CN107998099A - A kind of enteric capsulation sealing compound - Google Patents
A kind of enteric capsulation sealing compound Download PDFInfo
- Publication number
- CN107998099A CN107998099A CN201711294494.9A CN201711294494A CN107998099A CN 107998099 A CN107998099 A CN 107998099A CN 201711294494 A CN201711294494 A CN 201711294494A CN 107998099 A CN107998099 A CN 107998099A
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- China
- Prior art keywords
- enteric
- parts
- sealing compound
- coating material
- capsulation
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of enteric capsulation sealing compound.The sealing compound includes enteric-soluble coating material, filler, colouring agent and ethanol composition, and enteric-soluble coating material, filler, the weight ratio of colouring agent and ethanol are 20 38：12‑24:1‑3:42‑58；The enteric-soluble coating material is formed by starch, phthalic acid hydroxypropyl cellulose, chitosan, methacrylic acid methyl terpolymer by crosslinking；The filler includes the following component counted in parts by weight：0.1 0.5 parts of softener, 48 parts of colouring agent, 28 parts of nano-titanium dioxide, 25 parts of blueberry polysaccharide, 12 18 parts of dendrobium polysaccharide.The material as enteric coatings after starch, phthalic acid hydroxypropyl cellulose, chitosan, the crosslinking of methacrylic acid methyl terpolymer is improved the acid resistance of sealing compound by the present invention, is reduced medicine and is volatilized under sour environment risk.
Description
Technical field
The present invention relates to enteric capsulation preparing technical field, and in particular to a kind of enteric capsulation sealing compound.
Background technology
Capsulae enterosolubilis, is exactly that the capsule absorbed could be dissolved in human small intestine for popular.So-called enteric glue
Capsule, simply adds special pharmaceutical polymers or specially treated in softgel shell in fact, it is not dissolved in gastric juice,
It is disintegrated and dissolves only in intestinal juice.The capsule is in stomach, in soaked in other words or even in boiling water, all without dissolved.Therefore, it is used for
The sealing compound of sealing need to meet acid resistance, so that opening breach in gastric juice, insoluble drug release out injures stomach.
Existing sealing compound is very much, but acid resistance is poor, reaches enteron aisle by gastric juice with the capsule that this sealing compound seals, can
There is the increase of content volatility, if long-term use of, undesirable stimulation can be produced to stomach.
The content of the invention
In view of the deficiencies of the prior art, it is an object of the invention to provide a kind of enteric capsulation sealing compound, the sealing
Glue acid resistance is strong, and it is small and non-aging that glutinous ability knots modification is glued in gastric juice.
A kind of enteric capsulation sealing compound, is made of, enteric solubility enteric-soluble coating material, filler, colouring agent and ethanol
Coating material, filler, the weight ratio of colouring agent and ethanol are 20-38：12-24:1-3:42-58；The enteric-soluble coating material
By starch, phthalic acid hydroxypropyl cellulose, chitosan, EUDRAGIT L100 by crosslinking
Form；The filler includes the following component counted in parts by weight：0.1-0.5 parts of softener, 4-8 parts of colouring agent, nano-silica
Change 2-8 parts of titanium, 2-5 parts of blueberry polysaccharide, 12-18 parts of dendrobium polysaccharide.
It is that the colouring agent is a kind of in carmine, indigo, lemon yellow or chlorophyll as improved.
It is as improved, the content of methacrylic acid is in the EUDRAGIT L100
20-30%.
It is that the molecular weight of the chitosan is 1200-1500 as improved.
It is as improved, the preparation method of above-mentioned enteric-soluble coating material, comprises the following steps：Step 1, according to weight
Compare 2-6:12-18:1-3:8-12 weighs each component；Step 2, by phthalic acid hydroxypropyl cellulose and methacrylic acid-first
After base methyl acrylate copolymer melts, stir evenly, after adding chitosan and crosslinking agent stirring, be spray-dried to obtain the first mixing
Fine powder；Step 3, starch is added into fine powder, is extruded in blending input extruder, plasma irradiation 1-5s, you can.
It is further improved to be, be spray-dried in step 2 temperature be 80-100 DEG C.
Further improved to be, the extrusion temperature of blending extrusion machine is 50-60 DEG C in step 3.
Compared with prior art, enteric capsulation of the present invention is strong with sealing compound acid resistance, the capsule sealed with this sealing compound
It is not easy to be open in gastric juice, effectively reduces the risk for stimulating stomach insoluble drug release.
Embodiment
The present invention is further described in detail below by specific embodiment.
Embodiment 1
A kind of enteric capsulation sealing compound, including enteric-soluble coating material, filler, colouring agent and ethanol composition, enteric solubility bag
Clothing material, filler, the weight ratio of colouring agent and ethanol are 20：12:1:42；The enteric-soluble coating material is by starch, adjacent benzene two
Formic acid hydroxypropyl cellulose, chitosan, EUDRAGIT L100 are formed by crosslinking；The filler
Including the following component counted in parts by weight：0.1 part of softener, 4 parts carmine, 2 parts of nano-titanium dioxide, 2 parts of blueberry polysaccharide,
12 parts of dendrobium polysaccharide.
Wherein, the content of methacrylic acid is 20% in the EUDRAGIT L100.
The molecular weight of the chitosan is 1200.
The preparation method of above-mentioned enteric-soluble coating material, comprises the following steps：Step 1, according to weight ratio 2:12:1:8 claim
Take each component；Step 2, phthalic acid hydroxypropyl cellulose and EUDRAGIT L100 are melted
Afterwards, stir evenly, after adding chitosan and crosslinking agent stirring, 80 DEG C are spray-dried to obtain the first mixing fine powders；Step 3, to fine powder
Middle addition starch, blending put into 50 DEG C of extrusions in extruder, plasma irradiation 1s, you can.
Enteric capsulation is prepared with the preparation method of sealing compound with reference to the prior art, you can.
Embodiment 2
A kind of enteric capsulation sealing compound, including enteric-soluble coating material, filler, colouring agent and ethanol composition, enteric solubility bag
Clothing material, filler, the weight ratio of colouring agent and ethanol are 35：18:2:50；The enteric-soluble coating material is by starch, adjacent benzene two
Formic acid hydroxypropyl cellulose, chitosan, EUDRAGIT L100 are formed by crosslinking；The filler
Including the following component counted in parts by weight：0.4 part of softener, 6 parts of lemon yellow, 5 parts of nano-titanium dioxide, 3 parts of blueberry polysaccharide,
15 parts of dendrobium polysaccharide.
Wherein, the content of methacrylic acid is 25% in the EUDRAGIT L100.
The molecular weight of the chitosan is 1300.
The preparation method of above-mentioned enteric-soluble coating material, comprises the following steps：Step 1, according to weight ratio 5:15:2:10 claim
Take each component；Step 2, phthalic acid hydroxypropyl cellulose and EUDRAGIT L100 are melted
Afterwards, stir evenly, after adding chitosan and crosslinking agent stirring, 90 DEG C are spray-dried to obtain the first mixing fine powders；Step 3, to fine powder
Middle addition starch, blending put into 55 DEG C of extrusions in extruder, plasma irradiation 4s, you can.
Embodiment 3
A kind of enteric capsulation sealing compound, including enteric-soluble coating material, filler, colouring agent and ethanol composition, enteric solubility bag
Clothing material, filler, the weight ratio of colouring agent and ethanol are 38：24:3:58；The enteric-soluble coating material is by starch, adjacent benzene two
Formic acid hydroxypropyl cellulose, chitosan, EUDRAGIT L100 are formed by crosslinking；The filler
Including the following component counted in parts by weight：0.5 part of softener, 8 parts of lemon yellow, 8 parts of nano-titanium dioxide, 5 parts of blueberry polysaccharide,
18 parts of dendrobium polysaccharide.
Wherein, the content of methacrylic acid is 30% in the EUDRAGIT L100.
The molecular weight of the chitosan is 1500.
The preparation method of above-mentioned enteric-soluble coating material, comprises the following steps：Step 1, according to weight ratio 2-6:12-18:
1-3:8-12 weighs each component；Step 2, by phthalic acid hydroxypropyl cellulose and methacrylic acid-methyl methacrylate
After copolymer melts, stir evenly, after adding chitosan and crosslinking agent stirring, 100 DEG C are spray-dried to obtain the first mixing fine powders；Step
Rapid 3, starch is added into fine powder, is extruded for 60 DEG C in blending input extruder, plasma irradiation 1-5s, you can.
Comparative example 1
In addition to enteric coatings are changed to phthalic acid hydroxypropyl cellulose, remaining is the same as embodiment 2.
The correlated performance of embodiment 1-3 and the sealing compound of comparative example 1 is detected, and above-mentioned sealing compound is sealed for capsule,
The dissolution situation of observed content thing.
From upper several results as can be seen that by starch, phthalic acid hydroxypropyl cellulose, chitosan, methacrylic acid-
The material as enteric coatings after methylmethacrylate copolymer crosslinking, improves the acid resistance of sealing compound, reduces
Medicine volatilizees risk under sour environment.
In addition, the invention is not restricted to the above embodiment, as long as in without departing from the scope of the present invention, can take various
Mode implements the present invention.
Claims (7)
1. a kind of enteric capsulation sealing compound, it is characterised in that by enteric-soluble coating material, filler, colouring agent and ethanol group
Weight ratio into, enteric-soluble coating material, filler, colouring agent and ethanol is 20-38：12-24:1-3:42-58；The enteric solubility
Coating material is by starch, phthalic acid hydroxypropyl cellulose, chitosan, EUDRAGIT L100
Formed by crosslinking；The filler includes the following component counted in parts by weight：0.1-0.5 parts of softener, 4-8 parts of colouring agent,
2-8 parts of nano-titanium dioxide, 2-5 parts of blueberry polysaccharide, 12-18 parts of dendrobium polysaccharide.
2. a kind of enteric capsulation sealing compound according to claim 1, it is characterised in that the colouring agent is kermes
It is a kind of in red, indigo, lemon yellow or chlorophyll.
A kind of 3. enteric capsulation sealing compound according to claim 1, it is characterised in that the methacrylic acid-first
The content of methacrylic acid is 20-30% in base methyl acrylate copolymer.
A kind of 4. enteric capsulation sealing compound according to claim 1, it is characterised in that the molecular weight of the chitosan
For 1200-1500.
A kind of 5. enteric capsulation sealing compound according to claim 1, it is characterised in that the enteric-soluble coating material
Preparation method, comprise the following steps：Step 1, according to weight ratio 2-6:12-18:1-3:8-12 weighs each component；Step 2, will
After phthalic acid hydroxypropyl cellulose and EUDRAGIT L100 melt, stir evenly, add shell
After glycan and crosslinking agent stirring, the first mixing fine powders are spray-dried to obtain；Step 3, starch, blending input extrusion are added into fine powder
Extruded in machine, plasma irradiation 1-5s, you can.
6. a kind of enteric capsulation sealing compound according to claim 5, it is characterised in that be spray-dried in step 2
Temperature is 80-100 DEG C.
A kind of 7. enteric capsulation sealing compound according to claim 5, it is characterised in that blending extrusion machine in step 3
Extrusion temperature be 50-60 DEG C.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711294494.9A CN107998099A (en) | 2017-12-08 | 2017-12-08 | A kind of enteric capsulation sealing compound |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711294494.9A CN107998099A (en) | 2017-12-08 | 2017-12-08 | A kind of enteric capsulation sealing compound |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107998099A true CN107998099A (en) | 2018-05-08 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711294494.9A Pending CN107998099A (en) | 2017-12-08 | 2017-12-08 | A kind of enteric capsulation sealing compound |
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| CN (1) | CN107998099A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006003014A2 (en) * | 2004-07-05 | 2006-01-12 | Complex Biosystems Gmbh | Hydrogel polymeric conjugates of a prodrug |
| CN101588790A (en) * | 2006-07-06 | 2009-11-25 | 艾博特呼吸有限责任公司 | Superporous hydrogels |
| 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 |
| CN103977412A (en) * | 2014-04-23 | 2014-08-13 | 湖南尔康正阳药用胶囊有限公司 | Enteric-coated capsule material composition |
-
2017
- 2017-12-08 CN CN201711294494.9A patent/CN107998099A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006003014A2 (en) * | 2004-07-05 | 2006-01-12 | Complex Biosystems Gmbh | Hydrogel polymeric conjugates of a prodrug |
| CN101588790A (en) * | 2006-07-06 | 2009-11-25 | 艾博特呼吸有限责任公司 | Superporous hydrogels |
| 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 |
| CN103977412A (en) * | 2014-04-23 | 2014-08-13 | 湖南尔康正阳药用胶囊有限公司 | Enteric-coated capsule material composition |
Non-Patent Citations (4)
| Title |
|---|
| KHALED ET AL.: "Preparation and application of chitosan/poly(methacrylic acid)graft copolymer", 《CARBOHYDRATE POLYMERS》 * |
| KHATIK ET AL: "Colon-specific delivery of curcumin by exploiting Eudragit-decorated chitosan nanoparticles in vitro and in vivo", 《J NANOPART RES》 * |
| 屠莹等: "胶囊封口技术对药物稳定性的影响研究", 《中草药》 * |
| 朱照静主编: "《药剂学》", 30 June 2010, 科学出版社 * |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
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| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180508 |