Stable pitavastatin calcium pharmaceutical composition and preparation method thereof

A technology of pitavastatin calcium and its composition, which is applied in the field of stable pharmaceutical composition and its preparation, can solve the problems of product stability, uneven tablet color, and color change of magnesium oxide, and achieve good stability, To avoid drug degradation, the effect of simple preparation process operation

Active Publication Date: 2014-10-15
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN96192065.3 discloses a stable pitavastatin calcium composition. The stabilization effect is achieved by adding an alkaline stabilizer. The pH value of its aqueous solution or suspension is greater than 7 and less than 8, but the inventor found through repeated experiments that Only controlling the pH value cannot make the product stable, and the stability of the pitavastatin calcium composition also depends on the specific stabilizer
[0007] In the pitavastatin calcium solid preparation disclosed in Chinese patent CN201010237658.6, magnesium oxide is used as an alkaline stabilizer, but due to the uncontrollable color change of magnesium oxide during the preparation process, the color of the prepared tablet is extremely uneven , thus affecting the pro...

Method used

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  • Stable pitavastatin calcium pharmaceutical composition and preparation method thereof
  • Stable pitavastatin calcium pharmaceutical composition and preparation method thereof
  • Stable pitavastatin calcium pharmaceutical composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Element

[0033] Pass the crude drug and each auxiliary material in the above composition through an 80-mesh sieve for later use. Add the prescribed amount of pitavastatin calcium and red iron oxide in equal amounts and mix well, add the prescribed amount of microcrystalline cellulose, and then fully mix for 30 minutes, then add the prescribed amount of magnesium stearate, and continue mixing for 5 minutes, Obtain a homogeneous mixed powder. The obtained homogeneous mixed powder was pressed into 1000 tablets.

Embodiment 2

[0035] Element

[0036] Pass the crude drug and each auxiliary material in the above composition through an 80-mesh sieve for later use. Add the prescribed amount of pitavastatin calcium and aluminum oxide in equal increments and mix well, then add the prescribed amount of microcrystalline cellulose and hydroxypropyl cellulose in turn, and mix thoroughly for another 30 minutes, then add the prescribed amount of magnesium stearate , and continue to mix for 5 minutes to obtain a uniform mixed powder. The obtained homogeneous mixed powder was pressed into 1000 tablets.

Embodiment 3

[0038] Element

[0039] Pass the crude drug and each auxiliary material in the above composition through an 80-mesh sieve for later use. Add the prescribed amount of pitavastatin calcium and yellow iron oxide in equal increments and mix well, then add the prescribed amount of microcrystalline cellulose and hydroxypropyl cellulose in turn, and mix thoroughly for 30 minutes, then add the prescribed amount of stearic acid Magnesium, continue mixing for 5 minutes to obtain a homogeneous mixed powder. The obtained homogeneous mixed powder was pressed into 1000 tablets.

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Abstract

The invention discloses a stable pitavastatin calcium pharmaceutical composition, at least one of zinc oxide, aluminium oxide and ferric oxide is taken as a stabilizing agent, and the obtained pitavastatin calcium pharmaceutical composition and a further-prepared preparation product both have good stability, and the dissolving-out property of the preparation accords with the medicinal standard.

Description

technical field [0001] The invention relates to a stable pharmaceutical composition and a preparation method thereof, in particular, the invention relates to a stable pitavastatin calcium pharmaceutical composition and a preparation method thereof. Background technique [0002] The chemical name of Pitavastatin Calcium (CAS147526-32-7) is (+)-bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)3 -quinolyl]-3,5-dihydroxy-6-heptenoic acid} monocalcium salt, molecular formula C50H46CaF2N2O8, molecular weight 880.98, its structural formula is as follows: [0003] [0004] Pitavastatin Calcium is a new type of statin blood lipid-lowering drug jointly developed by Nissan Chemical Co., Ltd. and Kowa Co., Ltd., which belongs to the third generation of statin drugs. Its preparation product was approved for marketing in Japan for the first time in July 2003. "Liqingzhi" (LIVALO) is mostly used clinically for the treatment of hypercholesterolemia and familial hypercholesterolemia. C...

Claims

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Application Information

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IPC IPC(8): A61K31/47A61K9/20A61K47/02A61P3/06
Inventor 张宣张小杰李洪陈金托杨贵
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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