Quick-disintegration tablets of calcium atovastatine, and its prepn. method

A technology of atorvastatin calcium and disintegrant, applied in the field of medicine, can solve the problems of delayed disintegration of ordinary tablets, affecting clinical efficacy, inconvenience and the like

Active Publication Date: 2007-02-14
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The clinical use of atorvastatin calcium has definite curative effect and significant effect, but because atorvastatin calcium has a bitter taste and is slightly soluble in water, it is highly sensitive to heat, humidity, low pH environment and light, especially in acid environment , Atorvastatin calcium will be degraded into corresponding lactones, and its ordinary tablets have problems such as delayed disintegration and slow dissolution, which directly affect its clinical efficacy
In addition, in clinical practice, the initial dose of atorvastatin calcium is 10mg (one capsule) a day, and as the treatment time goes on, the dosage range is 10-60mg (1-6 capsules). Taken orally, it is also inconvenient for children, the elderly, or patients with swallowing difficulties

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1, prepare 1000 atorvastatin calcium tablets whose specification is 10 mg / tablet, the consumption of each component is as follows:

[0033] Atorvastatin calcium (calculated as atorvastatin) 10.0g

[0034] Microcrystalline cellulose (added inside) 50g

[0035] Microcrystalline cellulose (extra) 25g

[0036] 80g pregelatinized starch

[0037] PVPP (inside) 15g

[0038] PVPP (extra) 5g

[0039] Sodium Lauryl Sulfate 2g

[0040] Sweet Orange Powder Flavor 2g

[0041] Talc powder 3g

[0042] 5% pvp aqueous solution appropriate amount

Embodiment 2

[0043] Embodiment two, prepare 1000 atorvastatin calcium tablets of the present invention whose specification is 20 mg / tablet, the consumption of each component is as follows:

[0044] Atorvastatin calcium (calculated as atorvastatin) 20.0g

[0045] Microcrystalline cellulose (added inside) 40g

[0046] Microcrystalline cellulose (extra) 20g

[0047] Lactose 50g

[0048] PVPP (inside) 30g

[0049] PVPP (extra) 10g

[0050] Sodium Lauryl Sulfate 10g

[0051] Cyclamate 10g

[0052] Magnesium Stearate 10g

[0053] 5% pvp aqueous solution appropriate amount

Embodiment 3

[0054] Embodiment three, prepare 1000 atorvastatin calcium tablets whose specification is 40 mg / tablet, the consumption of each component is as follows:

[0055] Atorvastatin calcium (calculated as atorvastatin) 40.0g

[0056] Microcrystalline cellulose (added inside) 36.5g

[0057] Microcrystalline cellulose (extra) 18.2g

[0058] Powdered sugar 93.1g

[0059] PVPP (inside) 45g

[0060] PVPP (extra) 15g

[0061] Sodium Lauryl Sulfate 5g

[0062] Glycyrrhizin 5.32g

[0063] Silicon dioxide 7.98g

[0064] 5% pvp aqueous solution appropriate amount

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PUM

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Abstract

A fast disintegrated atorvastin calcium tablet is prepared from atorvastin calcium, disintegrant, flavouring, filler and lubricant proportionally. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method, in particular to a rapidly disintegrating atorvastatin calcium tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Atorvastatin (Atorvastatin Calcium) is a selective and competitive inhibitor of 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase, which is a rate-limiting An enzyme that converts 3-hydroxy-3-methyl-glutaryl-CoA to mevalonate (a precursor of sterols including cholesterol). Triglycerides and cholesterol are combined in the liver to form very low-density lipoprotein cholesterol (VLDL) and released into the plasma for further transport to surrounding tissues. Low-density lipoprotein cholesterol (LDL) is formed from very low-density lipoprotein cholesterol (VLDL) and is catabolized primarily by high-affinity low-density lipoprotein cholesterol (LDL) receptors. [0003] Atorvastatin reduces ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/40A61K47/38A61K47/20A61P3/06
Inventor 郭卫芹张育李国聪魏树辉
Owner CSPC OUYI PHARM CO LTD
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