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Nisoldipine oral disintegration tablet for treating hypertension and preparing method

A technology of orally disintegrating tablets and nisoldipine, which is applied in the field of nisoldipine orally disintegrating tablets and its preparation, can solve the problems of poor compressibility of tablets, differences in tablet appearance or tablet weight, inconvenient use by patients, etc. problem, to achieve the effect of convenient use

Inactive Publication Date: 2005-01-12
JIANGXI HERBI SKY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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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  • Nisoldipine oral disintegration tablet for treating hypertension and preparing method
  • Nisoldipine oral disintegration tablet for treating hypertension and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Product Name: Nisoldipine Orally Disintegrating Tablets

[0050] Specification: 5mg / tablet

[0051] Formula 1: Nisoldipine 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 nisoldipine, 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 hard Magnesium fatty acid and flavor powder are evenly mixed, passed through a 18-mesh sieve for granulation, and compressed into 1000 tablets on a tablet machine.

Embodiment 2

[0060] Product Name: Nisoldipine Orally Disintegrating Tablets

[0061] Specification: 10mg / tablet

[0062] Formula 2: Nisoldipine 10g

[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 nisoldipine, stir to dissolve all 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 by wet method,...

Embodiment 3

[0071] Product Name: Nisoldipine Orally Disintegrating Tablets

[0072] Specification: 20mg / tablet

[0073] Formula 3: Nisoldipine 20g

[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 evenly with all auxiliary materials, and then directly pressed into tablets.

[0082] In Example 1, Example 2, and Example 3, an appropriate amount of essence or mint or one of the effervescent agents, or their mixture, 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 each main drug nisoldipine 5mg, 10mg, and 20mg in the three embo...

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Abstract

An oral disintegrating tablet for nisoldipine for treating coronary heart disease, hypertension, ischemic heart disease and congestive heart failure is prepared from nisoldipine, souring agnet, excipient and disintegrant.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to a nisoldipine orally disintegrating tablet for treating hypertension and a preparation method thereof. technical background [0002] Nisoldipine is currently the strongest calcium antagonist, which selectively dilates coronary arteries and is 4-10 times stronger than nifedipine. Pharmacological studies have shown that: Nisoldipine inhibits the voltage-dependent transmembrane calcium ion flow of smooth muscle, has a highly selective effect on vascular smooth muscle, improves oxygen supply by dilating blood vessels, and reduces oxygen consumption by reducing afterload. Nisoldipine is almost completely absorbed after oral administration, reaching the peak blood level 1 hour after oral administration. The half-life of the drug in the body (t 1 / 2 ) has a large inter-patient variability, and a single oral dose of t 1 / 2 It is 11.4h. The dosage for the treatment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/12
Inventor 刘智张执一吴朝阳徐发红黄经球
Owner JIANGXI HERBI SKY CO LTD
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