Non-steroidal anti-inflammatory drug orally disintegrating tablet and producing method thereof

Abstract

The invention discloses a non-steroidal anti-inflammatory drug orally disintegrating tablet and a producing method thereof, and relates to the non-steroidal anti-inflammatory drug orally disintegrating tablet and a prescription and a process utilizing the freeze-drying method to produce the non-steroidal anti-inflammatory drug orally disintegrating tablet. The non-steroidal anti-inflammatory drug orally disintegrating tablet is produced by main drug and pharmaceutic adjuvant, no water is needed while users take the tablet, and the tablet disintegrates rapidly after being delivered to the mouth, thereby the tablet is suitable for dysphagia patients such as the old, children and the like; the tablet is suitable for traveling under the condition that water is not easy to get; the non-steroidal anti-inflammatory drug orally disintegrating tablet has the advantages of convenience in taking, rapid absorption, small first pass effect, small irritation to digestive tract mucosa and the like, the tablet has a broad application prospect in the market, and the non-steroidal anti-inflammatory drug orally disintegrating tablet is capable of effectively reducing side effects of non-steroidal anti-inflammatory drugs. In addition, the invention further relates to the non-steroidal anti-inflammatory drug orally disintegrating tablet producing method.

Description

Technical field:

[0001] The invention relates to a non-steroidal anti-inflammatory drug orally disintegrating tablet and a preparation method thereof, in particular to a non-steroidal anti-inflammatory drug orally disintegrating tablet prepared by a freeze-drying method. Background technique:

[0002] Non-steroidal anti-inflammatory drugs (NSAIDs) are a class of anti-inflammatory drugs that do not contain a steroidal structure. At present, there are more than 100 kinds of thousands of brands on the market, such drugs include meloxicam, indomethacin, diclofenac sodium, lornoxicam, ketoprofen, etc. These drugs have anti-inflammatory, anti-rheumatic and pain-relieving properties. , antipyretic and anticoagulant effects, it is widely used clinically to relieve osteoarthritis, rheumatoid arthritis, various fevers and various pain symptoms. At present, NSAIDs are one of the most used drugs in the world, and about 30 million people in the world use them every day.

[0003] Non-st...

Examples

Embodiment 1

[0154] The preparation formula of the present invention is made up of following components:

[0155] Meloxicam 7.50g

[0156] Glycine 4.00g

[0157] Pullulan 7.00g

[0158] Xanthan gum 0.06g

[0159] Acesulfame K 0.06g

[0160] Sweet orange essence 0.10g

[0161] Purified water 182.28g

[0162] A total of 1000 pieces were made.

[0163] The specific preparation method is as follows: add meloxicam, glycine, pullulan, acesulfame potassium, and sweet orange essence to the fully dissolved xanthan gum solution, and mix to form a homogeneous solution; After inflating, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer to a freeze dryer, and freeze at a pressure of 0.01mbar to 10mbar and at a temperature of -30°C to 30°C Dry for 1-10 hours to obtain the orally disintegrating meloxicam tablet of the present invention; in the above method, after the pre-freezing step, before transferring to the freeze dryer, an ice crystal incubati...

Embodiment 2

[0165] The preparation formula of the present invention is made up of following components:

[0166] Meloxicam 7.50g

[0167] Mannitol 4.00g

[0168] Pullulan 6.00g

[0169] Xanthan gum 0.06g

[0170] Acesulfame K 0.06g

[0171] Sweet orange essence 0.10g

[0172] Purified water 182.28g

[0173] A total of 1000 pieces were made.

[0174] The specific preparation method is as follows: meloxicam, mannitol, pullulan, acesulfame potassium, and sweet orange essence are added to the fully dissolved xanthan gum solution, and mixed to form a homogeneous solution; the following preparation method With embodiment 1.

Embodiment 3

[0176] The preparation formula of the present invention is made up of following components:

[0177] Meloxicam 7.50g

[0178] Glycine 2.40g

[0179] Mannitol 2.00g

[0180] Pullulan 4.00g

[0181] Sodium alginate 2.40g

[0182] Konjac gum 0.36g

[0183] Aspartame 0.08g

[0184] Sweet orange essence 0.10g

[0185] Purified water 181.16g

[0186] A total of 1000 pieces were made.

[0187] The specific preparation method is as follows: meloxicam, glycine, mannitol, pullulan, sodium alginate, aspartame, and sweet orange essence are added to the fully dissolved konjac gum solution, and mixed to form Homogeneous solution; The following preparation method is the same as in Example 1.

Technical field:

[0001] The invention relates to a non-steroidal anti-inflammatory drug orally disintegrating tablet and a preparation method thereof, in particular to a non-steroidal anti-inflammatory drug orally disintegrating tablet prepared by a freeze-drying method. Background technique:

[0002] Non-steroidal anti-inflammatory drugs (NSAIDs) are a class of anti-inflammatory drugs that do not contain a steroidal structure. At present, there are more than 100 kinds of thousands of brands on the market, such drugs include meloxicam, indomethacin, diclofenac sodium, lornoxicam, ketoprofen, etc. These drugs have anti-inflammatory, anti-rheumatic and pain-relieving properties. , antipyretic and anticoagulant effects, it is widely used clinically to relieve osteoarthritis, rheumatoid arthritis, various fevers and various pain symptoms. At present, NSAIDs are one of the most used drugs in the world, and about 30 million people in the world use them every day.

[0003] Non-st...

Examples

Embodiment 1

[0154] The preparation formula of the present invention is made up of following components:

[0155] Meloxicam 7.50g

[0156] Glycine 4.00g

[0157] Pullulan 7.00g

[0158] Xanthan gum 0.06g

[0159] Acesulfame K 0.06g

[0160] Sweet orange essence 0.10g

[0161] Purified water 182.28g

[0162] A total of 1000 pieces were made.

[0163] The specific preparation method is as follows: add meloxicam, glycine, pullulan, acesulfame potassium, and sweet orange essence to the fully dissolved xanthan gum solution, and mix to form a homogeneous solution; After inflating, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer to a freeze dryer, and freeze at a pressure of 0.01mbar to 10mbar and at a temperature of -30°C to 30°C Dry for 1-10 hours to obtain the orally disintegrating meloxicam tablet of the present invention; in the above method, after the pre-freezing step, before transferring to the freeze dryer, an ice crystal incubati...

Embodiment 2

[0165] The preparation formula of the present invention is made up of following components:

[0166] Meloxicam 7.50g

[0167] Mannitol 4.00g

[0168] Pullulan 6.00g

[0169] Xanthan gum 0.06g

[0170] Acesulfame K 0.06g

[0171] Sweet orange essence 0.10g

[0172] Purified water 182.28g

[0173] A total of 1000 pieces were made.

[0174] The specific preparation method is as follows: meloxicam, mannitol, pullulan, acesulfame potassium, and sweet orange essence are added to the fully dissolved xanthan gum solution, and mixed to form a homogeneous solution; the following preparation method With embodiment 1.

Embodiment 3

[0176] The preparation formula of the present invention is made up of following components:

[0177] Meloxicam 7.50g

[0178] Glycine 2.40g

[0179] Mannitol 2.00g

[0180] Pullulan 4.00g

[0181] Sodium alginate 2.40g

[0182] Konjac gum 0.36g

[0183] Aspartame 0.08g

[0184] Sweet orange essence 0.10g

[0185] Purified water 181.16g

[0186] A total of 1000 pieces were made.

[0187] The specific preparation method is as follows: meloxicam, glycine, mannitol, pullulan, sodium alginate, aspartame, and sweet orange essence are added to the fully dissolved konjac gum solution, and mixed to form Homogeneous solution; The following preparation method is the same as in Example 1.

Images