CN1582903A - Plug capsules for enzyme decomposable dependent medicinal release positioned in colon and their preparation - Google Patents
Plug capsules for enzyme decomposable dependent medicinal release positioned in colon and their preparation Download PDFInfo
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- CN1582903A CN1582903A CN 200410020719 CN200410020719A CN1582903A CN 1582903 A CN1582903 A CN 1582903A CN 200410020719 CN200410020719 CN 200410020719 CN 200410020719 A CN200410020719 A CN 200410020719A CN 1582903 A CN1582903 A CN 1582903A
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Abstract
An enzymolysis dependent plunger capsule able to release medicine in colon is composed of acid-resistant soluble cap of capsule, high-pH soluble capsule body, soluble plunger able to be degradated by colon enzyme, medicine and alkaline auxiliary.
Description
Technical field:
The present invention relates to medical technical field, exactly it is PH, time, enzymatic degradation dependent colon-specific drug delivery plunger capsule and preparation method thereof.
Background technology:
The oral colon-specific drug release system is the novel medicine-releasing system of a class, can with drug selectivity be transported to the colon position and discharge.Colon positioning release has following advantage: 1, can be positioned with and treat colon position local disease targetedly, increase the drug level of disease sites, improve curative effect, as diseases such as treatment colitis, colonic ulcers; 2, make things convenient for clinical administration, alleviate patient's misery, improve its compliance; 3, increase drug stabilisation and effectiveness, improve bioavailability, be particularly suitable for protein and peptide drugs, and at the medicine that hangs down poor stability under the pH; 4, avoid the absorption of medicine, reduce dosage, reduce toxic and side effects at the harmonization of the stomach small intestinal; 5, delay pharmaceutical release time and drug absorption, reach medication purpose when selecting.
Reach the main method principle and the shortcoming of colon positioning release at present
PH dependent form design principle: because pH is higher than other zones of gastrointestinal tract in terminal ileum and colon, so adopt dissolved material preparation colon-specific drug delivery system under the high pH value condition.The deficiency of such medicine-releasing system: the pH environment of the small intestinal of human body and colon is comparatively similar in practice, and there is very big individual variation in pH, and has the colon pH value of inflammatory obviously to reduce, and colon position pH is about 3～4, is prone to the phenomenon of not release of not disintegrate.So the pH value dependent colon-specific drug delivery system is subject to the influence of intestinal pH value, cause locating in the body inaccurate.
The time-dependent design principle: the gastric emptying time is about 2 hours on an empty stomach behind the drug oral, preparation generally is not subjected to dosage form or food intake whether influence to be about 3 ± 1 hours in the small intestinal transhipment time, prepare the preparation of about 5～6 hours time lags by control release technic, and reach the purpose of colon positioning release.The deficiency that such release exists: in the reality preparation under one's belt the time of staying be subjected to the influence of food and preparation nature very big, and the individual variation of gastric emptying is also very big, the transhipment time is uncertain, easily causes locate failure.
Colonic enzyme degraded dependent form design principle: utilize in the colon bacteriogenic enzyme that some material is had single-minded degradation property and make.Colonic enzyme degradation-type medicine-releasing system is generally slower at the degradation speed of colon, and this system is not suitable for medicine and discharges rapidly, and is slower because of its release, easily misses best colon absorption site---ascending colon, causes drug bioavailability lower.
So rely on principles such as pH, time or enzymolysis to be difficult to realize preferably conlon targeting merely, for strengthening the stability and the reliability of colon administration, the present invention prepares the colon positioning release transmission system of multiple principle associating release, and obtains proof in the research in vivo and in vitro.
Summary of the invention:
The purpose of this invention is to provide a kind of pH, time, enzymatic degradation dependent colon-specific drug delivery plunger capsule and preparation method thereof.It comprises acid resistant form capsule cap A, and timing and enzyme degradable plunger B, high pH dissolve capsule body E as drug depot, interior powder charge thing micropill C and alkaline micropill D.Capsule body E outsourcing pH dissolved material, pH is 7～8, can in gastric juice or small intestinal solution, be kept perfectly, be that 7～8 dissolvings are broken at the pH of colon or ileocecus, discharge medicine.Described pH dissolved material comprises crylic acid resin.Described plunger be pectin, calcium pectinate, chitosan, alginate, cyclodextrin, amylose, glucosan, guar gum, chondroitin sulfate plunger or with the plunger that mixes of other adjuvants such as hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, gelatin, arabic gum, carbomer, lactose.Ratio 0～1: 1～0 between corrosion/lysotype and the enzymolysis type adjuvant, its purpose are that plunger both can be degraded by the colonic enzyme specificity again by corrosion or dissolving.Described acid resistance capsule cap, the antiacid layer material of outsourcing comprises all enteric solubility coating materials.Described coating material is hydroxypropylmethyl cellulose phthalate class, hydroxypropyl emthylcellulose acetate succinate, crylic acid resin etc., or these macromolecules mixture effect that can resist gastric acid in varing proportions, get rid of gastric emptying difference, below duodenum, can dissolve.Capsular preparation method is as follows, and recipe quantity medicine and alkaline matter are filled in the pH dissolved gum utricule, loads onto plunger, the seam sealing, and plunger should be concordant with capsule mouth upper limb, covers the acid resistant form capsule cap then, knot mouthful place's sealing.Alkaline matter is the mixture of sodium carbonate, sodium bicarbonate, dibastic sodium phosphate or alkaline matter and other pharmaceutic adjuvants, with the proportioning of medicine be 0～1: 1～0, plunger is made up of low methoxyl pectin and hydroxypropyl emthylcellulose, its proportion of composing is 8.5: 1.5, acid resistance capsule cap adopts No. 0 common gelatine capsule medicated cap, outsourcing hydroxypropylmethyl cellulose phthalate class.Plunger and capsule body seam be with the sealing of 8%EC alcoholic solution, put acid resistance capsule cap after, seam seals with HP-50.
PH, time, enzymatic degradation dependent colon-specific drug delivery plunger capsule release principle
This plunger capsule system relies on triple principle releases by pH, time, enzymatic degradation.The release principle is seen accompanying drawing 2.
1, pH relies on the release principle
Under the normal situation of gastrointestinal tract pH value, can rely on the purpose that the release principle reaches colon positioning release by pH.Basic condition in the body: the influence that acid resistance capsule cap and knot enteric solubility capsule housing all can be resisted gastric acid under one's belt; Gastric emptying rear intestinal pH value raises, the acid resistance capsule cap dissolving, but plunger has been closed the capsule mouth, and medicine does not discharge.In the gastrointestinal tract transport process of normal ph, ileocecus pH reaches about 7.8 approximately, the dissolving of colon colloidal sol capsule, and medicine discharges rapidly, reaches colon positioning release.(seeing accompanying drawing 1)
2, pH-time-dependent release principle
The intestinal pH value is on the low side (as the inflammatory colon of pH about 3～4), and the small intestinal transhipment time, (2～4h) was under the upper limit case, can reach the purpose of colon positioning release by this release principle.Basic condition in the body: acid resistance capsule cap dissolving behind the gastric emptying, plunger is met water and is formed gel, corrosion in time or dissolving, after 3.5～4.5 hours, water enters drug depot, and alkaline micropill dissolves rapidly, the drug depot local pH raises, the dissolving of colon colloidal sol utricule, and medicine discharges rapidly.(seeing accompanying drawing 2)
3, pH-enzyme degradable relies on the release principle
The intestinal pH value is on the low side, and the small intestinal transhipment time is lacked (being lower than the upper limit) partially, under the normal situation of colon bacteria, can reach the colon positioning release purpose by this release principle.Basic condition in the body: acid resistance capsule cap dissolving behind the gastric emptying, plunger is met water and is formed gel, when reaching colon, its plunger material-pectin of bacteriogenic enzymatic degradation and derivant thereof have been degraded when plunger in the colon, and water enters drug depot, the alkalescence micropill dissolves rapidly, the drug depot local pH raises, the dissolving of colon colloidal sol utricule, and medicine discharges rapidly.
Three principles realize the conlon targeting release medicines, and it is rapid to have improved the stability of colon positioning release and reliability and release.
Advantage of the present invention is:
1, overcomes pH, time, the single defective of planting the oral colon-specific drug release principle of enzymolysis dependent form, improve the reliability and stability of colon positioning release.
PH, pH-time, every kind of release principle of pH-enzymatic degradation type release all can independent or multiple while onsets under certain physiological status, all can reach the purpose of colon positioning release.Three kinds of release principles can be regarded three paralleling switches that reach colon positioning release as, open any switch, all can realize colon positioning release, so improved the reliability and stability of colon positioning release greatly.
This system can overcome the difference of the pH of colon positioning release, especially has the colon pH value of inflammatory obviously to reduce, and causes the inaccuracy of simple pH dependent form conlon targeting; Overcome simple time dependence colon-specific drug delivery system because the difference in gastric emptying time, the inefficacy of the conlon targeting that causes; It is slow to overcome the hair style colon-specific drug delivery system effect of enzyme angle, the shortcoming that supplementary product consumption is big.
2, overcome normal pulsed plunger release shortcoming slowly
Present pulse plug capsule, the insoluble capsule shells that adopts ethyl cellulose to prepare, its oral area filled with water gel plug is formed, and after medicine-releasing system entered gastrointestinal tract, impelling was gone out after the imbibition of water-setting plug, separates drug release with utricule.After adopting the hydrogel corrosion plug corrosion of HPMC preparation on the one hand, after gastro-intestinal Fluid enters capsule body in a period of time, the capsule oral area still has the residue of gel plug, make medicine be difficult for impelling from capsule, on the other hand because the part medicine is positioned at the depths of insoluble capsule shells, because the interior dissolution medium of capsule body is few and hydrodynamic force is little, medicine can not discharge in capsule fully fully in the short time, even very well medicine also can only stripping 40% in 2 hours for water solublity.By adding alkaline micropill, in water entered capsule, alkaline micropill dissolved rapidly in this device, and local pH raises in the capsule, and colon colloidal sol softgel shell body is met high pH dissolving, and medicine discharges rapidly, significantly improves release rate of drugs, and discharges fully.
3, this system can be easily by changing time and the position that plunger composition and thickness change release, for clinical realization individual administration is provided convenience.
4, preparation technology simply is beneficial to suitability for industrialized production
Can prepare capsule body, plunger and drug moiety respectively, then together, compare the production efficiency height, the system easy to control the quality of product with coating type and osmotic pump type pulse preparation with its " assembling ".Because plunger and medicine are isolating, therefore can medicine be made fast-release tablet according to conventional formulation technology in capsule.In the preparation process of plunger,, be convenient to the prescription screening and the preparation of plunger part because therefore composite medicine not need not consider to change the influence of plunger prescription to drug release.And by the investigation of hardness to time lag, the result show identical prescription within the specific limits plunger hardness time lag is not had influence, less demanding to the degree of accuracy of pressure and hardness, so be fit to the big production of industrialization.
5, be suitable for the medicine of variform, have versatility
Because every kind of pharmaceutical properties difference so generally all need pass through study tour, is selected adjuvant and corresponding preparation technology respectively, especially medicines such as some end-on photo-thermal sensitivities, protein and peptide have more increased difficulty in preparation process.This plunger colloid system does not need every kind of medicine is prepared the oral colon-specific drug release system respectively, the solid preparation of not only can packing into, the preparations such as liquid with the softgel shell melon of yet can packing into not.Medicine different, that need conlon targeting release can be filled in this capsule system, realize the oral colon-specific drug release purpose quickly and easily.
Description of drawings:
Fig. 1 is pH, time, enzymatic degradation type colon positioning release plunger capsule structure figure sketch map
Fig. 2 is a plunger capsule apparatus pH-dependent colon-specific drug delivery schematic diagram
Fig. 3 is a plunger capsule apparatus pH-time-dependent colon positioning release schematic diagram
Fig. 4 is a plunger capsule apparatus pH-enzymatic degradation dependent colon-specific drug delivery schematic diagram
Fig. 5 is that colon positioning release plunger capsule is in intravital transhipment of volunteer and disintegrate situation
The specific embodiment:
Embodiment 1
Prescription and preparation
Capsule 's content: diclofenac sodium fast release micropill, alkaline micropill (sodium carbonate 50%, microcrystalline Cellulose 45%, interlinkage sodium carboxymethyl cellulose 5%);
Plunger preparation: by low methoxyl pectin and hydroxypropyl emthylcellulose (HPMC) proportion of composing 8.5: 1.5,80mg, the flat punching press system plunger of 7mm.
Acid resistance capsule cap: No. 0 flexible gelatine capsule medicated cap, outsourcing hydroxypropylmethyl cellulose phthalate class (HP-50), weightening finish 7%.
The recipe quantity micropill is filled in No. 0 Type B enteric coated capsule body, loads onto plunger, seam puts acid resistance capsule cap with the sealing of 8%EC alcoholic solution peace, and seam seals with HP-50, promptly.
The feasible demonstration of in-vitro simulated gastrointestinal tract situation
1, pH relies on the feasibility of conlon targeting system
Dress micropill in No. 0 Type B enteric coated capsule, the capsule mouth seals with the EC alcoholic solution.37 ℃, 100rmin
-1, the 900mL dissolution medium, the oar method, capsule fixedly prevents floating with stainless steel coil.Dissolution medium simulation human gastrointestinal tract condition, the stripping 2h in Ph1.2 manual simulation gastric juice of elder generation, change manual simulation intestinal fluid pH6.8D phosphate buffer stripping 3 hours again into, place the phosphate buffer of manual simulation colonic fluid Ph7.8 to carry out stripping investigation (n=6) then.
The result shows that the Type B enteric coated capsule can resist the effect of gastric acid and intestinal fluid, discharges rapidly at the colon simulated solution Chinese medicine of higher PH.
2, the time dependent feasibility of pH-
The small intestinal transhipment time is generally more constant to be 2～4 hours.Can be implemented in the time hysteresis stripping of dissolution medium about 4 hours of simulation intestinal fluid, realize colon positioning release.At first place the medium of Ph1.2, change pH6.8 phosphate buffer (n=12) stripping experiment behind the 2h into, 37 ℃, 100rmin
-1, the 900mL dissolution medium, the oar method, capsule is used for stainless steel coil and fixedly prevents floating.
Experimental result shows in the simulation intestinal fluid and behind time lag 4.3 ± 0.21h (n=12), discharge medicine, and is consistent with the small intestinal transhipment time, can realize the time-dependent conlon targeting.
3, alkaline micropill adds the influence to drug release
Contrast adds and does not add the plunger capsule stripping release situation of alkaline micropill.At first place the 0.1MHCL medium in 2 hours, change Ph6.8 phosphate buffer (n=6) again into, measure the drug release situation.
Discharge slowly at the plunger capsule Chinese medicine that does not add alkaline micropill, medicine begins to discharge back 4h cumulative release quantity not sufficient 60%.Trace it to its cause is because of after the progressively dissolving of breaking through certain time lag capsule cap, the medicament pellet imbibition, because of utricule can be not destroyed in the simulation intestinal fluid, make medicine be positioned at the depths of insoluble capsule body, because the interior dissolution medium of capsule body is few and hydrodynamic force is little, cause medicine not remain intact fully in the short time, arrive at ileocecus or ascending colon, medicine discharges rapidly.
Add alkaline micropill in capsule body, medium enters the interior alkaline micropill of capsule body and dissolves rapidly, and the drug depot local pH raises, high pH colloidal sol utricule dissolving, and medicine discharges rapidly.The result shows the adding of alkaline micropill, through the time lag behind, medium enters in the utricule, local pH raises, and can make the capsule shells dissolving of breaking, drug release rapidly and fully discharges less than 60% by former 4h, is increased to 30min release more than 80%.
4, the feasibility of pH-enzymatic degradation
By adding the stripping experiment that pectase or rat colon content are medium, contrast with plunger degraded and medicine stripping in the medium of the corresponding pH that does not add pectase or rat colon liquid.Plunger can be by pectase and the degraded of rat colon content, and speed can realize the enzymatic degradation dependent colon-specific drug delivery faster than the corrosion speed in the medium of corresponding pH.
Experiment in vitro proves that this plunger capsule system can realize that pH, time, enzymatic degradation triple associating dependent form release principle reach colon positioning release.
In the intravital transhipment location disintegrate of people situation
The capsular basic design philosophy of conlon targeting plunger is exactly can keep the intact of medicine in the harmonization of the stomach small intestinal after taking medicine, and reaches behind ileocecus or the ascending colon to discharge rapidly, makes medicine bring into play curative effect rapidly.Observe capsule time of discharging of disintegrate in vivo by the general picture technology of γ-flicker, determine the position at place when preparation discharges medicine.
The experimenter: volunteer 3 people, there is not any disease, gastrointestinal function is normal, take medicine the first two week and experimental session non-smoking, does not drink and spills, do not contact or take other active materials.Before the test, the volunteer is informed that clearly this tests contingent untoward reaction and voluntary signature Informed Consent Form.
Assay method: 3 of volunteers, (micropill is used to take plunger 1 capsules
99mThe TC labelling), use low-intensity
99mTC warm water 200mL swallows, and detects immediately after taking medicine, and the volunteer lies on the back and takes pictures before ECT machine probe and in different time, and the record capsule is in gastrointestinal tract transport process, disintegrate position and time.Low fat meal is advanced in volunteer's unification behind the 4h that takes medicine.
The result reaches ileocecus or ascending colon at 8h, 4h and 6h respectively through different time, discharges medicine, and Fig. 5 is that colon positioning release plunger capsule is in intravital transhipment of volunteer and disintegrate situation.
As seen the oval bright spot under one's belt of taking medicine among the figure behind the 1h; 2h can be observed capsule and enters small intestinal from gastric emptying; 4.0h capsule arrives at ileocecus, bright spot begins hangover to occur, illustrates that capsule begins disintegrate, 8.0h can be observed the capsule ascending colon, bright spot all presents band shape along ascending colon scatters, and illustrates that micropill disperses, in all visible bright spot of whole colon, illustrate that medicine discharges at whole colon behind the 22h
Observe colon positioning release plunger capsule transhipment situation in vivo by γ-flicker spike imaging technique, can confirm that this plunger capsule can realize the desired design of " colon positioning release ", and can eliminate individual variations such as gastric emptying, all discharge through the difference transhipment time after taking medicine at colon.
Claims (10)
1, pH, time, enzymatic degradation dependent colon-specific drug delivery plunger capsule, it is characterized in that: it dissolves capsule body, erodable/dissolving by acid resistance capsule cap, pH value and can be formed by the plunger of colonic enzyme enzymatic degradation and basic auxiliary, pH value dissolving capsule body (E) front end is stamped acid resistance capsule cap (A), have erodable/dissolving and degradability plunger (B) to cover the front end at capsule body E in the capsule cap (A), medicine (C) and basic auxiliary (D) are contained in the capsule body (E).
2, pH according to claim 1, time, enzymatic degradation dependent colon-specific drug delivery plunger capsule, it is characterized in that: capsule body E outsourcing pH dissolved material, pH is 7～8, can in gastric juice or small intestinal solution, be kept perfectly, at the pH of colon or ileocecus is that 7～8 dissolvings are broken, and discharges medicine.
3, pH according to claim 2, time, the cold capsule of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: described pH dissolved material comprises crylic acid resin.
4, the cold capsule of pH according to claim 1, time, enzymatic degradation dependent colon-specific drug delivery post is characterized in that: described plunger be pectin, calcium pectinate, chitosan, alginate, cyclodextrin, amylose, glucosan, guar gum, chondroitin sulfate plunger or with the plunger that mixes of other adjuvants such as hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, gelatin, arabic gum, carbomer, lactose.
5, pH according to claim 4, time, the cold capsule of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: the ratio 0～1: 1～0 between corrosion/lysotype and the enzymolysis type adjuvant, its purpose is that plunger both can be degraded by the colonic enzyme specificity again by corrosion or dissolving.
6, pH according to claim 1, time, the cold capsule of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: described acid resistance capsule cap, the antiacid layer material of outsourcing comprises all enteric solubility coating materials.
7, pH according to claim 6, time, the cold capsule of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: described coating material is hydroxypropylmethyl cellulose phthalate class, hydroxypropyl emthylcellulose acetate succinate, crylic acid resin etc., or these macromolecules mixture effect that can resist gastric acid in varing proportions, get rid of gastric emptying difference, below duodenum, can dissolve.
8, a kind of pH as claimed in claim 1, time, the cold capsular preparation method of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: recipe quantity medicine and alkaline matter are filled in the pH dissolved gum utricule, load onto plunger, the seam sealing, plunger should be concordant with capsule mouth upper limb, cover the acid resistant form capsule cap then, knot mouthful place's sealing.
9, pH according to claim 8, time, the cold capsule preparation method thereof of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: alkaline matter is the mixture of sodium carbonate, sodium bicarbonate, dibastic sodium phosphate or alkaline matter and other pharmaceutic adjuvants, with the proportioning of medicine be 0～1: 1～0, plunger is made up of low methoxyl pectin and hydroxypropyl emthylcellulose, its proportion of composing is 8.5: 1.5, acid resistance capsule cap adopts No. 0 common gelatine capsule medicated cap, outsourcing hydroxypropylmethyl cellulose phthalate class.
10, a kind of pH as claimed in claim 8, time, the cold capsular preparation method of enzymatic degradation dependent colon-specific drug delivery post, it is characterized in that: plunger and capsule body seam seal with the 8%EC alcoholic solution, after putting acid resistance capsule cap, seam seals with HP-50.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410020719 CN1582903A (en) | 2004-06-11 | 2004-06-11 | Plug capsules for enzyme decomposable dependent medicinal release positioned in colon and their preparation |
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| CN 200410020719 CN1582903A (en) | 2004-06-11 | 2004-06-11 | Plug capsules for enzyme decomposable dependent medicinal release positioned in colon and their preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102342918A (en) * | 2011-05-26 | 2012-02-08 | 重庆时珍阁普生药业有限公司 | Colon-targeting coating system, colon-targeting oral preparation and preparation method of colon-targeting oral preparation |
| CN108201531A (en) * | 2016-12-19 | 2018-06-26 | 湖南尔康湘药制药有限公司 | Segmented intestine targeted starch capsule of highly dissoluble sulbenicillin sodium and preparation method thereof |
| CN109464742A (en) * | 2018-12-29 | 2019-03-15 | 上海安翰医疗技术有限公司 | Gastrointestinal tract position-sensing switch and preparation method thereof and alimentary canal site-specific drug release capsule |
-
2004
- 2004-06-11 CN CN 200410020719 patent/CN1582903A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102342918A (en) * | 2011-05-26 | 2012-02-08 | 重庆时珍阁普生药业有限公司 | Colon-targeting coating system, colon-targeting oral preparation and preparation method of colon-targeting oral preparation |
| CN102342918B (en) * | 2011-05-26 | 2013-02-13 | 重庆时珍阁普生药业有限公司 | Colon-targeting coating system, colon-targeting oral preparation and preparation method of colon-targeting oral preparation |
| CN108201531A (en) * | 2016-12-19 | 2018-06-26 | 湖南尔康湘药制药有限公司 | Segmented intestine targeted starch capsule of highly dissoluble sulbenicillin sodium and preparation method thereof |
| CN109464742A (en) * | 2018-12-29 | 2019-03-15 | 上海安翰医疗技术有限公司 | Gastrointestinal tract position-sensing switch and preparation method thereof and alimentary canal site-specific drug release capsule |
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Open date: 20050223 |