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Levocarnitine thin film coated tablets and preparation method thereof

A technology for film-coated tablets and coated tablets is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., which can solve the problems of unachievable product disintegration, shorten working hours, reduce production costs, and avoid easy moisture absorption. Effect

Active Publication Date: 2013-06-26
NORTHEAST PHARMA SHENYANG SCI & TECH DEV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The test results show that the hardness of the product is 7Kg, and the disintegration of the tablet takes 17-18 minutes. The disintegration of the product cannot meet the requirements of the Pharmacopoeia.

Method used

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  • Levocarnitine thin film coated tablets and preparation method thereof
  • Levocarnitine thin film coated tablets and preparation method thereof
  • Levocarnitine thin film coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1: Weigh 330 g of levo-carnitine, 270 g of microcrystalline cellulose, 50 g of lactose, and 6.5 g of silicon dioxide, mix them, add 6.5 g of magnesium stearate, mix them, mix them evenly, and press them into 1000 tablets. The weight is 0.663g, and the tablet hardness is controlled at 6-7Kg; the premix made of 6.6g hydroxypropyl methylcellulose and ethylcellulose film-forming material is dissolved in 76ml of 95% ethanol solution to prepare the isolation layer coating solution, stirred for 45 minutes, sprayed evenly on the surface of levocarnitine tablet core by spray gun, and prepared into levocarnitine isolation gown tablet; dispersing the premix made of 20g polyvinyl alcohol film-forming material in 95ml of distilled water to prepare Moisture-proof layer coating solution, stirred for 45 minutes, uniformly sprayed on the surface of levocarnitine isolation coat tablet through a spray gun; testing and packaging.

Embodiment 2

[0017] Example 2: Weigh 330 g of levocarnitine, 210 g of microcrystalline cellulose, 20 g of pregelatinized starch, 15 g of hydroxypropyl cellulose, 9 g of silicon dioxide, and 20 g of talcum powder for mixing, and add 6 g of magnesium stearate for mixing. Mix evenly and tablet, 1000 tablets, tablet weight 0.61g, tablet hardness control 6-7Kg; 3.1g premix containing ethyl cellulose, polyvinylpyrrolidone film-forming material, dissolved in 95% ethanol solution 36.8ml was prepared as an isolation layer coating solution, stirred for 45 minutes, and evenly sprayed on the surface of levocarnitine tablet core by a spray gun to prepare levocarnitine isolation coating tablet; 12.2g of methacrylic acid copolymer film-forming material was prepared The prepared premix is ​​dispersed in 100ml of distilled water, prepared as a moisture-proof layer coating solution, stirred for 45 minutes, and uniformly sprayed on the surface of the levocarnitine isolation coating tablet by a spray gun; test...

Embodiment 3

[0018] Embodiment 3, take by weighing prescription amount levocarnitine 330g, microcrystalline cellulose 270g, hydroxypropyl cellulose 10g, lactose 15g, silicon dioxide 3.2g, polyethylene glycol 3.2 mix, add magnesium stearate 6.4g mix , mixed evenly, and compressed into 1000 tablets, the tablet weight is 0.638g, and the tablet hardness is controlled at 6-7Kg; the premix made of 9.6g hydroxypropyl methylcellulose film-forming material is dissolved in 95% ethanol solution 111.5 ml to be prepared as an isolation layer coating liquid, stirred for 45 minutes, and evenly sprayed on the surface of levocarnitine tablet cores by a spray gun to prepare levocarnitine isolation coating tablets; The mixed material is dispersed in 73ml of distilled water to prepare a moisture-proof layer coating solution, stirred for 45 minutes, and evenly sprayed on the surface of the levocarnitine isolation coat tablet through a spray gun; tested and packaged.

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Abstract

The invention relates to levocarnitine thin film coated tablets applied in medicine and sanitation industries. The levocarnitine thin film coated tablets are prepared from a levocarnitine tablet core and a coating layer, wherein the levocarnitine tablet core is composed of 45-55wt% of levocarnitine, 40-50wt% of filling agent, 0.5-5wt% of glidant and 0.5-3wt% of lubricant; the coating layer comprises an isolation coating layer and a moisture-proof coating layer; the filling agent is one or more of microcrystalline cellulose, lactose, calcium hydrogen phosphate, hydroxypropyl cellulose and pregelatinized starch; the glidant is one or more of silicon dioxide and talc powder; the lubricant is one or more of magnesium stearate, polyethylene glycol and leucine; and the isolation coating layer of the coating layer is one or more film forming materials of hydroxypropyl methyl cellulose, ethyl cellulose and polyvinyl pyrrolidone or a premixed material containing the film forming materials. Thelevocarnitine thin film coated tablets and the preparation method thereof have the advantages that: the levocarnitine tablet core is prepared by direct tabletting through prescription screening; the operation is easy to control; the raw material pulverizing and screening processes are omitted; moisture absorption of the raw materials after pulverization is avoided; the process is simplified; the production cost is lowered; and the production efficiency is improved.

Description

technical field [0001] The invention relates to a levocarnitine film-coated tablet in the medical and health industry and a preparation method thereof. Background technique [0002] Levocarnitine, also known as vitamin Bt, L-carnitine, and L-carnitine, is an essential substance in the energy metabolism of mammals, and plays an important role in the production and transport of energy in cells. It can bring long-chain fatty acids into mitochondria to promote their oxidative decomposition and provide energy for cells. Fatty acids in skeletal muscle and cardiac muscle are the main energy metabolism substrates. L-carnitine plays an essential role in the energy metabolism of skeletal muscle and cardiac muscle role. Clinically, it is mainly used to prevent and treat primary and secondary carnitine deficiency of carnitine, such as L-carnitine deficiency caused by hemodialysis in patients with chronic renal failure; to improve myocardial ischemia, anti-angina pectoris, clinical mani...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K9/36A61K31/205A61P3/02
Inventor 陈雅琴王虹刘嫱石秀芹阎研王慧颖
Owner NORTHEAST PHARMA SHENYANG SCI & TECH DEV
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