CN102552290A - Glimepiride medicinal composition tablets and preparation method and application thereof - Google Patents
Glimepiride medicinal composition tablets and preparation method and application thereof Download PDFInfo
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- CN102552290A CN102552290A CN2012100414385A CN201210041438A CN102552290A CN 102552290 A CN102552290 A CN 102552290A CN 2012100414385 A CN2012100414385 A CN 2012100414385A CN 201210041438 A CN201210041438 A CN 201210041438A CN 102552290 A CN102552290 A CN 102552290A
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Abstract
The invention provides glimepiride medicinal composition tablets. The glimepiride medicinal composition tablets are characterized by comprising the following components: glimepiride and chromium picolinate, wherein the weight ratio of the glimepiride to the chromium picolinate is (10-80): (1-100). A glimepiride Chinese herbal medicine and the chromium picolinate are taken as active ingredients; and compared with the conventional glimepiride preparation, the invention has the advantages that: the medicinal composition improves the sensitivity and activity of peripheral tissues to insulin, and the chromium picolinate can also improve the endurance capacity of organisms to glucose and reduce the blood sugar level after abrosia, so the glycometabolism of the organisms can be improved. Excess glucose in a human body can be converted into fat, so that the metabolism of the glucose can be effectively improved, the metabolism of the fat is indirectly regulated, the deposition of the fat in the human body is reduced, and the levels of total glycerin (TG), low-density lipoprotein (LDL) and total cholesterol are reduced. The function of the insulin is improved to affect the metabolism of saccharides, lipids, protein, nucleic acid and the like.
Description
Technical field
The present invention relates to a kind of drug regimen of treating diabetes, relate to a kind of glimepiride pharmaceutical composition tablet, method for preparing and application thereof in particular.
Technical background
Diabetes spread in the world everywhere at present, and diabetes are lifelong diseases, and wherein type 2 diabetes mellitus accounts for 90%～95%, and the pathogenesis basis of type 2 diabetes mellitus is insulin resistant and β cell dysfunction.Discovering so-called " type 2 diabetes mellitus ", is under the effect of various paathogenic factors, forms through very long pathological process.Because the existence of virulence factor, normal blood constitutional balance is destroyed, and insulin is renderd a service and weakened relatively in the blood, through the startup of body internal feedback system, at first involves islets of langerhans, makes it long-term overwork and loses compensatory capacity.Be main feature clinically with the hyperglycemia; The secular blood sugar increasing of diabetics can quicken the beta Cell of islet apoptosis; Cause blood capillary, trunk and neuropathy widely, cause the functional lesion even the depletion of vitals such as the heart, brain, kidney, serious threat patient's life.Controlling needs strict blood sugar control, the protection target organ.The type 2 diabetes mellitus patient is tending towards more early, more being prone to take place cardiovascular complication.Except that hyperglycemia, dyslipidemia, the disorder of fibrinolytic balance all are the key factors that promotes that cardiovascular event takes place.
At present, OHA commonly used clinically mainly comprises sulfonylurea drugs (like gliclazide, glimepiride etc.), biguanides (like metformin etc.), blood sugar regulator used during user having meals (like glyburide etc.), thiazolidinediones medicine (like rosiglitazone etc.) and alpha-glucosidase inhibitor (like acarbose etc.) totally five big classes.But the type 2 diabetes mellitus patient is along with the prolongation of the course of disease, and the phenomenon that insulin resistant and pancreas B cell function go down in its body can increase the weight of gradually.
Summary of the invention
The blood sugar reducing function of discovering glimepiride mainly is through combining with β cell sulfonylurea receptor, stimulating β emiocytosis insulin.Chromium in the chromium picolinate is the key component of glucose tolerance factor (GTF).By means of GTF, insulin can transmit glucose and important amino acid rapidly, through cell membrane, gets into cell, produce power and formative tissue.Therefore blood sugar concentration is maintained normal level, and aminoacid is used for proteinic synthetic, produces muscle.Except participating in the metabolism of protein and carbohydrate, the organic chromium element also plays an important role in the metabolism of lipid, can be as serum cholesterol concentration regulator in the body, thus prevent the accumulation of fatty tissue.For solving the problem described in the background technology; The invention provides the medicine composition of a kind of glimepiride and chromium picolinate; Can not only effectively control type 2 diabetes mellitus patient blood glucose, also have the insulin resistant of improvement simultaneously, and the outer accent fat of blood sugar lowering, improve blood fibrinolytic system active function; Chromium in the pharmaceutical composition can be as the ingredient of glucose tolerance factor GTF, improves the function of insulin and influences the metabolism of saccharide, lipid, protein and nucleic acid etc.The more important thing is and to improve sensitivity and the activity of peripheral tissues, regulate the metabolism of fat insulin; So this drug regimen can effectively improve the sensitivity and the quality of insulin at the type 2 diabetes mellitus initial phase, thereby efficacious therapy type 2 diabetes mellitus.Concrete summary of the invention is:
A kind of glimepiride pharmaceutical composition tablet, its component comprises: glimepiride and chromium picolinate; Wherein, the weight ratio of glimepiride and chromium picolinate is 10～80:1～100.
Its component is made up of glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate.
The weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 10～80:1～100:300～600:30～100:4～30.
The weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 20:5:600:50:5.
The weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 10:5:600:50:5.
A kind of method for preparing of glimepiride pharmaceutical composition tablet may further comprise the steps:
1) adopt inert gas flow pulverizing preparation to become particle diameter respectively glimepiride crude drug and chromium picolinate crude drug less than 2
μThe powder of m; Lactose, crosslinked carboxymethyl fecula sodium and the magnesium stearate Processing of Preparation of sieving is become less than 250
μThe powder of m.
2) glimepiride raw material, chromium picolinate crude drug, lactose, crosslinked carboxymethyl fecula sodium and magnesium stearate are added in the three-dimensional motion mixer, incorporation time 15～30 minutes promptly gets and always mixes thing.
3) will always mix the thing direct compression and obtain glimepiride pharmaceutical composition tablet.
The application of above-mentioned glimepiride pharmaceutical composition tablet in preparation treatment type 2 diabetes mellitus medicine.
Useful technique effect of the present invention is: glimepiride pharmaceutical composition tablet provided by the invention is an active component with glimepiride crude drug and chromium picolinate; Conventional glimepiride preparation; This pharmaceutical composition improves sensitivity and the activity of peripheral tissues to insulin; Chromium picolinate can also improve the tolerance of body to glucose, reduces the blood sugar level after the fasting, therefore can improve the carbohydrate metabolism of body.Glucose unnecessary in the body can be converted into fat, can improve the metabolism of glucose effectively, and the metabolism of indirect regulation fat has reduced fat deposition in vivo, reduces the level of TG and LDL and T-CHOL.Improve the function of insulin and influence the metabolism of saccharide, lipid, protein and nucleic acid etc.
The specific embodiment
The preparation of embodiment 1 glimepiride pharmaceutical composition tablet
The method for preparing of glimepiride pharmaceutical composition tablet is following:
1) takes by weighing glimepiride 1g, chromium picolinate 0.5g, lactose 60g, crosslinked carboxymethyl fecula sodium 5g, magnesium stearate 0.5g.
2) getting glimepiride crude drug and chromium picolinate adopts inert gas flow pulverizing preparation to become particle diameter less than 2
μThe powder of m; Lactose, crosslinked carboxymethyl fecula sodium and the magnesium stearate Processing of Preparation of sieving becomes less than 250
μThe powder of m.
3) get the glimepiride raw material of recipe quantity, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate.Add in the three-dimensional motion mixer, incorporation time 15-30 minute, promptly get and always mix thing.
4) always mix the thing direct compression, obtain 1000 in glimepiride pharmaceutical composition tablet as group I.
As stated above, take by weighing glimepiride 2g, chromium picolinate 0.5g, lactose 60g, crosslinked carboxymethyl fecula sodium 5g, magnesium stearate 0.5g.Obtain the experimental group II.
As stated above, take by weighing glimepiride 1g, chromium picolinate 10g, lactose 60g, crosslinked carboxymethyl fecula sodium 5g, magnesium stearate 0.5g.Obtain the experimental group III.
As stated above, take by weighing glimepiride 8g, chromium picolinate 0.1g, lactose 60g, crosslinked carboxymethyl fecula sodium 5g, magnesium stearate 0.5g.Obtain the experimental group IV.
Embodiment 2 glimepiride pharmaceutical composition tablet stability accelerated tests are investigated
The glimepiride pharmaceutical composition tablet samples that makes with embodiment 1 said method; Respectively get 3 batches of aluminum-plastic packaged wrapping of usefulness; Put under the condition of temperature (40 ± 2) ℃, relative humidity (75 ± 5) % accelerated test 6 months, and measured its related substance, dissolution and content results and see table 1.
Table 1 embodiment 1 sample accelerated test result
Embodiment 3 glimepiride pharmaceutical composition tablet blood sugar reducing functions investigate 2
100 of healthy Chinese hamsters of 6 monthly ages, body constitution amount (128 ± 16.5) g.Before the experiment, survey blood glucose, select blood glucose to be higher than the animal 5O of 6.661mmoL/L with the oxidation enzyme process.The single cage of animal is raised, and freely drinks water 12h illumination.Fasting 12h before the Chinese hamster experiment; But can't help water, the eye socket venous plexus is got blood with oxidation enzymatic assays blood glucose, by the document requirement; The animal of selecting blood glucose to be higher than 6.661mmoL/L makes an experiment; By the layering of animal blood glucose height animal is divided into 5 groups, every group of lO only gives following medicine respectively: 1. matched group (0.1% tween); 2.-4. the basic, normal, high dose groups of glimepiride (2,6,20mg/kg); 5.-7. the basic, normal, high dose groups of the described glimepiride pharmaceutical composition of group I tablet (2,6,20mg/kg) gastric infusion irritates that body of stomach is long-pending to be 20mL/kg, 7d continuously, and every day 1 time, 2h gets blood after inferior last administration.
With oxidation enzymatic assays blood glucose, and calculate blood glucose reduction value and reduce percentage rate.Use the serum measured by radioimmunoassay insulin.Using software SPSS13.0 that group difference is used the check of t method analyzes.Like table 2, shown in 3.
Table 2 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster
Annotate: with comparison before the administration
* P﹥ 0.05; Compare with matched group
△ P﹤ 0.01; Compare with the glimepiride dose groups
# P﹥ 0.05
Table 3 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster serum insulin
Annotate: compare with matched group
* P﹥ 0.05;
△ P﹤ 0.05; Compare with the glimepiride dose groups
# P﹥ 0.05
Embodiment 4 glimepiride pharmaceutical composition tablet blood sugar reducing functions investigate 3
Adopt embodiment 3 described methods, investigate the described glimepiride pharmaceutical composition of the experimental group II sheet that embodiment 1 obtains,, and calculate blood glucose reduction value and reduce percentage rate with oxidation enzymatic assays blood glucose.Use the serum measured by radioimmunoassay insulin.Using software SPSS13.0 that group difference is used the check of t method analyzes.Like table 4, shown in 5.
Table 4 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster
Annotate: with comparison before the administration
* P﹥ 0.05; Compare with matched group
△ P﹤ 0.01; Compare with the glimepiride dose groups
# P﹥ 0.05
Table 5 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster serum insulin
Annotate: compare with matched group
* P﹥ 0.05;
△ P﹤ 0.05; Compare with the glimepiride dose groups
# P﹥ 0.05
Embodiment 5 glimepiride pharmaceutical composition tablet blood sugar reducing functions investigate 3
Adopt embodiment 3 described methods, investigate the described glimepiride pharmaceutical composition of the experimental group III sheet that embodiment 1 obtains,, and calculate blood glucose reduction value and reduce percentage rate with oxidation enzymatic assays blood glucose.Use the serum measured by radioimmunoassay insulin.Using software SPSS13.0 that group difference is used the check of t method analyzes.Like table 6, shown in 7.
Table 6 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster
Annotate: with comparison before the administration
* P﹥ 0.05; Compare with matched group
△ P﹤ 0.01; Compare with the glimepiride dose groups
# P﹥ 0.05
Table 7 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster serum insulin
Annotate: compare with matched group
* P﹥ 0.05;
△ P﹤ 0.05; Compare with the glimepiride dose groups
# P﹥ 0.05
Embodiment 6 glimepiride pharmaceutical composition tablet blood sugar reducing functions investigate 4
Adopt embodiment 3 described methods, investigate the described glimepiride pharmaceutical composition of the experimental group IV sheet that embodiment 1 obtains,, and calculate blood glucose reduction value and reduce percentage rate with oxidation enzymatic assays blood glucose.Use the serum measured by radioimmunoassay insulin.Using software SPSS13.0 that group difference is used the check of t method analyzes.Like table 8, shown in 9.
Table 8 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster
Annotate: with comparison before the administration
* P﹥ 0.05; Compare with matched group
△ P﹤ 0.01; Compare with the glimepiride dose groups
# P﹥ 0.05
Table 9 glimepiride pharmaceutical composition sheet is to influence (n=10,
± s) of spontaneous hyperglycemia Chinese hamster serum insulin
Annotate: compare with matched group
* P﹥ 0.05;
△ P﹤ 0.05; Compare with the glimepiride dose groups
# P﹥ 0.05
Embodiment 7 glimepiride pharmaceutical composition tablets are to the investigation 1 of blood lipid level influence
Experimental rat is divided into 4 groups, first group: quiet normal diet group (AP); Second group: quiet high lipid food group (AG); The 3rd group: high lipid food exercise group (CS); The 4th group: high lipid food+administration+exercise group (GGS), 10 every group, first group gives normal diet, and all the other each groups all give high lipid food.First, second and third is organized and irritates stomach 1mL distilled water every morning; Irritate the solution (according to the suspension of 4mg/kg body weight compounding pharmaceutical) of stomach 1mL embodiment 1 said glimepiride pharmaceutical composition tablet group I the 4th group of every day; The the 3rd and the 4th group of rat 1h that moves at dusk every day, continuous 8 weeks.Second group average weight is about 1.3-1.4 times of first group of average weight, and the modeling success is described.
Wherein, the high lipid food prescription is that per 100 g contain milk powder 10 g, Adeps Sus domestica 10 g, yolk powder 5 g, normal feedstuff 75 g and Concentrated Cod-liver Oil 1O and drip (containing vitamin A 17000U, vitamin D 1700U) mixing; Normal diet is commercially available rat laboratory animal feedstuff.Motion model is the rat treadmill exercise, continues for 8 weeks, 5d weekly, every day movement time 1h, preceding 10min speed 15m/min, back 50min is increased to 20m/min and is equivalent to 60%～70% VOMAX.
The data SPSS10.0 software processes, each is organized data and all uses mean ± standard deviation to represent, and the significance of group difference carries out statistical procedures with two-way analysis of variance.
Respectively organize rat body weight (g), epididymal adipose tissues and perirenal fat pad percentage ratio (%) and blood lipid level (mmoL/L) result after 8 weeks, as shown in table 10.
Table 10 is respectively organized rat index test situation relatively after 8 weeks
Annotate: fat is than referring to epididymis and the kidney percent fat of percentage of liveweight on every side.
﹟Expression and normal diet matched group
P﹤ 0.05;
△Expression and AG group
P﹤ 0.05;
△ △Expression and AG group
P﹤ 0.001;
*Expression AG group and normal diet matched group
P﹤ 0.05.
The ratio that AG organizes the rat average weight and AP organizes the rat average weight is explained fat modeling success near 1.3, and the AG group has significant difference (p ﹤ 0.001) with other several groups of body weight.Epididymal adipose tissues and perirenal fat percentage of liveweight percentage ratio situation: AG group and AP group fat ratio have significant difference (p ﹤ 0.05); AG group and CS group also have significant difference (p ﹤ 0.001); The AG group has significant difference (p ﹤ 0.001) with the GGS group; The GGS group is a little less than the AG group, and both do not have significant difference.The triglyceride levels of the horizontal AG group of triglyceride (TG) is higher than the AP group, but does not have significant difference; The AG group does not have significant difference with the AG group yet; But the AG group has significant difference (p ﹤ 0.05) with the GGS group.Can infer that thus motion and administration can reduce triglyceride level in the blood largely, have statistical significance.The hdl level of the horizontal AP group of high density lipoprotein (HDL) is the highest, secondly is the AG group, along with people Jie of aerobatic exercise; Hdl level reduces; After the administration, hdl level still reduces, and GGS organizes the rat hdl level and the AG group presents notable difference (p ﹤ 0.05); But compare with the AG group, administration is nonsensical for the level that improves high density lipoprotein.
Embodiment 8 glimepiride pharmaceutical composition tablets are to the investigation 2 of blood lipid level influence
Adopt embodiment 7 described methods to investigate embodiment 1 said glimepiride pharmaceutical composition tablet experimental group II, respectively organize rat body weight (g), epididymal adipose tissues and perirenal fat pad percentage ratio (%) and blood lipid level (mmoL/L) result after 8 weeks, as shown in table 11.
Table 11 is respectively organized rat index test situation relatively after 8 weeks
Annotate: fat is than referring to epididymis and the kidney percent fat of percentage of liveweight on every side.
﹟Expression and normal diet matched group
P﹤ 0.05;
△Expression and AG group
P﹤ 0.05;
△ △Expression and AG group
P﹤ 0.001;
*Expression AG group and normal diet matched group
P﹤ 0.05.
The ratio that AG organizes the rat average weight and AP organizes the rat average weight is explained fat modeling success near 1.3, and the AG group has significant difference (p ﹤ 0.001) with other several groups of body weight.Epididymal adipose tissues and perirenal fat percentage of liveweight percentage ratio situation: AG group and AP group fat ratio have significant difference (p ﹤ 0.05); AG group and CS group also have significant difference (p ﹤ 0.001); The AG group has significant difference (p ﹤ 0.001) with the GGS group; The GGS group is a little less than the AG group, and both do not have significant difference.The triglyceride levels of the horizontal AG group of triglyceride (TG) is higher than the AP group, but does not have significant difference; The AG group does not have significant difference with the AG group yet; But the AG group has significant difference (p ﹤ 0.05) with the GGS group.Can infer that thus motion and administration can reduce triglyceride level in the blood largely, have statistical significance.The hdl level of the horizontal AP group of high density lipoprotein (HDL) is the highest, secondly is the AG group, along with people Jie of aerobatic exercise; Hdl level reduces; After the administration, hdl level still reduces, and GGS organizes the rat hdl level and the AG group presents notable difference (p ﹤ 0.05); But compare with the AG group, administration is nonsensical for the level that improves high density lipoprotein.
Embodiment 9 glimepiride pharmaceutical composition tablets are to the investigation 3 of blood lipid level influence
Adopt embodiment 7 described methods to investigate embodiment 1 said glimepiride pharmaceutical composition tablet experimental group III, respectively organize rat body weight (g), epididymal adipose tissues and perirenal fat pad percentage ratio (%) and blood lipid level (mmoL/L) result after 8 weeks, as shown in table 12.
Table 12 is respectively organized rat index test situation relatively after 8 weeks
Annotate: fat is than referring to epididymis and the kidney percent fat of percentage of liveweight on every side.
﹟Expression and normal diet matched group
P﹤ 0.05;
△Expression and AG group
P﹤ 0.05;
△ △Expression and AG group
P﹤ 0.001;
*Expression AG group and normal diet matched group
P﹤ 0.05.
The ratio that AG organizes the rat average weight and AP organizes the rat average weight is explained fat modeling success near 1.3, and the AG group has significant difference (p ﹤ 0.001) with other several groups of body weight.Epididymal adipose tissues and perirenal fat percentage of liveweight percentage ratio situation: AG group and AP group fat ratio have significant difference (p ﹤ 0.05); AG group and CS group also have significant difference (p ﹤ 0.001); The AG group has significant difference (p ﹤ 0.001) with the GGS group; The GGS group is a little less than the AG group, and both do not have significant difference.The triglyceride levels of the horizontal AG group of triglyceride (TG) is higher than the AP group, but does not have significant difference; The AG group does not have significant difference with the AG group yet; But the AG group has significant difference (p ﹤ 0.05) with the GGS group.Can infer that thus motion and administration can reduce triglyceride level in the blood largely, have statistical significance.The hdl level of the horizontal AP group of high density lipoprotein (HDL) is the highest, secondly is the AG group, along with people Jie of aerobatic exercise; Hdl level reduces; After the administration, hdl level still reduces, and GGS organizes the rat hdl level and the AG group presents notable difference (p ﹤ 0.05); But compare with the AG group, administration has significant meaning for the level page or leaf that improves high density lipoprotein.
Embodiment 10 glimepiride pharmaceutical composition tablets are to the investigation 4 of blood lipid level influence
Adopt embodiment 7 described methods to investigate embodiment 1 said glimepiride pharmaceutical composition tablet experimental group IV, respectively organize rat body weight (g), epididymal adipose tissues and perirenal fat pad percentage ratio (%) and blood lipid level (mmoL/L) result after 8 weeks, as shown in table 13.
Table 13 is respectively organized rat index test situation relatively after 8 weeks
Annotate: fat is than referring to epididymis and the kidney percent fat of percentage of liveweight on every side.
﹟Expression and normal diet matched group
P﹤ 0.05;
△Expression and AG group
P﹤ 0.05;
△ △Expression and AG group
P﹤ 0.001;
*Expression AG group and normal diet matched group
P﹤ 0.05.
The ratio that AG organizes the rat average weight and AP organizes the rat average weight is explained fat modeling success near 1.3, and the AG group has significant difference (p ﹤ 0.001) with other several groups of body weight.Epididymal adipose tissues and perirenal fat percentage of liveweight percentage ratio situation: AG group and AP group fat ratio have significant difference (p ﹤ 0.05); AG group and CS group also have significant difference (p ﹤ 0.001); The AG group has significant difference (p ﹤ 0.001) with the GGS group; The GGS group is a little less than the AG group, and both do not have significant difference.The triglyceride levels of the horizontal AG group of triglyceride (TG) is higher than the AP group, but does not have significant difference; The AG group does not have significant difference with the CS group yet; But the AG group does not have significant difference with the GGS group.Can infer that thus motion reduces triglyceride level in the blood to a great extent, has statistical significance.The hdl level of the horizontal AP group of high density lipoprotein (HDL) is the highest, secondly is the AG group, along with people Jie of aerobatic exercise; Hdl level reduces; After the administration, hdl level still reduces, and GGS organizes the rat hdl level and the AG group does not have notable difference (p ﹤ 0.05); But compare with the AG group, administration is nonsensical for the level that improves high density lipoprotein.
Claims (7)
1. glimepiride pharmaceutical composition tablet, it is characterized in that: its component comprises: glimepiride and chromium picolinate; Wherein, the weight ratio of glimepiride and chromium picolinate is 10～80:1～100.
2. glimepiride pharmaceutical composition tablet according to claim 1 is characterized in that: its component is made up of glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate.
3. glimepiride pharmaceutical composition tablet according to claim 2 is characterized in that: the weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 10～80:1～100:300～600:30～100:4～30.
4. glimepiride pharmaceutical composition tablet according to claim 3 is characterized in that: the weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 20:5:600:50:5.
5. glimepiride pharmaceutical composition tablet according to claim 3 is characterized in that: the weight ratio of said glimepiride, chromium picolinate, lactose, crosslinked carboxymethyl fecula sodium, magnesium stearate is 10:5:600:50:5.
6. the method for preparing of a glimepiride pharmaceutical composition tablet is characterized in that: said method comprising the steps of:
1) adopt inert gas flow pulverizing preparation to become particle diameter respectively glimepiride crude drug and chromium picolinate crude drug less than 2
μThe powder of m; Lactose, crosslinked carboxymethyl fecula sodium and the magnesium stearate Processing of Preparation of sieving is become less than 250
μThe powder of m;
2) by one of claim 1-5 described prescription glimepiride raw material, chromium picolinate crude drug, lactose, crosslinked carboxymethyl fecula sodium and magnesium stearate are added in the three-dimensional motion mixer, incorporation time 15～30 minutes promptly gets and always mixes thing;
3) will always mix the thing direct compression and obtain glimepiride pharmaceutical composition tablet.
7. the application of the arbitrary described glimepiride pharmaceutical composition tablet of claim 1-5 in preparation treatment type 2 diabetes mellitus medicine.
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Citations (4)
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|---|---|---|---|---|
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| US20030078269A1 (en) * | 2001-03-22 | 2003-04-24 | Chronorx, Llc | Biguanide and sulfonylurea formulations for the prevention and treatment of insulin resistance and type 2 diabetes mellitus |
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| CN101352498A (en) * | 2008-09-22 | 2009-01-28 | 张卫红 | Formulation for reducing medicine toxicity damage and improving immunity and regulating blood sugar and preparation method thereof |
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2012
- 2012-02-23 CN CN2012100414385A patent/CN102552290A/en active Pending
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|---|---|---|---|---|
| CN1218054A (en) * | 1998-10-09 | 1999-06-02 | 董国臣 | Preparation of chromium methionine and its composition as Jiangtangyikang tablets (capsules) series |
| US20030078269A1 (en) * | 2001-03-22 | 2003-04-24 | Chronorx, Llc | Biguanide and sulfonylurea formulations for the prevention and treatment of insulin resistance and type 2 diabetes mellitus |
| CN1686547A (en) * | 2005-03-30 | 2005-10-26 | 淮北市辉克药业有限公司 | Long time use compound preparation for treating diabetes |
| WO2006102804A1 (en) * | 2005-03-30 | 2006-10-05 | Pficker Pharmaceuticals Ltd. | The compound preparation for treating diabetes mellitus |
| CN101352498A (en) * | 2008-09-22 | 2009-01-28 | 张卫红 | Formulation for reducing medicine toxicity damage and improving immunity and regulating blood sugar and preparation method thereof |
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Application publication date: 20120711 |