CN108743561A - A kind of segmented intestine targeted capsule of Indomethacin and preparation method thereof - Google Patents
A kind of segmented intestine targeted capsule of Indomethacin and preparation method thereof Download PDFInfo
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- CN108743561A CN108743561A CN201810683154.3A CN201810683154A CN108743561A CN 108743561 A CN108743561 A CN 108743561A CN 201810683154 A CN201810683154 A CN 201810683154A CN 108743561 A CN108743561 A CN 108743561A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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Abstract
The invention discloses segmented intestine targeted capsule of a kind of Indomethacin and preparation method thereof, the capsule is made of insoluble capsule body, Indomethacin fast release micropill, plunger piece and capsulae enterosolubilis cap；Indomethacin fast release micropill is seated in insoluble capsule body, and plunger piece seals the opening of insoluble capsule body, and capsulae enterosolubilis cap sleeve is loaded on sealing end.Preparation method is that Indomethacin fast release micropill is filling in insoluble capsule body, fills in plunger piece, and the capsule is obtained after covering enteric capsule cap.The segmented intestine targeted capsule of Indomethacin of the present invention has high specific, and Indomethacin can be made largely to be discharged rapidly in colon site, realizes optimum therapeuticing effect.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of segmented intestine targeted capsule of Indomethacin and its preparation side
Method.
Background technology
Colon cancer is one of highest malignant tumour of alimentary canal incidence, and incidence was in rising trend in recent years.At present
The treatment of colon cancer based on excision of performing the operation, be aided with chemotherapy and immunization therapy etc..Currently, being clinically usually used in treatment of colon cancer
Drug is oxaliplatin and fluorouracil, and administering mode is intravenous drip, and administration is extremely inconvenient, and after most of patients medication
There are the complication such as the inflammation of vein caused by intravenous drip, acroanesthesia.Oral medication is always that patient is most ready to receive
A kind of administering mode not only considerably increases the compliance of patient, and production cost is relatively low.
Currently, the main having time control type drug release of the oral administration system that colon cancer can be treated and the drug release of pH dependent forms.
The drug release of time control type mostly uses special material and is coated, and main ingredient can be released from coating material after a certain time.
But since there are greatest differences between human individual, the time that drug reaches colon site, also difference was huge, time control type
Drug release can not reach segmented intestine targeted well.Using pH sensitive materials reach it is segmented intestine targeted be in the oral medication of current colon most
Common mode, but the pH of human body alimentary canal, there are individual difference, the pH of small intestine and colon is very close, and colon site occurs
The apparent small reverse of pH transiences, so the drug release of pH dependent forms can not reach accurately segmented intestine targeted.
Indomethacin is widely used as anti-inflammation analgesic by people, but Recent study shows that Indomethacin can be good
Inhibition colon cancer cell increment and transfer, Apoptosis of Colon Cancer Cells can be induced and inhibit tumor vascular formation.One
Straight Indomethacin of taking for a long time can reduce the death rate of colorectal cancer patients, and it has the immune function of cancer late stage patients
Good protective effect.It is reported that Indomethacin is concentration-dependant for inhibiting the increase of colon cancer cell number.Indoles
Mei Xin is prepared into preparation for when treating colon cancer, optimal drug release mode to be rapid a large amount of releases after reaching colon site.
But Indomethacin poorly water-soluble, and there is intense irritation, long-term use to easily lead to gastric perforation, gastrointestinal bleeding etc., change gastrointestinal tract
Its damage for normal portions can be reduced by being prepared into colon targeting preparation after its kind dissolubility.
Therefore one kind is made in Indomethacin has height segmented intestine targeting specific, for the clinical treatment of colon cancer
Be very it is necessary to.
Invention content
The purpose of the present invention is overcoming above-mentioned the deficiencies in the prior art, provide a kind of segmented intestine targeted capsule of Indomethacin and its
Preparation method, segmented intestine targeted capsule obtained make Indomethacin largely be discharged rapidly in colon site, realize optimum therapeuticing effect.
In order to achieve the above-mentioned object of the invention, the technical solution adopted by the present invention is as follows：
A kind of segmented intestine targeted capsule of Indomethacin, by insoluble capsule body, Indomethacin fast release micropill, plunger piece and enteric
Capsule cap forms；Indomethacin fast release micropill is filling in insoluble capsule body, and plunger piece seals the opening of insoluble capsule body
It closes, capsulae enterosolubilis cap sleeve is loaded on sealing end；
Capsulae enterosolubilis cap is after small intestine dissolving, and plunger piece is degraded in colon, and Indomethacin fast release micropill is in colon drug delivery.
The main component of plunger piece is guar gum, and guar gum water swellability is stronger, and when exclusive use is easier to disintegration, so
Hydroxypropyl methyl cellulose is added, forms it into the stronger gel of intensity；But when only with hydroxypropyl methyl cellulose compatibility, gel
Structure is stronger, and enzyme solutions are not easily accessed internal degradation gel structure, therefore lactose is added in prescription to accelerate plunger piece in enzyme
Degradation in solution.
Further, the plunger piece, by weight percentage, by lactose 35.5-40.4%, hydroxypropyl methyl cellulose
4.9-9.9%, guar gum 46.2%, filler 8.1% and lubricant 0.4% are made.
Preferably, the plunger piece is by lactose 40.4%, hydroxypropyl methyl cellulose 4.9%, guar gum 46.2%, filling
Agent 8.1% and lubricant 0.4% are made.
Preferably, hydroxypropyl methyl cellulose viscosity is 3mpas, and plunger sheet weight is 102mg.
Further, the filler is microcrystalline cellulose or starch；The lubricant is talcum powder.
Preferably, the filler is microcrystalline cellulose.Microcrystalline cellulose can improve tablet flowing for direct tablet compressing
Property and compressibility, it is advantageous to microcrystalline celluloses as filler.
Further, the Indomethacin fast release micropill is by weight percentage, beautiful by cane sugar core 55.6%, indoles
Pungent 11.1-12.5% and hydrophilic carrier 25.0-33.3% are made.
Preferably, the Indomethacin fast release micropill, by weight percentage, by cane sugar core 55.6%, Indomethacin
11.1% and hydrophilic carrier 33.3% be made.
Further, the hydrophilic carrier is selected from PVP K30, PLURONICS F87 or polyethylene glycol
6000。
Preferably, the hydrophilic carrier is PVP K30.When using PVP K30, quick-release
Best results.
The preparation method of the above-mentioned segmented intestine targeted capsule of Indomethacin, includes the following steps：
Step 1, Indomethacin and hydrophilic carrier are dissolved in absolute ethyl alcohol respectively and solution is made, two kinds of solution are mixed
It closes, making coating solution with mixed liquor is coated cane sugar core using fluid bed, and Indomethacin fast release micropill is made；
Step 2, by guar gum, lactose, hydroxypropyl methyl cellulose, filler and lubricant sieving mixing, direct tablet compressing
Plunger piece is made；
Step 3, Indomethacin fast release micropill is filling in insoluble capsule body, plunger piece is filled in, enteric capsule cap is covered,
To obtain the final product.
The advantages that natural polysaccharide Yin Qiyi is obtained, is nontoxic and biodegradable is widely used in drug delivery system.Guar gum
It is that separation and Extraction obtains from the guar gum beans seed for originate in the ground such as India, Pakistan, guar gum main component is sweet dew
Glycan, the mannosidase selective degradation that can be generated by special flora in colon, be with certain fluidity powdered substance,
There is beany flavor, can be dissolved in cold water or hot water, forms colloidal sol after being dissolved in water, the pH value of colloidal sol is between 6~8.Currently, guar gum
Can be used as pharmaceutical carrier and prepare drug-loading microcapsule to efficiently control the release of drug, also can with xanthans is compound is used as tablet
Adhesive, not only bonding force is strong and will not be overly hard.
The segmented intestine targeted capsule of Indomethacin of the present invention is can be by the sweet dew of special flora generation in colon using guar gum
Glycosidase selective degradation realizes colon-targeted delivery system.After the segmented intestine targeted capsule administration of the Indomethacin, small intestines is reached
Enteric capsule cap dissolves when position, and plunger piece is gradually exposed, and when reaching colon site, plunger piece is a large amount of due to containing
Guar gum by the mannase of colon site so gradually degraded so that Indomethacin fast release micropill is exposed to colon solution
In, Indomethacin largely discharges rapidly.The medicine-releasing system that the present invention is triggered using microbiologic population, it depends on human stomach
Special flora in enteron aisle, is not influenced by individual difference, can reach good segmented intestine targeted effect.This high specific is oral
Segmented intestine targeted pulse plug capsule makes Indomethacin largely be discharged rapidly in colon site, realizes optimum therapeuticing effect.
Description of the drawings
Fig. 1 is the segmented intestine targeted capsule structure schematic diagram of Indomethacin of the present invention；
Fig. 2 is the release in vitro of the Indomethacin segmented intestine targeted capsule and commercially available Indometacin Enteric-coated Tablets of 1 gained of embodiment
Curve.
Specific implementation mode
Technical scheme of the present invention is described further with reference to specific embodiment.
The most preferred recipe determination of the present invention is as follows：
(1) plunger tablet recipe
Plunger tablet recipe determines that can it not be degraded in small intestine and only by special microflora degradation in colon.Wherein shadow
Ring it is maximum be guar gum, lactose, hydroxypropyl methyl cellulose three weight ratio, the viscosity of hydroxypropyl methyl cellulose and
The piece weight of plunger piece.These three factors are investigated using Box-behnken response surfaces design method, using lag time as
Inspection target.According to contour map and three-dismensional effect surface chart, the optimizing prescriptions of plunger piece are predicted.The experimental results showed that preparing column
The most preferably formula of patch is：The viscosity of hydroxypropyl methyl cellulose be 3mpas, plunger sheet weight be 102mg, guar gum,
Lactose, hydroxypropyl methyl cellulose weight ratio be 4.8: 4.2: 0.5.
(2) filler in plunger piece
In order to increase the weight of tablet, volume and convenient for production, tablet total weight is typically no less than 100mg, and diameter is generally not
Less than 6mm, so needing addition filler in plunger piece, filler can also reduce the deviation of volume.Microcrystalline cellulose tabletting can
To improve tablet mobility and compressibility, increase tablet hardness, the needs of plunger piece can be met by experiment, so selection
Microcrystalline cellulose is as filler.
(3) hydrophilic carrier in Indomethacin fast release micropill
When insoluble drug prepares solid dispersions and increases its solubility, common hydrophilic carrier has polyvinylpyrrolidine
Ketone K30, PLURONICS F87 and Macrogol 6000.The content of itself and Indomethacin is fixed as 3: 2, prepares fast release micropill simultaneously
And investigate its release.The experimental results showed that using quick-release most pronounced effects when PVP K30 and Indomethacin is released
Put most completely, it is advantageous to hydrophilic carrier be PVP K30.In order to reach best quick-release effect, to poly-
The dosage of vinylpyrrolidone K30 is screened, the experimental results showed that PVP K30 and Indomethacin ratio are
Quick-release best results when 3: 1.
Embodiment 1-4
The specific prescription of 10 segmented intestine targeted capsules of Indomethacin is as follows：
Preparation method：
Step 1, it by the Indomethacin bulk pharmaceutical chemicals of the recipe quantity, is dissolved in 200mL absolute ethyl alcohols；Weigh the parent of recipe quantity
Aqueous solid disperses auxiliary material, is dissolved in 100mL absolute ethyl alcohols.Above two solution is stirred into 2h, mixing is standby to get coating solution
With.The cane sugar core of the recipe quantity is placed in fluid bed, coating solution is sprayed into pot and carries out the medicine-feeding coating of bottom spray, coating
Flow velocity is 5~6mL/min, maintains 38 ± 2 DEG C of temperature of charge.
Step 2, the guar gum of the recipe quantity, lactose, hydroxypropyl methyl cellulose and pharmaceutic adjuvant are crossed into 80 mesh respectively
Sieve is sufficiently mixed uniformly according to equal increments method, plunger piece is prepared using direct powder compression after mixing of being sieved.
Step 3, Indomethacin fast release micropill is filling in insoluble capsule body, plunger piece is bonded with capsule wall and column
The upper surface of patch is flushed with the open end of capsule body, covers enteric capsule cap to obtain the final product.
The obtained a diameter of 1mm of Indomethacin fast release micropill, a diameter of 6mm of plunger piece, piece weighs 102mg, segmented intestine targeted
Capsules weight difference, friability meet pharmacopoeial requirements.
As a comparison case with commercially available Indometacin Enteric-coated Tablets, according to《Chinese Pharmacopoeia》Dissolution method as defined in 2015 editions
First method carries out investigation comparison to the segmented intestine targeted capsule of embodiment 1 and the dissolution in vitro of commercially available enteric coatel tablets, and dissolution test is
At 37 DEG C successively in 2h using the simulate the gastric juice of the pH1.2 of 900mL to be small with the simulation of the pH6.8 of 900mL in solvent, 2~5h
Intestinal juice is solvent, has added the simulation colonic fluid of the pH6.0 of mannase as solvent using 900mL in 5~8h, and rotating speed is
100rpm, ultraviolet spectrophotometry are detected.Enteric coatel tablets discharge completely before reaching colon site in 4h, and of the invention releases
Degree of putting parameter is following (percentage referenced below is weight percent), and In-vitro release curves are shown in the attached drawing 2 in description of the drawings.
| After 1 hour | Accumulative releasing degree is about：0% |
| After 2 hours | Accumulative releasing degree is about：0% |
| After 3 hours | Accumulative releasing degree is about：0% |
| After 4 hours | Accumulative releasing degree is about：0% |
| After 5 hours | Accumulative releasing degree is about：1.8% |
| After 6 hours | Accumulative releasing degree is about：83.07% |
| After 7 hours | Accumulative releasing degree is about：89.49% |
| After 8 hours | Accumulative releasing degree is about：89.88% |
As shown in Fig. 2, high specific is fast when the segmented intestine targeted capsule of the present invention can reach colon site after 5 hours
Fast a large amount of release Indomethacins, therapeutic effect is played to colon cancer.The present invention has filled up oral medication colon cancer drug targeting
Poor defect, while compared with enteric coatel tablets, avoid Indomethacin the damage to normal gastrointestinal tract and has because releasing the drug in advance
The effect of higher.
Claims (10)
1. a kind of segmented intestine targeted capsule of Indomethacin, it is characterised in that：By insoluble capsule body, Indomethacin fast release micropill, column
Patch and capsulae enterosolubilis cap composition；Indomethacin fast release micropill is filling in insoluble capsule body, and plunger piece is by insoluble capsule
The opening of body seals, and capsulae enterosolubilis cap sleeve is loaded on sealing end；
Capsulae enterosolubilis cap after small intestine dissolving, in colon degrade by plunger piece, and Indomethacin fast release micropill is insoluble in colon drug delivery
Capsule body is not degraded, and is finally excreted.
2. the segmented intestine targeted capsule of Indomethacin according to claim 1, it is characterised in that：The plunger piece, with weight hundred
Divide than meter, by guar gum 46.2%, lactose 35.5-40.4%, hydroxypropyl methyl cellulose 4.9-9.9%, 8.1% and of filler
Lubricant 0.4% is made；The guar gum, lactose, hydroxypropyl methyl cellulose, filler and lubricant weight percent it
Be 100%.
3. the segmented intestine targeted capsule of Indomethacin according to claim 2, it is characterised in that：The plunger piece, with weight hundred
Divide than meter by guar gum 46.2%, lactose 40.4%, hydroxypropyl methyl cellulose 4.9%, filler 8.1% and lubricant
0.4% is made.
4. the segmented intestine targeted capsule of Indomethacin according to claim 2 or 3, it is characterised in that：The filler is crystallite
Cellulose or starch；The lubricant is talcum powder.
5. the segmented intestine targeted capsule of Indomethacin according to claim 4, it is characterised in that：The filler is microcrystalline cellulose
Element, the lubricant are talcum powder.
6. the segmented intestine targeted capsule of Indomethacin according to claim 1, it is characterised in that：The Indomethacin quick-release is micro-
Ball, by weight percentage, by cane sugar core 55.6%, Indomethacin 11.1-12.5% and hydrophilic carrier 25.0-33.3%
It is made；The sum of the cane sugar core, mass percent of Indomethacin and hydrophilic carrier are 100%.
7. the segmented intestine targeted capsule of Indomethacin according to claim 6, it is characterised in that：The Indomethacin quick-release is micro-
Ball is made of cane sugar core 55.6%, Indomethacin 11.1% and hydrophilic carrier 33.3% by weight percentage.
8. the segmented intestine targeted capsule of Indomethacin according to claim 6, it is characterised in that：The hydrophilic carrier is selected from poly-
Vinylpyrrolidone K30, PLURONICS F87 or Macrogol 6000.
9. the segmented intestine targeted capsule of Indomethacin according to claim 8, it is characterised in that：The hydrophilic carrier is poly- second
Alkene pyrrolidone K30.
10. the preparation method of the segmented intestine targeted capsule of Indomethacin described in claim 1, it is characterised in that：Include the following steps：
Step 1, Indomethacin and hydrophilic carrier are dissolved in absolute ethyl alcohol respectively and solution is made, two kinds of solution are mixed, with
Mixed liquor is made coating solution and is coated to cane sugar core using fluid bed, and Indomethacin fast release micropill is made；
Step 2, by guar gum, lactose, hydroxypropyl methyl cellulose, filler and lubricant sieving mixing, direct tablet compressing is made
Plunger piece；
Step 3, Indomethacin fast release micropill is filling in insoluble capsule body, plunger piece is filled in, covers enteric capsule cap, i.e.,
?.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810683154.3A CN108743561A (en) | 2018-06-22 | 2018-06-22 | A kind of segmented intestine targeted capsule of Indomethacin and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810683154.3A CN108743561A (en) | 2018-06-22 | 2018-06-22 | A kind of segmented intestine targeted capsule of Indomethacin and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101537184A (en) * | 2009-04-30 | 2009-09-23 | 杭州中美华东制药有限公司 | Composition containing water-insoluble high-activity drug and preparation method thereof |
| CN102805742A (en) * | 2012-08-02 | 2012-12-05 | 平阳县人民医院 | Indometacin target capsules for colons and preparation method thereof |
-
2018
- 2018-06-22 CN CN201810683154.3A patent/CN108743561A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101537184A (en) * | 2009-04-30 | 2009-09-23 | 杭州中美华东制药有限公司 | Composition containing water-insoluble high-activity drug and preparation method thereof |
| CN102805742A (en) * | 2012-08-02 | 2012-12-05 | 平阳县人民医院 | Indometacin target capsules for colons and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| JING LIU ETAL: "Preparation of konjac glucomannan-based pulsatile capsule for colonic drug delivery system and its evaluation in vitro and in vivo", 《CARBOHYDRATE POLYMERS》 * |
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Application publication date: 20181106 |