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Pitavastatin soluble tablet composition and preparation method thereof

A technology of pitavastatin calcium and soluble tablets, which is applied in the direction of drug combination, active ingredients of heterocyclic compounds, pill delivery, etc., can solve the problems of limiting the use of pitavastatin calcium, singleness, and no new dosage form research reports, etc., and achieve drug dissolution Good degree and stable quality effect

Inactive Publication Date: 2005-11-23
南京馗珂生物医药技术有限公司
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  • Summary
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AI Technical Summary

Problems solved by technology

[0004] Because pitavastatin calcium is almost insoluble in water, it is prone to configuration transformation under acidic conditions. At present, ordinary tablets of pitavastatin calcium are mainly used clinically. There are no better research reports on new dosage forms. Due to the singleness of dosage forms , limiting the clinical use of pitavastatin calcium

Method used

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Examples

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Embodiment 1

[0032] The preparation method of pitavastatin calcium soluble tablet:

[0033] Pretreatment of raw and auxiliary materials: erythritol, lactose, croscarmellose sodium, polyvinylpyrrolidone K 30 Pass through a 80-mesh sieve and adipic acid through a 120-mesh sieve respectively, and set aside.

[0034] Preparation of granules: mix erythritol, lactose, croscarmellose sodium, etc., and mix pitavastatin calcium and polyvinylpyrrolidone K 30 Add an appropriate amount of acetone to dissolve and make a solution, add it to the mixture of auxiliary materials, stir well to make a soft material, pass through a 40-mesh sieve for granulation, dry at 50°C for 3 hours, pass through a 20-mesh sieve for granulation, and then add adipic acid well mixed. Samples were taken for intermediate analysis.

[0035] Tablet compression: take the whole and mixed granules, calculate the tablet weight according to the measured pitavastatin calcium content, and punch the tablet with a 5mm shallow concave t...

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Abstract

The invention relates to a pitavastatin soluble tablet composition and preparation process wherein the composition is prepared from soluble medicinal auxiliary materials by a predetermined proportion, the composition becomes solution state in oral liquid, thus facilitating the dissolution, absorption and application of pitavastatin calcium.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition of a new dosage form of pitavastatin calcium and a preparation method thereof. Background technique [0002] In recent years, with the improvement of people's living standards and the continuous acceleration of the pace of work, the morbidity and mortality of cardiovascular diseases have shown an obvious upward trend. The incidence of hyperlipidemia among the middle-aged and elderly in western developed countries is as high as 60%. The prevalence of hyperlipidemia is more than 7%, and there are about 90 million hyperlipidemia patients. The general trend is that the north is larger than the south, and the city is larger than the countryside. Hyperlipidemia has become the number one killer threatening human health. The prevention and treatment of cardiovascular diseases in the early medical circles focused on the development of antihypertensive drugs, and la...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47
Inventor 邢为藩
Owner 南京馗珂生物医药技术有限公司
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