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Sustained-release preparation of nicorandil

A sustained-release preparation and nicorandil technology, which is applied to the sustained-release preparation of nicorandil and its preparation field, can solve problems such as inconvenience in use, influence on drug efficacy, influence on steady-state blood drug concentration of the drug, and achieve effectiveness Or the effect of improving adaptability and reducing the frequency of medication

Inactive Publication Date: 2007-07-11
刘凤鸣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Intramuscular injection or intravenous injection: 5~10mg each time, 2~3 times a day, which brings inconvenience to patients, and at the same time, due to the influence of sleep time and other factors, it affects the steady state blood drug concentration of the drug, thus affecting the efficacy of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1-nicorandil sustained release tablet (1)

[0050] Method: Take 5 grams of Nicorandil, 50 grams of hydroxypropyl cellulose, 15 grams of hypromellose, 10 grams of lactose, 10 grams of microcrystalline cellulose, 1 gram of carbomer, and 30 grams of polyethylene glycol 4000 gram, mixed evenly, dry granulated, mixed with magnesium stearate, tableted to obtain finished product, the drug content is 5mg / tablet. Then, the dissolution rate of the Nicorandil sustained-release tablet (1) in 900 ml of 0.1 M hydrochloric acid at 37° C. was determined. After release measurement, the results are shown in Table 1, which meets the requirements.

[0051] The dissolution rate of table 1 nicorandil sustained-release tablet (1)

[0052] Sampling time (hours)

Embodiment 2

[0053] The preparation of embodiment 2-nicorandil sustained release tablet (2)

[0054] Method: Take 5 grams of Nicorandil, 10 grams of hydroxypropyl cellulose, 20 grams of stearyl alcohol, 15 grams of hypromellose, 1 gram of carbomer, and 10 grams of lactose, pass through 80-mesh sieve, grind Mix evenly, add 95% ethanol solution of 10% polyvinylpyrrolidone as a binder and stir to make a soft material, granulate through a 16-mesh sieve, dry the granules at room temperature for 2 hours, granulate with a 16-mesh sieve, and then add hard 4.5 grams of magnesium fatty acid, 2 grams of micro-powder silica gel, mixed evenly, and tableted to obtain a finished product, with a drug content of 5 mg / tablet. Then the dissolution rate of the Nicorandil sustained-release tablet (2) in 900 ml of 0.1 M hydrochloric acid at 37° C. was determined. After release measurement, the results are shown in Table 2, which meets the requirements.

[0055] The dissolution rate of table 2 Nicorandil susta...

Embodiment 3

[0057] The preparation of embodiment 3-nicorandil sustained release tablet (3)

[0058] Method: Take 5g of nicorandil, 35g of hypromellose, 5g of microcrystalline cellulose, and 1g of carbomer respectively, pass through 80 mesh sieves, mix well, add 95% ethanol with a concentration of 10% polyvinylpyrrolidone The solution is used as a binder and stirred to make a soft material, granulated through a 16-mesh sieve, dried at 60°C for 1 hour, granulated through a 16-mesh sieve, added with 2.5 grams of magnesium stearate, mixed evenly, and compressed to obtain a finished product, containing Drug dosage is 5mg / tablet. Then, the dissolution rate of the Nicorandil sustained-release tablet (3) in 900 ml of 0.1 M hydrochloric acid at 37° C. was determined. After release measurement, the results are shown in Table 3, meeting the requirements.

[0059] Table 3 Dissolution of Nicorandil Sustained-release Tablets (3)

[0060] Sampling time (hours)

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PUM

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Abstract

The invention relates to a slow-release agent of Nicotie and relative production, wherein it uses Nicotie as material, adds slow-release skeleton material and drug to obtain solid disperser; releases the drug to hold blood density. The invention can reduce feeding time, reduce blood peak-valley condition, improve safety and reduce drug consumption.

Description

[0001] [Technical Field] The present invention relates to a sustained-release preparation of nicorandil and a preparation method thereof. [Background technique] [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. Prolonged formulation. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability have been improved, thereby reducing the number of medications, which greatly facilitates patients, especially patients who have been taking medication for a long time. Commonly used oral dosage forms include matrix tablets, microporous coated surface...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/48A61K47/02A61K47/12A61K47/34A61K47/38A61K47/42A61K47/44A61K31/4406A61P9/10A61K47/10A61K47/32
Inventor 刘凤鸣
Owner 刘凤鸣
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