tabletting method, the dry pelleting tabletting method or the direct tabletting method. The lappaconitine hydrobromide orally disintegrating tablets have good mouthfeel, do not influence medicament release, have a simple preparation process, high yield and low cost, and are suitable for industrialized production.

Description

technical field

[0001] The invention belongs to the field of pharmacy, and relates to an orally disintegrating tablet, in particular to an orally disintegrating tablet of homogenine hydrobromide, and also relates to a preparation method of the orally disintegrating tablet. Background technique

[0002] Aconitum sinomonatum is a diterpene alkaloid extracted from the root of the ranunculaceae plant Aconitum sinomonatum. Its hydrobromide is commonly used in clinical practice. It is the first non-addictive analgesic in my country. Moderate analgesics recommended in the Ministry of Health's "Guiding Principles of Three-Step Pain Relief Therapy for Cancer Patients", suitable for gastrointestinal ulcers, gastritis, hepatitis, cholecystitis, rheumatism, sciatica, toothache, postoperative pain, cancer pain, etc. . Its analgesic effect is equivalent to pethidine, although the onset time is slower, but the drug effect lasts longer. In addition, homogenate hydrobromide also has local an...

Examples

Embodiment 1

[0031] Embodiment 1. Preparation (wet granulation and tablet compression method) and inspection of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription

[0032]Prescription: 5g of homogenate hydrobromide, 4.8g of cross-linked polyvinylpyrrolidone, 15g of microcrystalline cellulose, 30g of mannitol, 5g of aspartame, 30g of water, 0.5g of magnesium stearate, made into 1000 tablets in total .

[0033] Preparation process: mix homogenine hydrobromide, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, mannitol and aspartame, pass through a 100-mesh sieve twice, add water to make a soft material, and granulate with a 20-mesh sieve. Dry at 60°C until the water content is less than or equal to 3%, then add magnesium stearate, mix well, and press into tablets to control the hardness of the tablet to 3Kg to obtain the orally disintegrating tablet of urine hydrobromide.

[0034] According to the above ...

Embodiment 2

[0063] Embodiment 2. Preparation of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription (dry granulation and tablet compression method)

[0064] Prescription: 10g of homogenate hydrobromide, 5g of cross-linked polyvinylpyrrolidone, 40g of modified starch-1500, 30g of sorbitol, 2g of glycyrrhizin, 5g of thaumatin, 1g of mint essence, 1g of magnesium stearate, talc Powder 1g, made into 1000 tablets in total.

[0065] Preparation process: mix homogenate hydrobromide, cross-linked polyvinylpyrrolidone, modified starch-1500, sorbitol, glycyrrhizin, thaumatin and mint essence, pass through a 120-mesh sieve for 3 times, and dry granulate , pulverized, crossed 20 mesh sieves, then added magnesium stearate and talcum powder, mixed evenly, compressed into tablets, and the tablet hardness was controlled to be 5Kg, to obtain the orally disintegrating tablets of uricine hydrobromide.

[0066] Similar to the orally d...

Embodiment 3

[0067] Embodiment 3. Preparation of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription (direct compression method)

[0068] Prescription: 5g of urine hydrobromide, 3g of croscarmellose sodium, 15g of microcrystalline cellulose, 15g of sorbitol, 2g of glycyrrhizin, 2g of aspartame, 1g of citric acid, 1g of orange essence, Magnesium stearate 0.5g, made into 1000 tablets in total.

[0069] Preparation process: mix homogenate hydrobromide, croscarmellose sodium, microcrystalline cellulose, sorbitol, glycyrrhizin, aspartame and chocolate essence, pass through 80-mesh sieve for 3 times, Then add magnesium stearate, mix evenly, and press into tablets to control the hardness of the tablet to 4Kg to obtain the orally disintegrating tablet of uricine hydrobromide.

[0070] Similar to the orally disintegrating tablet obtained in Example 1, the orally disintegrating tablet of homogenate hydrobromide prepared in th...

technical field

[0001] The invention belongs to the field of pharmacy, and relates to an orally disintegrating tablet, in particular to an orally disintegrating tablet of homogenine hydrobromide, and also relates to a preparation method of the orally disintegrating tablet. Background technique

[0002] Aconitum sinomonatum is a diterpene alkaloid extracted from the root of the ranunculaceae plant Aconitum sinomonatum. Its hydrobromide is commonly used in clinical practice. It is the first non-addictive analgesic in my country. Moderate analgesics recommended in the Ministry of Health's "Guiding Principles of Three-Step Pain Relief Therapy for Cancer Patients", suitable for gastrointestinal ulcers, gastritis, hepatitis, cholecystitis, rheumatism, sciatica, toothache, postoperative pain, cancer pain, etc. . Its analgesic effect is equivalent to pethidine, although the onset time is slower, but the drug effect lasts longer. In addition, homogenate hydrobromide also has local an...

Examples

Embodiment 1

[0031] Embodiment 1. Preparation (wet granulation and tablet compression method) and inspection of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription

[0032]Prescription: 5g of homogenate hydrobromide, 4.8g of cross-linked polyvinylpyrrolidone, 15g of microcrystalline cellulose, 30g of mannitol, 5g of aspartame, 30g of water, 0.5g of magnesium stearate, made into 1000 tablets in total .

[0033] Preparation process: mix homogenine hydrobromide, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, mannitol and aspartame, pass through a 100-mesh sieve twice, add water to make a soft material, and granulate with a 20-mesh sieve. Dry at 60°C until the water content is less than or equal to 3%, then add magnesium stearate, mix well, and press into tablets to control the hardness of the tablet to 3Kg to obtain the orally disintegrating tablet of urine hydrobromide.

[0034] According to the above ...

Embodiment 2

[0063] Embodiment 2. Preparation of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription (dry granulation and tablet compression method)

[0064] Prescription: 10g of homogenate hydrobromide, 5g of cross-linked polyvinylpyrrolidone, 40g of modified starch-1500, 30g of sorbitol, 2g of glycyrrhizin, 5g of thaumatin, 1g of mint essence, 1g of magnesium stearate, talc Powder 1g, made into 1000 tablets in total.

[0065] Preparation process: mix homogenate hydrobromide, cross-linked polyvinylpyrrolidone, modified starch-1500, sorbitol, glycyrrhizin, thaumatin and mint essence, pass through a 120-mesh sieve for 3 times, and dry granulate , pulverized, crossed 20 mesh sieves, then added magnesium stearate and talcum powder, mixed evenly, compressed into tablets, and the tablet hardness was controlled to be 5Kg, to obtain the orally disintegrating tablets of uricine hydrobromide.

[0066] Similar to the orally d...

Embodiment 3

[0067] Embodiment 3. Preparation of orally disintegrating tablets of homogenate hydrobromide without gastric-soluble acrylic resin component in the prescription (direct compression method)

[0068] Prescription: 5g of urine hydrobromide, 3g of croscarmellose sodium, 15g of microcrystalline cellulose, 15g of sorbitol, 2g of glycyrrhizin, 2g of aspartame, 1g of citric acid, 1g of orange essence, Magnesium stearate 0.5g, made into 1000 tablets in total.

[0069] Preparation process: mix homogenate hydrobromide, croscarmellose sodium, microcrystalline cellulose, sorbitol, glycyrrhizin, aspartame and chocolate essence, pass through 80-mesh sieve for 3 times, Then add magnesium stearate, mix evenly, and press into tablets to control the hardness of the tablet to 4Kg to obtain the orally disintegrating tablet of uricine hydrobromide.

[0070] Similar to the orally disintegrating tablet obtained in Example 1, the orally disintegrating tablet of homogenate hydrobromide prepared in th...

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