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Atorvastatin calcium dried suspension and preparation method thereof

A technology of atorvastatin calcium and dry suspension, which is applied in pharmaceutical formulations, drug delivery, metabolic diseases, etc., can solve the problems of clinical drug effect, difficulty in swallowing, low solubility, etc., and achieves good compliance and avoidance difficulties. Swallow, high bioavailability effect

Inactive Publication Date: 2010-02-03
FOSHAN DAYI TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral administration of such large doses can cause inconvenience to children, the elderly, and patients with dysphagia
In addition, atorvastatin calcium has a bitter taste, very low solubility in water, and is very sensitive to heat, humidity, low pH environments, and light
In addition, in an acidic environment, atorvastatin calcium will be degraded into the corresponding lactone, which will directly affect its clinical efficacy
[0005] Therefore, need a kind of novel atorvastatin calcium preparation to overcome problems such as patient's dysphagia that common tablet has on the market at present

Method used

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  • Atorvastatin calcium dried suspension and preparation method thereof
  • Atorvastatin calcium dried suspension and preparation method thereof

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preparation example Construction

[0026] The preparation method of the present invention preferably also includes: passing atorvastatin calcium through a 120 mesh sieve before step (1), and passing filler, suspending agent and / or suspending agent, flavoring agent, and lubricant 100 mesh sieve steps.

[0027] In the preparation method of the present invention, the mixing in step (1) is preferably carried out by crossing a 60 mesh-80 mesh sieve; the granulation in step (3) is preferably carried out by crossing a 18-24 mesh sieve; step ( The drying in 4) is preferably carried out by blast drying at 50°C until the water content in the granules is less than or equal to 1 part by weight; the granulation in step (5) is preferably carried out by passing the dried granules 18-24 mesh sieve method.

[0028] In the preparation method of the present invention, the wetting agent is preferably 40%-60% by volume ethanol aqueous solution.

[0029] In the preparation method of the present invention, before atorvastatin calci...

Embodiment 1

[0044] Pass atorvastatin calcium through a 120-mesh sieve, and pass the rest of the auxiliary materials through a 100-mesh sieve.

[0045] Take by weighing 10.0g (calculated as atorvastatin) atorvastatin calcium after sieving as main ingredient; take by weighing 10g sodium carboxymethylcellulose as suspending agent and / or suspending agent; 200g lactose as filler ; 2g aspartame, 30g stevioside and 3g citric acid as flavoring agent. Mix these materials evenly through a 60 mesh-80 mesh sieve, add 100ml of 50% by volume ethanol aqueous solution to the resulting mixture as a wetting agent to make a soft material, then granulate through a 18-24 mesh sieve, and then drum under 50°C. Air drying until the moisture content in the obtained material is less than or equal to 1 part by weight.

[0046] The dried material is passed through a 18-24 mesh sieve for granulation, and 2 g of magnesium stearate is added as a lubricant, mixed evenly, and packaged to obtain the atorvastatin calcium ...

Embodiment 2

[0048] Prepare the atorvastatin calcium dry suspension of embodiment 2 according to the method identical with embodiment 1, difference is to take by weighing 20.0g (calculated as atorvastatin) atorvastatin calcium as principal agent; Sodium methylcellulose and 10g crospovidone are used as suspending agent and / or suspending agent; 400g lactose is used as filler; 3g aspartame, 40g stevioside and 4g citric acid are used as flavoring agents; and 150l 50% by volume of ethanol aqueous solution is used as a wetting agent, and 4 g of magnesium stearate is used as a lubricant.

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Abstract

The invention relates to an atorvastatin calcium dried suspension and a preparation method thereof. The atorvastatin calcium dried suspension comprises the following components in portion by weight: 1to 10 portions of atorvastatin calcium, 10 to 95 portions of filling agent, 1 to 30 portions of suspension and / or suspending agent, 2 to 40 portions of flavoring agent, and 0.2 to 2.0 portions of lubricating agent. The atorvastatin calcium dried suspension has the advantages of high dispersity, even distribution, quick absorption, high bioavailability, good adaptability, good mouthfeel, stabilityand the like. The atorvastatin calcium dried suspension can be applied to regulation of blood fat.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an atorvastatin calcium dry suspension and a preparation method thereof. Background technique [0002] Cardiovascular disease is one of the most common and serious diseases that endanger human health (especially the health of middle-aged and elderly people). Dyslipidemia is an important risk factor for atherosclerosis, coronary heart disease and other cardiovascular and cerebrovascular diseases. Investigations show that hyperlipidemia among middle-aged and elderly people in my country has accounted for 7-8% of the total incidence. In our country, only 10% of adults with dyslipidemia receive lipid-lowering treatment, and less than 3% of them persist in treatment for a long time. [0003] Atorvastatin (Atorvastatin) and its salts belong to statin blood lipid regulating drugs, and are inhibitors of hydroxymethylglutaryl-CoA (HMG-CoA) reductase. It itself is inactive, but its hydrolyzate c...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/00A61K31/40A61P9/00A61P3/06A61P9/10
Inventor 陈宝林雍智全阴元魁陈皓赖观平韩为跃闻业磊
Owner FOSHAN DAYI TECH LTD
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