CN105168195A - Drug composition containing metformin and schizandrin and used for treating diabetes - Google Patents
Drug composition containing metformin and schizandrin and used for treating diabetes Download PDFInfo
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- CN105168195A CN105168195A CN201510641005.7A CN201510641005A CN105168195A CN 105168195 A CN105168195 A CN 105168195A CN 201510641005 A CN201510641005 A CN 201510641005A CN 105168195 A CN105168195 A CN 105168195A
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- deoxyschizandrin
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Abstract
The invention discloses drug composition for treating diabetes. Metformin or medicinal salt thereof and schizandrin are taken as effective ingredients. The insulin resistance can be remarkably improved through the drug composition, the glucose adsorption of insulin resistance hepatocyte is increased, and the effect is remarkably superior to that of any single ingredient.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of pharmaceutical composition for the treatment of diabetes, particularly a kind of pharmaceutical composition containing metformin or its officinal salt and deoxyschizandrin.
Background technology
The common endocrine metabolism disease of diabetes to be a kind of with hyperglycemia be feature.In recent years, along with the raising of living standards of the people, living-pattern preservation and aged tendency of population, the sickness rate of diabetes constantly raises.According to IDF (InternationalDiabetesFederatio, IDF) statistics, the diabetics in the whole world in 2014 has 3.87 hundred million, and global incidence is 8.3%, estimates 2035, and global diabetes number can reach 5.92 hundred million.The Diabetes Epidemiological Investigation display that diabetology branch of Chinese Medical Association carried out in 2007 to 2008 years in China some areas: China's more than 20 years old crowd's diabetes prevalence is 9.7%, and the ratio of prediabetes is 15.5%.Diabetes are a kind of chronic diseases, along with the prolongation of the course of disease, various metabolism disorder can cause various tissue, particularly eye, kidney, heart, blood vessel, neural chronic lesion and dysfunction, the cardio cerebrovascular affection caused thus, renal failure, blind, lower limb are gangrenous etc. becomes diabetes and to disable lethal main cause.Within 2014, the whole world has 4,900,000 people to die from diabetes.Diabetes not only bring the human body and spiritual infringement to diseased individuals and cause the shortening in life-span, return individual, country brings heavy financial burden.Prevent diabetes early stage to diabetes transform and be most important strategy in Guidelines for Management of Diabetes Mellitus to diagnosing patient to carry out good treatment.
Type 2 diabetes mellitus accounts for all diabetes more than 90%, and its pathogenesis has two basic links: insulin resistant and beta Cell of islet insulin secretion relative deficiency.Insulin resistant refers to that the insulin of target organ to normal concentration of the insulin actions such as liver, muscle, fat produces hyporeactive pathological and physiological condition.In this state, beta Cell of islet needs to secrete more insulin (hyperinsulinemia is levied) and resists hyperglycemia.Beta Cell of islet can not produce enough islets of langerhans and usually resist insulin resistant serious all the more, finally causes beta Cell of islet exhaustion.
Type 2 diabetes mellitus is a kind of disease of chronic progressive external, and Most patients needs lifelong medication.Traditional antidiabetic medicine single therapy strategy can not keep the up to standard for a long time of glycemic control.According to statistics, single therapy is after 3 years, and the diabetics of about 50% needs therapeutic alliance, and after 9 years, this ratio rises to 75%.Along with the prolongation for the treatment of time, Most patients just can need make glycemic control up to standard by multi-medicament therapeutic alliance.Compared with single therapy, therapeutic alliance blood sugar lowering amplitude is comparatively large, contributes to the glycemic control compliance rate improving patient, reduces the occurrence risk of all kinds of complication of diabetes further, improve the long-term prognosis of patient.Therapeutic alliance is type 2 diabetes mellitus treatment trend.
Metformin is the first-line drug of type 2 diabetes mellitus treatment, is common pancreotropic hormone sensitive medicaments, can reduces the output of hepatic glucose and improve peripheral insulin resistance.The common untoward reaction of metformin has digestive tract uncomfortable, and dosage is excessive the danger causing lactic acidosis, therefore applies therapeutic alliance, diabetes can be controlled better, reduce the dosage of single medicine, reduce the drug resistance of diabetics, reduce possible untoward reaction.
Fructus Schisandrae Chinensis is the dry mature fruit of magnoliaceae schisandra Schisandrachinensis (Turcz.) Baill. or schisandra chinensis SchisandrasphenantheraRehd.etWils..Effect of Fructus Schisandrae Chinensis is astringed the lung, and nourishing kidney is promoted the production of body fluid, and receives antiperspirant, arresting seminal emission.The traditional Chinese medical science claims diabetes to be diabetes, and basic pathogenesis is cloudy body fluid deficiency consumption, scorching inclined Sheng.All contain Fructus Schisandrae Chinensis in a lot for the treatment of Chinese medicine for treating diabetes prescription, some researchs show that the extract of Fructus Schisandrae Chinensis has the effect reducing diabetes glucose.The principle active component of Fructus Schisandrae Chinensis is lignanoids, and deoxyschizandrin is exactly the Lignanoids compounds in Fructus Schisandrae Chinensis.But the report of deoxyschizandrin and diabetes medicament coupling has no any report.
Summary of the invention
The invention provides a kind of pharmaceutical composition being effective ingredient with metformin or its officinal salt and deoxyschizandrin.Utilize this pharmaceutical composition effectively can control blood glucose, its Be very effective is better than any one-component.
Be used for the treatment of a pharmaceutical composition for diabetes, comprise as the metformin of effective ingredient or its officinal salt and deoxyschizandrin.
Research finds, this pharmaceutical composition significantly can improve insulin resistant, increases the hepatocellular glucose absorption of insulin resistant.
As preferably, described metformin officinal salt is the one in metformin hydrochloride and dimethyl sulfate biguanide.
As preferably, described metformin or its officinal salt in the concentration ratio of metformin and deoxyschizandrin for 100:1 ~ 400:1.
As preferably, described metformin or its officinal salt in the concentration of metformin for 1mM ~ 2mM.
As preferably, the concentration of described deoxyschizandrin is 5 μMs ~ 10 μMs.
As preferably, pharmaceutical composition comprises pharmaceutically acceptable auxiliaries.Excipient substance can give medicine certain dosage form, effectively ensures the emission and absorption of effective ingredient.
As preferably, described pharmaceutical composition is the dosage form of oral administration.Oral administration is easy, not coup injury skin or mucosa, reduces infection risk.Because diabetics needs long-term prescription, therefore oral administration is a kind of mode of economic security.
More preferred, the dosage form of described oral administration is solution, tablet, capsule or granule.
The beneficial effect that the present invention possesses: the drug combination of metformin or its officinal salt and deoxyschizandrin produces to work in coordination with and falls hypoglycemic effect, significantly improves the effect for the treatment of diabetes.
Accompanying drawing explanation
Fig. 1 is each experimental group glucose relative consumption comparison diagram in embodiment 1;
Fig. 2 is each experimental group glucose relative consumption comparison diagram in embodiment 2;
Wherein, significance test method is t inspection, compares, * * P<0.01, * * * P<0.001 with model group; Compare with pharmaceutical composition group,
###p<0.001.
Detailed description of the invention
Below in conjunction with specific embodiments and the drawings, the invention will be further described.
Embodiment 1
The low-sugar type DMEM of mice embryonic hepatocyte BNLCL.2 containing 10% hyclone cultivates based on 37 DEG C, 5%CO
2hatch in cell culture incubator, change fresh medium every other day.When Growth of Cells is to 80-90%, discard culture fluid, add 3mLPBS rinse once, add 1mL0.05% trypsin-EDTA solutions and digest about 2min, add triplication culture fluid and stop digestion, by centrifugal for Cell sap 900r/min 5min, abandoning supernatant, add a certain amount of culture fluid, cell is dispelled, gets 10 μ L and count, BNLCL.2 cell is inoculated in 96 orifice plates, every hole 20,000 cell, and establish acellular blank control wells.Cultivate after 24 hours, discard former culture medium, wash one time with phosphate buffer (PBS), change serum-free without phenol red low sugar DMEM culture fluid, grouping adds by reagent.
If blank group (adding normal cell culture fluid 100 μ L), model group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM), deoxyschizandrin group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM and the deoxyschizandrin of 10 μMs), metformin group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM and the metformin of 1mM), and the compositions group of deoxyschizandrin and metformin (adding the insulin containing 1 μM and the cell culture fluid 100 μ L containing 10 μMs of deoxyschizandrin+1mM metformin).Act on after 24 hours, with the glucose content of determination of glucose oxidase every hole culture fluid, namely 5 μ L culture fluid are got in another 96 orifice plate in every hole, add 200 μ L glucoseoxidase test fluid, hatch 30min for 37 DEG C, under 492nm wavelength, measure every hole absorbance.Every hole glucose content is calculated by standard curve method in glucose 0-10mmol/L concentration range.Every hole glucose utilization=acellular blank well culture fluid glucose content-every hole culture fluid glucose content, often group establishes more than 3 or 3 holes again, and identical experiment repeats 3 times.
After glucose assays, former culture hole discards original fluid, and every hole adds the culture fluid containing 0.5mg/mLMTT solution, in 37 DEG C, 5%CO
2condition under hatch 4h.Abandoning supernatant, every hole adds 100 μ lDMSO, 37 DEG C, and vibration 10min, measures the absorbance in every hole, for reflecting the proliferative conditions of cell, to correct the glucose absorption difference that cell number difference causes under 550nm wavelength.Finally calculate the percentage ratio of each group of glucose utilization relative to model group consumption.
The results are shown in Figure 1, deoxyschizandrin group, the BNLCL.2 cell that the compositions of metformin group and deoxyschizandrin and metformin acts on insulin resistant all can increase the glucose utilization of cell after 24 hours, through t inspection, compare have significant difference with model group.And the increase grape cell sugar consumption amount Be very effective of 1mM metformin and 10 μMs of deoxyschizandrin compositionss is better than deoxyschizandrin and metformin group (P<0.001).The grape cell sugar consumption amount that compositions group increases is greater than the glucose utilization summation of metformin group and the increase of deoxyschizandrin group, proves that metformin and deoxyschizandrin combination produce synergism.
Embodiment 2
The low-sugar type DMEM of mice embryonic hepatocyte BNLCL.2 containing 10% hyclone cultivates based on 37 DEG C, 5%CO
2hatch in cell culture incubator, change fresh medium every other day.When Growth of Cells is to 80-90%, discard culture fluid, add 3mLPBS rinse once, add 1mL0.05% trypsin-EDTA solutions and digest about 2min, add triplication culture fluid and stop digestion, by centrifugal for Cell sap 900r/min 5min, abandoning supernatant, add a certain amount of culture fluid, cell is dispelled, gets 10 μ L and count, BNLCL.2 cell is inoculated in 96 orifice plates, every hole 20,000 cell, and establish acellular blank control wells.Cultivate after 24 hours, discard former culture medium, wash one time with phosphate buffer (PBS), change serum-free without phenol red low sugar DMEM culture fluid, grouping adds by reagent.
If blank group (adding normal cell culture fluid 100 μ L), model group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM), deoxyschizandrin group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM and the deoxyschizandrin of 5 μMs), metformin group (adding the cell culture fluid 100 μ L containing the insulin of 1 μM and the metformin of 2mM), and the compositions group of deoxyschizandrin and metformin (adding the insulin containing 1 μM and the cell culture fluid 100 μ L containing 5 μMs of deoxyschizandrin+2mM metformin).Act on after 24 hours, with the glucose content of determination of glucose oxidase every hole culture fluid, namely 5 μ L culture fluid are got in another 96 orifice plate in every hole, add 200 μ L glucoseoxidase test fluid, hatch 30min for 37 DEG C, under 492nm wavelength, measure every hole absorbance.Every hole glucose content is calculated by standard curve method in 0-10mmol/L concentration range.Every hole glucose utilization=acellular blank well culture fluid glucose content-every hole culture fluid glucose content, often group establishes more than 3 or 3 holes again, and identical experiment repeats 3 times.
After glucose content measures, former culture hole discards original fluid, and every hole adds the culture fluid containing 0.5mg/mLMTT solution, in 37 DEG C, 5%CO
2condition under hatch 4h.Abandoning supernatant, every hole adds 100 μ lDMSO, 37 DEG C, and vibration 10min, measures the absorbance in every hole, for reflecting the proliferative conditions of cell, to correct the glucose absorption difference that cell number difference causes under 550nm wavelength.Finally calculate the percentage ratio of each group of glucose utilization relative to model group consumption.
The results are shown in Figure 2,5 μMs of deoxyschizandrins, the BNLCL.2 cell that 2mM metformin acts on insulin resistant all can increase glucose utilization after 24 hours, through t inspection, compares have significant difference with model group.The increase glucose utilization Be very effective of 2mM metformin and 5 μMs of deoxyschizandrin compositionss is better than 5 μMs of deoxyschizandrins and 2mM metformin.And the grape cell sugar consumption amount that compositions group increases is greater than the grape cell sugar consumption amount summation of 2mM metformin and 5 μMs of deoxyschizandrin group increases, prove that metformin and deoxyschizandrin combination produce synergism.
Embodiment 3
Prepared by metformin hydrochloride and deoxyschizandrin composition tablet
Preparation technology: microcrystalline Cellulose in prescription and low substituent methyl cellulose are crossed 80 mesh sieves, the deoxyschizandrin, the metformin hydrochloride that weigh recipe quantity are mixed homogeneously with microcrystalline Cellulose and low substituent methyl cellulose, add 2% hydroxypropyl methylcellulose solution to granulate in right amount, dry, granulate, add the magnesium stearate mixing of recipe quantity, tabletting, obtains 1000.
Embodiment 4
Prepared by metformin hydrochloride and deoxyschizandrin composition tablet
Preparation technology: microcrystalline Cellulose in prescription and low substituent methyl cellulose are crossed 80 mesh sieves, the deoxyschizandrin, the metformin hydrochloride that weigh recipe quantity are mixed homogeneously with microcrystalline Cellulose and low substituent methyl cellulose, add 2% hydroxypropyl methylcellulose solution to granulate in right amount, dry, granulate, add the magnesium stearate mixing of recipe quantity, tabletting, obtains 1000.
Embodiment 5
Prepared by metformin hydrochloride and deoxyschizandrin composition capsule
Preparation technology: microcrystalline Cellulose in prescription and adjuvant are crossed 80 mesh sieves respectively, after the deoxyschizandrin of weighing recipe quantity, metformin hydrochloride are mixed homogeneously with each adjuvant, add 5% aqueous povidone solution soft material, granulate, dry, granulate, add Pulvis Talci, mixing, load capsule and namely obtain 1000.
Embodiment 6
Prepared by metformin hydrochloride and deoxyschizandrin composition capsule
Preparation technology: microcrystalline Cellulose in prescription and adjuvant are crossed 80 mesh sieves respectively, after the deoxyschizandrin of weighing recipe quantity, metformin hydrochloride are mixed homogeneously with each adjuvant, add 5% aqueous povidone solution soft material, granulate, dry, granulate, add Pulvis Talci, mixing, load capsule and namely obtain 1000.
Claims (8)
1. treat a pharmaceutical composition for diabetes, it is characterized in that, comprise as the metformin of effective ingredient or its officinal salt and deoxyschizandrin.
2. pharmaceutical composition as claimed in claim 1, is characterized in that, described metformin officinal salt is the one in metformin hydrochloride and dimethyl sulfate biguanide.
3. pharmaceutical composition as claimed in claim 1, is characterized in that, described metformin or its officinal salt in the concentration ratio of metformin and deoxyschizandrin for 100:1 ~ 400:1.
4. pharmaceutical composition as claimed in claim 1, is characterized in that, described metformin or its officinal salt in the concentration of metformin for 1mM ~ 2mM.
5. pharmaceutical composition as claimed in claim 1, it is characterized in that, the concentration of described deoxyschizandrin is 5 μMs ~ 10 μMs.
6. pharmaceutical composition as claimed in claim 1, is characterized in that, comprise pharmaceutically acceptable auxiliaries.
7. pharmaceutical composition as claimed in claim 1, it is characterized in that, described pharmaceutical composition is the dosage form of oral administration.
8. pharmaceutical composition as claimed in claim 7, it is characterized in that, the dosage form of described oral administration is solution, tablet, capsule or granule.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1588037A (en) * | 2004-08-30 | 2005-03-02 | 广州中一药业有限公司 | <<XIAOKEWAN>> medicine quality control method for treating diabetes |
| CN1879793A (en) * | 2006-05-16 | 2006-12-20 | 刘海涛 | A medicine for treating dryness heat exuberance type diabetes |
| US20070020345A1 (en) * | 2005-07-22 | 2007-01-25 | The Hong Kong University Of Science And Technology | Schisandrin B preparation |
| CN103597071A (en) * | 2011-01-07 | 2014-02-19 | 埃尔舍利克斯治疗公司 | Chemosensory receptor ligand-based therapies |
-
2015
- 2015-09-30 CN CN201510641005.7A patent/CN105168195A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1588037A (en) * | 2004-08-30 | 2005-03-02 | 广州中一药业有限公司 | <<XIAOKEWAN>> medicine quality control method for treating diabetes |
| US20070020345A1 (en) * | 2005-07-22 | 2007-01-25 | The Hong Kong University Of Science And Technology | Schisandrin B preparation |
| CN1879793A (en) * | 2006-05-16 | 2006-12-20 | 刘海涛 | A medicine for treating dryness heat exuberance type diabetes |
| CN103597071A (en) * | 2011-01-07 | 2014-02-19 | 埃尔舍利克斯治疗公司 | Chemosensory receptor ligand-based therapies |
Non-Patent Citations (5)
| Title |
|---|
| DAE YOUNG KWON等: "The lignan-rich fractions of Fructus Schisandrae improve insulin sensitivity via the PPAR-γ pathways in in vitro and in vivo studies", 《JOURNAL OF ETHNOPHARMACOLOGY》 * |
| 王锦鸿，陈仁寿主编: "《临床实用中药辞典》", 30 November 2003, 金盾出版社 * |
| 蔡镇等: "五味子煎剂对2型糖尿病患者血清IL-2及IL-6水平的影响", 《现代生物医学进展》 * |
| 赵郴等: "玉泉丸合二甲双胍治疗2型糖尿病48例总结", 《湖南中医杂志》 * |
| 陈孝治编: "《药物处方手册（第二版）》", 30 June 2012, 湖南科学技术出版社 * |
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Application publication date: 20151223 |