CN103550186A - Colon sigmoideum targeting empty capsule - Google Patents
Colon sigmoideum targeting empty capsule Download PDFInfo
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- CN103550186A CN103550186A CN201310525828.4A CN201310525828A CN103550186A CN 103550186 A CN103550186 A CN 103550186A CN 201310525828 A CN201310525828 A CN 201310525828A CN 103550186 A CN103550186 A CN 103550186A
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Abstract
The invention provides a colon sigmoideum targeting empty capsule. The colon sigmoideum targeting empty capsule comprises a capsule wall material made from gelatin or vegetable gelatin and a coating layer outside the capsule wall material and is characterized in that the coating layer is ethyecellulose, ferric oxide is contained in the capsule wall material, the colon sigmoideum targeting empty capsule comprises the following components in percentage by weight: 65%-75% of gelatin or vegetable glue, 20-30% of the ethyecellulose, and 3-5% of the ferric oxide. The colon sigmoideum targeting empty capsule does not disintegrate within two hours in gastric juice with the pH value of 2, cannot dissolve or disintegrate within 3 hours in intestinal juice with the pH value of 6.8, does not disintegrate within 1 hour in intestinal juice with the pH value of 7.8, disintegrates within 30 minutes in colon sigmoideum juice with the pH value of 8.0 and can rapidly reach a colon sigmoideum part under the guidance of an external magnetic field.
Description
One, technical field
The present invention relates to a kind of pharmaceutic adjuvant Capsules, particularly enteric hollow capsule, specifically dissolves the targeting Capsules of (disintegrate) at specific human body sigmoid colon position.
Two, background technology
Sigmoidocolic end is connected with rectum, is the position of the most easily falling ill in human colon position, and therefore directly drug delivery discharges to sigmoid colon position, can effectively improve bioavailability and the curative effect thereof of medicine.
The Capsules of 2010 editions regulations of < < Chinese Pharmacopoeia > > has molten three kinds of gastric solubleness, enteric and colon, index disintegration to colonic-coated hollow capsule is: (pH value 2.0) not disintegrate in 2 hours in gastric juice, then at human small intestine position, (pH value 6.8) can not dissolve or disintegrate for 3 hours, disintegrate in human colon position (pH value 7.8) 1 hour.Human colon is consisted of ascending colon, transverse colon, descending colon and sigmoid colon (pH value 8.0), and therefore, existing colonic-coated hollow capsule is difficult to medicine directly to send to Sigmoidocolic lesions position.
At present first colonic-coated hollow capsule is processed encystation material on capsule production line by gelatin, then at the anti-gastric acid of capsule material outsourcing with in pH value 6.8 not disintegrates and the knot enteric-coating material acrylic resin III of dissolving at pH value 7.8 etc.Production technology is glue after the first water soaking of gelatin, swelling, after send capsule production line through dipping in gum forming, dry solidification, wrapping specific enteric-coating material acrylic resin III etc. again.
The coating materials such as acrylic resin III are mixed with to the coating solution of certain concentration with organic solvents such as ethanol, on coating streamline, by capsule material coating, then the operation such as dry, cooling, demoulding, cutting obtains colonic-coated hollow capsule.
Three, summary of the invention
The present invention is directed to existing colonic-coated hollow capsule and medicine directly can not be sent to the defect of Sigmoidocolic lesions position, aim to provide a kind of can be at the Capsules of sigmoid colon disintegrate, technical problem to be solved is to select suitable coating material, and not disintegrate but can disintegrate in the sigmoid colon liquid of pH value 8.0 in the colonic fluid of pH value 7.8 for this coating material.
The technical program comprises the coatings outside capsule material and capsule material, described capsule material is the capsule material of the machine-shaping on capsule production line by gelatin or plant gum, difference with the prior art is that the coatings outside capsule material is ethyl cellulose, in capsule material, contain ferrum oxide, each constituent mass percentage ratio is gelatin or plant gum 65-75%, ethyl cellulose 20-30%, ferrum oxide 3-5%.
Preferred gelatin or plant gum 70%, ethyl cellulose 25%, ferrum oxide 5%.
Ethyl cellulose is mixed with to coating solution with etoh solvent or acetone, on coating streamline, carries out coating.
The water soluble protein that the collagen protein of described gelatin in the connective tissues such as the skin of animal, bone, tendon, ligament obtains through hydrolysis.Described plant gum hydroxypropyl emthylcellulose, pulullan polysaccharide etc. are the primary raw materials of processing gastric-dissolved capsule.
Described ferrum oxide is selected from iron sesquioxide or ferroso-ferric oxide, ferrum oxide is normally processed the pigment adjuvant that Capsules is used, but in this Capsules, be one of Main Components, except playing mark action, its Main Function is the lower human body sigmoid colon position that arrives fast of outside magnetic field guiding.
This Capsules and colonic-coated hollow capsule carry out contrast test by the method for pharmacopeia regulation, and result is as following table:
Four, the specific embodiment
Non-limiting examples is described below:
1, the preparation of capsule material
Proportion (being the concentration of glue) is filtered, adjusted to heated and stirred in gelatin or plant gum and water input mixing kettle after dissolving, as use plant gum separately need add firming agent and flocculation aid, add an iron sesquioxide oversubscription prose style free from parallelism for proportional quantity.In addition, also can need to add opacifier titanium dioxide and other adjuvant etc. according to user, standing insulation bubble removing, then put on capsule production line through capsule cap mould and dip in glue, solidify and oven dry obtains capsule material.
2, coating
With ethanol, or/and acetone is solvent, ethyl cellulose is made into 10% coating solution, on coating streamline after coating at least one times, then dry, the demoulding, cutting, fit make sigmoid colon targeting Capsules.
Claims (3)
1. a sigmoid colon targeting Capsules, comprise by gelatin or the capsule material of plant gum processing and the coatings outside capsule material, it is characterized in that: described coatings is ethyl cellulose, in capsule material, contain ferrum oxide, each constituent mass percentage ratio is gelatin or plant gum 65-75%, ethyl cellulose 20-30%, ferrum oxide 3-5%.
2. Capsules according to claim 1, is characterized in that:
Each constituent mass percentage ratio is gelatin or plant gum 70%, ethyl cellulose 25%, ferrum oxide 5%.
3. Capsules according to claim 1 and 2, is characterized in that: described ferrum oxide is selected from iron sesquioxide.
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CN201310525828.4A CN103550186B (en) | 2013-10-29 | 2013-10-29 | A kind of sigmoid colon targeting Capsules |
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CN201310525828.4A CN103550186B (en) | 2013-10-29 | 2013-10-29 | A kind of sigmoid colon targeting Capsules |
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CN103550186A true CN103550186A (en) | 2014-02-05 |
CN103550186B CN103550186B (en) | 2015-12-30 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111388454A (en) * | 2020-04-05 | 2020-07-10 | 刘立新 | Digestive tract regularly disintegrating capsule and its production process |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103340838A (en) * | 2013-06-05 | 2013-10-09 | 绍兴康可胶囊有限公司 | Enteric gelatin hollow capsule |
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2013
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Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103340838A (en) * | 2013-06-05 | 2013-10-09 | 绍兴康可胶囊有限公司 | Enteric gelatin hollow capsule |
Non-Patent Citations (3)
Title |
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吴庆喜等: "口服结肠靶向给药系统和制备方法的研究进展", 《化工学报》, vol. 64, no. 1, 31 January 2013 (2013-01-31), pages 210 - 222 * |
季崇敏等: "结肠定位释药瓜尔胶/乙基纤维素包衣小丸", 《药学学报》, vol. 42, no. 6, 31 December 2007 (2007-12-31), pages 656 - 662 * |
崔福德: "《药剂学》", 31 July 2003, article "第三篇 药物制剂的新技术与新剂型", pages: 402 * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111388454A (en) * | 2020-04-05 | 2020-07-10 | 刘立新 | Digestive tract regularly disintegrating capsule and its production process |
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Effective date of registration: 20160711 Address after: 242600, Xuancheng County, Anhui City, Jingde Province, white land town of Hong Chuan Patentee after: Anhui Huangshan Capsule Co.,Ltd. Address before: 242600 Anhui Province, Xuancheng City Jingyang town Jingde County Liang Jia No. 5 Patentee before: Liu Songlin |