CN102805709A - Vacant capsule production process and enteric vacant capsule and colonic-coated vacant capsule produced thereby - Google Patents
Vacant capsule production process and enteric vacant capsule and colonic-coated vacant capsule produced thereby Download PDFInfo
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- CN102805709A CN102805709A CN2011101469944A CN201110146994A CN102805709A CN 102805709 A CN102805709 A CN 102805709A CN 2011101469944 A CN2011101469944 A CN 2011101469944A CN 201110146994 A CN201110146994 A CN 201110146994A CN 102805709 A CN102805709 A CN 102805709A
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Abstract
The invention provides a vacant capsule production process. The vacant capsule production process includes the steps of preparing intestinal fluid; dipping with glue; demoulding; cutting; inspecting; and encapsulating. The step of digging with glue includes: b1, dipping moulds with the glue, drying the moulds on a dry production line of vacant capsules to form inner walls of capsules; b2, dipping the outer sides of the inner walls of capsules with the intestinal fluid obtained in step A, and allowing for drying to form intestinal fluid layers on the inner walls of capsules; and b3, dipping the outer sides of the intestinal fluid layers with the glue, and allowing for drying to form outer walls of capsules outside the intestinal fluid layers. The invention further provides vacant capsules produced by the production process. The enteric/colonic-coated vacant capsules produced by the production process are convenient for demoulding, and proneness to breakage in production and encapsulation in pharmaceutical factories can be reduced. The intestinal fluid layers containing polyacrylic resins are sandwiched in the capsule walls without contact with pharmaceuticals and the outside, so that the vacant capsules are stable, no requirement for filling pharmaceuticals is needed, and the application range of the vacant capsules is enlarged.
Description
Technical field
The present invention relates to a kind of production technology of medicinal hollow capsule.
The invention still further relates to the Capsules that this production technology is produced.
Background technology
It is a kind of drug-specific carrier that enteric/colon dissolves Capsules, can disintegrate in intestinal/colon road, discharge medicine, and make medicine reach targeting, more effective focus is treated.At present enteric/colon dissolves the domestic existing production of Capsules, and its structure includes Capsules base shell, and with the intestinal juice layer, wherein mostly capsule base shell is that gelatin processes, and also can adopt the other materials preparation on capsule base shell outer wall.The composition of intestinal juice layer is that polyacrylic resin II, III, plasticizer, acetone, medicinal alcohol mix.Because the intestinal juice layer itself has certain adstringency, so enteric/colon dissolves Capsules and can occur being difficult for the demoulding in process of production, and to produce cover fashionable frangible in the pharmaceutical factory, bring loss can for the medical producer of Capsules manufacturer and use.And include the polyacrylic resin constituents in the intestinal juice layer, and like polyacrylic resin II, III, this composition is unstable in alkaline environment, therefore runs into alkaline environment, and it is impaired that the intestinal juice layer is easy to, and breaks.If for solving the problem of above-mentioned Capsules, the intestinal juice layer is arranged on the most inboard, then can directly contact with medicine, can not be used for alkalescent medicine, reduced the scope of application of Capsules like this.
Summary of the invention
The present invention provides a kind of production technology of Capsules, and purpose is to address the above problem, and can produce and can from mould, separate easily with this technology, simultaneously easy fit, not breakable Capsules.
The enteric hollow capsule that the present invention also provides a kind of above-mentioned explained hereafter to obtain its objective is that providing a kind of can separate easily from mould, simultaneously easy fit, and not breakable enteric hollow capsule, disintegrate point is accurate.
The colon that the present invention also provides a kind of above-mentioned explained hereafter to obtain dissolves Capsules; Its objective is that providing a kind of can separate easily from mould; Simultaneously easy fit, not breakable colon dissolves Capsules, and prescription is simpler than existing colon colloidal sol capsule; Thereby save technology and cost, disintegrate point is accurate.
The technical scheme that the present invention deals with problems and adopts:
The production technology of Capsules is characterized in that: comprise the steps:
A, preparation intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in glue, dry under Capsules production line drying condition, form inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms the intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in glue again, dry back forms capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
The above-mentioned demoulding, cutting, check, fit are existing operation.
The glue of said step b1 is gelatin glue or Sargassum polysaccharides glue or water-soluble cellulose glue or water-soluble cellulose derivative glue or pulullan polysaccharide glue or soybean polysaccharide body glue; The glue of said step b2 is gelatin glue or Sargassum polysaccharides glue or water-soluble cellulose glue or water-soluble cellulose derivative glue or pulullan polysaccharide glue or soybean polysaccharide body glue; Step b1 and step b2 select the glue of same material for use.
Said glue is a material of producing common Capsules; During actual the manufacturing; Inside capsule wall can be according to different needs with capsule outer walls; The material that adopts all to be suitable for making inside capsule wall and capsule outer walls, for example Sargassum polysaccharides, water-soluble cellulose or derivatives thereof, pulullan polysaccharide, soybean polysaccharide body etc., inside capsule wall and capsule outer walls are also selected identical materials for use.The implication of above-mentioned " material " is " major ingredients "; For example " material is a gelatin "; Or " gelatin glue "; Referring to main component is gelatin; Also comprise auxiliary elements such as other compositions such as plasticizer, wetting agent, binding agent so that it can be shaped to the capsule husk, plasticizer wherein, wetting agent, binding agent specifically select for use which kind of material and ratio to be prior art, and situation was identical with gelatin when material was Sargassum polysaccharides, water-soluble cellulose or derivatives thereof, pulullan polysaccharide, soybean polysaccharide body.
When producing enteric hollow capsule, the described intestinal juice of steps A is enteric hollow capsule intestinal liquid; The inside capsule wall thickness of step B is the 4-6 silk, and the intestinal juice layer thickness is greater than 2, capsule outer walls thickness 1-3 silk.
Intestinal juice can be selected the composition of the enteric hollow capsule intestinal juice of prior art for use; Because the intestinal juice layer is sandwiched between inside capsule wall and the capsule outer walls, so the goal of the invention of the prescription of intestinal juice and " from mould, separate easily; simultaneously easy fit, be difficult for broken " of the present invention is irrelevant.
Described enteric hollow capsule intestinal juice can be polyacrylic resin II 5-8 weight portion, plasticizer 6.5-7.5 weight portion, and acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume mixed dissolution forms.
Above-mentioned intestinal juice prescription is preferred prescription, is in order to realize another goal of the invention of the present invention: " save technology and cost, and still can obtain good disintegrate index ".
Solid constituent among the present invention adopts weight portion, and liquid component adopts parts by volume, and corresponding relation is the corresponding every ml volumes part of every gram weight part.
Go out enteric hollow capsule with above-mentioned explained hereafter: have the inside capsule wall of thickness 4-6 silk, with the enteric hollow capsule intestinal juice layer of thickness, outside enteric hollow capsule intestinal juice layer, have the capsule outer walls of thickness 1-3 silk outside the inside capsule wall greater than 2; Said enteric hollow capsule intestinal juice composition of layer is a polyacrylic resin II 5-8 weight portion, plasticizer 6.5-7.5 weight portion, acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume.Described plasticizer can be selected ATEC or glyceryl triacetate.The inside capsule wall material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Described capsule outer walls material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Inside capsule wall is identical with the capsule outer walls material.
When producing the colon Capsules, the described intestinal juice of steps A is that colon dissolves Capsules intestinal liquid; The inside capsule wall thickness 4-6 silk of step B, intestinal juice layer thickness be greater than 4, capsule outer walls thickness 1-3 silk.
Intestinal juice can be selected the composition of the molten Capsules intestinal juice of colon of prior art for use, for example comprises the prescription of polyacrylic resin II, polyacrylic resin III simultaneously.
Described colon dissolves Capsules intestinal juice can be polyacrylic resin III9-11 weight portion, plasticizer 9.5-10.5 weight portion, and acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume mixed dissolution forms.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: have the inside capsule wall of thickness 4-6 silk, have thickness outside the inside capsule wall, dissolve the capsule outer walls of having thickness 1-3 silk outside the Capsules intestinal juice layer at colon greater than the molten Capsules intestinal juice layer of 4 colon; It is polyacrylic resin III9-11 weight portion that said colon dissolves Capsules intestinal juice composition of layer, plasticizer 9.5-10.5 weight portion, acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume.Described plasticizer is ATEC or glyceryl triacetate.Described inside capsule wall material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Described capsule outer walls material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Inside capsule wall is identical with the capsule outer walls material.
Beneficial effect of the present invention: the enteric/colon among the present invention dissolves Capsules, and is owing to the intestinal juice layer is clipped between the two-layer capsule wall, not only conveniently stripped; Reduce the pharmaceutical factory and produce the fashionable frangible situation of cover; And containing the intestinal juice layer of polyacrylic resin class owing to use in the middle of being clipped in capsule wall, discord medicine, the external world directly contact, and not only make Capsules itself stable; And the medicine of filling do not required yet, increased the scope of application of Capsules.
Colon of the present invention dissolves Capsules and adopts polyacrylic resin III; Lack polyacrylic resin II than existing prescription; Therefore all lacked polyacrylic resin II, the blended operation of polyacrylic resin III proportioning than prior art, reduced error rate and cost, and disintegrate point is accurate.
Description of drawings:
Fig. 1 is a Capsules generalized section of the present invention;
Fig. 2 is the Capsules generalized section that assembles of the present invention.
Among the figure: 10: capsule shells A; 20: capsule shells B; 1: inside capsule wall; 2: the intestinal juice layer; 3: capsule outer walls.
The specific embodiment:
Below in conjunction with accompanying drawing and specific embodiment the present invention is described further.
Embodiment 1
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; Select prior art intestinal juice prescription for use: polyacrylic resin II numbers 200 gram plasticizer ATECs 200 grams, mix well, be dissolved in 2000 milliliters in acetone, medicinal alcohol obtains intestinal liquid in right amount;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the gelatin glue, dry under Capsules production line drying condition, form thick 5 inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 3 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the gelatin glue again, dry back forms thick 2 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Gelatin materials inside capsule wall 1 with 5 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 3 of thickness outside the inside capsule wall; With the gelatin materials capsule outer walls 3 of 2 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 2:
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; The intestinal juice prescription: polyacrylic resin enteric solubility II number 500 grams, plasticizer ATEC 650 restrain, and 2000 milliliters in acetone, 1600 milliliters of mixed dissolutions of medicinal alcohol obtain intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the gelatin glue, dry under Capsules production line drying condition, form thick 5 inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 3 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the gelatin glue again, dry back forms thick 2 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Gelatin materials inside capsule wall 1 with 5 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 3 of thickness outside the inside capsule wall; With the gelatin materials capsule outer walls 3 of 2 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 3:
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; The intestinal juice prescription: polyacrylic resin enteric solubility II number 600 grams, plasticizer ATEC 680 restrain, and 1800 milliliters in acetone, 2000 milliliters of mixed dissolutions of medicinal alcohol obtain intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the Sargassum polysaccharides glue, dry under Capsules production line drying condition, form thick 4 inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 4 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the Sargassum polysaccharides glue again, dry back forms thick 2 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Sargassum polysaccharides material inside capsule wall 1 with 4 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 4 of thickness outside the inside capsule wall; With the Sargassum polysaccharides material capsule outer walls 3 of 2 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
：
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 4:
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; The intestinal juice prescription: polyacrylic resin enteric solubility II number 800 grams, plasticizer ATEC 720 restrain, and 2500 milliliters in acetone, 1650 milliliters of mixed dissolutions of medicinal alcohol obtain intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the water-soluble cellulose glue, dry under Capsules production line drying condition, form thick 6 inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 3 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the water-soluble cellulose glue again, dry back forms thick 1 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Water-soluble cellulose material inside capsule wall 1 with 6 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 3 of thickness outside the inside capsule wall; With the water-soluble cellulose material capsule outer walls 3 of 1 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 5:
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; The intestinal juice prescription: polyacrylic resin enteric solubility II number 750 grams, plasticizer glyceryl triacetate 720 restrain, and 2500 milliliters in acetone, 1650 milliliters of mixed dissolutions of medicinal alcohol obtain intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the pulullan polysaccharide glue, dry under Capsules production line drying condition, form thick 6 inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 3 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the pulullan polysaccharide glue again, dry back forms thick 1 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Pulullan polysaccharide material inside capsule wall 1 with 6 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 3 of thickness outside the inside capsule wall; With the pulullan polysaccharide material capsule outer walls 3 of 1 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 6:
The production technology of enteric hollow capsule is characterized in that: comprise the steps:
A, preparation intestinal liquid; The intestinal juice prescription: polyacrylic resin enteric solubility II number 6000 grams, plasticizer glyceryl triacetate 6500 restrain, and 2300 milliliters in acetone, 1500 milliliters of mixed dissolutions of medicinal alcohol obtain intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1:, form thick 4 inside capsule wall dipping in soybean polysaccharide body glue (making) drying under Capsules production line drying condition on the mould like embodiment 7 methods;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms thick 4 intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in soybean polysaccharide body glue (making like embodiment 7 methods) again, dry back forms thick 2 capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
Go out enteric hollow capsule with above-mentioned explained hereafter: structure is as shown in Figure 1; Soybean polysaccharide body material inside capsule wall 1 with 4 of thickness; The enteric hollow capsule intestinal juice layer 2 of having 4 of thickness outside the inside capsule wall; With the soybean polysaccharide body material capsule outer walls 3 of 2 of thickness, this is enteric hollow capsule capsule shells A10, obtains less enteric hollow capsule capsule shells B20 with a less mould of diameter at last according to aforementioned production method outside enteric hollow capsule intestinal juice layer; As shown in Figure 2 enteric hollow capsule capsule shells A10 and enteric hollow capsule capsule shells B20 are linked in together at last, promptly get enteric hollow capsule.
Above-mentioned enteric hollow capsule disintegrate parameter: check by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carry out three groups of parallel tests,
Enteric hollow capsule carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 7:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; Select prior art colonic fluid prescription for use: polyacrylic resin II numbers 200 grams, III number 200 grams, plasticizer ATEC 450 grams, mix well, be dissolved in 2000 milliliters in acetone, medicinal alcohol obtains colonic fluid in right amount;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the gelatin glue, dry under Capsules production line drying condition, form thick 5 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the colon liquid layer, dip in the gelatin glue again, dry back forms thick 1 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Gelatin materials inside capsule wall 1 with 5 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules intestinal juice layer 2; Dissolve the gelatin materials capsule outer walls 3 of having 1 of thickness outside the Capsules intestinal juice layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 8:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; The colonic fluid prescription: polyacrylic resin III number 1000 grams, plasticizer ATEC 1000 restrain, and 2000 milliliters in acetone, medicinal alcohol obtain colonic fluid for 1700 milliliters;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the gelatin glue, dry under Capsules production line drying condition, form thick 4 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the gelatin glue again, dry back forms thick 2 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Gelatin materials inside capsule wall 1 with 4 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules intestinal juice layer 2; Dissolve the gelatin materials capsule outer walls 3 of having 2 of thickness outside the Capsules intestinal juice layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 9:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; The colonic fluid prescription: polyacrylic resin III number 1100 grams, plasticizer ATEC 950 restrain, and 1800 milliliters in acetone, medicinal alcohol obtain colonic fluid for 1500 milliliters;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the Sargassum polysaccharides glue, dry under Capsules production line drying condition, form thick 4 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in Sargassum polysaccharides gum deposit liquid again, dry back forms thick 1 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Sargassum polysaccharides material inside capsule wall 1 with 4 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules colon liquid layer 2; Dissolve the Sargassum polysaccharides material capsule outer walls 3 of having 1 of thickness outside the Capsules intestinal juice layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 10:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; The colonic fluid prescription: polyacrylic resin III number 1100 grams, plasticizer ATEC 1000 restrain, and 1900 milliliters in acetone, medicinal alcohol obtain colonic fluid for 1600 milliliters;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in water-soluble cellulose gum deposit liquid, dry under Capsules production line drying condition, form thick 4 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the colon liquid layer, dip in water-soluble cellulose gum deposit liquid again, dry back forms thick 1 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Water-soluble cellulose material inside capsule wall 1 with 4 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules intestinal juice layer 2; Dissolve the water-soluble cellulose material capsule outer walls 3 of having 1 of thickness outside the Capsules colon liquid layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 11:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; The colonic fluid prescription: polyacrylic resin III number 1000 grams, plasticizer ATEC 1020 restrain, and 2300 milliliters in acetone, medicinal alcohol obtain colonic fluid for 1620 milliliters;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in the pulullan polysaccharide glue, dry under Capsules production line drying condition, form thick 6 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in the pulullan polysaccharide glue again, dry back forms thick 1 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Pulullan polysaccharide material inside capsule wall 1 with 6 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules intestinal juice layer 2; Dissolve the pulullan polysaccharide material capsule outer walls 3 of having 1 of thickness outside the Capsules intestinal juice layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Embodiment 12:
Colon dissolves the production technology of Capsules, it is characterized in that: comprise the steps:
A, preparation colonic fluid; The colonic fluid prescription: polyacrylic resin III number 900 grams, plasticizer ATEC 990 restrain, and 2400 milliliters in acetone, medicinal alcohol obtain intestinal liquid for 1630 milliliters;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in soybean polysaccharide body gum deposit liquid (making) like embodiment 15 methods, dry under Capsules production line drying condition, form thick 4 inside capsule wall;
B2: outside inside capsule wall, dip in the colonic fluid that obtains among the above-mentioned steps A, dry back forms thick 5 colon liquid layer on inside capsule wall;
B3: outside the colon liquid layer, dip in soybean polysaccharide body gum deposit liquid (making like embodiment 15 methods) again, dry back forms thick 1 capsule outer walls outside the colon liquid layer;
C, the demoulding, cutting, check, fit.
Go out colon with above-mentioned explained hereafter and dissolve Capsules: structure is as shown in Figure 1; Soybean polysaccharide body material inside capsule wall 1 with 4 of thickness; Colon with 5 of thickness outside the inside capsule wall dissolves Capsules intestinal juice layer 2; Dissolve the soybean polysaccharide body material capsule outer walls 3 of having 1 of thickness outside the Capsules intestinal juice layer at colon, this is that colon dissolves Capsules capsule shells A10, obtains less colon with a less mould of diameter at last according to aforementioned production method and dissolves Capsules capsule shells B20; As shown in Figure 2 molten Capsules capsule shells A10 of colon and the molten Capsules capsule shells B20 of colon are linked in together at last, promptly get colon and dissolve Capsules.
Above-mentioned colon dissolves Capsules disintegrate parameter: checks by Pharmacopoeia of the People's Republic of China version in 2010 inspection technique disintegration disintegration, carries out three groups of parallel tests,
Colon dissolves Capsules and carries out the inspection of friability according to the friability experimental technique of stipulating in the current edition Pharmacopoeia of the People's Republic of China, and every group of 50 capsules repeat 40 times, its as a result capsule do not have breakage.
Claims (12)
1. the production technology of Capsules is characterized in that: comprise the steps:
A, preparation intestinal liquid;
B, dip in glue, comprise following b1, b2, b3 step:
B1: on mould, dip in glue, dry under Capsules production line drying condition, form inside capsule wall;
B2: outside inside capsule wall, dip in the intestinal juice that obtains among the above-mentioned steps A, dry back forms the intestinal juice layer on inside capsule wall;
B3: outside the intestinal juice layer, dip in glue again, dry back forms capsule outer walls outside the intestinal juice layer;
C, the demoulding, cutting, check, fit.
2. the production technology of Capsules as claimed in claim 1, it is characterized in that: the described intestinal juice of steps A is enteric hollow capsule intestinal liquid; The inside capsule wall thickness of step B is the 4-6 silk, and the intestinal juice layer thickness is greater than 2, capsule outer walls thickness 1-3 silk.
3. the production technology of Capsules as claimed in claim 2; It is characterized in that: described enteric hollow capsule intestinal juice is polyacrylic resin II5-8 weight portion; Plasticizer 6.5-7.5 weight portion, acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume mixed dissolution forms; Wherein, the relation of weight portion and parts by volume is a grams per milliliter.
4. the production technology of Capsules as claimed in claim 1 is characterized in that: the described intestinal juice of steps A is that colon dissolves Capsules intestinal liquid; The inside capsule wall thickness 4-6 silk of step B, intestinal juice layer thickness be greater than 4, capsule outer walls thickness 1-3 silk.
5. the production technology of Capsules as claimed in claim 4; It is characterized in that: it is polyacrylic resin III9-11 weight portion that described colon dissolves Capsules intestinal juice; Plasticizer 9.5-10.5 weight portion, acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume mixed dissolution forms; Wherein, the relation of weight portion and parts by volume is a grams per milliliter.
6. the production technology of Capsules as claimed in claim 1, it is characterized in that: the glue of said step b1 is gelatin glue or Sargassum polysaccharides glue or water-soluble cellulose glue or water-soluble cellulose derivative glue or pulullan polysaccharide glue or soybean polysaccharide body glue; The glue of said step b2 is gelatin glue or Sargassum polysaccharides glue or water-soluble cellulose glue or water-soluble cellulose derivative glue or pulullan polysaccharide glue or soybean polysaccharide body glue; Step b1 and step b2 select the same material glue for use.
7. the enteric hollow capsule that Capsules production technology as claimed in claim 3 is produced; It is characterized in that: inside capsule wall with thickness 4-6 silk; With the enteric hollow capsule intestinal juice layer of thickness, outside enteric hollow capsule intestinal juice layer, has the capsule outer walls of thickness 1-3 silk outside the inside capsule wall greater than 2; Said enteric hollow capsule intestinal juice composition of layer is a polyacrylic resin II5-8 weight portion, plasticizer 6.5-7.5 weight portion, and acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume, wherein, the relation of weight portion and parts by volume is a grams per milliliter.
8. enteric hollow capsule as claimed in claim 7 is characterized in that: described plasticizer is ATEC or glyceryl triacetate.
9. enteric hollow capsule as claimed in claim 7 is characterized in that: described inside capsule wall material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Described capsule outer walls material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Capsule outer walls is identical with the inside capsule wall material.
10. the colon produced of the production technology of Capsules as claimed in claim 5 dissolves Capsules; It is characterized in that: inside capsule wall with thickness 4-6 silk; Have thickness outside the inside capsule wall greater than the molten Capsules intestinal juice layer of 4 colon, dissolve the capsule outer walls of having thickness 1-3 silk outside the Capsules intestinal juice layer at colon; It is polyacrylic resin III9-11 weight portion that said colon dissolves Capsules intestinal juice composition of layer, plasticizer 9.5-10.5 weight portion, and acetone 18-26 parts by volume, medicinal alcohol 15-17 parts by volume, wherein, the relation of weight portion and parts by volume is a grams per milliliter.
11. colon as claimed in claim 10 dissolves Capsules, it is characterized in that: described plasticizer is ATEC or glyceryl triacetate.
12. colon as claimed in claim 10 dissolves Capsules, it is characterized in that: described inside capsule wall material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Described capsule outer walls material is gelatin or Sargassum polysaccharides or water-soluble cellulose or water-soluble cellulose derivative or pulullan polysaccharide or soybean polysaccharide body; Capsule outer walls is identical with the inside capsule wall material.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101469944A CN102805709A (en) | 2011-06-02 | 2011-06-02 | Vacant capsule production process and enteric vacant capsule and colonic-coated vacant capsule produced thereby |
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| CN2011101469944A CN102805709A (en) | 2011-06-02 | 2011-06-02 | Vacant capsule production process and enteric vacant capsule and colonic-coated vacant capsule produced thereby |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106038304A (en) * | 2016-05-20 | 2016-10-26 | 夏放军 | Empty capsule |
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| CN1031487A (en) * | 1987-07-29 | 1989-03-08 | 中山大学 | The micro capsule technology of delamination packing clothes |
| CN1084385A (en) * | 1993-04-19 | 1994-03-30 | 李加海 | Process for preparing enteric hollow capsules |
| CN1084386A (en) * | 1993-04-19 | 1994-03-30 | 李加海 | Production process of enteric hollow capsules |
| CN101049380A (en) * | 2007-05-11 | 2007-10-10 | 张冰文 | Enteric solubility soft capsule containing camellia oil, and preparation method |
| US20090074855A1 (en) * | 2007-09-18 | 2009-03-19 | Viva Pharmaceuticals Inc. | Enteric coastings for orally ingestible compositions |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1031487A (en) * | 1987-07-29 | 1989-03-08 | 中山大学 | The micro capsule technology of delamination packing clothes |
| CN1084385A (en) * | 1993-04-19 | 1994-03-30 | 李加海 | Process for preparing enteric hollow capsules |
| CN1084386A (en) * | 1993-04-19 | 1994-03-30 | 李加海 | Production process of enteric hollow capsules |
| CN101049380A (en) * | 2007-05-11 | 2007-10-10 | 张冰文 | Enteric solubility soft capsule containing camellia oil, and preparation method |
| US20090074855A1 (en) * | 2007-09-18 | 2009-03-19 | Viva Pharmaceuticals Inc. | Enteric coastings for orally ingestible compositions |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106038304A (en) * | 2016-05-20 | 2016-10-26 | 夏放军 | Empty capsule |
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Application publication date: 20121205 |