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Acetylkitasamycin dispersible tablet and method of preparing the same

A technology of acetylkitasamycin and kitasamycin, which is applied in the field of acetylkitasamycin dispersible tablets and its preparation, to achieve the effects of convenient administration, fast disintegration speed and less side effects

Inactive Publication Date: 2008-08-27
徐建平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Method used

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Experimental program
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preparation example Construction

[0019] The preparation method of the dispersible tablet of the present invention is close to the preparation method of common tablets, and this preparation method is called wet granulation tabletting on tablet preparation. The details are as follows: first process and pulverize the drug and pharmaceutical excipients separately, so that the fineness is above 80 mesh, preferably 100 mesh or 120 mesh particle size grade. Mix acetylkitamycin with the filler, do not add or add part or all of it first Disintegrating agent, add wet binder to make soft material, make wet granules, dry, granulate, add another part or all of disintegrating agent, add lubricant, mix well, compress into tablets, and obtain acetylkitamycin Dispersible tablets. This preparation method is called wet granulation in tablet preparation.

[0020] During the preparation process, the disintegrant is made into granules together with the prescription powder, which is called the disintegrating agent internal additio...

example 1

[0024] Prescription: ingredient weight percentage content

[0025] Acetyl kitasamycin (calculated as kitasamycin) 20%

[0026] Lactose 15%

[0027] Pregelatinized Starch 20%

[0028] Microcrystalline Cellulose 35%

[0029] Low Substituted Hydroxypropyl Cellulose 7%

[0030] Aqueous solution of polyvinylpyrrolidone 2%

[0031] Magnesium Stearate 1%

[0032] Preparation method: first crush the above materials and pass through a 100-mesh sieve. Mix acetylkitamaycin, lactose, pregelatinized starch, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose thoroughly, and add an appropriate amount of polyvinylpyrrolidone aqueous solution to prepare It is made into a soft material, granulated with a 20-mesh sieve, dried, granulated with a 20-mesh sieve, mixed with magnesium stearate, and the weight of the tablet is controlled, and the tablet is pressed to obtain the Acetylkitamycin Dispersible Tablet.

example 2

[0034] Prescription: ingredient weight percentage content

[0035] Acetyl kitasamycin (calculated as kitasamycin) 35%

[0036] Lactose 15%

[0037] Sodium Starch Carboxymethyl 10%

[0038] Microcrystalline Cellulose 35%

[0039] Water (or ethanol aqueous solution) 2%

[0040] Sodium Lauryl Sulfate 3%

[0041] Preparation method: first crush the above-mentioned materials through a 100-mesh sieve, fully mix acetylkitasamycin, lactose, sodium carboxymethyl starch, and microcrystalline cellulose, add appropriate amount of water (or ethanol aqueous solution) to make a soft material, 40 After granulating with a mesh sieve, dry it, granulate with a 40 mesh sieve, add sodium lauryl sulfate, mix well, control the weight of the tablet, and press the tablet to obtain the Acetylkitamycin Dispersible Tablet.

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Abstract

The invention relates to a novel acetylkitasamycin dispersible tablet and a preparation method thereof. The acetylkitasamycin dispersible tablet contains 20-60% of acetylkitasamycin by weight and 80-40% of pharmaceutically-acceptable adjuvant by weight including at least one selected from disintegrating agent, filling agent, lubricating binder and lubricant, wherein acetylkitasamycin contains acetylkitasamycin A6, acetylkitasamycin A7, acetylkitasamycin A4, acetylkitasamycin A5, acetylkitasamycin A1, acetylkitasamycin A3 and acetylkitasamycin A13 as major components. The preparation method of the acetylkitasamycin dispersible tablet involves wet-method granulation tableting process. The inventive acetylkitasamycin dispersible tablet has the advantages of rapid disintegration speed, convenient administration, less side effect, easy absorption, high bioavailability and blood drug concentration, and improved antibacterial effect. The preparation method is similar to the common tablet and is easy to be operate and control.

Description

technical field [0001] The invention relates to a new dosage form of an antibiotic drug acetylkitatamycin and a preparation method thereof. Background technique [0002] Acetylkitamycin is a macrolide antibiotic drug and is an acetylated derivative of kitasamycin. Its dosage forms include ordinary tablets, capsules, granules, etc., and there is no dispersible tablet form yet. [0003] Dispersible tablets are a new drug dosage form developed in recent years. The 1993 edition of the British Pharmacopoeia and the 2005 edition of the Chinese Pharmacopoeia also recorded the new drug dosage form of dispersible tablets. Compared with ordinary tablets, dispersible tablets require a disintegration medium The temperature is 20±2℃, the disintegration time limit is less than 3 minutes, and all the disintegrated particles should pass through the 710um sieve. Taking dispersible tablets has the advantages of fast drug release, high bioavailability, and less adver...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7048A61K47/30A61P31/00
Inventor 徐建平
Owner 徐建平