CN105596339A - Metformin and acipimox compound composition and preparation method thereof - Google Patents
Metformin and acipimox compound composition and preparation method thereof Download PDFInfo
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- CN105596339A CN105596339A CN201510975442.2A CN201510975442A CN105596339A CN 105596339 A CN105596339 A CN 105596339A CN 201510975442 A CN201510975442 A CN 201510975442A CN 105596339 A CN105596339 A CN 105596339A
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
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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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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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
- A61K9/14—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
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
The invention discloses metformin and acipimox compound composition and a preparation method thereof. The composition comprises components in parts by weight as follows: 5-10 parts of metformin, 5-10 parts of acipimox, 5-8 parts of a diluent, 0.3-0.6 parts of a surfactant, 10-15 parts of a disintegrating agent and 0.5-0.8 parts of a lubricant. The preparation method comprises steps as follows: material preparation, granulation, size grading and tabletting. The compound composite can treat hyperglycemia and hyperlipidemia; the curative effect of the medicine can be improved, the effective proportion of the medicine is high, the medicine is convenient to take, and compliance of patients is improved. The auxiliary and packaging costs of the compound composition are reduced, medicine price is reduced, and industrial production is facilitated.
Description
Technical field
The invention belongs to medical technical field, is a kind of melbine Acipimox compound concretelyAnd preparation method.
Background technology
Melbine, English name: Metformin, Chinese another name: melbine, Metformin,Metformin, metformin hydrochloride, first good fortune are raw, hypoglycemic, Metformin, Metformin. Main application: 1) useThe type II diabetes of failing to respond to any medical treatment in diet-treated only and physical training, particularly fat type II diabetes.2) this product and insulin share, and can reduce insulin dosage, prevent that hypoglycemia from occurring. 3) can with yellow urideClass is share blood sugar medicine, tool synergy. Mechanism of action: 1. promote surrounding tissue cell (muscle etc.) to grapeThe utilization of sugar; 2. suppress gluconeogenesis function of liver, therefore reduce glycogen output; 3. suppress the picked-up of intestines parietal cellGlucose, different from insulin action, this product is without the effect that impels Fatty synthesis, to normal person without obviouslyHypoglycemic activity, therefore, does not generally cause hypoglycemia.
Acipimox, English name: Acipimox, Chinese another name: acipimox. Indication: for respectivelyPlant primary and Secondary Hyperlipidemia, can reduce total plasma cholesterol, triglycerides, low-density lipoproteinWith VLDL content, improve hdl concentration, effect lasting stability. This product both can be doneFor first-selected fat-reducing medicament, treat slight hyperlipidemia, can be used as again basic fat-reducing medicament, with other lipid lowerersThing share to improve curative effect this product and still can be used as hypoglycemic medicine, in treatment diabetes, brings into play booster action. MedicineMoving learning: this product absorbs rapidly completely, 1 oral rear 2h PC peaking, some drugs and blood plasma eggCombine in vain. Medicine half life in blood is 4h, and medicine is seldom metabolism in vivo, and the overwhelming majority is logical with original shapeCrossing kidney excretes.
Along with the live raising of condition of modern, most diabetics are with hyperlipemia, due to singleMedicine often can not be obtained desirable curative effect, clinically usually by hypoglycemic agent and hypolipidemic use in conjunction,Can obtain good curative effect; But two kinds or two or more folk prescription medicine use in conjunction, take inconvenience,Separately compressing tablet supplementary product consumption is relatively many, and packing cost is high, therefore two kinds or two or more medicines is madeAfter compound preparation, not only facilitate medication, and reduced auxiliary material and packing cost, be conducive to reduce medicine valency and workIndustryization is produced.
Summary of the invention
The present invention is exactly in order to overcome the defect of two kinds or two or more medicine use in conjunction, to propose a kind ofHyperglycaemia can either be treated, the melbine Acipimox compound of high fat of blood can be treated again simultaneously,This compound can improve medication curative effect, and the effective ratio of medicine is high, and taking convenience has improved patient'sCompliance.
The present invention seeks to be realized by following technical scheme:
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two5～10 parts of first biguanides, 5～10 parts of Acipimoxs, 5～8 parts of diluents, 0.3～0.6 part, surfactant, collapseSeparate 10～15 parts of agent, 0.5～0.8 part of lubricant.
Further, the object of the invention can also be realized by following technical scheme:
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two5 parts of first biguanides, 5 parts of Acipimoxs, 5 parts of diluents, 0.3 part, surfactant, 10 parts of disintegrants,0.5 part of lubricant.
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two10 parts of first biguanides, 10 parts of Acipimoxs, 8 parts of diluents, 0.6 part, surfactant, 15 parts of disintegrants,0.8 part of lubricant.
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two8 parts of first biguanides, 8 parts of Acipimoxs, 6 parts of diluents, 0.4 part, surfactant, 14 parts of disintegrants,0.7 part of lubricant.
A kind of melbine Acipimox compound, surfactant comprises: sucrose ester, aliphatic acid mountainPears are smooth, at least one in polysorbate.
A kind of melbine Acipimox compound, disintegrant comprises: sodium carboxymethyl starch, crosslinked poly-At least one in vinylpyrrolidone, Ac-Di-Sol.
A kind of melbine Acipimox compound, diluent comprises: in starch, sweet mellow wine at leastA kind of.
A kind of melbine Acipimox compound, lubricant comprises: dolomol, superfine silica gel powder,At least one in talcum powder.
The present invention also provides a kind of preparation method of melbine Acipimox compound, comprises as followsStep:
1) get the raw materials ready, according to component and the parts by weight of described a kind of melbine Acipimox compoundGet the raw materials ready, wherein melbine was pulverized 120 mesh sieves, and Acipimox was pulverized 200 mesh sieves, diluent, tableSurface-active agent, disintegrant, lubricant were pulverized respectively 100 mesh sieves;
2) granulate, by step 1) the standby mixing of materials of institute is even, wet granulation, adhesive therefor is that quality is denseDegree is 60%～70% alcohol, and alcohol consumption is 0.5 times of solid material parts by weight;
3) whole grain, by step 2) gained material crosses the whole grain of 20 mesh sieves;
4) compressing tablet, by step 3) gained material is by high speed tablet press compressing tablet, and specification is melbine200～250mg/ sheet, Acipimox 200～250mg/ sheet.
The preparation method of a kind of melbine Acipimox compound of the present invention, can also be by following skillArt scheme realizes:
A preparation method for melbine Acipimox compound, described step 2) granulating process instituteWith drying equipment be fluid bed, technological parameter is: EAT is 55～60 DEG C, temperature of charge is 45～50 DEG C,Leaving air temp is 35～40 DEG C.
Beneficial effect of the present invention
The present invention has overcome the defect of two kinds or two or more medicine use in conjunction, compound group of the present inventionCompound can either be treated hyperglycaemia, can treat again high fat of blood simultaneously, and this compound can improve medicationCurative effect, the effective ratio of medicine is high, and taking convenience has improved patient's compliance. Compound combination of the present inventionThing has reduced auxiliary material and packing cost, is conducive to reduce medicine valency and suitability for industrialized production.
Detailed description of the invention
According to following embodiment, the present invention may be better understood. But those skilled in the art is easyUnderstand, the described concrete material proportion of embodiment, process conditions and result thereof are only for illustrating the present inventionAnd should can not limit the present invention described in detail in claims yet.
Embodiment 1
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two5 parts of first biguanides, 5 parts of Acipimoxs, 5 parts of starch, 0.3 part of sucrose ester, 10 parts of sodium carboxymethyl starches,0.5 part of dolomol.
A preparation method for melbine Acipimox compound, comprises the steps:
1) get the raw materials ready, according to component and the parts by weight of described a kind of melbine Acipimox compoundGet the raw materials ready, wherein melbine was pulverized 120 mesh sieves, and Acipimox was pulverized 200 mesh sieves, starch, sucroseEster, sodium carboxymethyl starch, dolomol were pulverized respectively 100 mesh sieves;
2) granulate, by step 1) the standby mixing of materials of institute is even, wet granulation, adhesive therefor is that quality is denseDegree is 60%～70% alcohol, and alcohol consumption is 0.5 times of solid material parts by weight; Drying equipment usedFor fluid bed, technological parameter is: EAT is 55～60 DEG C, and temperature of charge is 45～50 DEG C, leaving air tempIt is 35～40 DEG C;
3) whole grain, by step 2) gained material crosses the whole grain of 20 mesh sieves;
4) compressing tablet, by step 3) gained material is by high speed tablet press compressing tablet, and specification is melbine 200mg/Sheet, Acipimox 200mg/ sheet.
Usage and dosage: three times on the oral 1st, each 1 or follow the doctor's advice.
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two10 parts of first biguanides, 10 parts of Acipimoxs, 8 parts, sweet mellow wine, smooth 0.6 part of aliphatic acid sorb, crosslinked polyethylene15 parts of pyrrolidones, 0.8 part of superfine silica gel powder.
A preparation method for melbine Acipimox compound, comprises the steps:
1) get the raw materials ready, according to component and the parts by weight of described a kind of melbine Acipimox compoundGet the raw materials ready, wherein melbine was pulverized 120 mesh sieves, and Acipimox was pulverized 200 mesh sieves, sweet mellow wine, fatFat acid sorb is smooth, PVPP, superfine silica gel powder were pulverized respectively 100 mesh sieves;
2) granulate, by step 1) the standby mixing of materials of institute is even, wet granulation, adhesive therefor is that quality is denseDegree is 60%～70% alcohol, and alcohol consumption is 0.5 times of solid material parts by weight; Drying equipment usedFor fluid bed, technological parameter is: EAT is 55～60 DEG C, and temperature of charge is 45～50 DEG C, leaving air tempIt is 35～40 DEG C;
3) whole grain, by step 2) gained material crosses the whole grain of 20 mesh sieves;
4) compressing tablet, by step 3) gained material is by high speed tablet press compressing tablet, and specification is melbine 250mg/Sheet, Acipimox 250mg/ sheet.
Usage and dosage: three times on the oral 1st, each 1 or follow the doctor's advice.
Embodiment 3
A kind of melbine Acipimox compound, component and the parts by weight of said composition comprise: two8 parts of first biguanides, 8 parts of Acipimoxs, 3 parts, sweet mellow wine, 3 parts of starch, 0.4 part of polysorbate, crosslinked carboxylic14 parts of sodium carboxymethylcellulose pyces, 0.7 part of talcum powder.
A preparation method for melbine Acipimox compound, comprises the steps:
1) get the raw materials ready, according to component and the parts by weight of described a kind of melbine Acipimox compoundGet the raw materials ready, wherein melbine was pulverized 120 mesh sieves, and Acipimox was pulverized 200 mesh sieves, sweet mellow wine, shallow lakePowder, polysorbate, Ac-Di-Sol, talcum powder were pulverized respectively 100 mesh sieves;
2) granulate, by step 1) the standby mixing of materials of institute is even, wet granulation, adhesive therefor is that quality is denseDegree is 60%～70% alcohol, and alcohol consumption is 0.5 times of solid material parts by weight; Drying equipment usedFor fluid bed, technological parameter is: EAT is 55～60 DEG C, and temperature of charge is 45～50 DEG C, leaving air tempIt is 35～40 DEG C;
3) whole grain, by step 2) gained material crosses the whole grain of 20 mesh sieves;
4) compressing tablet, by step 3) gained material is by high speed tablet press compressing tablet, and specification is melbine 250mg/Sheet, Acipimox 250mg/ sheet.
Usage and dosage: three times on the oral 1st, each 1 or follow the doctor's advice.
Embodiment 4
Compound friability of the present invention checks
Check according to " Chinese pharmacopoeia " 2010 editions (two) annex XG tablet friability inspection technique.
Instrument: friability tester.
Method: get 10, blow away the powder coming off with hair-dryer, precise weighing, puts in cylinder, rotates 100Inferior. Take out, remove powder with method, precise weighing, less loss weight must not cross 1%, and must not detect fracture,Be full of cracks and the sheet of pulverizing. This test is generally only done 1 time. While exceeding 1% as less loss weight, should recheck 2 times,The average less loss weight of 3 times must not cross 1%, and the sheet that must not detect fracture, be full of cracks and pulverize.
Result: embodiments of the invention 1-3 gained sample checks and all conforms with the regulations through friability test.
Embodiment 5
Dissolution test of the present invention
According to 2010 editions two annex XC dissolution method the second methods of Chinese pharmacopoeia, with 0.4% cetylTrimethyl amine bromide phosphate buffer (pH6.5) 500ml is medium, and rotating speed is 100 revs/min, in accordance with the lawOperation. Measure respectively the dissolution rate of the obtained sample of embodiment 1-3. Detect by HPLC, melbine is moltenOut-degree (%) the results are shown in Table 1, and Acipimox dissolution rate (%) the results are shown in Table 2.
Table 1
Table 2
Conclusion: compound dissolution rate of the present invention conforms with the regulations.
Embodiment 6
Toxicity Analysis of the present invention
By 30 of wistar high fat of blood mouse models, fasting 12h, by 60mg/kg body weight lumbar injection Streptozocin(STZ) 1 time, and give high-calorie feed and raise 12 weeks, successfully prepare animal model of diabetes mellitus type II, toolHave that overweight, Impaired Glucose Tolerance Treated, blood fat raise, serum insulin raises and combination rate of insulin receptor reduces companionThe feature of insulin resistance, is similar to the Clinical symptoms of Patients with NIDDM.
High fat of blood, Model of diabetic rat are equally divided into three groups at random, are respectively negative control group, positive rightAccording to group, test group. Positive controls folk prescription single dose gastric infusion melbine three times on the 1st, 1 10mg/kg,Acipimox three times on the 1st, 1 10mg/kg, the compound compound list that test group is prepared with embodiment 1Dosage gastric infusion melbine three times on the 1st, 1 10mg/kg, Acipimox three times on the 1st, 1 10mg/kg.Get blood morning every day and survey fasting blood sugar and blood fat value, continuous detecting 10 days.
Blood sugar test: tail venous blood sampling, 3000rpm × 10min, separation of serum, uses glucose oxidase methodMeasure blood glucose value, average blood sugar value the results are shown in Table 3.
Lipid examination: adopt cholesterol oxidase method to detect.
Each group mouse average blood sugar value result (mmol/l)
Conclusion: compound drug dose of the present invention is identical with positive controls, but result for the treatment of is excellentIn control group.
Each group mouse average blood fat value result (mmol/l)
Conclusion: compound drug dose of the present invention is identical with positive controls, but result for the treatment of is excellentIn control group.
The present invention adopts melbine, Acipimox to make compound combination as active drug composition through screeningThing. The active drug composition melbine of this compound, gliquidone synergistic action effect are good, effectivelyDrug ingedient and pharmaceutic adjuvant consumption are few, and effective ingredient content is high. The present invention has reduced medicining times,The compliance that has improved patient, technique is simple, and favorable reproducibility is easy to suitability for industrialized production; Cost is low, favourableIn reducing product price.
Above embodiment is only explanation technical conceive of the present invention and feature, and its object is to allow is familiar with thisThe people of technology understands content of the present invention and is implemented, and can not limit the scope of the invention with this, allThe equivalence that Spirit Essence does according to the present invention changes or modifies, and all should be encompassed in protection scope of the present invention.
Claims (10)
1. a melbine Acipimox compound, is characterized in that, the component of said composition and heavyAmount umber comprises: 5～10 parts of melbine, 5～10 parts of Acipimoxs, 5～8 parts of diluents, surface-active0.3～0.6 part of agent, 10～15 parts of disintegrants, 0.5～0.8 part of lubricant.
2. a kind of melbine Acipimox compound according to claim 1, is characterized in that,Component and the parts by weight of said composition comprise: 5 parts of melbine, 5 parts of Acipimoxs, 5 parts of diluents,0.3 part, surfactant, 10 parts of disintegrants, 0.5 part of lubricant.
3. a kind of melbine Acipimox compound according to claim 1, is characterized in that,Component and the parts by weight of said composition comprise: 10 parts of melbine, 10 parts of Acipimoxs, diluent 8Part, 0.6 part, surfactant, 15 parts of disintegrants, 0.8 part of lubricant.
4. a kind of melbine Acipimox compound according to claim 1, is characterized in that,Component and the parts by weight of said composition comprise: 8 parts of melbine, 8 parts of Acipimoxs, 6 parts of diluents,0.4 part, surfactant, 14 parts of disintegrants, 0.7 part of lubricant.
5. according to a kind of melbine Acipimox compound described in claim 1～4 any one, itsBe characterised in that, surfactant comprises: sucrose ester, aliphatic acid sorb are smooth, at least one in polysorbate.
6. according to a kind of melbine Acipimox compound described in claim 1～4 any one, itsBe characterised in that, disintegrant comprises: sodium carboxymethyl starch, PVPP, cross-linked carboxymethyl fibreTie up at least one in plain sodium.
7. according to a kind of melbine Acipimox compound described in claim 1～4 any one, itsBe characterised in that, diluent comprises: at least one in starch, sweet mellow wine.
8. according to a kind of melbine Acipimox compound described in claim 1～4 any one, itsBe characterised in that, lubricant comprises: at least one in dolomol, superfine silica gel powder, talcum powder.
9. a preparation method for melbine Acipimox compound, is characterized in that, comprises as followsStep:
1) get the raw materials ready, according to a kind of melbine Acipimox compound combination described in claim 1～4 any oneComponent and the parts by weight of thing are got the raw materials ready, and wherein melbine was pulverized 120 mesh sieves, and Acipimox pulverized 200Mesh sieve, diluent, surfactant, disintegrant, lubricant were pulverized respectively 100 mesh sieves;
2) granulate, by step 1) the standby mixing of materials of institute is even, wet granulation, adhesive therefor is that quality is denseDegree is 60%～70% alcohol, and alcohol consumption is 0.5 times of solid material parts by weight;
3) whole grain, by step 2) gained material crosses the whole grain of 20 mesh sieves;
4) compressing tablet, by step 3) gained material is by high speed tablet press compressing tablet, and specification is melbine200～250mg/ sheet, Acipimox 200～250mg/ sheet.
10. a preparation method for melbine Acipimox compound, is characterized in that, described stepRapid 2) granulating process drying equipment used is fluid bed, and technological parameter is: EAT is 55～60 DEG C,Temperature of charge is 45～50 DEG C, and leaving air temp is 35～40 DEG C.
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| CN201510975442.2A CN105596339A (en) | 2015-12-23 | 2015-12-23 | Metformin and acipimox compound composition and preparation method thereof |
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| CN201510975442.2A CN105596339A (en) | 2015-12-23 | 2015-12-23 | Metformin and acipimox compound composition and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1596103A (en) * | 2001-11-29 | 2005-03-16 | 曼纳里尼国际经营卢森堡有限公司 | Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type II diabetes mellitus |
| CN103271907A (en) * | 2013-05-30 | 2013-09-04 | 东北制药（沈阳）科技发展有限公司 | Oral medicine composition consisting of berberine and melbine, and preparation method thereof |
| CN104906115A (en) * | 2015-06-18 | 2015-09-16 | 青岛海之星生物科技有限公司 | Melbine and gliquidone compound sustained-release tablet and preparation method thereof |
-
2015
- 2015-12-23 CN CN201510975442.2A patent/CN105596339A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1596103A (en) * | 2001-11-29 | 2005-03-16 | 曼纳里尼国际经营卢森堡有限公司 | Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type II diabetes mellitus |
| CN103271907A (en) * | 2013-05-30 | 2013-09-04 | 东北制药（沈阳）科技发展有限公司 | Oral medicine composition consisting of berberine and melbine, and preparation method thereof |
| CN104906115A (en) * | 2015-06-18 | 2015-09-16 | 青岛海之星生物科技有限公司 | Melbine and gliquidone compound sustained-release tablet and preparation method thereof |
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Application publication date: 20160525 |