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Deamlexanox oral disintegration tablet for treating hypertension and angina and preparing method

A technology of levamlodipine and orally disintegrating tablets, which is applied in the field of levamlodipine orally disintegrating tablets and its preparation, can solve problems such as poor compressibility, unhealthy health, difficulty in achieving differences in tablet appearance or tablet weight, etc. To achieve the effect of ease of use

Inactive Publication Date: 2005-01-12
刘智
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In recent years, there are many orally disintegrating tablets developed at home and abroad, which have become a development direction of oral dosage forms. The currently developed orally disintegrating tablets cannot meet the clinical needs of patients with various etiologies, and their preparation methods Each has its own advantages and disadvantages, and the orally disintegrating tablet represented by the "freeze-drying method" disintegrates fastest in the oral cavity, but the strength of the tablet is poor, and the tablet is easily broken, which is not suitable for industrialized production and is inconvenient for patients to use. Also can not satisfy the demand of market; Other preparation methods of orally disintegrating tablets have " heating sublimation method " and direct tableting method, although they have overcome the shortcoming of the poor intensity of tablet, most when patient uses, oral cavity feels No gritty and unacceptable uncomfortable feeling or too long disintegration time, especially the orally disintegrating tablets prepared by the heating sublimation method may still have residual sublimable substances, which are chemical substances that are not conducive to health; "directly In the preparation process of "tablet compression method", the tablet's compressibility is poor, so that the difference in tablet appearance or tablet weight is not easy to meet the requirements of the Pharmacopoeia for tablets, which limits the development of orally disintegrating tablets

Method used

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  • Deamlexanox oral disintegration tablet for treating hypertension and angina and preparing method
  • Deamlexanox oral disintegration tablet for treating hypertension and angina and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Product Name: Levoamlodipine Orally Disintegrating Tablets

[0050] Specification: 2.5mg / tablet

[0051] Formula 1: Levoamlodipine 2.5g

[0052] Lactose 65g

[0053] Cross-linked polyvinylpyrrolidone (CPVP) 4g

[0054] Citric acid 0.5g

[0055] Aspartame 1g

[0056] Flavor powder 0.5g

[0057] Magnesium stearate 0.5g

[0058] Preparation method: Mix levoamlodipine, lactose, cross-linked polyvinylpyrrolidone, citric acid, and aspartame evenly, make 20-mesh granules with water, dry at 60°C for 4-6 hours, mix the dried granules with lubricant After magnesium stearate and essence powder are mixed evenly, pass through an 18-mesh sieve for granulation, and compress 1000 tablets on a tablet machine.

Embodiment 2

[0060] Product Name: Levoamlodipine Orally Disintegrating Tablets

[0061] Specification: 5mg / tablet

[0062] Formula 2: Levoamlodipine 5g

[0063] Mannitol 100g

[0064] Croscarmellose Sodium 10g

[0065] Tartaric acid 2g

[0066] Stevioside 1g

[0067] 5% polyvinylpyrrolidone ethanol solution appropriate amount

[0068] Magnesium stearate 0.5g

[0069] Preparation method: First, take a certain amount of polyvinylpyrrolidone and dissolve it with 30-90% ethanol to form a 5% (weight / volume, W / V) concentration of polyvinylpyrrolidone ethanol solution. Then measure an appropriate amount of the solution, add levamlodipine, stir to completely dissolve the medicine in the polyvinylpyrrolidone ethanol solution, then add tartaric acid and stevioside, and stir evenly. Mix mannitol and croscarmellose sodium evenly, pass through a 120-mesh sieve, add the prepared clear solution into it, stir to make a soft material, make 20-mesh granules b...

Embodiment 3

[0071] Product Name: Levoamlodipine Orally Disintegrating Tablets

[0072] Specification: 10mg / tablet

[0073] Formula 3: Levoamlodipine 10g

[0074] Mannitol 150g

[0075] Cross-linked polyvinylpyrrolidone (CPVP) 6g

[0076] Croscarmellose Sodium 8g

[0077] Citric acid 3g

[0078] Aspartame 0.2g

[0079] 5% polyvinylpyrrolidone ethanol solution appropriate amount

[0080] Magnesium Stearate 1g

[0081] Preparation method: The main ingredient is mixed with all auxiliary materials evenly, and then directly compressed into tablets.

[0082] In Example 1, Example 2, and Example 3, an appropriate amount of essence or mint or one of the foaming agents, or a mixture thereof, can be added to the granules or mixed powder before tablet compression to make the tablet disintegrate in the oral cavity. Produce a satisfying feeling. The above enumerates three specifications of levamlodipine 2.5 mg, 5 mg, and 10 mg per main drug in t...

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Abstract

An oral disintegrating tablet of levoamlidipine for treating hypertension and angina pectoris is prepared from levoamlodipine, souring agent, excipient and disintegrant.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to a levoamlodipine orally disintegrating tablet for treating hypertension and angina pectoris and a preparation method thereof. technical background [0002] Levoamlodipine is the left-handed isomer [(s)-(-) amlodipine] of amlodipine, and at a therapeutic dose, the curative effect is twice that of the racemate (amlodipine is a racemate), while The toxic and side effects are significantly reduced, which is especially important for patients with long-term use to lower blood pressure or angina pectoris. This product is a third-generation long-acting dihydropyridine calcium channel (mainly L channel) blocker. It is a peripheral and coronary vasodilator. At therapeutic doses, it has little effect on cardiac conduction and negative inotropic effects . It can reduce peripheral resistance, blood pressure and afterload, increase coronary flow and reflexively increase...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/12
Inventor 刘智张执一
Owner 刘智
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