Novel enteric controlled-release tablet preparation and preparation method thereof

A controlled-release preparation and enteric-coated technology, applied in the field of pharmaceutical preparations, can solve the problems of inconvenient multi-component drugs and unstable drugs, etc., and achieve the effects of long effective duration, good patient compliance, and good safety

Inactive Publication Date: 2010-03-03
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention provides a novel controlled-release formulation based on osmotic pump formulations, thereby overcoming the disadvantages that the existing osmotic pump formu...

Method used

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  • Novel enteric controlled-release tablet preparation and preparation method thereof
  • Novel enteric controlled-release tablet preparation and preparation method thereof
  • Novel enteric controlled-release tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The weight ratio of the drug tablet core to the semipermeable film coating is 1:0.035; the weight ratio of the drug tablet core to the semipermeable film coating to the enteric coating is 1:0.12. release tablet preparation, wherein:

[0053] The composition of the drug tablet core is: 22.5 parts of salvianolic acid B, 101 parts of microcrystalline cellulose, 30 parts of lactose, 60 parts of sodium chloride, 6 parts of povidone K30 and 1 part of magnesium stearate.

[0054] The composition of the semipermeable film coating is: 4 parts of cellulose acetate and 1 part of polyethylene glycol 1500.

[0055] The composition of the enteric coating is: 45 parts of acrylic resin No. I, 12 parts of liquid paraffin, 4 parts of diethyl phthalate, 12 parts of castor oil, 12 parts of Tween-80 and 15 parts of talcum powder.

[0056] The preparation method of the above-mentioned salvianolic acid B enteric-coated controlled-release tablet preparation comprises the following steps:

[...

Embodiment 2

[0064]The weight ratio of the drug tablet core to the semipermeable film coating is 1:0.05; the weight ratio of the drug tablet core to the semipermeable film coating to the enteric coating is 1:0.15. release tablet preparation, wherein:

[0065] The composition of the medicine tablet core is: 22.5 parts of salvianolic acid B, 105 parts of microcrystalline cellulose, 40 parts of lactose, 50 parts of sodium chloride, 6 parts of povidone K30 and 0.1 part of magnesium stearate.

[0066] The composition of the semipermeable film coating is: 3 parts of cellulose acetate and 1 part of polyethylene glycol 1500.

[0067] The composition of the enteric coating is: 55 parts of acrylic resin No. I, 10 parts of liquid paraffin, 5 parts of diethyl phthalate, 10 parts of castor oil, 10 parts of Tween-80 and 10 parts of talcum powder.

[0068] The preparation method of the above-mentioned salvianolic acid B enteric-coated controlled-release tablet preparation comprises the following steps: ...

Embodiment 3

[0076] The weight ratio of the drug tablet core to the semipermeable film coating is 1:0.02; the weight ratio of the drug tablet core to the semipermeable film coating to the enteric coating is 1:0.05. release tablet preparation, wherein:

[0077] The composition of the drug tablet core is: 22.5 parts of salvianolic acid B, 88 parts of microcrystalline cellulose, 25 parts of lactose, 80 parts of sodium chloride, 6 parts of povidone K30 and 10 parts of magnesium stearate.

[0078] The composition of the semipermeable film coating is: 12 parts of cellulose acetate and 1 part of polyethylene glycol 1500.

[0079] The composition of the enteric coating is: 50 parts of acrylic resin No. I, 9 parts of liquid paraffin, 6 parts of diethyl phthalate, 15 parts of castor oil, 8 parts of Tween-80 and 12 parts of talcum powder.

[0080] The preparation method of the above-mentioned salvianolic acid B enteric-coated controlled-release tablet preparation comprises the following steps:

[0...

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Abstract

The invention discloses a novel controlled-release preparation based on osmotic pump preparation and a preparation method thereof. The controlled-release preparation comprises a medicine tablet core containing active medicine, a semipermeable film coating coated on the outer layer of the medicine tablet core and provided with small holes, and an enteric coating arranged at the outermost layer, wherein the medicine tablet core comprises 20-70 parts of danshinolic acid B, 50-250 parts of loading agent, 1-120 parts of osmotic pressure accelerant, 1-20 parts of adhesive and 0.1-20 parts of lubricants; the semipermeable film coating comprises 3-15 parts of semipermeable film coating material and 1 part of plasticizer; and the enteric coating comprises 35-65 parts of enteric coating material, 10-35 parts of plasticizer, 5-15 parts of surface active agent and 10-25 parts of antiplastering aid. The preparation has reasonable composition, better controlled-release effect, long effective duration, little gastrointestinal tract side effects, few influences of individual difference, high safety, and excellent patient compliance, and only needs to be taken twice one day. The invention also discloses a danshinolic acid B enteric controlled-release tablet preparation and a preparation method thereof.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a novel enteric-coated controlled-release tablet preparation and a preparation method of the controlled-release tablet preparation. Background technique [0002] In 1974, Theeuwes proposed the concept and structure of the primary single-chamber osmotic pump, which made the osmotic pump preparation move towards industrial production and clinical application. The principle of osmotic pump preparation is to use the permeability of the drug itself and the effect of some osmotic pressure enhancers to provide power for drug release. When in use, water is sucked into the tablet from the semi-permeable membrane, so that a high osmotic pressure is formed in the tablet. , so that the saturated aqueous solution of the drug in the tablet is released from the small holes on the surface of the tablet; since the semipermeable membrane has no ductility, the volume in the membrane remai...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K9/22A61K31/343
Inventor 刘志东高秀梅张伯礼
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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