CN103933009A - Composition used for preparing cellulose hard capsule and application thereof - Google Patents
Composition used for preparing cellulose hard capsule and application thereof Download PDFInfo
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- CN103933009A CN103933009A CN201410129189.4A CN201410129189A CN103933009A CN 103933009 A CN103933009 A CN 103933009A CN 201410129189 A CN201410129189 A CN 201410129189A CN 103933009 A CN103933009 A CN 103933009A
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Abstract
The invention relates to a composition used for preparing a cellulose hard capsule and application thereof. The composition consist of 12wt%-25wt% of hydroxypropyl methyl cellulose, 0.5wt%-7wt% of soluble starch, 0.4wt%-2wt% of gelling agent and the balance of water, wherein aqueous liquor of the hydroxypropyl methyl cellulose with concentration of 2wt% at 20 DEG C has viscosity of 3 mpa.s-7mpa.s; and aqueous liquor of the soluble starch with concentration of 9wt% at 20 DEG C is 5mpa.s-300mpa.s. According to the composition, since a proper amount of soluble starch is added into cellulose substrate to improve the cellulose substrate, viscosity of mixed components is lowered, paste fibers get short and easy to form, so that production efficiency is improved; meanwhile, a compact structure of the cellulose hard capsule in a dissolving process is effectively broken, dissolution speed of the hydroxypropyl methyl cellulose substrate is accelerated, disintegration is effectively promoted, and drug release is quickened.
Description
Technical field
The present invention relates to the compositions for the preparation of the cellulose hard capsules of food, medicine etc., and the application of said composition.
Background technology
At least history of existing nearly 200 years of capsule of utilizing the gelatin of animal origin to make.Because gelatin can be covered bad mouthfeel, abnormal smells from the patient or the zest to stomach of many medicines, therefore, gelatine capsule is applied in the production of various solid preparations very soon.Past, over 100 years, the various capsules taking gelatin as raw material were once in great demand for a long time in international medical market.And at the end of last century, the outburst of bovine spongiform encephalopathy the most at last gelatine capsule has been pulled in a unprecedented trust crisis.And in April, 2012, " toxic capsule " event of China's outburst has been aggravated the distrust of China people to gelatine capsule undoubtedly.In addition, also there are a lot of shortcomings in gelatine capsule itself, as: be easy to grow microorganism, the easily moisture absorption, the low pliability of ambient humidity is poor, frangible, and ambient humidity is greatly easy to stick together, thereby can not load easy moisture absorption or the medicine to water sensitive; Gelatin chains, containing a large amount of reactive groups, is easy to same fill drug reaction; In addition,, due to religious reasons, gelatine capsule is subject to Moslem and Jewry and vegetarian's conflict.
Compare with gelatine capsule, adopt plant base raw material to prepare capsule and can obviously improve above-mentioned shortcoming.The application report of at present existing various plants matter capsule.It is also non-gelatine capsule---the Vcaps having the greatest impact at present that capsule portion of Pfizer Inc. (Capsugel) takes the lead in developing the global the first of listing.Its primary raw material is the hydroxypropyl methylcellulose (HPMC) from plant, not only being applicable to occidentals takes, the numerous crowds such as Moslem, Hinduism, kosher and Buddhist that are more suitable for take, and after Vcaps listing, volume of production and marketing is soaring rapidly, and sales volume is tens billion of left and right now.Vcaps also has production and sales in China at present, and has applied for Patents (CN200780040028.6) in China.Afterwards, French Capsugel capsule company releases again the second plant capsule new product NPcaps, and rapidly at international capsule market share one seat.It is introduced, a kind of polysaccharide material from plant---pulullan is that raw material is made in this product system employing.This vegetable polysaccharides not only has good aqueous solubility and colorless and odorless, can be in human body alimentary canal complete biodegradable.There are the various advantages similar to gelatine capsule with the capsule of its making, as low oxygen penetration, be applicable to machine fillibility, not can with capsule shells in medicine generation chemical reaction, be applicable to any crowd and take etc.NPcaps is subject to very soon the welcome of preparation factory all over the world after listing, and a year sales volume raises rapidly, and annual production approximately reaches over ten billion grain.Although NPcaps exists plurality of advantages, its raw material pulullan polysaccharide is expensive, is difficult to promote at home.
In recent years, there are numerous patent applications about phyteral hard capsule (for example: CN02827414.8, CN200610093987.1, CN200910186831.1, CN200810016500.9 etc.), but the hard capsule that is primary raw material divided by hydroxypropyl emthylcellulose had enterprise to go into operation outside listing in recent years, and have no the capsule manufacture of other material.Although the price of hydroxypropyl emthylcellulose is very not expensive, glue ratio of water to material is larger in process of production, the comparatively difficulty that dewaters, and the disintegration of the capsule of preparing taking it as primary raw material is longer, and therefore, current market share is at home not high.
Summary of the invention
One of object of the present invention is the defect existing for cellulose hard capsules, by add appropriate soluble starch in cellulose matrix, thereby provides a kind of compositions for the preparation of cellulose hard capsules.
Two of object of the present invention is to be provided for to prepare the cellulose hard capsules that disintegrating property prepared by the compositions of cellulose hard capsules improves.
Compositions for the preparation of cellulose hard capsules of the present invention, in gross weight, described compositions is made up of the hydroxypropyl emthylcellulose of 12～25wt%, soluble starch, the gellant of 0.4～2wt% and the water of surplus of 0.5～7wt%.
Described hydroxypropyl emthylcellulose, in the time of 20 DEG C, the aqueous solution of the hydroxypropyl emthylcellulose that concentration is 2wt% has the viscosity of 3～7mpas, is preferably the viscosity of 3～5mpas.
Described soluble starch, in the time of 20 DEG C, the aqueous solution of the soluble starch that concentration is 9wt% has the viscosity of 5～300mpas, is preferably the viscosity of 10～100mpas.
Described soluble starch is that common starch is obtained through the mineral acid treatment technique of starch industry routine.
Described common starch is selected from one or more in tapioca, wheaten starch, potato starch, sweet potato starch, corn starch, bean starch, rice starch; The preferably one in tapioca, wheaten starch, potato starch, sweet potato starch.
Described gellant is selected from one or more in pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, arabic gum, mannan, guar gum and Konjac glucomannan.
The preparation method of the compositions for the preparation of cellulose hard capsules of the present invention is: the water of the gellant of the soluble starch of the hydroxypropyl emthylcellulose of 12～25wt%, 0.5～7wt%, 0.4～2wt% and surplus is mixed, prepare the compositions for the preparation of cellulose hard capsules.
The compositions of cellulose hard capsules of the present invention can adopt routine to prepare the technique preparation cellulose hard capsules of disintegrate rapidly of capsule.
The present invention is by the further investigation that the hard capsule of being prepared by hydroxypropyl methylcellulose matrix is carried out, method by add appropriate soluble starch modified cellulose substrate in cellulose matrix has been proposed, make the reduced viscosity of blending ingredients, sticking with paste silk shortens, be easy to molding, improved production efficiency; While is due to the existence of soluble starch, in disintegrating procedue, can dissolve rapidly, effectively break the compact texture of cellulose hard capsules in course of dissolution, form and dissolve passage, accelerate the dissolution velocity of hydroxypropyl methylcellulose matrix, effectively promote the disintegrate of hard capsule, accelerated release.
Detailed description of the invention
Embodiment 1
By the hydroxypropyl emthylcellulose of 12wt% (20 DEG C time, concentration is the viscosity that the aqueous solution of the hydroxypropyl emthylcellulose of 2wt% has 7.0mpas), the solubility tapioca of 7wt% is (in the time of 20 DEG C, concentration is the viscosity that the aqueous solution of the solubility tapioca of 9wt% has 5.0mpas, the solubility tapioca of this viscosity is to be obtained via salt acid treatment by tapioca), the carrageenan of 0.4wt% and the water of surplus mix, and obtain the compositions for the preparation of cellulose hard capsules.
Adopt the conventional technique of preparing capsule, utilize the compositions for the preparation of cellulose hard capsules obtained above to prepare cellulose hard capsules.Prepared cellulose hard capsules is with reference to the method for two regulations of Chinese Pharmacopoeia version in 2010, adopts huge day and send out a ZB-lE Intelligent disintegration tester to carry out disintegrate experiment, and test 50 samples all can whole disintegrate in 7 minutes, reaches pharmacopeia requirement its disintegration.
Embodiment 2
By the hydroxypropyl emthylcellulose of 22wt% (20 DEG C time, concentration is the viscosity that the aqueous solution of the hydroxypropyl emthylcellulose of 2wt% has 3.0mpas), the solubility potato starch of 3wt% is (in the time of 20 DEG C, concentration is the viscosity that the aqueous solution of the solubility potato starch of 9wt% has 20.0mpas, the solubility potato starch of this viscosity is to be obtained via sulfuric acid treatment by potato starch), the locust bean gum of 2wt% and the water of surplus mix, and obtain the compositions for the preparation of cellulose hard capsules.
Adopt the conventional technique of preparing capsule, utilize the compositions for the preparation of cellulose hard capsules obtained above to prepare cellulose hard capsules.Prepared cellulose hard capsules is with reference to the method for two regulations of Chinese Pharmacopoeia version in 2010, adopts huge day and send out a ZB-lE Intelligent disintegration tester to carry out disintegrate experiment, and test 50 samples all can whole disintegrate in 6 minutes, reaches pharmacopeia requirement its disintegration.
Embodiment 3
By the hydroxypropyl emthylcellulose of 25wt% (20 DEG C time, concentration is the viscosity that the aqueous solution of the hydroxypropyl emthylcellulose of 2wt% has 3.0mpas), the solubility corn starch of 0.5wt% is (in the time of 20 DEG C, concentration is the viscosity that the aqueous solution of the solubility corn starch of 9wt% has 300.0mpas, the solubility corn starch of this viscosity is to be obtained via salt acid treatment by corn starch), the arabic gum of 1wt% and the water of surplus mix, and obtain the compositions for the preparation of cellulose hard capsules.
Adopt the conventional technique of preparing capsule, utilize the compositions for the preparation of cellulose hard capsules obtained above to prepare cellulose hard capsules.Prepared cellulose hard capsules is with reference to the method for two regulations of Chinese Pharmacopoeia version in 2010, adopts huge day and send out a ZB-lE Intelligent disintegration tester to carry out disintegrate experiment, and test 50 samples all can whole disintegrate in 8 minutes, reaches pharmacopeia requirement its disintegration.
Embodiment 4
By the hydroxypropyl emthylcellulose of 20wt% (20 DEG C time, concentration is the viscosity that the aqueous solution of the hydroxypropyl emthylcellulose of 2wt% has 3.0mpas), the solubility wheaten starch of 5wt% is (in the time of 20 DEG C, concentration is the viscosity that the aqueous solution of the solubility wheaten starch of 9wt% has 50.0mpas, the solubility corn starch of this viscosity is to be obtained via salt acid treatment by corn starch), the mannan of 1.5wt% and the water of surplus mix, and obtain the compositions for the preparation of cellulose hard capsules.
Adopt the conventional technique of preparing capsule, utilize the compositions for the preparation of cellulose hard capsules obtained above to prepare cellulose hard capsules.Prepared cellulose hard capsules is with reference to the method for two regulations of Chinese Pharmacopoeia version in 2010, adopts huge day and send out a ZB-lE Intelligent disintegration tester to carry out disintegrate experiment, and test 50 samples all can whole disintegrate in 6 minutes, reaches pharmacopeia requirement its disintegration.
Embodiment 5
By the hydroxypropyl emthylcellulose of 15wt% (20 DEG C time, concentration is the viscosity that the aqueous solution of the hydroxypropyl emthylcellulose of 2wt% has 5.00mpas), (weight ratio of solubility wheaten starch and solubility rice starch is that 1:1 is in the time of 20 DEG C for the solubility wheaten starch of 6wt% and solubility rice starch, concentration is the viscosity that the aqueous solution of solubility wheaten starch of 9wt% and solubility rice starch that concentration is 9wt% all have 50.0mpas, the solubility corn starch of this viscosity and solubility rice starch are to be obtained via salt acid treatment respectively by corn starch and rice starch), the water of the pectin of 1wt% and xanthan gum (weight ratio is 1:1) and surplus mixes, obtain the compositions for the preparation of cellulose hard capsules.
Adopt the conventional technique of preparing capsule, utilize the compositions for the preparation of cellulose hard capsules obtained above to prepare cellulose hard capsules.Prepared cellulose hard capsules is with reference to the method for two regulations of Chinese Pharmacopoeia version in 2010, adopts huge day and send out a ZB-lE Intelligent disintegration tester to carry out disintegrate experiment, and test 50 samples all can whole disintegrate in 6 minutes, reaches pharmacopeia requirement its disintegration.
Claims (7)
1. for the preparation of a compositions for cellulose hard capsules, it is characterized in that: described compositions is made up of the hydroxypropyl emthylcellulose of 12～25wt%, soluble starch, the gellant of 0.4～2wt% and the water of surplus of 0.5～7wt%;
Described hydroxypropyl emthylcellulose, in the time of 20 DEG C, the aqueous solution of the hydroxypropyl emthylcellulose that concentration is 2wt% has the viscosity of 3～7mpas;
Described soluble starch, in the time of 20 DEG C, the aqueous solution of the soluble starch that concentration is 9wt% has the viscosity of 5～300mpas.
2. the compositions for the preparation of cellulose hard capsules according to claim 1, is characterized in that: described hydroxypropyl emthylcellulose, in the time of 20 DEG C, the aqueous solution of the hydroxypropyl emthylcellulose that concentration is 2wt% has the viscosity of 3～5mpas.
3. the compositions for the preparation of cellulose hard capsules according to claim 1, is characterized in that: described soluble starch, in the time of 20 DEG C, the aqueous solution of the soluble starch that concentration is 9wt% has the viscosity of 10～100mpas.
4. according to the compositions for the preparation of cellulose hard capsules described in claim 1 or 3, it is characterized in that: described soluble starch is that common starch is obtained through mineral acid treatment.
5. the compositions for the preparation of cellulose hard capsules according to claim 4, is characterized in that: described common starch is selected from one or more in tapioca, wheaten starch, potato starch, sweet potato starch, corn starch, bean starch, rice starch.
6. the compositions for the preparation of cellulose hard capsules according to claim 1, is characterized in that: described gellant is selected from one or more in pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, arabic gum, mannan, guar gum and Konjac glucomannan.
7. a cellulose hard capsules, is characterized in that: described cellulose hard is to be prepared by the compositions for the preparation of cellulose hard capsules described in claim 1～6 any one.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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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| Publication Number | Publication Date |
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| CN103933009A true CN103933009A (en) | 2014-07-23 |
| CN103933009B CN103933009B (en) | 2016-08-17 |
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| CN201410129189.4A Expired - Fee Related CN103933009B (en) | 2014-04-01 | 2014-04-01 | For preparing compositions and the application thereof of cellulose hard capsules |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997932A (en) * | 2016-07-19 | 2016-10-12 | 中国科学院化学研究所 | Composition for preparing empty capsules with modified starch matrixes and empty capsules |
| 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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998572A (en) * | 2006-12-20 | 2007-07-18 | 刘杰 | Hard medicine capsule |
-
2014
- 2014-04-01 CN CN201410129189.4A patent/CN103933009B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998572A (en) * | 2006-12-20 | 2007-07-18 | 刘杰 | Hard medicine capsule |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997932A (en) * | 2016-07-19 | 2016-10-12 | 中国科学院化学研究所 | Composition for preparing empty capsules with modified starch matrixes and empty capsules |
| 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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| Publication number | Publication date |
|---|---|
| CN103933009B (en) | 2016-08-17 |
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