Calcium-ion antagonist orally disintegrating tablet and preparation method thereof

A technology for calcium ion antagonist and oral disintegrating tablet, applied in the field of calcium ion antagonist oral disintegrating tablet and preparation thereof, can solve the problems of gritty feeling, affecting patient's taste and compliance, slow disintegration of preparations, etc.

Active Publication Date: 2012-07-04
BEIJING QUANTUM HI TECH PHARMA TECHCO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, most of them adopt the direct compression method to prepare orally disintegrating tablets. Most disintegrants are insoluble in water, so the orally disintegrating tablets prepared by this method often have a gritty feeling after tasting, which affects the taste and compliance of patients when taking it; and the disintegration of the preparation will be very slow

Method used

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  • Calcium-ion antagonist orally disintegrating tablet and preparation method thereof
  • Calcium-ion antagonist orally disintegrating tablet and preparation method thereof
  • Calcium-ion antagonist orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0155] The preparation formula of the present invention is made up of following components:

[0156] Amlodipine besylate 6.93g

[0157] Glycine 5.60g

[0158] Pullulan 7.60g

[0159] Konjac Gum 0.60g

[0160] Aspartame 1.00g

[0161] Mint essence 0.20g

[0162] Purified water 178.07g

[0163] A total of 1000 pieces were made.

[0164] The specific preparation method is as follows: Amlodipine besylate, glycine, pullulan, aspartame, and peppermint essence are added to the fully dissolved konjac gum solution, and mixed to become a uniform solution; After degassing, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer it to a freeze dryer, under the conditions of 0.01mbar to 10mbar and -30°C to 30°C Freeze-dry for 1-10 hours to obtain the orally disintegrating amlodipine besylate tablet of the present invention; after the pre-freezing step in the above method, a step of ice crystal incubation can also be added before being trans...

Embodiment 2

[0166] The preparation formula of the present invention is made up of following components:

[0167] Amlodipine besylate 6.93g

[0168] Mannitol 5.60g

[0169] Pullulan 7.60g

[0170] Konjac Gum 0.60g

[0171] Aspartame 1.00g

[0172] Mint essence 0.20g

[0173] Purified water 178.07g

[0174] A total of 1000 pieces were made.

[0175] The specific preparation method is as follows: Amlodipine besylate, mannitol, pullulan, aspartame, and peppermint essence are added to the fully dissolved konjac gum solution, and mixed to become a homogeneous solution; The preparation method is the same as in Example 1.

Embodiment 3

[0177] The preparation formula of the present invention is made up of following components:

[0178] Amlodipine besylate 6.93g

[0179] Glycine 3.00g

[0180] Mannitol 2.00g

[0181] Pullulan 7.00g

[0182] Xanthan gum 0.10g

[0183] Acesulfame K 1.20g

[0184] Mint essence 0.20g

[0185] Purified water 179.57g

[0186] A total of 1000 pieces were made.

[0187] The specific preparation method is as follows: add amlodipine besylate, glycine, mannitol, pullulan, acesulfame potassium, and mint essence to the fully dissolved xanthan gum solution, and mix to form a uniform solution; The following preparation method is the same as in Example 1.

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Abstract

The invention discloses a calcium-ion antagonist orally disintegrating tablet and a preparation method thereof, and relates to a calcium-ion antagonist orally disintegrating tablet as well as a formula and technology for preparing the calcium-ion antagonist orally disintegrating tablet by use of a freeze drying method. The calcium-ion antagonist orally disintegrating tablet disclosed by the invention is mainly prepared from major medicines and medicinal accessories; the calcium-ion antagonist orally disintegrating tablet is taken without water and can be quickly disintegrated in mouth, thus being convenient to take; the compliance of the patient taking the medicine for a long time can be improved, the curative effect of the medicine is enhanced, and the orally disintegrating tablet is suitable for old patients, patients with difficulty in swallowing and the like and also applicable when water sources are not easily available during travel; and the orally disintegrating tablet is convenient to take, has the advantages of low first pass effect, low irritation to alimentary canal mucosa, wide market application prospect and the like, and can be used for obviously reducing the side effect of the calcium-ion antagonist. Moreover, the invention also relates to a preparation method of the calcium-ion antagonist orally disintegrating tablet.

Description

Technical field: [0001] The invention relates to a calcium ion antagonist orally disintegrating tablet and a preparation method thereof, in particular to a calcium ion antagonist orally disintegrating tablet prepared by a freeze-drying method. Background technique: [0002] Hypertension is a common cardiovascular disease. The global incidence rate is as high as 31.3%. There are about 1 billion hypertensive patients, and China accounts for 11.36% (about 160 million). There are 3 to 4 million new patients every year. Hypertension is an important risk factor for stroke, myocardial infarction, heart failure and chronic kidney disease, and it is called the "silent killer". According to the survey, there are nearly 1.5 million stroke patients caused by hypertension in my country every year, which brings a heavy burden to society, families and individuals. Essential hypertension is closely related to the renin-angiotensin-aldosterone system, body fluid volume system, and sympathet...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K45/00A61K47/36A61K31/4422A61P9/12
Inventor 王丛威王洪飞赵淑欣王丽滨周立运
Owner BEIJING QUANTUM HI TECH PHARMA TECHCO
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