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Oral azithromycin resin suspension and its preparing method

A technology of oral suspension and azithromycin, which is applied in the directions of liquid delivery, pharmaceutical formulation, emulsion delivery, etc., can solve problems such as poor patient compliance, and achieve the effects of simple preparation method and good taste.

Active Publication Date: 2007-06-27
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the very bitter taste of azithromycin, its oral liquid is not well tolerated by patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0040] The preparation method of azithromycin resin oral suspension of the present invention comprises the following steps: 1. Preparation of azithromycin resin complex: take azithromycin and inorganic acid or / and organic acid according to the aforementioned weight-to-volume ratio, add purified water, and Stir in the ground, the mixer uses the MAZELAZ mixer of Japan EYELA company to dissolve it into a clear solution; then add the ion exchange resin of the aforementioned weight to volume ratio to the above solution, continue stirring for 1 to 12 hours, then let the drug resin settle and filter , take out the filtrate and put it in a tray, and place it at a temperature of 30 ° C to 80 ° C for hot air drying, using the CS101-2E electric blast drying oven of Chongqing Sida Company, or performing reduced pressure drying, using Japanese EYELA The company's VOS-451SD vacuum drying oven can also be dried in a fluidized bed, using the GCCP1.1 fluidized bed of Germany's GLATT company to ...

Embodiment 1

[0046] Embodiment 1, preparation 1000ml azithromycin resin oral suspension (10ml: 0.025g)

[0047] ingredient name

Content (g)

g / 100ml

Azithromycin (pure)

2.5

0.25

citric acid

1.0

0.10

Ion exchange resin Amberlite IRP69

5.0

0.50

Surfactant (Tween-80)

1.0

0.10

Suspending agent (Carbopol, American Novo Corporation)

5.0

0.50

Suspending agent (sucrose)

250

25.0

Edetate disodium

1.0

0.10

Flavoring (cherry essence)

2.5

0.25

Preservative (Ethyl Paraben)

2.5

0.25

Colorant (FD&C Red No. 3)

0.1

0.01

Add purified water to

1000ml

[0048] Relative density (tested according to Chinese Pharmacopoeia 2005 edition)

1.12

Sedimentation volume ratio (tested according to Chinese Pharmacopoeia 2005 edition)

1.0

Taste (according to the taste of healthy volunteers)

good, no b...

Embodiment 2

[0054] Embodiment 2, preparation 1000ml azithromycin resin oral suspension (10ml: 0.05g)

[0055] ingredient name

[0056] Surfactant (Tween-80)

[0057] Preparation process: with embodiment 1.

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PUM

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Abstract

The present invention discloses a kind of oral azithromycin resin suspension and its preparation process, and aims at making the suspension possess good taste. The oral azithromycin resin suspension consists of in each 100 ml azithromycin 0.25-4.0 g, ion exchange resin 0.5-8.0 g and water for the rest. Its preparation process includes the following steps: mixing azithromycin, inorganic acid and / or organic acid and pure water; adding ion exchange resin to obtain mixed liquid; preparing suspension medium with suspending agent, surfactant and pure water; adding metal ion complexing agent, preservative, corrective and colorizing agent; adding the mixed liquid. The present invention is superior to available technology in that the oral azithromycin resin suspension has the bitter of azithromycin masked by the ion exchange resin and thus good taste.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to an azithromycin resin oral suspension and an industrially applicable preparation method thereof. Background technique [0002] Oral preparations are currently the most widely used preparations in clinical practice, which are convenient and safe. However, it is difficult for patients to take medicines with bad odors after they are made into liquid preparations. Ion exchange resin is a kind of functional polymer material, which has been widely used in water treatment, petrochemical, analytical chemistry and other fields for a long time. In the pharmaceutical industry, it is mainly used for the separation and purification of antibiotics, vitamins, natural products and biochemical drugs. At present, the main dosage forms of azithromycin in the domestic market are: ordinary tablets, dispersible tablets, capsules, granules and dry suspensions. Since azi...

Claims

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Application Information

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IPC IPC(8): A61K31/7052A61K9/10A61K47/32A61K47/36A61K47/38A61P31/04
Inventor 闫志刚曾环想王磊曹明兰
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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