Diacerein quick-release pellet preparation and preparation method

A technology of diacerein and pellets, applied in the directions of pill delivery, anti-inflammatory agents, pharmaceutical formulations, etc., can solve problems such as affecting intestinal flora and the like

Inactive Publication Date: 2017-05-10
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 chemotherap

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Formula 1

[0031] Diacerein 50mg Microcrystalline Cellulose Blank Ball Core 3000g 0.3% acetic acid solution 200ml Hypromellose (HPMC) 300g talcum powder 50g water 4500g

[0032] Preparation:

[0033] (1) Preparation of drug solution: take 10 mg of diacerein according to the formula, add 200 mL of 0.3% acetic acid solution to dissolve, then dissolve in an aqueous solution containing 100 g of hypromellose (HPMC) to prepare 1500 g of drug solution .

[0034] (2) Spraying medicine at the bottom of the fluidized bed: 3000g of microcrystalline cellulose blank ball cores are placed in the fluidized bed, the fluidized bed is started, and the parameters of the fluidized bed medicine are set: fan air volume 150m3 h-1, liquid supply The pump speed is 5r·min-1, the temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied...

Embodiment 2

[0037] Example 2 Formula 2

[0038] Diacerein 25mg Sucrose Blank Ball Core 3000g 0.1% citrate solution 300ml Povidone (PVP) 8g Acrylic 200g water 3000g

[0039] Preparation:

[0040] (1) Preparation of drug solution: take by weighing diacerein 20mg by formula, add 0.1% citrate solution 300mL and dissolve, be dissolved in the aqueous solution that contains povidone (PVP) 8g then and be mixed with 1500g drug solution .

[0041] (2) Spray medicine at the bottom of the fluidized bed: place 3000 g of sucrose blank ball cores in the fluidized bed, start the fluidized bed, set the parameters of the fluidized bed medicine: fan air volume 150m3 h-1, liquid supply pump speed 5r ·min-1. The temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied, it is fluidized and dried for 15 minutes.

[0042] (3) Fluidized bed coating-protective fi...

Embodiment 3

[0043] Embodiment 3 Formula 3

[0044] Diacerein 20mg Sucrose Blank Ball Core 3000g 0.6% hydrochloric acid solution 700ml syrup 70g Acrylic 200g water 3500g

[0045] Preparation:

[0046](1) Preparation of drug solution: take 40 mg of diacerein according to the formula, add 700 mL of 0.6% hydrochloric acid solution to dissolve, then dissolve in an aqueous solution containing 70 g of syrup to prepare 1500 g of drug solution.

[0047] (2) Spray medicine at the bottom of the fluidized bed: place 3000 g of sucrose blank ball cores in the fluidized bed, start the fluidized bed, set the parameters of the fluidized bed medicine: fan air volume 150m3 h-1, liquid supply pump speed 5r ·min-1. The temperature of the material is controlled at 30-40°C, the atomization pressure is 0.16MPa, and the drug is applied in a fluidized state. After the drug is applied, it is fluidized and dried for 15 minutes.

[0048] (3) Fluidized bed coating-protect...

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PUM

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Abstract

The invention discloses a diacerein quick-release pellet preparation and a preparation method, and relates to the field of pharmaceutical preparations and application. A drug-delivery way of the quick-release pellet preparation is oral medication, a core pellet is utilized as a carrier, and diacerein water solution containing a cosolvent and adhesive serves as a medicine applying solution. The diacerein quick-release pellet preparation has the characteristics of high medicine applying rate, good content evenness, quick drug release, quick effect in abirritation and the like. Meanwhile, the quick-release pellet preparation has the characteristics of good clinical use adaptability, high safety and the like. In addition, a fluidized bed medicine applying method of the core pellet is suitable for preparing extremely-low-standard diacerein oral preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparation technology and application, in particular to a diacerein immediate-release pellet preparation, preparation method and application 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 admini...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/36A61K31/222A61P19/02A61P19/08A61P29/00
CPCA61K9/2866A61K9/2846A61K31/222
Inventor 王雪峰
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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