Atorvastatin calcium tablet

A technology of atorvastatin calcium and tablets, which is applied in the directions of pill delivery, metabolic diseases, active ingredients of heterocyclic compounds, etc., can solve the problems of increased drug production cost, poor tablet stability, indigestion, etc. The effect of rapid dissolution, stable quality and low packaging cost

Active Publication Date: 2012-01-11
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Abstract
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  • Claims
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AI Technical Summary

Problems solved by technology

Its preparation method adopts wet granulation, and uses a large amount of disintegrants, resulting in poor stability of the prepared tablet, producing more related substances, and the increase of related substances is relatively fast during long-term storage at room temperature
CN1630510A (Atorvastatin calcium in pharmaceutical form, its composition and pharmaceutical formulation containing atorvastatin calcium, published on June 22, 2005) discloses an atorvastatin calcium prepared by wet granulation Tablets, and add alkaline substance calcium carbonate as a stabilizer to ensure the stability of the preparation, but the addition of calcium carbonate will cause adverse reac...

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  • Atorvastatin calcium tablet

Examples

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Effect test

Embodiment 5

[0052] Example 5 Stability Study of Atorvastatin Calcium Tablets

[0053] The tablets (specification 20mg) prepared in Examples 1-4 of the present invention and the tablets (control group) prepared in Example 1 of CN1911209A were placed under accelerated conditions (temperature 40°C, relative humidity 75% ± 5 %), the stability study was carried out for 6 months.

[0054] The detection method of related substances is in accordance with high performance liquid chromatography (Appendix VD of Chinese Pharmacopoeia 2010 Edition). Among them, chromatographic conditions and system adaptability test: use octylsilane bonded silica gel as filler, acetonitrile-0.05mol / L citric acid (50:50) (adjust pH 4.0 with ammonia water) as mobile phase, detection wavelength 244nm, the number of theoretical plates is not less than 4000 based on atorvastatin. Determination method: Take an appropriate amount of fine powder of this product (approximately equivalent to C 33 h 35 FN 2 o 5 12.5mg), pu...

Embodiment 6

[0058] Example 6 Disintegration time limit and dissolution rate investigation of atorvastatin calcium tablet

[0059] (1) Determination of disintegration time limit

[0060] Take 6 atorvastatin calcium tablets (specification 20mg) prepared in Examples 1-4 of the present invention, put them in a 250ml beaker, add 100ml of water at 15-25°C, shake for 3 minutes, and measure the disintegration time limit. See Table 2 for test results.

[0061] sample Sheet hardness (N) Disintegration time limit (s) Example 1 55-60 68-74 Example 2 53-58 71-75 Example 3 55-59 72-81 Example 4 54-56 68-76

[0062] According to the test results in Table 2, it can be seen that the hardness of the atorvastatin calcium tablet prepared by the present invention reaches 50-60N, and in 15-25°C water, it disintegrates completely within 80s and passes through the No. 2 sieve. This shows that the tablet of the present invention disinte...

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Abstract

The invention which relates to an atorvastatin calcium tablet for treating hyperlipidemia belongs to the technical field of western medicine preparations. In the tablet, the weight ratio of atorvastatin calcium: a filler: a disintegrant: a lubricant is 1:8-15:0.5-1.5:0.1-0.3. The tablet of the present invention has the advantages of stable quality, rapid disintegration and leaching, moderate tablet hardness, and simple preparation technology.

Description

Technical field [0001] The present invention belongs to the field of western medicine preparation technology, and specially involves a Atorvastatin calcium tablets that treat hyperlipidemia. Background technique [0002] With the continuous development of life science, people generally recognize that the high content of cholesterol and fat is the basic cause of cardiovascular disease. Hyperlipidemia is the main risk factors for coronary heart disease and hypertension.Therefore, researchers began to take the development of blood lipid regulatory drugs as the focus of cardiovascular disease.Since the end of the 1980s, a large number of lower blood lipid drugs were launched. Among them, his citine drugs were well received, and its clinical efficacy was not comparable to all kinds of regulatory blood lipid drugs.For more than a decade, the completion of several international large -scale coronary heart disease prevention tests have confirmed that statins can reduce the incidence and ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/40A61P3/06
Inventor 不公告发明人
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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