CN104288161A - Pharmaceutical composition containing pioglitazone and glimepiride - Google Patents
Pharmaceutical composition containing pioglitazone and glimepiride Download PDFInfo
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- CN104288161A CN104288161A CN201410484205.1A CN201410484205A CN104288161A CN 104288161 A CN104288161 A CN 104288161A CN 201410484205 A CN201410484205 A CN 201410484205A CN 104288161 A CN104288161 A CN 104288161A
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- glimepiride
- pioglitazone
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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Abstract
The invention provides a pharmaceutical composition containing pioglitazone and glimepiride. Glimepiride which is one of components of the pharmaceutical composition disclosed by the invention can be used for lowering the blood sugar of a patient with II diabetes by stimulating insulin to release from a functional pancreatic beta cell. By virtue of a non-insulin mechanism, the glimepiride further can be used for increasing the sensitivity of a peripheral tissue to insulin. Another component pioglitazone hydrochloride is a peroxysome proliferator-activated receptor-gamma agonist with strong effect and high selectivity, and capable of lowering the insulin resistance of livers and the peripheral tissue, so that the insulin-dependent glucose utilization is increased, and the output of hepatic glucose is lowered.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of pharmaceutical composition containing pioglitazone glimepiride.
Background technology
Along with the raising preventing and treating treatment of diabetes level, the diabetics life-span increases, the course of disease extends, the appearance of the diabetic complications such as the heart, brain, kidney, vascular lesion and neuropathy has become very important problem, these complication have accounted for Diabetes Die Reason more than 70%, therefore, the Clinical and experimental study of chronic complicating diseases of diabetes is just progressively become a kind of necessary.
Type 2 diabetes mellitus people can control blood glucose effectively with during sulfonylureas at first, and curative effect reduces the phenomenon even lost efficacy gradually thereafter, is called secondary failure of sulfonylurea.Its main cause is: the first, and the prolongation of the course for the treatment of makes beta Cell of islet decline to the sensitivity of sulfonylureas, and the blood sugar lowering mechanism because of sulfonylureas is by impelling its excreting insulin to the direct stimulation of beta Cell of islet.The second, islet beta cell function worsens further, because of the effect of sulfonylureas, makes beta Cell of islet long-term over loading ground excreting insulin, to meet the needs of organism metabolism and to maintain the stable of blood glucose.Extend with the course of disease, the further exhaustion of β cell function, then give sulfonylureas stimulation β cell, the secretion of its insulin can not be promoted further.3rd, insulin resistant and insufficient insulin are two basic links of type 2 diabetes mellitus morbidity.Insulin resistant can increase the weight of further with the course of disease.Sulfonylureas is the most frequently used drug type of diabetics, and how solving secondary failure of sulfonylurea is also the clinical difficult points of diabetes.The non-enzymatic protein saccharifying that hyperglycemia causes and affect the normal configuration of protein and function generally be familiar with by people.Have many research work being just devoted to find and can blocking the medicine of nonenzymatic glycosylation, but at present still in the experimental stage, high due to R & D Cost, the price of its preparation also will be very expensive.Utilize existing resource, research and development suppress the medicine of advanced glycosylation end products generation in vivo, become the key issue of containment diabetic complication.
Pioglitazone hydrochloride is thiazolidinediones antidiabetic medicine, belong to euglycemic agent, mechanism of action is relevant with the existence of insulin, can reduce the insulin resistant of peripheral tissues and liver, increase the process of the glucose relying on insulin, and reduce the output of glycogen.Different from sulfonylurea, this product is not an insulin secretagogue medicine.Its mechanism of action is the exciting many control glucoses of activation scalable of microperoxisome growth factor activation receptor-gamma PPAR-γ 1, PPAR-γ of high selectivity and transcribing of the insulin related gene of lipid metabolism.Existing document WO2005021542 and WO2002028857 reports the new crystal formation of pioglitazone.
Glimepiride is third generation sulfonyl urea antidiabetic medicine, has and suppresses hepatic glucose synthesis, promotion muscular tissue to the picked-up of periphery glucose and the effect promoting insulin secretion.This product is applicable to diet-treated only, and exercise therapy and ameliorate body weight average fully can not control the type 2 diabetes mellitus patient of blood glucose.Be not suitable for type 1 diabetes, Diabetic ketosis poisoning and diabetes precoma or stupor treatment.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition containing pioglitazone glimepiride, be made up of pioglitazone hydrochloride and glimepiride.
Above-mentioned pharmaceutical composition, in the X-ray powder diffraction of its pioglitazone hydrochloride, 9.8512,14.3333,16.0188,18.0053,18.7858,20.9950,21.5345, there is characteristic peak at 23.0157,26.4437,26.8850,27.1113 and 30.5751 places.
Above-mentioned pharmaceutical composition, described pioglitazone hydrochloride has collection of illustrative plates similar to accompanying drawing 1.
Above-mentioned pharmaceutical composition, described pioglitazone hydrochloride has collection of illustrative plates similar to accompanying drawing 2.
Above-mentioned pharmaceutical composition, is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 15:1.
Above-mentioned pharmaceutical composition, is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 15:2.
Above-mentioned pharmaceutical composition, is characterized in that described pharmaceutical composition adds pharmaceutically acceptable adjuvant and can be prepared into tablet, capsule, pill, syrup, granule, oral solution, oral suspensions, Orally taken emulsion, small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder.
The application of the above-mentioned pharmaceutical composition contained in the diabetes complicated disease drug of preparation treatment.
The above-mentioned pharmaceutical composition contained, comprises pharmaceutically acceptable adjuvant, can be selected from starch, dextrin, carboxymethyl starch is received, hydroxypropyl starch, modified starch, lactose, microcrystalline Cellulose, hydroxypropyl methylcellulose, methylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, magnesium oxide, micropowder silica gel, aluminium oxide, aluminium hydroxide, boric acid, magnesium stearate, water, ethanol, phospholipid, tween 20, Tween-40, Tween-60, tween 80, Arlacel-20, Arlacel-40, Arlacel-60, Arlacel-80, sucrose ester, polyglyceryl fatty acid ester, carbomer, pluronic, hydroxyethyl-cellulose, chitin, chitose, agar, xanthan gum, glycine, malic acid, ascorbic acid, sodium sulfite, sodium pyrosulfite, sorbic acid, ethylparaben, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, benzoic acid, Polyethylene Glycol PEG-200, Polyethylene Glycol PEG-400, Polyethylene Glycol PEG-600, Polyethylene Glycol PEG-1000, Polyethylene Glycol PEG-4000, one or more combination in Polyethylene Glycol PEG-6000.
Invent described combination and relevant report is showed no to nonenzymatic glycosylation of protein.After clinical experiment, surprisingly find that the pharmaceutical composition containing pioglitazone glimepiride is apart from outside blood sugar reducing function, also to the generation that can block advanced glycosylation end products, is improved and reverse effect chronic complicating diseases of diabetes; In addition, the present invention also has good glucose-lowering treatment effect to the patient that secondary failure of sulfonylurea occurs, and can reverse and prevent secondary failure of sulfonylurea.
The generation of pharmaceutical composition of the present invention to AGEs simultaneously has stronger inhibitory action, illustrates that pharmaceutical composition of the present invention is improved effect to the diabetic complication that AGEs causes.Also observe in an experiment, under same concentration, contain the pharmaceutical composition of pioglitazone glimepiride to the suppression of AGEs, comparatively strong with the inhibitory action of fluorescence-causing substance, this may be because AGEs complicated component, some generation fluorescence reactions and without brown phenomenon etc., but both general trends are consistent.When the inhibitory action of timing to AGEs of sulfonylureas and pioglitazone glimepiride is stronger; And pioglitazone glimepiride and biguanides metformin or glycosidase suppress the inhibitory action of class medicine acarbose compatibility AGEs very weak, and dosage is not had to be correlated with.
Accompanying drawing explanation
Fig. 1 is the x-ray diffractogram of powder of pioglitazone crystal formation of the present invention;
Fig. 2 is the DSC figure of pioglitazone crystal formation of the present invention;
Detailed description of the invention
Further describe the present invention by embodiment below, be conducive to the understanding to the present invention and advantage thereof, better effects if, but described embodiment is only for illustration of the present invention instead of restriction the present invention.
Embodiment 1
30g pioglitazone, 240mL acetone acetonitrile mixed solvent (volume ratio is 3:1), 20mL concentrated hydrochloric acid (37%) is dropped in 500mL reaction bulb, stir temperature rising reflux 70 minutes, add activated carbon 2g, reflux 10 minutes, filtered while hot, filtrate crystallisation by cooling, sucking filtration, filter cake dries to obtain pioglitazone hydrochloride 21.6g at 55C.
Powder X-ray diffraction: gained pioglitazone hydrochloride uses Cu-K radiation, and accompanying drawing 1 is shown in by X-ray ray powder diffraction (XRPD) collection of illustrative plates of this compound.
Differential scanning calorimetric analysis: the differential scanning calorimetric thermogram spectrum of pioglitazone hydrochloride is shown in accompanying drawing 2.
Embodiment 2
Embodiment 3
Experimental example 1
Experiment purpose: set up nonenzymatic glycosylation of protein system and test by external, observation contains the pharmaceutical composition of pioglitazone glimepiride to the inhibitory action of protein glycation end-product (AGEs).
1 experiment material
1.1 reagent: bovine serum albumin, content is 96%-99%, Sigma Products (Huamei Bio-Engrg Co.,'s import subpackage).
1.2 medicines: the present composition.
1.3 instruments: 752 type ultraviolet spectrophotometers, Shanghai the 3rd analytical tool factory; RF-5302PC double wave length fluorescent photometer, Japanese Shimadzu Corporation; DNP-9272 type electro-heating standing-temperature cultivator, the accurate experimental facilities company limited in Shanghai.
2 methods and result
The each pharmaceutical composition final concentration of 2.1 preparation is 0.5,0.1mg/mL, and add that glucose (Glu) final concentration is 200mmol/L, bovine serum albumin final concentration is 40g/L saccharifying system respectively, the dual anti-liquid of 200U/mL penicillin and streptomycin is antibacterial.Separately establish other to contrast: (1) does not add the complete nonenzymatic glycosylation system of medicine simultaneously; (2) medicine is not added not containing the system of glucose; (3) medicine is added with not containing albuminous system; (4) medicine is added with not containing the system of glucose.After 37 DEG C of temperature incubate 8 weeks, measure the ultraviolet light absorption angle value (A) of the brown change of AGEs respectively at 400nm place and adopt fluorophotometer (excitation wavelength 370nm, emission wavelength 440nm, seam 1.5nm) measure the fluorescence angle value (F) of AGEs, and be calculated as follows suppression ratio (IR), the results are shown in Table 1.
Brown product suppression ratio IR (%)=[A medicine-A contrasts 3-A contrast 4]/[A contrasts 1-A contrast 2] × 100%
Fluorescence-causing substance suppression ratio IR (%)=[F medicine-F contrasts 3-F contrast 4]/[F contrasts 1-F contrast 2] × 100%
Table 1AGEs is to the screening active ingredients result of the pharmaceutical composition containing pioglitazone glimepiride
3 conclusions: the present invention has stronger inhibitory action containing the generation of pharmaceutical composition to AGEs of pioglitazone, illustrates that pharmaceutical composition is improved effect to the diabetic complication that AGEs causes.Also observe in inventor's experiment, under same concentration, contain the pharmaceutical composition of pioglitazone to the suppression of AGEs, comparatively strong with the inhibitory action of fluorescence-causing substance, this may be because AGEs complicated component, some generation fluorescence reactions and without brown phenomenon etc., but both general trends are consistent.When the inhibitory action of timing to AGEs of sulfonylureas and pioglitazone is stronger.
Experimental example 2
Experiment purpose: the medicament composition capsule agent (embodiment 2) containing pioglitazone of invention and glibenclamide sheet are to the Comparison of therapeutic for the treatment of diabetes.
1 physical data:
1.1 case-datas:
In the diabetics that this 76 example is made a definite diagnosis first, man 36 example, female 30 example, age 48-71 year, average 51 ± 13 years old.Diabetics is divided into treatment group, matched group.Treatment group: man 18 example, female 15 example, totally 33 examples; Matched group: man 18 example, female 15 example, totally 33 examples.All there is not the aspect complication such as diabetic ophthalmopathy, diabetic nephropathy, hepatopathy, cardiovascular and cerebrovascular disease and peripheral neuropathy in patient, does not need hospitalization.
1.2 diagnostic criterias: according to the standard of World Health Organization (WHO), fasting glucose is equal to or higher than 7.8mmol/1.
1.3 Therapeutic Method:
1.3.1 treatment group:
The preparation (embodiment 2) of the pharmaceutical composition containing pioglitazone of invention is oral.One time one, 1 time on the one, take when the 1st dinner.Continuous use case follows up a case by regular visits to 18 months, monthly make regular check on 1 preprandial glucose level, treatment group carries out 33 × 18=594 person-time of detection altogether; 0, within 12,15,18 months, the examination of 1 diabetic nephropathy is respectively carried out.
1.3.2 matched group:
Glibenclamide sheet is oral, every day 2-3 time, and each 1-2 grain, takes before the meal half an hour.After taking 10-14 day, the situation adjustment medication dose according to 2 hours blood glucoses after the meal: as satisfactory effect can decrement be every day 2 times gradually, the maintenance dose of each 1; As needed dosage, maximal dose is each 2, every day 3 times.Continuous use case follows up a case by regular visits to 18 months, monthly make regular check on 1 preprandial glucose level, matched group carries out 33 × 18=594 person-time of detection altogether; 0, within 12,15,18 months, the examination of 1 diabetic nephropathy is respectively carried out.
2 therapeutic effect
2.1. blood Sugar Monitoring: in 18 months, patient blood glucose controls at more than 7.8mmol/1, is judged to hyperglycemia occurs, and patient blood glucose, lower than 2.8mmol/1, is judged to hypoglycemia sugar-free occurs.Monitor data the results are shown in Table 2.
The monitor data that table 2 couple patient blood glucose controls
| Project | Hyperglycemia generation person-time | Prevalence of high blood glucose | Hypoglycemia generation person-time | Hypoglycemia incidence rate |
| Treatment group | 3 | 0.5％ | 1 | 0.2％ |
| Matched group | 14 | 2.4％ | 18 | 3.0％ |
The examination of 2.2 diabetic complications: to the monitoring of the diabetic nephropathy of experimenter, diabetic nephropathy under normal circumstances twenty-four-hour urine sample Protein Detection structure is less than 30mg/24hr, Microalbuminuria urine sample Protein Detection result is the critical state being in diabetic nephropathy between 30-299mg/24hr, clinical proteinuria urine sample Protein Detection result is greater than 300mg/24hr, can be diagnosed as diabetic nephropathy.Monitor data is in table 3.
The monitor data of table 3 pair diabetes mellitus's renal complications
3 conclusions:
Compared with glibenclamide sheet, from the dosage pharmaceutical composition containing pioglitazone of the present invention, glibenclamide dosage is also lower than matched group, and the pharmaceutical composition containing pioglitazone of invention is better than glibenclamide sheet for the control of patient blood glucose; The pharmaceutical composition containing pioglitazone of invention controls hyperglycemia and the sick nephropathy of diabetes occurs, and greatly reduces hypoglycemic Probability.From clinical effectiveness, the pharmaceutical composition containing pioglitazone of invention should demonstrate,prove the selection result of experimental example 1, and this invention can reduce the generation of diabetic complication.
Experimental example 3
Clinical observation object: containing the clinical efficacy of the medicine composite for curing sulfonylurea hypoglycemic agent secondary failure of pioglitazone.
Type 2 diabetes mellitus patient in early days by keeping on a diet, appropriate exercise and oral sulfonylureas majority can by glycemic control in normal ranges, but along with the prolongation of administration time, there will be sulfonylurea hypoglycemic agent secondary failure more.
1 data and method
1.1 physical data: 50 routine patients all meet the diabetes diagnostic criterion that WHO promulgated in 1999, wherein man 30 example, female 20 example; Age 32-70 year, average 51 years old; Course of disease 3-18, average 10.5.On the basis of diet control and appropriate exercise, glimepiride is all with to maximum, take the course for the treatment of all more than 9 months, but unsatisfactory curative effect, fasting glucose (FBG) is at 10.3-15.5mmol/L, 2 hours blood glucoses (2hBG) are at 11.1-25.6mmol/L, HbA1c>10% after the meal.Above case thing has confirmed as sulfonylurea hypoglycemic agent secondary failure case.
1.2 Therapeutic Method: cut out former sulfonylurea hypoglycemic agent thing, change the pharmaceutical composition (embodiment 2) containing pioglitazone taking invention into, every day 1 time, every day 1, capsules, took just before the meal, and the whole course for the treatment of is 3 weeks.
1.3 efficacy assessment standards are in table 4.
Table 4 blood glucose control standard (mmol/L)
| ? | Satisfied | Well | Fair | Poor |
| Fasting glucose (FBG) | <6.1 | 6.1－7.2 | 7.3－8.9 | >8.9 |
| 2 hours blood glucoses (2hBG) after the meal | <7.8 | 7.8－8.9 | 9.0－11.1 | >11.1 |
2 therapeutic outcomes
In 50 routine cases, fasting glucose controls the person of satisfaction 30 example, accounts for 60%; Good person 13 example, accounts for 26%; Still can person 6 example, account for 12%; Chump 1 example, accounts for 2%; Total effective rate reaches 98%.2 hours blood glucoses control the person of satisfaction 28 example after the meal, account for 56%; Good person 15 example, accounts for 30%; Still can person 4 example, account for 8%; Chump 3 example, accounts for 6%; Total effective rate reaches 94%.
3 discuss
Found by clinical observation, when patient's glimepiride therapy effectively can not control blood glucose, the medicine composite for curing used instead containing pioglitazone continues type 2 diabetes mellitus, can by the fasting glucose of patient and after the meal 2 hours blood glucoses be all down to desirable level.
Claims (8)
1., containing a pharmaceutical composition for pioglitazone glimepiride, it is characterized in that described pharmaceutical composition is made up of pioglitazone hydrochloride and glimepiride.
2. pharmaceutical composition according to claim 1, is characterized in that in the X-ray powder diffraction of described pioglitazone hydrochloride, 9.8512,14.3333,16.0188,18.0053,18.7858,20.9950,21.5345,23.0157,26.4437, there is characteristic peak at 26.8850,27.1113 and 30.5751 places.
3. pharmaceutical composition according to claim 2, is characterized in that described pioglitazone hydrochloride has collection of illustrative plates similar to accompanying drawing 1.
4. pharmaceutical composition according to claim 2, is characterized in that described pioglitazone hydrochloride has collection of illustrative plates similar to accompanying drawing 2.
5., according to arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 15:1.
6., according to arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 15:2.
7., according to arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that described pharmaceutical composition adds pharmaceutically acceptable adjuvant and can be prepared into tablet, capsule, pill, syrup, granule, oral solution, oral suspensions, Orally taken emulsion, small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder.
8. claim 1-6 arbitrary described in the application of pharmaceutical composition in the diabetes complicated disease drug of preparation treatment that contain.
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2014
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| US20040147564A1 (en) * | 2003-01-29 | 2004-07-29 | Rao Vinay U. | Combinations of glimepiride and the thiazolidinedione for treatment of diabetes |
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Application publication date: 20150121 |