CN1486686A - Stomach floating pulsed releasing tablet - Google Patents
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- CN1486686A CN1486686A CNA031418376A CN03141837A CN1486686A CN 1486686 A CN1486686 A CN 1486686A CN A031418376 A CNA031418376 A CN A031418376A CN 03141837 A CN03141837 A CN 03141837A CN 1486686 A CN1486686 A CN 1486686A
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Abstract
The present invention relates to medicinal technology, and is one kind of stomach floating pulsed releasing tablet capable of floating in gastric juice and releasing its active component timely. The stomach floating pulsed releasing tablet consists of core with medicine inside it, coating and floating layer. The coating consists of mixed light hydrophilic matter and light hydrophobic matter in certain ratio, and the tablet formed under certain pressure has proper hardness and density smaller than 1. The hydrophilic matter capable of dissolving in gastric juice and the hydrophobic matter capable of lowering the water permeability of the coating are properly proportioned to regulated the water permeating rate of the coating and thus the medicine releasing time. The present invention can prepare various pulsed releasing tablets of different medicines to form pulsed administration system according to physiological and treatment requirement.
Description
Technical field:
The present invention relates to medical technical field, is a kind of can be in gastric juice floating and regularly discharge the stomach float type pulse release sheet of active constituents of medicine.
Background technology:
In recent years, studies show that of chronobiology and chronopharmacology, the physiological function of human body and the outbreak of some disease demonstrate tangible rhythmicity and change, and promptly have circadian rhythm, and the also all free rhythm and pace of moving things of the therapeutical effect of medicine, toxic reaction and physiological disposition.Traditional slow/controlled release preparation with zero level speed, first-rate release can satisfy medicine and keep metastable blood drug level in vivo, guaranteed the long-acting of slow release or medicine, in clinical treatment, play positive role, as time passes, the slow/controlled release preparation also exposes deficiency, can not satisfy the needs of clinical treatment.As medication repeatedly during treating, or use some drugs slow/controlled release preparation, cause curative effect to descend, side effect increases, and increased by medicine (as levodopa etc.) the biodegradation amount of " first pass effect " a large amount of metabolic degradations, has influenced bioavailability.Nitrate esters medicine and for example, with acceptor interaction, long-time stimulus makes it deactivation, produces drug resistance and causes curative effect and reduce; Oral drugs such as cardiovascular drug, NSAID (non-steroidal anti-inflammatory drug), treating asthma medicine all are subjected to the physiological rhythm influence, and traditional drug-supplying system can not adapt to the psychological need that rhythmicity changes.
The chronokinetics research data shows, because the most physiological functions relevant with transport of drug, as cardiac output, liver, renal blood flow, the secretion speed and the pH value of various body fluid, gastrointestinal functions etc. all have circadian rhythm, make one or more pharmacokinetic parameters of many medicines present variation round the clock.Confirm many commonly encountered diseases as clinical practice, all present circadian rhythm as asthma, hypertension, angina pectoris, arthritis and change.The best administration time of asthma is 4 points in the morning; 3 etc. in the morning of the best administration times of hypertension.The tradition administration often daytime the blood drug level height, do not match with circadian rhythm.Therefore, in order to make drug release meet physiological rhythm,, carried out the preparation design in recent years, formed according to the needs of physiology and treatment the pulsatile administration system of release at regular time and quantity according to these biorhythies variation characteristics of human body.
For example, disclose a kind of pulse preparation among the W090/09168, it is the water-insoluble capsule that clogs with a kind of hydroexpansivity thromboembolism, and the thromboembolism imbibition is arrived to a certain degree after taking, and thromboembolism is deviate from from capsule, and the medicine in the capsule just is released." time lag " that this hydroexpansivity thromboembolism water absorption course is produced is predictable and repeatably.Covera-HS verapamil controlled release preparation in U.S.'s listing is exactly the pulse preparation for preparing with the osmotic pumps technology; Ireland Elan company adopts the verapamil pulse preparation Veralan PM of CODAS technological development, and the pulsation-releasing preparation of enalapril and nitrate, then is to adopt coating method.(PharmaceuticalResearch, 1998,5 (3): 474-480) the made erodible thromboembolism of pulse plug capsule water is lived the water-insoluble capsule to Ina Kr gela, has sealed the drug particles that contains effervescent, has realized predictable " time lag " equally.CN 1385149A discloses a kind of pulse preparation, adopts high molecular film material as the coating main material, and is used in combination a kind of swellability material in label inside, and coating membrane can be broken at special time, plays the pulse release effect.The coating material that this invention is adopted comprises hydroxypropyl methylcellulose, ethyl cellulose, diethyl phthalate.
The pulse preparation is the system that discharges medicine behind the oral administration, and there is individual variation in preparation in the holdup time of gastric, determines that therefore gastral release position is very difficult.And coating type and corrosion plug type pulse preparation all are to utilize the water penetration theory to produce pulse, and the generation of effect is relevant time of contact with Digestive system with preparation when therefore controlling.Because the transhipment of gastric emptying and digestive tract is variant in the human body, thus the gastric emptying of preparation is too fast and the intestinal transport temporal differences has limited pulse " time lag " but set point.The degree of enriching of gastric juice far surpasses intestinal juice, and time lag mainly is subjected to and the Digestive system influence of time of contact in the body of coating type and corrosion plug type pulse preparation, and promptly preparation can improve the pulse preparation repeatability of time lag in vivo if can prolong at gastric transit time.Above-mentioned pulse preparation, the long meeting of pulse " time lag " design cause in screening (medicine does not discharge, and tablet excretes) or the body release time lag difference big, and therefore, the bioavailability of preparation can not guarantee.
Summary of the invention:
The invention provides and a kind ofly can in gastric juice, continue floating and can discharge the pulse release tablet of medicine in the time of setting rapidly.
Stomach float type pulse release sheet of the present invention is made up of label and outer coatings, and medicine is at the sheet in-core, and outer coatings with the label parcel wherein.According to the water balance principle of dynamics, outer coatings after being mixed by a certain percentage by hydrophilic light material and hydrophobicity light material is placed in one label, depress to the tablet of suitable hardness at certain pressure, the global density that makes tablet is less than 1, therefore can float in the gastric juice and is difficult for entering intestinal; Can make outer coatings become permeable because of dissolving gradually behind the hydrophilic material contact gastric juice again, hydrophobic material can make the outer coatings permeation rate slow down, therefore adopt the different proportionings of hydrophilic and hydrophobic material, regulate and control the permeation rate of outer coatings, that is regulation and control tablet drug release time in vivo.Just because of stomach float type pulse release sheet has when control concurrently and helps the effect of floating, therefore as long as take medicine in good time, effective disease preventing and treating just.The hydrophilic material of outer coatings is selected from Macrogol 2000～6000, poloxamer, crylic acid resin, cellulose acetate-phthalate, wherein preferred Polyethylene Glycol; Hydrophobic material is selected from stearic acid, hexadecanol, octadecanol, glyceryl monostearate, castor oil hydrogenated, Brazil wax, tripalmitin, glycerol tristearate, cocoa butter, white beeswax, Cera Chinensis, gelatin, hydrogenated vegetable oil, hydrogenated groundnut, hydrogenated fish oil, hydrogenated cottonseed oil, Cera Flava, hard wax, wherein preferred hexadecanol.Outer coatings of the present invention can also contain plastic material or swellability macromolecular material.Plastic material is selected from polyvinyl alcohol, polypropylene, polyisobutylene, poly-third ethylene, polrvinyl chloride, polyvinyl acetate, polyvinyl acetate phthalate, ethylene-vinyl acetate copolymer, wherein optimal ethylene-acetate ethylene copolymer.The swellability macromolecular material comprises hydroxypropyl methylcellulose, hydroxypropyl cellulose, L-hydroxypropyl cellulose, methylcellulose, carboxymethyl starch sodium, polyvinyl alcohol, hydroxypropyl starch, microcrystalline Cellulose, crospolyvinylpyrrolidone etc.The proportioning of hydrophilic light material and hydrophobicity light material is 10～90: 10～90, the ratio 0～20% of plastic material or swellability macromolecular material is advisable, select corresponding ratio with the drug release time of setting, the total amount of preparation and the hardness of control so that the global density of tablet be as the criterion less than 1.Physical mixed was made granule after the preparation of outer coatings can be adopted each material elder generation crushing screening, or crushing screening is made granule after adopting melting mixing.
For increasing the floating reliability of float type pulse release sheet, can be provided with floating layer in a side of tablet, it is made up of hydroxypropyl methylcellulose and effervescent, and weight ratio is 10～100: 90～0.Hydroxypropyl methylcellulose is selected from K4M, K15M, and swelling behind this material contact Digestive system makes tablet increase buoyancy, realizes floating; Effervescent is made up of organic acid plus carbonate, and organic acid is selected from citric acid, tartaric acid, malic acid, fumaric acid etc., and carbonate is selected from sodium bicarbonate, magnesium carbonate, and weight ratio is 90～0: 10～100.Produce bubble behind this material contact Digestive system, swollen hydroxypropyl methylcellulose proportion is reduced, increase the floating force of preparation.Floating layer material can be standby with dry method direct compression or the floating layer of wet granulation granule earlier.
Label comprises active constituents of medicine, disintegrating agent/effervescent and medicated premix commonly used.Material as disintegrating agent is selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose, L-hydroxypropyl cellulose, methylcellulose, carboxymethyl starch sodium, polyvinyl alcohol, hydroxypropyl starch, microcrystalline Cellulose, crospolyvinylpyrrolidone, wherein preferred crospolyvinylpyrrolidone.The composition of effervescent as mentioned above.Medicated premix is the various additives commonly used in this area such as the dissolution aids of excipient, bonding agent, lubricant, anti-agglutinant, medical compounds.Because the effect of disintegrating agent or effervescent, in case Digestive system penetrates outer coatings, label is with regard to imbibition or effervescent, and medicine can the short time pulsed discharge, and reaches treatment concentration, thereby effectively prevents or disease controlling.
The preparation method of stomach float type pulse release sheet is as follows:
1, preparation label: label is according to the direct compression process or the wet granule compression tablet of routine.
2, prepare the outer coatings granule: it is standby to make the outer coatings granule after hydrophilic light material, hydrophobicity light material and additive are mixed in proportion.
3, preparation stomach float type pulse release sheet: earlier the half outer coatings granule of measuring is put in the punch die light the pressure; Again label is placed granule central authorities, then other is partly measured the outer coatings granule and add in the punch die, adjust compression force, tabletting.Hardness Control is at 1～8kg/cm
2Make global density less than 1, so that floatability is in water.If tablet adds floating layer, then after the outer coatings granule is partly measured in adding for the second time, add floating layer granule again, adjust the compression force tabletting.
Description of drawings:
Fig. 1 is the sectional structure sketch map of stomach float type pulse release sheet of the present invention
The sectional structure sketch map of Fig. 2 stomach float type pulse release sheet of floating layer for the present invention establishes
Fig. 3 is that tablet of the present invention is the medicine pulse release figure of release medium with the 900ml simulated gastric fluid.
The specific embodiment:
Stomach float type pulse release sheet of the present invention is formed (Fig. 1) by outer coatings 1 and label 2, also can form (Fig. 2) by outer coatings 1, label 2 and floating layer 3.
Embodiment 1: the particulate preparation of outer coatings
The prescription and the proportioning of preparation outer coatings:
Composition consumption/1000 slice
Hexadecanol 80g
Macrogol 4000 145g
Ethylene-vinyl acetate copolymer 28/250 15g
Preparation method: with hexadecanol 80g, Macrogol 4000 145g and ethylene-vinyl acetate copolymer 28/25015g mixing, put in 98～100 ℃ of water-baths and heat, constantly stir, treat the rearmounted room temperature cooling curing of complete fusion, put in the mortar and grind, cross 40 mesh sieves and get outer coated granule.
Embodiment 2: the preparation of label
The prescription of label and proportioning:
Composition consumption/1000 slice
Verapamil 40g
Crospolyvinylpyrrolidone 15g
Preparation method: verapamil raw material 40g makes bonding agent with after crospolyvinylpyrrolidone 15g mixes with 5% polyvinylpyrrolidone alcoholic solution, makes soft material and crosses 20 mesh sieves and granulate, in 50 ℃ of oven dry, cross 20 mesh sieve granulate, add 0.3% magnesium stearate, mixing, tabletting gets label.
For increasing the floating reliability of float type pulse release sheet, can increase a floating layer in a side of tablet, as Fig. 2.The prescription and the proportioning that prepare floating layer:
Composition consumption/1000 slice
Hydroxypropyl methylcellulose K4M 70g
Sodium bicarbonate 30g
Preparation method: hydroxypropyl methylcellulose K4M 70g is with after sodium bicarbonate 30g mixes, polyvinylpyrrolidone alcoholic solution with 5% is made bonding agent, make soft material and cross the granulation of 20 mesh sieves, in 50 ℃ of oven dry, cross 20 mesh sieve granulate, add 0.3% magnesium stearate, as lubricant, mixing gets floating layer granule.
The preparation of embodiment 4, stomach float type pulse release sheet
1, the stomach float type pulse release sheet of preparation structure such as Fig. 1:, the outer coatings granule 120mg of above-mentioned preparation is put in the punch die light the pressure with the rotary bag core of ZPW20 machine; The label of above-mentioned preparation is placed granule central authorities, and the outer coatings granule with 120mg adds in the punch die again, adjusts compression force, and tabletting makes tablet hardness be controlled at 4.5～5.0kg/cm
2
2, the stomach float type pulse release sheet of preparation structure such as Fig. 2:, 120mg outer coatings granule is put in the punch die light the pressure with the rotary bag core of ZPW20 machine; Label places granule central authorities, 120mg outer coatings granule is added in the punch die again, adds the floating layer of 100mg granule at last, adjusts compression force, and tabletting makes tablet hardness be controlled at 4.5～5.0kg/cm
2
The release test of embodiment 5, stomach float type pulse release sheet
Three kinds of tablets, label is verapamil raw material and crospolyvinylpyrrolidone, and weight ratio is 40: 15, and gross weight is 65mg.Outer coatings adopts hexadecanol, Macrogol 4000 and ethylene-vinyl acetate copolymer 28/250, and its weight ratio respectively is: tablet 1 60: 165: 15, tablet 2 50: 175: 15, tablet 3 40: 185: 15, gross weight was 240mg; Floating layer material is hydroxypropyl methylcellulose K4M and sodium bicarbonate, and weight ratio is 70: 30, and gross weight is 100mg.
Above-mentioned 3 kinds of tablets are by " 2000 editions appendix XC of Chinese pharmacopoeia dissolution method, second method is changeed the basket method and carried out the release test, and release conditions: with the 900ml simulated gastric fluid is release medium, rotating speed (100 ± 1) r/min, temperature (37 ± 0.5) ℃.With the clad sheet commentaries on classics basket of packing into, open rotary switch, timing.Timing sampling 6ml, 0.8 μ m filtering with microporous membrane, and mend with same amount dissolution medium, absorbance is measured in filtrate dilution back at the 229nm place, press standard curve calculation medium concentration, further asks and calculates the stripping percentage rate.Release profiles as shown in Figure 3, ■ represents tablet 1 ,+expression tablet 2, ● the expression tablet 3.The result shows that three kinds of tablets of the present invention all float on to be changeed in the basket, and three kinds of tablets discharged medicine after 240,380,480 minutes, realized the pulse release of preparation.Therefore, the invention provides a kind of stomach float type pulse release sheet that the predefined time discharges medicine rapidly that can in gastric juice, continue to be floated to.The present invention can be prepared into various oral drugs the stomach float type pulse release sheet of corresponding time lag, has formed the novel pulsatile administration system that needs release at regular time and quantity according to physiology and treatment.
Claims (4)
1. stomach float type pulse release sheet, form by outer coatings and label, medicine is at the sheet in-core, outer coatings with the label parcel wherein, it is characterized in that after outer coatings is mixed by a certain percentage by hydrophilic light material, hydrophobicity light material and additive label being placed in one, depress to the tablet of suitable hardness in certain compression force, said hydrophilic light material is selected from Macrogol 2000～6000, poloxamer, polyacrylic resin, cellulose acetate-phthalate; The hydrophobicity light material is selected from stearic acid, hexadecanol, octadecanol, glyceryl monostearate, castor oil hydrogenated, Brazil wax, tripalmitin, glycerol tristearate, cocoa butter, white beeswax, Cera Chinensis, gelatin, hydrogenated vegetable oil, hydrogenated groundnut, hydrogenated fish oil, hydrogenated cottonseed oil, Cera Flava, hard wax, the hydrophilic light material is 10～90: 10～90 with the ratio of hydrophobicity light material, said additive is plastic material or swellability macromolecular material, consumption is 0～20%, and plastic material is selected from polyvinyl alcohol, polypropylene, polyisobutylene, poly-third ethylene, polrvinyl chloride, polyvinyl acetate, polyvinyl acetate phthalate, ethylene-vinyl acetate copolymer; The swellability macromolecular material is selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose, L-hydroxypropyl cellulose, methylcellulose, carboxymethyl starch sodium, polyvinyl alcohol, hydroxypropyl starch, microcrystalline Cellulose, crospolyvinylpyrrolidone; Tablet hardness is controlled at 1～8kg/cm
2
2. by the described stomach float type of claim 1 pulse release sheet, it is characterized in that said hydrophobicity light material is a hexadecanol, the hydrophilic light material is a Macrogol 4000, and plastic material is an ethylene-vinyl acetate copolymer 28/250.
3. by claim 1 or 2 described stomach float type pulse release sheets, it is characterized in that also being provided with floating layer in a side of outer coatings, it is made up of hydroxypropyl methylcellulose and effervescent, and weight ratio is 10～100: 90～0; Said hydroxypropyl methylcellulose is selected from K4M, K15M; Said effervescent is made up of organic acid plus carbonate, and organic acid is selected from citric acid, tartaric acid, malic acid, fumaric acid, and carbonate is selected from sodium bicarbonate, magnesium carbonate.
4. by the described stomach float type of claim 3 pulse release sheet, it is characterized in that said floating layer is made up of hydroxypropyl methylcellulose K4M and sodium bicarbonate, weight ratio is 70: 30.
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| CN 03141837 CN1202813C (en) | 2003-07-25 | 2003-07-25 | Stomach floating pulsed releasing tablet |
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| CN 03141837 CN1202813C (en) | 2003-07-25 | 2003-07-25 | Stomach floating pulsed releasing tablet |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100333712C (en) * | 2005-06-03 | 2007-08-29 | 华中科技大学 | Material gradient controlled-release administrating system and its three-dimensional printing-forming preparation method |
| CN100346791C (en) * | 2004-07-08 | 2007-11-07 | 中国药科大学 | Controlled and released preparation of kurarinone detained in stomach |
| CN101579317A (en) * | 2009-05-27 | 2009-11-18 | 沈阳药科大学 | Intragastric floating slowly releasing micropill and preparation method thereof |
| CN101269056B (en) * | 2007-03-19 | 2010-05-19 | 天津药物研究院 | Metoprolol salt oral administration impulse pellet preparation |
| CN101234095B (en) * | 2007-02-02 | 2011-06-01 | 上海医药工业研究院 | Timely released preparation and preparation thereof |
| CN102973533A (en) * | 2012-11-12 | 2013-03-20 | 中国药科大学 | Preparation method of famotidine gastric-floating-type pellet tablets |
| CN106964053A (en) * | 2017-04-11 | 2017-07-21 | 张家港市沙工医疗器械科技发展有限公司 | A kind of J-type conduit of high-elastic disintegratable |
| CN109601763A (en) * | 2018-12-20 | 2019-04-12 | 浙江大学 | A kind of high stability aquatic feeds particle and preparation method thereof |
| CN110448535A (en) * | 2019-09-04 | 2019-11-15 | 湖南宇山玉月农业科技有限公司 | A kind of schizophyllum abamectin gastric floating tablet |
| CN112336696A (en) * | 2020-12-01 | 2021-02-09 | 苏州中化药品工业有限公司 | Long-acting pulse preparation and preparation method thereof |
| CN114081944A (en) * | 2021-10-26 | 2022-02-25 | 吉林市国科医工科技发展有限公司 | Gastric floating agent for treating helicobacter pylori infection |
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2003
- 2003-07-25 CN CN 03141837 patent/CN1202813C/en not_active Expired - Fee Related
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100346791C (en) * | 2004-07-08 | 2007-11-07 | 中国药科大学 | Controlled and released preparation of kurarinone detained in stomach |
| CN100333712C (en) * | 2005-06-03 | 2007-08-29 | 华中科技大学 | Material gradient controlled-release administrating system and its three-dimensional printing-forming preparation method |
| CN101234095B (en) * | 2007-02-02 | 2011-06-01 | 上海医药工业研究院 | Timely released preparation and preparation thereof |
| CN101269056B (en) * | 2007-03-19 | 2010-05-19 | 天津药物研究院 | Metoprolol salt oral administration impulse pellet preparation |
| CN101579317A (en) * | 2009-05-27 | 2009-11-18 | 沈阳药科大学 | Intragastric floating slowly releasing micropill and preparation method thereof |
| CN101579317B (en) * | 2009-05-27 | 2014-03-19 | 沈阳药科大学 | Intragastric floating slowly releasing micropill and preparation method thereof |
| CN102973533A (en) * | 2012-11-12 | 2013-03-20 | 中国药科大学 | Preparation method of famotidine gastric-floating-type pellet tablets |
| CN106964053A (en) * | 2017-04-11 | 2017-07-21 | 张家港市沙工医疗器械科技发展有限公司 | A kind of J-type conduit of high-elastic disintegratable |
| CN109601763A (en) * | 2018-12-20 | 2019-04-12 | 浙江大学 | A kind of high stability aquatic feeds particle and preparation method thereof |
| CN110448535A (en) * | 2019-09-04 | 2019-11-15 | 湖南宇山玉月农业科技有限公司 | A kind of schizophyllum abamectin gastric floating tablet |
| CN112336696A (en) * | 2020-12-01 | 2021-02-09 | 苏州中化药品工业有限公司 | Long-acting pulse preparation and preparation method thereof |
| CN114081944A (en) * | 2021-10-26 | 2022-02-25 | 吉林市国科医工科技发展有限公司 | Gastric floating agent for treating helicobacter pylori infection |
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