CN102349881A - Levocarnitine thin film coated tablets and preparation method thereof - Google Patents
Levocarnitine thin film coated tablets and preparation method thereof Download PDFInfo
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- CN102349881A CN102349881A CN2011103283600A CN201110328360A CN102349881A CN 102349881 A CN102349881 A CN 102349881A CN 2011103283600 A CN2011103283600 A CN 2011103283600A CN 201110328360 A CN201110328360 A CN 201110328360A CN 102349881 A CN102349881 A CN 102349881A
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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. The levocarnitine 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
The present invention relates to a kind of levocarnitine Film coated tablets in the medical and health industry and preparation method thereof.
Background technology
Levocarnitine is claimed vitamin B t again, L-carnitine, and levocarnitine is a substance in vivo necessary in the mammal energy metabolism, the generation of energy and transhipment play an important role in the pair cell.It can be brought long-chain fatty acid into mitochondrion and promote its oxidation Decomposition, and for cell provides energy, fatty acid is main energy metabolism substrate in skeletal muscle and the cardiac muscle, and levocarnitine plays requisite effect in skeletal muscle and energy metabolism of myocardial.Clinical being mainly used in prevented and treated carnitine constitutional and Secondary cases levocarnitine shortage, and levocarnitine lacks due to analysing like chronic renal failure patients's hemodialysis; Improve myocardial ischemia, antianginal, clinical manifestation is muscular spasm etc. in cardiomyopathy, skeleton myopathy (bitterly), arrhythmia, hyperlipidemia and hypotension and the dialysis.No matter its pharmacology and physiological action have been carried out extensive research from the eighties in last century both at home and abroad since the listing always, its production and the scope of application are progressively expanded, be food, health product or field of medicaments, all obtained extensive use.The levocarnitine determined curative effect, side effect is little.A tree name is reported with 15g/ day high dose, the generation of almost being free from side effects during the treatment.The U.S. Committee of Experts in 1993 thinks that levocarnitine is " generally recognized as safe is nontoxic ", German hygiene department regulation in 1994, and the levocarnitine use amount need not set upper limit.This product is defined as legal multipurpose nutritive agent by Switzerland, France, the U.S. and World Health Organization (WHO) at present, so levocarnitine more and more causes extensive interest of people and concern.
Levocarnitine is the research and development of Italian Sigma-tau company, puts on market in 1981, and the dosage form of having gone on the market at present has tablet, oral liquid, injection.The levocarnitine raw material has stronger hygroscopicity; Process oral solid formulation and on production process is still packed and stored, all have big difficulty; Therefore be developed at present injection and oral liquid more; Though yet the injection effect rapidly; Bioavailability is high; Be suitable for some patients with severe symptoms; But because its price is higher; And the patient must just can receive treatment in hospital; Therefore this product receives very big restriction in clinical use; Though and the oral liquid taking convenience, its production; Storage; Carry and have many difficulties, it is necessary developing its oral solid formulation for this reason.
Principal agent levocarnitine among the present invention has stronger hygroscopicity; Therefore in order to improve product stability; Need to carry out coating on the surface of slice, thin piece; The damp-proof coating material need be made into aqueous dispersion usually at present; Promptly adopt water to make the coating solution coating of solvent, dissolution phenomena can appear in the product label like this, and unilateral appearance is uneven; Residual moisture is prone to too much in the label in addition, can occur deliquescing, decortication phenomenon in the product put procedure.
The preparation technology of tablet adopts wet granulation technology more at present, is about to raw material pulverizing, sieves, and granulates drying, tabletting together with adjuvant.This technology shortcoming is that levocarnitine raw material hygroscopicity is very strong, and the process of pulverizing, sieve all needs strictly controlled environment humidity, is controlled at below 30% usually.Because levocarnitine has good dissolubility in water, common wet granulation, binding agent can only adopt alcohol to make solvent, after the binding agent that adopts water to make solvent ran into raw material, dissolving promptly appearred in raw material in addition, was difficult to granulate.So not only cost increases, and equipment all needs explosion-proof simultaneously.Boiling granulating technology can adopt water to do the binding agent of solvent, but owing to light weight and serious static after the levocarnitine raw material pulverizing, the grain density of processing is little, fills difficulty.
2007 the 28th the 7th phases of volume of Shanghai medicine; Delivered one piece of research article about levocarnitine tablet recipe and preparation technology; This study tour several method for preparinies, comprising direct compression technology, this technology preparation is levocarnitine 200g; Microcrystalline Cellulose 500g; Micropowder silica gel 3g, magnesium stearate 12g, polyvinylpyrrolidone 30g; Process 1000, the principal agent proportion is 27%.Testing result shows that product hardness is 7Kg, and slice, thin piece disintegrate 17-18 minute, product disintegrate can not reach the requirement of pharmacopeia regulation.Therefore, develop a kind of levocarnitine Film coated tablets and preparation method thereof is the new problem that needs to be resolved hurrily always.
Summary of the invention
The object of the present invention is to provide a kind of levocarnitine Film coated tablets and preparation method thereof; The present invention passes through prescription screening; Process levocarnitine Film coated tablets with contagion gown and moistureproof clothing two-layered coating; Overcome the strong hygroscopicity of levocarnitine; The dissolved phenomenon of label; Improved the levocarnitine stability of formulation greatly, giving to produce, transport, preserve and to carry provides great convenience.
The objective of the invention is to realize like this: a kind of levocarnitine Film coated tablets; Form by levocarnitine label and coatings; This levocarnitine label is made up of levocarnitine, filler, fluidizer, lubricant; Said each weight percentages of components of levocarnitine label is levocarnitine 45-55%; Filler 40-50%; Fluidizer 0.5-5%, lubricant 0.5-3%; Coatings is divided into the contagion gown layer and moistureproof clothing layer is two-layer; Said filler is one or more in microcrystalline Cellulose, lactose, calcium hydrogen phosphate, hyprolose, the pregelatinized Starch; Said fluidizer is one or more in silicon dioxide, the Pulvis Talci; Said lubricant is one or more in magnesium stearate, Polyethylene Glycol, the leucine; The contagion gown layer of said coatings is one or more filmogens in hydroxypropyl emthylcellulose, ethyl cellulose, the polyvinylpyrrolidone or the premix material that contains above-mentioned filmogen; The moistureproof clothing layer of said coatings is one or more filmogens in ethyl cellulose, polyvinyl alcohol, the methacrylic acid copolymer or the premix material that contains above-mentioned filmogen; This method for preparing may further comprise the steps:
(1) it is even to take by weighing levocarnitine and filler, fluidizer, the mix lubricant of recipe quantity, measures mixture content;
(2) adopt direct powder compression to prepare label;
(3) the sealing coat coating material is dissolved in the alcoholic solution, is mixed with the sealing coat coating solution, in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying;
(4) the damp-proof layer coating material is scattered in is mixed with the damp-proof layer coating solution in the water, isolate the garment piece surface in levocarnitine, be prepared into the levocarnitine Film coated tablets through the spray gun even spraying;
(5) detect, pack.
Main points of the present invention are its Film coated tablets and method for preparing.Its principle is; The levocarnitine Film coated tablets adopts the clothing of double-baging; Be to adopt direct tablet compressing technology simultaneously; Direct tablet compressing technology can be reduced to mixing → compressing tablet with mixing → system softwood → system wet granular → drying → whole grain → compressing tablet process; This technology is to be applied to the new technology of producing in recent decades; Adopt microcrystalline cellulose and lactose etc. to unite among the present invention and done filler; Not only need not add adhesive (polyvinylpyrrolidone) in the prescription like this; Product can have good compressibility and flowability; And disintegration obviously improves; The product hardness of the present invention's preparation is 6-7Kg, slice, thin piece disintegration 9-10 minute.
A kind of levocarnitine Film coated tablets and preparation method thereof compared with prior art; Have through prescription screening; Select direct compression prepared levocarnitine label; Easy operating control has reduced raw material pulverizing; The process of sieving has been avoided being prone to moisture absorption after the raw material pulverizing; Be difficult for granulating; And the granule of processing is soft, is difficult for the problem of tabletting, through simplifying technology; Reduce production costs; Time-saving energy-saving has shortened man-hour, enhances productivity; Product adopts the damp-proof coating material; Obviously improved the product moisture pick-up properties, improved advantages such as product stability greatly, will be widely used in the medical and health industry.
The specific embodiment:
Embodiment one, takes by weighing recipe quantity levocarnitine 330g, microcrystalline Cellulose 270g, lactose 50g, silicon dioxide 6.5g mixing, adds magnesium stearate 6.5g and mixes, and mix homogeneously, tabletting are 1000, the heavy 0.663g of sheet, slice, thin piece Hardness Control 6-7Kg; The premix material that 6.6g hydroxypropyl emthylcellulose, ethyl cellulose filmogen are processed; Be dissolved among the 95% alcoholic solution 76ml and be mixed with the sealing coat coating solution; Stirred 45 minutes, and in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying; The premix material that 20g polyvinyl alcohol filmogen is processed is scattered in and is mixed with the damp-proof layer coating solution among the distilled water 95ml, stirs 45 minutes, isolates the garment piece surface through the spray gun even spraying in levocarnitine; Detect, pack.
Embodiment two, take by weighing recipe quantity levocarnitine 330g, microcrystalline Cellulose 210g, pregelatinized Starch 20g, hyprolose 15g, silicon dioxide 9g; Pulvis Talci 20g mixes, and adds magnesium stearate 6g and mixes mix homogeneously, tabletting; Be 1000, the heavy 0.61g of sheet, slice, thin piece Hardness Control 6-7Kg; 3.1g is contained the premix material that ethyl cellulose, polyvinylpyrrolidone filmogen are processed; Be dissolved among the 95% alcoholic solution 36.8ml and be mixed with the sealing coat coating solution; Stirred 45 minutes, and in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying; The premix material that 12.2g methacrylic acid copolymer filmogen is processed is scattered among the distilled water 100ml, is mixed with the damp-proof layer coating solution, stirs 45 minutes, isolates the garment piece surface through the spray gun even spraying in levocarnitine; Detect, pack.
Embodiment three, take by weighing recipe quantity levocarnitine 330g, microcrystalline Cellulose 270g, hyprolose 10g, lactose 15g, silicon dioxide 3.2g, Polyethylene Glycol 3.2 mixing, add magnesium stearate 6.4g and mix; Mix homogeneously, tabletting; Be 1000, the heavy 0.638g of sheet, slice, thin piece Hardness Control 6-7Kg; With the premix material that 9.6g hydroxypropyl emthylcellulose filmogen is processed, be dissolved among the 95% alcoholic solution 111.5ml and be mixed with the sealing coat coating solution, stirred 45 minutes,, be prepared into levocarnitine and isolate garment piece in levocarnitine sheet wicking surface through the spray gun even spraying; The premix material that 16g ethyl cellulose filmogen is processed is scattered in and is mixed with the damp-proof layer coating solution among the distilled water 73ml, stirs 45 minutes, isolates the garment piece surface through the spray gun even spraying in levocarnitine; Detect, pack.
Embodiment four, get recipe quantity levocarnitine 330g, microcrystalline Cellulose 270g, lactose 20g, silicon dioxide 9.6g, Polyethylene Glycol 12.8g mixing, add magnesium stearate 3.2g and mix; Mix homogeneously, tabletting; Be 1000, the heavy 0.646g of sheet, slice, thin piece Hardness Control 6-7Kg; The premix material that 12.9g hydroxypropyl emthylcellulose filmogen is processed; Be dissolved among the 95% alcoholic solution 147.3ml and be mixed with the sealing coat coating solution; Stirred 45 minutes, and in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying; The premix material that 25.6g polyvinyl alcohol filmogen is processed is scattered in and is mixed with the damp-proof layer coating solution among the distilled water 116.8ml, stirs 45 minutes, isolates the garment piece surface through the spray gun even spraying in levocarnitine; Detect, pack.
Embodiment five, get recipe quantity levocarnitine 330g, microcrystalline Cellulose 300g, calcium hydrogen phosphate 30g, lactose 35g, silicon dioxide 30g mixing, add magnesium stearate 4g and mix, and mix homogeneously, tabletting are 1000, the heavy 0.729g of sheet, slice, thin piece Hardness Control 6-7Kg; The premix material that 8.75g ethyl cellulose, polyvinylpyrrolidone filmogen are processed; Be dissolved among the 95% alcoholic solution 100ml and be mixed with the sealing coat coating solution; Stirred 45 minutes, and in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying.The premix material that 23.3g polyvinyl alcohol filmogen is processed is scattered in and is mixed with the damp-proof layer coating solution among the distilled water 105ml, stirs 45 minutes, isolates the garment piece surface through the spray gun even spraying in levocarnitine; Detect, pack.
The laboratory report of a kind of levocarnitine Film coated tablets and preparation method thereof:
1, the stability contrast is investigated
Prescription according to the embodiment of the invention one prepares the levocarnitine label, the moistureproof clothing of bag monolayer, and as the control sample of embodiment one levocarnitine Film coated tablets, the result sees table 1.
Table 1: the present invention and control sample stability result be (40 ℃ ± 2 ℃ 75% ± 5%) relatively
2, the levocarnitine Film coated tablets to the embodiment of the invention one preparation has carried out disintegrate, dissolution detects, and has carried out the dissolution contrast test with imported product, has carried out stability test on this basis.The result shows that the product disintegrate is qualified, and dissolution is similar with imported product, constant product quality property.
Dissolution detects data and sees table 2, table 3, and levocarnitine Film coated tablets study on the stability result sees table 4, table 5.
Table 2: the present invention's accumulative total stripping percentage rate detects data
Table 3: (Korea S: L-Carn) accumulative total stripping percentage rate detects data to the import sheet
Visible by table 2, table 3, from film-making and import sheet stripping behavior no significant difference.
Stability experiment:
These article are pressed commercially available back; Put 40 ℃ ± 2 ℃, relative humidity and be 75% ± 5% condition held 6 months; 25 ℃ ± 2 ℃, relative humidity are 60% ± 5% condition held 24 months; Take a sample respectively at the stipulated time; Measure content, related substance, dissolution index, result of the test is seen table 4, table 5.
Table 4: accelerated stability test result
Table 5: long-term stable experiment result
The result shows that levocarnitine Film coated tablets steady quality of the present invention is placed 24 months each item indexs for a long time and do not had significant change.
Claims (7)
1. levocarnitine Film coated tablets; Form by levocarnitine label and coatings; It is characterized in that: this levocarnitine label is made up of levocarnitine, filler, fluidizer, lubricant; Said each weight percentages of components of levocarnitine label is levocarnitine 45-55%; Filler 40-50%; Fluidizer 0.5-5%, lubricant 0.5-3%; Coatings is divided into the contagion gown layer and moistureproof clothing layer is two-layer.
2. a kind of levocarnitine Film coated tablets according to claim 1 is characterized in that: said filler is one or more in microcrystalline Cellulose, lactose, calcium hydrogen phosphate, hyprolose, the pregelatinized Starch.
3. a kind of levocarnitine Film coated tablets according to claim 1 is characterized in that: said fluidizer is one or more in silicon dioxide, the Pulvis Talci.
4. a kind of levocarnitine Film coated tablets according to claim 1 is characterized in that: said lubricant is one or more in magnesium stearate, Polyethylene Glycol, the leucine.
5. according to the described a kind of levocarnitine Film coated tablets of claim 1, it is characterized in that: the contagion gown layer of said coatings is one or more filmogens in hydroxypropyl emthylcellulose, ethyl cellulose, the polyvinylpyrrolidone or the premix material that contains above-mentioned filmogen.
6. according to the described a kind of levocarnitine Film coated tablets of claim 1, it is characterized in that: the moistureproof clothing layer of said coatings is one or more filmogens in ethyl cellulose, polyvinyl alcohol, the methacrylic acid copolymer or the premix material that contains above-mentioned filmogen.
7. the method for preparing of a kind of levocarnitine Film coated tablets according to claim 1 is characterized in that: this method for preparing may further comprise the steps:
(1) it is even to take by weighing levocarnitine and filler, fluidizer, the mix lubricant of recipe quantity, measures mixture content;
(2) adopt direct powder compression to prepare label;
(3) the sealing coat coating material is dissolved in the alcoholic solution, is mixed with the sealing coat coating solution, in levocarnitine sheet wicking surface, be prepared into levocarnitine and isolate garment piece through the spray gun even spraying;
(4) the damp-proof layer coating material is scattered in is mixed with the damp-proof layer coating solution in the water, isolate the garment piece surface in levocarnitine, be prepared into the levocarnitine Film coated tablets through the spray gun even spraying;
(5) detect, pack.
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Cited By (4)
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| CN102525992A (en) * | 2012-03-09 | 2012-07-04 | 徐奎 | L-alpha-glycerophosphoryl choline film-coated tablet and preparation method thereof |
| CN104224759A (en) * | 2014-09-28 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | L-carnitine oral instantly-dissolving film and preparation method thereof |
| CN104511018A (en) * | 2013-09-27 | 2015-04-15 | 北京诚济制药有限公司 | Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets |
| CN112826803A (en) * | 2021-02-24 | 2021-05-25 | 东北制药集团沈阳第一制药有限公司 | Levocarnitine tablets and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525992A (en) * | 2012-03-09 | 2012-07-04 | 徐奎 | L-alpha-glycerophosphoryl choline film-coated tablet and preparation method thereof |
| CN104511018A (en) * | 2013-09-27 | 2015-04-15 | 北京诚济制药有限公司 | Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets |
| CN104511018B (en) * | 2013-09-27 | 2017-08-18 | 北京诚济制药股份有限公司 | It is a kind of to improve the prescription and technique of the strong hygroscopicity of levocarnitine piece and dissolved corrosion |
| CN104224759A (en) * | 2014-09-28 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | L-carnitine oral instantly-dissolving film and preparation method thereof |
| CN112826803A (en) * | 2021-02-24 | 2021-05-25 | 东北制药集团沈阳第一制药有限公司 | Levocarnitine tablets and preparation method thereof |
| CN112826803B (en) * | 2021-02-24 | 2024-01-19 | 东北制药集团沈阳第一制药有限公司 | Levocarnitine tablets and preparation method thereof |
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Inventor after: Chen Yaqin Inventor after: Wang Hong Inventor after: Liu Qiang Inventor after: Shi Xiuqin Inventor after: Yan Yan Inventor after: Wang Huiying Inventor before: Chen Yaqin Inventor before: Wang Hong Inventor before: Liu Qiang Inventor before: Shi Xiuqin Inventor before: Yan Yan Inventor before: Wang Huiying |