Pitavastatin soluble tablet composition and preparation method thereof

A technology of pitavastatin calcium and soluble tablets, applied in the directions of drug combination, active ingredients of heterocyclic compounds, pill delivery, etc., can solve problems such as singleness, limited use of pitavastatin calcium, no research reports on new dosage forms, etc., and achieve stable quality , Good drug dissolution effect

Inactive Publication Date: 2007-09-05
南京馗珂生物医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Experimental program
Comparison scheme
Effect test

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 After passing through an 80-mesh sieve, respectively, and adipic acid through a 120-mesh sieve, set aside.

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

[0035] Tablet compression: take the granules that have been reorganized and mixed evenly, calculate the weight of the tablet according to the measured pitavastatin calcium content, and punch ...

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PUM

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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 continuous improvement of people's living standards and the continuous acceleration of work rhythm, the incidence and mortality of cardiovascular diseases have been on the rise. The prevalence of hyperlipidemia is more than 7%, and there are about 90 million hyperlipidemia patients. The overall trend is that the north is larger than the south, and the city is larger than the rural area. Hyperlipidemia has become the number one killer that threatens human health. In the early days, the prevention and treatment of cardiovascular diseases in the medical field focused on the development of antihypertensive drugs. Later, it was gradually recognized that the concentration of plasma cholesterol, especially the concentration of low...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/47A61K9/20A61P3/06
Inventor 邢为藩
Owner 南京馗珂生物医药技术有限公司
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