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Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same

A technology of osmotic pump controlled release and salvianolic acid, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery. It can solve the problems of fast distribution, difficulty in maintaining effective blood drug concentration, and poor compliance. The effect of low requirements, prolonging the effective time of action, and simple preparation method

Active Publication Date: 2011-05-04
惠州市九惠药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after intravenous injection, salvianolic acid distributes quickly in the body and eliminates quickly, so it is difficult to maintain a long-term effective blood concentration.
If repeated intravenous injection, the compliance is also poor
At present, there is no technical report on salvianolic acid microporous osmotic pump controlled-release tablets

Method used

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  • Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same
  • Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same
  • Salvianolic acid controlled porosity osmotic pump tablets and method of preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 prepares tablet core materials according to the following formula:

[0029] Salvianolic acid 50 75 100mg

[0030] Sucrose 75 112.5 150mg

[0031] Lactose 75 112.5 150mg

[0032] Medicinal alcohol (95% ethanol) appropriate amount

[0033] Magnesium stearate 1.0 1.5 2mg

[0034] Wherein, the consumption of medicinal alcohol refers to pharmaceutical routines, as long as the purpose of making the tablet core material into a soft material can be achieved. All reagents are commercially available reagents commonly used in this field, and the following examples are the same.

[0035] Pass the materials for the tablet core through a 60-mesh sieve, mix evenly according to the proportion, add 95% ethanol soft material, pass through a 20-mesh sieve to granulate, dry at 40°C for 5 minutes, pass through a 20-mesh sieve for granulation, add lubricant and mix well, and use Press a 9.5mm punch to make a tablet core with a hardness of 6-7kg.

[0036] Prepare the coatin...

Embodiment 2

[0045] Embodiment 2 prepares tablet core materials according to the following formula:

[0046] Salvianolic acid 50 75 100mg

[0047] Lactose 75 112.5 150mg

[0048] Sodium chloride 75 112.5 150mg

[0049] Medicinal alcohol (95% ethanol) appropriate amount

[0050] Magnesium stearate 1.0 1.5 2mg

[0051] Pass the materials for the tablet core through a 60-mesh sieve, mix evenly according to the proportion, add 95% ethanol soft material, pass through a 20-mesh sieve to granulate, dry at 40°C for 5 minutes, pass through a 20-mesh sieve for granulation, add lubricant and mix well, and use Press a 9.5mm punch to make a tablet core with a hardness of 6-7kg.

[0052] Prepare the coating solution according to the following formula:

[0053] Cellulose acetate 30mg

[0054]Polyethylene glycol 400 6ml

[0055] Diethyl phthalate 9ml

[0056] Acetone 800ml

[0057] Isopropanol 200ml

[0058] Weigh 30 mg of cellulose acetate, measure 6 ml of polyethylene glycol 400, and 9 ml of d...

Embodiment 3

[0059] Embodiment 3 prepares tablet core material according to following formula:

[0060] Salvianolic acid 50 75 100mg

[0061] Mannitol 75 112.5 150mg

[0062] Sodium chloride 75 112.5 150mg

[0063] Appropriate amount of medicinal alcohol

[0064] Magnesium stearate 1.0 1.5 2mg

[0065] Pass the materials for the tablet core through a 60-mesh sieve, mix evenly according to the proportion, add soft materials made of anhydrous ethanol, pass through a 20-mesh sieve to granulate, dry at 40°C for 5 minutes, pass through a 20-mesh sieve for granulation, add lubricant and mix well, use Press a 9.5mm punch to make a tablet core with a hardness of 6-7kg / mm 2 .

[0066] Prepare the coating solution according to the following formula:

[0067] Cellulose acetate 30mg

[0068] Macrogol 400 9ml

[0069] Diethyl phthalate 3ml

[0070] Acetone 800ml

[0071] Isopropanol 200ml

[0072] Weigh 30 mg of cellulose acetate, 9 ml of polyethylene glycol 400, and 3 ml of diethyl phthalat...

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Abstract

The invention discloses a salvianolic acid micropore osmotic pump controlled release tablet, comprising a tablet core and a coating; the tablet core is composed of salvianolic acid bulk drug, controlled release supplementary material, lubricant and moderate anhydrous ethanol; the weight ratio of the salvianolic acid bulk drug, the controlled release supplementary material and the lubricant is 50:150:1; the coating is composed of cellulose acetate, polyethylene glycol 400 solution and diethyl ester phthalate. In the invention, on the basis of controlling the content of 50-90% of salvianolic acid B, the content of 5-15% of tanshinol, protocatechualdehyde, salvianolic acid C, etc. in raw materials and by the optimal screening of penetrating agent, pore-forming agent, plasticizer and film thickness, an osmotic pump controlled release tablet which releases 85%-95% of a drug for 12 hours and conforms to the release characteristic of zero order kinetics is successfully prepared and used for preparing the drug for treating coronary heart disease and cerebral arteriosclerosis, which is good for the drug to form steady blood concentration in a body and lengthening the effective acting time of the drug, thus having good clinical compliance and treatment quality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a salvianolic acid microporous osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] Salvianolic acid is a water-soluble active ingredient of traditional Chinese medicine Danshen, which is clinically used to treat coronary heart disease and cerebral arteriosclerosis. In terms of pharmacological activity, salvianolic acid has protective effects on the heart, protective effects on brain damage, inhibition of thrombus formation, good selectivity in anti-platelet aggregation, anti-cataract formation, and protective effects on liver and kidney damage. [0003] At present, the development of salvianolic acid in China is mainly concentrated in intravenous injection powder injection. However, after intravenous injection, salvianolic acid distributes quickly in the body and eliminates quickly, so it is diffi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/343A61K31/192A61P9/10
Inventor 高崇凯李宁徐文进
Owner 惠州市九惠药业有限公司
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