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Nitroglycerin tablet and preparation method thereof

A technology of nitroglycerin and diluent, applied in the field of medicine, can solve the problems of delayed tablet disintegration and dissolution, poor taste of sublingual tablets, etc.

Pending Publication Date: 2022-05-13
河北坤安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above method can utilize polyvinylpyrrolidone to absorb nitroglycerin and prevent volatilization, polyvinylpyrrolidone, as a commonly used binder, will cause tablet disintegration and delay in dissolution
Moreover, the gritty feeling caused by microcrystalline cellulose in the mouth will make the taste of sublingual tablets very bad.

Method used

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  • Nitroglycerin tablet and preparation method thereof
  • Nitroglycerin tablet and preparation method thereof
  • Nitroglycerin tablet and preparation method thereof

Examples

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Effect test

preparation example Construction

[0053] The preparation method of above-mentioned nitroglycerin tablet provided by the invention comprises the following steps:

[0054] Mix 9%-11% (mg / mL) ethanol solution of nitroglycerin with the first diluent, dry and granulate to obtain the first mixture;

[0055] mixing the stabilizer and the glidant, pulverizing, and sieving to obtain the second mixture;

[0056] After the first mixture, the second mixture and the disintegrating agent are mixed, a lubricant is added for mixing, and tableted to obtain the nitroglycerin tablet.

[0057] In the preparation method, 9%-11% (mg / mL) ethanol solution of nitroglycerin is preferentially mixed with the first diluent, dried, and then granulated. This is a key step in the preparation method. When the ethanol solution of nitroglycerin is mixed with When the granular lactose is mixed, the microstructure of the granular lactose is used (the granular lactose is a complex formed by the stacking and embedding of the fine powder lactose, a...

Embodiment 1

[0068] The present embodiment provides a kind of nitroglycerin tablet, and its formula is as follows:

[0069]

[0070] The specific preparation method is as follows:

[0071] Mix 9% (9mg / 100mL) nitroglycerin ethanol solution (the mass of nitroglycerin after conversion is 0.5g) with the first diluent, boil and dry at 10-20°C for 0.5h, and granulate to obtain the first mixture;

[0072] Mix the second diluent, glyceryl monostearate and silicon dioxide, pulverize, and pass through a 60-mesh sieve to obtain the second mixture;

[0073] After the first mixture, the second mixture 2, the third diluent and the pregelatinized starch are uniformly mixed, calcium stearate is added, mixed, and pressed into tablets to obtain the nitroglycerin tablets.

Embodiment 2

[0075] The present embodiment provides a kind of nitroglycerin tablet, and its formula is as follows:

[0076]

[0077]

[0078] The specific preparation method is as follows:

[0079] Mix 10% (10mg / 100mL) nitroglycerin ethanol solution (the mass of nitroglycerin after conversion is 0.5g) with the first diluent, air-dry at 20-30°C for 2 hours, and granulate to obtain the first mixture;

[0080] The second diluent, glyceryl monostearate and silicon dioxide were mixed, pulverized, and passed through a 40-mesh sieve to obtain the second mixture;

[0081] After the first mixture, the second mixture 2, the third diluent and the pregelatinized starch are uniformly mixed, calcium stearate is added, mixed, and pressed into tablets to obtain the nitroglycerin tablets.

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Abstract

The invention discloses a nitroglycerin tablet and a preparation method thereof. The nitroglycerin tablet comprises nitroglycerin, a first diluent, a stabilizer, a flow aid, a disintegrating agent and a lubricant, wherein the content of the nitroglycerin is 1.25 wt%-1.85 wt%, the content of the first diluent is 61.5 wt%-75 wt%, the first diluent is granular lactose, and the particle size of the granular lactose is 150-500 [mu] m. According to the nitroglycerin tablet provided by the invention, the first diluent is limited to be the granular lactose with the particle size of 150-500 microns, and the dosage of the nitroglycerin and the first diluent in the tablet is combined, so that the dissolution speed and the stability of the nitroglycerin can be remarkably improved, and the sublingual mouth feel is good.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a nitroglycerin tablet and a preparation method thereof. Background technique [0002] Nitroglycerin, also known as glyceryl trinitrate, molecular formula: C 3 h 5 N 3 o 9 , molecular weight: 227.09, its structural formula is as follows: [0003] [0004] Nitroglycerin is a powerful vasodilator for the peripheral circulation and coronary arteries. It is widely used clinically in the treatment and prevention of coronary heart disease and angina pectoris, as well as in the treatment of lowering blood pressure or congestive heart failure. Its sublingual administration can quickly dissolve into the blood , Play the role of dilating coronary arteries, and can moderately lower blood pressure and reduce heart consumption. [0005] Nitroglycerin is a light yellow viscous liquid, insoluble in water, miscible in acetone, ether, ethanol, nitrobenzene, pyridine, ethyl ac...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K31/21A61P9/10
CPCA61K9/2018A61K9/006A61K31/21A61P9/10
Inventor 赵晓雷樊根遥赵亚翡张倩如任玉新张岩常章峰杨春光李萍
Owner 河北坤安药业有限公司
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