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Pitavastatin calcium composition stabilized by using alkaline reagent and preparation method thereof

A technology of pitavastatin calcium and alkaline reagent, which is applied in the directions of drug combination, active ingredients of heterocyclic compounds, metabolic diseases, etc. good effect

Inactive Publication Date: 2010-11-24
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] According to experimental research, the stability of the pharmaceutical composition of pitavastatin calcium is particularly poor without the addition of alkaline reagents, and its stability cannot be improved by adding calcium hydrogen phosphate and / or sodium bicarbonate to the pharmaceutical composition.

Method used

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  • Pitavastatin calcium composition stabilized by using alkaline reagent and preparation method thereof
  • Pitavastatin calcium composition stabilized by using alkaline reagent and preparation method thereof
  • Pitavastatin calcium composition stabilized by using alkaline reagent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] prescription:

[0022]

[0023] Preparation Process:

[0024] (1) Pitavastatin calcium was crushed through a 100-mesh sieve for use, and other excipients were passed through a 80-mesh sieve for use.

[0025] (2) The pitavastatin calcium and magnesium oxide of the recipe quantity are weighed and mixed with lactose in equal amounts, then the carboxymethyl starch sodium and calcium hydrogen phosphate of the prescription quantity are added, and the material I is mixed uniformly.

[0026] (3) Add an appropriate amount of water to material I, mix well, and pass through a 20-mesh sieve to obtain wet granules.

[0027] (4) Dry the wet granules in an oven at 50°C with air blast.

[0028] (5) The dry granules are granulated with a 20-mesh sieve, weighed, and the magnesium stearate in the prescription ratio is added and mixed evenly.

[0029] (6) Punch the sheet with a shallow concave of φ7mm.

[0030] (7) Prepare a coating solution with OPADRY Y-1-7000, coat and dry, and t...

Embodiment 2

[0032] prescription:

[0033]

[0034] Preparation Process:

[0035] (1) Pitavastatin calcium was crushed through a 100-mesh sieve for use, and other excipients were passed through a 80-mesh sieve for use.

[0036] (2) Take by weighing the pitavastatin calcium of recipe quantity and magnesium oxide mix to obtain material I, mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose are mixed uniformly to obtain material II, and material I and material II are equally delivered Add and mix evenly to obtain material III.

[0037] (3) Add an appropriate amount of water to the material III, mix well, and pass through a 18-mesh sieve to obtain wet granules.

[0038] (4) Dry the wet granules in an oven at 50°C with air blast.

[0039] (5) The dry granules are granulated with a 20-mesh sieve, weighed, and the magnesium stearate in the prescription ratio is added and mixed evenly.

[0040] (6) Punch the sheet with a shallow concave of φ8mm.

[0041] (7) Pr...

Embodiment 3

[0043] prescription:

[0044]

[0045] Preparation Process:

[0046] (1) Pitavastatin calcium was crushed through a 100-mesh sieve for use, and other excipients were passed through a 80-mesh sieve for use.

[0047] (2) Take by weighing the pitavastatin calcium of recipe quantity and magnesium oxide mix to obtain material I, microcrystalline cellulose, sucrose, cross-linked povidone and micropowder silica gel mix homogeneously to obtain material II, and material I and material II are equally delivered Add and mix evenly to obtain material III.

[0048](3) Fill capsules with material III, and pack.

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PUM

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Abstract

The invention relates to a medicinal composition, in particular to a pitavastatin calcium composition stabilized by using an alkaline reagent and a preparation method thereof. The pitavastatin calcium composition is characterized in that: the alkaline reagent is magnesium oxide, the pH of the aqueous solution or the suspension of the magnesium oxide is more than 9 and less than 12, and the alkaline reagent can remarkably improve the stability of the pitavastatin calcium composition. The pitavastatin calcium composition is suitable for long-term storage and has good clinical effect. The preparation method for the pitavastatin calcium composition is simple, convenient to operate and suitable for industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pitavastatin calcium composition stabilized with an alkaline agent and a preparation method thereof. Background technique [0002] The chemical name of Pitavastatin Calcium is (+)-bis{(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl] -3,5-dihydroxy-6-heptanoic acid} monocalcium salt is a new type of statin hypolipidemic drug jointly developed by Nissan Chemical Industry Co., Ltd. and Kowa Co., Ltd., which was approved for marketing in Japan for the first time in July 2003. The dosage form on the market is tablet, and the trade name of domestically imported pitavastatin calcium tablets is "Liqingzhi", and the indications are hypercholesterolemia and familial hypercholesterolemia. Pitavastatin Calcium is a third-generation statin drug. Compared with other statin drugs, it can effectively reduce LDL-C and TG levels, with "excellent" pharmacokinetic indicators, long half-...

Claims

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Application Information

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IPC IPC(8): A61K31/47A61K47/02A61P3/06
Inventor 胡淑娟毕华张志芳
Owner 北京华禧联合科技发展有限公司
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