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Diacerein solid dispersion preparation and preparation method thereof

A technology of solid dispersion and diacerein, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pill delivery, which can solve problems affecting intestinal flora

Inactive Publication Date: 2017-05-31
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Diacerein increases the likelihood of enterocolitis in patients taking antibiotics and / or chemotherapy, which affect the intestinal flora
Accidental or spontaneous overdose of diacerein can cause diarrhea

Method used

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  • Diacerein solid dispersion preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: Diacerein solid dispersion tablet

[0047] prescription:

[0048] components parts by weight Diacerein 5０ Povidone K30 100 Microcrystalline Cellulose 102 50 Croscarmellose Sodium 20 Sodium dodecyl sulfate 10 silica 2 Sheet weight 232

[0049] Preparation process: solvent evaporation method

[0050]Dissolve the prescribed amount of diacerein and povidone K30 in a solvent of acetone:methanol (1:3), volatilize under reduced pressure in a water bath at 60°C, vacuum degree 0.07-0.08MPa, and recover organic matter under reduced pressure. After the solvent becomes viscous, continue vacuum drying under reduced pressure for 1 hour, transfer to a vacuum drying oven, dry at 40°C for 48 hours, and pass through an 80-mesh sieve to pulverize to obtain a solid dispersion.

[0051] The prepared solid dispersion was added into the prescribed amount of microcrystalline cellulose pH102, croscarmellose sodium, sodium ...

Embodiment 2

[0052] Embodiment 2: Diacerein solid dispersion tablet

[0053] prescription:

[0054] components parts by weight Diacerein 100 Povidone K30 200 Microcrystalline Cellulose 102 50 Croscarmellose Sodium 20 Sodium dodecyl sulfate 10 talcum powder 2 Sheet weight 387

[0055] Preparation process: solvent evaporation method

[0056] Take the prescribed amount of diacerein and povidone K30, dissolve in the solvent of methanol:dichloromethane (4:1), put in a water bath at 60°C, vacuum degree 0.07-0.08MPa, recover the organic solvent under reduced pressure, wait for After becoming viscous, continue vacuum drying under reduced pressure for 1 hour, transfer to a vacuum drying oven, dry at 40°C for 48 hours, and pass through an 80-mesh sieve to pulverize to obtain a solid dispersion.

[0057] The prepared solid dispersion is added into the prescribed amount of microcrystalline cellulose pH102, crospovidone, sodium lauryl sulfate, ...

Embodiment 3

[0058] Embodiment 3: Diacerein solid dispersion tablet

[0059] prescription:

[0060] components parts by weight Diacerein 25 Povidone K30 100 Microcrystalline Cellulose 102 50 Croscarmellose Sodium 20 Sodium dodecyl sulfate 10 silica 2 Sheet weight ２０７

[0061] Preparation process: solvent evaporation method

[0062] Dissolve the prescribed amount of diacerein and povidone K30 in a solvent of acetone:dichloromethane (3:1), in a water bath at 55°C, with a vacuum of 0.07-0.08MPa, and recover the organic solvent under reduced pressure. After becoming viscous, continue vacuum drying under reduced pressure for 3 hours, transfer to a vacuum drying oven, dry at 60°C for 48 hours, and pass through an 80-mesh sieve to pulverize to obtain a solid dispersion.

[0063] The prepared solid dispersion is added to the prescribed amount of pregelatinized starch, low-substituted hydroxypropyl cellulose, sodium lauryl sulfate, and sili...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a diacerein solid dispersion preparation and a preparation method thereof. The diacerein solid dispersion preparation is prepared from diacerein, povidone, a specific lubricating agent, a specific disintegrating agent and a diluent. The dissolution effect, bioavailability and stability of the diacerein solid dispersion preparation are beneficial to the industrial production of the diacerein solid dispersion preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a diacerein solid dispersion preparation and a preparation method thereof. Background technique [0002] 1. Pharmacological and clinical effects [0003] Diacerelate is the primary inhibitor of IL-1 in osteoarthritis. It has been confirmed by cell experiments and animal experiments that the pharmacological effects of this product mainly include (1) this product can induce cartilage production, has analgesic, anti-inflammatory and antipyretic effects; (2) does not inhibit the synthesis of prostaglandins; (3) has the effect on bone Arthritis has the effect of delaying the progression of the disease. Pharmacokinetic studies have shown that in animals and humans, orally administered diacerein undergoes deacetylation into the active metabolite rhein before entering the systemic circulation. The peak time of a single oral administration to healthy adults is about 2.4 hours...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/222A61K47/32A61K9/48A61K9/20A61P19/02
CPCA61K31/222A61K9/1635A61K9/2027A61K9/2054A61K9/2059A61K9/4858
Inventor 王雪峰
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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