A kind of roxithromycin capsule and its production process

A technology for roxithromycin and capsules, which is applied in the field of roxithromycin capsules and its production technology, can solve problems such as being unfavorable to pass through the gastrointestinal mucosa, the oil-water distribution coefficient is reduced, and is unstable, so as to improve the relative bioavailability The effect of increasing the solubility, increasing the solubility, and evenly distributing

Active Publication Date: 2020-01-14
珠海安生凤凰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] A kind of roxithromycin capsule provided by the invention and its production process are aimed at improving roxithromycin under gastric acid environment (pH=1~3) instability while improving the dissolution rate of roxithromycin, and the oil-water partition coefficient varies with The pH value is lowered, which is not conducive to the disadvantages of passing through the gastrointestinal mucosa

Method used

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  • A kind of roxithromycin capsule and its production process
  • A kind of roxithromycin capsule and its production process
  • A kind of roxithromycin capsule and its production process

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Embodiment 1, a kind of roxithromycin capsule

[0035] Described roxithromycin capsule is made up of following composition and content thereof:

[0036]

[0037]

[0038] The adhesive is composed of 2.25kg povidone K30 and 0.27kg polysorbate 80, and the weight ratio is 4.5:0.54.

[0039] Its production process steps are as follows:

[0040] S1. Add povidone K30 into purified water, dissolve and disperse evenly, then add polysorbate 80, disperse evenly, soak in a mixer for 1 hour, stir evenly, and obtain an adhesive;

[0041]S2. Divide roxithromycin, lactose and the adhesive prepared in step S1 into three parts on average, take the first part of roxithromycin and lactose and add them to the granulator, adjust the pressure to 0.4Mpa~1.0Mpa, mix 6min, take the first binder, add it in three times, the binder mass added for the first time and the first total binder mass ratio are 10 / 11, mix and granulate for 2min; The mass ratio of the added binder to the first tota...

Embodiment 2

[0044] Embodiment 2, a kind of roxithromycin capsule

[0045] Described roxithromycin capsule is made up of following composition and content thereof:

[0046]

[0047]

[0048] The adhesive is composed of 1.35kg povidone K30 and 0.225kg polysorbate 80, and the weight ratio is 3.375:0.5625.

[0049] The production technology of described roxithromycin capsule is similar to embodiment 1.

Embodiment 3

[0050] Embodiment 3, a kind of roxithromycin capsule

[0051] Described roxithromycin capsule is made up of following composition and content thereof:

[0052]

[0053] The adhesive is composed of 1.8kg povidone K30 and 0.27kg polysorbate 80, and the weight ratio is 4:0.6.

[0054] The production technology of described roxithromycin capsule is similar to embodiment 1.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a roxithromycin capsule and a preparation process thereof. The roxithromycin capsule is prepared from roxithromycin, silicon dioxide, povidone K30, polysorbate 80, hydroxypropyl methyl cellulose, glidant, disintegrant, a diluting agent, a lubricating agent and purified water. The problem that roxithromycin easily absorbs moisture and is not stable can be solved by adopting the adhesive consisting povidone K30 and polysorbate 80 in certain parts, and the dissolution rate of roxithromycin is increased; and theproblem that roxithromycin is easily degraded and cannot easily penetrate through gastrointestinal mucosa is solved by adopting the hydroxypropyl methyl cellulose, and the time of staying in stomachcan be increased. Furthermore, the roxithromycin preparation process can be used for large-scale production, can produce 0.45 million of roxithromycin capsules once, is stable and safe in process, simple and convenient to operate, and can save resources.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a roxithromycin capsule and a production process thereof. Background technique [0002] Roxithromycin is a semi-synthetic 14-membered ring macrolide antibiotic, which is insoluble in water but soluble in acidic solutions, and its solubility in acidic solutions is much higher than that in neutral solutions. Roxithromycin has a basic antibacterial spectrum. It is similar to erythromycin, but its antibacterial effect is 6 times stronger than erythromycin. It is suitable for pharyngitis and tonsillitis caused by streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, and acute exacerbation of chronic bronchitis caused by sensitive bacteria. Pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae, urethritis and cervicitis caused by Chlamydia trachomatis, and skin and soft tissue infections caused by sensitive bacteria are therefore widely used. [0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/32A61K47/26A61K47/38A61K31/7048A61P31/04
CPCA61K9/4866A61K31/7048A61P31/04
Inventor 李国成符丽马静
Owner 珠海安生凤凰制药有限公司
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