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Diltiazem hydrochloride delayed release bilayer osmotic pump controlled released tablet and its preparation method

A controlled-release technology of diltiazem hydrochloride and osmotic pumps, which is applied in the fields of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc., and can solve the problems of low blood drug concentration, short maintenance time of blood drug concentration, and no chronological rhythm of blood pressure fluctuations. Pertinence and other issues to achieve the effect of maintaining blood drug concentration

Inactive Publication Date: 2012-06-06
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the controlled-release preparation of diltiazem hydrochloride has the characteristics of sustained release, the drug can be slowly absorbed into the blood circulation and exert a mild and long-lasting pharmacological effect, but it can only maintain a relatively low and gentle blood concentration, and has no effect on the chronological rhythm of blood pressure fluctuations. Sex is not targeted

Method used

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  • Diltiazem hydrochloride delayed release bilayer osmotic pump controlled released tablet and its preparation method
  • Diltiazem hydrochloride delayed release bilayer osmotic pump controlled released tablet and its preparation method
  • Diltiazem hydrochloride delayed release bilayer osmotic pump controlled released tablet and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Tablet prescription:

[0031]

[0032] Preparation Process:

[0033] Pass the prescribed amount of medicine, polyoxyethylene with a molecular weight of 200,000, and mannitol through a 80-mesh sieve, mix evenly, use absolute ethanol as a binder to make a soft material, granulate with a 20-mesh sieve, and dry the wet granules through a 18-mesh sieve Granules, dry granules and lubricants are mixed to obtain the drug layer, and the same method will obtain the booster layer. The tablet core is obtained by compressing the two layers of auxiliary materials twice. Dissolve polyvinyl alcohol and polyethylene glycol with an average molecular weight of 10,000 in a mixed solvent of acetone and water and disperse evenly; dissolve cellulose acetate and polyethylene glycol with an average molecular weight of 4,000 in acetone and water respectively and mix evenly . Use a coating pan to first coat the tablet core with an isolation coat with a weight gain of 20%, and then coat the ...

Embodiment 2

[0035] Tablet prescription:

[0036]

[0037] Preparation Process:

[0038] Pass the prescribed amount of medicine, polyoxyethylene with a molecular weight of 200,000, and sodium chloride through an 80-mesh sieve, mix evenly, use absolute ethanol as a binder to make a soft material, and granulate with a 20-mesh sieve. After the wet granules are dried, the 18-mesh Sieve the granules, and mix the dry granules with a lubricant to obtain the drug layer. The same method will obtain the booster layer. The tablet core is obtained by compressing the two layers of auxiliary materials twice. Dissolve polyvinylpyrrolidone and polyethylene glycol with an average molecular weight of 10,000 in a mixed solvent of acetone and water and disperse evenly; dissolve cellulose acetate and polyethylene glycol with an average molecular weight of 4,000 in acetone and water and mix evenly . Use a coating pan to first coat the tablet core with an isolation coat with a weight gain of 20%, and then ...

Embodiment 3

[0040] Tablet prescription:

[0041]

[0042] Preparation Process:

[0043]Pass the prescribed amount of medicine, polyoxyethylene with a molecular weight of 200,000, and sodium chloride through an 80-mesh sieve, mix evenly, use absolute ethanol as a binder to make a soft material, and granulate with a 20-mesh sieve. After the wet granules are dried, the 18-mesh Sieve the granules, and mix the dry granules with a lubricant to obtain the drug layer. The same method will obtain the booster layer. The tablet core is obtained by compressing the two layers of auxiliary materials twice. Dissolve hypromellose and polyethylene glycol with an average molecular weight of 10,000 in a mixed solvent of acetone and water and disperse evenly; dissolve cellulose acetate and polyethylene glycol with an average molecular weight of 4,000 in acetone and water and well mixed. Use a coating pan to first coat the tablet core with an isolation coat with a weight gain of 20%, and then coat the o...

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Abstract

Belonging to the technical field of medicinal preparations, the invention discloses a diltiazem hydrochloride delayed release bilayer osmotic pump controlled released tablet and its preparation method. The preparation is composed of a diltiazem hydrochloride-containing tablet core, a water-soluble polymeric membrane, and a semipermeable coating membrane with drug release holes. The table core comprises a drug-containing layer, which is made up of 12g of diltiazem hydrochloride, 0.5-8g of an osmotic pressure active material, 10g-30g of a suspension, and 0.2g-0.7g of a lubricant, and a boosting layer composed of 5g-15g of a swelling agent and 0.5g-5g of an osmotic pressure active material. The water-soluble polymeric membrane contains 50g-100g of a polymer material. The semipermeable coating membrane is made of 10-20g of a semipermeable polymer material and 2g-6g of a water-soluble pore forming agent. The water-soluble polymeric isolating membrane accounts for 12%-50% of the weight of the tablet core, and the coating membrane accounts for 6%-12% of the weight of the tablet core. And two drug release holes are disposed on sides of the drug-containing layer in a coated tablet. Characterized by constant speed and delayed release, the controlled released tablet of the invention can generate stable plasma concentration, improve patient compliance, and reach good lipid regulating effect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to diltiazem hydrochloride delayed-release double-layer osmotic pump controlled-release tablets and a preparation method thereof. Background technique [0002] Diltiazem Hydrochloride is a calcium ion channel blocker, and its effect is related to the inhibition of calcium ion influx when the myocardium and vascular smooth muscle are depolarized. It can effectively dilate the epicardial and subendocardial coronary arteries, relieve spontaneous angina pectoris or angina pectoris caused by ergotine-induced coronary artery spasm; reduce myocardial oxygen demand, increase exercise tolerance and Relieve exertional angina. It can relax vascular smooth muscle, reduce peripheral vascular resistance, and lower blood pressure. The magnitude of its blood pressure reduction is related to the degree of hypertension, and those with normal blood pressure only slightly lower bloo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/32A61K9/36A61K47/32A61K47/34A61K47/36A61K47/38A61K31/554A61P9/10A61P9/12
Inventor 潘卫三
Owner SHENYANG PHARMA UNIVERSITY
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