Calcium polycarbophil tablet easy to rapidly and completely disintegrate

A technology of polycarbophil calcium tablets and polycarbophil calcium, which is applied in the field of pharmaceutical preparations, can solve problems such as complex processes and unfavorable labor protection, and achieve the effects of simple preparation process, accelerated drug dissolution, and good stability

Pending Publication Date: 2022-07-29
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Organic solvents such as ethanol are used in this process, which is not conducive to labor protection and the process is complicated

Method used

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  • Calcium polycarbophil tablet easy to rapidly and completely disintegrate
  • Calcium polycarbophil tablet easy to rapidly and completely disintegrate
  • Calcium polycarbophil tablet easy to rapidly and completely disintegrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1) Prescription

[0035]

[0036] 2) Preparation process

[0037] (a) Put calcium polycarbophil and mannitol into the lifting hopper mixer in turn according to the recipe quantity, and mix at 10rpm / min for 15min.

[0038] (b) Keep the air supply pressure of the jet mill at 0.6-0.8Mpa, feed the mixed powder of polycarbophil calcium and mannitol to the pulverizer, carry out jet milling, and co-process the polycarbophil calcium and mannitol after jet milling The particle size of the material is controlled in the range of 50-100 μm.

[0039] (c) The polycarbophil calcium and mannitol co-processing product of recipe quantity, microcrystalline cellulose, crospovidone, sodium bicarbonate and colloidal silicon dioxide are successively put into the lifting hopper mixer, and mixed for 30min.

[0040] (d) granulating the above-mentioned mixed powder through a conical granulator, the speed of the granulator is 1000 rpm, and the aperture of the screen mesh is 2 mm.

[0041] (e...

Embodiment 2

[0044] 1) Prescription

[0045]

[0046] 2) Preparation process

[0047] (a) Put calcium polycarbophil and mannitol into the lifting hopper mixer in turn according to the recipe quantity, and mix at 10rpm / min for 15min.

[0048] (b) Keep the air supply pressure of the jet mill at 0.6-0.8Mpa, feed the mixed powder of polycarbophil calcium and mannitol to the pulverizer, carry out jet milling, and co-process the polycarbophil calcium and mannitol after jet milling The particle size of the material is controlled in the range of 50-100 μm.

[0049] (c) The polycarbophil calcium and mannitol co-treated product of recipe quantity, silicified microcrystalline cellulose, crospovidone, calcium carbonate and colloidal silicon dioxide are successively put into the lifting hopper mixer, and mixed for 30min.

[0050] (d) granulating the above-mentioned mixed powder through a conical granulator, the speed of the granulator is 1000 rpm, and the aperture of the screen mesh is 2 mm.

[0...

Embodiment 3

[0054] 1) Prescription

[0055]

[0056] 2) Preparation process

[0057] (a) Put calcium polycarbophil and mannitol into the lifting hopper mixer in turn according to the recipe quantity, and mix at 10rpm / min for 15min.

[0058] (b) Keep the air supply pressure of the jet mill at 0.6-0.8Mpa, feed the mixed powder of polycarbophil calcium and mannitol to the pulverizer, carry out jet milling, and co-process the polycarbophil calcium and mannitol after jet milling The particle size of the material is controlled in the range of 50-100 μm.

[0059] (c) the polycarbophil calcium of recipe quantity and mannitol co-treated product, cellulose lactose, croscarmellose sodium, sodium carbonate and colloidal silicon dioxide are dropped into the lifting hopper mixer successively, mixed for 30min .

[0060] (d) granulating the above-mentioned mixed powder through a conical granulator, the speed of the granulator is 1000 rpm, and the aperture of the screen mesh is 2 mm.

[0061] (e) t...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and discloses a calcium polycarbophil tablet easy to rapidly and completely disintegrate. The tablet is prepared by directly tabletting an air jet pulverization co-treatment substance of mixed powder of polycarbophil calcium and mannitol, a filling agent, a disintegrating agent / gas production disintegrating agent, a flow aid and a lubricating agent. According to the invention, the particle size of calcium polycarbophil is reduced, the tablet is completely disintegrated by virtue of combined application of a common disintegrating agent and a gas-producing disintegrating agent, excellent water solubility and non-hygroscopicity of mannitol and a direct tabletting process, calcium ions in a 0.1 mol / L HCl solution are fully removed, and the disintegration effect under an accelerated condition is obviously superior to that of a commercially available preparation. Meanwhile, the preparation is simple in process, free of solvent addition, good in stability and process reproducibility and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a calcium polycarbophil tablet that is easy to disintegrate rapidly and completely and a preparation method thereof. Background technique [0002] Irritable bowel syndrome (IBS) is a chronic functional disease of unknown etiology, characterized by abdominal pain or discomfort and changes in bowel habits, and is a frequently-occurring disease worldwide. Calcium polycarbophil was first developed by Abbott in the United States and has been widely used in Europe, America and Japan for the relief of IBS and constipation symptoms of various causes. In September 2011, the State Food and Drug Administration approved the domestic preparation of polycarbophil calcium tablets (trade name Libofil) in China. Polycarbophil calcium tablets are also included in the 2021 edition of the National Medical Insurance List. [0003] The active ingredient of polycarboph...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/78A61K47/26A61P1/00A61P1/10
CPCA61K9/2095A61K9/2018A61K31/78A61P1/00A61P1/10
Inventor 李丹马晓华
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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