CN102764246A - Trospium chloride controlled release capsule and preparation method thereof - Google Patents
Trospium chloride controlled release capsule and preparation method thereof Download PDFInfo
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- CN102764246A CN102764246A CN2012101963074A CN201210196307A CN102764246A CN 102764246 A CN102764246 A CN 102764246A CN 2012101963074 A CN2012101963074 A CN 2012101963074A CN 201210196307 A CN201210196307 A CN 201210196307A CN 102764246 A CN102764246 A CN 102764246A
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Abstract
The present invention provides a trospium chloride controlled release capsule and a preparation method thereof. A capsule shell is filled with pills; the pills are wrapped with film coatings; a pill cladded with the coating is provided with a hole with a diameter of 0.05 mm; the pills in the capsule shell comprise an active ingredient trospium chloride; controlled release carriers in the pills are sodium carboxymethyl cellulose and natural alginate; a weight ratio of trospium chloride and the controlled release carrier is 1:0.6; a weight ratio of sodium carboxymethyl cellulose sodium and natural alginate is 1:0.8; viscosity of the sodium carboxymethyl cellulose is 3000-5000 centipoise; and viscosity of the natural alginate is 300-500 centipoise. According to the invention, the trospium chloride can be released at a constant speed in 9-12 h, so as to reduce frequency of drug usage.
Description
Technical field
The present invention relates to medicine, is a kind of trospium chloride controlled release capsule and preparation method thereof.
Background technology
The trospium chloride capsule is a kind of medicine that is used to treat overactive bladder, is a kind of new strong effect m receptor blocker, m receptor is had high-affinity and specificity again, and it is fat-soluble low, does not pass through blood brain barrier.
The fugitive pharmaceutical dosage form of trospium chloride on the domestic and international market generally is trospium chloride sheet 20mg (like trade name Sanctura, Germany) and capsule at present.Because belonging to, this medicine improves the symptom medicine, so need the long-term concomitant medication of elderly patients.But at present these fugitive tablet and capsules on the domestic and international market are taken 3 every day, take to bring loaded down with trivial detailsly often to the patient, and the patient is difficult to adhere to, forget easily in long-term prescription.Germany newly pushed away trospium chloride slow releasing tablet 60mg (Sanctura XR Germany doctor Ma MadausAG produces) again in 2007, and the release in vitro curve of this slow releasing tablet does not steadily reach the purpose of constant release.
The granted patent CN100588423C of U.S. PR Pharmaceuticals, Inc. discloses a kind of controlled release composition; Select one or more combination of polymers to become release vehicle; As gather and third hand over fat, gather glycolide, gather lactone; Obtained comparatively ideal release profiles, but this polymer shortcoming is easy degraded, causes controlled release carrier in long-term storage, to have unstability.
The granted patent CN100389752C of Canadian Labopharm Europ Ltd discloses a kind of controlled release composition; Its controlled release matrix is that branch is two-layer: the first controlled release matrix material is a CLA, and second controlled release matrix is the mixture of polyvinyl acetate and polyvinylpyrrolidone.The release of medicine in first controlled release matrix is slower, and in second controlled release matrix, discharges comparatively fast, therefore reaches the purpose that controlled release discharges.But the controlled release matrix price that this method is used is all expensive, and technology is difficult to extensive popularization.
Summary of the invention
The objective of the invention is, a kind of trospium chloride controlled release capsule and preparation method thereof is provided, it can reach trospium chloride the purpose of constant release medicine in 9-12 hour, thereby reduced the medication number of times.
The present invention realizes through following technical scheme for realizing above-mentioned purpose: powder charge ball in a kind of trospium chloride controlled release capsule, capsule shells, and the peripheral film coating that coats of pill, coating and offering diameter on the pill behind the film coating is 0.05 millimeter hole; The active ingredient of pill is in the capsule shells: trospium chloride; Controlled release carrier in the pill is: sodium carboxymethyl cellulose and natural seaweed acid sodium; The weight ratio of trospium chloride and controlled release carrier is 1:0.6; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise.Film coating adopts semipermeable materials to make, and semipermeable materials has cellulose acetate, PEG400 or poloxamer, and the weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1, and selecting acetone for use is the solvent medium.
The method for preparing of described a kind of trospium chloride controlled release capsule; Comprise the steps: 1. to prepare pill: get trospium chloride and controlled release carrier mixes by weight the ratio of 1:0.6; Controlled release carrier is Carboxymethyl cellulose sodium and natural seaweed; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise; Select for use 90% ethanol to do binding agent, employing is extruded spheronizator and is produced pill; 2. film coating: pill is inserted fluidized-bed coating machine carry out film coating; Thin film coating material is cellulose acetate, PEG400 or poloxamer; The weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1; Selecting acetone for use is the solvent medium, and behind the employing fluidized-bed coating machine coating, the weight before the weight ratio coating of pill increases 3%-13%; 3. with step 2. the pill behind the film coating insert under 40 ℃-50 ℃, dry 12-48 hour, obtain exsiccant coated pills; 4. exsiccant coated pills is inserted on the laser machine and punched, the diameter in hole is 0.05 millimeter, obtains coated pills with holes; 5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
The method for preparing of described a kind of trospium chloride controlled release capsule; Concrete steps are following: 1. prepare pill: with 600g trospium chloride, 200g viscosity is the sodium carboxymethyl cellulose of 4000 centipoises, the natural seaweed acid sodium that 160g viscosity is 400 centipoises, and behind 60 eye mesh screens, mix homogeneously obtains mixture excessively; With the alcoholic solution that adds 95% in the mixture; Blend together sticky matter, the weight ratio of 95% alcoholic solution and mixture is 9:1, sticky matter is inserted to extrude process pill in the spheronizator;
2. film coating: get acetone as the solvent medium, under agitation add cellulose acetate 70g, stir, add PEG400 10g again, be stirred to dissolving, as coating solution until dissolving; The pill of step described in 1. placed fluidized-bed coating machine, 55 ℃ of temperature are set, air intake air pressure is 0.2MPa, and the pill temperature is 30 ℃ and carries out coating that the pill weight before the pill weight ratio coating behind the coating increases by 8%;
3. the pill that 2. step is carried out behind the film coating was inserted 50 ℃ of baking oven inner dryings 24 hours, obtained exsiccant coated pills;
4. exsiccant coated pills is placed on the laser-beam drilling machine hole that to make a call to a diameter be 0.05mm;
5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
Trospium chloride capsule of the present invention is oral medicine, is effective ingredient with the trospium chloride, is controlled release matrix with sodium carboxymethyl cellulose and natural seaweed acid sodium; Realized the purpose of 9-12 hour constant release medicine; The controlled release matrix of selecting for use has cheap advantage, and is easy to patient's acceptance, simultaneously; This controlled release matrix can also guarantee the steady quality of product, thereby has further reached better therapeutic effect.Controlled release capsule of the present invention is once oral every day.Capsule of the present invention has thoroughly solved the patient, has been easy to when particularly the gerontal patient takes medicine forget the problem of taking that guaranteed the therapeutic effect of medicine, the present invention also has advantages such as storage ability is good.
The release in vitro curve of controlled release capsule of the present invention shows that the drug release constant speed is stable.Present the near linear state at external stripping curve; Explain that medicine is the process of approximate constant release; Promptly relatively all rapid release is put, and can keep in the process discharging medicine speed relatively stably at 12 hours, and promptly can being expected at once takes medicine in the body can keep the stable blood drug level of long period; The medicine of embodiment 2 prescriptions preparations is optimum, in 12 hours near linear state.
Description of drawings
Fig. 1 release in vitro curve chart of relatively filling a prescription; Be parabola state, it is very fast to explain that medicine discharged in elementary period, and the later stage discharges slack-off, i.e. the process of non-uniform velocity release; In 12 hours processes, discharged the medicine more than 70% in 5 hours, promptly can be expected at once take medicine in the body after; In 5 little periods of beginning, medicine presents rapid release, and blood drug level is high; And slack-off in back 7 h drug release, blood drug level reduces, and has influenced the curative effect of medicine;
The trospium chloride controlled release capsule release in vitro curve chart of preparation in Fig. 2 embodiments of the invention 1;
The trospium chloride controlled release capsule release in vitro curve chart of preparation in Fig. 3 embodiments of the invention 2;
The trospium chloride controlled release capsule release in vitro curve chart of preparation in Fig. 4 embodiments of the invention 3;
The trospium chloride controlled release capsule release in vitro curve chart of preparation in Fig. 5 embodiments of the invention 4;
The trospium chloride controlled release capsule release in vitro curve chart of preparation in Fig. 6 embodiments of the invention 5.
The specific embodiment
Trospium chloride controlled release capsule according to the invention is a powder charge ball in capsule shells, and the periphery of pill coats the thin film coating, and coating and offering diameter on the pill behind the film coating is 0.05 millimeter hole; The active ingredient of pill is in the capsule shells: trospium chloride; Controlled release carrier in the pill is: sodium carboxymethyl cellulose and natural seaweed acid sodium; The weight ratio of trospium chloride and controlled release carrier is 1:0.6; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise.
Described film coating adopts semipermeable materials to make, and semipermeable materials has cellulose acetate, PEG400 or poloxamer, and the weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1, and selecting acetone for use is the solvent medium.
The active ingredient and the controlled release carrier of pill have multiple combination in the trospium chloride controlled release capsule of the present invention, capsule shells:
The composition dosage
Trospium chloride 600g
Sodium carboxymethyl cellulose (viscosity 4000 centipoises) 200g
Sodium alginate (viscosity 400 centipoises) 160g.
The composition dosage
Trospium chloride 600g
Sodium carboxymethyl cellulose (viscosity 3000 centipoises) 200g
Sodium alginate (viscosity 300 centipoises) 160g.
The composition dosage
Trospium chloride 600g
Sodium carboxymethyl cellulose (viscosity 5000 centipoises) 200g
Sodium alginate (viscosity 500 centipoises) 160g.
Embodiment 4,
The composition dosage
Trospium chloride 600g
Sodium carboxymethyl cellulose (viscosity 5000 centipoises) 200g
Sodium alginate (viscosity 300 centipoises) 160g.
The composition dosage
Trospium chloride 600g
Sodium carboxymethyl cellulose (viscosity 3000 centipoises) 200g
Sodium alginate (viscosity 500 centipoises) 160g.
1, the method for preparing of trospium chloride controlled release capsule of the present invention comprises the steps:
1. prepare pill: get trospium chloride and controlled release carrier mixes by weight the ratio of 1:0.6; Controlled release carrier is Carboxymethyl cellulose sodium and natural seaweed; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise; Select for use 90% ethanol to do binding agent, employing is extruded spheronizator and is produced pill; 2. film coating: pill is inserted fluidized-bed coating machine carry out film coating; Thin film coating material is cellulose acetate, PEG400 or poloxamer; The weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1; Selecting acetone for use is the solvent medium, and behind the employing fluidized-bed coating machine coating, the weight before the weight ratio coating of pill increases 3%-13%; 3. with step 2. the pill behind the film coating insert under 40 ℃-50 ℃, dry 12-48 hour, obtain exsiccant coated pills; 4. exsiccant coated pills is inserted on the laser machine and punched, the diameter in hole is 0.05 millimeter, obtains coated pills with holes; 5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
2, the method for preparing of trospium chloride controlled release capsule, concrete steps are following:
1. prepare pill: with 600g trospium chloride, 200g viscosity is the sodium carboxymethyl cellulose of 4000 centipoises, the natural seaweed acid sodium that 160g viscosity is 400 centipoises; After crossing 60 eye mesh screens; Mix homogeneously obtains mixture, and the alcoholic solution with adding 95% in the mixture blendes together sticky matter; The weight ratio of 95% alcoholic solution and mixture is 9:1, sticky matter is inserted to extrude process pill in the spheronizator;
2. film coating: get acetone as the solvent medium, under agitation add cellulose acetate 70g, stir, add PEG400 10g again, be stirred to dissolving, as coating solution until dissolving; The pill of step described in 1. placed fluidized-bed coating machine, 55 ℃ of temperature are set, air intake air pressure is 0.2MPa, and the pill temperature is 30 ℃ and carries out coating that the pill weight before the pill weight ratio coating behind the coating increases by 8%;
3. the pill that 2. step is carried out behind the film coating was inserted 50 ℃ of baking oven inner dryings 24 hours, obtained exsiccant coated pills;
4. exsiccant coated pills is placed on the laser-beam drilling machine hole that to make a call to a diameter be 0.05mm;
5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
3, the method for preparing of trospium chloride controlled release capsule, concrete steps are following:
1. prepare pill: with 600g trospium chloride, 200g viscosity is the sodium carboxymethyl cellulose of 3000 centipoises, the natural seaweed acid sodium that 160g viscosity is 300 centipoises; After crossing 60 eye mesh screens; Mix homogeneously obtains mixture, and the alcoholic solution with adding 95% in the mixture blendes together sticky matter; The weight ratio of 95% alcoholic solution and mixture is 9:1, sticky matter is inserted to extrude process pill in the spheronizator;
2. film coating: get acetone as the solvent medium, under agitation add cellulose acetate 70g, stir, add PEG400 10g again, be stirred to dissolving, as coating solution until dissolving; The pill of step described in 1. placed fluidized-bed coating machine, 55 ℃ of temperature are set, air intake air pressure is 0.2MPa, and the pill temperature is 30 ℃ and carries out coating that the pill weight before the pill weight ratio coating behind the coating increases by 8%;
3. the pill that 2. step is carried out behind the film coating was inserted 50 ℃ of baking oven inner dryings 24 hours, obtained exsiccant coated pills;
4. exsiccant coated pills is placed on the laser-beam drilling machine hole that to make a call to a diameter be 0.05mm;
5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
4, the method for preparing of trospium chloride controlled release capsule, concrete steps are following:
1. prepare pill: with 600g trospium chloride, 200g viscosity is the sodium carboxymethyl cellulose of 5000 centipoises, the natural seaweed acid sodium that 160g viscosity is 500 centipoises; After crossing 60 eye mesh screens; Mix homogeneously obtains mixture, and the alcoholic solution with adding 95% in the mixture blendes together sticky matter; The weight ratio of 95% alcoholic solution and mixture is 9:1, sticky matter is inserted to extrude process pill in the spheronizator;
2. film coating: get acetone as the solvent medium, under agitation add cellulose acetate 70g, stir, add poloxamer 10g again, be stirred to dissolving, as coating solution until dissolving; The pill of step described in 1. placed fluidized-bed coating machine, 55 ℃ of temperature are set, air intake air pressure is 0.2MPa, and the pill temperature is 30 ℃ and carries out coating that the pill weight before the pill weight ratio coating behind the coating increases by 8%;
3. the pill that 2. step is carried out behind the film coating was inserted 50 ℃ of baking oven inner dryings 24 hours, obtained exsiccant coated pills;
4. exsiccant coated pills is placed on the laser-beam drilling machine hole that to make a call to a diameter be 0.05mm;
5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
Claims (4)
1. trospium chloride controlled release capsule is characterized in that: powder charge ball in the capsule shells, and the peripheral film coating that coats of pill, coating and offering diameter on the pill behind the film coating is 0.05 millimeter hole; The active ingredient of pill is in the capsule shells: trospium chloride; Controlled release carrier in the pill is: sodium carboxymethyl cellulose and natural seaweed acid sodium; The weight ratio of trospium chloride and controlled release carrier is 1:0.6; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise.
2. a kind of trospium chloride controlled release capsule according to claim 1; It is characterized in that: film coating adopts semipermeable materials to make; Semipermeable materials has cellulose acetate, PEG400 or poloxamer; The weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1, and selecting acetone for use is the solvent medium.
3. the method for preparing of claim 1 or 2 described a kind of trospium chloride controlled release capsules; It is characterized in that: comprise the steps: 1. to prepare pill: get trospium chloride and controlled release carrier mixes by weight the ratio of 1:0.6; Controlled release carrier is Carboxymethyl cellulose sodium and natural seaweed; The weight ratio of sodium carboxymethyl cellulose and natural seaweed acid sodium is 1:0.8, and the viscosity of sodium carboxymethyl cellulose is the 3000-5000 centipoise, and the viscosity of natural seaweed acid sodium is the 300-500 centipoise; Select for use 90% ethanol to do binding agent, employing is extruded spheronizator and is produced pill; 2. film coating: pill is inserted fluidized-bed coating machine carry out film coating; Thin film coating material is cellulose acetate, PEG400 or poloxamer; The weight ratio of cellulose acetate and PEG400 or poloxamer is 7:1; Selecting acetone for use is the solvent medium, and behind the employing fluidized-bed coating machine coating, the weight before the weight ratio coating of pill increases 3%-13%; 3. with step 2. the pill behind the film coating insert under 40 ℃-50 ℃, dry 12-48 hour, obtain exsiccant coated pills; 4. exsiccant coated pills is inserted on the laser machine and punched, the diameter in hole is 0.05 millimeter, obtains coated pills with holes; 5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
4. the method for preparing of a kind of trospium chloride controlled release capsule according to claim 3; It is characterized in that: concrete steps are following: 1. prepare pill: with 600g trospium chloride, 200g viscosity is the sodium carboxymethyl cellulose of 4000 centipoises, the natural seaweed acid sodium that 160g viscosity is 400 centipoises; After crossing 60 eye mesh screens; Mix homogeneously obtains mixture, and the alcoholic solution with adding 95% in the mixture blendes together sticky matter; The weight ratio of 95% alcoholic solution and mixture is 9:1, sticky matter is inserted to extrude process pill in the spheronizator;
2. film coating: get acetone as the solvent medium, under agitation add cellulose acetate 70g, stir, add PEG400 10g again, be stirred to dissolving, as coating solution until dissolving; The pill of step described in 1. placed fluidized-bed coating machine, 55 ℃ of temperature are set, air intake air pressure is 0.2MPa, and the pill temperature is 30 ℃ and carries out coating that the pill weight before the pill weight ratio coating behind the coating increases by 8%;
3. the pill that 2. step is carried out behind the film coating was inserted 50 ℃ of baking oven inner dryings 24 hours, obtained exsiccant coated pills;
4. exsiccant coated pills is placed on the laser-beam drilling machine hole that to make a call to a diameter be 0.05mm;
5. the specification that requires according to capsule incapsulates step coated pills with holes 4. in the shell, is the trospium chloride controlled release capsule.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690506A (en) * | 2013-11-08 | 2014-04-02 | 舒泰神（北京）生物制药股份有限公司 | Trospium chloride slow-release composition and preparation method thereof |
| CN104887646A (en) * | 2015-06-26 | 2015-09-09 | 舒泰神（北京）生物制药股份有限公司 | Trospium chloride composition and preparation method thereof |
| CN106706832A (en) * | 2015-08-06 | 2017-05-24 | 舒泰神（北京）生物制药股份有限公司 | Method for determining content of trospium chloride |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1294519A (en) * | 1999-02-18 | 2001-05-09 | 英法马有限公司 | Pharmaceutical Compsns. contg. compounds with activity for enhancement of absorption of active ingredients |
| WO2009052353A2 (en) * | 2007-10-17 | 2009-04-23 | Dr. Reddy's Laboratories Ltd. | Trospium pharmaceutical formulations |
| CN101596170A (en) * | 2009-07-06 | 2009-12-09 | 沈阳亿灵医药科技有限公司 | Trospium chloride slow-release tablet |
-
2012
- 2012-08-17 CN CN 201210196307 patent/CN102764246B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1294519A (en) * | 1999-02-18 | 2001-05-09 | 英法马有限公司 | Pharmaceutical Compsns. contg. compounds with activity for enhancement of absorption of active ingredients |
| WO2009052353A2 (en) * | 2007-10-17 | 2009-04-23 | Dr. Reddy's Laboratories Ltd. | Trospium pharmaceutical formulations |
| CN101596170A (en) * | 2009-07-06 | 2009-12-09 | 沈阳亿灵医药科技有限公司 | Trospium chloride slow-release tablet |
Non-Patent Citations (1)
| Title |
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| 刘小荣，卢海儒: "曲司氯铵片", 《中国新药杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690506A (en) * | 2013-11-08 | 2014-04-02 | 舒泰神（北京）生物制药股份有限公司 | Trospium chloride slow-release composition and preparation method thereof |
| CN103690506B (en) * | 2013-11-08 | 2015-05-13 | 舒泰神（北京）生物制药股份有限公司 | Trospium chloride slow-release composition and preparation method thereof |
| CN104887646A (en) * | 2015-06-26 | 2015-09-09 | 舒泰神（北京）生物制药股份有限公司 | Trospium chloride composition and preparation method thereof |
| CN106706832A (en) * | 2015-08-06 | 2017-05-24 | 舒泰神（北京）生物制药股份有限公司 | Method for determining content of trospium chloride |
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