A kind of novel roxithromycin capsule and preparation method thereof

A technology of roxithromycin and capsules, which is applied in the field of new roxithromycin capsules and its preparation, can solve the problems of poor oral absorption and low bioavailability, and achieve simple operation, good reproducibility, and good curative effect Effect

Inactive Publication Date: 2011-12-07
江苏黄河药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The technical problem to be solved by this invention is to provide a ...

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  • A kind of novel roxithromycin capsule and preparation method thereof

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Effect test

Embodiment 1

[0032] A kind of novel roxithromycin slow-release capsule comprises the component of following percentage by weight:

[0033] Roxithromycin 64%,

[0034] Hydroxypropyl Methyl Cellulose 4%,

[0035] Ethyl Cellulose 18%,

[0036] Dibutyl Sebacate 7%,

[0037] Polyethylene glycol (PEG1540) 6.2%,

[0038] Magnesium Stearate 0.8%.

[0039] The production method is as follows:

[0040] (1) Take roxithromycin and hydroxypropyl methylcellulose, add water of 10% (w / w) of its gross weight and mix evenly to make a soft material, granulate with a 20 mesh sieve, and dry at 60°C;

[0041] (2) After adding magnesium stearate and mixing, press to form a 2mm diameter drug chip;

[0042] (3) Weigh ethyl cellulose, dibutyl sebacate and polyethylene glycol (PEG1540), add its total weight 5% (w / w) to dissolve in water as coating solution;

[0043] (4) Carry out fluidized bed coating to the roxithromycin drug chip obtained in step (2) using the coating solution obtained in step (3), the air ...

Embodiment 2

[0046] A kind of novel roxithromycin slow-release capsule comprises the component of following percentage by weight:

[0047] Roxithromycin 68%,

[0048] Sodium Carboxymethyl Cellulose 5.5%,

[0049] Acrylic resin (Eudragit RS 30D-55) 15%,

[0050] Dibutyl Phthalate 6%,

[0051] Lactose 5%,

[0052] Talc 0.5%.

[0053] The production method is as follows:

[0054] (1) Take roxithromycin and sodium carboxymethyl cellulose, add water of 10% (w / w) of its gross weight and mix evenly to make soft material, granulate with 20 mesh sieve, and dry at 60°C;

[0055] (2) After adding talcum powder and mixing evenly, press it into a medicine chip with a diameter of 2mm;

[0056] (3) Acrylic resin (Eudragit RS 30D-55), dibutyl phthalate and lactose were weighed, and dissolved in water with a total weight of 5% (w / w) as a coating solution;

[0057] (4) Carry out fluidized bed coating to the roxithromycin drug chip obtained in step (2) using the coating solution obtained in step (3), th...

Embodiment 3

[0059] Example 3: In vitro release test.

[0060] Assay method: get the roxithromycin sustained-release capsules prepared in Examples 1 and 2 and the commercially available roxithromycin sustained-release capsules, according to the release degree (Appendix XD of Part Two of the Chinese Pharmacopoeia Edition in 2010). Adopt the second method device of dissolution assay (Chinese Pharmacopoeia 2010 edition two appendix XC) with hydrochloric acid solution (1→1000) 900ml as solvent, rotating speed is 50 revolutions per minute, operate according to law. At 2, 4, and 8 hours, 5ml of the solution was taken and filtered, and 5ml of solvent was added to the operating container immediately. Take appropriate amount of filtrate respectively, add hydrochloric acid solution to make a solution containing roxithromycin 60ug per 1ml as reference substance solution. Accurately measure each 4ml of the above solution and put it in a 10ml graduated test tube bottle, add 4ml of sulfuric acid soluti...

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Abstract

The invention discloses a novel roxithromycin capsule, which comprises the following components in percentage by weight: 55-70% of roxithromycin, 3-6% of a binder, 15-20% of a coating material, and 6% of a plasticizer. ~8%, porogen 5~9%, glidant 0.5~1.5%. The invention also discloses a preparation method of the novel roxithromycin capsule. The roxithromycin capsule of the present invention greatly improves the disadvantages of the common oral dosage form of roxithromycin, which are frequently taken and have low bioavailability. Roxithromycin was made into pellets, and the roxithromycin pellets were made into sustained-release tablets by an improved fluidized bed coating method, and then filled into capsules to obtain roxithromycin sustained-release capsules. The operation is simple and reproducible. Well, it is easy to achieve mass production, and compared with other commercially available sustained-release capsule dosage forms, through the re-vulcanization process after fluidized coating, the coating material can exert a sustained-release effect, so as to achieve better curative effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a novel roxithromycin capsule and a preparation method thereof. Background technique [0002] Roxithromycin is a white or off-white powder, odorless, bitter, slightly hygroscopic crystalline powder. It is easily soluble in ethanol, soluble in methanol and ether, and almost insoluble in water. The chemical name of roxithromycin is 9-[0-[(2-methoxyethoxy)-methyl]oxime] erythromycin, which is stable to acid and easy to absorb when taken orally. Excellent erythromycin product. First launched in France in 1987, it has been widely used in more than 90 countries and regions including my country. It has antibacterial effects on Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Enterococcus, anaerobic bacteria, Mycoplasma pneumoniae, Chlamydia, Neisseria gonorrhoeae, etc. [0003] In the patent (publication number CN101224217A), a skeleton-type ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/7048A61K47/44A61K47/38A61K47/34A61K47/32A61P31/04
Inventor 葛海涛唐俊
Owner 江苏黄河药业股份有限公司
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