CN103933009B - For preparing compositions and the application thereof of cellulose hard capsules - Google Patents
For preparing compositions and the application thereof of cellulose hard capsules Download PDFInfo
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- CN103933009B CN103933009B CN201410129189.4A CN201410129189A CN103933009B CN 103933009 B CN103933009 B CN 103933009B CN 201410129189 A CN201410129189 A CN 201410129189A CN 103933009 B CN103933009 B CN 103933009B
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- cellulose
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Abstract
The present invention relates to compositions and the application thereof of cellulose hard capsules.Described compositions is made up of the gellant of the soluble starch of hydroxypropyl methyl cellulose, 0.5~7wt%, 0.4~2wt% and the water of surplus of 12~25wt%;Described hydroxypropyl methyl cellulose, when 20 DEG C, concentration is the viscosity that the aqueous solution of the hydroxypropyl methyl cellulose of 2wt% has 3~7mpa s;Described soluble starch, when 20 DEG C, concentration is the viscosity that the aqueous solution of the soluble starch of 9wt% has 5~300mpa s.The present invention is by the method adding appropriate soluble starch modified cellulose substrate in cellulose matrix so that the viscosity of blending ingredients reduces, and sticks with paste silk and shortens, it is easy to molding, improves production efficiency;Effectively break cellulose hard capsules compact texture in course of dissolution simultaneously, accelerated the dissolution velocity of hydroxypropyl methylcellulose matrix, effectively facilitated disintegrate, accelerate release.
Description
Technical field
The present invention relates to prepare the compositions of the cellulose hard capsules for food, medicine etc., and this group
The application of compound.
Background technology
Utilize the capsule history of at least existing nearly 200 years that the gelatin of animal origin makes.Owing to gelatin can
Covering many bad mouthfeels of medicine, abnormal smells from the patient or the zest to stomach, therefore, gelatine capsule is quickly pushed away
Extensively it is applied in the production of various solid preparation.The past various capsules over 100 years, with gelatin as raw material
It is in great demand for a long time in world pharmaceutical market.And at the end of last century, the outburst of bovine spongiform encephalopathy gelatine capsule the most at last
Pull 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 fill drug reaction;Additionally, due to religious reasons,
Gelatine capsule is conflicted by Moslem and Jewry and vegetarian.
Compared with gelatine capsule, use plant base raw material to prepare capsule and can obviously improve disadvantages mentioned above.Mesh
The application report of front existing various plants matter capsule.Pfizer Inc. capsule portion (Capsugel) takes the lead in developing
The first is also non-gelatin capsules Vcaps that impact is maximum at present to list the whole world.Its primary raw material is next
From the hydroxypropyl methylcellulose (HPMC) of plant, be not only suitable for occidentals and take, be more suitable for Moslem,
The many people such as Hinduism, kosher and Buddhist take, and after Vcaps listing, volume of production and marketing rises rapidly, existing
Year, sales volume was at about tens billion of.Vcaps also has production and sales in China at present, and applies in China
Patents (CN200780040028.6).Afterwards, France Capsugel capsule company releases again the second
Plant capsule new product NPcaps, and the rapidly one seat at international capsule market share.It is introduced,
This product system uses a kind of polysaccharide material pulullan from plant to be that raw material is made.This
Vegetable polysaccharides not only has good aqueous solubility and colorless and odorless, can in human body alimentary canal complete biodegradable.
With its capsule made, there are the various advantages similar to gelatine capsule, such as low oxygen penetration, be suitable for machine
Device 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 reach over ten billion grain.Although NPcaps exists plurality of advantages, but its raw material pulullan polysaccharide price is held high
Expensive, it is difficult to promote at home.
In recent years, have numerous patent application about phyteral hard capsule (such as: CN02827414.8,
CN200610093987.1, CN200910186831.1, CN200810016500.9 etc.), but divided by hydroxyl
Propyl methocel is that the hard capsule of primary raw material had enterprise to go into operation outside listing in recent years, and has no other
The capsule manufacture of material.Although the price of hydroxypropyl methyl cellulose is the most sufficiently expensive, but producing
In journey, glue ratio of water to material is relatively big, except water is the most difficult, during with the disintegrate of its capsule prepared for primary raw material
Limiting longer, therefore, market share the most at home is the highest.
Summary of the invention
An object of the present invention is the defect existed for cellulose hard capsules, by cellulose base
Matter is added appropriate soluble starch, thus a kind of compositions for preparing cellulose hard capsules is provided.
The two of the purpose of the present invention are to provide for preparing disintegrate prepared by the compositions of cellulose hard capsules
The cellulose hard capsules that performance improves.
The compositions for preparing cellulose hard capsules of the present invention, in terms of gross weight, described compositions
It is the hydroxypropyl methyl cellulose by 12~25wt%, 0.5~the glue of the soluble starch of 7wt%, 0.4~2wt%
The water composition of solidifying agent and surplus.
Described hydroxypropyl methyl cellulose, when 20 DEG C, concentration is the hydroxypropyl methyl cellulose of 2wt%
Aqueous solution there is the viscosity of 3~7mpa s, preferably 3~the viscosity of 5mpa s.
Described soluble starch, when 20 DEG C, concentration is that the aqueous solution of the soluble starch of 9wt% has
The viscosity of 5~300mpa s, preferably 10~the viscosity of 100mpa s.
Described soluble starch is common starch to be obtained through the mineral acid treatment technique that starch industry is conventional
Arrive.
Described common starch is selected from tapioca, wheaten starch, potato starch, sweet potato starch, jade
One or more in rice starch, bean starch, rice starch;Preferably be selected from tapioca, wheaten starch,
One in potato starch, sweet potato starch.
Described gellant is selected from pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, Arab
One or more in glue, mannan, guar gum and Konjac glucomannan.
The preparation method of the compositions for preparing cellulose hard capsules of the present invention is: by 12~25wt%
The gellant of the soluble starch of hydroxypropyl methyl cellulose, 0.5~7wt%, 0.4~2wt% and the water of surplus
Mixing, i.e. prepares the compositions for preparing cellulose hard capsules.
Prepared by the technique that the compositions of the cellulose hard capsules of the present invention can use routine to prepare capsule can be rapid
The cellulose hard capsules of disintegrate.
The present invention by the further investigation that the hard capsule prepared by hydroxypropyl methylcellulose matrix is carried out,
Propose the method by adding appropriate soluble starch modified cellulose substrate in cellulose matrix,
The viscosity making blending ingredients reduces, and sticks with paste silk and shortens, it is easy to molding, improves production efficiency;Simultaneously by
In the existence of soluble starch, can dissolve rapidly in disintegrating procedue, effectively break cellulose hard
Capsule compact texture in course of dissolution, is formed and dissolves passage, accelerate hydroxypropyl methylcellulose matrix
Dissolution velocity, effectively facilitated the disintegrate of hard capsule, accelerated release.
Detailed description of the invention
Embodiment 1
By the hydroxypropyl methyl cellulose of 12wt%, (when 20 DEG C, concentration is the hydroxypropyl methyl of 2wt%
The aqueous solution of cellulose has the viscosity of 7.0mpa s), the solubility tapioca of 7wt% is (at 20 DEG C
Time, concentration is the viscosity that the aqueous solution of the solubility tapioca of 9wt% has 5.0mpa s, this viscosity
Solubility tapioca be to be obtained via HCl treatment by tapioca), the carrageenan of 0.4wt% and surplus
Water mixing, obtain the compositions for preparing cellulose hard capsules.
Use routine to prepare the technique of capsule, utilize the group for preparing cellulose hard capsules obtained above
Compound prepares cellulose hard capsules.Prepared cellulose hard capsules is with reference to Chinese Pharmacopoeia version two in 2010
The method that portion specifies, uses huge sky to send out ZB-lE Intelligent disintegration tester and carries out disintegrate experiment, test 50 samples
Product all can whole disintegrates in 7 minutes, reach pharmacopoeial requirements its disintegration.
Embodiment 2
By the hydroxypropyl methyl cellulose of 22wt%, (when 20 DEG C, concentration is the hydroxypropyl methyl of 2wt%
The aqueous solution of cellulose has the viscosity of 3.0mpa s), the soluble potato starch of 3wt% is (at 20 DEG C
Time, concentration is the viscosity that the aqueous solution of the soluble potato starch of 9wt% has 20.0mpa s, should
The soluble potato starch of viscosity is to be obtained via sulfuric acid treatment by potato starch), the locust bean gum of 2wt%
The water mixing of glue and surplus, obtains the compositions for preparing cellulose hard capsules.
Use routine to prepare the technique of capsule, utilize the group for preparing cellulose hard capsules obtained above
Compound prepares cellulose hard capsules.Prepared cellulose hard capsules is with reference to Chinese Pharmacopoeia version two in 2010
The method that portion specifies, uses huge sky to send out ZB-lE Intelligent disintegration tester and carries out disintegrate experiment, test 50 samples
Product all can whole disintegrates in 6 minutes, reach pharmacopoeial requirements its disintegration.
Embodiment 3
By the hydroxypropyl methyl cellulose of 25wt%, (when 20 DEG C, concentration is the hydroxypropyl methyl of 2wt%
The aqueous solution of cellulose has the viscosity of 3.0mpa s), the soluble corn starch of 0.5wt% is (at 20 DEG C
Time, concentration is the viscosity that the aqueous solution of the soluble corn starch of 9wt% has 300.0mpa s, and this glues
The soluble corn starch of degree is to be obtained via HCl treatment by corn starch), the arabic gum of 1wt% and remaining
The water mixing of amount, obtains the compositions for preparing cellulose hard capsules.
Use routine to prepare the technique of capsule, utilize the group for preparing cellulose hard capsules obtained above
Compound prepares cellulose hard capsules.Prepared cellulose hard capsules is with reference to Chinese Pharmacopoeia version two in 2010
The method that portion specifies, uses huge sky to send out ZB-lE Intelligent disintegration tester and carries out disintegrate experiment, test 50 samples
Product all can whole disintegrates in 8 minutes, reach pharmacopoeial requirements its disintegration.
Embodiment 4
By the hydroxypropyl methyl cellulose of 20wt%, (when 20 DEG C, concentration is the hydroxypropyl methyl of 2wt%
The aqueous solution of cellulose has the viscosity of 3.0mpa s), the solubility wheaten starch of 5wt% is (at 20 DEG C
Time, concentration is the viscosity that the aqueous solution of the solubility wheaten starch of 9wt% has 50.0mpa s, and this glues
The soluble corn starch of degree is to be obtained via HCl treatment by corn starch), the mannan of 1.5wt% and
The water mixing of surplus, obtains the compositions for preparing cellulose hard capsules.
Use routine to prepare the technique of capsule, utilize the group for preparing cellulose hard capsules obtained above
Compound prepares cellulose hard capsules.Prepared cellulose hard capsules is with reference to Chinese Pharmacopoeia version two in 2010
The method that portion specifies, uses huge sky to send out ZB-lE Intelligent disintegration tester and carries out disintegrate experiment, test 50 samples
Product all can whole disintegrates in 6 minutes, reach pharmacopoeial requirements its disintegration.
Embodiment 5
By the hydroxypropyl methyl cellulose of 15wt%, (when 20 DEG C, concentration is the hydroxypropyl methyl of 2wt%
The aqueous solution of cellulose has the viscosity of 5.00mpa s), the solubility wheaten starch of 6wt% and solubility
Rice starch (weight ratio of solubility wheaten starch and solubility rice starch be 1:1 when 20 DEG C, dense
Aqueous solution and the solubility rice starch that concentration is 9wt% of the solubility wheaten starch that degree is 9wt% all have
Having the viscosity of 50.0mpa s, soluble corn starch and the solubility rice starch of this viscosity are by Semen Maydis
Starch and rice starch obtain via HCl treatment respectively), the pectin of 1wt% and xanthan gum (weight ratio is 1:
1) and surplus water mixing, obtain the compositions for preparing cellulose hard capsules.
Use routine to prepare the technique of capsule, utilize the group for preparing cellulose hard capsules obtained above
Compound prepares cellulose hard capsules.Prepared cellulose hard capsules is with reference to Chinese Pharmacopoeia version two in 2010
The method that portion specifies, uses huge sky to send out ZB-lE Intelligent disintegration tester and carries out disintegrate experiment, test 50 samples
Product all can whole disintegrates in 6 minutes, reach pharmacopoeial requirements its disintegration.
Claims (6)
1., for preparing the compositions of cellulose hard capsules, it is characterized in that: described compositions be by
The gellant of the soluble starch of hydroxypropyl methyl cellulose, 0.5~7wt%, 0.4~the 2wt% of 12~25wt%
And the water composition of surplus;
Described hydroxypropyl methyl cellulose, when 20 DEG C, concentration is the hydroxypropyl methyl cellulose of 2wt%
Aqueous solution there is the viscosity of 3~7mPa s;
Described soluble starch, when 20 DEG C, concentration is that the aqueous solution of the soluble starch of 9wt% has
The viscosity of 5~300mPa s;
Described soluble starch is common starch to be obtained through mineral acid treatment.
Compositions for preparing cellulose hard capsules the most according to claim 1, is characterized in that: institute
The hydroxypropyl methyl cellulose stated, when 20 DEG C, concentration is the water-soluble of the hydroxypropyl methyl cellulose of 2wt%
Liquid has the viscosity of 3~5mPa s.
Compositions for preparing cellulose hard capsules the most according to claim 1, is characterized in that: institute
The soluble starch stated, when 20 DEG C, concentration is that the aqueous solution of the soluble starch of 9wt% has
The viscosity of 10~100mPa s.
Compositions for preparing cellulose hard capsules the most according to claim 1, is characterized in that: institute
The common starch stated selected from tapioca, wheaten starch, potato starch, sweet potato starch, corn starch,
One or more in bean starch, rice starch.
Compositions for preparing cellulose hard capsules the most according to claim 1, is characterized in that: institute
The gellant stated is selected from pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, arabic gum, sweet
One or more in dew polysaccharide, guar gum and Konjac glucomannan.
6. a cellulose hard capsules, is characterized in that: described cellulose hard is by Claims 1 to 5
Being used for described in any one is prepared the compositions of cellulose hard capsules and prepares.
Priority Applications (1)
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CN201410129189.4A CN103933009B (en) | 2014-04-01 | 2014-04-01 | For preparing compositions and the application thereof of cellulose hard capsules |
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CN201410129189.4A CN103933009B (en) | 2014-04-01 | 2014-04-01 | For preparing compositions and the application thereof of cellulose hard capsules |
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CN103933009A CN103933009A (en) | 2014-07-23 |
CN103933009B true CN103933009B (en) | 2016-08-17 |
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Families Citing this family (4)
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CN105997932B (en) * | 2016-07-19 | 2019-08-16 | 中国科学院化学研究所 | It is used to prepare the composition and Capsules of the Capsules of converted starch matrix |
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 |
CN109528678A (en) * | 2019-01-14 | 2019-03-29 | 武汉海吉亚生物科技有限公司 | A kind of hydroxypropyl methylcellulose capsules and its preparation method and application |
CN111920780A (en) * | 2020-07-22 | 2020-11-13 | 青岛益青生物科技股份有限公司 | Instant hypromellose empty capsule and preparation method thereof |
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CN100577155C (en) * | 2006-12-20 | 2010-01-06 | 刘杰 | Hard medicine capsule |
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