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Roxithromycin capsule and preparation process thereof

A technology for roxithromycin and capsules, which is applied in the field of pharmaceutical preparations, can solve the problems of unstable dissolution curve, difficult drug detection work, influence of detection results, etc., and achieves the effect of simple and easy preparation process

Active Publication Date: 2019-01-22
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the inventor studied the roxithromycin capsules, he found that roxithromycin had adhesiveness, even if the medicine was prepared into capsules after granules, when the contents of the capsules were poured out, the capsule shell still adhered A small amount of medicament powder or granules, the present invention finds that the roxithromycin capsules prepared by the prior art all have the above-mentioned phenomenon, cause when detecting the dissolution rate of roxithromycin capsules, often have the capsule shell that adheres to the roxithromycin capsules to float , the dissolution curve is not stable due to adhesion, which affects the test results and brings difficulties to the test work of the drug

Method used

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  • Roxithromycin capsule and preparation process thereof
  • Roxithromycin capsule and preparation process thereof
  • Roxithromycin capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of Roxithromycin Capsules of the Invention

[0033] Prepare according to the following formula:

[0034]

[0035]

[0036] Preparation:

[0037] a. Roxithromycin is crushed and sieved first, and then PVP K30 and poloxamer aqueous solutions are prepared for use;

[0038] b. Weigh roxithromycin, low-substituted hydroxypropyl cellulose, and corn starch, mix them evenly, and prepare soft materials with PVPK30 and poloxamer aqueous solution;

[0039] c. Put it directly in a drying oven to dry, and the dried particles are passed through a 20-mesh sieve to be granulated;

[0040] d. Weigh and mix finely powdered silica gel, magnesium stearate, talc and dry granules, and fill the capsules and pack them.

Embodiment 2

[0041] Example 2 Preparation of Roxithromycin Capsules of the Invention

[0042] Prepare according to the following formula:

[0043]

[0044] Preparation:

[0045] a. Roxithromycin is crushed and sieved first, and then PVP K30 and poloxamer aqueous solutions are prepared for use;

[0046] b. Weigh roxithromycin, low-substituted hydroxypropyl cellulose, and corn starch, mix them evenly, and prepare soft materials with PVPK30 and poloxamer aqueous solution;

[0047] c. Put it directly in a drying oven to dry, and the dried particles are passed through a 20-mesh sieve to be granulated;

[0048] d. Weigh and mix finely powdered silica gel, talcum powder and dry granules as additional auxiliary materials, fill the capsules and pack.

Embodiment 3

[0049] Example 3 Preparation of Roxithromycin Capsules of the Invention

[0050]

[0051] a. Roxithromycin is crushed and sieved first, and then PVP K30 and poloxamer aqueous solutions are prepared for use;

[0052] b. Weigh roxithromycin, low-substituted hydroxypropyl cellulose, and corn starch, mix them evenly, and prepare soft materials with PVPK30 and poloxamer aqueous solution;

[0053] c. Put it directly in a drying oven to dry, and the dried particles are passed through a 20-mesh sieve to be granulated;

[0054] d. Weigh out the finely powdered silica gel and dry granules, fill the capsules and pack.

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PUM

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Abstract

The invention relates to a roxithromycin capsule and a preparation method of the roxithromycin capsule. The roxithromycin capsule is prepared from the following constituents in percentage by weight:50-75 % of roxithromycin, 5-25 % of corn starch, 10-30 % of low-substituted hydroxypropyl cellulose, 0.5-6 % of a wetting agent, 0.5-3 % of a binder, and 0.5-3 % of a lubricant, wherein the binder ispolyvinylpyrrolidone; the wetting agent is selected from sodium dodecyl sulfate, Tween 80 and poloxamer; and the lubricant is selected from one or more of micropowder silica gel, magnesium stearate and talcum powder.

Description

Technical field [0001] The invention relates to the technical field of medical preparations, in particular to roxithromycin capsules and a preparation process thereof Background technique [0002] Roxithromycin, the chemical name is 9-[O-[(2-methoxyethoxy)-methyl]oximino]erythromycin, the molecular formula is C41H76N2O15, and the structural formula is as follows: [0003] [0004] Roxithromycin is a semi-synthetic 14-membered ring macrolide antibiotic. It is a derivative of erythromycin derived from the C9 position. The original formulation company is Sanofi-Aventis. The 150mg tablet was first marketed in France. , Suitable for pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute attack of chronic bronchitis caused by sensitive bacteria, pneumonia caused by Mycoplasma pneumonia or Chlamydia pneumonia; Urethritis caused by Chlamydia trachomatis And cervicitis; skin and soft tissue infections caused by sensitive bacteria. Af...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7048A61K47/36A61K47/38A61K47/04A61P31/04
CPCA61K9/485A61K9/4866A61K31/7048A61P31/04
Inventor 潘海群刘立媛霍志强葛志敏
Owner 北京鑫开元医药科技有限公司
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