CN104434952B - It is a kind of to treat pharmaceutical composition of diabetes and preparation method thereof - Google Patents
It is a kind of to treat pharmaceutical composition of diabetes and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical composition for treating diabetes and preparation method thereof, the bilayer tablet that pharmaceutical composition is made up of release layer and slow release layer, it is made up of the raw material of following weight parts：Colesevelam hydrocholoride：3~15；Gliclazide：0.1~1.5；Auxiliary material：1.5~3；Preparation method comprises the following steps：Get the raw materials ready, prepare release layer, prepare slow release layer and tabletting.Colesevelam hydrocholoride acts synergistically with gliclazide in said composition, and the hypoglycemic effect of significant increase gliclazide, said composition has composition simple, the characteristics of convenient drug administration, persistent, curative effect are stable；Preparation method is simple to operate, convenient for production, requirement to equipment is low, it is adaptable to which batch production is mass produced.
Description
Technical field
The present invention relates to drug field, and in particular to a kind of to treat pharmaceutical composition of diabetes and preparation method thereof.
Background technology
Diabetes turn into the fourth-largest cause of the death of the mankind, and having more than 3,800,000 people dies from diabetes and its complication every year in the whole world.
Current existing 2.46 hundred million diabetics in the whole world.China over nearly 20 years diabetes morbidity add more than 5 times, be global growth
One of most fast country.So high diabetes morbidity expedites the emergence of out the diabetic market having a high potential.Diabetic
Field has also turned into the emphasis that major medicines are looked forward to going on an expedition.2008, it is beautiful that global diabetes medicament market total sales volume is up to 24,000,000,000
Member, and in global diabetes medicament, the oral medicine market share is slightly above insulin preparation.It is expected that between following 10 to 20 years, sugar
The sick number of patients of urine has shelter first of disease.Especially in Asia, diabetic's number speedup is by rapid increase.2010
Year, global diabetes medicament total sales volume was up to 344.3 hundred million dollars, was significantly higher than the other diseases medication market share.
Gliclazide (gliclazid, gliclazide) belongs to second generation sulfonylurea OHA, and chemical noun is：
1- (3- azabicyclos [3,3,0] octyl group) -3- tolylsulfonylureas, structure is as follows：
White crystals or crystalline powder during gliclazide, it is odorless, tasteless；Fusing point is 162~166 DEG C；It is in chloroform
Dissolving, slightly molten in methyl alcohol, slightly soluble, insoluble in water in ethanol, belongs to typical insoluble drug.Gliclazide is mainly used
In the treatment of II type (non-insulin-depending type) diabetes, its mechanism of action be on insulin β cell membranes with specific receptor
With reference to rear, stream in metabolic defect in cellular calcium ion can be promoted, suppress the activity of phosphodiesterase, raise intracellular CAMP levels, so as to pierce
Swash the release of insulin, increase sensitiveness of the beta Cell of islet to stimulant, and can increase hepatic glycogen synthesis, decompose and reduce, lead to
Cross to the effect after granulocyte acceptor or acceptor, surrounding tissue is strengthened the sensitiveness of insulin, the intake to glucose increases
It is many.Gliclazide is compared with first generation sulfonylureas, and oral absorption is fast, and effect is strong, trigger hypoglycemia, granulocyte to reduce with
And the probability of cardiovascular adverse effects is smaller.It has double action that is hypoglycemic and improving coagulation function concurrently, can not only improve
The metabolism of diabetic, and can improve or delay the generation of diabetic vascular complications, at home and abroad extensively should
For clinic, as one of the most frequently used medicine of current treatment type II diabetes.Human pharmacokineticses, which are studied, to be shown, Ge Lieqi
Spy's infiltration rate in human body is rapid, is combined with plasma protein extensively, and the overwhelming majority is the generation without hypoglycemic activity in liver metabolism
Thank to thing, metabolin is with a small amount of original shape medicine from kidney excretion, and half-life period is 8-10 hours.
Colesevelam, English is entitled：Colesevelam, colesevelam hydrochorlde, trade name WelChol,
Chemistry is entitled：N, N, N- trimethyl-the 6- own ammoniums of (2- allylaminos) -1- and (chloromethyl) oxirane, 2- propylene -1- amine and
The polymer of N-2- acrylic -1- decyl amine salt hydrochloric acid, molecular formula：(C13H27N)n.(C12H27ClN2)n.(C3H7N)n.
(C3H5ClO) n.xHCl, is the courage of a non-absorbing type of GelTex Pharmaceuls Inc Centre companies of U.S. exploitation
Juice acid sequestering agent, FDA in 2000 ratifies to be used to treat hypercholesterolemia, and in September, 2000 is in U.S.'s Initial Public Offering.Colesevelam
A kind of bile acid sequestrant, it be not absorbed into after one kind is taken blood, in enteron aisle by congugated bile acids suppress its inhale
Receive and reduce the polymer of blood fat.Colesevelam can be used alone or with other fat-reducing medicament use in conjunction, it is primary for reducing
Low-density lipoprotein (LDL-C) level of property high fat of blood adult patient and family's child patient, it can also be used to improve diabetes B
The different blood glucose levels of patient.Colesevelam is due to determined curative effect, and Small side effects are more as cooperation diet and fortune abroad
Dynamic therapy, in reduction, the important drugs of slight high fat of blood use, the medicine can also coordinate with conventional lipid-lowering medicine, such as Statins, combine
Using reducing blood lipid level.
The purpose of drug regimen is to allow it to play synergy, is the direction of pharmaceutical preparation development.Hydrochloric acid in the prior art
Colesevelam is used for reducing blood fat, present invention discover that colesevelam hydrocholoride and gliclazide are applied in combination, can significantly increase lattice
Lie Qite hypoglycemic effect.
The content of the invention
It is an object of the invention to the shortcoming for overcoming prior art there is provided a kind of pharmaceutical composition for treating diabetes, it is somebody's turn to do
Colesevelam hydrocholoride acts synergistically with gliclazide in composition, the hypoglycemic effect of significant increase gliclazide, should
Composition has composition simple, the characteristics of convenient drug administration, persistent, curative effect are stable.
Another object of the present invention is to the preparation method for the pharmaceutical composition for providing such a treatment diabetes, the preparation side
Method is simple to operate, convenient for production, requirement to equipment is low, it is adaptable to which batch production is mass produced.
The purpose of the present invention is achieved through the following technical solutions：A kind of pharmaceutical composition for treating diabetes, it be by
The bilayer tablet of release layer and slow release layer composition, described pharmaceutical composition is made up of the raw material of following weight parts：Hydrochloric acid Kao Laiwei
Logical sequence：3~15；Gliclazide：0.1~1.5；Auxiliary material：1.5~3.
Further, the bilayer tablet that it is made up of release layer and slow release layer, described pharmaceutical composition is by following weight
The raw material composition of part：Colesevelam hydrocholoride：5~10；Gliclazide：0.3~1；Auxiliary material：1.8~2.5.
As optimal case, the bilayer tablet that it is made up of release layer and slow release layer, described pharmaceutical composition is by following
The raw material composition of parts by weight：Colesevelam hydrocholoride：6.25；Gliclazide：0.8；Auxiliary material：2.
Further, the auxiliary material is cross-linked carboxymethyl cellulose sodium, agar, vertical compression lactose, lactose, crosslinking carboxymethylstarch
Sodium, polyvinylpyrrolidone, microcrystalline cellulose, mannitol, hydroxypropyl methylcellulose K series, superfine silica gel powder, carboxyrnethyl starch sodium or hard
One or more combinations in fatty acid magnesium.
Further, the release layer is made up of colesevelam hydrocholoride and release layer auxiliary material, and the slow release layer is by Ge Lieqi
Special and slow release layer auxiliary material composition.
Further, the release layer auxiliary material be cross-linked carboxymethyl cellulose sodium, it is vertical compression lactose, CCMS-Na, micro-
One or more combinations in crystalline cellulose, magnesium stearate or carboxyrnethyl starch sodium；The slow release layer auxiliary material be lactose, agar,
One or more groups in mannitol, hydroxypropyl methylcellulose K series, superfine silica gel powder, polyvinylpyrrolidone or magnesium stearate
Close.
A kind of preparation method for the pharmaceutical composition for treating diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, and auxiliary material is divided into release layer auxiliary material and slow release layer auxiliary material, and again
Amount is than being 0.8~1.2:1, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 16~24 mesh sieves, particle is dried to moisture≤5% at 50~65 DEG C, is pressed into advance
Type；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
The present invention has advantages below：
1. colesevelam hydrocholoride occurs with gliclazide in the pharmaceutical composition of the treatment diabetes of the present invention, said composition
Synergy, while reducing blood lipid, the hypoglycemic effect of significant increase gliclazide, the generation for correcting diabetic
Thank to syndrome, the high fat of blood for advantageously reducing diabetic is at a specified future date dangerous；Said composition has composition simple, to prescription
Just the characteristics of, persistent, curative effect are stable；
2. the present invention is double-layer sustained release tablet, it is found through experiments that in the release layer 10 minutes of the present invention and is disintegrated, 30 minutes
Drug-eluting amount is no less than 90%；Slow release layer 1 hour, labelled amount should be mutually should be respectively with the release amount of medicine of 10 hours within 3 hours
20%~40%, 40%~65% and more than 75%；
3. the preparation method of the present invention is simple to operate, convenient for production, requirement to equipment is low, it is adaptable to which batch production is extensive
Production.
Embodiment
With reference to embodiment, the present invention will be further described, and protection scope of the present invention is not limited to following institute
State：
Embodiment 1：A kind of pharmaceutical composition for treating diabetes, the double-layer tablets that it is made up of release layer and slow release layer
Agent, described pharmaceutical composition is made up of the raw material of following weight parts：Release layer：Colesevelam hydrocholoride：3；Slow release layer：Ge Lieqi
It is special：0.1；Release layer auxiliary material is cross-linked carboxymethyl cellulose sodium：0.7；Slow release layer auxiliary material is hydroxypropyl methylcellulose K series：0.8.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 16 mesh sieves, particle is dried to moisture≤5%, pre-molding at 50 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
Embodiment 2：A kind of pharmaceutical composition for treating diabetes, the double-layer tablets that it is made up of release layer and slow release layer
Agent, described pharmaceutical composition is made up of the raw material of following weight parts：Release layer：Colesevelam hydrocholoride：15；Slow release layer：Ge Lieqi
It is special：1.5；Release layer auxiliary material is vertical compression lactose：0.4；CCMS-Na：1.1；Slow release layer auxiliary material is superfine silica gel powder:0.6；
Lactose：0.5.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 24 mesh sieves, particle is dried to moisture≤5%, pre-molding at 65 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
Embodiment 3：A kind of pharmaceutical composition for treating diabetes, the double-layer tablets that it is made up of release layer and slow release layer
Agent, described pharmaceutical composition is made up of the raw material of following weight parts：Release layer：Colesevelam hydrocholoride：5；Slow release layer：Ge Lieqi
It is special：0.3；Release layer auxiliary material is magnesium stearate：0.4；Agar：0.4；Carboxyrnethyl starch sodium：0.1；Slow release layer auxiliary material is superfine silica gel powder：
0.2；Magnesium stearate：0.3；Mannitol：0.4.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, and auxiliary material is divided into release layer auxiliary material and slow release layer auxiliary material, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 20 mesh sieves, particle is dried to moisture≤5%, pre-molding at 52 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
Embodiment 4：A kind of pharmaceutical composition for treating diabetes, the double-layer tablets that it is made up of release layer and slow release layer
Agent, described pharmaceutical composition is made up of the raw material of following weight parts：Release layer：Colesevelam hydrocholoride：10；Slow release layer：Ge Lieqi
It is special：1；Release layer auxiliary material is vertical compression lactose:0.3；CCMS-Na：0.1；Cross-linked carboxymethyl cellulose sodium：0.4；Crystallite is fine
Dimension element：0.4；Slow release layer auxiliary material is lactose：0.3；Superfine silica gel powder：0.5；Polyvinylpyrrolidone：0.2；Hydroxypropyl methylcellulose K systems
Row：0.3.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, and auxiliary material is divided into release layer auxiliary material and slow release layer auxiliary material, and again
Amount is than being 0.8~1.2:1, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 16 mesh sieves, particle is dried to moisture≤5%, pre-molding at 57 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
Embodiment 5：A kind of pharmaceutical composition for treating diabetes, the double-layer tablets that it is made up of release layer and slow release layer
Agent, described pharmaceutical composition is made up of the raw material of following weight parts：Release layer：Colesevelam hydrocholoride：6.25；Slow release layer：Lattice are arranged
Qi Te：0.8；Release layer auxiliary material is magnesium stearate：0.1；Cross-linked carboxymethyl cellulose sodium：0.2；Vertical compression lactose：0.1；It is crosslinked carboxylic first
Sodium starch：0.1；Microcrystalline cellulose：0.2；Magnesium stearate：0.3；Slow release layer auxiliary material is lactose：0.3；Superfine silica gel powder：0.3；It is stearic
Sour magnesium：0.1；Polyvinylpyrrolidone：0.1；Mannitol：0.1；Hydroxypropyl methylcellulose K series：0.1.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, it comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, and auxiliary material is divided into release layer auxiliary material and slow release layer auxiliary material, and again
Amount is than being 0.8~1.2:1, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, is directly pressed using powder
Sheetmolding；S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, by gliclazide and slow release layer
Auxiliary material mixes uniform to dry and wet, is pelletized with 24 mesh sieves, particle is dried to moisture≤5%, pre-molding at 60 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
Below by way of description of test beneficial effects of the present invention：
1. it is sustained dissolution test
(1) present composition double-layer sustained release tablets, recipe quantity in terms of 1000
A. 1. prescription 1：It is made 1000
Release layer：
Slow release layer：
2. prescription 2：It is made 1000
Release layer：
Slow release layer：
3. prescription 3：It is made 1000
Release layer：
Slow release layer：
B. experimental design and method：
A quick-release slaking tests：Photo agent disintegration time mensuration method (two annex X of Chinese Pharmacopoeia), due to being that double-layer tablets are delayed
Release layer not to be disintegrated, only observe the disintegration time of release layer.
B is sustained dissolution test：
This product is taken, according to drug release determination method (two methods of annex first of Chinese Pharmacopoeia), using the method for dissolution method first
Device, using pH7.4 phosphate buffer 1s 000ml as solvent, 150 turns per minute of rotating speed is operated in accordance with the law, respectively 2 hours, 4
Hour, 10 hours, solution 8ml is taken, filtered, and phosphate buffer 8ml is filled up in process container immediately, take subsequent filtrate, the
2nd, the solution direct titration of 4 hours, the solution precision of the 10th hour measures 5ml and put in 10ml measuring bottles, plus pH7.4 phosphate-buffereds
Liquid shakes up to scale and makees test liquid；Precision is weighed in 105 DEG C of dry 2 hours gliclazide reference substances in right amount, and the hydrochlorate that phosphorates delays
Solution of every 1ml containing about 15 μ g is made in fliud flushing, is used as reference substance solution.Reference substance and need testing solution are taken, according to AAS
(two annex of Chinese Pharmacopoeia), determine trap respectively at 226nm wavelength, and every is calculated respectively in above-mentioned each time
Burst size.
C. result of the test：
Prescription 1：Release layer disintegration time<5min, 30min colesevelam hydrocholoride stripping quantity 97.7%；Slow release layer Ge Lieqi
Special release 1 hour, 3 hours and 10 hours is respectively 31.3%, 58.6%, 88.7%.
Prescription 2：Release layer disintegration time<5min, 30min colesevelam hydrocholoride stripping quantity 96.2%；Slow release layer Ge Lieqi
Special release 1 hour, 3 hours and 10 hours is respectively 31.2%, 59.1%, 98.6%.
Prescription 3：Release layer disintegration time<5min, 30min colesevelam hydrocholoride stripping quantity 96.2%；Slow release layer Ge Lieqi
Special release 1 hour, 3 hours and 10 hours is respectively 27.8%, 60.2%, 94.2%.
2. hypoglycemic effect compares
(1) laboratory apparatus：Stable blood glucose meter (Hunan food medicine prison tool (standard) word 2008 the 2400069th, special number of unit
BIDI28F0068) with test strip for blood-sugar (Hunan food medicine prison tool (standard) word 2008 the 2400070th, lot number：2226NC) the promise of Changsha three
Biosensor technique limited company.
(2) experiment packet：
Gliclazide sustained-release tablet group：Celestial being inspires confidence in enlightening, Chengdu Hengrui Pharmaceutical Co., Ltd's product, the box of lot number 20131202,2；
The print of prescription 1, lot number 20140101；
The print of prescription 2, lot number 20140101.
The print of prescription 3, lot number 20140101.
(3) process of the test：
Test period：On May 27,13 days~2014 January in 2014
Rat is randomly divided into high sugared model group (n=40), blank control group (n=10), high sugar model group is by daily
(alloxan is damaged cell DNA to 100mg/kg intraperitoneal injections alloxan by destroying insulin β cells, and activates two phosphorus
The activity of adenosine monophosphate Ribosome biogenesis enzyme, declines cozymase content, ultimately results in insulin deficit, make metabolic disorder, blood glucose liter
It is high.), after continuously raising 4 weeks, by America Diabetes complication model association (AMDCC) proposed standard, fasting 6 hours：Morning 7
Point takes blood point at 13 points at noon：An angular vein peripheral blood about 0.4ml is taken to determine after anesthesia.It is required that：Blood glucose (Glu)>
11.1mmol/l is considered as modeling success, has 53 modeling successes.Blank control group is raised with normal diet, continuous to raise 13 weeks.
(4) result of the test：As shown in table 1.
Table 1：Hypoglycemic effect comparative experiments result
As known from Table 1：(celestial being inspires confidence in enlightening, and the permanent auspicious pharmacy in Chengdu is limited than Gliclazide sustained-release tablet for prescription 1, prescription 2 and prescription 3
Company produces, lot number：20131202) group has more significant blood sugar reducing function, illustrates that the present composition has collaboration to hypoglycemic
Effect.
Claims (1)
1. a kind of preparation method for the pharmaceutical composition for treating diabetes, it is characterised in that described pharmaceutical composition is by quick-release
The bilayer tablet that layer and slow release layer are constituted；The release layer is made up of colesevelam hydrocholoride and release layer auxiliary material；The slow release layer
It is made up of gliclazide and slow release layer auxiliary material；The parts by weight of the colesevelam hydrocholoride are：3~15；The parts by weight of gliclazide
For：0.1~1.5；The parts by weight summation of release layer auxiliary material and slow release layer auxiliary material is：1.5~3；The release layer auxiliary material and sustained release
The weight ratio of layer auxiliary material is 0.8~1.2:1；
The release layer auxiliary material is cross-linked carboxymethyl cellulose sodium, agar, vertical compression lactose, CCMS-Na, microcrystalline cellulose
Or one or more combinations in carboxyrnethyl starch sodium；Slow release layer auxiliary material is in hydroxypropyl methylcellulose and polyvinylpyrrolidone
One or two kinds of mixtures are constituted with one or more of mixtures in lactose, mannitol, superfine silica gel powder or magnesium stearate；
The preparation method of described pharmaceutical composition comprises the following steps：
S1. get the raw materials ready：Each raw material is weighed according to the above ratio, it is standby；
S2. release layer is prepared：Colesevelam hydrocholoride crosses 100 mesh sieves, and release layer auxiliary material crosses 80 mesh sieves, using direct powder compression
Shaping；
S3. slow release layer is prepared：Gliclazide crosses 100 mesh sieves, and slow release layer auxiliary material crosses 80 mesh sieves, and gliclazide and slow release layer is auxiliary
Material mixes uniform to dry and wet, is pelletized with 16~24 mesh sieves, particle is dried to moisture≤5%, pre-molding at 50~65 DEG C；
S4. tabletting：The slow release layer and release layer of preparation are compressed into bilayer tablet.
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| CN101757627A (en) * | 2009-09-29 | 2010-06-30 | 北大方正集团有限公司 | Combined drug and drug combination for treating diabetes |
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