Sustained-release agent of nitric acid dinitrate and preparation method thereof

A technology of isosorbide dinitrate and sustained-release preparations, which is applied in the field of drug sustained-release preparations, can solve the problems of short time, usually 1.8 to 2 hours, increased difficulty and inconvenience when going out, and difficulty in preventing sudden onset, etc. Therapy and self-prevention of sudden onset are reliable and the effect of protecting daily life

Active Publication Date: 2008-05-21
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patients with angina pectoris often develop symptoms at 1 to 3 o'clock at night (morning peak period) and after the patient wakes up (morning peak period). Due to the short half-life of ordinary tablet drugs, generally 1.8 to 2 hours, the drug effect lasts for a short time and requires several times a day. Repeated administratio

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Sustained-release tablet of the present invention is formulated by the raw material of following weight ratio:

[0024] Isosorbide Dinitrate 10%

[0025] Hypromellose (E4M) 15%

[0026] Sodium Carboxymethyl Cellulose 10%

[0027] Microcrystalline Cellulose 30%

[0028] Lactose 30%

[0029] Micronized silica gel 4%

[0030] Magnesium Stearate 1%

[0031] Wherein, hypromellose (E4M) and sodium carboxymethylcellulose are sustained-release agents, lactose and microcrystalline cellulose are fillers, and micronized silica gel and magnesium stearate are lubricants.

[0032] Crushing, sieving, weighing and mixing of raw and auxiliary materials, granulating, and tableting, and crushing isosorbide dinitrate with a 100-mesh stainless steel screen, and storing for later use; weighing isosorbide dinitrate, slow-release materials and other pharmaceutical excipients according to the formula amount, And use a three-dimensional mixer to fully mix them evenly; use a dry granulator ...

Embodiment 2

[0034] Sustained-release tablet of the present invention is formulated by the raw material of following weight ratio:

[0035] Isosorbide Dinitrate 10%

[0036] Hypromellose (E4M) 20%

[0037] Sodium Carboxymethyl Cellulose 7.5%

[0038] Microcrystalline Cellulose 27.5%

[0039] Lactose 30%

[0040] Micronized silica gel 5%

[0041] Wherein, hypromellose (E4M) and sodium carboxymethylcellulose are slow-release agents, lactose and microcrystalline cellulose are fillers, and micronized silica gel is a lubricant.

[0042] Crushing, sieving, weighing and mixing of raw and auxiliary materials, granulating, and tableting, and crushing isosorbide dinitrate with a 100-mesh stainless steel screen, and storing for later use; weighing isosorbide dinitrate, slow-release materials and other pharmaceutical excipients according to the formula amount, And use a three-dimensional mixer to fully mix them evenly; use a dry granulator to granulate the above-mentioned uniformly mixed componen...

Embodiment 3

[0044] Sustained-release tablet of the present invention is formulated by the raw material of following weight ratio:

[0045] Isosorbide Dinitrate 10%

[0046] Hypromellose (E4M) 20%

[0047] Sodium Carboxymethyl Cellulose 5%

[0048] Microcrystalline Cellulose 25%

[0049] Lactose 25%

[0050] Powdered sugar 10%

[0051] Micronized silica gel 4%

[0052] Magnesium Stearate 1%

[0053] Wherein, hypromellose (E4M) and sodium carboxymethylcellulose are sustained-release agents, lactose, powdered sugar, and microcrystalline cellulose are fillers, and micronized silica gel and magnesium stearate are lubricants.

[0054] Crushing, sieving, weighing and mixing of raw and auxiliary materials, granulating, and tableting, and crushing isosorbide dinitrate with a 110-mesh stainless steel screen, and storing for later use; weighing isosorbide dinitrate, slow-release materials and other pharmaceutical excipients according to the formula amount, And use a three-dimensional mixer to...

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PUM

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Abstract

An isosorbide dinitrate sustained-release preparation is a tablet which consists of isosorbide dinitrate, sustained-release materials and other pharmaceutical excipients, wherein, the sustained-release materials are selected from hypromellose (E4M) and carmellose sodium. As the drug is released in digestive tract according to the procedure after the oral administration, the effective plasma drug concentration in human body can be maintained stably and sustainedly, therefore the invention has the advantages of good healing efficacy, long drug effect, less side effects, small number of the times of the administration of the patients, convenient usage and so on; the invention not only has the function of treating and alleviating angina symptoms, but also has the special advantages of preventing sudden onset and protecting the daily lives of the patients and safely passing through the incidence peak of the diseases, therefore, the invention provides reliable means and great convenience for the treatment of the patients and the self-prevention of sudden onset; the price of the drug is cheap, which is conductive to the administration of ordinary patients.

Description

technical field [0001] The invention relates to a medicine slow-release preparation, specifically an isosorbide dinitrate slow-release preparation for treating angina pectoris, and a preparation method of the slow-release preparation. technical background [0002] Angina pectoris is a common clinical syndrome in cardiovascular emergencies. Most patients have coronary heart disease or myocardial disease. Threat or unexpected sudden death. The traditional treatment method is to use isosorbide dinitrate tablets to treat angina pectoris, and the dosage form is generally a common tablet. Patients with angina pectoris often develop symptoms at 1 to 3 o'clock at night (morning peak period) and after the patient wakes up (morning peak period). Due to the short half-life of ordinary tablet drugs, generally 1.8 to 2 hours, the drug effect lasts for a short time and requires several times a day. Repeated administration has large side effects and is difficult to prevent sudden onset, ...

Claims

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Application Information

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IPC IPC(8): A61K31/34A61K47/38A61K9/22A61P9/10
Inventor 高义才吴康袁方孙桂荣
Owner QINGDAO HUANGHAI PHARM CO LTD
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