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Isosorbide mononitrate capsule and dry preparation method

A preparation technology of isosorbide dinitrate, which is applied in the field of medicine, can solve the problems of sublimation loss, slow disintegration, and rapid onset of uncomfortable drugs, etc., and achieve the effect of simple process and improved product output rate

Inactive Publication Date: 2006-02-01
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Abstract
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  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The isosorbide mononitrate capsule prepared by the general method disintegrates slowly, and is not suitable for rapid onset of action of the medicine. It is granulated by a wet process, and by measuring the difference between the isosorbide mononitrate and the theoretical value (feeding amount), it shows that the wet Due to the degradation or sublimation of isosorbide mononitrate by heating, especially the melting point of isosorbide mononitrate is only about 90 ℃, which has strong sublimation property, and heating will cause obvious loss
Other methods to avoid heating are common vacuum drying, but vacuum also causes significant loss of sublimation

Method used

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  • Isosorbide mononitrate capsule and dry preparation method

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Embodiment Construction

[0015] The present invention will be further described below in conjunction with accompanying drawing:

[0016] Calculated on the basis of 1,000,000 capsules:

[0017] Isosorbide mononitrate 20kg

[0018] Filler 221kg

[0019] Carboxymethyl starch sodium 5kg

[0020] Magnesium stearate 0.5kg

[0021] Fillers include: calcium hydrogen phosphate 70kg, microcrystalline cellulose 75kg, lactose 76kg

[0022] The disintegrant is sodium carboxymethyl starch, the lubricant is magnesium stearate

[0023] With reference to accompanying drawing, according to this process, at first 70kg of calcium hydrogen phosphate, 75kg of microcrystalline cellulose, 76kg of lactose are used as fillers, 20kg of isosorbide mononitrate, and 5kg of disintegrating agent are uniformly mixed by a fluidized bed one-step granulator, and then mixed with Dry press granulation and pass through a 24-mesh sieve, add 0.5kg of lubricant and mix evenly in a mixer, me...

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Abstract

An isosorbitol mononitrate capsule with high disintegrating speed is prepared from isosorbitol mononitrate, filler, carboxymethly starch sodium and magnesium stearate through mixing the first three, granulating, mixing with lubricant, loading it in capsules and Al-plastic packing.

Description

1. Technical field: [0001] The isosorbide mononitrate capsule and the dry preparation method thereof of the present invention relate to the technical field of medicine. Isosorbide mononitrate is a long-acting nitrate antiangina drug, mainly used for the prevention and relief of angina. 2. Background technology: [0002] The isosorbide mononitrate capsule prepared by the general method disintegrates slowly, and is not suitable for rapid onset of action of the medicine. It is granulated by the wet process, and by measuring the difference between the isosorbide mononitrate and the theoretical value (feeding amount), it shows that the wet Isosorbide mononitrate is degraded or sublimated by heating, especially the melting point of isosorbide mononitrate is only about 90°C, which has strong sublimation property, and heating will cause obvious loss. Other methods to avoid heating are common vacuum drying, but vacuum also causes significant loss of sublimation. 3. Contents of the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/34A61K9/48A61P9/10
Inventor 牛萍甘益民邱雪飞
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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