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Hydroxychloroquine sulfate pharmaceutical preparation

A technology for hydroxychloroquine sulfate and pharmaceutical preparations, applied in the field of medicine, can solve the problems of tablet fragility, cracking, sticking and punching, etc., achieve good dissolution properties, and solve the effects of poor compressibility

Pending Publication Date: 2021-08-13
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the defects of the prior art, the present invention provides a hydroxychloroquine sulfate pharmaceutical preparation, which effectively solves production problems such as sticky punching caused by easy moisture absorption of hydroxychloroquine sulfate in the tableting process, and the tablet is fragile and cracked, and the prepared Hydroxychloroquine sulfate preparation has good dissolution rate

Method used

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  • Hydroxychloroquine sulfate pharmaceutical preparation
  • Hydroxychloroquine sulfate pharmaceutical preparation
  • Hydroxychloroquine sulfate pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033]

[0034] Preparation:

[0035] (1) Premixing: add mannitol, pregelatinized starch, hydroxychloroquine sulfate and povidone K25 into the wet mixing granulator and mix, turn on the stirring paddle (50-70rpm) and the cutting knife (250-500rpm), Mix for 600 seconds, and pass the resulting mixed powder through a swinging granulator (screen aperture: 40 mesh) once to obtain hydroxychloroquine sulfate tablet premixed powder;

[0036] (2) Granulation: with water as the wetting agent, the atomization pressure is set and controlled at 0.3MPa, the hydroxychloroquine sulfate tablet premixed powder is granulated, and after the liquid spray is finished, it is dried, and the granules are passed through a swinging granulator (sieve) Mesh pore size: 26 meshes) whole grains to obtain solid granules containing hydroxychloroquine sulfate;

[0037] (3) Blending and tableting: uniformly mix the solid granules containing hydroxychloroquine sulfate and magnesium stearate to obt...

Embodiment 2

[0039] composition Dosage (g) Hydroxychloroquine Sulfate 200.0 Mannitol 46.0 pregelatinized starch 140.0 gelatin 6.0 magnesium lauryl sulfate 8.0

[0040] Preparation:

[0041] (1) Premixing: add mannitol, pregelatinized starch, hydroxychloroquine sulfate and gelatin into the wet mixing granulator and mix, turn on the stirring paddle (50-70rpm) and cutter (250-500rpm), and mix for 600 seconds , the resulting mixed powder is passed through a oscillating granulator (screen aperture: 40 mesh) once to obtain hydroxychloroquine sulfate tablet premixed powder;

[0042] (2) Granulation: with water as the wetting agent, the atomization pressure is set and controlled at 0.2MPa, the hydroxychloroquine sulfate tablet premixed powder is granulated, and after the liquid spray is finished, it is dried, and the granules pass through a swinging granulator (sieve) Mesh aperture: 20 mesh) whole grain, obtain the solid grain containing hydroxychloroq...

Embodiment 3

[0045]

[0046]

[0047] Preparation:

[0048] (1) Premixing: add mannitol, pregelatinized starch, hydroxychloroquine sulfate and hypromellose to the wet mixing granulator and mix, turn on the stirring blade (50-70rpm) and the cutting knife (250-500rpm) , mixed for 600 seconds, and the resulting mixed powder was passed through a swinging granulator (screen aperture: 40 mesh) once to obtain hydroxychloroquine sulfate tablet premixed powder;

[0049] (2) Granulation: with water as the wetting agent, the atomization pressure is set and controlled at 0.2MPa, the hydroxychloroquine sulfate tablet premixed powder is granulated, and after the liquid spray is finished, it is dried, and the granules pass through a swinging granulator (sieve) Mesh aperture: 18 meshes) whole grains, to obtain solid particles containing hydroxychloroquine sulfate;

[0050] (3) Blending and tableting: uniformly mix the solid granules containing hydroxychloroquine sulfate and magnesium stearate to ob...

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Abstract

The invention provides a hydroxychloroquine sulfate pharmaceutical preparation. The hydroxychloroquine sulfate pharmaceutical preparation comprises the following components in percentage by weight: 50-75% of hydroxychloroquine sulfate, 5-15% of mannitol, 15-35% of pregelatinized starch, 0.5-2.0% of a water-soluble adhesive and 0.5-2.0% of a lubricant. According to the hydroxychloroquine pharmaceutical preparation disclosed by the invention, the mannitol and the pregelatinized starch are used as filling agents, and are matched with the adhesive and the lubricant, so that the problem that the hydroxychloroquine pharmaceutical preparation is extremely likely to stick and the problem of poor compressibility caused by high friability of tablets can be solved, the hydroxychloroquine pharmaceutical preparation has good dissolution property, and the dissolution effect is consistent with that of a reference reagent.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a hydroxychloroquine sulfate pharmaceutical preparation. Background technique [0002] Hydroxychloroquine sulfate is an antimalarial drug that also has anti-inflammatory, immunomodulatory and anticoagulant effects. At present, hydroxychloroquine is mainly used clinically to treat rheumatoid arthritis, juvenile chronic arthritis, discoid lupus erythematosus and systemic erythematosus lupus. The structural formula of hydroxychloroquine sulfate is: [0003] [0004] Hydroxychloroquine sulfate raw material is white or off-white crystalline powder, easily soluble in water and highly hygroscopic. Due to the high hygroscopicity and dissociation of hydroxychloroquine sulfate, it has brought great difficulties to the industrial production of its tablets, especially in the tablet compression stage, which is extremely easy to stick and punch, and the tablet has poor compressibility, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4706A61K47/36A61K47/26A61P7/02A61P19/02A61P29/00A61P33/06A61P37/02
CPCA61K9/2059A61K9/2018A61K9/2095A61K31/4706A61P33/06A61P19/02A61P29/00A61P37/02A61P7/02
Inventor 邹文娟张永强史亚男
Owner BEIJING WINSUNNY PHARMA CO LTD
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