CN1682699A - Colon soluble and intestine soluble hollow hard capsule and producing process - Google Patents
Colon soluble and intestine soluble hollow hard capsule and producing process Download PDFInfo
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- CN1682699A CN1682699A CN 200510051018 CN200510051018A CN1682699A CN 1682699 A CN1682699 A CN 1682699A CN 200510051018 CN200510051018 CN 200510051018 CN 200510051018 A CN200510051018 A CN 200510051018A CN 1682699 A CN1682699 A CN 1682699A
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- soluble
- colon
- hard capsule
- intestine
- hollow hard
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Abstract
The present invention relates to colon soluble hard medicine capsule disintegrated in colon and its production process. The colon soluble hard hollow capsule includes skeleton layer and coating layer. The production process includes the following steps: dipping the skeleton layer material solution with mold and stoving; coating the skeleton layer material with coating layer; stoving and curing; demolding; cutting; matching; and inspection. The colon soluble hard hollow capsule has stable quality, may be disintegrated in fixed position, and suitable for colon administration. The hollow capsule may be filled with medicine, solid, liquid and soft matter, which are released in colon.
Description
1, technical field:
The present invention is a kind of oral medicinal hard capsule and production technology that is positioned the human colon disintegrate, belongs to the innovative technology of colon soluble and intestine soluble hollow hard capsule and production technology.
2, background technology:
The shortcoming that existing colon soluble and intestine soluble hollow hard capsule exists is that quality is stable inadequately, particularly is difficult to realize the location disintegrate, can not satisfy the use needs of some medicines that need be positioned the human colon disintegrate.
3, summary of the invention:
The objective of the invention is to consider the problems referred to above and a kind of steady quality is provided, can realize locating disintegrate, be fit to colon locating administrated colon soluble and intestine soluble hollow hard capsule.
Another object of the present invention is to provide a kind of making production technology of colon soluble and intestine soluble hollow hard capsule simply and easily.
Colon soluble and intestine soluble hollow hard capsule of the present invention includes casing play and coating rete, and casing play includes following component:
1) is gelatin, pectin, starch, water-soluble cellulose at least and prolongs a kind of in biology, agar gum, guar gum, tragon, carrageenin, carrageenan, Radix Acaciae senegalis, ghatti gum, Tragacanth, araban, xanthan gum, Gellan gum, Konjac mannan, the chitin; 2) opacifier; 3) coloring agent; 4) surfactant; 5) water;
The coating rete includes following component:
1) is a kind of in the adjacent benzene diacetate of acryhic material polymerization copolyreaction thing, Hydroxypropyl Methylcellulose Phathalate, polyethylene at least; 2) plasticizer; 3) organic solvent.
Aforesaid propylene acid material polymerization copolyreaction thing includes following component:
1) have at least two kinds to be selected from methacrylic acid, methyl methacrylate, ethyl methacrylate, ethylacrylic acid, ethylacrylic acid methyl ester, ethyl propylene acetoacetic ester; 2) initiator; 3) organic solvent.
It is diethyl phthalate, dibutyl phthalate, tributyl citrate, tributyl 2-acetylcitrate, triethyl citrate, acetyl triethyl citrate, triacetyl glycerine, Polyethylene Glycol, Tween 80, di-n-octyl sebacate, dibutyl sebacate that above-mentioned plasticizer has at least a kind of.
It is ethanol, isopropyl alcohol or acetone that above-mentioned organic solvent has at least a kind of.
It is to be selected from benzoyl peroxide, hydrogen peroxide that above-mentioned initiator has at least a kind of.
The production technology of colon soluble and intestine soluble hollow hard capsule of the present invention, carry out as follows:
1) the casing play material solution is glued with mould dips in, dries;
2) colonic-coat material solution of coating rete is coated on the outer surface of casing play material;
3) baking and curing molding;
4) shelling;
5) otch;
6) fit;
7) check.
Above-mentioned steps 2) outer surface that the colonic-coat material solution of coating rete is coated on the casing play material can wrap once or once.
The above-mentioned wall thickness of being made up of casing play and coating rete is between 0.08mm~0.2mm.
Colon soluble and intestine soluble hollow hard capsule of the present invention, steady quality can realize locating disintegrate, is fit to colon locating administrated.Adopt this Capsules filling medicine or fill solid, liquid, software material, in the conlon targeting disintegrate of human body, discharge the content material after the oral administration.This Capsules detects in external disintegrate: fill Pulvis Talci and check not disintegrate in 2 hours in hydrochloric acid solution (9 → 1000), not disintegrate in 3 hours is checked at phosphate buffer (PH6.8) in the back, changes into phosphate buffer (PH7.2-8.0) planted agent's off-bottom in 1 hour or disintegrate.The production technology of colon soluble and intestine soluble hollow hard capsule of the present invention is made simple and convenient, and cost is low.
4, the specific embodiment:
Embodiment 1:
Colon soluble and intestine soluble hollow hard capsule of the present invention includes casing play and coating rete, and casing play includes following component:
1) is gelatin, pectin, starch, water-soluble cellulose at least and prolongs a kind of in biology, agar gum, guar gum, tragon, carrageenin, carrageenan, Radix Acaciae senegalis, ghatti gum, Tragacanth, araban, xanthan gum, Gellan gum, Konjac mannan, the chitin; 2) opacifier; 3) coloring agent; 4) surfactant; 5) water;
The coating rete includes following component:
1) is a kind of in the adjacent benzene diacetate of acryhic material polymerization copolyreaction thing, Hydroxypropyl Methylcellulose Phathalate, polyethylene at least; 2) plasticizer; 3) organic solvent.
Aforesaid propylene acid material polymerization copolyreaction thing includes following component:
1) have at least two kinds to be selected from methacrylic acid, methyl methacrylate, ethyl methacrylate, ethylacrylic acid, ethylacrylic acid methyl ester, ethyl propylene acetoacetic ester; 2) initiator; 3) organic solvent.
It is diethyl phthalate, dibutyl phthalate, tributyl citrate, tributyl 2-acetylcitrate, peaceful lemon triethylenetetraminehexaacetic acid ester, acetyl triethyl citrate, triacetyl glycerine, Polyethylene Glycol, Tween 80, di-n-octyl sebacate, dibutyl sebacate that above-mentioned plasticizer has at least a kind of.
It is ethanol, isopropyl alcohol or acetone that above-mentioned organic solvent has at least a kind of.
It is to be selected from benzoyl peroxide, hydrogen peroxide that above-mentioned initiator has at least a kind of.
The coating rete colon soluble and intestine soluble coating solution of present embodiment is selected acrylic acid copolymer polymer 5%-30%, plasticizer 5%-20% for use, is added ethanol 30%-50%, acetone 10%-40%.
The production technology of colon soluble and intestine soluble hollow hard capsule of the present invention, carry out as follows:
1) the casing play material solution is glued with mould dips in, dries;
2) colonic-coat material solution of coating rete is coated on the outer surface of casing play material;
3) baking and curing molding;
4) shelling;
5) otch;
6) fit;
7) check.
Above-mentioned steps 2) outer surface that the colonic-coat material solution of coating rete is coated on the casing play material can wrap once or once.
The above-mentioned wall thickness of being made up of casing play and coating rete is between 0.08mm~0.2mm.Loss on drying is controlled between the 12%-19%, its human vitronectin detects, fill Pulvis Talci and in hydrochloric acid solution (9 → 1000), check not disintegrate in 2 hours, not disintegrate in 3 hours is checked at phosphate buffer (PH6.8) in the back, changes into phosphate buffer (PH7.2-8.0) planted agent's off-bottom in 1 hour or disintegrate.Locate disintegrate in human colon behind this kind institute filling drug oral.
Embodiment 2:
The component of present embodiment casing play is identical with embodiment 1, and difference is that coating rete colon soluble and intestine soluble coating solution selects adjacent benzene diacetate (PVAP) 5%-10% of acrylic acid copolymer polymer 5%-10%, Hydroxypropyl Methylcellulose Phathalate (HPMCP) 5%-10%, polyethylene, plasticizer 5%-10% for use, adds ethanol 30%-50%, acetone 10%-40%.
Claims (9)
1, a kind of colon soluble and intestine soluble hollow hard capsule includes casing play and coating rete, it is characterized in that casing play includes following component:
1) is gelatin, pectin, starch, water-soluble cellulose at least and prolongs a kind of in biology, agar gum, guar gum, tragon, carrageenin, carrageenan, Radix Acaciae senegalis, ghatti gum, Tragacanth, araban, xanthan gum, Gellan gum, Konjac mannan, the chitin; 2) opacifier; 3) coloring agent; 4) surfactant; 5) water;
The coating rete includes following component:
1) is a kind of in the adjacent benzene diacetate of acryhic material polymerization copolyreaction thing, Hydroxypropyl Methylcellulose Phathalate, polyethylene at least; 2) plasticizer; 3) organic solvent.
2, colon soluble and intestine soluble hollow hard capsule according to claim 1, it is characterized in that aforesaid propylene acid material polymerization copolyreaction thing includes following component:
1) have at least two kinds to be selected from methacrylic acid, methyl methacrylate, ethyl methacrylate, ethylacrylic acid, ethylacrylic acid methyl ester, ethyl propylene acetoacetic ester; 2) initiator; 3) organic solvent.
3, colon soluble and intestine soluble hollow hard capsule according to claim 1, it is characterized in that it is diethyl phthalate, dibutyl phthalate, tributyl citrate, tributyl 2-acetylcitrate, triethyl citrate, acetyl triethyl citrate, triacetyl glycerine, Polyethylene Glycol, Tween 80, di-n-octyl sebacate, dibutyl sebacate that above-mentioned plasticizer has at least a kind of.
4, colon soluble and intestine soluble hollow hard capsule according to claim 1 is characterized in that it is ethanol, isopropyl alcohol or acetone that above-mentioned organic solvent has at least a kind of.
5, colon soluble and intestine soluble hollow hard capsule according to claim 2 is characterized in that it is to be selected from benzoyl peroxide, hydrogen peroxide that above-mentioned initiator has at least a kind of.
6, colon soluble and intestine soluble hollow hard capsule according to claim 2 and production technology is characterized in that it is ethanol, isopropyl alcohol or acetone that above-mentioned organic solvent has at least a kind of.
7, a kind of production technology according to the described colon soluble and intestine soluble hollow hard capsule of claim 1 is characterized in that carrying out as follows:
1) the casing play material solution is glued with mould dips in, dries;
2) colonic-coat material solution of coating rete is coated on the outer surface of casing play material;
3) baking and curing molding;
4) shelling;
5) otch;
6) fit;
7) check.
8, the production technology of colon soluble and intestine soluble hollow hard capsule according to claim 7 is characterized in that above-mentioned steps 2) outer surface that the colonic-coat material solution of coating rete is coated on the casing play material can wrap once or once.
9, the production technology of colon soluble and intestine soluble hollow hard capsule according to claim 8 is characterized in that the above-mentioned wall thickness of being made up of casing play and coating rete is between 0.08mm~0.2mm.
Priority Applications (1)
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CN 200510051018 CN1682699A (en) | 2005-02-28 | 2005-02-28 | Colon soluble and intestine soluble hollow hard capsule and producing process |
Applications Claiming Priority (1)
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CN 200510051018 CN1682699A (en) | 2005-02-28 | 2005-02-28 | Colon soluble and intestine soluble hollow hard capsule and producing process |
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CN1682699A true CN1682699A (en) | 2005-10-19 |
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Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009062356A1 (en) * | 2007-11-13 | 2009-05-22 | Shanghai Huiyuan Vegetal Capsule Co., Ltd | Non-gelatin enteric hard capsule shell and preparation method thereof |
CN101953816A (en) * | 2010-09-08 | 2011-01-26 | 浙江昂利康胶囊有限公司 | Medicinal hollow capsules and preparation method and manufacturing equipment thereof |
CN101708174B (en) * | 2009-12-11 | 2011-04-13 | 梁贤昌 | Plant hollow capsule, soft capsule composition and preparation methods thereof |
CN103520134A (en) * | 2013-10-29 | 2014-01-22 | 刘松林 | Duodenum targeted hollow capsules |
CN103937037A (en) * | 2014-04-28 | 2014-07-23 | 中国科学院化学研究所 | Modified starch adhesive for preparing hollow capsule and starch-base hollow capsule thereof |
CN103961332A (en) * | 2014-04-23 | 2014-08-06 | 湖南尔康北山明胶有限公司 | Composition used as replacement of gelatin for preparation of enteric capsule materials and preparation method for composition |
CN104288120A (en) * | 2014-10-16 | 2015-01-21 | 绍兴康可胶囊有限公司 | Enteric-coated plant cellulose hard empty capsules and preparation method thereof |
WO2016058160A1 (en) * | 2014-10-16 | 2016-04-21 | 绍兴康可胶囊有限公司 | Enteric plant cellulose hard hollow capsule and preparation method therefor |
CN107744146A (en) * | 2017-11-21 | 2018-03-02 | 河南牧业经济学院 | A kind of application of the Capsules with segmented intestine targeted function |
CN108201531A (en) * | 2016-12-19 | 2018-06-26 | 湖南尔康湘药制药有限公司 | Segmented intestine targeted starch capsule of highly dissoluble sulbenicillin sodium and preparation method thereof |
CN113244187A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric hypromellose empty capsule with new formula and preparation method thereof |
CN113244186A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric gelatin hollow capsule with new formula and preparation method thereof |
-
2005
- 2005-02-28 CN CN 200510051018 patent/CN1682699A/en active Pending
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009062356A1 (en) * | 2007-11-13 | 2009-05-22 | Shanghai Huiyuan Vegetal Capsule Co., Ltd | Non-gelatin enteric hard capsule shell and preparation method thereof |
CN101708174B (en) * | 2009-12-11 | 2011-04-13 | 梁贤昌 | Plant hollow capsule, soft capsule composition and preparation methods thereof |
CN101953816A (en) * | 2010-09-08 | 2011-01-26 | 浙江昂利康胶囊有限公司 | Medicinal hollow capsules and preparation method and manufacturing equipment thereof |
CN103520134A (en) * | 2013-10-29 | 2014-01-22 | 刘松林 | Duodenum targeted hollow capsules |
CN103520134B (en) * | 2013-10-29 | 2015-07-22 | 刘松林 | Duodenum targeted hollow capsules |
CN103961332A (en) * | 2014-04-23 | 2014-08-06 | 湖南尔康北山明胶有限公司 | Composition used as replacement of gelatin for preparation of enteric capsule materials and preparation method for composition |
CN103961332B (en) * | 2014-04-23 | 2016-04-20 | 湖南尔康北山明胶有限公司 | A kind of composition and method of making the same preparing enteric capsulation material for replacing gelatin |
CN103937037B (en) * | 2014-04-28 | 2016-09-21 | 北京崇尚科技开发有限公司 | For preparing modified starch glue and the starch matrix Capsules thereof of Capsules |
CN103937037A (en) * | 2014-04-28 | 2014-07-23 | 中国科学院化学研究所 | Modified starch adhesive for preparing hollow capsule and starch-base hollow capsule thereof |
CN104288120A (en) * | 2014-10-16 | 2015-01-21 | 绍兴康可胶囊有限公司 | Enteric-coated plant cellulose hard empty capsules and preparation method thereof |
WO2016058160A1 (en) * | 2014-10-16 | 2016-04-21 | 绍兴康可胶囊有限公司 | Enteric plant cellulose hard hollow capsule and preparation method therefor |
CN108201531A (en) * | 2016-12-19 | 2018-06-26 | 湖南尔康湘药制药有限公司 | Segmented intestine targeted starch capsule of highly dissoluble sulbenicillin sodium and preparation method thereof |
CN107744146A (en) * | 2017-11-21 | 2018-03-02 | 河南牧业经济学院 | A kind of application of the Capsules with segmented intestine targeted function |
CN113244187A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric hypromellose empty capsule with new formula and preparation method thereof |
CN113244186A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric gelatin hollow capsule with new formula and preparation method thereof |
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