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Pravastatin sodium tablet as well as application and preparation method thereof

A technology of pravastatin sodium and tablets, which is applied in the field of medicine, can solve problems such as difficulties in tablet production and affect product quality, and achieve the effects of facilitating storage and transportation, high stability, and improving stability

Active Publication Date: 2012-05-30
LIVZON PHARM GRP INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Pravastatin sodium is very sensitive to acidic environment, and it is easy to form lactone and various isomers, which will affect product quality
Therefore, in actual production, it is relatively difficult to obtain tablet products whose stability meets the requirements.

Method used

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  • Pravastatin sodium tablet as well as application and preparation method thereof
  • Pravastatin sodium tablet as well as application and preparation method thereof
  • Pravastatin sodium tablet as well as application and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The present embodiment provides a preferred prescription of pravastatin sodium tablet of the present invention:

[0033] Pravastatin Sodium 100g

[0034] Mannitol 724g

[0035] 750g microcrystalline cellulose

[0036] PVP K30 84g

[0037] Sodium Carboxymethyl Cellulose 84g

[0038] Titanium dioxide 100g

[0039] Magnesium Oxide 100g

[0040] Magnesium Stearate 17g

[0041] Made into 10000 pieces

[0042] The prepared pravastatin sodium tablet has a specification of 10 mg and a clinical dosage of 10-40 mg.

Embodiment 2

[0044] The present embodiment provides a preferred prescription of pravastatin sodium tablet of the present invention:

[0045] Pravastatin Sodium 300g

[0046] Mannitol 2172g

[0047] Microcrystalline Cellulose 2250g

[0048] PVP K30 252g

[0049] Sodium Carboxymethyl Cellulose 252g

[0050] Titanium dioxide 300g

[0051] Magnesium Oxide 300g

[0052] Magnesium Stearate 51g

[0053] Made 30000 pieces

[0054] The prepared pravastatin sodium tablet has a specification of 10 mg and a clinical dosage of 10-40 mg.

Embodiment 3

[0056] Pravastatin sodium tablet of the present invention adopts the method preparation of direct compression tablet, and its specific operation steps are as follows:

[0057] According to the formula of embodiment 1 or 2, the pravastatin sodium of the stated amount of the formula is first mixed with the magnesium oxide of the stated amount of the formula, after dropping into the HLSG20A wet mixing granulator and mixing uniformly, then adding 600 grams of mannitol and mixing, Add the remaining mannitol and mix evenly, then add microcrystalline cellulose, PVP K30, sodium carboxymethyl cellulose, and magnesium stearate in the amount specified in the formula and mix for 5 minutes, then discharge. The mixed material is directly compressed using a ZP-12 rotary tablet press. Plain tablets can be sold directly on the market, or choose Opadry 85G68918 as the coating material, and use BG-5 high-efficiency coating machine to coat the film (inlet air temperature 50°C, tablet bed temperat...

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PUM

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Abstract

The invention provides a pravastatin sodium tablet as well as application and a preparation method thereof. The pravastatin sodium tablet contains pravastatin sodium, mannitol as filler, a basifier, a caking agent and a lubricating agent. The pravastatin sodium tablet is prepared by using a direct tablet compressing method, has higher stability and is beneficial to the storage and the transportation of medicines.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular, the invention relates to a pravastatin sodium tablet, its application and its preparation method. Background technique [0002] Pravastatin sodium is an HMG-CoA reductase inhibitor, and is a hydrophilic statin hypolipidemic drug (US 4,346,227). Pravastatin (pravastatin, Pravachol) was developed by Sankyo Corporation of Japan, and was first launched in Japan in 1989 under the trade name "Mevalotin". In 1996, the global sales volume was 950 million US dollars, with an annual growth rate of 2%. With the permission of Sankyo, Bristol-Myers Squibb's pravastatin sodium, with the trade name "Pravachol", is suitable for primary hypercholesterolemia that cannot be controlled by dietary restrictions or combined with high triglycerides patients with hemorrhage. [0003] Pravastatin sodium is very sensitive to acidic environment, and it is easy to form lactone and various isomers, which wil...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/22A61P3/06
Inventor 石海涛马小玲龙春容
Owner LIVZON PHARM GRP INC
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