Rosuvastatin calcium tablet and preparation method thereof

A technology for rosuvastatin calcium and tablets, which is applied in the field of preparation of rosuvastatin calcium tablets and rosuvastatin calcium tablets, can solve the problems of uncontrollable quality stability, low bioavailability and dissolution rate. The problem is not high, to achieve the effect of controllable product quality, high quality stability and simple process

Active Publication Date: 2015-04-01
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing rosuvastatin calcium tablets have the problems of slow dissolution rate, low dissolution rate, low bioavailability, high cost, and uncontrollable quality stability.

Method used

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  • Rosuvastatin calcium tablet and preparation method thereof
  • Rosuvastatin calcium tablet and preparation method thereof
  • Rosuvastatin calcium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The rosuvastatin calcium tablet of the present embodiment comprises the following components by weight: rosuvastatin calcium 5.21g, microcrystalline cellulose 20.08g, lactose 78.71g, calcium carbonate 40g, cross-linked polyvinylpyrrolidone 4.5g, Magnesium stearate 1.5g. The weight of the rosuvastatin tablet in this embodiment is 150 mg, and the specification of rosuvastatin is 5 mg, and a total of 1000 tablets are made.

[0051] The preparation method of the rosuvastatin calcium tablet of the present embodiment comprises the following steps:

[0052] 1) Rosuvastatin calcium and cross-linked polyvinylpyrrolidone are respectively pulverized and passed through a 100-mesh drug sieve for subsequent use; microcrystalline cellulose, lactose, calcium carbonate, and magnesium stearate are respectively passed through a 100-mesh drug sieve for subsequent use;

[0053] 2) Take the prescribed amount of rosuvastatin calcium and lactose and place them in a high-efficiency wet mixing ...

Embodiment 2

[0057] The rosuvastatin calcium tablet of the present embodiment comprises a tablet core and a coating, and the tablet core comprises the following components by weight: rosuvastatin calcium 5.21g, microcrystalline cellulose 20.08g, lactose 78.71g, carbonate 40g of calcium, 4.5g of cross-linked polyvinylpyrrolidone, 1.5g of magnesium stearate; the weight of the tablet chip is 150mg, and the rosuvastatin is counted as 5mg specification, and 1000 tablets are made in total;

[0058] The coating is mainly made of the following raw materials: Opadry 295K620010Yellow; the mass of the coating is 4% of the mass of the tablet core.

[0059] The preparation method of the rosuvastatin calcium tablet of the present embodiment comprises the following steps:

[0060] 1) Rosuvastatin calcium and cross-linked polyvinylpyrrolidone are respectively pulverized and passed through a 100-mesh drug sieve for subsequent use; microcrystalline cellulose, lactose, calcium carbonate, and magnesium steara...

Embodiment 3

[0066] The rosuvastatin calcium tablet of the present embodiment comprises the following components by weight: rosuvastatin calcium 10.42g, microcrystalline cellulose 20.08g, lactose 73.5g, calcium carbonate 40g, cross-linked polyvinylpyrrolidone 4.5g, Magnesium stearate 1.5g. The weight of the rosuvastatin tablet in this embodiment is 150 mg, and the specification of rosuvastatin is 10 mg, and a total of 1000 tablets are made.

[0067] The preparation method of the rosuvastatin calcium tablet of the present embodiment comprises the following steps:

[0068] 1) Rosuvastatin calcium and cross-linked polyvinylpyrrolidone are respectively pulverized and passed through a 100-mesh drug sieve for subsequent use; microcrystalline cellulose, lactose, calcium carbonate, and magnesium stearate are respectively passed through a 100-mesh drug sieve for subsequent use;

[0069] 2) Take the prescribed amount of rosuvastatin calcium and lactose and place them in a high-efficiency wet mixing...

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Abstract

The invention discloses a rosuvastatin calcium tablet and a preparation method thereof. The rosuvastatin calcium tablet comprises components in parts by weight as follows: 5.0-10.5 parts of rosuvastatin calcium, 20-22 parts of microcrystalline cellulose, 73.5-78.8 parts of lactose, 40 parts of calcium carbonate, 4.5 parts of crosslinked polyvinylpyrrolidone and 1.5 parts of magnesium stearate. The rosuvastatin calcium tablet comprises the rosuvastatin calcium, the microcrystalline cellulose, the lactose, the calcium carbonate, the crosslinked polyvinylpyrrolidone and the magnesium stearate, dosages of all the components are strictly controlled, main medicines and auxiliary materials complement one another to realize a synergistic effect, and the prepared tablet is high in dissolution speed, high in dissolution rate and high in bioavailability; raw materials are easy to obtain, the cost is low, the product equality is controllable, the quality stability and the safety are high, and the rosuvastatin calcium tablet is suitable for popularization and application.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a rosuvastatin calcium tablet, and also relates to a preparation method of the rosuvastatin calcium tablet. Background technique [0002] Rosuvastatin Calcium (Rosuvastatin Calcium), the chemical name is (+)-bis-{7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl( Methylsulfonyl)amino]-5-pyrimidinyl]-3R,5S-dihydroxy-6(E)-heptenoic acid]calcium; English name: 7-{4-(4-Fluorophenyl)-6-isopropyl-2 -[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydr oxyhept-6-enoic acid), is an odorless, tasteless, white to light yellow powder; the structural formula is: [0003] [0004] The CAS number is 147098-20-2; the molecular formula is (C 22 h 27 FN 3 o 6 S) 2 Ca; molecular weight 1001.14. Rosuvastatin calcium is slightly soluble in methanol, very slightly soluble in water, almost insoluble in ethanol, and easily soluble in glacial acetic acid; the specific rotation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/505A61P3/06
Inventor 靳勇
Owner HENAN RUNHONG PHARMA
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