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Oral composition of spiramycin and preparation method thereof

A technology of spiramycin and its composition, which is applied in the field of oral composition of spiramycin and its preparation, can solve the problems of cumbersome process and poor taste correction effect, and achieve low cost, no influence on drug bioavailability, good taste effect

Active Publication Date: 2014-07-16
ZHUOHE PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the poor taste correction effect or cumbersome process in the prior art, and provide a composition and preparation process that can effectively mask the bitter taste of spiramycin

Method used

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  • Oral composition of spiramycin and preparation method thereof
  • Oral composition of spiramycin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1. Prescription of spiramycin particles:

[0040] The proportion of the spiramycin microparticles in solid weight percentage is as follows: 50% spiramycin, 22% stearyl alcohol, 12% microcrystalline cellulose, and 16% ethyl cellulose.

[0041] 2. The preparation process of spiramycin particles:

[0042] Mix spiramycin with stearyl alcohol, microcrystalline cellulose, and ethyl cellulose, use water as a binder to prepare soft materials, use extrusion spheronization to prepare particles, extrude with a sieve plate with an aperture of 0.25mm, and use 1000rpm to rotate Make a round. The obtained microparticles were first dried in an oven at 40°C for 2 hours to remove moisture, and then heat-treated at 70°C for 0.5 hour. After cooling to room temperature, size the particles and collect particles with a particle size between 0.05 and 0.3 mm.

[0043] The above-mentioned spiramycin particles are mixed with auxiliary materials such as suspending agent, corrective agent, essen...

Embodiment 2

[0045] 1. Prescription of spiramycin particles:

[0046] The proportion of the spiramycin microparticles in solid weight percentage is as follows: 30% of spiramycin, 10% of glyceryl distearate, 15% of microcrystalline cellulose, and 35% of acrylic resin.

[0047] 2. The preparation process of spiramycin particles:

[0048] Mix evenly the microcrystalline cellulose and acrylic resin with half the prescription quantity, put it in the centrifugal granulator, adjust the position of the mixing knife, make the material in the vortex reflux state in the granulator, adjust the spray gun Atomization pressure, jet flow and blast flow. Use water as a binder, control the process conditions until the mother nucleus grows to an average particle size of 0.05-0.15mm, and then take it out. Dry at 60°C to remove moisture. Sieve and select particles with a particle size between 0.05 and 0.15 mm as the core and place them in a centrifugal granulator. Mix spiramycin, glyceryl distearate, and t...

Embodiment 3

[0050] 1. Prescription of spiramycin particles:

[0051] The proportion of the spiramycin microparticles in solid weight percentage is as follows: 49% spiramycin, 35% glyceryl behenate, 10% microcrystalline cellulose, and 6% starch.

[0052] 2. The preparation process of spiramycin particles:

[0053] Using a method known in the pharmaceutical industry, mix the prescribed amount of spiramycin, glyceryl behenate and microcrystalline cellulose evenly and place them in the fluidized bed cavity to adjust the air intake to keep the materials in a suitable fluidized state. The wind temperature is 45°C, adjust the atomization pressure and spray speed of the spray, and use the prepared 5% starch slurry as the binder to granulate. After the prescribed amount of slurry is completely sprayed, continue to dry at an inlet air temperature of 45°C. After the material is completely dried, set the inlet air temperature to 80°C and heat-treat for 0.5 hours. Stop heating, continue blasting, a...

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Abstract

The invention discloses an oral composition of spiramycin, which comprises the following components in percentage by weight: 30 to 70 percent of spiramycin or active components of medical spiramycin, 10 to 35 percent of wax lipidLazhi (with white wax as the main component thereof) materials, and 10 to 50 percent of water insoluble materials (except the wax lipidLazhi materials). The oral composition of the spiramycin has the positive effects that: the taste masking effect of the spiramycin particles is good, medicaments can be quickly released in stomachs and intestinal tracts, and the bioavailability of the medicament is not affected.

Description

technical field [0001] The invention relates to a spiramycin, more specifically, a spiramycin oral composition and a preparation method thereof. Background technique [0002] Spiramycin is a 16-membered macrolide antibiotic with a moderate antibacterial spectrum. It works by inhibiting the 50S subunit of bacterial ribosomes and blocking the synthesis of bacterial proteins. It is mainly used clinically for respiratory tract infections, dental Treatment of Zhou Yan and toxoplasmosis in early pregnancy. Because spiramycin has high intracellular drug concentration, long post-antibiotic effect and low side effects, it has broad application prospects in the field of anti-infection. [0003] Spiramycin, like other macrolides, has a strong bitter taste. Made into granules, dry suspensions or dispersible tablets, which can be conveniently taken by the elderly or children who have difficulty swallowing, but the bad taste of the medicine makes it difficult for patients to accept. In...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61P31/04A61K47/10A61K47/12A61K47/14A61K47/44
Inventor 柴旭煜缪苗赵雁李勇印玺璟陶涛
Owner ZHUOHE PHARM GRP CO LTD
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