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Medicinal composition stabilized by base reagent containing pitavastatin calcium and preparation technology thereof

A technology of pitavastatin calcium and its composition, which is applied in the field of preparation of pharmaceutical compositions, and can solve problems such as pitavastatin calcium unstable compound, discoloration, and humidity instability

Active Publication Date: 2008-01-16
HAINAN SHENGKE LIFE SCI RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, pitavastatin calcium is an unstable compound, and when in an environment with a low pH, it is unstable even at low humidity and discoloration occurs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Preparation Process

[0019] Pitavastatin calcium is crushed through an 80-mesh sieve, mixed with microcrystalline cellulose PH101, lactose, calcium hydrogen phosphate, and low-substituted hydroxypropyl cellulose according to the prescription amount in a fast stirring granulator, granulated with water, and added after drying. Magnesium stearate compressed tablet, tablet weight is about 145mg. Coating with OPADRY II 85 G 68918, the weight gain is about 2% to 3%. It was made into a 5% suspension and the measured pH was 9.62.

Embodiment 2

[0022] Preparation Process

[0023] Pitavastatin calcium is crushed through a 80-mesh sieve, mixed with sodium bicarbonate, microcrystalline cellulose PH101, lactose, calcium hydrogen phosphate, and low-substituted hydroxypropyl cellulose in a fast-stirring granulator according to the prescribed amount, and then granulated with water. After drying, add magnesium stearate and mix in a V-type mixer, fill capsules with a loading capacity of about 142 mg, make it into a suspension with a concentration of 5%, and measure the pH value to be 9.43.

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PUM

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Abstract

The invention provides a drug compound containing Pitavastatin, pH regulator and other excipient and the preparation process. The invention is characterized in that the pH regulator is chosen from calcium hydrogenphosphate and sodium bicarbonate; the pH of the water solution or suspension of the compound is more than 9 but less than 10, ensuring the stability of the preparation.

Description

technical field [0001] The invention relates to a preparation process of a pharmaceutical composition. In particular, the present invention relates to a compound containing pitavastatin calcium (chemical name (E)-3,5-dihydroxy-7-[4'-4"-fluorobenzene) whose stability is changed depending on the pH value. Base-2'-cyclopropyl-quinolin-3'-yl]-6-calcium heptenoate) pharmaceutical composition and preparation process. Background technique [0002] Cardiovascular and cerebrovascular diseases are the main diseases affecting human health today. In my country, with the improvement of people's living standards, the incidence and mortality of coronary heart disease, hypertension, angina pectoris, hyperlipidemia and other circulatory system diseases continue to rise, becoming life-threatening number one killer. There are more than 140 million people over the age of 65 in my country, and more than half of them have cardiovascular and cerebrovascular diseases. Including people of other age...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47A61K9/20A61K9/48A61P3/06A61P9/10
Inventor 李铮
Owner HAINAN SHENGKE LIFE SCI RES INST
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