A kind of solid pharmaceutical composition of tolvaptan

A technology for tolvaptan and protan tablets, which is applied in the directions of drug combinations, active ingredients of heterocyclic compounds, metabolic diseases, etc., can solve the problems of low drug inclusion rate, the need for investigation of related substances, and the increase of cost.

Active Publication Date: 2016-06-15
PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method improves the in vitro dissolution rate of tolvaptan, the inclusion rate of the drug using the inclusion technology is not high, and a large amount of inclusion materials are used, which increases the cost of research and development, and the related substances of the inclusion complex need to be investigated

Method used

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  • A kind of solid pharmaceutical composition of tolvaptan
  • A kind of solid pharmaceutical composition of tolvaptan
  • A kind of solid pharmaceutical composition of tolvaptan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] This embodiment is in the form of a tablet.

[0025]

[0026] Preparation process: weigh tolvaptan and mannitol according to the prescription ratio, mix them, grind them with a ball mill, and pass through a 200-mesh sieve. Weigh microcrystalline cellulose and hydroxypropyl cellulose according to the prescription quantity, mix them uniformly by equal-volume incremental method, add water-based soft materials, granulate with a 20-mesh sieve, dry, and measure moisture; Sodium Methyl Starch, Magnesium Stearate. Φ6mm shallow concave stamping sheet.

Embodiment 2

[0028] This embodiment is in the form of a tablet.

[0029]

[0030] Preparation process: Weigh tolvaptan and lactose according to the prescription ratio, mix them, grind them with a ball mill, and pass through a 200-mesh sieve. Weigh microcrystalline cellulose and hydroxypropyl cellulose according to the prescription amount and mix them uniformly by equal-volume incremental method, then add soft material made of 50% ethanol, granulate with 20 mesh sieve, dry, measure moisture; granulate with 18 mesh sieve, add low Substitute for hypromellose and magnesium stearate. Φ6mm shallow concave stamping sheet.

Embodiment 3

[0032] This embodiment is in the form of a capsule.

[0033]

[0034] Preparation process: Weigh tolvaptan and lactose according to the prescription ratio, mix them, grind them with a ball mill, and pass through a 200-mesh sieve. Weigh the pregelatinized starch, sodium carboxymethyl starch, and talcum powder according to the prescription and mix them evenly. Pack No. 3 capsules.

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Abstract

The invention discloses a solid medicine composition of tolvaptan. The solid medicine composition of tolvaptan comprises granular or unformed powder of tolvaptan, sugar and a sugar alcohol diluent. The preparation method comprises the following steps of: highly dispersing the active component tolvaptan into the diluent to obtain solid dispersoid; and preparing into oral solid preparation with pharmaceutically acceptable auxiliary materials. The solid medicine composition is clinically used for treating hyponatremia.

Description

Technical field: [0001] The invention relates to a solid pharmaceutical composition of tolvaptan, belonging to the technical field of medicine. Background technique: [0002] Hyponatremia: defined as a patient with a serum sodium level below 135 mmol / L. It only reflects the reduction of sodium concentration in plasma, and does not necessarily mean the loss of total sodium in the body. The total sodium can be normal or even slightly increased. [0003] Hyponatremia is divided into four categories: 1. Natrium-deficiency hyponatremia: that is, hypotonic dehydration. The total sodium and intracellular sodium in the body are reduced, and the serum sodium concentration is reduced; 2 dilution hyponatremia: that is, too much water, and the blood sodium is diluted. Total sodium can be normal or increased, intracellular fluid and serum sodium concentration decreased; 3 metastatic hyponatremia: rare. When the body is deficient in sodium, sodium moves from the outside of the cells in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/26A61K31/55A61K9/14A61P3/12
Inventor 顾群李志刚孙学伟肖万宏
Owner PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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