CN106924270A - A kind of pharmaceutical composition with weight losing function containing orlistat - Google Patents
A kind of pharmaceutical composition with weight losing function containing orlistat Download PDFInfo
- Publication number
- CN106924270A CN106924270A CN201710141721.8A CN201710141721A CN106924270A CN 106924270 A CN106924270 A CN 106924270A CN 201710141721 A CN201710141721 A CN 201710141721A CN 106924270 A CN106924270 A CN 106924270A
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- Prior art keywords
- orlistat
- pharmaceutical composition
- resveratrol
- oligosaccharide
- losing function
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7016—Disaccharides, e.g. lactose, lactulose
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
-
- 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
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
-
- 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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- 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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/733—Fructosans, e.g. inulin
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of pharmaceutical composition with weight losing function containing orlistat, the pharmaceutical composition contains orlistat, resveratrol and oligosaccharide.Wherein, the weight ratio of orlistat, resveratrol and oligosaccharide is 1:0.42~3.75:0.1~0.6.The FOS that the present invention is equipped with high, medium and low any dosage again with low dosage orlistat (the 1/3 of routine dose) with the combination of the resveratrol of high dose is applied in combination, can significant fat-reducing effect be produced to alimentary obesity disease rat, its fat-reducing effect is better than the orlistat of routine dose, and its gastrointestinal side effect incidence of disease is substantially less than the orlistat of routine dose.Described pharmaceutical composition is a kind of low slimming medicine of healthy, side effect, meets requirement of the modern to slimming medicine.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of drug regimen with weight losing function containing orlistat
Thing.
Background technology
With developing rapidly for social economy, the living standard of the people is improved constantly, and the dietary structure of people also there occurs
Huge change, problem of obesity is increasingly severe.Obesity is the unbalance metabolic disease for causing of human body energy revenue and expenditure, mainly
The chronic metabolic disease caused by factors such as the poor eating habits of people, habits and customs, and E＆Hs, is also high
The risk factors of various diseases such as blood pressure, diabetes, dyslipidemia, coronary heart disease, miocardial infarction, are cited as by the World Health Organization
It is the fifth-largest hazards for influenceing human health.
In recent years, because the life stress of people is big, rhythm it is fast and to the shortage of health knowledge, it is overweight to go out with fat phenomenon
The trend of rejuvenation is showed, Most of children teenager has appeared vividly as fat family.It has been investigated that, obesity is serious
Jeopardize teen-age growth and development.
Chemical entitled N- formyls-L-Leu (s) -1 [epoxide -2- epoxies third of (2s, 3s) -3- hexyls -4 of orlistat
Ylmethyl] ten diester, also referred to as ORLISTAT (THL) is a kind of semi-synthetic lipstatin derivative, and its chemical structural formula is as follows
Shown in formula,
Orlistat (orlistat) system researches and develops lipase inhibitor class slimming drugs, trade name by company of Roche Group
Xenical, eighties of last century late nineteen nineties take the lead in America and Europe list, 2001 in Discussion on Chinese Listed, and in 2005 by China eat
The approval of product Drug Administration switchs to non-prescribed medicine.Orlistat is taken with the capsule of its II crystal formation and tablet hyoscine
After this product, 1/3 discharges not by absorption from enteron aisle in the fat of intake, so as to reach fat-reducing effect.Common dose is with meal one
Secondary oral 120 milligrams, 3~6 months can 7~10 kilograms of loss of weight, additionally, orlistat is also unique a kind of not shadow both at home and abroad at present
Ring appetite, do not act on the chemical slimming drugs of central nervous system, security features are superior.
Alimentary canal is mainly acted on yet with orlistat, long-term use can cause a series of intestines and stomach bad anti-
Should, such as oiliness spot, the band just exhaust of property stomach and intestine, the urgent sense of stool, the increase of fat (oil) property example, steatorrhea, defecation, incontinence of faces
Deng.Additionally, domestic and foreign literature is thought, after orlistat medication the overweight body weight with obesity patient can only occur medium strong
The reduction of degree, fat-reducing effect is barely satisfactory.Domestic clinical test results show, 120mg orlistats capsule administration body after 6 months
Weight degree of alleviation accounts for 72.5% and 25.9% respectively more than or equal to the patient of baseline weight 5% and 10%.In addition, Pamela
The research of Morales etc. confirms that unabsorbed fat enters colon after orlistat medication, can raise excrement calcium in excrement and defend egg
In vain (one of biomarker of inflammation), raise the oxidation activity of liquid dung, and can make colon flora that small change occurs.
The content of the invention
In view of singly taking orlistat has gastrointestinal reaction risk, and fat-reducing effect is not notable, and the present invention provides one kind and contains
The pharmaceutical composition of orlistat, improves the fat-reducing effect of commercially available orlistat product, while reducing its gastrointestinal side effect.
The present invention provides a kind of pharmaceutical composition with weight losing function containing orlistat, described pharmaceutical composition
Contain orlistat, resveratrol and oligosaccharide.
Further, the weight ratio of described orlistat, resveratrol and oligosaccharide is 1:0.42~3.75:0.1~
0.6。
Preferably, the weight ratio of described orlistat, resveratrol and oligosaccharide is 1:0.5~1.5:0.1~0.3.
Further, described oligosaccharide is selected from least one in FOS, xylo-oligosaccharide and soyabean oligosaccharides.
Further, described pharmaceutical composition can be prepared by known method in field of pharmaceutical preparations, for example, ginseng
See that Cui Fude is edited,《Pharmacy》(the 7th edition) (People's Health Publisher's publication), is incorporated herein by reference altogether.Specifically, can
Mixed with least one pharmaceutically acceptable excipient with by orlistat, resveratrol and oligosaccharide, the excipient
Such as citric acid or Dicalcium Phosphate, or：(a) filler or extender, for example, starch, lactose, sucrose, glucose, mannitol
And silicic acid；(b) adhesive, for example, cellulose derivative, starch, alginate, gelatin, PVP, sucrose and
Acacia gum；(c) disintegrant, for example, agar, calcium carbonate, potato or tapioca, alginic acid, Croscarmellose
Sodium, composition silicate and sodium carbonate；(d) solution retardant, for example, paraffin；(e) sorbefacient, such as quaternary ammonium compound；
(f) wetting agent, for example, cetanol and glycerin monostearate, magnesium stearate etc.；G () adsorbent, such as kaolin and soap glue
Soil；(h) lubricant, for example, talcum powder, calcium stearate, magnesium stearate, solid polyglycols, NaLS or they
Mixture.In the case of capsule, tablet and pill, the formulation also includes buffer.
Preferably, described pharmaceutical composition is oral solid formulation.
It is highly preferred that described pharmaceutical composition is capsule.
The pharmaceutical composition with weight losing function containing orlistat that the present invention is provided, finds through experiment, can be notable
The body weight of rat is reduced, is compared with simple feeding nutrient fodder group (model group), with significant difference (P<0.05), additionally,
Compare with the nutrient fodder group for giving orlistat merely, the present invention is provided the pharmaceutical composition of offer, rat can be significantly reduced
There is the incidence (P of grease in hair<0.05), show the pharmaceutical composition fat-reducing effect of present invention offer significantly, and can reduce
The gastrointestinal side effect of orlistat, is a kind of low slimming medicine of healthy, side effect, meets modern to slimming medicine
It is required that.
Compared with prior art, advantage of the invention is that：
The present invention has found orlistat with resveratrol, oligosaccharide combination application in treatment or prevention fertilizer by lot of experiments
Unexpected effect is achieved during fat disease, animal test results show, the present invention with low dosage orlistat (routine dose
1/3) FOS for being equipped with high, medium and low any dosage again with the combination of the resveratrol of high dose is applied in combination, you can with right
Alimentary obesity disease rat produces significant fat-reducing effect, its fat-reducing effect better than routine dose orlistat, and its stomach and intestine
The road adverse reaction incidence of disease is substantially less than the orlistat of routine dose.
Additionally, with resveratrol, oligosaccharide be applied in combination orlistat by the present invention, be conducive to improve it is overweight with it is fat
The medication compliance of disease patient.
Specific embodiment
The present invention is further described below by way of specific embodiment, but the present invention is not limited only to following examples.
The preparation of medicament composition capsule agent with weight losing function of the embodiment 1 containing orlistat
Formulation (in terms of 1000)：
Preparation method：
Lauryl sodium sulfate (SDS), PVP K30, carboxyrnethyl starch sodium, microcrystalline cellulose, orlistat powder, white lamb's-quarters
Reed alcohol, FOS cross 80 mesh sieves with preceding.By recipe quantity weigh lauryl sodium sulfate, PVP K30, carboxyrnethyl starch sodium,
Microcrystalline cellulose, orlistat powder, resveratrol, FOS, will first measure few lauryl sodium sulfate, PVP K30,
Carboxyrnethyl starch sodium is well mixed, and adds microcrystalline cellulose and orlistat, resveratrol, FOS are well mixed, crosses 80
Twice of mesh sieve.50% ethanol solution containing 10% PVP K30, softwood processed, the extruding of 20 mesh are slowly added in mixed powder
Sieve series wet granular is crossed, wet granular is dried 6 hours in putting 30 DEG C of air dry ovens, takes out 20 mesh sieve whole grains, loads capsule shells, i.e.,
.
The preparation of medicament composition capsule agent with weight losing function of the embodiment 2 containing orlistat
Formulation (in terms of 1000)：
Preparation method：
Lauryl sodium sulfate (SDS), PVP K30, carboxyrnethyl starch sodium, microcrystalline cellulose, orlistat powder, white lamb's-quarters
Reed alcohol, xylo-oligosaccharide cross 80 mesh sieves with preceding.By recipe quantity weigh lauryl sodium sulfate, PVP K30, carboxyrnethyl starch sodium,
Microcrystalline cellulose, orlistat powder, resveratrol, xylo-oligosaccharide, will first measure few lauryl sodium sulfate, PVP K30,
Carboxyrnethyl starch sodium is well mixed, and adds microcrystalline cellulose and orlistat, resveratrol, xylo-oligosaccharide are well mixed, crosses 80
Twice of mesh sieve.50% ethanol solution containing 10% PVP K30, softwood processed, the extruding of 20 mesh are slowly added in mixed powder
Sieve series wet granular is crossed, wet granular is dried 6 hours in putting 30 DEG C of air dry ovens, takes out 20 mesh sieve whole grains, loads capsule shells, i.e.,
.
The preparation of medicament composition capsule agent with weight losing function of the embodiment 3 containing orlistat
Formulation (in terms of 1000)：
Preparation method：
Lauryl sodium sulfate (SDS), PVP K30, carboxyrnethyl starch sodium, microcrystalline cellulose, orlistat powder, white lamb's-quarters
Reed alcohol, soyabean oligosaccharides cross 80 mesh sieves with preceding.Lauryl sodium sulfate, PVP K30, carboxymethylstarch are weighed by recipe quantity
Sodium, microcrystalline cellulose, orlistat powder, resveratrol, soyabean oligosaccharides, will first measure few lauryl sodium sulfate, poly- dimension
Ketone K30, carboxyrnethyl starch sodium are well mixed, and add microcrystalline cellulose and orlistat, resveratrol, soyabean oligosaccharides mixing
It is even, cross twice of 80 mesh sieve.50% ethanol solution containing 10% PVP K30, softwood processed, 20 are slowly added in mixed powder
Mesh extruded sieve series wet granular, and wet granular is dried 6 hours in putting 30 DEG C of air dry ovens, takes out 20 mesh sieve whole grains, loads capsule
Shell, obtains final product.
Fat-reducing of pharmaceutical composition with weight losing function of the embodiment 4 containing orlistat to alimentary obesity disease rat
Effect
1 material
1.1 medicines
120mg orlistats capsule (Zhong Shanwanhan Pharmaceutical Technology Co., Ltd)；What embodiment 1 was prepared contains profit difficult to understand
Take charge of the capsule of his pharmaceutical composition with weight losing function.All capsules are taking out content before use, and every capsule is used
40mL0.5% carboxymethylcellulose sodium solutions dissolve.
1.2 animals and feed
Male cleaning grade SD rats, are provided by Zhongshan University's Experimental Animal Center, credit number SCXK (Guangdong) 2015-
0019, body weight 75g~85g.Normal diet and auxotype are provided by Zhongshan University's Experimental Animal Center, both constituents
It is as shown in the table.
2 methods
2.1 modelings, packet and administration
Foundation《Herbal pharmacodynamics are studied and evaluated》Middle obesity pharmacodynamic study and evaluation method, using pre- preventing obesity mould
Type method, chooses 240 SD rats as experimental animal, and 30 groups, every group of n=8 are randomly divided into by body weight.Each group feed is used with treatment
It is as shown in the table for medicine.Each group animal is provided to corresponding feed when every morning 9, and food is taken away during evening 7, quantitative daily
Administration (eaten up with most animals and adjust feed administered dose daily for principle).With during drug-treated group every morning 9 time-division in the afternoon 3
It is not dissolved in the solution gavage of 0.5% sodium carboxymethylcellulose, week for 7 weeks by 10mL/kg dosage correspondence medicine twice.It is all dynamic
The equal single cage of thing is raised.
2.2 evaluation indexes
A body weight is weighed weekly；The number of animals of grease (the visible light of naked eyes) is speckled with the observation statistics daily hair of each group
Amount, and by Zhou Jinhang comprehensive statistics
3 results
3.1 changes of weight situations
There is the rat quantity of grease distribution in 3.2 hairs
Result above shows that compare with simple feeding nutrient fodder group (model group), what the present invention was provided contains Ao Lisi
His pharmaceutical composition with weight losing function can significantly reduce the body weight (P of rat<0.05).Low dosage orlistat is (conventional
1/3) FOS for being equipped with high, medium and low any dosage again with the combination of the resveratrol of high dose of dosage is applied in combination, i.e.,
Significant fat-reducing effect, orlistat of its fat-reducing effect better than routine dose can be produced to alimentary obesity disease rat.Together
When due in composition orlistat consumption reduce, greatly reduce the risk of the gastrointestinal discomfort that orlistat causes, greatly
There is the confirmation of grease probability in mouse hair, and the pharmaceutical composition with weight losing function containing orlistat that the present invention is provided can drop
There is the probability of grease in low Hair of Rats, compares with the orlistat group for giving routine dose merely, with significant difference (P<
0.05).The pharmaceutical composition for showing present invention offer is a kind of low slimming medicine of healthy, side effect, meets modern to subtracting
The requirement of fertile medicine.
The above is only the preferred embodiment of the present invention, it is noted that it is right that above-mentioned preferred embodiment is not construed as
Limitation of the invention, protection scope of the present invention should be defined by claim limited range.For the art
For those of ordinary skill, without departing from the spirit and scope of the present invention, some improvements and modifications can also be made, these change
Enter and retouch and also should be regarded as protection scope of the present invention.
Claims (6)
1. a kind of pharmaceutical composition with weight losing function containing orlistat, it is characterised in that described pharmaceutical composition
Contain orlistat, resveratrol and oligosaccharide.
2. the pharmaceutical composition with weight losing function containing orlistat according to claim 1, it is characterised in that institute
The weight ratio of orlistat, resveratrol and the oligosaccharide stated is 1:0.42~3.75:0.1~0.6.
3. the pharmaceutical composition with weight losing function containing orlistat according to claim 2, it is characterised in that institute
The weight ratio of orlistat, resveratrol and the oligosaccharide stated is 1:0.5~1.5:0.1~0.3.
4. according to any described pharmaceutical compositions with weight losing function containing orlistat of claim 1-3, its feature
It is that described oligosaccharide is selected from least one in FOS, xylo-oligosaccharide and soyabean oligosaccharides.
5. according to any described pharmaceutical compositions with weight losing function containing orlistat of claim 1-3, its feature
It is that described pharmaceutical composition is oral solid formulation.
6. the pharmaceutical composition with weight losing function containing orlistat according to claim 5, it is characterised in that institute
The pharmaceutical composition stated is capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710141721.8A CN106924270B (en) | 2017-03-10 | 2017-03-10 | Orlistat-containing pharmaceutical composition with weight-losing function |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710141721.8A CN106924270B (en) | 2017-03-10 | 2017-03-10 | Orlistat-containing pharmaceutical composition with weight-losing function |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN106924270A true CN106924270A (en) | 2017-07-07 |
| CN106924270B CN106924270B (en) | 2020-07-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710141721.8A Active CN106924270B (en) | 2017-03-10 | 2017-03-10 | Orlistat-containing pharmaceutical composition with weight-losing function |
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| Country | Link |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108524495A (en) * | 2018-07-10 | 2018-09-14 | 中山万汉制药有限公司 | Purposes of the orlistat in the drug for preparing treatment constipation |
| CN112294798A (en) * | 2020-10-31 | 2021-02-02 | 中山万汉制药有限公司 | Composition for reducing absorption of lipase inhibitor in digestive tract |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009049105A2 (en) * | 2007-10-09 | 2009-04-16 | Gelesis, Inc. | Methods for inducing satiation |
| CN102613456A (en) * | 2012-03-05 | 2012-08-01 | 苏州先阔生物科技有限公司 | Xylo-oligosaccharide composition with lipase activity inhibition effect and application of xylo-oligosaccharide composition |
| CN103142457A (en) * | 2013-01-17 | 2013-06-12 | 西安电子科技大学 | Resveratrol nanometer-preparation preparation method |
-
2017
- 2017-03-10 CN CN201710141721.8A patent/CN106924270B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009049105A2 (en) * | 2007-10-09 | 2009-04-16 | Gelesis, Inc. | Methods for inducing satiation |
| CN102613456A (en) * | 2012-03-05 | 2012-08-01 | 苏州先阔生物科技有限公司 | Xylo-oligosaccharide composition with lipase activity inhibition effect and application of xylo-oligosaccharide composition |
| CN103142457A (en) * | 2013-01-17 | 2013-06-12 | 西安电子科技大学 | Resveratrol nanometer-preparation preparation method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108524495A (en) * | 2018-07-10 | 2018-09-14 | 中山万汉制药有限公司 | Purposes of the orlistat in the drug for preparing treatment constipation |
| CN108524495B (en) * | 2018-07-10 | 2019-02-26 | 中山万汉制药有限公司 | Purposes of the orlistat in the drug of preparation treatment constipation |
| CN112294798A (en) * | 2020-10-31 | 2021-02-02 | 中山万汉制药有限公司 | Composition for reducing absorption of lipase inhibitor in digestive tract |
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| Publication number | Publication date |
|---|---|
| CN106924270B (en) | 2020-07-31 |
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