Isosorbide mononitrate tablet and quality detection method thereof

A technology of isosorbide tablet and isosorbide dinitrate, which is applied in the field of medicine, can solve the problems that the slow-release effect needs to be improved, and achieve the effects of consistent stability, reasonable composition and simple preparation process

Inactive Publication Date: 2019-12-13
仁和堂药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But the slow-release effect of this medicine still needs t

Method used

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  • Isosorbide mononitrate tablet and quality detection method thereof
  • Isosorbide mononitrate tablet and quality detection method thereof
  • Isosorbide mononitrate tablet and quality detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of isosorbide mononitrate tablet, its formula is:

[0031]

[0032] The preparation process is as follows:

[0033] Pretreatment: If there is agglomeration of isosorbide mononitrate and colloidal silicon dioxide, use a 24-mesh sieve to remove the agglomerates. Single weighing: Weigh each raw and auxiliary material according to the prescription amount, and set aside.

[0034] Isosorbide dinitrate embedding: Add isosorbide mononitrate in the amount of 1g:10ml to carboxymethyl chitosan aqueous solution with a concentration of 30g / L, ultrasonically disperse for 10 min, and then add the same volume of Pan-80 liquid paraffin, stirred at 200 rpm for 10 min, cooled to 4°C, added 5% (v / v) glutaraldehyde to cross-link and solidify for 3 h, removed the oil layer, vacuum filtered, then washed with petroleum ether, and then Dehydrate with acetone and dry in a vacuum oven to obtain isosorbide mononitrate microspheres (drug loading 40%).

[0035] Pre-mixing: put the weigh...

Embodiment 3

[0050] 1. Stability test:

[0051] Adopt the tablet among the embodiment 1 to carry out stability study, investigate the stability of placing 8 months under the condition of 80% relative humidity at 35 ℃ with the Isosorbide mononitrate tablet that this prescription process makes. They were measured at the 0th, 2nd, 4th, and 8th months respectively, see Table 1 for details.

[0052] Table 1

[0053] time month character content% Release% 0 white or off-white 100 qualified 2 white or off-white 100 qualified 4 white or off-white 99.9 qualified 8 white or off-white 99.7 qualified

[0054] Above stability test result shows, with the tablet of embodiment 1 through the accelerated test of 8 months, each index all reaches the standard, and its stability meets the requirements.

[0055] 2. In vitro release assay:

[0056] Chromatographic conditions: use octadecylsilane bonded silica gel as filler, water-methanol (25:75) as mobil...

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Abstract

The invention belongs to the technical field of medicines, and discloses an isosorbide mononitrate tablet, which comprises 50 mg of isosorbide mononitrate microspheres, 30 mg of lactose monohydrate (1), 92.1 mg of lactose monohydrate (2), 40 mg of microcrystalline cellulose, 3.5 mg of colloidal silicon dioxide, 27 mg of potato starch and 2.4 mg of magnesium stearate. The tablet is reasonable in components and high in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an isosorbide mononitrate tablet and a quality detection method thereof. Background technique [0002] In the field of clinical medicine today, cardiovascular system diseases have always been one of the diseases most likely to cause human death, and coronary heart disease and angina pectoris are the most common frequently-occurring diseases in cardiovascular system diseases. Angina pectoris is a clinical symptom caused by acute and temporary ischemia and hypoxia of the myocardium. Most of the patients are middle-aged and elderly people. It often occurs when some inducement exists. It is characterized by paroxysmal chest compression or The pain sensation is mainly located at the back of the sternum, and can radiate to the patient's precordial area, left upper limb, neck pharynx or mandible. In severe cases, it is even life-threatening, which greatly affects people's...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/04A61K47/36A61K31/34A61P9/10G01N30/02
CPCA61K9/2009A61K9/205A61K31/34A61P9/10G01N30/02
Inventor 林业翔郭增光薛颖杜玲杰
Owner 仁和堂药业有限公司
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