CN105879005A - Pharmaceutical composition for treating ulcerative colitis as well as preparation method and application of pharmaceutical composition - Google Patents
Pharmaceutical composition for treating ulcerative colitis as well as preparation method and application of pharmaceutical composition Download PDFInfo
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- CN105879005A CN105879005A CN201610068130.8A CN201610068130A CN105879005A CN 105879005 A CN105879005 A CN 105879005A CN 201610068130 A CN201610068130 A CN 201610068130A CN 105879005 A CN105879005 A CN 105879005A
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
- A61K31/401—Proline; Derivatives thereof, e.g. captopril
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Abstract
The invention provides a pharmaceutical composition for treating ulcerative colitis as well as a preparation method and an application of the pharmaceutical composition. The pharmaceutical composition consists of the following components in parts by weight: 5-35 parts of glutamic acid, 1-10 parts of adenosine, 1-10 parts of dopamine, 5-35 parts of arginine, 5-25 parts of glutamine, 5-25 parts of threonine, 1-10 parts of methionine, 1-10 parts of serine, 5-25 parts of proline and 5-25 parts of cyclo-(gly-pro) dipeptide. The pharmaceutical composition can be prepared in any pharmaceutical dosage forms suitable for taking, preferably the pharmaceutical composition is in the form of a liquid preparation. The total effective rate of the pharmaceutical composition on treating the ulcerative colitis can reach 94%, and the pharmaceutical composition, after curing the ulcerative colitis, is low in recurrence rate.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of pharmaceutical composition treating ulcerative colitis and preparation side thereof
Method and application.
Background technology
Ulcerative colitis (ulcerative colitis, UC), is called for short knot of bursting, and is a kind of knot, rectal mucosal fills the air
Property inflammation, symptom, based on diarrhoea, is discharged containing blood, pus and the feces of mucus, is often accompanied by paroxysmal spastic colon pain, and
Tenesmus, can obtain alleviation after defecation.
The most clinical many employing aminosalicylic acids and the solid acids Medication in Ulcerative Colitis of cortex class, but exist and stop
The shortcomings such as bounce-back after medicine, curative effect is unstable, long-term prescription side effect is bigger；Operative treatment, it is simply that excise whole colon, but due to
The complication of operation is more, has a strong impact on the quality of life of postoperative patient.
So, now it is badly in need of finding a kind of medicine that can effectively treat ulcerative colitis, alleviates the burden of patient.
Summary of the invention
For above-mentioned technical problem, it is an object of the invention to provide a kind of medicine that can effectively treat ulcerative colitis
Compositions, the therapeutic effect of ulcerative colitis substantially and is had no side effect by described pharmaceutical composition, and relapse rate is low.
The present invention also aims to provide the preparation method and application of described pharmaceutical composition.
Constituent and the content thereof of pharmaceutical composition of the present invention include by weight: glutamic acid 5～35 parts,
Adenosine 1～10 parts, dopamine 1～10 parts, arginine 5～35 parts, glutamine 5～25 parts, threonine 5～25 parts, first sulfur ammonia
Acid 1～10 part, serine 1～10 parts, proline 5～25 parts, ring (sweet-dried meat) dipeptides 5～25 parts.
Preferably, constituent and the content thereof of described pharmaceutical composition include by weight: glutamic acid 10～25
Part, adenosine 3～7 parts, dopamine 3～7 parts, arginine 15～25 parts, glutamine 8～15 parts, threonine 8～15 parts, first sulfur
Propylhomoserin 3～7 parts, serine 3～7 parts, proline 8～15 parts, ring (sweet-dried meat) dipeptides 8～15 parts.
Preferably, constituent and the content thereof of described pharmaceutical composition include by weight:
20 parts of glutamic acid, adenosine 5 parts, dopamine 5 parts, arginase 12 0 part, glutamine 10 parts, threonine 10 parts, methionine 5
Part, serine 5 parts, proline 10 parts, ring (sweet-dried meat) dipeptides 10 parts.
Ring of the present invention is sweet-and dried meat dipeptides is with reference to " Qin Xiancan, Yu Zhengpeng etc., the synthesis of ring (L-group-L-dried meat) dipeptides
[J], Hainan Normal University's journal: natural science edition, 2008,21(2): the 173-175 " synthesis of medium ring (L-group-L-dried meat) dipeptides
Prepared by method.
Pharmaceutical composition of the present invention can be prepared as any pharmaceutics according to the conventional method of pharmaceutical field
Upper described dosage form；The described pharmaceutical composition preferred dosage form of the present invention is liquid preparation.
For making above-mentioned dosage form be capable of, pharmaceutically acceptable adjuvant need to be added when preparing these dosage forms, such as: system
Need to add one or more in filler, lubricant, binding agent during standby one-tenth capsule；Need when being prepared as liquid preparation to add
Enter solubilizing agent, correctives, preservative, pH adjusting agent one or more.
Described filler includes starch, microcrystalline Cellulose, lactose, dextrin, pregelatinized Starch etc..
Described lubricant includes magnesium stearate, micropowder silica gel, Pulvis Talci, polyethylene glycols etc..
Described binding agent includes starch, polyvidone, polyvinylpyrrolidone, sodium carboxymethyl cellulose etc..
Described solubilizing agent includes: poly yamanashi esters, polyoxyethylene fatty acid class etc.
Described correctives includes: essence, glycerol, sorbitol, mannitol etc.
Described preservative includes: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide etc..
Described pH adjusting agent includes: sodium hydroxide or hydrochloric acid.
The administering mode of medicine composite for curing ulcerative colitis of the present invention can be that oral administration can also
Being that coloclysis is administered, preferably coloclysis is administered, once a day, and each 50～100ml.
The preparation method of pharmaceutical composition of the present invention, may comprise steps of: (1) is by described component and contains
Amount weighs raw material；(2) by after raw material mix homogeneously, the medicine system that pharmaceutically acceptable adjuvant is prepared as pharmaceutically commonly using is added
Agent.
Pharmaceutical composition of the present invention has significant curative effect to ulcerative colitis, and total effective rate can reach
94%, control recurrence rate after healing low, have no side effect.
Detailed description of the invention
Following example are used for illustrating the present invention, but are not to limit scope of the present invention.
Aminoacid used by the present invention is to purchase in Tianjin TianAn Medicine Industry Co., Ltd.
Adenosine used by the present invention, dopamine are purchased in Shanghai ten thousand boundary Bioisystech Co., Ltd.
Adjuvant and medicine used by the present invention commercially can be purchased.
Embodiment 1 ring of the present invention is sweet-preparation of dried meat dipeptides
The ring of the present invention is sweet-the preparation method reference literature of dried meat dipeptides " Qin Xiancan, Yu Zhengpeng etc., ring (L-group-L-dried meat) dipeptides
Synthesis [J], Hainan Normal University's journal: natural science edition, 2008,21(2): 173-175 " medium ring (L-group-L-dried meat) dipeptides
Synthetic method prepare ring of the present invention sweet-dried meat dipeptides, method particularly includes: L-PROLINE methyl ester and N-tertbutyloxycarbonyl-
L-glycine propylhomoserin is raw material, is condensed to obtain straight chain dipeptides through DCC, then takes off Boc protection, cyclization under weak basic condition through HCl/Et2O
Obtain ring (sweet-dried meat) dipeptides.
Embodiment 2
Weigh glutamic acid 20g, adenosine 5g, dopamine 5g, arginase 12 0g, glutamine 10g, threonine 10g, methionine 5g,
Serine 5g, proline 10g, ring (sweet-dried meat) dipeptides 10g(is prepared by the method for embodiment 1), add purification after mix homogeneously
Water dissolution, to 1000ml, stirring and evenly mixing, adds 50ml glycerol and 1g potassium sorbate, and regulation pH value to 6.5～7.5, filters, fills
Envelope, 115 DEG C of sterilizing 30min, packaging, to obtain final product.
Embodiment 3
Weigh glutamic acid 20g, adenosine 5g, dopamine 5g, arginase 12 0g, glutamine 10g, threonine 10g, methionine 5g,
Serine 5g, proline 10g, ring (sweet-dried meat) dipeptides 10g(is prepared by the method for embodiment 1), after mixing, add 79g and form sediment
Powder, 8g carboxymethyl starch sodium mix, and pelletize, add the micropowder silica gel of 2g, be filled in enteric coated capsule, to obtain final product.
Embodiment 4
Glutamic acid 5g, adenosine 1g, dopamine 1g, arginine 5g, glutamine 5g, threonine 5g, methionine 1g, serine
1g, proline 5g, ring (sweet-dried meat) dipeptides 5g(is prepared by the method for embodiment 1), after mixing, add 1000ml purified water,
After stirring and dissolving, adding 80g PEG400, sodium benzoate 1.5g, regulation pH value, to 6.5～7.5, filters, embedding, 115
DEG C sterilizing 30min, packaging, to obtain final product.
Embodiment 5
Glutamic acid 10g, adenosine 3g, dopamine 3g, arginine 15g, glutamine 8g, threonine 8g, methionine 3g, serine
3g, proline 8g, ring (sweet-dried meat) dipeptides 8g(is prepared by the method for embodiment 1), after mixing, add the purification of 1000ml
Water, after stirring and dissolving, adds 40ml glycerol, and 1g benzoic acid, and regulation pH value, to 6.5～7.5, filters, embedding, 115 DEG C of sterilizings
30min, packaging, to obtain final product.
Embodiment 6
Glutamic acid 25g, adenosine 7g, dopamine 7g, arginase 12 5g, glutamine 15g, threonine 15g, methionine 7g, silk ammonia
Acid 7g, proline 15g, ring (sweet-dried meat) dipeptides 15g(are prepared by the method for embodiment 1), after mixing, add 54g dextrin,
15g polyvinylpyrrolidone, after mixing, pelletizes, is packed in enteric coated capsule, to obtain final product.
Embodiment 7
Glutamic acid 35g, adenosine 10g, dopamine 10g, arginine 35g, glutamine 25g, threonine 25g, methionine 10g,
Serine 10g, proline 25g, ring (sweet-dried meat) dipeptides 25g(is prepared by the method for embodiment 1), after mixing, add 81g
Pregelatinized Starch, 24g sodium carboxymethyl cellulose, after mixing, pelletize, be packed into enteric coated capsule, to obtain final product.
By experiment, pharmaceutical composition of the present invention will be described further for the curative effect of ulcerative colitis below:
The experimental example 1 therapeutic effect to ulcerative colitis
1. case-data and packet:
107 examples, the maleest 59 examples, female 48 example, the age, 107 example patients were through electronic colonoscopy and pass through 26～65 years old
Tissue pathology checking is diagnosed as ulcerative colitis.Patient need to cut out other drug 1 week before accepting experiment.Clinical table
Existing mucus bloody purulent stool, stomachache, tenesmus, heating, lose weight, anemia, one or more symptoms in parenteral pathological changes.Will
Patient is randomly divided into 3 groups: matched group 54 example (male 30 examples, female 24 example), test group 53 example (male 28 examples, female 25 example).
2. method:
Test group: the liquid preparation 100ml containing pharmaceutical composition of the present invention prepared according to embodiment 2 method, adds
Warm to 38 DEG C, retention enema.Once a day, 2 weeks it are used in conjunction.
Matched group: 5-ASA 2g dissolves in 0.9% normal saline 100ml, is heated up to 38 DEG C, retention enema.Once a day, even
With 2 weeks.
3. curative effect determinate standard
Clinical cure: main clinical symptoms all disappears, and secondary symptom substantially disappears, and patient just checks for conventional 3 times
The most normal；
Clinical effective: main clinical symptoms disappears the most substantially, and its improvement degree of secondary symptom is the most obvious.Patient
Just within conventional prompting is white, erythrocyte is 3 under the visual field of high power lens；
Symptom takes a turn for the better: main clinical symptoms is improved, and patient's just conventional prompting is white, erythrocyte is equal under the visual field of high power lens
It it is about 5；
Fail to respond to any medical treatment: after treating patient, its pathologic finding, colonoscopy and clinical symptoms are showed no improvement；
Total effective rate=(cure+effective+take a turn for the better)/case load) × 100%
4. experimental result:
After off-test 6 months, the patient curing this test pays a return visit, and finds: in 15 people cured in matched group
Having 4 people's recurrences, 25 people cured in test group always only have 1 people's recurrence.This tests concrete outcome such as table 1 below:
| Case load | Cure | Effective | Effectively | Invalid | Total effective rate | |
| Matched group | 54 | 15 | 13 | 16 | 10 | 81.48% |
| Test group | 53 | 25 | 15 | 10 | 3 | 94.34% |
Can be obtained by the result in table 1, in the curative effect of medicine composite for curing ulcerative colitis of the present invention substantially
Higher than 5-ASA curative effect in treatment ulcerative colitis, there is statistical significance.
In sum, pharmaceutical composition of the present invention has a significant effect in treatment ulcerative colitis, its
Middle total effective rate can reach about 94%, and it is low to control recurrence rate after healing.
Claims (6)
1. the pharmaceutical composition treating ulcerative colitis, it is characterised in that the constituent of described pharmaceutical composition
And content includes by weight: glutamic acid 5～35 parts, adenosine 1～10 parts, dopamine 1～10 parts, arginine 5～35 parts,
Glutamine 5～25 parts, threonine 5～25 parts, methionine 1～10 parts, serine 1～10 parts, proline 5～25 parts, ring
Sweet-dried meat dipeptides 5～25 parts.
Pharmaceutical composition the most according to claim 1, it is characterised in that the constituent of described pharmaceutical composition and
Content includes by weight: glutamic acid 10～25 parts, adenosine 3～7 parts, dopamine 3～7 parts, arginine 15～25 parts, paddy ammonia
Amide 8～15 parts, threonine 8～15 parts, methionine 3～7 parts, serine 3～7 parts, proline 8～15 parts, ring be sweet-dried meat two
Peptide 8～15 parts.
Pharmaceutical composition the most according to claim 1 and 2, it is characterised in that the constituent of described pharmaceutical composition
And content includes by weight: 20 parts of glutamic acid, adenosine 5 parts, dopamine 5 parts, arginase 12 0 part, glutamine 10 parts,
Threonine 10 parts, methionine 5 parts, serine 5 parts, proline 10 parts, ring (sweet-dried meat) dipeptides 10 parts.
Pharmaceutical composition the most according to claims 1 to 3, it is characterised in that described pharmaceutical composition can be according to system
The conventional method in medicine field is prepared as dosage form described on any pharmaceutics.
Pharmaceutical composition the most according to claim 4, it is characterised in that described dosage form is enteric coated capsule or liquid system
Agent.
Pharmaceutical composition the most according to claims 1 to 5, it is characterised in that the preparation method of described pharmaceutical composition,
May comprise steps of: (1) weighs raw material by described component and content；(2) by after raw material mix homogeneously, add pharmaceutically
Acceptable adjuvant is prepared as the pharmaceutical preparation pharmaceutically commonly used.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610068130.8A CN105879005A (en) | 2016-02-01 | 2016-02-01 | Pharmaceutical composition for treating ulcerative colitis as well as preparation method and application of pharmaceutical composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610068130.8A CN105879005A (en) | 2016-02-01 | 2016-02-01 | Pharmaceutical composition for treating ulcerative colitis as well as preparation method and application of pharmaceutical composition |
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| Publication Number | Publication Date |
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| CN105879005A true CN105879005A (en) | 2016-08-24 |
Family
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| CN201610068130.8A Pending CN105879005A (en) | 2016-02-01 | 2016-02-01 | Pharmaceutical composition for treating ulcerative colitis as well as preparation method and application of pharmaceutical composition |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022160323A1 (en) * | 2021-01-31 | 2022-08-04 | 兰州大学 | Application of nucleoside analogue in preparation of drugs for preventing or treating gastrointestinal diseases |
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2016
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| WO2003039487A2 (en) * | 2001-11-09 | 2003-05-15 | Neuronz Limited | Cyclo(prolyl-glycine) and methods of use to treat neural disorders |
| CN101395164A (en) * | 2006-01-10 | 2009-03-25 | 罗伊·J·于 | N-(phosphonoalkyl)-amino acids, derivatives thereof and compositions and methods of use |
| WO2008033575A9 (en) * | 2006-09-15 | 2008-06-26 | Metabolon Inc | Methods of identifying biochemical pathways |
| CA2796963A1 (en) * | 2010-04-23 | 2011-10-27 | Piramal Enterprises Limited | Nitric oxide releasing prodrugs of therapeutic agents |
| CN103200952A (en) * | 2010-09-07 | 2013-07-10 | Dmi采集公司 | Treatment of diseases |
| CN103432091A (en) * | 2013-09-13 | 2013-12-11 | 钟术光 | Improved-performance tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022160323A1 (en) * | 2021-01-31 | 2022-08-04 | 兰州大学 | Application of nucleoside analogue in preparation of drugs for preventing or treating gastrointestinal diseases |
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Application publication date: 20160824 |