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Method for preparing sweet clarithromycin granules

A technology for sweetening clarithromycin and clarithromycin, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of unfavorable product quality control, complicated operation process, etc., Achieve the effect of benefiting human health, controlling product quality, and facilitating production and operation

Active Publication Date: 2013-09-25
XINHUA PHARMA GAOMI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese Patent Publication No. CN101502492A provides a method for preparing clarithromycin debitter granules, but it adopts a conventional fluidized coating method, first preparing a coating consisting of three solutions: solution A, solution B, and solution C There are many types of coating materials, plasticizers, surfactants, etc., and at least 16 ingredients are used in the prescription, and at least 8 ingredients are used in the formulation of coating granules. The operation process is complicated, which is not conducive to product quality control.

Method used

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  • Method for preparing sweet clarithromycin granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Take the preparation of 50,000 bags of sweet clarithromycin granules, specifications: 2g:0.125g as an example:

[0027] 1. Pretreatment of raw and auxiliary materials:

[0028] Mannitol, cyclamate, sodium saccharin, and sodium bicarbonate are pulverized separately (using a pulverizer with a screen of Φ0.8mm).

[0029] 2. Weighing materials:

[0030] Weigh each raw and auxiliary material according to the prescription weight:

[0031] Material name

Dosage(kg)

clarithromycin

6.25

Glyceryl monostearate

12.50

Polyacrylic resin IV

2.50

Carboxymethyl Starch Sodium

10.00

sodium bicarbonate

0.20

Hypromellose

5.00

Cyclamate

7.00

sodium saccharin

0.50

[0032] purified water

6.40

orange flavor

0.20

Mannitol

55.85

Co-made

100.00

[0033] Remarks: 6.40kg of purified water in the prescription evaporated during the prepar...

Embodiment 2

[0046] Take the preparation of 50,000 bags of sweet clarithromycin granules, specifications: 2g:0.125g as an example:

[0047] 1. Pretreatment of raw and auxiliary materials:

[0048] Mannitol, acesulfame potassium, steviol glycoside, and sodium citrate were pulverized separately (using a pulverizer with a screen of Φ0.8mm).

[0049] 2. Weighing materials:

[0050] Weigh each raw and auxiliary material according to the prescription weight.

[0051] Material name

Dosage(kg)

[0052] clarithromycin

6.25

Glyceryl monostearate

12.96

Polyacrylic resin IV

2.04

Carboxymethyl Starch Sodium

10.00

sodium citrate

0.20

Hypromellose

5.00

Acesulfame K

6.50

steviol glycoside

1.00

purified water

6.40

lemon zest

0.20

Mannitol

55.85

Co-made

100.00

[0053] Remarks: 6.40kg of purified water in the prescription evaporated during the ...

Embodiment 3

[0066] Take the preparation of 50,000 bags of sweet clarithromycin granules, specifications: 2g:0.125g as an example:

[0067] 1. Pretreatment of raw and auxiliary materials:

[0068] Mannitol, cyclamate, sodium saccharin, and sodium bicarbonate are pulverized separately (using a pulverizer with a screen of Φ0.8mm).

[0069] 2. Weighing materials:

[0070] Weigh each raw and auxiliary material according to the prescription weight.

[0071] Material name

Dosage(kg)

clarithromycin

6.25

Glyceryl monostearate

12.10

Polyacrylic resin IV

2.90

Carboxymethyl Starch Sodium

10.00

sodium bicarbonate

0.20

Hypromellose

5.00

Cyclamate

7.00

sodium saccharin

0.50

purified water

6.40

orange flavor

0.20

Mannitol

55.85

Co-made

100.00

[0072] Remarks: 6.40kg of purified water in the prescription evaporated during the preparation process, and 10...

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PUM

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Abstract

The invention relates to an antibiotic medicine and in particular relates to a method for preparing sweet clarithromycin granules. The method comprises the following steps of: coating the clarithromycin through hot melting at first, and then adding auxiliaries, and finally, performing pelletizing, drying and grain shaping, thereby obtaining the sweet clarithromycin granules, wherein a corrigent is sprayed in the grain shaping process; and finally mixing and subpackaging the sweet clarithromycin granules. The method is used for preparing the sweet clarithromycin granules through hot melting, coating and pelletizing, and has the characteristics of simple operation process, low amount of auxiliaries used and convenient production operations; therefore, the quality of product is well controlled.

Description

technical field [0001] The invention relates to an antibiotic drug, in particular to a method for preparing sweet clarithromycin granules. Background technique [0002] Clarithromycin has a very obvious bitter taste, and the product made by ordinary preparation technology is difficult for patients to swallow. For solid preparation drugs that can be ingested, the taste directly determines whether patients are willing to take the drug. Chinese Patent Publication No. CN101502492A provides a method for preparing clarithromycin debitter granules, but it adopts a conventional fluidized coating method, first preparing a coating consisting of three solutions: solution A, solution B, and solution C There are many types of coating materials, plasticizers, surfactants, etc. used in the liquid, and at least 16 ingredients are used in the prescription, of which the coating granule preparation prescription has at least 8 ingredients. The operation process is complicated, which is not cond...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/7048A61K47/14A61K47/32
Inventor 张忠胜董洪文赵海军
Owner XINHUA PHARMA GAOMI CO LTD
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