Levamlodipine beaylate tablets and preparation method thereof

A technology of levamlodipine besylate and levo-amlodipine besylate, which is applied in the field of levamlodipine besylate tablets and its preparation, can solve the problem of unstable hygroscopicity, small drug specifications, and difficulty in uniform and stable preparations Requirements and other issues, to achieve the effect of improving bioavailability, simple preparation process, and reducing related substances

Active Publication Date: 2010-07-07
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] These patent documents make levamlodipine besylate into dripping pills and ordinary tablets respectively, which improves the dissolution rate of the main drug to a certain extent, but the drug specification is small, and has strong hygroscopicity and instability. T...

Method used

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  • Levamlodipine beaylate tablets and preparation method thereof
  • Levamlodipine beaylate tablets and preparation method thereof
  • Levamlodipine beaylate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1. Prescription composition

[0034] (1) Levoamlodipine besylate tablet core prescription

[0035] Ingredients Dosage

[0036]

[0037] Levoamlodipine Besylate 5g

[0038] Micronized silica gel 20g

[0039]Microcrystalline Cellulose 45g

[0040] Hydroxypropyl Cellulose 10g

[0041] Carboxymethyl Starch Sodium 20g

[0042] Magnesium Stearate 3g

[0043] 95% ethanol appropriate amount

[0044]

[0045] A total of 1000 pieces were made

[0046] (2) Prescription of coating material

[0047] Ingredients Dosage

[0048]

[0049] Polyvinyl acetal diethylamine acetate 5g

[0050] Hypromellose 1g

[0051] PEG4000 1g

[0052] Talc powder 1.5g

[0053] Titanium dioxide 1.5g

[0054] 5% ethanol 125ml

[0055]

[0056] 2. Preparation method ...

Embodiment 2

[0061] 1. Prescription composition

[0062] (1) Levoamlodipine besylate tablet core prescription

[0063] Ingredients Dosage

[0064]

[0065] Levoamlodipine Besylate 2.5g

[0066] Diatomaceous earth 10g

[0067] Lactose 40g

[0068] Hydroxypropyl Cellulose 30g

[0069] Crospovidone 15g

[0070] Magnesium Stearate 2.54g

[0071]

[0072] A total of 1000 pieces were made

[0073] (2) Prescription of coating material

[0074] Ingredients Dosage

[0075]

[0076] Hypromellose 6g

[0077] PEG6000 1g

[0078] Talc powder 1.5g

[0079] Titanium dioxide 1.5g

[0080] Purified water 100ml

[0081]

[0082] 2. Preparation method

[0083] (1) Weigh the prescription amount of levamlodipine besylate and 2 / 3 of the prescription amount of micropowder silica gel, mix them uniformly by equal volume addition method, the...

Embodiment 3

[0086] 1. Prescription composition

[0087] (1) Levoamlodipine besylate tablet core prescription

[0088] Ingredients Dosage

[0089]

[0090] Levoamlodipine Besylate 5g

[0091] Micronized silica gel 20g

[0092] Pregelatinized starch 50g

[0093] Hydroxypropyl Cellulose 10g

[0094] Croscarmellose Sodium 12g

[0095] Talc powder 3g

[0096] 95% ethanol appropriate amount

[0097]

[0098] A total of 1000 pieces were made

[0099] (2) Prescription of coating material

[0100] Ingredients Dosage

[0101]

[0102] Acrylic resin No. IV 8g

[0103] Talc powder 2g

[0104] Titanium dioxide 2g

[0105] 95% ethanol solution 100ml

[0106]

[0107] 2. Preparation method

[0108] (1) Take by weighing the levamlodipine besylate and diatomaceous earth of prescription quantity, after adopting equal am...

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PUM

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Abstract

The invention belongs to the technical field of medicament, and provides levamlodipine beaylate tablets and a preparation method thereof. The tablets consist of tablet cores using the levamlodipine beaylate as an active component and film coatings coated on the outer layer, wherein diluent in the tablet cores contains diatomite or aerosil, or a mixture of diatomite and aerosil, and contains other pharmaceutically acceptable supplementary materials; and the outer film coating accounts for 8 to 12 percent of the weight of the tablets, and can play a role in resisting humidity and avoiding light to ensure that the medicinal stability can be greatly improved, and related substances are obviously reduced. Furthermore, the tablets have small specification, so the tablets ensure uniform content, and improve dissolution; and the method is simple and controllable, and ensures that the hygroscopicity of the medicament is obviously reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a tablet of levamlodipine besylate and a preparation method thereof. Background technique [0002] Cardiovascular disease is one of the major diseases that endanger human health in the world. In China alone, millions of people die of cardiovascular disease every year. According to the latest medical data, the incidence of cardiovascular disease is increasing year by year, and Patients are younger. Cardiovascular disease has the characteristics of high morbidity, high mortality, high disability rate, and high recurrence rate. People pay more and more attention to the treatment of cardiovascular disease, and its drug market potential is huge. Hypertension is one of the most common cardiovascular diseases in the world today and the leading cause of death and disability in adults. Due to the improvement of people's living standards and increasingly tense job com...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4422A61K47/04A61K47/38A61K47/36A61K47/32A61P9/12
Inventor 赵志全
Owner 鲁南新时代生物技术有限公司
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