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Pharmaceutical composition containing atorvastatin calcium

A technology of atorvastatin calcium and its composition, which is applied in the field of medicine, can solve problems affecting clinical drug efficacy, delayed disintegration and slow dissolution of atorvastatin calcium tablets, and achieves simple and easy production operations and stable products Good performance and complete dissolution effect

Inactive Publication Date: 2018-01-26
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Atorvastatin calcium tablets have problems such as delayed disintegration and slow dissolution, which directly affect its clinical efficacy

Method used

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  • Pharmaceutical composition containing atorvastatin calcium
  • Pharmaceutical composition containing atorvastatin calcium
  • Pharmaceutical composition containing atorvastatin calcium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] prescription

[0064]

[0065] Preparation

[0066] (1) After mixing 10 g of atorvastatin calcium and 10 g of anhydrous lactose, carry out microwave vacuum drying;

[0067] (2) crush the mixture of atorvastatin calcium and anhydrous lactose obtained in step (1), pass through an 80-mesh sieve, and set aside;

[0068] (3) After passing the remaining 40g of anhydrous lactose, 4g of dry starch, and 1.8g of micropowdered silica gel through an 80-mesh sieve, set aside;

[0069] (4) Anhydrous lactose, dry starch, and micropowdered silica gel sieved in step (3), step (2)

[0070] The resulting mixture is poured into a mixer for mixing;

[0071] (5) pulverize the mixture of step (4), and cross 80 mesh sieves;

[0072] (6) Add gelatin to the granules obtained in step (5) as a binder, mix, granulate, and compress into tablets.

Embodiment 2

[0074] prescription

[0075]

[0076] Preparation

[0077] (1) After mixing 15g of atorvastatin calcium and 15g of anhydrous lactose, carry out microwave vacuum drying;

[0078] (2) crush the mixture of atorvastatin calcium and anhydrous lactose obtained in step (1), pass through an 80-mesh sieve, and set aside;

[0079] (3) Pass 30g of anhydrous lactose, 8g of sodium carboxymethyl starch, and 2.8g of talc through an 80-mesh sieve respectively, and set aside;

[0080] (4) The anhydrous lactose, sodium carboxymethyl starch, talcum powder sieved in step (3), and the mixture obtained in step (2) are poured into a mixer for mixing;

[0081] (5) pulverize the mixture of step (4), and cross 80 mesh sieves;

[0082] (6) Add gelatin to the granules obtained in step (5) as a binder, mix, granulate, and compress into tablets.

Embodiment 3

[0084] prescription

[0085]

[0086]

[0087] Preparation

[0088] (1) After mixing 20 g of atorvastatin calcium and 10 g of anhydrous lactose, carry out microwave vacuum drying;

[0089] (2) crush the mixture of atorvastatin calcium and anhydrous lactose obtained in step (1), pass through a 100-mesh sieve, and set aside;

[0090] (3) Pass 30g of anhydrous lactose, 12g of low-substituted hydroxypropyl cellulose, and 2.5g of micropowder silica gel through a 100-mesh sieve respectively, and set aside;

[0091] (4) Pour the remaining amount of anhydrous lactose, low-substituted hydroxypropyl cellulose, micronized silicon after sieving, and the mixture obtained in step (2) into a mixer for mixing;

[0092] (5) The mixture of step (4) is pulverized and passed through a 100-mesh sieve;

[0093] (6) Add gelatin to the granules obtained in step (5) as a binder, mix, granulate, and compress into tablets.

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PUM

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Abstract

The invention specifically relates to a pharmaceutical composition containing atorvastatin calcium, belonging to the field of medical technology. The pharmaceutical composition contains atorvastatin calcium, a filler, a disintegrating agent, a lubricant, anhydrous lactose and gelatin. The pharmaceutical composition of the invention has good stability, complete dissolution and more excellent product quality; and a production method for the pharmaceutical composition is easy and practical to operate and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing atorvastatin calcium and a preparation method of tablets thereof. Background technique [0002] Atorvastatin calcium, chemical name: 7-[2-(4-fluorophenyl)-3-phenyl-4-(anilinoformyl)-5-(2-propyl)pyrrol-1-yl] Calcium -3,5-dihydroxyheptanoate; [R,(R*,R*)]-2-(4-fluorophenyl)-Β,Α-dihydroxy-5-(1-methylethyl) -3-Phenyl-[(anilino)-hydroxy]-1H-pyrrole-1-heptanoate calcium salt (2:1), a 3-hydroxy-3-methylglutaryl-CoA reductase (HMG-CoA reductase) inhibitor for hypercholesterolemia and hyperlipidemia. [0003] Atorvastatin calcium is a sensitive and unstable substance to heat, moisture, light and low pH, and is very slightly soluble in water. Under the above conditions, atorvastatin calcium changes from carboxylic acid form to lactone form (US5686104 ; Hurley, T.R. et al., Tetrahedron (1993), 49, 1979-1984). Atorvastatin calcium tabl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/40A61K47/26A61K47/42A61P3/06
Inventor 马小涛于乐刘春梅宋丽影徐璐
Owner 长春海悦药业股份有限公司
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