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Amiodarone hydro chloride dispensible tablet, and its preparing method

A technology of amiodarone hydrochloride and dispersible tablets, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., and can solve the large impact of absorption in the body, the absorption of amiodarone hydrochloride tablets, and the difference in bioavailability And other issues

Inactive Publication Date: 2006-08-09
江永忠
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In summary, the clinical efficacy of amiodarone hydrochloride is significant, but it is insoluble in water, so its absorption in the body is greatly affected by dosage form factors
The 2000 edition of the Chinese Pharmacopoeia only stipulates the disintegration time limit inspection for ordinary tablets, and does not require the dissolution rate. Therefore, there are large differences in the absorption and bioavailability of amiodarone hydrochloride tablets from different manufacturers.

Method used

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  • Amiodarone hydro chloride dispensible tablet, and its preparing method
  • Amiodarone hydro chloride dispensible tablet, and its preparing method
  • Amiodarone hydro chloride dispensible tablet, and its preparing method

Examples

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Embodiment 1

[0071] Get raw materials: Amiodarone hydrochloride 200g, microcrystalline cellulose 100g, sodium starch glycolate 60g, 4g Tween-80, povidone K30 solution (3%, w / v; 50% ethanol solution) 120ml, micropowder silica gel 10g , stevia 2g, magnesium stearate 5g, prepare according to the following steps:

[0072] Get amiodarone hydrochloride, microcrystalline cellulose and 30g carboxymethyl starch sodium, amiodarone hydrochloride is micronized, with 95% powder particle size being less than 10 μ m, average particle diameter (50% powder body particle diameter) is less than 5 μ m as micropowder Mix well; dissolve Tween-80 in an appropriate amount of povidone K30 solution, add it to the above mixture to make a soft material, and continuously rinse the container with povidone K30 solution, add the washing liquid to the soft material, Until the soft material meets the granulation requirements, pass through a 24-mesh sieve to granulate, and dry at 55°C by air blast; take the dried granules a...

Embodiment 2

[0074] Raw materials: 200g of amiodarone hydrochloride, 50g of microcrystalline cellulose, 13g of crospovidone XL-10, an appropriate amount of povidone K30 solution (3%, w / v; 50% ethanol solution), micronized silica gel 10g, stevia Su 2g, magnesium stearate 5g, prepare according to the following steps:

[0075] Weigh the raw material of micronized amiodarone hydrochloride, microcrystalline cellulose and half amount of crospovidone XL-10, and mix them evenly; Granulate with a 24-mesh sieve and blow dry at 55°C; take the dried granules and pass through a 20-mesh sieve for granulation, add the remaining amount of crospovidone XL-10 and the prescribed amount of magnesium stearate, and mix well; use φ= 8.5mm shallow concave punched tablet, made into 1000 pieces, the hardness of the tablet is controlled at 3-6kg, and the tablet weight is 280mg.

Embodiment 3

[0077] Get raw materials: amiodarone hydrochloride 200g, microcrystalline cellulose 100g, 30g crospovidone XL-10, 6.8g Tween-80, povidone K30 solution (3%, w / v; 50% ethanol solution) Appropriate amount, micropowder silica gel 10g, stevioside 2g, magnesium stearate 5g, prepare according to the following steps:

[0078] Weigh the micronized amiodarone hydrochloride raw material, microcrystalline cellulose and crospovidone XL-10, and mix them evenly; dissolve the prescription amount of Tween 80 in an appropriate amount of povidone K30 solution, and add it to the above mixture to prepare Soft materials, and continuously rinse the container with povidone K30 solution, add the washing solution to the soft materials until the soft materials meet the granulation requirements, pass through a 24-mesh sieve to granulate, and blow dry at 55 °C; take the dried granules and pass through Sieve through a 20-mesh sieve, add the remaining amount of crospovidone XL-10 and the prescribed amount o...

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Abstract

The present invention relates to an amiodarone hydrochloride dispersing tablet and its preparation method. The described amiodarone hydrochloride dispersing tablet contains 5-30% of amiodarone hydrochloride, the rest is auxiliary material. The described auxiliary material can be excipient, disintegrating agent, surfactant, adhesive, corrective and lubricating agent. Its preparation method adopts conventional tableting process.

Description

technical field [0001] The invention relates to an amiodarone hydrochloride dispersible tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] In recent years, there has been little progress in the treatment of antiarrhythmic drugs, and the only one worth mentioning may be amiodarone, which has been clinically used for more than 20 years. After the results of the Arrhythmia Suppression Test (CAST) were published in the United States in the early 1990s, people re-recognized and re-evaluated amiodarone. At present, amiodarone has become one of the main drugs for the clinical treatment of arrhythmia. [0003] Amiodarone was first synthesized by Labze laboratory in 1961. It was originally introduced as a coronary artery dilator. In the 1970s, Singh discovered its electrophysiological mechanism of action. In 1976, Rosenbaum took the lead in applying it to the treatment of antiarrhythmia. In his report, the...

Claims

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Application Information

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IPC IPC(8): A61K31/343A61K9/20A61P9/06
Inventor 江永忠
Owner 江永忠
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