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Phloroglucine orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and phloroglucinol, which is applied in the fields of pill delivery, effective ingredients of hydroxyl compounds, antipyretics, etc., can solve the problem of high process conditions and equipment requirements, difficulty in ensuring the integrity of the appearance, inconvenient packaging, storage and Transportation and other issues, achieve the effect of simple process conditions and equipment requirements, maintain the integrity of the appearance, and improve bioavailability

Inactive Publication Date: 2011-08-17
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But both have shortcomings: the hardness of the finished product is relatively small, and the degree of brittleness is relatively high. Even after special packaging, it is difficult to ensure the integrity of its appearance during storage and transportation; Equipment requirements are relatively high
[0006] The current orally disintegrating tablet of phloroglucinol is prepared by freeze-drying tablet method, which has remarkable efficacy, but requires relatively high process conditions and equipment, special process, high development cost, high price, and low hardness , not convenient for packaging, storage and transportation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Weigh each component according to the table below, and mix evenly the phloroglucinol and the auxiliary materials except the binder and the lubricant according to the method of equal increment. Pass the resulting mixture through a 40 mesh screen twice and place the resulting material in a suitable container. A 5% (g / 100ml) PVP aqueous solution of the binder was added to the container to make a soft material. The soft material was extruded through a 20 mesh screen to produce wet granules. The wet granules were placed in a dry enamel tray, and put together into a forced air constant temperature drying oven, and dried at 50° C. for 2 hours. Weigh the weight of the dry granules, add a lubricant, mix well, and press into tablets with a tablet machine to obtain orally disintegrating tablets containing phloroglucinol.

[0044] The hardness of the tablet was measured with a hardness tester, and the particle size, disintegration time and dissolution rate of the prepared orally ...

Embodiment 2

[0055] The preparation method is the same as in Example 1, and the adhesive is prepared as a 10% (g / 100ml) aqueous solution for use. The components and measurement results of the phloroglucinol orally disintegrating tablet are shown below.

[0056] Features

[0057] Hardness (N)

Embodiment 3

[0059] The preparation method is the same as in Example 1, and the components and measurement results of the phloroglucinol orally disintegrating tablet are shown below.

[0060] Features

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PUM

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Abstract

The invention discloses a phloroglucinol orally disintegrating tablet and a preparation method thereof. The phloroglucinol orally disintegrating tablet is prepared by adopting a powder pelletization and compression method by a wet method and contains a therapeutically effective amount of phloroglucinol and a pharmaceutical excipient, and the excipient comprises a disintegrant; and according to the total weight of the tablet, the content of the phloroglucinol is between 15 and 30 percent, the content of the excipient is between 70 and 85 percent, and the content of the disintegrant is between 3 and 23 percent. The phloroglucinol orally disintegrating tablet has the advantages of higher hardness, simple preparation technology, and remarkable curative effect, is quickly disintegrated within 10 seconds at the soonest when contacting saliva in an oral cavity, and is convenient for patients to take.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a phloroglucinol orally disintegrating tablet and a preparation method thereof. Background technique [0002] Pain caused by smooth muscle spasm is one of the most common clinical emergencies, such as acute spastic pain caused by digestive system and biliary tract dysfunction; acute spastic urethral, ​​bladder, and renal colic; gynecological spastic pain, etc. A new type of myotropic non-atropine, non-opapaverine pure smooth muscle antispasmodic drug recently developed and clinically applied abroad: Phloroglucinol (Phloroglucinol, trade name: Spasfon), which can directly act on gastrointestinal smooth muscle of the tract and genitourinary tract, relieve smooth muscle spasm, and will not produce a series of anticholinergic side effects such as atropine and papaverine smooth muscle antispasmodics, and will not cause symptoms such as hypotension, increased heart rate, and ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/05A61P29/00
Inventor 陆伟根刘小浩吴宝剑卢文芸
Owner SHANGHAI INST OF PHARMA IND CO LTD
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