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A kind of rosuvastatin calcium tablet and preparation technology thereof

A technology for rosuvastatin calcium and tablets, which is applied in the field of tablets containing rosuvastatin calcium and its preparation process, can solve the problems of rosuvastatin calcium tablets with good stability, high fluidity requirements, and poor particle size. Uniformity and other issues, to achieve the effects of easy industrial production, solving release stability, and simple preparation process

Inactive Publication Date: 2018-01-16
KUNMING MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention does not fundamentally solve the stability problem of rosuvastatin calcium. Since all the excipients have relatively high hygroscopicity, the degradation products will still increase significantly during storage.
At the same time, direct compression has high requirements on the fluidity of excipients, and excipients suitable for direct compression are generally expensive; moreover, rosuvastatin calcium has strong adsorption, and the most obvious defect of direct compression is poor content uniformity
However, the unevenness of dry granulation particles will lead to problems such as large differences in tablet weight, uneven hardness, and rapid dissolution.
[0013] In summary, the prior art has failed to provide a rosuvastatin calcium tablet with good stability, stable dissolution, few side effects, and simple preparation process.

Method used

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  • A kind of rosuvastatin calcium tablet and preparation technology thereof
  • A kind of rosuvastatin calcium tablet and preparation technology thereof
  • A kind of rosuvastatin calcium tablet and preparation technology thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034]

[0035] Preparation process: The prescription quantity weighed rosuvastatin calcium, polystyrene maleic anhydride copolymer, and poloxamer 407 through a 100-mesh sieve, added to absolute ethanol, suspended, and dried under reduced pressure at 40°C to remove ethanol. The dry matter is passed through a 80-mesh sieve, mixed evenly with the prescribed amount of hydroxypropyl methylcellulose, sodium alginate, and microcrystalline cellulose passed through a 100-mesh sieve, then mixed with magnesium stearate, and compressed into tablets.

Embodiment 2

[0037]

[0038]

[0039] Preparation process: The prescription quantity weighed rosuvastatin calcium, polystyrene maleic anhydride copolymer, and poloxamer 407 through a 100-mesh sieve, added to absolute ethanol, suspended, and dried under reduced pressure at 40°C to remove ethanol. The dried product is passed through a 80-mesh sieve, mixed evenly with the prescribed amount of hydroxypropyl methylcellulose, sodium alginate, and starch passed through a 100-mesh sieve, then mixed with calcium stearate, and compressed into tablets.

Embodiment 3

[0041]

[0042] Preparation process: The prescription quantity weighed rosuvastatin calcium, polystyrene maleic anhydride copolymer, and poloxamer 407 through a 100-mesh sieve, added to absolute ethanol, suspended, and dried under reduced pressure at 40°C to remove ethanol. The dried product is passed through an 80-mesh sieve, mixed evenly with the prescribed amount of hydroxypropyl methylcellulose, sodium alginate, and mannitol passed through a 100-mesh sieve, then mixed with sodium stearyl fumarate, and compressed into tablets.

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Abstract

The invention discloses a rosuvastatin calcium tablet and a preparation method thereof, which belong to the aspect of chemical pharmaceutical preparations and are formed by mixing a rosuvastatin calcium solid dispersion and pharmaceutically acceptable auxiliary materials uniformly and then directly compressing the tablet. The rosuvastatin calcium solid dispersion is made by suspending rosuvastatin calcium, polystyrene maleic anhydride copolymer, and poloxamer 407 in absolute ethanol, drying and removing ethanol to obtain rosuvastatin calcium The solid dispersion is uniformly mixed with other pharmaceutically acceptable auxiliary materials and directly compressed into tablets. The invention successfully solves the release problem of rosuvastatin calcium and significantly improves the dissolution stability of rosuvastatin calcium.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation, in particular to a tablet containing rosuvastatin calcium and a preparation process thereof. Background technique [0002] Rosuvastatin Calcium is a white amorphous powder, slightly soluble in water and methanol, very slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with an oil-water partition coefficient (octanol / water) of 0.13 at pH 7. The chemical name is bis-[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]-pyrimidin-5-yl]( 3R,5S)-3,5-Hydroxyhept-6-enoic acid] calcium salt (2:1), the molecular formula is (C 22 h 27 FN 3 o 6 S) 2 Ca, the structural formula is as follows: [0003] [0004] Pharmacological type: Rosuvastatin calcium is a 3-hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, so it can reduce the cholesterol level in plasma. [0005...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/10A61K47/32A61K31/505A61K9/20A61K47/38A61K47/36A61P3/06
Inventor 沈志强陈鹏杨仁华李璠张小超何波
Owner KUNMING MEDICAL UNIVERSITY
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