Clarithromycin dispersible tablet preparation method

A technology for clarithromycin and dispersible tablets, which is applied in the field of preparation of clarithromycin dispersible tablets, can solve the problems of difficult quality standard control, high quality requirements, increased production processes, etc., so as to avoid excessive drug concentration and increase the ratio of Surface area, the effect of reducing irritation of the gastrointestinal tract

Inactive Publication Date: 2015-02-11
哈药集团人民同泰医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production process, it is generally required to micronize the raw material drug, which increases the production process; due to the selection of a good disintegrant, the cost is high; the quality requirements are relatively high, and the quality standard control is difficult

Method used

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  • Clarithromycin dispersible tablet preparation method
  • Clarithromycin dispersible tablet preparation method
  • Clarithromycin dispersible tablet preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The plain tablet formula of clarithromycin dispersible tablet is as follows:

[0032]

[0033] The preparation method of above-mentioned clarithromycin dispersible tablet is as follows:

[0034] 1. Superfinely pulverize clarithromycin and 200 mg of lactose into micropowders with a diameter of less than 10 μm to obtain mixed powder A, and set aside, and pass the rest of the auxiliary materials through an 80-mesh sieve for set aside;

[0035] 2. Weigh the remaining lactose, starch and sodium starch glycolate 5 mg and mix evenly to obtain mixed powder B;

[0036] 3. Make hydroxypropyl cellulose into a 5.5% aqueous solution for subsequent use;

[0037] 4. Mix powder A and powder B evenly to get powder C

[0038] 5. Add the aqueous solution prepared in 3 to the mixed powder C to prepare soft materials, pass through a 20-mesh nylon sieve, dry at 50-70°C, and granulate with a 20-mesh stainless steel sieve;

[0039] 6. Add the remaining sodium starch glycolate, talcum pow...

Embodiment 2

[0044]

[0045]

[0046] 1. Superfinely pulverize clarithromycin and 200 mg of lactose into micropowders with a diameter of less than 10 μm to obtain mixed powder A, and set aside, and pass the rest of the auxiliary materials through an 80-mesh sieve for set aside;

[0047] 2. Weigh the remaining lactose and mix with microcrystalline cellulose and sodium starch glycolate 5 mg evenly to obtain mixed powder B;

[0048] 3. Make hydroxypropyl cellulose into a 5.5% aqueous solution for subsequent use;

[0049] 4. Mix powder A and powder B evenly to obtain powder C;

[0050] 5. Add the aqueous solution prepared in 3 to the mixed powder C to prepare soft materials, pass through a 20-mesh nylon sieve, dry at 50-70°C, and granulate with a 20-mesh stainless steel sieve;

[0051] 6. Add the remaining sodium starch glycolate, talcum powder, magnesium stearate and sodium saccharin into the above granules, and mix well. Detect the content of semi-finished products, determine the tab...

Embodiment 3

[0054]

[0055] 1. Superfinely pulverize clarithromycin and 200 mg of lactose into micropowders with a diameter of less than 10 μm to obtain mixed powder A, and set aside, and pass the rest of the auxiliary materials through an 80-mesh sieve for set aside;

[0056] 2. Weigh the rest of the lactose, microcrystalline cellulose, and 5 mg of cross-linked polyvinylpyrrolidone and mix evenly to obtain the mixed powder B;

[0057] 3. Make hypromellose into a 5.5% aqueous solution for subsequent use;

[0058] 4. Mix powder A and powder B evenly to obtain powder C;

[0059] 5. Add the aqueous solution prepared in 3 to the mixed powder C to prepare soft materials, pass through a 20-mesh nylon sieve, dry at 50-70°C, and granulate with a 20-mesh stainless steel sieve;

[0060] 6. Add the remaining cross-linked polyvinylpyrrolidone, silicon dioxide, magnesium stearate and aspartame into the above granules, and mix well. Detect the content of semi-finished products, determine the table...

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Abstract

The present invention provides a clarithromycin dispersible tablet preparation method, which comprises: carrying out ultrafine crushing on clarithromycin and part of lactose into micro-powder with the diameter of less than 10 [mu]m to obtain mixed powder A; taking the remaining filler and part of a disintegrant, and mixing to form mixed powder B; mixing an adhesive and purified water to prepare an aqueous solution with the mass fraction of 1-10%; mixing the mixed powder B with the mixed powder A in an equal increase manner, placing into a three-dimensional mixer to mix for 30-40 min, adding to the adhesive aqueous solution to prepare a soft material, and screening with a 16-24 mesh sieve; drying at a temperature of 50-70 DEG C, and screening the whole particle with a 16-24 mesh sieve; externally adding the remaining disintegrant, a lubricant and a sweetener to the particles to obtain a material C; and tableting the material C to obtain the clarithromycin dispersible tablets. According to the invention, the clarithromycin and part of the lactose are subjected to ultrafine crushing, such that the particle size is small, the specific surface area is increased, the adsorption property and the solubility are correspondingly increased, the bitterness of the product can be reduced, and the patient compliance can be improved; and with the process, the clarithromycin dispersible tablet with characteristics of stable quality, rapid drug dissolution and no bad odor can be prepared.

Description

technical field [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of clarithromycin dispersible tablets. Background technique [0002] Clarithromycin overcomes the disadvantage that erythromycin loses antibacterial activity due to spiro ketal changes in macrocyclic molecules in acidic environments. Its antibacterial effect is enhanced with the increase of pH value, the strongest is at pH8-8.5, and its activity is 8-12 times stronger than that at pH5. [0003] Clarithromycin is a 14-membered ring macrolide antibiotic. Its mechanism is to inhibit the synthesis of protein by hindering the connection of the 50S subunit of nuclear protein. Its characteristics are: 1. It is stable to acid and penetrates tissues. Strong; 2. Wide antibacterial spectrum, long half-life, and small side effects; 3. Suitable for the treatment of various infections caused by clarithromycin-sensitive bacteria, especially due to its strong antibacteria...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7048A61P31/04
Inventor 刘春凤刘占滨王海荣王群
Owner 哈药集团人民同泰医药股份有限公司
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