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Tablet containing Rosuvastatin calcium and preparation process thereof

A technology of rosuvastatin calcium and tablet, applied in the field of medicine, can solve problems such as complicated process and achieve the effects of easy promotion, small dissolution difference and strong compressibility

Active Publication Date: 2010-07-07
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But the process is more complicated

Method used

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  • Tablet containing Rosuvastatin calcium and preparation process thereof
  • Tablet containing Rosuvastatin calcium and preparation process thereof
  • Tablet containing Rosuvastatin calcium and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: Preparation of rosuvastatin calcium tablet

[0034] Rosuvastatin 5%

[0035] Lactose 52.9%

[0036] Hydroxypropyl Cyclodextrin 33%

[0037] Cross-linked polyvinylpyrrolidone 8%

[0038] Magnesium Stearate 1%

[0039] Medicinal Iron Oxide 0.1%

[0040] The specific preparation method is as follows: pass medicinal iron oxide red and raw materials through 80 mesh sieve respectively, weigh according to the prescription amount, mix evenly, then mix evenly with hydroxypropyl cyclodextrin according to the method of equal amount addition, pass through 60 mesh sieve, and then Mix evenly with the rest of the excipients in the prescribed amount, measure the content of the semi-finished product, calculate the weight of the tablet, and press the tablet. The appearance and hardness of the prepared tablet are very good, and the dissolution rate is 99.35% ± 0.8% in 45 minutes.

Embodiment 2

[0041] The preparation of embodiment 2 rosuvastatin calcium tablet

[0042] Rosuvastatin 10%

[0043] Lactose 50.9%

[0044] Hydroxypropyl Cyclodextrin 30%

[0045] Cross-linked polyvinylpyrrolidone 8%

[0046] Magnesium Stearate 1%

[0047] Medicinal iron oxide red 0.1%

[0048] The specific preparation method is as follows: pass medicinal iron oxide red and raw materials through 80 mesh sieve respectively, weigh according to the prescription amount, mix evenly, then mix evenly with hydroxypropyl cyclodextrin according to the method of equal amount addition, pass through 60 mesh sieve, and then Mix evenly with the rest of the excipients in the prescribed amount, measure the content of the semi-finished product, calculate the weight of the tablet, and press the tablet. The appearance and hardness of the prepared tablet are very good, and the dissolution rate is 101.23% ± 0.5% in 45 minutes.

Embodiment 3

[0049] The preparation of embodiment 3 rosuvastatin calcium tablet

[0050] Rosuvastatin 5%

[0051] Lactose 44%

[0052] Hydroxypropyl Cyclodextrin 43.9%

[0053] Cross-linked polyvinylpyrrolidone 8%

[0054] Magnesium Stearate 1%

[0055] Medicinal iron oxide red 0.1%

[0056] The specific preparation method is as follows: pass medicinal iron oxide red and raw materials through 80 mesh sieve respectively, weigh according to the prescription amount, mix evenly, then mix evenly with hydroxypropyl cyclodextrin according to the method of equal amount addition, pass through 60 mesh sieve, and then Mix evenly with the rest of the excipients in the prescribed amount, measure the content of the semi-finished product, calculate the weight of the tablet, and press the tablet. The appearance and hardness of the prepared tablet are very good, and the dissolution rate is 99.35% ± 0.8% in 45 minutes.

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Abstract

The invention belongs to the filed of medicine, in particular to a tablet containing Rosuvastatin calcium and a preparation process thereof. As for the tablet containing the Rosuvastatin calcium of the invention, lactose and hydroxypropyl cyclodextrin with the ratio ranging from 1:1 to 2.5:1 are selected to serve as fillers, and opacifier medicinal iron oxide red is added in production process. In the invention, a direct powder tabletting method is utilized for taletting, and the prepared tablet containing the Rosuvastatin calcium has the characteristics of stable long-term preservation, rapid disintegration rate, high dissolution and high bioavailability.

Description

technical field [0001] The invention belongs to the field of medicine, and specifically relates to a tablet of rosuvastatin calcium and a preparation process thereof. The rosuvastatin calcium tablet is compressed by a powder direct compression method, and has the advantages of fast disintegration, high dissolution rate, and high bioavailability. It is a high-efficiency and safe blood lipid regulating drug. Background technique [0002] In recent years, with the change of eating habits, the improvement of living standards and the increase of work pressure, there are more and more patients with hyperlipidemia and hyperalbuminemia, and the patients are getting younger and younger. Epidemiological studies have shown that increased levels of plasma low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) are important factors for premature atherosclerosis and coronary heart disease. Statistical analysis shows that for every 1% decrease in serum cholesterol, the risk...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/505A61K47/38A61K47/26A61P3/06
Inventor 赵志全王洪臣
Owner LUNAN BETTER PHARMA
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