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Ranolazine oral sustained-release preparation and preparation method thereof

A technology of sustained-release preparations and sustained-release tablets, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve the problems of poor medication compliance, frequent administration, and short plasma half-life of patients.

Inactive Publication Date: 2010-02-03
FUREN PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because its solubility decreases with the increase of body fluid pH, and the plasma half-life of this product is short, which leads to the need for frequent administration during the treatment process and poor drug compliance of patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Ranolazine 200g

[0022] Hydroxypropyl Methylcellulose Phthalate 150g

[0023] Methylcellulose 100g

[0024] Microcrystalline Cellulose 50g

[0025] Polyvinylpyrrolidone K29 / 30 20g

[0026] Magnesium Stearate 15g

[0027] Makes 1000 pieces

[0028] Preparation:

[0029] The prescribed amount of ranolazine, hydroxypropyl methylcellulose phthalate, methylcellulose and microcrystalline cellulose were respectively crushed and passed through a 100-mesh sieve, mixed evenly, and an appropriate amount of anhydrous polyvinylpyrrolidone K29 was added Soft material made from ethanol, granulated, dried at 50°C, granulated, added with sodium carboxymethyl starch and magnesium stearate, mixed evenly, compressed into tablets, coated, to obtain.

[0030] Indications: Treatment of chronic stable angina.

[0031] Usage and dosage: 2-4 tablets each time, 2-3 times a day.

Embodiment 2

[0033] Ranolazine 300g

[0034] Hydroxypropyl Methylcellulose Phthalate 150g

[0035] Methylcellulose 75g

[0036] Microcrystalline Cellulose 30g

[0037] Polyvinylpyrrolidone K29 / 30 20g

[0038] Magnesium Stearate 10g

[0039] Makes 1000 pieces

[0040] Preparation:

[0041] The prescribed amount of ranolazine, hydroxypropyl methylcellulose phthalate, 75 mg of methylcellulose and microcrystalline cellulose were respectively pulverized and passed through a 100-mesh sieve, mixed evenly, and an appropriate amount of polyvinylpyrrolidone K29 was added without Soft material made of water and ethanol, granulated, dried at 50°C, granulated, added with sodium carboxymethyl starch and magnesium stearate, mixed evenly, compressed into tablets, coated, to obtain

[0042] Indications: Treatment of chronic stable angina.

[0043] Usage and dosage: 2-3 tablets each time, 2-3 times a day.

Embodiment 3

[0045] Ranolazine 350g

[0046] Hydroxypropyl Methylcellulose Phthalate 75g

[0047] Methylcellulose 40g

[0048] Microcrystalline Cellulose 20g

[0049] Polyvinylpyrrolidone K29 / 30 10g

[0050] Magnesium Stearate 5g

[0051] Preparation:

[0052] The prescribed amount of ranolazine, hydroxypropyl methylcellulose phthalate, methylcellulose and microcrystalline cellulose were respectively crushed and passed through a 100-mesh sieve, mixed evenly, and an appropriate amount of anhydrous polyvinylpyrrolidone K29 was added Soft material made of ethanol, granulated, dried at 50°C, granulated, added with sodium carboxymethyl starch and magnesium stearate, mixed evenly, compressed into tablets, coated, to obtain

[0053] Indications: Treatment of chronic stable angina.

[0054] Usage and dosage: 2-4 tablets each time, 2-3 times a day.

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PUM

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Abstract

The invention provides a Ranolazine oral sustained-release preparation and a preparation method. The Ranolazine oral sustained-release preparation comprises Ranolazine, a sustained-release skeleton material, a filling agent, an adhesive and a lubricating agent, and is characterized in that the weight of the Ranolazine is between 35 and 85 percent in the sustained-release preparation; a prescription composition is preferably selected according to a large number of experiments; hydroxypropyl methyl cellulose phthalate and methyl cellulose are served as the sustained-release skeleton material ofthe sustained-release preparation in the preferable weight ratio of 2:1-1.5; and microcrystalline cellulose is served as the filling agent; the 29 / 39 ethanol solution of polyvinyl pyrrolidone K is served as the adhesive, and magnesium stearate is served as the lubricating agent.

Description

Field of invention: [0001] The invention belongs to the field of pharmaceutical technology inventions, and relates to a slow-release preparation containing ranolazine and a preparation method thereof. technical background: [0002] Angina pectoris is a common symptom of coronary heart disease, and it is also an important signal to detect coronary heart disease. At present, the drugs commonly used to treat angina pectoris in China, such as propranolol, nifedipine, and pectoris, all have varying degrees of dependence on patients, complications or lead to primary disorders. An ideal antianginal drug should not only reduce myocardial metabolic oxygen demand, but also increase coronary blood flow, be effective for both symptomatic and asymptomatic myocardial ischemia, and be easily accepted by patients, allowing patients to maintain certain physical activities, and can When used in combination with other drugs, it should not cause tolerance, do not cause orthostatic hypotension,...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/28A61K31/495A61P9/10
Inventor 朱成功
Owner FUREN PHARMA GROUP
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