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Orally disintegrating tablet of amlodipine besylate and its preparation process

A technology of amlodipine besylate and orally disintegrating tablets, which is applied in the field of amlodipine besylate orally disintegrating tablets and its preparation, can solve problems such as bad smell, easy retention in the mouth, difficulty in swallowing, etc., and achieve no gravel Sensation and unpleasant taste, simple preparation process, good therapeutic effect

Inactive Publication Date: 2004-11-17
CHENGDU SHENGNUO BIOTEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, although amlodipine besylate has various oral dosage forms, it is not very convenient for the elderly and children who have certain difficulties in swallowing
For example: In the case of tablets and capsules commonly used as oral preparations, many elderly people and children with poor swallowing ability are reluctant to take these solid dosage forms, complaining of difficulty swallowing medicine or esophageal obstruction, while chewable tablets are also It is also not suitable for the elderly and children with weak chewing ability
As far as powders or granules are concerned, in addition to their difficulty in swallowing, they are also easy to stay in the mouth, resulting in an unpleasant feeling in the mouth. At the same time, drinking water is required when taking the above oral preparations, especially the elderly and children need to take a lot of water However, drinking too much water will affect the night rest of the elderly and children
Syrup was once considered an ideal dosage form for the elderly and children, but for many elderly and infirm patients, they still cannot get liquid preparations into their mouths, and there are still many problems in use, and many oral drugs have a bitter taste and bad smell are often unacceptable. Some patients refuse treatment in order to avoid taking this medicine, which leads to delaying the best time for treatment.

Method used

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  • Orally disintegrating tablet of amlodipine besylate and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The amlodipine besylate orally disintegrating tablet comprises main ingredients and auxiliary materials, and is characterized in that it is prepared according to the following weight percentages: the main ingredient is 5.8%, and auxiliary materials are 94.2%.

[0042] The orally disintegrating tablet of the present invention is prepared from the following raw materials in weight ratio:

[0043] Amlodipine Besylate 5.8g

[0044] Lactose 44.0g

[0045] Mannitol 17.0g

[0046] Microcrystalline Cellulose 21.8g

[0047] Low-substituted hydroxypropyl cellulose 2.4g

[0048] Cross-linked polyvinylpyrrolidone 5.0g

[0049] Sodium bicarbonate 1.0g

[0050] Citric acid 1.0g

[0051] Aspartame 0.5g

[0052] Mint essence 0.5g

[0053] Magnesium Stearate 1.0g

[0054] A total of 1000 tablets were produced

[0055] Among them, lactose and mannitol are fillers; low-substituted hydroxypropyl cellulose, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disin...

Embodiment 2

[0065] The amlodipine besylate orally disintegrating tablet comprises main ingredients and auxiliary materials, and is characterized in that it is prepared according to the following weight percentages: the main ingredient is 5.8%, and auxiliary materials are 94.2%.

[0066] The orally disintegrating tablet of the present invention is prepared from the following raw materials in weight ratio:

[0067] Amlodipine Besylate 5.8g

[0068] Mannitol 60.0g

[0069] Microcrystalline Cellulose 21.6g

[0070] Low-substituted hydroxypropyl cellulose 2.4g

[0071] Cross-linked polyvinylpyrrolidone 5.0g

[0072] Sodium bicarbonate 1.0g

[0073] Citric acid 1.0g

[0074] Aspartame 0.5g

[0075] Mint essence 0.25g

[0076] Cherry essence 0.75g

[0077] Magnesium Stearate 1.0g

[0078] A total of 1000 tablets were produced

[0079] Among them, lactose and mannitol are fillers. Low-substituted hydroxypropyl cellulose, microcrystalline cellulose and cross-linked polyvinylpyrrolidone ...

Embodiment 3

[0091] The amlodipine besylate orally disintegrating tablet comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 10% of main ingredients and 90% of auxiliary materials.

[0092] The orally disintegrating tablet of the present invention is prepared from the following raw materials in weight ratio:

[0093] Amlodipine Besylate 10.0g

[0094] Lactose 40.0g

[0095] Mannitol 20.0g

[0096] Microcrystalline Cellulose 20.0g

[0097] Low-substituted hydroxypropyl cellulose 4.0g

[0098] Cross-linked polyvinylpyrrolidone 5.0g

[0099] Sodium bicarbonate 1.0g

[0100] Citric acid 1.0g

[0101] Aspartame 0.5g

[0102] Mint essence 0.25g

[0103] Cherry essence 0.75g

[0104] Magnesium Stearate 1.0g

[0105] A total of 1000 tablets were produced

[0106] Among them, lactose and mannitol are fillers. Low-substituted hydroxypropyl cellulose, microcrystalline cellulose and cross-linked po...

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Abstract

The invention discloses an Amlodipine Besylate oral disintegration tablet, wherein the principal drug employs Amlodipine Besylate, the auxiliary materials include lactose, mannitol, crystalline cellulose, low substituted methylcellulose propylene glycol ether, cross bonding polyvinylpyrrolidone, sodium hydrogen carbonate, citric acid, Aspartame, perfume compound, magnesium stearate, The tablet has good treatment action for hypertension and stenocardia.

Description

Technical field: [0001] The invention relates to an oral pharmaceutical preparation for treating hypertension and angina pectoris and a preparation method thereof, in particular to an orally disintegrating amlodipine besylate tablet capable of rapidly disintegrating, releasing and masking bad smell and a preparation method thereof. Background technique: [0002] Amlodipine besylate is an effective antihypertensive drug, which is clinically used to treat hypertension and angina pectoris. Taking it once a day can effectively control blood pressure 24 hours a day, prevent angina pectoris, and is safe and well tolerated. The drug is a calcium ion channel blocker, launched in 1990, and is currently the most prescribed antihypertensive drug. [0003] At present, although amlodipine besylate has various oral dosage forms, it is not very convenient for the elderly and children who have certain difficulties in swallowing. For example: In the case of tablets and capsules commonly us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/10A61P9/12
Inventor 谢期林谢海峰马进
Owner CHENGDU SHENGNUO BIOTEC CO LTD
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