CN101444507A - Pharmaceutical composition for treating type 2 diabetes - Google Patents
Pharmaceutical composition for treating type 2 diabetes Download PDFInfo
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- CN101444507A CN101444507A CNA2007101504068A CN200710150406A CN101444507A CN 101444507 A CN101444507 A CN 101444507A CN A2007101504068 A CNA2007101504068 A CN A2007101504068A CN 200710150406 A CN200710150406 A CN 200710150406A CN 101444507 A CN101444507 A CN 101444507A
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- pioglitazone
- taurine
- xylitol
- pharmaceutical composition
- diabetes
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Abstract
The invention relates to a pharmaceutical composition containing pioglitazone, taurine and xylitol thereof. The pharmaceutical composition contains 10-100mg of the pioglitazone, 1-10g of the taurine, 1-10g of the xylitol thereof and a pharmaceutically acceptable carrier thereof. The composition can improve curative effect of single drug use and reduce dosage of antidiabetic drugs. Taking the composition can help relieve 'three-much' symptoms (much drinking, much eating and polyuria) of patients, substantially eliminate thirst and hunger, and reduce glucose in urine. After long-term use of the composition, the symptoms disappear, and diabetic complications are effectively controlled.
Description
Technical field
The present invention relates to treat the pharmaceutical composition of diabetes, particularly a kind of pharmaceutical composition that contains pioglitazone and taurine and xylitol composition thereof.
Background technology
Along with 21 century the whole world enter aging society, the raising of living standards of the people and the variation of dietary structure, the sickness rate of diabetes increases year by year, has become at present after cardiovascular system is unified tumor, threatens the third-largest disease of human life's health.Nowadays diabetes no longer only are the threats to the old people, and patient's rejuvenation is more and more obvious.According to an international research prediction, some developing countries' sharp increase of 21 century diabetes in China, India and Africa.The diabetes number of China will be the first in the world.
Diabetes are listed in the third-largest " killer " after AIDS, cancer in medical circle, the title of " inferior cancer " are arranged.According to the permanent resident population investigation of China Preventive Medicial Science Institute to more than 40,000 20-74 of national 11 provinces (city) year, the result shows: this sick sickness rate is 3.12%, the impaired glucose tolerance person is 4.76%, and this patient of China and impaired glucose tolerance person add up to can reach 5000-6000 ten thousand people.Wherein 5% with subordinate I type, is more common in child and teenager, and onset is anxious, the interior severe insulin deficiency of body.Belong to the II type more than 95%, mostly occur the old people, onset relaxes, easily ignores and fails to pinpoint a disease in diagnosis, it is not fearful to get diabetes, fearful is the complication that causes therefrom, as acute complications---mainly comprise ketoacidosis, high infiltration stupor, lactic acidosis, chronic complicating diseases-mainly comprise cardiovascular, retina, kidney, neuropathy.Complication has not only been brought misery to patient, and severe patient can jeopardize patient's life.
(pioglitazone hydrochloride can be united to improve and blood sugar control with diet control and physical training for noninsulindependent diabetes, NIDDM) patient for type 2 diabetes mellitus.Pioglitazone hydrochloride can use separately, and when diet control, physical training and single therapy can not Satisfactory Control blood glucose, it also can share with sulphur urea, metformin or insulin.Clinical research shows that pioglitazone can improve insulin resistant patient's insulin sensitivity, improves the reactivity of insulin pair cell, and improves glucose disequilibrium in the body.Act on sustainable at least 1 year, in controlled clinical trial, pioglitazone and sulfonylureas, metformin or insulin share, and can improve curative effect.The unusual patient of lipid has also been selected in the clinical trial of pioglitazone, and the patient treats through pioglitazone, can reduce the triacylglycerol level, increase HDL-C, but LDL and TC does not then have conforming change.After this product gave rabbit 10 times every day, the serum-concentration of pioglitazone and active metabolite thereof continued to raise, and reaches Css in the 7d.Under steady statue, the plasma concentration of 2 active metabolite III (M-III) of pioglitazone and plasma concentration 〉=pioglitazone of IV (M-IV), pioglitazone accounts for 30%～50% its AUC and accounts for 20%～25% of total AUC.
Taurine (Taurine) chemical name is 2-aminoethyl sulfonic acid (C
2H
7NO
3S), it is a kind of special aminoacid, is the requisite a kind of nutrient of human body, and the marvellous effect of balance health is arranged.Except eyes, taurine also has important effect to other organ.For example, through studies confirm that content of taurine is the highest in the human heart.Taurine is cardiac function enhancing by protecting cardiac muscle.Measure when too high when calcium ion inflow in the myocardial cell, will cause coronary heart disease.Taurine can be adjusted the amount of calcium ion in the myocardial cell, keeps its balance, realizes heart tonifying.The relation of taurine and heart has become one of problem of whole world primary study.It is a kind of beta amino acids sulfinic acid analog of sulfur-bearing.Taurine combines with Insulin receptor INSR, promotes muscle to glucose, amino acid whose picked-up and utilization, quickens glycolysis, increases gluconeogenesis, and this has important compensatory meaning when situations such as insulin release deficiency or insulin resistant.
Xylitol is a kind of pentose alcohol, it is the normal intermediate product of xylose metabolism, profile is the crystallinity white powder, and very easily water-soluble (about 160g/100ml) extensively is present in the plants such as the group food of fruit, vegetable, frumentum, mushroom and timber, Caulis et Folium Oryzae, corn cob.Xylitol is as the carbohydate metabolism intermediate, do not need the promotion (can promote the pancreas excreting insulin) of insulin, with own unique metabolic pathway, produce ribose phosphate by glucuronic acid xylulose and pentose phosphate pathway, and then generation 6-glucose 1-phosphate1-, resynthesis glycogen or further oxidative metabolism obtain energy, xylitol can be adjusted abnormal carbohydrate metabolism, when the patient lacks insulin, xylitol is the energy permeate through cell membranes as usual, supplies with cytotrophy and energy, plays the function that glucose adds insulin, after taking this product, " more than three " condition of illness of patient alleviates, thirsty and hungry basic the disappearance, and glucose in urine reduces, take the back disease for a long time and disappear, controlled the generation of diabetic complication effectively.
Summary of the invention
In view of the foregoing, the present invention discloses a kind of compositions that contains pioglitazone and taurine and xylitol thereof first, and said composition can significantly improve the curative effect of independent medication, and then can reduce taking dose, effectively reduces the toxic and side effects of independent medication.
The technical solution used in the present invention is as follows: a kind of pharmaceutical composition for the treatment of type ii diabetes is characterized in that containing pioglitazone and taurine and xylitol thereof; It consists of pioglitazone, taurine 10-100mg, 1-10g xylitol and pharmaceutically acceptable carrier.
Pioglitazone consumption consumption of the present invention is generally 10mg-100mg; Preferred 30mg-80mg.Preferred especially 30mg-50mg;
Taurine is generally 10mg-100mg; Preferred 30mg-80mg.Preferred especially 30mg-50mg;
The xylitol consumption is generally 1g-10g; Preferred 1g-6g.
Taurate of the present invention is: free taurine, Ascorbate or taurine magnesium salt.
Preparation of drug combination method provided by the invention; it is characterized in that: pioglitazone, taurate and xylitol thereof and pharmaceutic adjuvant are mixed together; comprise: 10mg-100mg pioglitazone, taurine and 1g-10g xylitol and pharmaceutic adjuvant are mixed together, make the medicinal various dosage forms of acceptable that go up.
Usually said composition is applicable to oral administration.But the administering mode that also is fit to other, for example, parenteral, sublingual administration or percutaneous dosing.The dosage form that is used for oral administration can be tablet, capsule, soft capsule, oral liquid, effervescent tablet, coated tablet or uncoated tablets, slow releasing tablet or the like.When parenteral administration, the present composition be applicable to injection or chronic venous instillation be packaged in the bottle or the bag in injection solution and form of suspension.
Pharmaceutic adjuvant of the present invention comprises following excipient: filler: lactose, sucrose, starch, microcrystalline Cellulose, sorbitol, cellulose.Binding agent: gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, starch, dextrin.Disintegrating agent: microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, polyvinylpyrrolidone.Lubricant: magnesium stearate; High-molecular bone frame material, for example hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil, acrylic resin.
Pioglitazone is the treatment diabetes medicament of using always, and taurine is not generally as the treatment diabetes medicament.Now; there is wonderful reality to show; pioglitazone and taurate and xylitol combination medicine form thereof can provide useful especially glycemic control effect and not observe untoward reaction, and observed synergism is the remarkable improvement of hyperglycemia symptom, and curative effect improves.Therefore, it is sick that this combination medicine form is used in particular for treating II type sugar.
The pharmaceutical composition of pioglitazone of the present invention and taurate and xylitol thereof has passed through the pharmacology rat experiment, to the protective effect and the mechanism thereof of diabetes rat kidney.Method: 30 of female sd inbred rats are divided into 3 groups: normal control group, diabetic groups and pioglitazone group.Detect and respectively to organize wk4,8 o'clock blood glucose, glycolated hemoglobin, renal function, blood fat, the variation of indexs such as blood transforminggrowthfactor-(TGF-β 1) level, the immunohistochemistry detection fibers connects albumen (FN) and laminin (LN) expression.The result: the pioglitazone group obviously reduces than the diabetic groups excretion quantity of urinary protein during wk8, (20.8 ± s0.7) μ g24h^-1vs (12.6 ± 1.4) μ g24h^-1, P＜0.01; Blood TGF-β 1 level decline (P＜0.01); Pioglitazone group renal tubules FN and glomerule LN express and are lower than diabetic groups, P＜0.01 and P＜0.05 during wk8.Conclusion: pioglitazone has the part protective effect for the diabetes nephropathy, can suppress TGF-β 1 level in the blood, reduces the deposition of extracellular matrix.
Reduce side effect: can reduce the consumption of independent use pioglitazone during owing to employing combination treatment diabetes, thereby reduce the side effect that the life-time service pioglitazone causes.This is because because taurine; have facedown beta Cell of islet damage, keep the double protection that its structural intergrity and endocrine function and promotion are damaged cytothesis, can resist owing to the life-time service pioglitazone causes the insulin excessive secretion and cause the consequent secondary failure of beta Cell of islet depletion.Simultaneously because xylitol can promote the pancreas excreting insulin, produce ribose phosphate by glucuronic acid xylulose and pentose phosphate pathway, and then generation 6-glucose 1-phosphate1-, resynthesis glycogen or further oxidative metabolism obtain energy, xylitol can be adjusted abnormal carbohydrate metabolism, when the patient lacks insulin, xylitol is the energy permeate through cell membranes as usual, supplies with cytotrophy and energy, plays the function that glucose adds insulin, after taking compositions of the present invention, " more than three " condition of illness of patient alleviates, thirsty and hungry basic the disappearance, and glucose in urine reduces, take the back disease for a long time and disappear, controlled the generation of diabetic complication effectively.
The specific embodiment
The present invention will be further described below in conjunction with embodiment.
Embodiment 1
Capsular preparation:
To contain pioglitazone 10g, 5g xylitol, the pharmaceutical composition of taurine 60g, micropowder silica gel 5g, mix homogeneously, 10% hydroxypropyl emthylcellulose, 80% ethanol liquid be as binding agent, the fluidized bed prilling coating, and the capsule of packing into No. 0 is made 1000.
Embodiment 2
The preparation of tablet:
To contain pioglitazone 100g, 10g xylitol, the pharmaceutical composition of taurine 80g adds amylum pregelatinisatum 100g, dextrin 25g, microcrystalline Cellulose 5g, magnesium stearate 2.5g, and mix homogeneously, 40% ethanol pelletize, tabletting is made 1000, the bag film-coat.
Embodiment 3
The preparation of oral liquid:
To contain pioglitazone 10g, 3g xylitol, the pharmaceutical composition of taurine 20g, sorbitol 100g mix homogeneously adds water and makes 1000ml, bottling.
Embodiment 4
To contain pioglitazone 30g, 7g xylitol, the pharmaceutical composition of taurine 60g, micropowder silica gel 5g, mix homogeneously, 10% hydroxypropyl emthylcellulose, 80% ethanol liquid be as binding agent, the fluidized bed prilling coating, and the capsule of packing into No. 0 is made 1000.
Embodiment 4
To contain pioglitazone 50g, 5g xylitol, the pharmaceutical composition of Ascorbate 50g, micropowder silica gel 5g, mix homogeneously, 10% hydroxypropyl emthylcellulose, 80% ethanol liquid be as binding agent, the fluidized bed prilling coating, and the capsule of packing into No. 2 is made 1000.
Although more than the present invention done detailed description in conjunction with its special embodiment; but clearly still can make various changes and improvements concerning the skilled people in present technique field, these can not depart from the spirit and the protection domain of claim of the present invention.
Claims (4)
1, a kind of pharmaceutical composition for the treatment of type ii diabetes is characterized in that containing pioglitazone and taurine and xylitol thereof; It consists of 10-100mg pioglitazone, 10-100g taurate, 1-10g xylitol and pharmaceutically acceptable carrier.
2, compositions according to claim 1, wherein, pioglitazone, taurine consumption are that 30mg-80mg, xylitol consumption are 1-6g.
3, as compositions as described in the claim 1-2, wherein, taurate is: free taurine, Ascorbate or taurine magnesium salt.
4, the described preparation of compositions method of claim 1 is characterized in that: pioglitazone, taurate and xylitol thereof and pharmaceutic adjuvant are mixed together, make the medicinal various dosage forms of acceptable that go up.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101504068A CN101444507A (en) | 2007-11-26 | 2007-11-26 | Pharmaceutical composition for treating type 2 diabetes |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101504068A CN101444507A (en) | 2007-11-26 | 2007-11-26 | Pharmaceutical composition for treating type 2 diabetes |
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| CN101444507A true CN101444507A (en) | 2009-06-03 |
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| CNA2007101504068A Pending CN101444507A (en) | 2007-11-26 | 2007-11-26 | Pharmaceutical composition for treating type 2 diabetes |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106110310A (en) * | 2016-06-26 | 2016-11-16 | 卢连伟 | A kind of compound for reducing blood suger containing pioglitazone and preparation method thereof |
-
2007
- 2007-11-26 CN CNA2007101504068A patent/CN101444507A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106110310A (en) * | 2016-06-26 | 2016-11-16 | 卢连伟 | A kind of compound for reducing blood suger containing pioglitazone and preparation method thereof |
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Open date: 20090603 |