Soft capsule of atovastatine salts and prepn. method therefor

A technology of atorvastatin and soft capsule, applied in the field of medicine, can solve the problems of instability, stability and reduction, and achieve the effects of easy storage and storage, high bioavailability and rapid dissolution

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

Therefore, it becomes unstable or less stable when formulated into dosage forms such as tablets or powders

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, the preparation specification is a soft capsule of 10 mg, based on the components contained in 1000 soft capsules:

[0027] 1. Capsule shell

[0028] Gelatin 80g

[0029] Glycerin 40g

[0030] Distilled water 100g

[0031] Ethylparaben 0.10g

[0032] Ferric oxide 2.0g

[0033] Microcrystalline Cellulose 0.10g

[0034] Sodium metabisulfite 1.0g

[0035] 2. Contents

[0036] Raw material name dosage

[0037] Atorvastatin salt

[0038] (calculated as atorvastatin) 10.0g

[0039] Starch 10.0g

[0040] Micronized silica gel 8.0g

[0041] Poloxamer 3.5g

[0042] Span-80 1.5g

[0043] Corn Oil 400.0g

Embodiment 2

[0044] Embodiment two, the preparation specification is the soft capsule of 80mg, calculated by the component contained in 1000 soft capsules:

[0045] 1. Capsule shell

[0046] Gelatin 120g

[0047] Glycerin 50g

[0048] Distilled water 120g

[0049] Ethylparaben 0.30g

[0050] Ferric oxide 4.0g

[0051] Microcrystalline Cellulose 1.0g

[0052] Vitamin E 5.0g

[0053] 2. Contents

[0054] Raw material name dosage

[0055] Atorvastatin salt

[0056] (calculated as atorvastatin) 80.0g

[0057] Starch 2.0g

[0058] Ethylcellulose 2.0g

[0059] Poloxamer 1.0g

[0060] Tween-80 1.0g

[0061] Castor oil 200.0g

Embodiment 3

[0062] Embodiment three, preparation specification is the soft capsule of 20mg, calculates with the component contained in 1000 soft capsules:

[0063] 1. Capsule shell

[0064] Gelatin 90g

[0065] Glycerin 42g

[0066] Distilled water 105g

[0067] Ethylparaben 0.15g

[0068] Ferric oxide 2.5g

[0069] Microcrystalline Cellulose 0.2g

[0070] Glycine 1.5g

[0071] 2. Contents

[0072] Raw material name dosage

[0073] Atorvastatin salt (calculated as atorvastatin) 20.0g

[0074] Starch 4.0g

[0075] Beeswax 3.0g

[0076] Poloxamer 1.5g

[0077] Span-80 2.5g

[0078] Soybean oil 350.0g

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Abstract

A soft capsule of lipitor salt with high stability and disintegrating speed is prepared from lipitor salt, auxiliary, and soft shell prepared from gelatin, glycerin, distilled water, ethylparaben, Fe2O3, microcrystalline cellulose and antioxidant. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method, in particular to an atorvastatin salt soft capsule 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 plasma cholesterol ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/40A61K47/34A61K47/38A61K47/10A61P3/06A61K47/26
Inventor 郭卫芹张育李国聪
Owner CSPC OUYI PHARM CO LTD
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