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Ranolazine quick-release mini-pill preparation and preparation method thereof

A technology of ranolazine and pellets, which is applied in the field of pharmaceutical preparation technology and application, and can solve problems such as affecting cardiac electrical conduction and QT interval prolongation

Inactive Publication Date: 2018-06-01
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that it can partially inhibit fatty acid oxidation, but at the same time it can also affect the electrical conduction of the heart, causing dose-related QT interval prolongation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Formula 1

[0026] ranolazine

100mg

Microcrystalline Cellulose Blank Ball Core

4000g

0.3% acetic acid solution

200ml

Hypromellose (HPMC)

300g

talcum powder

50g

water

5500g

[0027] Preparation:

[0028] (1) Preparation of drug solution: take ranolazine 100 mg 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.

[0029] (2) Spraying medicine at the bottom of the fluidized bed: place 4000 g of microcrystalline cellulose 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 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 ap...

Embodiment 2

[0032] Example 2 Formula 2

[0033] ranolazine

80mg

Sucrose Blank Ball Core

4000g

0.1% citrate solution

300ml

Povidone (PVP)

8g

Acrylic

200g

water

5000g

[0034] Preparation:

[0035] (1) Preparation of drug-on-drug solution: take ranolazine 200mg by formula, add 0.1% citrate solution 300mL and dissolve, then be dissolved in the aqueous solution that contains povidone (PVP) 8g and be mixed with 1500g drug-on-drug solution.

[0036] (2) Spray medicine at the bottom of the fluidized bed: place 4000g 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.

[0037] (3) Fluidize...

Embodiment 3

[0038] Embodiment 3 Formula 3

[0039] ranolazine

50mg

Sucrose Blank Ball Core

4000g

0.6% hydrochloric acid solution

700ml

syrup

70g

Acrylic

200g

water

4500g

[0040] Preparation:

[0041] (1) Preparation of drug solution: Weigh 300 mg of ranolazine 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.

[0042] (2) Spray medicine at the bottom of the fluidized bed: place 4000g 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.

[0043] (3) Fl...

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Abstract

The invention provides a ranolazine quick-release mini-pill preparation and a preparation method thereof, and relates to the fields of a medicine preparation technology and application. The administration mode of the quick-release mini-pill preparation is oral administration, a blank pill core serves as a carrier, a ranolazine aqueous solution containing a cosolvent and adhesive is a medicine applying solution, and the use amount of the ranolazine is 0.01 to 0.3 percent of the weight of the pill core according to the weight ratio; and the oral dosage of the ranolazine is not more than 100 micrograms. The ranolazine quick-release mini-pill preparation has the characteristics of high medicine applying rate, high content uniformity, quick medicine release, quick response of analgesic effect and the like. Meanwhile, the quick-release mini-pill preparation has the characteristics of high clinical use compliance, high safety and the like. In addition, the blank pill core fluidized bed medicine applying method is suitable for preparation of a ranolazine medicine oral preparation with extremely low specification.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparation technology and application, in particular to a preparation of ranolazine quick-release pellets, a preparation method and application thereof. Background technique [0002] Ranolazine has anti-angina pectoris and anti-myocardial ischemia effects, but its specific mechanism of action is still unclear. Studies have shown that it can partially inhibit fatty acid oxidation, but at the same time it can also affect the electrical conduction of the heart, causing dose-related QT interval prolongation. Ranolazine is limited to the use of long-acting nitrates, calcium ion channel blockers and β2 receptor blockers and other anti-angina drugs ineffective. Clinical trials have shown that the effect of ranolazine on male patients is better than that on female patients, but adverse reactions such as dizziness, headache, constipation and nausea may occur after long-term use. [0003] Ranolazine, a new ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/495A61K47/32A61K47/38A61P9/10
CPCA61K9/5078A61K9/5026A61K9/5047A61K31/495
Inventor 欧泽桂
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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