CN1660357A - Capsule of tin liked powder released at localization of colon and preparation method - Google Patents
Capsule of tin liked powder released at localization of colon and preparation method Download PDFInfo
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Abstract
A Chinese medicine in the form of capsule for treating ulcerative colitis by releasing it in colon is prepared from 7 Chinese-medicinal materials including ivory dust, natural indigo, human nail, pearl, etc through proportionally mixing, pulverizing, adding flowing aid, stirring, and loading in capsules.
Description
Invention field
The present invention relates to a kind of capsule of tin liked powder released at localization of colon preparation and preparation method, belong to the field of Chinese medicines.
Background of invention
The invention discloses a kind of capsule of tin liked powder released at localization of colon preparation and preparation method.XILEI SAN is traditional ancient prescription, comes from " the golden deficient wing ", records in the 2nd in " ministry standard " Chinese medicine main component: Dens Elephatis, Indigo Naturalis, Concha (Pulvis Talci system), Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis etc.Function: separate and poison corruption, be used for the throat erosion and swell and ache.Range of application enlarges day by day clinically at present, has extended to be applied to interior, youngster, woman, Wai Geke, especially uses more in the treatment of ulcerative colitis.
Ulcerative colitis claims chronic non-specific ulcerative colitis again, is commonly encountered diseases, the frequently-occurring disease in the China and the whole world, and is relevant with the generation of intestinal cancer.Ulcerative colitis belongs to the colon local patholoic change, and the cause of disease is not clear and definite fully, still do not have specific short clinically, so the meaning of topical therapeutic is very big.The medicine for the treatment of ulcerative colitis at present clinically is salazosulfamide class medicine such as Western medicine such as SASP, adrenocortical hormone and immunosuppressant mostly, adopts the administering mode of retention enema, and side effect is big, brings bigger misery to patient.XILEI SAN belongs to pure Chinese medicinal preparation, is made up of seven flavor Chinese medicines, has to separate and poisons outside the rotten effect, also has the dampness pain relieving, the effect of convergence granulation promoting.Clinically, except that being used for the throat erosion swells and ache, also the administering mode with retention enema is widely used in treatment colitis, and curative effect is very sure.Play a role though adopt the medication of coloclysis can make the through colon local lesion of medicine, because administration is very inconvenient, patient's poor compliance.
Summary of the invention
Develop that a kind of to be positioned that colon discharges, XILEI SAN novel form easy to use be clinical pressing for.Up to the present, still find no the data of any destruction novelty of the present invention, studying intensively of present inventor's process, by clinical practice and checking repeatedly, a large amount of clinical observation materials have been collected, obtained treatment treatment ulcerative colitis has been had the XILEI SAN novel form of better curative effect, thereby finished the present invention.
One of purpose of the present invention is that a kind of capsule of tin liked powder released at localization of colon that treatment treatment ulcerative colitis is had better curative effect will be provided.
Two of purpose of the present invention is preparation methoies that described capsule of tin liked powder released at localization of colon will be provided.
The present invention is achieved in that it comprises capsule, capsule 's content, adjuvant; capsule 's content is mainly crude drug; it is characterized in that it mainly being to make: 85～105 parts of Dens Elephatiss, 165 parts～205 parts of Indigo Naturaliss, 10～20 parts of Conchas, 25～35 parts of Uroctea compatilis Koch. charcoals, 85～105 parts of Margaritas, 7～12 parts of Borneolum Syntheticums, 10～20 parts of Calculus Boviss by following bulk drugs and adjuvant; Concha prepares with Pulvis Talci, 1～50 part of fluidizer, 0～50 part of composition of coatings coating material.
The parts by weight of described crude drug and adjuvant are preferably: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas, 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss, 1～25 part of fluidizer, 8～25 parts of coatings coating materials.
The preparation method of described capsule of tin liked powder released at localization of colon: Dens Elephatis, Indigo Naturalis, Concha, Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis are mixed by described parts by weight, be ground into 120 orders～nanoscale fine powder, the fluidizer that adds the described parts by weight of proper auxiliary materials, mixing, be packed in the Capsules, employing is sealed solution and is sealed; Quality inspection, finished product or capsule carried out coating, quality inspection, finished product.
Preparation method preferred one: Dens Elephatis, Indigo Naturalis, Concha, Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis are mixed by described parts by weight, be ground into 200 order fine powders; The fluidizer micropowder silica gel or the Pulvis Talci of the parts by weight that add; Seal solution and be a kind of in the alcoholic solution, 1～10% styrene maleic acid copolymer alcoholic solution of 2%～50%EC alcoholic solution, 10～30% gelatin ethanol (40%) solution, 1～15%PVP and 0.1～5% polyethylene polypropylene glycol copolymer.
Capsules is common medicinal hard capsule, and capsule is carried out coating; Coating material is common medicinal hard capsule coating, and the coating weightening finish is 2～5%.
Coating material is preferably: a kind of composition in a kind of and plasticizer diethyl phthalate in acrylic resin base polymer, the cellulose acetate-phthalate (CAP), diacetyl monoglyceride, Lac, Oleum Ricini, the octadecanol.
Coating material the best is preferably: adopt arbitrary group in following five groups, each group is made by the composition of described percetage by weight respectively:
(1), Eudrait S100 1～6%, Eudrait L100 0.5～5%, diethyl phthalate 0.5～5%, Pulvis Talci 0.5～6%, ethanol 80～97%.
(2), Eudrait S100 2～10%, diacetyl monoglyceride 1～7%, Pulvis Talci 0.5～6%, ethanol 80～95%.
(3), Eudrait S100 1～7%, Eudrait L100 0.2～5%, diethyl phthalate 0.2～5%, Pulvis Talci 0.5～6%, ethanol 80～97%.
(4), II acroleic acid resin 1～10%, III acroleic acid resin 0.1～5%, diethyl phthalate 0.5～7%, Pulvis Talci 0.5～7%, tween 80 0.1～6%, ethanol 70～95%.
(5), Eudrait RS 0.1～5%, Eudrait S 0.1～6%, Eudrait L 2～12%, diethyl phthalate 0.1～6%, ethanol 45～85%, acetone 10～30%.
Preparation method preferred two: Dens Elephatis, Indigo Naturalis, Concha, Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis are mixed by described parts by weight, be ground into 200 order fine powders.Capsules is the knot enteric coated capsule; Described fluidizer is micropowder silica gel or Pulvis Talci; The knot enteric coated capsule is calcium pectinate type Capsules or knot enteric solubility (Type B) capsule (development of Chaozhou, Guangdong Province capsule for medicine factory), and the calcium content of calcium pectinate type Capsules is 2～20%; Seal solution and be a kind of in the alcoholic solution, 1～10% styrene maleic acid copolymer alcoholic solution of 2%～50%EC alcoholic solution, 10～30% gelatin ethanol (40%) solution, 1～15%PVP and 0.1～5% polyethylene polypropylene glycol copolymer.
Described colon location preparation is a capsule, and delivery mode is pH type and enzyme control type.
At present, the conlon targeting release pharmaceutical dosage form mostly is tablet, capsule, and wherein the production technology of capsule is more simple, uses adjuvant few, and disintegrate is rapid, and is rapid-action, relatively is received by the market.
The common preparation method of pH type knot enteric solubility capsule has the direct fill of medicine in the knot enteric coated capsule, or fill wraps pH responsive type knot enteric coating again behind common hard capsule, promptly.Coating material commonly used has the acroleic acid resin class, as the Youteqi of German rohm company
L type, S type and RS type (Eudrait
L type, S type and RS type), or both mixture by a certain percentage; Domestic have enteric II number, III acroleic acid resin, or both mixture by a certain percentage; Also has cellulose acetate-phthalate (CAP) etc.Because the thickness of coating can directly influence the disintegration time of preparation, coating weightening finish therefore of the present invention is 2～5%.
The preparation principle of enzyme control type knot enteric solubility capsule of the present invention is to utilize pectin not degraded by the enzyme of stomach and small intestinal, and the characteristics that can be degraded by colonic enzyme and the preparation that designs, because pectin is water soluble polysaccharide, be directly used in colon locating administrated weak effect, its calcification become water solublity reduces behind the calcium pectinate, and degraded character is constant, is ideal conlon targeting material therefore.During preparation, directly medicine is packed in the calcium pectinate Capsules and gets final product.The preparation method of calcium pectinate Capsules is to immerse the calcium chloride solution calcification again after the mould rod is immersed pectin solution, promptly.
XILEI SAN of the present invention belongs to pure Chinese medicinal preparation, adopt the modern pharmaceutical technology that it is modified into the conlon targeting release capsule through dosage form, can be with drug conveying to conlon targeting release, directly act on focus, effect is strong, because of this preparation administering mode with common oral solid formulation, use more conveniently, patient compliance is better.Therefore, the present invention has the advantage for the treatment of significantly when the treatment ulcerative colitis.
The specific embodiment
The present invention is described further by clinical observation test and embodiment.
One, prescription: Dens Elephatis, Indigo Naturalis, Concha (Pulvis Talci system), Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis.Record in the 2nd in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese medicine
Two, the side separates: the clear removing pathogen in the heart gastric heat of Indigo Naturalis poison in the side, relieving sore throat and diminishing swelling, cooling blood and relieving pain; Cooperate Calculus Bovis, Borneolum Syntheticum to strengthen the merit of clearing heat, releasing toxin, removing swelling; Margarita, Dens Elephatis, Concha help the Indigo Naturalis heat clearing away of drawing out pus by applying a plaster to the affected part, removing the necrotic tissue and promoting granulation, sore-throat relieving; It is flat nontoxic that Uroctea compatilis Koch. carbon becomes, heat-clearing and toxic substances removing, cooling blood and relieving pain.All medicines share, and play altogether to separate to poison corruption, the merit of muscle-growing and detumescence.
Three, the clinical effect of medical material:
(1) Indigo Naturalis: be the dry pigment in acanthaceous vegetable acanthaceous indigo, leguminous plant Folium et Caulis Indigoferae Tinctoriae, cruciferae isatis, careless Folium Isatidis or the polygonaceae plant polygonum tinctorium ait. leaf.Heat clearing away, removing heat from blood, detoxifcation.Control epidemic febrile disease intenseness of heat, macule, haematemesis, spitting of blood, pediatric epilepsy scared, skin ulcer is swollen, erysipelas, snake bite and insect sting.In in-vitro pharmacological experiments, its pure immersion (0.5g/ml) all has inhibitory action to anthrax bacillus, pneumobacillus, dysentery bacterium, golden yellow Fructus Vitis viniferae and Staphylococcus albus.
(2) Calculus Bovis: be the calculus in gallbladder, bile duct or the common hepatic duct of bovid cattle or Babalus bubalis L..Clear away heart-fire, function of gallbladder promoting reduces phlegm, and is relieving convulsion.Control that calentura coma, delirium, epilepsy are gone mad, infantile convulsion tic, ulcerative gingivitis, larynx are swollen, aphtha of the mouth and tongue, carbuncle, treatment poison.
(3) Borneolum Syntheticum: be the processed goods of Dipterocarpaceae plant Borneolum Syntheticum resin, or for Camphora, Lignum Pini Nodi wet goods with the synthetic product of being processed into of chemical method.Logical all keys, the stagnated fire of loosing, removing nebula makes eye bright, reducing swelling and alleviating pain.Control the apoplexy locked mouth, calentura coma, infantile convulsion expectorant fan, deafness with qi stagnation, sore throat, aphtha, otitis media, carbuncle, hemorrhoid, conjunctivitis, enterobiasis.
(4) Margarita: be the no nucleus pearl that forms in the shell-fish pearl sacs such as Pteriidae animal Margarita, Pteria martensii Dunker or Unionidae animal hydriopsis cumingii, cristaria plicata, anodonta woodiana pacifica.Tranquilizing mind, yin nourishing relieves dizziness, high fever, infantile convulsions, epilepsy, etc., and expectorant is weighed down in heat clearing away, and removing nebula makes eye bright, removing toxic substances and promoting granulation.Control palpitation with fear, palpitation with a distress feeling, epilepsy, infantile convulsion, dysphoria with smothery sensation is quenched one's thirst, the sore throat aphtha, order is given birth to cataracta, and skin infection does not close up for a long time.
(5) Dens Elephatis: be the tooth of Elephantidae animal elephant.Heat clearing away is relieving convulsion, removing toxic substances and promoting granulation.Control the sick palpitation with fear of epilepsy, hectic fever due to YIN-deficiency expectorant heat, carbuncle sore tumefacting virus, anal fistula.
(6) Concha: control epistaxis, hematuria, throat moth, order is given birth to cataracta, otitis media.
(7) Uroctea compatilis Koch. charcoal (Uroctea compatilis Koch.): be the Scorpio of Uroctea compatilis Koch. section animal Uroctea compatilis Koch..Control sore throat, ulcerative gingivitis, epistaxis, the hemorrhoid hematochezia, incised wound is hemorrhage.
Above medical material records in the Chinese medicine voluminous dictionary, and the new medical college in Jiangsu is compiled, and the People's Health Publisher publishes.
Four, the routine clinical observation on the therapeutic effect data of test
1. clinical data " diagnosis of ulcerative colitis and the criterion of therapeutical effect " of working out with reference to the whole nation, Taiyuan in 1993 chronic noninfective intestinal tract disease scientific seminar, according to clinical manifestation, colonoscope, mucosa biological tissue pathology, barium coloclysis, inspections such as stool routine examination and antibacterial culturing, and the eliminating crohn, anemia colitis, radiation colitis, bacillary dysentery, amebic dysentery, schistosomicide, tuberculosis of intestine, illness such as colon cancer and irritable bowel syndrome is made a definite diagnosis the ulcerative colitis case.By clinical severity extent divide light, in, weigh 3 degree, divide I level, II level, III level by colonoscopy inflammation degree with the Truelove staging.
2. Therapeutic Method
(1) general treatment: the patient with severe symptoms lies up, and gives easy digestion, few fiber and is rich in the vitamin diet; Spirit hypertonicity person gives an amount of tranquilizer; The heavier person that suffers from abdominal pain gives relieving spasm to stop pain medicine in a small amount; Electrolyte disturbance and acid-base balance are corrected in fluid infusion in time; Select antibiotic control secondary infection in case of necessity for use.
(2) test grouping:
1. XILEI SAN group: 2 of oral capsule of tin liked powder released at localization of colon (every contains 0.3 part of XILEI SAN), every day 3 times, 4 weeks were 1 course of treatment;
2. matched group: hydrocortisone 100m part is dissolved among the 0.5% metronidazole 100ml, 1 2h of retention enema every night, the emptying stool is adopted the Trendelenburg position and left and right sides clinostatism before each coloclysis, and the checker position makes medicinal liquid fully contact with intestinal wall, 4 weeks of the course of treatment.All case 4 Zhou Houjun do colonoscope and pathological examination.
3. criterion of therapeutical effect (1) produce effects: clinical cardinal symptom disappears, and routine inspection of excrement is normal, and intestinal mucosa recovers normally or only to stay cicatrix; (2) effective: clinical cardinal symptom alleviates, the stool routine examination erythrocyte 5/below the HP, the intestinal mucosal lesion area improves more than 50%, or slight mucous hyperemia is only arranged; (3) invalid: symptom does not have improvement, the stool routine examination erythrocyte 5/more than the HP, the intestinal mucosal lesion area improves below 50% or no change.
4. result of the test:
(1) physical data: the patient is divided into 2 groups:
1. treatment group: case 30 examples, wherein ascending colon, transverse colon and descending colon pathological changes 6 examples, rectum, sigmoid colon pathological changes 23 examples, total colectomy pathological changes 1 example; Man's 21 examples, women 9 examples; Age 20-67 year, average 37 years old; The course of disease 3 months-24 years, average 9.4 years; Slight 12 examples, moderate 17 examples, severe 1 example, I level 12 examples, II level 15 examples, III level 3 examples.
2. matched group: case 30 examples, wherein ascending colon, transverse colon and descending colon pathological changes 8 examples, rectum, sigmoid colon pathological changes 22 examples; Man's 18 examples, women 12 examples; Age 19-61 year, average 35 years old; The course of disease 2 months-19 years, average 11.3; Slight 13 examples, moderate 16 examples, severe 1 example, I level 13 examples, II level 15 examples, III level 2 examples.
(2) therapeutic outcome:
1. treatment group: produce effects 20 examples (66.67%), effective 8 examples (26.67%), invalid 2 examples (6.67%), total effective rate 28 examples (93.34%).
2. matched group: produce effects 14 examples (46.67%), effective 11 examples 36.67%), invalid 5 examples (16.67%), total effective rate 25 examples (83.34%).
(3) analysis: Ridit analyzes two groups of clinical test results, visible treatment group and matched group there was no significant difference (u=1.6516, P＞0.05).The results are shown in following table.
Two groups of clinical test results (n, %)
| Group | ????n | Produce effects | Effectively | Invalid | Total effective rate |
| XILEI SAN group matched group | ????30 ????30 | ????20(66.67) ????14(46.67) | 8(26.67) 11(36.67) | 2(6.67) 5(16.67) | 28(93.34) 25(83.34) |
5. discuss:
The XILEI SAN composition is Dens Elephatis, Indigo Naturalis, Uroctea compatilis Koch. charcoal, Concha, Margarita, Borneolum Syntheticum, Calculus Bovis etc., has heat-clearing and toxic substances removing, convergence granulation promoting, reducing swelling and alleviating pain, anticorrosion itching relieving effect, effectively promotes ulcer healing.Modern study confirms that it can impel gastrointestinal mucosa PEG
2Synthetic, can reduce capillary permeability, the secretion of gastric mucosa and blood flow are increased, promote epithelial hyperplasia, the broad-spectrum antibacterial action is arranged simultaneously, thereby promotes the ulcer surface healing.
In the treatment of ulcerative colitis routine, except that general treatment, mainly be first-selected salazosulfamide class medicine such as sulphur nitrogen sulfapyridine, or be used adrenocortical hormone, immunosuppressant etc., usually adopt the administering mode of retention enema, use very inconvenience, and these adverse effectes are big, bring very big misery to the patient.XILEI SAN belongs to pure Chinese medicinal preparation, adopt the modern pharmaceutical technology that it is modified into the conlon targeting release capsule through dosage form, can be with drug conveying to conlon targeting release, directly act on focus, effect is strong, curative effect is suitable with the administering mode that adopts the adrenocortical hormone retention enema, but untoward reaction is littler.Because of this preparation administering mode with common oral solid formulation, use more conveniently, patient compliance is better.Therefore, the present invention has the advantage for the treatment of significantly when the treatment ulcerative colitis.
Five, embodiment:
Embodiment 1:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss
Fluidizer: 25 parts of 1.5 parts of micropowder silica gels or Pulvis Talci
15 parts of coatings coating materials: coating material is made up of the composition of described percetage by weight: Eudrait S100 6%, diethyl phthalate 4%, Pulvis Talci 2%, ethanol 88%.
Sealing solution is 2%～50%EC alcoholic solution.
With fine drug powder and auxiliary materials and mixing, be packed into hard capsule, seal, coating, drying, promptly.
Embodiment 2:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 18 parts of 2.2 parts of micropowder silica gels or Pulvis Talci;
20 parts of coatings coating materials: coating material is made up of the composition of described percetage by weight: Eudrait S100 6%, diacetyl monoglyceride 3%, Pulvis Talci 2.5%, ethanol 88.5%.
Sealing solution is 10～30% gelatin ethanol (40%) solution.
With fine drug powder and auxiliary materials and mixing, be packed into hard capsule, seal, coating, drying, promptly.
Embodiment 3:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 18 parts of 2.2 parts of micropowder silica gels or Pulvis Talci;
20 parts of coatings coating materials: coating material is made up of the composition of described percetage by weight: Eudrait S100 3.75%, Eudrait L100 1.25%, diethyl phthalate 1.5%, Pulvis Talci 2.5%, ethanol 91%.
Sealing solution is the alcoholic solution of 1～15%PVP and 0.1～5% polyethylene polypropylene glycol copolymer.
With fine drug powder and auxiliary materials and mixing, be packed into hard capsule, seal, coating, drying, promptly.
Embodiment 4:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 18 parts of 2.2 parts of micropowder silica gels or Pulvis Talci;
15 parts of coatings coating materials: coating material is made up of the composition of described percetage by weight: II acroleic acid resin 5%, III acroleic acid resin 1%, diethyl phthalate 3%, Pulvis Talci 3%, tween 80 2%, ethanol 87%.
Sealing solution is 1～10% styrene maleic acid copolymer alcoholic solution.
With fine drug powder and auxiliary materials and mixing, be packed into hard capsule, seal, coating, drying, promptly.
Embodiment 5:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 18 parts of 2.2 parts of micropowder silica gels or Pulvis Talci;
15 parts of coatings coating materials: coating material is made up of the composition of described percetage by weight: Eudrait RS 1%, Eudrait S 2%, Eudrait L 7%, diethyl phthalate 2%, ethanol 68%, acetone 20%.
Sealing solution is 10～30% gelatin ethanol (40%) solution.
With fine drug powder and auxiliary materials and mixing, be packed into hard capsule, seal, coating, drying, promptly.
Embodiment 6:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 18 parts of 2.2 parts of micropowder silica gels or Pulvis Talci;
With fine drug powder and auxiliary materials and mixing, be packed in the knot enteric solubility Capsules (Chaozhou, Guangdong Province capsule for medicine factory), seal, promptly.
Sealing solution is the alcoholic solution of 1～15%PVP and 0.1～5% polyethylene polypropylene glycol copolymer.
Embodiment 7:
Capsule 's content: 93.8 parts of Dens Elephatiss, 187.5 parts of Indigo Naturaliss, 15.6 parts of Conchas (Pulvis Talci system), 31.3 parts of Uroctea compatilis Koch. charcoals, 93.8 parts of Margaritas, 9.4 parts of Borneolum Syntheticums, 15.6 parts of Calculus Boviss;
Fluidizer: 25 parts of 1.5 parts of micropowder silica gels or Pulvis Talci;
Sealing solution is 1～10% styrene maleic acid copolymer alcoholic solution.
The preparation of Capsules: 15% hypo-methoxy pectin solution 400ml, 5% calcium chloride ethanol (70%) solution 400ml, 5%PVP ethanol liquid 400ml.
Employing is dipped in the glue legal system and is equipped with capsule.With hypo-methoxy pectin solution ultrasonic degas, immersed in the glue 1 minute with metal bar, take out, immersed in the calcium chloride solution fully calcification more about 1 hour, take out, dry up in 30 ℃, immersed in the PVP ethanol liquid about 2 minutes, take out, in 30 ℃ of dryings, pull out shell, cutting, arrangement, promptly.
With fine drug powder and auxiliary materials and mixing, be packed in the calcium pectinate Capsules, seal, promptly.
Claims (10)
1, a kind of capsule of tin liked powder released at localization of colon; it comprises capsule, capsule 's content, adjuvant; capsule 's content is mainly crude drug; it is characterized in that it mainly being to make: 85～105 parts of Dens Elephatiss, 165 parts～205 parts of Indigo Naturaliss, 10～20 parts of Conchas, 25～35 parts of Uroctea compatilis Koch. charcoals, 85～105 parts of Margaritas, 7～12 parts of Borneolum Syntheticums, 10～20 parts of Calculus Boviss by following bulk drugs and adjuvant; Concha prepares with Pulvis Talci, 1～50 part of fluidizer, 0～50 part of composition of coatings coating material.
2, the preparation method of the capsule of tin liked powder released at localization of colon of claim 1, it is characterized in that: Dens Elephatis, Indigo Naturalis, Concha, Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis are mixed by described parts by weight, be ground into fine powder, the fluidizer that adds the described parts by weight of proper auxiliary materials, mixing, be packed in the Capsules, employing is sealed solution and is sealed; Quality inspection, finished product or capsule carried out coating, quality inspection, finished product.
3, the preparation method of capsule of tin liked powder released at localization of colon according to claim 3, its feature also are Dens Elephatis, Indigo Naturalis, Concha, Uroctea compatilis Koch. charcoal, Margarita, Borneolum Syntheticum, Calculus Bovis are mixed by described parts by weight, are ground into 120 orders～nanoscale fine powder.
4, the preparation method of capsule of tin liked powder released at localization of colon according to claim 3, its feature are that also Capsules is common medicinal hard capsule or knot enteric coated capsule, when adopting common medicinal hard capsule, carries out coating to capsule.
5, the preparation method of capsule of tin liked powder released at localization of colon according to claim 3, its feature also are to seal a kind of in alcoholic solution that solution is 2%～50%EC alcoholic solution, 10～30% gelatin ethanol (40%) solution, 1～15%PVP and 0.1～5% polyethylene polypropylene glycol copolymer, 1～10% styrene maleic acid copolymer alcoholic solution.
6, the preparation method of capsule of tin liked powder released at localization of colon according to claim 3 is characterized in that described fluidizer is micropowder silica gel or Pulvis Talci.
7, the preparation method of capsule of tin liked powder released at localization of colon according to claim 5, its feature are that also coating material adopts common medicinal hard capsule coating, and the coating material weightening finish is 2～5%; Described coating material is mainly by a kind of composition the in a kind of and plasticizer diethyl phthalate in acrylic resin base polymer, the cellulose acetate-phthalate (CAP), diacetyl monoglyceride, Lac, Oleum Ricini, the octadecanol.
8, the preparation method of capsule of tin liked powder released at localization of colon according to claim 5, its feature are that also coating material can adopt arbitrary group in following five groups, and each group is made by the composition of described percetage by weight respectively:
(1), Eudrait S100 1～6%, Eudrait L100 0.5～5%, diethyl phthalate 0.5～5%, Pulvis Talci 0.5～6%, ethanol 80～97%.
(2), Eudrait S100 2～10%, diacetyl monoglyceride 1～7%, Pulvis Talci 0.5～6%, ethanol 80～95%.
(3), Eudrait S100 1～7%, Eudrait L100 0.2～5%, diethyl phthalate 0.2～5%, Pulvis Talci 0.5～6%, ethanol 80～97%.
(4), II acroleic acid resin 1～10%, III acroleic acid resin 0.1～5%, diethyl phthalate 0.5～7%, Pulvis Talci 0.5～7%, tween 80 0.1～6%, ethanol 70～95%.
(5), Eudrait RS 0.1～5%, Eudrait S 0.1～6%, Eudrait L 2～12%, diethyl phthalate 0.1～6%, ethanol 45～85%, acetone 10～30%.
9, it is calcium pectinate type Capsules or knot enteric solubility Type B capsule that the preparation method of capsule of tin liked powder released at localization of colon according to claim 5, its feature also are to tie enteric coated capsule, and the calcium content of calcium pectinate type Capsules is 2～20%.
10, the preparation method of capsule of tin liked powder released at localization of colon according to claim 5, it is calcium pectinate type Capsules that its feature also is to tie enteric coated capsule, being prepared as of described calcium pectinate type Capsules: 15% hypo-methoxy pectin solution 400ml, 5% calcium chloride ethanol (70%) solution 400ml, 5%PVP ethanol liquid 400ml; Employing is dipped in the glue legal system and is equipped with capsule.With the hypo-methoxy pectin solution degassing, immersed in the glue 1～3 minute with metal bar, take out, immersed in the calcium chloride solution calcification again 1～3 hour, take out, dry up in 30 ℃, immersed in the PVP ethanol liquid 2～5 minutes, take out, in 30 ℃ of dryings, pull out shell, cutting, arrangement, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002471 CN1660357A (en) | 2005-01-24 | 2005-01-24 | Capsule of tin liked powder released at localization of colon and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002471 CN1660357A (en) | 2005-01-24 | 2005-01-24 | Capsule of tin liked powder released at localization of colon and preparation method |
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| CN1660357A true CN1660357A (en) | 2005-08-31 |
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| CN 200510002471 Pending CN1660357A (en) | 2005-01-24 | 2005-01-24 | Capsule of tin liked powder released at localization of colon and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505548A (en) * | 2013-06-25 | 2014-01-15 | 江苏七○七天然制药有限公司 | Traditional Chinese medicine used for treating ulcerative colitis, and preparation method and detection method thereof |
| CN111867583A (en) * | 2018-01-18 | 2020-10-30 | 学校法人庆应义塾 | Capsule for treating ulcerative colitis |
-
2005
- 2005-01-24 CN CN 200510002471 patent/CN1660357A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505548A (en) * | 2013-06-25 | 2014-01-15 | 江苏七○七天然制药有限公司 | Traditional Chinese medicine used for treating ulcerative colitis, and preparation method and detection method thereof |
| CN111867583A (en) * | 2018-01-18 | 2020-10-30 | 学校法人庆应义塾 | Capsule for treating ulcerative colitis |
| EP3741368A4 (en) * | 2018-01-18 | 2021-12-22 | Keio University | Capsule for treating ulcerative colitis |
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