CN107693526A - A kind of hypoglycemic oral formulations and preparation method thereof - Google Patents
A kind of hypoglycemic oral formulations and preparation method thereof Download PDFInfo
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- CN107693526A CN107693526A CN201711088888.9A CN201711088888A CN107693526A CN 107693526 A CN107693526 A CN 107693526A CN 201711088888 A CN201711088888 A CN 201711088888A CN 107693526 A CN107693526 A CN 107693526A
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
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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
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention belongs to pharmaceutical technology field, specifically discloses a kind of hypoglycemic oral formulations and preparation method thereof, by weight fraction meter, is made up of following raw material:5 10 parts of 5 10 parts of gliclazide, 15 20 parts of Metformin hydrochloride, 5 10 parts of acarbose, 10 15 parts of carboxymethyl cellulose, 0.1 0.5 parts of magnesium stearate, 15 parts of polacrilin potassium resin (IRP88), 0.1 0.5 parts of Aspartame and mannitol.The different hypoglycemic drug of several effects is combined by the present invention, has synergy each other, has complementary advantages, improve curative effect, effectively control blood glucose, reduce complication, can also effectively be lost weight while blood glucose is reduced, reduces blood fat etc..
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of hypoglycemic oral formulations and preparation method thereof.
Background technology
Diabetes (Diabetes Inellitus) are a kind of metabolic diseases of multi-pathogenesis, are characterized in chronic hyperglycemia,
It is disorderly with sugar, fat and protein metabolism caused by insulin secretion and/or effect defect.Diabetes can betide any
Age, as the course of disease extends, the easily histopathology infringement such as concurrent whole body nerve, capilary and macroangiopathy, and can causing
Chronic, the progressive lesion of the histoorgans such as the heart, brain, kidney, nerve and eye, so that final occur blindness, lower limb gangrene, uremic
Disease, headstroke or myocardial infarction, or even threat to life.With the improvement of living standards, diabetes turn into a kind of common disease, its
The incidence of disease is also increasing year by year.At present, the illness rate of developed country's diabetes is up to 5%-10%, the illness rate in China also oneself
Up to 3%.More than 90% is diabetes B in diabetic, and the ability that diabetes B produces insulin in patient body is not complete
Complete to lose, some patient's body insulin even produces excessively, but because the Insulin Resistance of body strengthens, and make pancreas islet
The action effect unobvious of element, therefore the insulin deficit of patient's body is a kind of relative shortage.
At present, treating the conventional medicine of diabetes has sulfonylureas, biguanides and alpha-glucosidase restrainer, independent medication
The defects of different degrees of be present, dosage is big, toxic side effect is obvious etc..Therefore, it is necessary to develop a kind of compound preparation, will act on
The different several drugses of mechanism combine, and have complementary advantages, and improve curative effect, effectively control blood glucose, reduce complication.
The content of the invention
In order to solve the above problems, the present invention provides kind of hypoglycemic oral formulations and preparation method thereof, by the mechanism of action
Different several drugses combine, and have complementary advantages, and improve curative effect, effectively control blood glucose, reduce complication.
The present invention is only applicable and simple diabetic, there is other diseases or hepatic and kidney function obstacle person disabling.
The technical scheme that the present invention solves above-mentioned technical problem is as follows:A kind of hypoglycemic oral formulations, by weight fraction
Meter, is made up of following raw material:Gliclazide 5-10 parts, Metformin hydrochloride 15-20 parts, acarbose 5-10 parts, carboxymethyl are fine
Tie up plain 10-15 parts, magnesium stearate 0.1-0.5 parts, polacrilin potassium resin (IRP88) 1-5 parts, Aspartame 0.1-0.5 parts and
Mannitol 5-10 parts.
On the basis of above-mentioned technical proposal, the present invention can also do following improvement.
Preferably, a kind of hypoglycemic oral formulations, by weight fraction meter, are made up of following raw material:5 parts of gliclazide,
20 parts of Metformin hydrochloride, 5 parts of acarbose, 15 parts of carboxymethyl cellulose, 0.5 part of magnesium stearate, polacrilin potassium resin
(IRP88) 8 parts of 4 parts, 0.2 part of Aspartame and mannitol.
Preferably, a kind of hypoglycemic oral formulations, by weight fraction meter, are made up of following raw material:10 parts of gliclazide,
15 parts of Metformin hydrochloride, 10 parts of acarbose, 10 parts of carboxymethyl cellulose, 0.3 part of magnesium stearate, polacrilin potassium resin
(IRP88) 10 parts of 5 parts, 0.1 part of Aspartame and mannitol.
Preferably, a kind of hypoglycemic oral formulations, by weight fraction meter, are made up of following raw material:8 parts of gliclazide,
18 parts of Metformin hydrochloride, 8 parts of acarbose, 12 parts of carboxymethyl cellulose, 0.3 part of magnesium stearate, polacrilin potassium resin
(IRP88) 8 parts of 3 parts, 0.5 part of Aspartame and mannitol.
Preferably, a kind of hypoglycemic oral formulations, by weight fraction meter, are made up of following raw material:5 parts of gliclazide,
15 parts of Metformin hydrochloride, 10 parts of acarbose, 10 parts of carboxymethyl cellulose, 0.3 part of magnesium stearate, polacrilin potassium resin
(IRP88) 5 parts of 5 parts, 0.1 part of Aspartame and mannitol.
The present invention also provides a kind of preparation method of hypoglycemic oral formulations, concretely comprises the following steps:
Step 1:Gliclazide 5-10 parts, Metformin hydrochloride 15-20 parts, acarbose 5- are taken in pharmaceutical grade clean area
10 parts, carboxymethyl cellulose 10-15 parts, magnesium stearate 0.1-0.5 parts, polacrilin potassium resin (IRP88) 1-5 parts, A Siba
Sweet tea 0.1-0.5 parts and mannitol 5-10 parts;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, A Siba
Sweet tea, mannitol are well mixed, tabletting, tablet format 0.25g/ pieces.
Compared with prior art, the beneficial effects of the invention are as follows:
The different hypoglycemic drug of several effects is combined by the present invention, has synergy each other, has complementary advantages,
Curative effect is improved, effectively controls blood glucose, complication is reduced, can also effectively be lost weight while blood glucose is reduced, reduces blood fat
Deng.
Embodiment
The principles and features of the present invention are described below, and the given examples are served only to explain the present invention, is not intended to limit
Determine the scope of the present invention.
Embodiment 1
A kind of preparation of hypoglycemic oral formulations, is concretely comprised the following steps:
Step 1:Gliclazide 5g, Metformin hydrochloride 20g, acarbose 5g, carboxymethyl are taken in pharmaceutical grade clean area
Cellulose 15g, magnesium stearate 0.5g, polacrilin potassium resin (IRP88) 4g, Aspartame 0.2g and mannitol 8g;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, A Siba
Sweet tea, mannitol are well mixed, tabletting, tablet format 0.25g/ pieces.
Embodiment 2
A kind of preparation of hypoglycemic oral formulations, is concretely comprised the following steps:
Step 1:Gliclazide 5g, Metformin hydrochloride 20g, acarbose 5g, carboxymethyl are taken in pharmaceutical grade clean area
Cellulose 15g, magnesium stearate 0.5g, polacrilin potassium resin (IRP88) 4g, Aspartame 0.2g and mannitol 8g;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, A Siba
Sweet tea, mannitol are well mixed, tabletting, tablet format 0.25g/ pieces.
Embodiment 3
A kind of preparation of hypoglycemic oral formulations, is concretely comprised the following steps:
Step 1:Gliclazide 8g, Metformin hydrochloride 18g, acarbose 8g, carboxymethyl are taken in pharmaceutical grade clean area
Cellulose 12g, magnesium stearate 0.3g, polacrilin potassium resin (IRP88) 3g, Aspartame 0.5g and mannitol 8g;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, A Siba
Sweet tea, mannitol are well mixed, tabletting, tablet format 0.25g/ pieces.
Embodiment 4:
A kind of preparation of hypoglycemic oral formulations, is concretely comprised the following steps:
Step 1:Gliclazide 5g, Metformin hydrochloride 15g, acarbose 10g, carboxymethyl are taken in pharmaceutical grade clean area
Cellulose 10g, magnesium stearate 0.3g, polacrilin potassium resin (IRP88) 5g, Aspartame 0.1g and mannitol 5g;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, A Siba
Sweet tea, mannitol are well mixed, tabletting, tablet format 0.25g/ pieces.
Comparative example
A kind of preparation of hypoglycemic oral formulations, is concretely comprised the following steps:
Step 1:Taken in pharmaceutical grade clean area Metformin hydrochloride 18g, carboxymethyl cellulose 12g, magnesium stearate 0.3g,
Polacrilin potassium resin (IRP88) 3g, Aspartame 0.5g and mannitol 8g;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds ripple
Clarke woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made,
It is standby to cross 80 mesh sieves;
Step 3:Drug containing toner and carboxymethyl cellulose, magnesium stearate, Aspartame, mannitol are well mixed,
Tabletting, tablet format 0.25g/ pieces.
The test of pesticide effectiveness:
The hypoglycemic oral formulations of present invention implementation 1 are used for the clinical test of hyperglycemic patients, evaluate the present embodiment 1
Oral formulations hypoglycemic effect.
1st, case selection:
300 diabetics, wherein male patient 180 are chosen, female patient 120, the oldest is 65 years old, most
Small is 38 years old, average age 48 years old, the course of disease -20 years 1 month, is randomly divided into experimental group and control group, every group of 150 people, Huan Zhejun
Without Other diseases or medical history, and hepatic and renal function is normal.
2nd, instructions of taking:
Experimental group takes oral formulations made from the embodiment of the present invention 1, three times per day, one at a time, takes before the meal, continuously
A week after taking.
Control group takes obtained oral formulations in comparative example of the present invention, three times per day, one at a time, takes before the meal, even
Continuous a week after taking
3rd, curative effect judges:
It is effective:Patient blood glucose recovers to normal level;
Effectively, blood glucose level in patients has declined, but to drop to normal level;
Invalid, blood glucose level in patients is without any downward trend.
4th, test result:
The therapeutic effect contrast of hypoglycemic oral formulations is shown in Table in this implementation 1 hypoglycemic oral formulations and comparative example
1, total effective rate 89.3%, inefficiency 10.7%.Specific data are shown in Table 1.
The test result contrast table of table 1
It is effective | Effectively | It is invalid | Total effective rate | Inefficiency | |
Experimental group | 78 | 56 | 16 | 89.3% | 10.7% |
Control group | 58 | 64 | 28 | 81.3% | 18.6% |
In summary, oral formulations hypoglycemic made from the embodiment of the present invention 1 can effectively control blood glucose, therapeutic effect
More preferably.
Claims (6)
1. a kind of hypoglycemic oral formulations, it is characterised in that fraction meter by weight, be made up of following raw material:Gliclazide 5-
10 parts, Metformin hydrochloride 15-20 parts, acarbose 5-10 parts, carboxymethyl cellulose 10-15 parts, magnesium stearate 0.1-0.5
Part, polacrilin potassium resin (IRP88) 1-5 parts, Aspartame 0.1-0.5 parts and mannitol 5-10 parts.
A kind of 2. hypoglycemic oral formulations according to claim 1, it is characterised in that fraction meter by weight, by following
Raw material forms:5 parts of gliclazide, 20 parts of Metformin hydrochloride, 5 parts of acarbose, 15 parts of carboxymethyl cellulose, magnesium stearate
8 parts of 0.5 part, 4 parts of polacrilin potassium resin (IRP88), 0.2 part of Aspartame and mannitol.
A kind of 3. hypoglycemic oral formulations according to claim 1, it is characterised in that fraction meter by weight, by following
Raw material forms:10 parts of gliclazide, 15 parts of Metformin hydrochloride, 10 parts of acarbose, 10 parts of carboxymethyl cellulose, magnesium stearate
10 parts of 0.3 part, 5 parts of polacrilin potassium resin (IRP88), 0.1 part of Aspartame and mannitol.
A kind of 4. hypoglycemic oral formulations according to claim 1, it is characterised in that fraction meter by weight, by following
Raw material forms:8 parts of gliclazide, 18 parts of Metformin hydrochloride, 8 parts of acarbose, 12 parts of carboxymethyl cellulose, magnesium stearate
8 parts of 0.3 part, 3 parts of polacrilin potassium resin (IRP88), 0.5 part of Aspartame and mannitol.
A kind of 5. hypoglycemic oral formulations according to claim 1, it is characterised in that fraction meter by weight, by following
Raw material forms:5 parts of gliclazide, 15 parts of Metformin hydrochloride, 10 parts of acarbose, 10 parts of carboxymethyl cellulose, magnesium stearate
5 parts of 0.3 part, 5 parts of polacrilin potassium resin (IRP88), 0.1 part of Aspartame and mannitol.
6. a kind of preparation method of hypoglycemic oral formulations, it is characterised in that concretely comprise the following steps:
Step 1:Gliclazide 5-10 parts, Metformin hydrochloride 15-20 parts, acarbose 5-10 are taken in pharmaceutical grade clean area
Part, carboxymethyl cellulose 10-15 parts, magnesium stearate 0.1-0.5 parts, polacrilin potassium resin (IRP88) 1-5 parts, Aspartame
0.1-0.5 parts and mannitol 5-10 parts;
Step 2:It is 1 in mass ratio that melbine, which is weighed, with water:30 ratio mixing, after being completely dissolved it, adds Andrea Pollack
Woods potassium (IRP88) resin carries out ion exchange, reacts 1h, filters washing, and in 60 DEG C of drying, drug containing toner is made, crosses 80
Mesh sieve is standby;
Step 3:By drug containing toner and gliclazide, acarbose, carboxymethyl cellulose, magnesium stearate, Aspartame, sweet
Dew alcohol is well mixed, tabletting, tablet format 0.25g/ pieces.
Priority Applications (1)
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CN201711088888.9A CN107693526A (en) | 2017-11-08 | 2017-11-08 | A kind of hypoglycemic oral formulations and preparation method thereof |
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CN201711088888.9A CN107693526A (en) | 2017-11-08 | 2017-11-08 | A kind of hypoglycemic oral formulations and preparation method thereof |
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CN107693526A true CN107693526A (en) | 2018-02-16 |
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CN201711088888.9A Withdrawn CN107693526A (en) | 2017-11-08 | 2017-11-08 | A kind of hypoglycemic oral formulations and preparation method thereof |
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2017
- 2017-11-08 CN CN201711088888.9A patent/CN107693526A/en not_active Withdrawn
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