CN105055413A - Medicine composition of berberine and repaglinide - Google Patents
Medicine composition of berberine and repaglinide Download PDFInfo
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- CN105055413A CN105055413A CN201510439206.9A CN201510439206A CN105055413A CN 105055413 A CN105055413 A CN 105055413A CN 201510439206 A CN201510439206 A CN 201510439206A CN 105055413 A CN105055413 A CN 105055413A
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Abstract
The invention relates to a medicine composition of berberine and repaglinide and a preparation method of the medicine composition, which are applied to the field of compound medicine preparations. The medicine composition is composed of medicine active ingredients and medicine preparation auxiliary materials, wherein the medicine active ingredients comprise berberine or pharmaceutically-acceptable salt and repaglinide. The pharmaceutically-acceptable salt is one of hydrochloride and sulfate. The medicine composition is conventional tablets, double-layer tablets, enteric-coated tablets, capsules, granules or powder, and is a medicine composition with the effects of reducing blood glucose, reducing blood fat, and preventing and treating diabetes or fatty liver complications. According to the invention, the product is simple in formula, berberine and repaglinide are good in dissolubility, the medicine composition is good in stability, the preparation method is simple and the cost is low.
Description
Technical field
The present invention relates to compound medicinal formulation field, particularly relate to compound preparation of a kind of berberine and repaglinide and preparation method thereof.
Background technology
Repaglinide is a kind of carbamyl benzoic acids derivant; it is one of current clinical conventional oral antidiabetic drug; it acts on Sulfonylurea receptor on β cell in vivo; cause K+ (KATP) pathway closure and Ca2+ channel opener; the secretion of final promotion insulin; its mechanism of action and sulfonylureas are unlike different with the binding site of SUR; the secretion of insulin the 1st phase being improved, having good curative effect when simulating meal in normal insulin secretion pattern, reduction level of postprandial blood sugar.
Berberine (Berberine) also known as berberine, be by extracting in the plants such as Cortex Phellodendri, Rhizoma Coptidis, Radix Berberidis, also can the alkaloid of synthetic.Originally berberine sheet is mainly used in the intestinal infection such as gastroenteritis, bacillary dysentery caused by responsive pathogen.The pharmacodynamics of this medicine is has a broad antifungal spectrum, external to multiple Gram-positive and gram negative bacteria all inhibited, wherein have stronger inhibitory action to Hemolytic streptococcus, S. aureus L-forms, vibrio cholera, meningococcus, Bacillus typhi, diphtheria corynebacterium etc.The mechanism of action is, berberine can make the colony counts of phage surface reduce, and antibacterial can not be attached on human body cell and cause infection, thus reach therapeutical effect.Oral untoward reaction is less, and clinical practice is extensive.
Current lot of documents report and expert thereof point out, berberine treatment type 2 diabetes mellitus effect clearly, applicant studies discovery further, and berberine, mainly through suppressing the function of mitochondrial electron transport chain complex, is induced glycolysis and plays good blood sugar lowering curative effect.Also confirmed by cell experiment, berberine has no stimulation to B cell, but can significantly improve the glucose utilization of hepatocyte, myocyte and adipose cell etc., and does not rely on the effect of insulin.Zoopery and clinical trial all confirm, berberine significantly can improve the insulin sensitivity of type 2 diabetes mellitus rat or patient, reduce blood glucose, blood triglyceride, T-CHOL and low density lipoprotein, LDL, lose weight, reduce the lipidosis of the tissues such as liver, and without hepatorenal damage.
Applicant studies discovery, repaglinide and berberine just in time complementary in the effect on type 2 diabetes mellitus for the treatment of.The effect of repaglinide is insulin secretion when stimulating meal, to reduce post-prandial glycemia, more weak to the regulating action of fasting glucose.No matter to reduction on an empty stomach or post-prandial glycemia all has good curative effect and the effect of berberine is to increase body to the consumption of glucose, increase insulin sensitivity, blood sugar reducing function is comparatively average.In addition, fasting glucose is mainly from hepatic gluconeogenic, and berberine directly can suppress hepatic gluconeogenic, most important to reduction fasting glucose.Repaglinide and berberine coupling, can either stimulate the secretion of insulin, also can strengthen the effectiveness of insulin, and save islet function by the increase of body cell self to glucose utilization, can also reduce fasting glucose by suppressing glyconeogenesis.In addition, repaglinide is to lipid metabolism and have no significant effect, and berberine can reduce blood fat significantly, and the disorders of lipid metabolism ingredient that to be type 2 diabetes mellitus one important.Therefore, the medicine that is comparatively perfectly treated type 2 diabetes mellitus can be formed after the two coupling.
Applicant is also found by further research, and to Diagnosed Type 2 Diabetes Mellitus, patient treats with berberine, and HbA1c can be made to reduce by 2%; Add with berberine to the type 2 diabetes mellitus patient of other oral antidiabetic drug secondary failures, HbA1c can be made to reduce by 0.8% on the original basis, therefore repaglinide and berberine coupling can not only reduce blood glucose better, effectively can also extend the time that patient uses oral antidiabetic drug, for the health of patient brought glad tidings with increase quality of life.Therefore, develop the compound preparation of a kind of berberine or its pharmaceutically acceptable salt and repaglinide, thus make its treatment being applied to the diseases such as diabetes be problem demanding prompt solution always.
Summary of the invention
The object of the invention is the compound preparation providing a kind of berberine or its pharmaceutically acceptable salt and repaglinide, and the dissolution of the stability of this pharmaceutical composition and two kinds of active component is good, and this invention preparation method is simple to operate.
The technical solution adopted in the present invention is:
A kind of pharmaceutical composition, is made up of active constituents of medicine and pharmaceutical preparation adjuvant, it is characterized in that described active constituents of medicine is made up of berberine or its pharmaceutically acceptable salt and repaglinide.
Described pharmaceutically acceptable salt is selected from the one in hydrochlorate or sulfate.
The mass ratio 1000:1-4 of pharmaceutical composition Berberine of the present invention or its pharmaceutically acceptable salt and repaglinide; Be preferably 500:1.
More preferably 500:1.4.
The pharmaceutical composition Berberine of this pharmaceutical composition unit dose or the quality of its pharmaceutically acceptable salt and repaglinide are specially 500mg:0.5mg; 500mg:1mg; Or 500mg:2mg.
Further, the pharmaceutical composition Berberine of this pharmaceutical composition unit dose or the quality of its pharmaceutically acceptable salt and repaglinide are specially 500mg:1.4mg.
In pharmaceutical composition of the present invention, by filler, disintegrating agent, lubricant or binding agent, wherein one or more form pharmaceutical adjunct.
In pharmaceutical composition of the present invention, the weight percent content of each composition is: active constituents of medicine 80.2-92.6%, filler 6.9-13.6%, disintegrating agent 0.8-3.3%, lubricant 2.4-3.5%, binding agent 0-3.4%.
Described filler is selected from one or more in starch, lactose, pregelatinized Starch, microcrystalline Cellulose; Disintegrating agent is selected from one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose; Lubricant is selected from one or more in micropowder silica gel, Pulvis Talci, magnesium stearate; Described binding agent is selected from one or more in methylcellulose, starch slurry, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose.
Pharmaceutical composition of the present invention is ordinary tablet, double-layer tablet, enteric coatel tablets, capsule, granule, powder.
Pharmaceutical composition of the present invention is prepared as preparation for can use preparation conventional method, such as compound capsule preparation method:
Step 1, by microcrystalline cellulose excipients, silicon dioxide, magnesium stearate and carboxymethyl starch sodium, by weight percentage 8:1.3:1:2 ratio mixing.
Step 2, by the crude drug of berberine hydrochloride, the crude drug of repaglinide and above-mentioned adjuvant by weight percentage 500:1:99 ratio mixing
Mix 30 minutes in step 3, mixer, blanking, is filled in a capsule by every part of 600mg, makes berberine hydrochloride 500mg repaglinide 1mg compound capsule.
Compound tablet preparation method:
Step 1, by adjuvant lactose, magnesium stearate, polyvinylpolypyrrolidone and hypromellose, by weight percentage 7.5:2:2.5:2 ratio mixing.
Step 2, by the crude drug of berberine sulfate, the crude drug of repaglinide and above-mentioned adjuvant by weight percentage 500:1.4:99 ratio mixing.
Mix 30 minutes in step 3, mixer, blanking, carries out tabletting by every part of 600.4mg tablet machine, makes berberine sulfate 500mg repaglinide 1.4mg compound tablet.
Pharmaceutical composition of the present invention is for blood sugar lowering, blood fat reducing, prevents and treats the pharmaceutical composition of diabetes or fatty liver complication.And applicant also find berberine sulfate and repaglinide according to percentage by weight be 500:1.4 be prepared into compound preparation time very remarkable to hypoglycemic activity effect.
Detailed description of the invention
Unless otherwise defined, all technology of the present invention's use are identical with the implication that the technical field of the invention those of ordinary skill is understood usually with the implication of scientific terminology.Usually, the present invention use name and following experimental technique be all well known in the art or conventional.In order to make technical problem solved by the invention, technical scheme and beneficial effect clearly understand, below in conjunction with specific embodiment, the present invention is further illustrated.
Embodiment 1
The preparation of compound capsule:
Step 1, by microcrystalline cellulose excipients, silicon dioxide, magnesium stearate and carboxymethyl starch sodium, by weight percentage 8:1.3:1:2 ratio mixing.
Step 2, by the crude drug of berberine hydrochloride, the crude drug of repaglinide and above-mentioned adjuvant by weight percentage 500:1:99 ratio mixing.
Mix 30 minutes in step 3, mixer, blanking, is filled in a capsule by every part of 600mg, makes berberine hydrochloride 500mg repaglinide 1mg compound capsule.
Embodiment 2
The preparation of compound tablet:
Step 1, by adjuvant lactose, magnesium stearate, polyvinylpolypyrrolidone and hypromellose, by weight percentage 7.5:2:2.5:2 ratio mixing.
Step 2, by the crude drug of berberine sulfate, the crude drug of repaglinide and above-mentioned adjuvant by weight percentage 500:1.4:99 ratio mixing.
Mix 30 minutes in step 3, mixer, blanking, carries out tabletting by every part of 600.4mg tablet machine, makes berberine sulfate 500mg repaglinide 1.4mg compound tablet.
Embodiment 3
Compound preparation is to the effectiveness study of type 2 diabetes mellitus patient
56 are not used Insulin secretagogues (comprising sulphanylureas and Lie Nai class) or berberine, also the type 2 diabetes mellitus patient of insulin is not used, age is between 18-65 year, HbA1c is between 7.5%-10%, be divided into 3 groups at random: berberine group 19 people, therapeutic scheme is that berberine hydrochloride 500mg takes for three times every day before the meal; Repaglinide group 18 people, therapeutic scheme is that repaglinide 1mg takes for three times every day before the meal; Compound preparation group 19 people, therapeutic scheme is that berberine hydrochloride 500mg repaglinide 1mg compound capsule is taken for three times every day before the meal, totally 12 weeks.
On the impact (mmol/L) of fasting glucose in table 3.1 contrast test
On the impact (mmol/L) of 2h-plasma glucose in table 3.2 contrast test
On the impact (%) of HbA1c in table 3.3 contrast test
On the impact (mmol/L) of serum triglycerides in table 3.4 contrast test
On the impact (mmol/L) of serum total cholesterol in table 3.5 contrast test
On the impact (mmol/L) of serum LDL cholesterol in table 3.6 contrast test
Compare berberine group and repaglinide group, compound preparation group fasting glucose, post-prandial glycemia and HbA1c all significantly reduce (P<0.05), lipid aspects, berberine group and compound preparation group no significant difference, but indices comparatively repaglinide group significantly reduce (P<0.05).
Embodiment 4
Compound preparation is to the effectiveness study of type 2 diabetes mellitus patient
60 are not used Insulin secretagogues (comprising sulphanylureas and Lie Nai class) or berberine, also the type 2 diabetes mellitus patient of insulin is not used, age is between 18-55 year, HbA1c is between 7.5%-10%, be divided into 3 groups at random: berberine group 20 people, therapeutic scheme is that berberine sulfate 500mg takes for three times every day before the meal; Repaglinide group 20 people, therapeutic scheme is that repaglinide 1mg takes for three times every day before the meal; Compound preparation group 20 people, therapeutic scheme is that berberine sulfate 500mg repaglinide 1.4mg compound tablet is taken for three times every day before the meal, totally 12 weeks.
On the impact (mmol/L) of fasting glucose in table 4.1 contrast test
On the impact (mmol/L) of 2h-plasma glucose in table 4.2 contrast test
On the impact (%) of HbA1c in table 4.3 contrast test
On the impact (mmol/L) of serum triglycerides in table 4.4 contrast test
On the impact (mmol/L) of serum total cholesterol in table 4.5 contrast test
On the impact (mmol/L) of serum LDL cholesterol in table 4.6 contrast test
Compare berberine group and repaglinide group, compound preparation group fasting glucose, post-prandial glycemia and HbA1c all significantly reduce (P<0.05), lipid aspects, berberine group and compound preparation group no significant difference, but indices comparatively repaglinide group significantly reduce (P<0.05).
Embodiment 5
With reference to Chinese Pharmacopoeia 2010 editions annex XIXC, by influence factor's high temperature (60 DEG C), high humidity (25 DEG C, RH92.5%) each placement 10 days under, illumination (4500Lux) condition, respectively at the 0th day, 5 days and sampling in 10 days, investigate its stability using content and dissolution as index.
Berberine Dissolution Rate Testing gets capsule 's content, and with water 1000ml for solvent, rotating speed is 120 turns per minute, through 45 minutes time, get solution 5ml, filter, get subsequent filtrate 2ml, put in 25ml measuring bottle, be diluted with water to scale, shake up, according to spectrophotography, measuring trap at the wavelength place of 263nm, is 724 stripping quantities calculating every sheet by the absorptance (E1%1cm) of C20H18ClNO4.2H2O.Limit is 70% of labelled amount, should conform with the regulations.
Repaglinide Dissolution Rate Testing is by capsule 's content, and with water 1000ml for solvent, rotating speed is 75 turns per minute, through 30 minutes time, gets solution 5ml, and filter, precision measures filtrate 20ul injection liquid chromatography.Chromatographic condition: chromatographic column: DiamonsilCl8 (250mmx4.6mm, 5um), mobile phase: 0.15% potassium dihydrogen phosphate (by phosphoric acid adjust ph to 2.3)-methanol-acetonitrile (40:10:50), column temperature: 40
dEG Cc, flow velocity: 1.0ml/min, fluorescence detector excitation wavelength: 244nm, wavelength of transmitted light: 348nm.
1, hot test
By berberine hydrochloride 500mg/ repaglinide 1mg compound capsule (temperature 40 DEG C under acceleration conditions, RH75%) place 6 months, in duration of test the 0th, l, within 2,3,6 months, sample respectively, investigate the stability of medicine using content and dissolution as index.Measurement result is in table 5.1.
Table 5.1 hot test berberine hydrochloride 500mg/ repaglinide 1mg compound capsule assay
2, long term test
By berberine hydrochloride 500mg/ repaglinide 1mg compound capsule (temperature 25 DEG C under long-range circumstances, RH60%) place 12 months, in duration of test the 0th, within 4,8,12 months, sample respectively, investigate the long-time stability of medicine using content and dissolution as index.Measurement result is in table 5.2.
Table 5.2 long term test berberine hydrochloride 500mg/ repaglinide 1mg compound capsule assay
By the acceleration of 6 months and the long term test of 12 months, compared with 0 month data, content and dissolution, all without significant change, show that berberine hydrochloride 500mg/ repaglinide 1mg compound capsule is through accelerating June and long term test December, steady quality.
Embodiment 6
With reference to Chinese Pharmacopoeia 2010 editions annex XIXC, by influence factor's high temperature (60 DEG C), high humidity (25 DEG C, RH92.5%) each placement 10 days under, illumination (4500Lux) condition, respectively at the 0th day, 5 days and sampling in 10 days, investigate its stability using content and dissolution as index.
Berberine Dissolution Rate Testing gets compound tablet, and with water 1000ml for solvent, rotating speed is 120 turns per minute, through 45 minutes time, get solution 5ml, filter, get subsequent filtrate 2ml, put in 25ml measuring bottle, be diluted with water to scale, shake up, according to spectrophotography, measuring trap at the wavelength place of 263nm, is 724 stripping quantities calculating every sheet by the absorptance (E1%1cm) of C20H18ClNO4.2H2O.Limit is 70% of labelled amount, should conform with the regulations.
Repaglinide Dissolution Rate Testing gets compound tablet, and with water 1000ml for solvent, rotating speed is 75 turns per minute, through 30 minutes time, gets solution 5ml, and filter, precision measures filtrate 20ul injection liquid chromatography.Chromatographic condition: chromatographic column: DiamonsilCl8 (250mmx4.6mm, 5um), mobile phase: 0.15% potassium dihydrogen phosphate (by phosphoric acid adjust ph to 2.3)-methanol-acetonitrile (40:10:50), column temperature: 40 DEG C, flow velocity: 1.0ml/min, fluorescence detector excitation wavelength: 244nm, wavelength of transmitted light: 348nm.
1, hot test
By berberine sulfate 500mg/ repaglinide 1.4mg compound tablet (temperature 40 DEG C under acceleration conditions, RH75%) place 6 months, in duration of test the 0th, l, within 2,3,6 months, sample respectively, investigate the stability of medicine using content and dissolution as index.Measurement result is in table 6.1.
Table 6.1 hot test berberine sulfate 500mg/ repaglinide 1.4mg compound tablet assay
2, long term test
By berberine sulfate 500mg/ repaglinide 1.4mg compound tablet (temperature 25 DEG C under long-range circumstances, RH60%) place 12 months, in duration of test the 0th, within 4,8,12 months, sample respectively, investigate the long-time stability of medicine using content and dissolution as index.Measurement result is in table 6.2.
Table 6.2 long term test berberine sulfate 500mg/ repaglinide 1.4mg compound tablet assay
| Sample time (moon) | Berberine sulfate | Repaglinide |
| Content % | Dissolution (45min) | Content % | Dissolution (30min) | |
| 0 | 98.92 | 79.32 | 96.46 | 90.41 |
| 4 | 97.51 | 85.12 | 98.14 | 86.02 |
| 8 | 98.37 | 83.91 | 99.31 | 87.82 |
| 12 | 96.25 | 78.58 | 97.31 | 89.59 |
By the acceleration of 6 months and the long term test of 12 months, compared with 0 month data, content and dissolution, all without significant change, show that berberine sulfate 500mg/ repaglinide 1.4mg compound tablet is through accelerating June and long term test December, steady quality.
Should be noted that; although the present invention discloses as above with preferred embodiment; so itself and be not used to limit the present invention; anyly have the knack of this those skilled in the art; without departing from the spirit and scope of the present invention; any amendment of doing, equivalent replacement and improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. a pharmaceutical composition, is made up of active constituents of medicine and pharmaceutical preparation adjuvant, it is characterized in that described active constituents of medicine is made up of berberine or its pharmaceutically acceptable salt and repaglinide.
2. a kind of pharmaceutical composition according to claim 1, is characterized in that described pharmaceutically acceptable salt is selected from the one in hydrochlorate or sulfate.
3. a kind of pharmaceutical composition according to claim 1, is characterized in that the mass ratio 1000:1-4 of described berberine or its pharmaceutically acceptable salt and repaglinide.
4. a kind of pharmaceutical composition according to claim 1, is characterized in that the mass ratio 500:1 of described berberine or its pharmaceutically acceptable salt and repaglinide.
5. a kind of pharmaceutical composition according to claim 1, is characterized in that the pharmaceutical composition Berberine of unit dose or the quality of its pharmaceutically acceptable salt and repaglinide are specially 500mg:0.5mg; Or 500mg:1mg; Or 500mg:1.4mg; Or 500mg:2mg.
6., according to a kind of pharmaceutical composition described in claim 1 to 5, it is characterized in that described pharmaceutical preparation adjuvant is made up of filler, disintegrating agent, lubricant, binding agent.
7. a kind of pharmaceutical composition according to claim 6, it is characterized in that at the weight percent content of each composition be: active constituents of medicine 80.2-92.6%, filler 6.9-13.6%, disintegrating agent 0.8-3.3%, lubricant 2.4-3.5%, binding agent 0-3.4%.
8. a kind of pharmaceutical composition according to claim 7, is characterized in that one or more that described filler is selected from starch, lactose, pregelatinized Starch, microcrystalline Cellulose; Disintegrating agent is selected from one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose; Lubricant is selected from one or more in micropowder silica gel, Pulvis Talci, magnesium stearate; Described binding agent is selected from one or more in methylcellulose, starch slurry, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose.
9. a kind of pharmaceutical composition according to claim 1, is characterized in that described pharmaceutical composition is ordinary tablet, double-layer tablet, enteric coatel tablets, capsule, granule, powder.
10. a kind of pharmaceutical composition according to claim 1, is characterized in that described pharmaceutical composition is blood sugar lowering, blood fat reducing, prevents and treats the pharmaceutical composition of diabetes or fatty liver complication.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105646512A (en) * | 2016-01-30 | 2016-06-08 | 合肥华方医药科技有限公司 | Preparation and medical application of glinides berberine coupling compound |
| CN106188077A (en) * | 2016-06-30 | 2016-12-07 | 合肥华方医药科技有限公司 | The Preparation method and use of 9 substituted double-functional group berberinc derivates |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101125144A (en) * | 2006-10-31 | 2008-02-20 | 左仁杰 | Compound medicine for treating diabetes |
| CN103037849A (en) * | 2010-06-22 | 2013-04-10 | 安成国际药业股份有限公司 | Controlled release compositions with reduced food effect |
| WO2014068007A1 (en) * | 2012-10-30 | 2014-05-08 | Pharnext | Compositions, methods and uses for the treatment of diabetes and related conditions by controlling blood glucose level |
-
2015
- 2015-07-23 CN CN201510439206.9A patent/CN105055413A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101125144A (en) * | 2006-10-31 | 2008-02-20 | 左仁杰 | Compound medicine for treating diabetes |
| CN103037849A (en) * | 2010-06-22 | 2013-04-10 | 安成国际药业股份有限公司 | Controlled release compositions with reduced food effect |
| WO2014068007A1 (en) * | 2012-10-30 | 2014-05-08 | Pharnext | Compositions, methods and uses for the treatment of diabetes and related conditions by controlling blood glucose level |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105646512A (en) * | 2016-01-30 | 2016-06-08 | 合肥华方医药科技有限公司 | Preparation and medical application of glinides berberine coupling compound |
| CN106188077A (en) * | 2016-06-30 | 2016-12-07 | 合肥华方医药科技有限公司 | The Preparation method and use of 9 substituted double-functional group berberinc derivates |
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