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 PDF

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Publication number
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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CN
China
Prior art keywords
soluble
colon
hard capsule
intestine
hollow hard
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 200510051018
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Chinese (zh)
Inventor
李加海
陈坤昭
李泳雪
王春龙
李煜龙
许锐鹏
许舜金
许雄群
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CHAOZHOU CITY QIANGJI PHARMACEUTICAL FACTORY
Original Assignee
CHAOZHOU CITY QIANGJI PHARMACEUTICAL FACTORY
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CHAOZHOU CITY QIANGJI PHARMACEUTICAL FACTORY filed Critical CHAOZHOU CITY QIANGJI PHARMACEUTICAL FACTORY
Priority to CN 200510051018 priority Critical patent/CN1682699A/en
Publication of CN1682699A publication Critical patent/CN1682699A/en
Pending legal-status Critical Current

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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

Colon soluble and intestine soluble hollow hard capsule and production technology
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.
CN 200510051018 2005-02-28 2005-02-28 Colon soluble and intestine soluble hollow hard capsule and producing process Pending CN1682699A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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)

Application Number Priority Date Filing Date Title
CN 200510051018 CN1682699A (en) 2005-02-28 2005-02-28 Colon soluble and intestine soluble hollow hard capsule and producing process

Publications (1)

Publication Number Publication Date
CN1682699A true CN1682699A (en) 2005-10-19

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Country Status (1)

Country Link
CN (1) CN1682699A (en)

Cited By (12)

* Cited by examiner, † Cited by third party
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

Cited By (15)

* Cited by examiner, † Cited by third party
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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