CN1814306A - Digestive tract evacuation-detecting slow-release tablet and its preparing process - Google Patents
Digestive tract evacuation-detecting slow-release tablet and its preparing process Download PDFInfo
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- CN1814306A CN1814306A CN 200510057395 CN200510057395A CN1814306A CN 1814306 A CN1814306 A CN 1814306A CN 200510057395 CN200510057395 CN 200510057395 CN 200510057395 A CN200510057395 A CN 200510057395A CN 1814306 A CN1814306 A CN 1814306A
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Abstract
This invention is an alimentary tract emptying function detection slow release pill and its preparation technique, and it includes framework core and coating. Materials of coating are medical use paraffin wax or silicon rubber, its thickness is 0.1mm - 1.5mm, via holes on coating is connected to framework core in coating. Cross sectional area of each hole is 0.1-10mm<SUP>2</SUP>, framework core length is 5-40mm, width is 5-15mm. its preparation technique mainly includes following procedures: providing framework core materials, and preparing framework core, coating liquor, and making coating, via holes. This product can be used to detect security of alimentary canel swallow electronic capsule, and its using is convenient, and security and reliability is high.
Description
Technical field:
The present invention relates to digestive tract evacuation-detecting slow-release tablet and preparation technology thereof, particularly a kind ofly be used to detect slow releasing tablet and the preparation technology thereof of digestive tract the emptying ability of solids.
Background technology:
Development along with technology such as microelectronics, integrated circuits, electronic capsule is as a kind of novel digestive tract diagnosis product, progressively entered clinical practice, as capsule endoscope, herbicide placement electronic capsule, digestive tract detected electrons capsule etc., one of common trait of these products is: the shell of electronic capsule is materials such as the medical plastic that can not degrade in digestive tract or rustless steel.In use there is serious hidden danger in these products: electronic capsule blocks in digestive tract easily.
Can not discharge gastral situation in case electronic capsule takes place, still stagnate as electronic capsule and in stomach, can not discharge, can take out by gastroscope; If but block in intestinal, particularly stagnate in small intestine distal end, utilize the operation of small intestinal endoscope taking-up electronic capsule just very difficult, in the time can not taking out, just can only take out by laparotomy ventrotomy, cause great injury to the patient.In clinical practice in the past, electronic capsule once repeatedly occurs and can not discharge digestive tract, must be by the case of laparotomy ventrotomy taking-up.
Before taking electronic capsule, for fear of the situation of blocking, employing method at present is: (1) disease history inquire, get rid of patient with digestive tract disease history; (2) digestive tract function detects, and the barium meal of swallowing carries out digestive tract X line perspective and detects, and when the patient exists digestive tract disease or dysfunction, then forbids the electronic capsule of swallowing.Clinical practice shows, even carried out disease history inquire and all-digestive tract detection, the still often generation of situation that electronic capsule blocks takes place.Therefore, for electronic capsule can more safely be used, press for the deficiency that a kind of method overcomes existing detection technique.
Clinical research shows, in order to detect the safety that the patient swallows electronic capsule, the most reliable way is once to simulate to swallow, and the simulation capsule swallowed of simulation should satisfy following requirement: (1) shape, size, weight are identical with the electronic capsule that will be swallowed, perhaps approximate; (2) in normal digestive tract evacuation time range, be generally about 24 hours, shape, the size of simulation slow releasing tablet do not change; (3) can be finally by disintegrate in digestive tract.
In view of above-mentioned instructions for use, identical with electronic capsule or the proximate simulation slow releasing tablet with extremely low disintegration rate of shape, size and weight can satisfy above-mentioned requirements.Current slow releasing tablet and preparation technology thereof, for example enteric-coated sustained-release tablet, the molten slow releasing tablet of colon, enteric coatel tablets or the like all can not satisfy above-mentioned 3 requirements simultaneously.Along with the increasingly extensive use of products such as electronic capsule, press for a kind of new simulation slow releasing tablet of development, can carry out digestive tract evacuation and detect.
Summary of the invention:
The objective of the invention is to overcome the deficiencies in the prior art, provide a kind of property esy to use, safe and reliable high digestive tract evacuation-detecting slow-release tablet.
For achieving the above object, technical scheme of the present invention is:
Size and shape according to electronic capsule, make a kind of at size and the shape digestive tract evacuation-detecting slow-release tablet identical or similar with electronic capsule, this slow releasing tablet comprises matrix core and coatings, the material of coatings is medical paraffin or medical grade silicon rubber, its thickness is 0.1mm-1.5mm, have through hole to communicate with matrix core in the coatings on coatings, the cross-sectional area of each through hole on coatings is 0.1-10mm
2, the length of described matrix core is 5-40mm, and width is 5-15mm, and thickness is 5-15mm.
The preparation technology of digestive tract evacuation-detecting slow-release tablet of the present invention, step is carried out in the following order:
1) prepares the matrix core material: according to the quantity of the matrix core of required preparation, take by weighing various materials in the matrix core, be positioned in the agitator and stir, the matrix core material comprises following component and mass percent: the indissoluble medicinal materials is 30-90%, the X ray developing agent is 5-50%, the disintegrate adjuvant is 5-65%, and described indissoluble medicinal materials is ethyl cellulose or cerotic acid cellulose or high viscosity hydroxypropyl cellulose or hypromellose phthalate ester or hydroxymethyl ethyl cellulose or acrylic resin; Described X ray developing agent is barium sulfate developing agent or iodide reagent; Described disintegrate adjuvant is Sodium Hydroxymethyl Stalcs or crospolyvinylpyrrolidone or low-substituted hydroxypropyl cellulose;
2) preparation matrix core: the distilled water that in the matrix core material, adds matrix core quality of materials 10-50%, mix homogeneously, utilize medicinal tablet machine and matrix core mould, be pressed into matrix core, matrix core is put into baking oven, 40-80 ℃ of oven dry, drying time is 4-12 hour, also natural drying at room temperature;
3) preparation coatings liquid: when coatings material selection medical paraffin, medical paraffin is put into heater be heated to 60-100 ℃, form medical paraffin liquid; When coatings material selection medical grade silicon rubber liquid, the silicone rubber liquid that takes by weighing is placed container;
4) preparation coatings: utilize medicinal spray generator, coatings liquid is sprayed on the matrix core continuously, the matrix core behind the coating is put into baking oven in 50-80 ℃ of maintenance 6-8 hour, perhaps at room temperature solidified 4-12 hour;
5) on coatings, drill through the hole.
Operation principle of the present invention is as follows:
After the patient swallows digestive tract evacuation-detecting slow-release tablet; because coatings is medical paraffin or medical grade silicon rubber material; these two kinds of materials all can not be degraded in digestive tract; and the awkward soluble materials of the main component of matrix core; therefore; the disintegration rate of digestive tract evacuation-detecting slow-release tablet in digestive tract is very slow, and disintegration time is far longer than general slow releasing tablet, and disintegration time was greater than 24 hours.Under the normal condition, the digestive tract evacuation time of human body is about 24 hours, and digestive tract evacuation-detecting slow-release tablet can keep original form to pass through human body alimentary canal substantially, thereby simulates the pass through situation of identical shaped electronic capsule in digestive tract well.
For various reasons, digestive tract evacuation-detecting slow-release tablet is detained or blocks certain position in patient's digestive tract, because the through hole of at least one connection is arranged between coatings and the matrix core, therefore, the liquid in the digestive tract, digestive enzyme, antibacterial can contact with matrix core by through hole, and matrix core is disintegrate lentamente, and progressively cause coatings disintegrate, subside, finally, the only remaining coatings that can't degrade of slow releasing tablet, coatings can excrete with feces.
In clinical practice, the doctor can make following analysis according to clinical response:
(1) when digestive tract evacuation-detecting slow-release tablet in the normal time complete or most of complete discharge when external, show that the patient has good emptying ability for the electronic capsule of equal volume.
(2) when digestive tract evacuation-detecting slow-release tablet in official hour, be generally 72 hours, fail discharge complete or that part is complete, then carry out the x-ray fluoroscopy inspection, owing to mixed the X ray developing agent in the digestive tract evacuation-detecting slow-release tablet, for example the barium sulfate powder can clearly be observed digestive tract evacuation-detecting slow-release tablet and be positioned at intravital position.If still shape is complete or complete substantially in vivo, volunteer or the patient emptying ability for the object of equal volume is described.
(3) if digestive tract evacuation-detecting slow-release tablet in official hour, be generally 24 hours, be in the some positions in the digestive tract always, illustrate that volunteer or patient may block in this position, the electronic capsule of the equal volume of swallowing has bigger risk.
The present invention compares with art methods, has following technique effect:
(1) easy to use.The present invention in use only needs a swallow digestive tract evacuation-detecting slow-release tablet and take the common drug no significant difference of patient, has avoided complicated health check-up.
(2) security reliability height.The present invention is a kind of low rate slow release type digestive tract evacuation-detecting slow-release tablet, can be in digestive tract final disintegrate, and when guaranteeing safety, pass through the situation of simulation electronic capsule in digestive tract realizes the digestive tract evacuation detection reliably.
Description of drawings
Fig. 1 is first kind of structure chart of the present invention;
Fig. 2 is second kind of structure chart of the present invention;
Fig. 3 is the process sketch map of the present invention's disintegrate in digestive tract;
Fig. 4 is the process sketch map that the present invention is caved in digestive tract;
In Fig. 1 to Fig. 3: 1-matrix core, 2-coatings, 3-through hole
The specific embodiment
Embodiment 1:
A kind of digestive tract evacuation-detecting slow-release tablet, the thickness of coatings are 0.8mm, and an end of coatings has the interior matrix core of 1 round tube hole and coatings to communicate, and the cross-sectional area of through hole is 3mm
2, the digestive tract evacuation-detecting slow-release tablet two ends of present embodiment are slick and sly curved-surface structure, and the centre is a cylinder, and the length of matrix core is 30mm, and width is 10mm, thickness is 10mm.Coatings material selection medical paraffin.The preparation technology of present embodiment step in the following order carries out:
1) prepares the matrix core material: according to the quantity of the matrix core of required preparation, take by weighing an amount of matrix core material, be positioned in the agitator, the matrix core material comprises following concrete component and mass percent: ethyl cellulose=60%, barium sulfate developing agent=15%, Sodium Hydroxymethyl Stalcs=25%;
2) preparation matrix core: add the distilled water of matrix core quality of materials 20% in the matrix core material, mix homogeneously utilizes medicinal tablet machine and matrix core mould, be pressed into matrix core, matrix core is put into baking oven, at 40 ℃ of bakings 12 hours, also natural drying at room temperature;
3) preparation coatings liquid: take by weighing an amount of medical paraffin, in heater, be heated to 70 ℃, form medical paraffin liquid;
4) preparation coatings: utilize medicinal mist generating device, vasoliniment is sprayed on the matrix core continuously, spontaneous curing at room temperature 4 hours;
5) drill through the hole on coatings, the through hole cross-sectional area is 3mm
2
Embodiment 2:
A kind of digestive tract evacuation-detecting slow-release tablet, the thickness of coatings are 0.5mm, and an end of coatings has the interior matrix core of 1 round tube hole and coatings to communicate, and the cross-sectional area of through hole is 2mm
2, the digestive tract evacuation-detecting slow-release tablet two ends of present embodiment are slick and sly curved-surface structure, and the centre is a cylinder, and the length of matrix core is 26mm, and width is 10mm, thickness is 10mm.Coatings material selection medical paraffin.The preparation technology of present embodiment step in the following order carries out:
1) prepares the matrix core material: according to the matrix core quantity of required preparation, take by weighing an amount of matrix core material, be positioned in the agitator, the matrix core material comprises following concrete component and mass percent: cerotic acid cellulose=70%, barium sulfate developing agent=15%, crospolyvinylpyrrolidone=15%;
2) preparation matrix core: the distilled water that in the matrix core material, adds matrix core quality of materials 25%, mix homogeneously, utilize medicinal tablet machine and matrix core mould, be pressed into matrix core, the matrix core of compression moulding is put into baking oven, 50 ℃ of oven dry 10 hours, also can natural drying;
3) preparation coatings liquid: take by weighing an amount of medical paraffin, in heater, be heated to 80 ℃, form medical paraffin liquid.
4) preparation coatings: utilize medicinal mist generating device, vasoliniment is sprayed on the matrix core continuously, spontaneous curing 6 hours;
5) drill through the hole on coatings, the through hole cross-sectional area is 2mm
2
Embodiment 3:
A kind of digestive tract evacuation-detecting slow-release tablet, the thickness of coatings are 0.3mm, and an end of coatings has the interior matrix core of 1 round tube hole and coatings to communicate, and the cross-sectional area of through hole is 0.75m
2, the digestive tract evacuation-detecting slow-release tablet two ends of present embodiment are slick and sly curved-surface structure, and the centre is a cylinder, and the length of matrix core is 25mm, and width is 9mm, thickness is 9mm.Coatings material selection medical paraffin.The preparation technology of present embodiment step in the following order carries out:
1) prepares the matrix core material: according to the matrix core quantity of required preparation, take by weighing an amount of matrix core material, be positioned in the agitator, the matrix core material comprises following concrete component and mass percent: high viscosity hydroxypropyl cellulose=75%, barium sulfate developing agent=10%, low-substituted hydroxypropyl cellulose=15%;
2) preparation matrix core: add the distilled water of matrix core quality of materials 40% in the matrix core material, mix homogeneously utilizes medicinal tablet machine and matrix core mould, be pressed into matrix core, the matrix core of compression moulding is put into baking oven, 70 ℃ of oven dry 6 hours, and also can natural drying;
3) preparation coatings liquid: take by weighing an amount of medical paraffin, be heated to 85 ℃ in cooking-vessel, it is standby to form medical paraffin liquid;
4) preparation coatings: utilize medicinal mist generating device, vasoliniment is sprayed on the matrix core continuously, spontaneous curing 8 hours;
5) drill through the hole on coatings, the through hole cross-sectional area is 0.75mm
2
Embodiment 4:
A kind of digestive tract evacuation-detecting slow-release tablet, the thickness of coatings are 1.2mm, respectively have 1 round tube hole to communicate with matrix core in the coatings at the two ends of coatings, and the cross-sectional area of through hole is 1.5mm
2, the digestive tract evacuation-detecting slow-release tablet two ends of present embodiment are slick and sly curved-surface structure, and the centre is a cylinder, and the length of matrix core is 30mm, and width is 10mm, thickness is 10mm.Coatings material selection medical paraffin.The preparation technology of present embodiment step in the following order carries out:
1) prepares the matrix core material: according to the matrix core quantity of required preparation, take by weighing an amount of matrix core material, be positioned in the agitator, the matrix core material comprises following concrete component and mass percent: ethyl cellulose=60%, barium sulfate developing agent=15%, Sodium Hydroxymethyl Stalcs=25%;
2) preparation matrix core: add the distilled water of matrix core quality of materials 35% in the matrix core material, mix homogeneously utilizes medicinal tablet machine and matrix core mould, be pressed into matrix core, the matrix core of compression moulding is put into baking oven, 75 ℃ of oven dry 5 hours, and also can natural drying;
3) preparation coatings liquid: take by weighing an amount of medical paraffin, be heated to 90 ℃ in heater, it is standby to form medical paraffin liquid;
4) preparation coatings: utilize medicinal mist generating device, vasoliniment is sprayed on the matrix core continuously, spontaneous curing 10 hours;
5) utilize cross-sectional area to be 1.5mm
2Drill bit, on coatings, drill through the hole.
Embodiment 5:
A kind of digestive tract evacuation-detecting slow-release tablet, the thickness of coatings are 0.5mm, respectively have 1 round tube hole to communicate with matrix core in the coatings at the two ends of coatings, and the cross-sectional area of through hole is 8mm
2, the digestive tract evacuation-detecting slow-release tablet two ends of present embodiment are slick and sly curved-surface structure, and the centre is a cylinder, and the length of matrix core is 32mm, and width is 11mm, thickness is 11mm.Coatings material selection medical grade silicon rubber.The preparation technology of present embodiment step in the following order carries out:
1) prepare the matrix core material: according to the matrix core quantity of required preparation, take by weighing an amount of matrix core material, be positioned in the agitator, the matrix core material comprises following concrete component and mass percent: hypromellose phthalate ester=50%; Iodide reagent=15%; Low-substituted hydroxypropyl cellulose=35%;
2) preparation matrix core: the distilled water that in the matrix core material, adds matrix core quality of materials 50%, mix homogeneously, utilize medicinal tablet machine and matrix core mould, be pressed into matrix core, the matrix core of compression moulding is put into baking oven, at 80 ℃ of oven dry 4 hours, also natural drying at room temperature;
3) preparation coatings liquid: take by weighing an amount of medical grade silicon rubber, select the implantation level medical grade silicon rubber of Dow corning company for use, model is MDX-4210, is positioned in the glass drying oven standby;
4) preparation coatings: utilize medicinal mist generating device, silicone rubber liquid is sprayed on the matrix core continuously, the matrix core behind the coating is put into baking oven kept 7 hours in 65 ℃;
5) drill through the hole on coatings, the through hole cross-sectional area is 8mm
2
Claims (7)
1. digestive tract evacuation-detecting slow-release tablet, comprise matrix core and coatings, the material that it is characterized in that described coatings is medical paraffin or medical grade silicon rubber, its thickness is 0.1mm-1.5mm, have through hole to communicate with matrix core in the coatings on coatings, the cross-sectional area of each through hole on coatings is 0.1-10mm
2, the length of described matrix core is 5-40mm, and width is 5-15mm, and thickness is 5-15mm.
2. digestive tract evacuation-detecting slow-release tablet according to claim 1, the thickness that it is characterized in that coatings is 0.8mm, has 1 round tube hole to communicate with matrix core in the coatings at an end of coatings, the cross-sectional area of this round tube hole is 3mm
2, the length of matrix core is 30mm, and width is 10mm, and thickness is 10mm.
3. digestive tract evacuation-detecting slow-release tablet according to claim 1, the thickness that it is characterized in that coatings is 0.5mm, has 1 round tube hole to communicate with matrix core in the coatings at an end of coatings, the cross-sectional area of this round tube hole is 2mm
2, the length of matrix core is 26mm, and width is 10mm, and thickness is 10mm.
4. digestive tract evacuation-detecting slow-release tablet according to claim 1, the thickness that it is characterized in that coatings is 0.3mm, has 1 round tube hole to communicate with matrix core in the coatings at an end of coatings, the cross-sectional area of this round tube hole is 0.75mm
2, the length of matrix core is 25mm, and width is 9mm, and thickness is 9mm.
5. digestive tract evacuation-detecting slow-release tablet according to claim 1, the thickness that it is characterized in that coatings is 1.2mm, respectively has 1 round tube hole to communicate with matrix core in the coatings at the two ends of coatings, the cross-sectional area of through hole is 1.5mm
2, the length of matrix core is 30mm, and width is 10mm, and thickness is 10mm.
6. digestive tract evacuation-detecting slow-release tablet according to claim 1, the thickness that it is characterized in that coatings is 0.5mm, respectively has 1 round tube hole to communicate with matrix core in the coatings at the two ends of coatings, the cross-sectional area of through hole is 8mm
2, the length of matrix core is 32mm, width is 11mm, and, thickness is 11mm.
7. preparation technology who implements the described digestive tract evacuation-detecting slow-release tablet of claim 1, it is characterized in that this preparation technology in the following order step carry out:
(1) prepares the matrix core material: according to the quantity of the matrix core of required preparation, take by weighing various materials in the matrix core, be positioned in the agitator and stir, the matrix core material comprises following component and mass percent: the indissoluble medicinal materials is 30-90%, the X ray developing agent is 5-50%, the disintegrate adjuvant is 5-65%, and described indissoluble medicinal materials is ethyl cellulose or cerotic acid cellulose or high viscosity hydroxypropyl cellulose or hypromellose phthalate ester or hydroxymethyl ethyl cellulose or acrylic resin; Described X ray developing agent is barium sulfate developing agent or iodide reagent; Described disintegrate adjuvant is Sodium Hydroxymethyl Stalcs or crospolyvinylpyrrolidone or low-substituted hydroxypropyl cellulose;
(2) preparation matrix core: the distilled water that in the matrix core material, adds matrix core quality of materials 10-50%, mix homogeneously, utilize medicinal tablet machine and matrix core mould, be pressed into matrix core, matrix core is put into baking oven, 40-80 ℃ of oven dry, drying time is 4-12 hour, also natural drying at room temperature;
(3) preparation coatings liquid: when coatings material selection medical paraffin, medical paraffin is put into heater be heated to 60-100 ℃, form medical paraffin liquid; When coatings material selection medical grade silicon rubber liquid, the silicone rubber liquid that takes by weighing is placed container;
(4) preparation coatings: utilize medicinal spray generator, coatings liquid is sprayed on the matrix core continuously, the matrix core behind the coating is put into baking oven in 50-80 ℃ of maintenance 6-8 hour, perhaps at room temperature solidified 4-12 hour;
(5) on coatings, drill through the hole.
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| CNB200510057395XA CN100354006C (en) | 2005-11-24 | 2005-11-24 | Digestive tract evacuation-detecting slow-release tablet and its preparing process |
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| CNB200510057395XA CN100354006C (en) | 2005-11-24 | 2005-11-24 | Digestive tract evacuation-detecting slow-release tablet and its preparing process |
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| CN100354006C CN100354006C (en) | 2007-12-12 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100482294C (en) * | 2006-12-26 | 2009-04-29 | 重庆大学 | Remote controlled modicine reliesing electronic capsule capable of partly degradation |
| CN102091335A (en) * | 2011-02-11 | 2011-06-15 | 张发明 | Gastrointestinal transit disorder diagnosis composition and use thereof |
| CN106923787A (en) * | 2015-12-29 | 2017-07-07 | 上海安翰医疗技术有限公司 | The leading piece of capsule endoscope and its detection method |
| CN109289058A (en) * | 2018-10-30 | 2019-02-01 | 河北科技大学 | A kind of radiopaque merkers barium sulfate pellet and preparation method thereof |
| CN113143877A (en) * | 2021-05-07 | 2021-07-23 | 苏州康恒研新药物技术有限公司 | Preparation method of metoprolol succinate pellet sustained-release tablet |
| CN113545344A (en) * | 2021-07-23 | 2021-10-26 | 安徽省通源环境节能股份有限公司 | Submerged plant growth-promoting sustained-release tablet and preparation method thereof |
| WO2023186155A1 (en) * | 2022-03-31 | 2023-10-05 | 上海安翰医疗技术有限公司 | Digestive tract simulation capsule and preparation method therefor |
-
2005
- 2005-11-24 CN CNB200510057395XA patent/CN100354006C/en not_active Expired - Fee Related
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100482294C (en) * | 2006-12-26 | 2009-04-29 | 重庆大学 | Remote controlled modicine reliesing electronic capsule capable of partly degradation |
| CN102091335A (en) * | 2011-02-11 | 2011-06-15 | 张发明 | Gastrointestinal transit disorder diagnosis composition and use thereof |
| CN106923787A (en) * | 2015-12-29 | 2017-07-07 | 上海安翰医疗技术有限公司 | The leading piece of capsule endoscope and its detection method |
| CN106923787B (en) * | 2015-12-29 | 2023-11-24 | 上海安翰医疗技术有限公司 | Capsule endoscope advanced lens and detection method thereof |
| CN109289058A (en) * | 2018-10-30 | 2019-02-01 | 河北科技大学 | A kind of radiopaque merkers barium sulfate pellet and preparation method thereof |
| CN109289058B (en) * | 2018-10-30 | 2021-12-03 | 河北科技大学 | X-ray-opaque marker barium sulfate pellet and preparation method thereof |
| CN113143877A (en) * | 2021-05-07 | 2021-07-23 | 苏州康恒研新药物技术有限公司 | Preparation method of metoprolol succinate pellet sustained-release tablet |
| CN113545344A (en) * | 2021-07-23 | 2021-10-26 | 安徽省通源环境节能股份有限公司 | Submerged plant growth-promoting sustained-release tablet and preparation method thereof |
| WO2023186155A1 (en) * | 2022-03-31 | 2023-10-05 | 上海安翰医疗技术有限公司 | Digestive tract simulation capsule and preparation method therefor |
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