CN103937038B - For preparing composition and the starch matrix Capsules thereof of Capsules - Google Patents
For preparing composition and the starch matrix Capsules thereof of Capsules Download PDFInfo
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- CN103937038B CN103937038B CN201410174687.0A CN201410174687A CN103937038B CN 103937038 B CN103937038 B CN 103937038B CN 201410174687 A CN201410174687 A CN 201410174687A CN 103937038 B CN103937038 B CN 103937038B
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Abstract
The present invention relates to manufacture the composition for preparing Capsules of the Capsules for the field such as food, medicine, and the starch matrix Capsules prepared by said composition.The present invention is to prepare after hydroxypropul starch or the hydroxypropul starch of acid treatment, activeness and quietness agent and gelling agent mixing for preparing the composition of Capsules.The substitution value DS of the hydroxypropul starch of described hydroxypropul starch or acid treatment is in 0.007～0.93 scope, and gelatinization point is 30～70 DEG C of scopes.Said composition after Heat Gelatinization gel, can be prepared starch matrix Capsules in water.Starch is modified by the present invention by introducing hydroxypropyl functional groups on starch molecule, both hydrogen bond force between starch molecule had been overcome, serve the effect of toughness reinforcing enhancing, the most effectively inhibit the effect of bringing back to life of starch, also add the hydrophilicity of starch molecule simultaneously, reduce gelatinization point, make the starch matrix Capsules prepared have good disintegrating property.
Description
Technical field
The present invention relates to manufacture Capsules for the field such as food, medicine for preparing Capsules
Composition, and the starch matrix Capsules prepared by said composition.
Background technology
The gelatin utilizing animal origin makes Capsules and at least has the history of nearly 200 years.Due to gelatin
Can cover many bad mouthfeels of medicine, smell or the excitant to stomach, therefore, gelatine capsule quickly by
It is applied in the production of various solid pharmaceutical preparation.The past various glue over 100 years, with gelatin as raw material
Capsule is in great demand for a long time in world pharmaceutical market.And at the end of last century, the outburst of rabid ox disease gelatin glue the most at last
Capsule has been pulled in a unprecedented trust crisis.And in April, 2012, " toxic capsule " of China's outburst
Event exacerbates our people's distrust to gelatine capsule undoubtedly.Additionally, gelatine capsule itself is also deposited
In a lot of shortcomings, such as: being prone to cooperating microorganisms, the easy moisture absorption, the low then pliability of ambient humidity is poor, easily
Broken, ambient humidity is the most then prone to stick together, thus can not load easy moisture absorption or the medicine to water sensitive；
Gelatin chains contains a large amount of reactive groups, it is easy to filling drug response；Additionally, due to religious reasons,
Gelatine capsule is conflicted by Moslem and Jewry and vegetarian.
Compared with gelatin hollow capsule, use plant base raw material to prepare Capsules and can obviously improve above-mentioned
Shortcoming.Have the application report of various plants matter capsule at present.Pfizer Inc. capsule portion (Capsugel)
The first is also non-gelatin capsules Vcaps affecting maximum at present to take the lead in developing the listing whole world.It is main
Raw material is the HPMC (HPMC) from plant, is not only suitable for occidentals and takes, is more suitable for
The many people such as Moslem, Hinduism, kosher and Buddhist take, and after Vcaps listing, volume of production and marketing is rapid
Soaring, sales volume is at about tens billion of now.Vcaps also has production and sales in China at present, and at me
State has applied for Patents (CN200780040028.6).Afterwards, France Capsugel capsule company pushes away again
Go out the second plant capsule new product NPcaps, and the one seat at international capsule market share rapidly.
It is introduced, this product system use a kind of polysaccharide material pulullan from plant be raw material make and
Become.This plant polyose not only has good aqueous solubility and colorless and odorless, can in human body alimentary canal completely
Biodegradable.With its capsule made, there are the various advantages similar to gelatine capsule, as low oxygen penetrates
Property, be suitable for machine fillibility, will not with the medicine generation chemical reaction in capsule shells, be suitable for any crowd
Take.NPcaps from listing after quickly welcome by preparation factory all over the world, year sales volume raise rapidly,
Annual production about reaches over ten billion grain.Although there is plurality of advantages in NPcaps, but its raw material pulullan polysaccharide
Expensive, it is difficult to promote at home.
In recent years, have numerous patent application about phyteral Capsules (such as: CN02827414.8,
CN200610093987.1, CN200910186831.1, CN200810016500.9 etc.), but divided by hydroxyl
Propyl methocel is that the Capsules of primary raw material had enterprise to go into operation outside listing in recent years, and has no it
The Capsules of its material produces.Although the price of hydroxypropyl methyl cellulose is the most sufficiently expensive, but with
It is relatively big that it prepares glue ratio of water to material in the production process of Capsules for primary raw material, except water is the most difficult,
And glue paste silk is longer, shaping difficulty is big, with the disintegration time limited of its Capsules prepared for primary raw material
Longer, therefore, occupation rate of market the most at home is the highest.Starch price is the cheapest, makes with it
Standby Capsules has the biggest attraction, and domestic many producers have applied for starch hollow capsule the most one after another
Patent, but owing to being easily formed the strongest hydrogen bond between starch molecule, starch film is brittle frangible, it is difficult to prepare
Intensity is high, the Capsules of resistance to filling.In recent years, the patent of the part U.S. and Japan is by starch base
Matter is added high-strength gel and prepares the Capsules shell with higher-strength, but also result in hollow simultaneously
Capsule shells is difficult to be disintegrated, the product that very difficult acquisition is disintegrated the most rapidly.Although therefore patent is numerous, but
So far there is not the product that can introduce to the market.
Summary of the invention
An object of the present invention is by starch carries out strand modification introducing hydroxypropyl, to improve
The pliability of starch and hydrophily, and add appropriate activeness and quietness agent and gelling agent further, thus carry
For a kind of group that can prepare the starch matrix Capsules with fine pliability and preferable disintegrating property
Compound.
The two of the purpose of the present invention are to provide a kind of by for preparing shallow lake prepared by the composition of Capsules
Powder matrix Capsules.
The present invention for preparing the composition of Capsules, in terms of gross weight, described composition be by
The hydroxypropul starch of 50～95wt% or the hydroxypropul starch (preferably 55～85wt%) of acid treatment,
0.5～49.5wt% activeness and quietness agent (preferably 5～35wt%) and 0.5～20wt% gelling agent (preferably
3～10wt%) composition.
Described hydroxypropul starch or the substitution value DS of the hydroxypropul starch of acid treatment are in 0.007～0.93 scope
Interior (preferably 0.05～0.25), gelatinization point is (preferably 35～50 DEG C) in the range of 30～70 DEG C.
Described hydroxypropul starch or the hydroxypropul starch of acid treatment can be prepared by common starch, described
Hydroxypropul starch is that common starch prepares through the reactive mode that starch industry is conventional with expoxy propane；For
The viscosity reducing hydroxypropul starch can use the hydroxypropul starch of acid treatment, the hydroxypropyl of described acid treatment
Starch is by common starch after the mineral acid treatment technique that starch industry is conventional carries out the glutinous process of degraded fall,
Prepare through the reactive mode that starch industry is conventional with expoxy propane again, or directly by hydroxypropul starch warp
The mineral acid treatment technique of starch industry routine obtains after carrying out the glutinous process of degraded fall.
Described common starch be selected from tapioca, wheaten starch, farina, starch from sweet potato,
One or more in cornstarch, bean starch, rice starch；Preferably tapioca, bean starch,
Farina, cornstarch.
Described activeness and quietness agent is selected from shitosan, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methyl
One or more in cellulose.
Described gelling agent selected from pectin, xanthans, locust bean gum, carragheen, gellan gum, agaropectin,
One or more in Arabic gum, mannosan, guar gum and konjac glucomannan.
The preparation method of the composition for preparing Capsules of the present invention is, in terms of gross weight, and will
The hydroxypropul starch of 50～95wt% or the hydroxypropul starch (preferably 55～85wt%) of acid treatment,
0.5～49.5wt% activeness and quietness agent (preferably 5～35wt%) and 0.5～20wt% gelling agent (preferably
3～10wt%) mixing, i.e. prepares the composition for preparing Capsules.
The present invention after Heat Gelatinization gel, often can use for preparing the composition of Capsules in water
Regulation for the technique of capsule prepare for food, medicine field there is fine pliability and preferable disintegrative
The starch matrix Capsules of energy.
Described composition is in water during Heat Gelatinization gel, and composition is 1:3～1:8 with the weight ratio of water,
It is preferably 1:4～1:7.
Described composition during Heat Gelatinization gel, can add flocculation aid in water further.Described helps
Solidifying agent is selected from the one in potassium chloride, potassium carbonate, potassium citrate, potassium acetate, calcium chloride, calcium acetate
Or it is several.
The present invention by the further investigation carried out for Capsules prepared by primary raw material with converted starch,
Propose and starch is modified, to improve starch base by introducing hydroxypropyl functional groups on starch molecule
The defect that matter exists, and by hydroxypropyl modified, both overcome hydrogen bond force between starch molecule, and served increasing
The effect of tough enhancing, the most effectively inhibits the effect of bringing back to life of starch, also add the parent of starch molecule simultaneously
Aqueous energy, reduces gelatinization point so that the starch matrix Capsules of preparation has good disintegrative
Energy.Appropriate toughening and reinforcing agent, has further functioned as toughening effect, thus has prepared and have on this basis
Pliability and the starch matrix Capsules of preferable disintegrating property very well.The starch base that the present invention prepares
Matter Capsules, has production compared with hydroxypropyl methyl cellulose plant capsule and is prone to shaping, and product collapses
The advantages such as solution speed is fast, cheap.
Do not introduced labile functional groups by PURE COTE so that the Capsules of preparation with starch and
Cellulose does not equally contain reactive group, thus does not interferes with the quality of filling medicine, and as far back as last generation
Recording the fifties, hydroxypropul starch is by U.S. Food FAD (FDA) approval for food, and it is pacified
Full property is unquestionable.
Detailed description of the invention
Embodiment 1
By hydroxypropyl corn starch (substitution value DS=0.007, the gelatinization point 70 DEG C of 55wt%；Hydroxypropyl
Cornstarch is to be prepared through the reactive mode that starch industry is conventional with expoxy propane by cornstarch),
The konjac glucomannan mixing of 49.5wt% methylcellulose and 0.5wt%, prepares for preparing Capsules
Composition.
Using the above-mentioned composition being used for preparing Capsules prepared and trace as flocculation aid
KCl (weight is about the 0.05% of composition), mixes with the water being described 8 times of weight of composition and adds
After hot gelatinization gel, the technique using routine to prepare capsule is prepared has fine pliability and preferably disintegration
The starch matrix Capsules of performance.
Prepared starch matrix Capsules, with reference to the method for Chinese Pharmacopoeia two regulations of version in 2010, is adopted
Sending out ZB-lE Intelligent disintegration tester with huge sky and carry out disintegration experiment, testing 50 samples all can be in 7 minute
All disintegration, reaches pharmacopoeial requirements its disintegration time limited.
Embodiment 2
By Hydroxypropyl Tapioca Starch (substitution value DS=0.93, gelatinization point 30 DEG C, the hydroxypropyl of 95wt%
Tapioca is to be prepared through the reactive mode that starch industry is conventional with expoxy propane by tapioca),
The shitosan of 4.5wt%, the carragheen mixing of 0.5wt%, prepare the combination for preparing Capsules
Thing.
Using the above-mentioned composition being used for preparing Capsules prepared and the lemon as flocculation aid of trace
Lemon acid potassium (weight is about the 0.15% of composition), mixes also with the water being described 6 times of weight of composition
After Heat Gelatinization gel, the technique using routine to prepare capsule is prepared to be had fine pliability and preferably collapses
Solve the starch matrix Capsules of performance.
Prepared starch matrix Capsules, with reference to the method for Chinese Pharmacopoeia two regulations of version in 2010, is adopted
Sending out ZB-lE Intelligent disintegration tester with huge sky and carry out disintegration experiment, testing 50 samples all can be in 6 minute
All disintegration, reaches pharmacopoeial requirements its disintegration time limited.
Embodiment 3
By hydroxypropyl potato starch (substitution value DS=0.21, gelatinization point 50 DEG C, the hydroxyl of 79.5wt%
Propyl group farina is to be prepared through the reactive mode that starch industry is conventional with expoxy propane by farina
Obtain), the hydroxypropyl cellulose of 0.5wt%, the guar gum mixing of 20wt%, prepare for preparing sky
The composition of heart-soothing capsule.
Using the above-mentioned composition being used for preparing Capsules prepared and the chlorine as flocculation aid of trace
Change calcium (weight is about the 0.2% of composition), be mixed and heated with the water being described 5 times of weight of composition
After gelatinization gel, the technique using routine to prepare capsule is prepared has fine pliability and preferable disintegrative
The starch matrix Capsules of energy.
Prepared starch matrix Capsules, with reference to the method for Chinese Pharmacopoeia two regulations of version in 2010, is adopted
Sending out ZB-lE Intelligent disintegration tester with huge sky and carry out disintegration experiment, testing 50 samples all can be in 8 minute
All disintegration, reaches pharmacopoeial requirements its disintegration time limited.
Embodiment 4
By the hydroxypropyl corn starch of the acid treatment of 75wt% (substitution value DS=0.15, gelatinization point 55 DEG C,
The hydroxypropyl corn starch of acid treatment be by cornstarch after HCl treatment with expoxy propane through starch industry
Conventional reactive mode prepares), the hydroxypropyl cellulose of 15wt%, the locust bean gum mixing of 10wt%,
Prepare the composition for preparing Capsules.
By the above-mentioned composition being used for preparing Capsules prepared be 3 times of weights of described composition
After the water of amount is mixed and heated gelatinization gel, use routine prepare the technique of capsule prepare have the most soft
The starch matrix Capsules of toughness and preferable disintegrating property.
Prepared starch matrix Capsules, with reference to the method for Chinese Pharmacopoeia two regulations of version in 2010, is adopted
Sending out ZB-lE Intelligent disintegration tester with huge sky and carry out disintegration experiment, testing 50 samples all can be in 9 minute
All disintegration, reaches pharmacopoeial requirements its disintegration time limited.
Claims (10)
1., for preparing the composition of Capsules, it is characterized in that: described composition be by
The hydroxypropul starch of 50～95wt% or the hydroxypropul starch of acid treatment, 0.5～49.5wt% activeness and quietness agent and
The gelling agent composition of 0.5～20wt%；
Described hydroxypropul starch or the substitution value DS of the hydroxypropul starch of acid treatment are in 0.007～0.93 scope
In, gelatinization point is in the range of 30～70 DEG C.
Composition for preparing Capsules the most according to claim 1, is characterized in that: described
The content of the hydroxypropul starch of hydroxypropul starch or acid treatment is 55～85wt%.
Composition for preparing Capsules the most according to claim 1, is characterized in that: described
The content of activeness and quietness agent is 5～35wt%.
Composition for preparing Capsules the most according to claim 1, is characterized in that: described
The content of gelling agent is 3～10wt%.
Composition for preparing Capsules the most according to claim 1 and 2, is characterized in that: institute
The hydroxypropul starch stated or the substitution value DS of the hydroxypropul starch of acid treatment are 0.05～0.25, gelatinization point
It it is 35～50 DEG C.
Composition for preparing Capsules the most according to claim 5, is characterized in that: described
Hydroxypropul starch is that common starch prepares with expoxy propane；The hydroxypropul starch of described acid treatment is
Common starch is after mineral acid treatment, then prepares with expoxy propane, or directly by hydroxypropul starch warp
Obtain after mineral acid treatment；
Described common starch is selected from tapioca, wheaten starch, farina, starch from sweet potato, jade
One or more in rice starch, bean starch, rice starch.
7., according to the composition for preparing Capsules described in claim 1 or 3, it is characterized in that: institute
State activeness and quietness agent selected from shitosan, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose
In one or more.
8., according to the composition for preparing Capsules described in claim 1 or 4, it is characterized in that: institute
State gelling agent selected from pectin, xanthans, locust bean gum, carragheen, gellan gum, agaropectin, Arab
One or more in glue, mannosan, guar gum and konjac glucomannan.
9. a starch matrix Capsules, is characterized in that: described starch matrix Capsules is by right
Require described in 1～8 any one for preparing the composition of Capsules in water after Heat Gelatinization gel
Preparing, described composition is in water during Heat Gelatinization gel, and composition with the weight ratio of water is
1:3～1:8.
Starch matrix Capsules the most according to claim 9, is characterized in that: described composition
Flocculation aid can be added during Heat Gelatinization gel in water；
Described flocculation aid is selected from potassium chloride, potassium carbonate, potassium citrate, potassium acetate, calcium chloride, acetic acid
One or more in calcium.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410174687.0A CN103937038B (en) | 2014-04-28 | 2014-04-28 | For preparing composition and the starch matrix Capsules thereof of Capsules |
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| CN201410174687.0A CN103937038B (en) | 2014-04-28 | 2014-04-28 | For preparing composition and the starch matrix Capsules thereof of Capsules |
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| CN103937038B true CN103937038B (en) | 2016-08-17 |
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| CN111040256A (en) * | 2014-09-19 | 2020-04-21 | 江苏崇尚生物科技有限公司 | Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule |
| CN105985449B (en) * | 2015-01-29 | 2019-02-01 | 深圳市思颖柏霖生物科技有限公司 | A kind of modified hydroxypropul starch and preparation method thereof, a kind of plant hollow capsule and preparation method thereof |
| CN105778160B (en) * | 2016-03-22 | 2019-02-01 | 浙江中同科技有限公司 | A kind of preparation method of hydroxypropul starch capsule |
| CN105726509A (en) * | 2016-03-25 | 2016-07-06 | 海南顿斯倍健生物科技有限公司 | Pantozol medicine capsule |
| CN105832694A (en) * | 2016-03-25 | 2016-08-10 | 海南汤臣史克生物科技有限公司 | Penicillins medicine capsule and preparation method of same |
| CN105832695A (en) * | 2016-03-28 | 2016-08-10 | 祝云琴 | Tizol-series medicine capsule |
| CN105796526A (en) * | 2016-03-28 | 2016-07-27 | 海南圣欣医药科技有限公司 | Cephalosporin medicine capsule and preparing method thereof |
| CN105997930A (en) * | 2016-07-04 | 2016-10-12 | 安顺济世科技有限公司 | Empty capsule and soft capsule based on modified starch |
| CN106349511A (en) * | 2016-08-24 | 2017-01-25 | 安徽顺彤包装材料有限公司 | Degradable granular medicine packaging material and preparation method thereof |
| CN106692104A (en) * | 2017-01-16 | 2017-05-24 | 青岛中科星淀新材料科技有限公司 | Plant starch composition for hollow capsule |
| CN106729728A (en) * | 2017-01-16 | 2017-05-31 | 青岛中科星淀新材料科技有限公司 | A kind of Capsules plant amylum composition |
| CN112057433A (en) * | 2020-09-08 | 2020-12-11 | 华侨大学 | Preparation method of composite plant hard capsule shell |
| CN117487211A (en) * | 2024-01-03 | 2024-02-02 | 广东亿超生物科技有限公司 | Modified carrageenan, carrageenan capsule shell and preparation method of modified carrageenan |
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| CN1687203A (en) * | 2005-04-07 | 2005-10-26 | 天津大学 | Vegetable capsule of starch composition and preparation method |
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|---|---|---|---|---|
| CN1687203A (en) * | 2005-04-07 | 2005-10-26 | 天津大学 | Vegetable capsule of starch composition and preparation method |
| CN100998572A (en) * | 2006-12-20 | 2007-07-18 | 刘杰 | Hard medicine capsule |
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