CN104055750B - There is Capsules and the preparation method of target function - Google Patents
There is Capsules and the preparation method of target function Download PDFInfo
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- CN104055750B CN104055750B CN201410313574.4A CN201410313574A CN104055750B CN 104055750 B CN104055750 B CN 104055750B CN 201410313574 A CN201410313574 A CN 201410313574A CN 104055750 B CN104055750 B CN 104055750B
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Abstract
The invention discloses a kind of Capsules with target function, its component has chitosan, pectin, carrageenan, resistant starch, plasticizer, water-repelling agent, and plasticizer selects sorbitol, glycerol, propylene glycol, mannitol and Polyethylene Glycol；Water-repelling agent selects polyvinyl alcohol and silicon dioxide；First pectin chitosan polymer is prepared；Carry out raw material mixed dissolution again；The Capsules with target function is finally made with conventional mode dunking method.The present invention can have duodenum targeted, ileum targeting and segmented intestine targeted capsule by different components and method preparation as required, in the amino protonated in chitosan and pectin, the carboxyl of ionization is combined into secondary bond by electrostatic attraction, form Polyelectrolyte Complex, duodenum, ileum and the segmented intestine targeted capsule accurate positioning of preparation, drug release is effective, has advantage little with dosage, that curative effect is high, toxic and side effects is low.
Description
Technical field
The present invention relates to a kind of Capsules and preparation method, a kind of Capsules with target function and system
Preparation Method, belongs to medicine food field.
Background technology
Capsule is as dosage form modal in health food pharmaceutical formulation, by its good taste masking effect, preferably
Bioavailability, and attractive in appearance it is prone to plurality of advantages such as swallowing, have become as the main packaging material of oral solid formulation, along with warp
Ji level and the raising of people's consuming capacity, and medical and health care system and the consumer pay attention to day by day to own health, medicine
Consumption will increase year by year, and pharmaceuticals industry provides broad development space with the growth rate of the nearlyest 20% for hard capsule industry.
Recently as developing rapidly of domestic and international medical industry, with the research of pharmaceutical preparation novel form and new varieties with open
Sending out particularly important, this, for improving the curative effect of medicine, reduces poisonous side effect of medicine, increases drug bioavailability, facilitates patient
Medication plays an important role.With minimum dose, the highest curative effect, minimum toxic and side effects, the approach target administration of most convenient, special
It not that the research and development of colon targeting drug administration have important clinical and are worth.Current enteric hollow capsule is mainly by anti-gastric acid
Enteric-coating material and gelatin composition.The enteric-coating material of anti-gastric acid mostly is cellulose acetate-phthalate, acrylic acid tree
Fat, Hydroxypropyl methyl cellulose phtalate, Lac etc., and organic solvent must be used when coating to dissolve and make bag
Clothing, some uses repeatedly coating could realize enteric effect, not only cumbersome, relatively costly, and uses a large amount of organic molten
Agent, pollutes environment；Gelatin is with animal skins etc. as raw material, but because raw material is limited, often utilizes leather-solid waste to prepare.Its edible peace
Complete and health is difficult to ensure that, media expose the most repeatedly.Novel capsule research becomes focus in recent years, has and goes out one for development of raw materials
The secondary enteric solubility Capsules dipping in gum forming: as Chinese patent CN101317830A disclose " a kind of enteric hollow capsule and
Preparation method ", the enteric hollow capsule made with the mixture of one or more in gelatin, cellulose family or polysaccharide, but
It it is the effect needing to be modified can be only achieved enteric to raw material；CN101708171A discloses " a kind of enteric plant hollow glue
Capsule ", use pectin to prepare enteric hollow capsule as primary raw material, although to eliminate enrobing processes, simplify technique；But this
The capsule of two invention preparations can only achieve the effect dissolved human small intestine.
Summary of the invention
It is an object of the invention to rely on the defects such as gelatin for undue existing for conventional hollow capsule, paying attention to prepared glue
While capsule itself is to body-care effect, also fully takes into account the health care of selected raw material itself, and provide one to have
The Capsules of target function and preparation method.
The present invention selects pectin, chitosan, carrageenan, resistant starch to be primary raw material, is combined.Pectin is as one
Water soluble dietary fiber, has irreplaceable functional characteristic, except having good gelling, protein stability, emulsifying
Outside characteristic, also hypertension, constipation chronic diseases had certain curative effect；Chitosan, as natural polysaccharose substance, has
Nontoxic, without features such as challeng, not haemolysis, can gradually be degraded and absorbed in human body, and have uniqueness physiology live
Property, such as biocompatibility, biological activity, biocidal property, the growth of microorganism can be suppressed significantly.Chitosan be a kind of containing-
NH2Alkalescence polyelectrolyte, pectin is a kind of faintly acid polyelectrolyte with-COOH, when the two mixes, in chitosan
In the amino of protonation and pectin, the carboxyl of ionization is combined into secondary bond by electrostatic attraction, forms Polyelectrolyte Complex, should
Polymer does not dissolves in gastric acid, can be as the new material of target administration thing；Resistant starch has regulating intestinal canal function, blood pressure lowering, subtracts
The several functions such as fertilizer, relieving constipation, blood sugar lowering.These abundant raw material source, function admirable, safe and reliable, and there is several functions.
The present invention has the Capsules of target function and is made up of the component of following weight portion:
Chitosan 1 ~ 5 part, pectin 12 ~ 25, carrageenan 5 ~ 10, resistant starch 1 ~ 10, plasticizer 1 ~ 5, water-repelling agent 1 ~ 3, water
50 ~ 100, its plasticizer selects sorbitol, glycerol, propylene glycol, mannitol to mix with one or more in Polyethylene Glycol
Thing；Its water-repelling agent selects polyvinyl alcohol and one or both mixture in silicon dioxide；
The Capsules its preparation method with target function is as follows:
A. pectin-chitosan polymer is prepared
A.1 chitosan is dissolved in 0.3% acetic acid (V/V) solution, makes the chitosan acetic acid that mass percent is 0.5 ~ 1%
Solution,
A.2 the pectin of 3 times of chitosan weight is dissolved in distilled water, makes the pectin solution that mass percent is 2 ~ 5%,
A.3 chitosan solution is slowly added in pectin solution, under 15000 ~ 20000r/min speed, uses beater
Homogenate 2 ~ 3min, makes to aggregate into emulsifying shape,
A.4 pectin-the chitosan solution of polymerization is at room temperature placed 24 ~ 48h, makes pectin and chitosan reaction complete,
A.5 pectin-chitosan solution centrifugal 10 ~ 15min under the speed of 3000r/min completely will be polymerized, in elimination
Clear liquid, obtains pectin-chitosan polymer standby；
B. raw material mixed dissolution
B.1 being added to the water by resistant starch, be heated to 60 ~ 70 DEG C, keep 10 ~ 20min, stirring is all
Even, it is prepared as the solution that mass percent is 20 ~ 30%,
B.2 pectin-chitosan polymer, carrageenan are joined resistant starch solution with the pectin of surplus in weight portion
In, and keep the skin wet by component ratio, heat at a temperature of 80 ~ 100 DEG C and stir, make solution exquisiteness without granular sensation, so
After add plasticizer, water-repelling agent by weight, mix homogeneously obtains colloid solution；
C. gum forming is dipped in
The colloid solution of mix homogeneously is carried out froth breaking, makes the Capsules with target function with conventional mode dunking method.
The present invention is prepared duodenum targeted, the ileum target with target function as required by different components and method
To with segmented intestine targeted capsule, in chitosan protonation amino and in pectin the carboxyl of ionization be combined into secondary valency by electrostatic attraction
Key, forms Polyelectrolyte Complex, and the duodenum targeted capsule of preparation may be implemented in duodenum and is administered continuously, have with
The advantage that dosage is little, curative effect is high, toxic and side effects is low, ileum and segmented intestine targeted capsule enter accurate positioning, and drug release is effective；
Abundant raw material source, natural safety, technique is simple, and relative to the coated tablet low cost on existing market, safety is good, can conduct
The substitute of gelatin, for solving the developing direction that capsule crises problem provides strong；Target function Capsules is as medicine
Carrier while, be again a kind of health-care assistance product, there is good health care.
Detailed description of the invention
Being described in further details the present invention below by way of example, these examples are only used for the present invention is described, do not limit
The scope of the present invention processed.
Embodiment one: the Capsules with duodenum targeted function is made up of the component of following weight portion:
Chitosan 1 ~ 2 part, pectin 20 ~ 25, carrageenan 5 ~ 10, resistant starch 1 ~ 5, glycerol 1 ~ 5, polyvinyl alcohol 1 ~ 3, water 50
~100；
There is the preparation method of the Capsules of duodenum targeted function, comprise the steps:
A. pectin-chitosan polymer is prepared
A.1 chitosan is dissolved in 0.3% acetic acid (V/V) solution, makes the chitosan acetic acid that mass percent is 0.5% molten
Liquid,
A.2 the pectin of 3 times of chitosan weight is dissolved in distilled water, makes the pectin solution that mass percent is 5%,
A.3 chitosan solution is slowly added in pectin solution, is homogenized with beater under 20000r/min speed
2min, makes to aggregate into emulsifying shape,
A.4 pectin-the chitosan solution of polymerization is at room temperature placed 48h, makes pectin and chitosan reaction complete,
A.5 by being polymerized pectin-chitosan solution centrifugal 10min under the speed of 3000r/min completely, supernatant is filtered off
Liquid, obtains pectin-chitosan polymer standby；
B. raw material mixed dissolution
By formula by carrageenan, the pectin of surplus, dissolve after resistant starch solution and preparation pectin-
Chitosan mixes, and is dissolved in water
B.1 resistant starch is added to the water, is heated to 70 DEG C, keep 10min, stir, system
Standby one-tenth mass percent is the solution of 30%；
B.2 by during in pectin-chitosan polymer, carrageenan and formula, the pectin of surplus joins resistant starch solution,
And keep the skin wet by formula proportion, heat at a temperature of 80 DEG C and stir, making solution exquisiteness without granular sensation, be subsequently adding sweet
Oil, polyvinyl alcohol, mix homogeneously obtains colloid solution；
C. gum forming is dipped in
The colloid solution of mix homogeneously is carried out froth breaking, makes the Capsules with target function with conventional mode dunking method.
The capsule prepared in aforementioned manners has duodenum targeted function, and capsule does not dissolves at gastric, arrives 12 fingers
Intestinal drug release, dosage is little, effective.
Embodiment two: the Capsules with ileum target function is made up of the component of following weight portion:
Chitosan 2 ~ 3 parts, pectin 15 ~ 25, carrageenan 5 ~ 10, resistant starch 1 ~ 5, sorbitol 1 ~ 2, glycerol 1 ~ 3, titanium dioxide
Silicon 1 ~ 3, water 50 ~ 100；
There is the preparation method of the Capsules of ileum target function, comprise the steps:
A. pectin-chitosan polymer is prepared
A.1 chitosan is dissolved in 0.3% acetic acid (V/V) solution, makes the chitosan acetic acid that mass percent is 1% molten
Liquid,
A.2 the pectin of 3 times of chitosan weight is dissolved in distilled water, makes the pectin solution that mass percent is 2%,
A.3 chitosan solution is slowly added in pectin solution, is homogenized with beater under 15000r/min speed
3min, makes to aggregate into emulsifying shape,
A.4 pectin-the chitosan solution of polymerization is at room temperature placed 24h, makes pectin and chitosan reaction complete,
A.5 by being polymerized pectin-chitosan solution centrifugal 15min under the speed of 3000r/min completely, supernatant is filtered off
Liquid, obtains pectin-chitosan polymer standby；
B. raw material mixed dissolution
B.1 resistant starch is added to the water, is heated to 60 DEG C, keep 20min, stir, system
Standby one-tenth mass percent is the solution of 20%,
B.2 pectin-chitosan polymer, carrageenan are joined resistant starch solution with the pectin of surplus in group component
In, and keep the skin wet by component ratio, heat at a temperature of 100 DEG C and stir, making solution exquisiteness without granular sensation, then add
Entering sorbitol, glycerol and silicon dioxide, mix homogeneously obtains colloid solution；
C. gum forming is dipped in
The colloid solution of mix homogeneously is carried out froth breaking, makes the Capsules with target function with conventional mode dunking method.
The capsule prepared in aforementioned manners has ileum target function, does not dissolves at gastric, arrives drug release after ileum,
Meet the requirement of ileum target administration.
Embodiment three: the Capsules with segmented intestine targeted function is made up of the component of following weight portion:
Chitosan 3 ~ 5 parts, pectin 12 ~ 25, carrageenan 5 ~ 10, resistant starch 5 ~ 10, propylene glycol 1 ~ 5, polyvinyl alcohol 1 ~
1.5, silica 1 ~ 1.5, water 50 ~ 100；
There is the preparation method of the Capsules of segmented intestine targeted function, comprise the steps:
A. pectin-chitosan polymer is prepared
A.1 chitosan is dissolved in 0.3% acetic acid (V/V) solution, makes the chitosan acetic acid that mass percent is 1% molten
Liquid,
A.2 the pectin of 3 times of chitosan weight is dissolved in distilled water, makes the pectin solution that mass percent is 3%,
A.3 chitosan solution is slowly added in pectin solution, is homogenized with beater under 18000r/min speed
3min, makes to aggregate into emulsifying shape,
A.4 pectin-the chitosan solution of polymerization is at room temperature placed 36h, makes pectin and chitosan reaction complete,
A.5 by being polymerized pectin-chitosan solution centrifugal 12min under the speed of 3000r/min completely, supernatant is filtered off
Liquid, obtains pectin-chitosan polymer standby；
B. raw material mixed dissolution
B.1 resistant starch is added to the water, is heated to 65 DEG C, keep 20min, stir, system
Standby one-tenth mass percent is the solution of 25%；
B. pectin-chitosan polymer, carrageenan are joined resistant starch solution with the pectin of surplus in group component
In, and keep the skin wet by component ratio, heat at a temperature of 90 DEG C and stir, making solution exquisiteness without granular sensation, then add
Entering propylene glycol, polyvinyl alcohol, silicon dioxide, mix homogeneously obtains colloid solution；
C. gum forming is dipped in
The colloid solution of mix homogeneously is carried out froth breaking, makes the Capsules with target function with conventional mode dunking method.
The capsule prepared in aforementioned manners has segmented intestine targeted function, does not dissolves at the little enteral of harmonization of the stomach, arrives after colon one
In hour, medicine discharges completely, meets the requirement of colon targeting drug administration.
As follows through the present invention being had the Capsules further testing inspection result of target function:
Capsules appearance surfaces is smooth, glossy, without flat head, thin head, wrinkle, the first-class phenomenon of Flos Mume；Wall thickness
0.09~.0.12mm；Moisture content 5.8 ~ 9.6%(relative humidity: 50%)；When water content is more than 5%, friability rate is 0.
Drug release rate measures: solution is prepared, and pH value is the preparation of the acid solution of 1.5: by deionized water solution HCl
Regulation pH value is to 1.5, and final HCI concentration is about 0.011mol/L；The preparation of simulated gastric fluid: add matter in deionized water solution
Amount volume ratio is the pepsin of 1%, then regulates pH to 1.5 with the HCl of 0.1M；The preparation of simulated intestinal fluid: be 6.8 at pH
0.02M phosphate buffer in, add mass volume ratio be the trypsin of 1%；The preparation of simulation colonic fluid: by SD rat
After paralysis, colon is taken out from abdominal part, nitrogen charging environment is collected colonic contents, and dilutes with the phosphate buffer that pH is 7.8
To 30% (w/v).
According to the Pharmacopoeia of the People's Republic of China drug release rate inspection technique of Chinese Pharmacopoeia Commission's establishment, by hollow glue
Capsule is placed in 1h in simulated gastric fluid 2h, simulated intestinal fluid 3h and simulation colonic fluid the most in order, measures its releasing effect.
Choose Vc as aids drug to measure the In Vitro Dissolution medicament contg of capsule, it is judged that it is good whether capsule has
Target administration ability.Take 6 seed lac capsule preparations, 200mgVc will be loaded, be the most first placed on simulated gastric fluid, little
In intestinal juice and colonic fluid, the content of Vc in 30min measures a solution.Result shows: fill in duodenum targeted capsule
The Vc carried does not has drug release in gastric juice, and in entering duodenum, medicine is complete, and release is complete in 1h；Ileum targeting glue
Capsule is not release in gastric juice, and after entering small intestinal, front 1h does not discharge, and 2h slowly discharges, release rate 9.54%, releases in 3h
Entirely, release rate reaches 98.27%；Segmented intestine targeted capsule is not release in gastric juice, discharges 6.8%, in colonic fluid in intestinal fluid
Middle release rapidly rises, and 6h reaches measured quantity maximum 96.09, meets the requirement of colon targeting drug administration.Measurement result is
It is that the Vc discharged is oxidized or other reason reacts away a part that big release rate is not reaching to the reason of 100%.
Claims (4)
1. there is the preparation method of the Capsules of target function, it is characterised in that have the Capsules of target function be by with
Made by the component of lower weight portion:
Chitosan 1 ~ 5 part, pectin 12 ~ 25, carrageenan 5 ~ 10, resistant starch 1 ~ 10, plasticizer 1 ~ 5, water-repelling agent 1 ~ 3, water 50 ~
100, its plasticizer selects sorbitol, glycerol, propylene glycol, mannitol and one or more mixture in Polyethylene Glycol；
Its water-repelling agent selects polyvinyl alcohol and one or both mixture in silicon dioxide；And complete by techniques below flow process:
A. pectin-chitosan polymer is prepared
A.1 chitosan is dissolved in 0.3%V/V acetic acid solution, makes the chitosan acetic acid solution that mass percent is 0.5 ~ 1%,
A.2 the pectin of 3 times of chitosan weight is dissolved in distilled water, makes the pectin solution that mass percent is 2 ~ 5%,
A.3 chitosan solution is slowly added in pectin solution, is homogenized with beater under 15000 ~ 20000r/min speed
2 ~ 3min, makes to aggregate into emulsifying shape,
A.4 pectin-the chitosan solution of polymerization is at room temperature placed 24 ~ 48h, makes pectin and chitosan reaction complete,
A.5 by being polymerized pectin-chitosan solution centrifugal 10 ~ 15min under the speed of 3000r/min completely, supernatant is filtered off,
Obtain pectin-chitosan polymer standby；
B. raw material mixed dissolution
B.1 resistant starch is added to the water, is heated to 60 ~ 70 DEG C, keep 10 ~ 20min, stir,
It is prepared as the solution that mass percent is 20 ~ 30%,
B.2 pectin-chitosan polymer, carrageenan are joined in resistant starch solution with the pectin of surplus in weight portion, and
Keep the skin wet by component ratio, heat at a temperature of 80 ~ 100 DEG C and stir, make solution exquisiteness without granular sensation, then press weight
Amount part adds plasticizer, water-repelling agent, and mix homogeneously obtains colloid solution；
C. gum forming is dipped in
The colloid solution of mix homogeneously is carried out froth breaking, makes the Capsules with target function with conventional mode dunking method.
The preparation method of the Capsules with target function the most according to claim 1, it is characterised in that described sky
Heart-soothing capsule has duodenum targeted function, is made by the component by following weight portion: chitosan 1 ~ 2 part, pectin 20 ~ 25,
Carrageenan 5 ~ 10, resistant starch 1 ~ 5, glycerol 1 ~ 5, polyvinyl alcohol 1 ~ 3, water 50 ~ 100.
The preparation method of the Capsules with target function the most according to claim 1, it is characterised in that described sky
Heart-soothing capsule has ileum target function, is made by the component by following weight portion: chitosan 2 ~ 3 parts, pectin 15 ~ 25, OK a karaoke club
Glue 5 ~ 10, resistant starch 1 ~ 5, sorbitol 1 ~ 2, glycerol 1 ~ 3, silica 1 ~ 3, water 50 ~ 100.
The preparation method of the Capsules with target function the most according to claim 1, it is characterised in that described sky
Heart-soothing capsule has segmented intestine targeted function, is made by the component by following weight portion: chitosan 3 ~ 5 parts, pectin 12 ~ 25, OK a karaoke club
Glue 5 ~ 10, resistant starch 5 ~ 10, propylene glycol 1 ~ 5, polyvinyl alcohol 1 ~ 1.5, silica 1 ~ 1.5, water 50 ~ 100.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644609B (en) * | 2015-01-28 | 2017-06-16 | 龙标兵 | A kind of feature masticatory pattern soft capsule skin |
| CN104688710B (en) * | 2015-02-11 | 2018-01-23 | 广州德拉蒙德食品科技有限公司 | The capsule skin and soft capsule prepared therefrom of a kind of masticatory pattern soft capsule with antibiotic property |
| CN105582544A (en) * | 2015-12-24 | 2016-05-18 | 广西大学 | Preparation method and application of resistant starch/pectin colon-targeted controlled release film |
| CN107744146A (en) * | 2017-11-21 | 2018-03-02 | 河南牧业经济学院 | A kind of application of the Capsules with segmented intestine targeted function |
| CN108992417B (en) * | 2018-09-27 | 2021-08-31 | 宁波大红鹰药业股份有限公司 | Capsule shell for preventing oral cavity adhesion and preparation method thereof |
| CN110193029B (en) * | 2019-07-04 | 2020-10-30 | 北京罗诺强施医药技术研发中心有限公司 | Colon-targeted drug delivery method of probiotics |
| CN112826115B (en) * | 2020-10-10 | 2022-04-08 | 广州玖洲胶囊生物科技有限公司 | Preparation method of hollow capsule capable of achieving targeted release in intestinal tract |
| CN114230815B (en) * | 2021-12-23 | 2023-08-18 | 中国农业科学院农产品加工研究所 | Emulsion gel bead for realizing targeting release of different parts of flavone and preparation method thereof |
| CN117137879A (en) * | 2023-09-15 | 2023-12-01 | 漯河医学高等专科学校 | Multifunctional targeting capsule with resistant starch as wall material |
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| US10525010B2 (en) * | 2012-05-02 | 2020-01-07 | Capsugel Belgium Nv | Aqueous dispersions of controlled release polymers and shells and capsules thereof |
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