Pharmaceutical composition containing simvastatin

The technology of a pharmaceutical preparation and simvastatin, which is applied in the field of medicines for regulating blood lipids, can solve the problems of decreased content, poor chemical stability, undisclosed formula and stability data, etc., and achieves the effects of controlling degradation and improving stability.

Active Publication Date: 2007-07-11
ZHEJIANG JINGXIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, simvastatin is easy to oxidize, has poor chemical stability, and its content decreases after long-term storage.
When made into tablets, powder or other dosage forms, contact with excipients, such as binders, diluents, etc., may cause simvastatin to become unstable or reduce stability, affecting tablet quality
At present, some manufacturers claim that adding the antioxidant BHA (butylated hydroxyanisole) to the excipients can increase its stability, but the specific formula and stability data have not been disclosed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] prescription:

[0038] Element

weight%

Function

Simvastatin *

10％

active ingredient

BHA

0.3％

antioxidant

citric acid

10％

pH regulator

lactose

47.9％

Thinner

Sodium carboxymethyl cellulose

5％

disintegrant

microcrystalline cellulose

25％

Thinner

Propyl gallate

0.5％

antioxidant

Magnesium stearate

1％

lubricant

Polyvinylpyrrolidone K30(PVP)

0.3％

Adhesive

[0039] * The percentages in the above formulations are calculated for tablets containing 40 mg of simvastatin, which can be 5 mg, 10 mg, 20 mg or 40 mg.

[0040] Take BHA and propyl gallate according to the prescription amount, pour into 80% (v / v) ethanol solution containing 2% (w / v) PVP, stir to form solution A after it dissolves;

[0041] Weigh simvastatin, lactose, sodium carboxymethyl cellulose, microcrystalline cellulose, and citric acid ...

Embodiment 2

[0044] prescription:

[0045] Element

weight%

Function

Simvastatin *

9.56％

active ingredient

BHA

1.05％

antioxidant

lactic acid

11.94％

pH regulator

lactose

28.67％

Thinner

Sodium carboxymethyl cellulose

4.78％

disintegrant

microcrystalline cellulose

43％

Thinner

Magnesium stearate

1％

lubricant

[0046] * The percentages in the above formulations are calculated for tablets containing 40 mg of simvastatin, which can be 5 mg, 10 mg, 20 mg or 40 mg.

[0047] Weigh BHA according to the prescription amount, pour it into 50% ethanol solution containing lactic acid, stir until it dissolves to form solution A;

[0048] Weigh simvastatin, lactose, sodium carboxymethyl cellulose, and microcrystalline cellulose according to the prescription amount, mix them uniformly in equal amounts, granulate with the above solution A, ventilate...

Embodiment 3

[0051] prescription:

[0052] Element

weight%

Function

Simvastatin *

10.05％

active ingredient

BHA

1.51％

antioxidant

L(+) tartaric acid

11.56％

pH regulator

Sodium carboxymethyl starch

5.03％

disintegrant

microcrystalline cellulose

42.71％

Thinner

lactose

27.34％

Thinner

Magnesium stearate

1.0％

lubricant

Polyvinylpyrrolidone K30(PVP)

0.3％

Adhesive

Talc powder

0.5％

glidants, lubricants

[0053] * The percentages in the above formulations are calculated for tablets containing 40 mg of simvastatin, which can be 5 mg, 10 mg, 20 mg or 40 mg.

[0054] Weigh BHA according to the prescription amount, add it into a 60% ethanol solution containing L(+) tartaric acid and 5% (w / v) PVP, stir and wait for it to dissolve to form solution A;

[0055] Weigh simvastatin, microcrystalline cellulose, lactose, and carboxymethylcellulose so...

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PUM

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Abstract

The invention relates to a drug which contains Simvastatin, wherein it comprises active component as Simvastatin and drug findings. Said drug findings comprise acid pH adjuster whose consumption can reduce pH value not higher than 3. 5 as 2. 5-3. 2. The invention, via pH adjuster, oxidization resistance and other findings can effectively restrain the oxidzation of Simvastatin, with high stability.

Description

technical field [0001] The invention relates to a medicine for regulating blood lipid, in particular to a medicine preparation containing simvastatin. Background technique [0002] Simvastatin is a HMG-CoA (β-hydroxy, β-methyl-glutaryl-CoA) reductase inhibitor, which is the most important class of blood lipid regulating drugs. It reduces the synthesis of endogenous cholesterol by competitively inhibiting the early rate-limiting enzyme (HMG-CoA reductase) in cholesterol synthesis and metabolism. Its main site of action is in the liver, which can reduce blood cholesterol and low-density lipoprotein cholesterol levels, moderately reduce serum triglyceride levels and increase blood high-density lipoprotein levels. Therefore, it is a lipid-lowering drug with clear mechanism of action and definite curative effect. [0003] Currently on the market are simvastatin tablets and capsules, which are mainly used clinically to prevent and treat hyperlipidemia and coronary heart disease,...

Claims

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Application Information

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IPC IPC(8): A61K31/366A61K47/12A61P3/06
Inventor 陆伟根李军陈绍碧黄咸银
Owner ZHEJIANG JINGXIN PHARMA
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