CN101856405B - A kind of pharmaceutical composition for treating type 2 diabetes and its preparation method - Google Patents
A kind of pharmaceutical composition for treating type 2 diabetes and its preparation method Download PDFInfo
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- CN101856405B CN101856405B CN 200910048888 CN200910048888A CN101856405B CN 101856405 B CN101856405 B CN 101856405B CN 200910048888 CN200910048888 CN 200910048888 CN 200910048888 A CN200910048888 A CN 200910048888A CN 101856405 B CN101856405 B CN 101856405B
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Abstract
本发明涉及一种治疗2型糖尿病的药物组合物及其制备方法，所述药物组合物包括以下按重量配比的组分：黄芪10～60份，灵芝10～100份，女贞子5～30份，乌梅6～30份。本发明的药物组合物，能有效降低空腹、餐后血糖、糖化血红蛋白，有效减轻炎症状态，对2型糖尿病患者的胰岛素抵抗具有较好的改善作用。The invention relates to a pharmaceutical composition for treating type 2 diabetes and a preparation method thereof. The pharmaceutical composition comprises the following components in proportion by weight: 10-60 parts of Radix Astragali, 10-100 parts of Ganoderma lucidum, 5-100 parts of Ligustrum lucidum 30 parts, 6 to 30 parts of dark plum. The pharmaceutical composition of the invention can effectively reduce fasting and postprandial blood sugar and glycosylated hemoglobin, effectively relieve inflammation, and has a better effect on improving insulin resistance of patients with type 2 diabetes.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, be specifically related to a kind of pharmaceutical composition of treating type 2 diabetes mellitus and preparation method thereof.
Background technology
Diabetes (Diabetes Mellitus) are that what to be caused by Different types of etiopathogenises is that the metabolism disorder of characteristic is sick with the chronic hyperglycemia, are fatality rate after cardiovascular and cerebrovascular disease, cancer, the third-largest disease that disability rate is the highest.In recent years, reasons such as Along with people's growth in the living standard, overnutrition, hypokinesia, onset diabetes rate increase severely year by year, have become a kind of disease that has a strong impact on human health, also bring the tremendous economic burden to society.It is low that type 2 diabetes mellitus comes from the B cell function; Insulin lacks and insulin resistant (Insulin Resistance relatively; IR), it shows as, and concentration of glucose raises unusually in the blood circulation, and causes the chronic pathological changes of many organ-tissues such as eye, kidney, nerve, blood vessel and heart.At present, the medicine of treatment type 2 diabetes mellitus mainly contains OHA and insulin.In general, Western medicine determined curative effect, mechanism are clear and definite, still, but have various side effect.Though and Chinese medicine has the advantage of treating both the principal and secondary aspects of a disease, safety, few side effects, effective in cure imprecise, deficiency such as mechanism is indeterminate.
Summary of the invention
One of technical problem to be solved by this invention provides a kind of pharmaceutical composition of treating type 2 diabetes mellitus, and to overcome the insufficient shortcoming of existing western medical treatment, pharmaceutical composition of the present invention has the advantage of determined curative effect, few side effects.
Two of technical problem to be solved by this invention provides the preparation of drug combination method of above-mentioned treatment type 2 diabetes mellitus.
A kind of pharmaceutical composition of treating type 2 diabetes mellitus as first aspect present invention comprises following component by weight ratio: 10～60 parts of the Radixs Astragali, 10～100 parts of Ganodermas, 5～30 parts of Fructus Ligustri Lucidi, 6～30 parts of Fructus Mumes.
Described pharmaceutical composition preferably includes following component by weight ratio: 10 parts of the Radixs Astragali, 10 parts of Ganodermas, 10 parts of Fructus Ligustri Lucidi, 10 parts of Fructus Mumes.
Described pharmaceutical composition preferably includes following component by weight ratio: 30 parts of the Radixs Astragali, 10 parts of Ganodermas, 15 parts of Fructus Ligustri Lucidi, 10 parts of Fructus Mumes.
Described pharmaceutical composition preferably includes following component by weight ratio: 30 parts of the Radixs Astragali, 30 parts of Ganodermas, 15 parts of Fructus Ligustri Lucidi, 15 parts of Fructus Mumes.
Described pharmaceutical composition preferably includes following component by weight ratio: 60 parts of the Radixs Astragali, 30 parts of Ganodermas, 30 parts of Fructus Ligustri Lucidi, 30 parts of Fructus Mumes.
Described pharmaceutical composition preferably includes following component by weight ratio: 40 parts of the Radixs Astragali, 30 parts of Ganodermas, 20 parts of Fructus Ligustri Lucidi, 10 parts of Fructus Mumes.
Said pharmaceutical composition can be made into acceptable forms on any pharmaceutics in pill, granule, tablet, syrup, mixture, oral liquid, drop pill, capsule, the injection.
Preparation of drug combination method as the treatment type 2 diabetes mellitus of second aspect present invention takes by weighing the Radix Astragali, Ganoderma, Fructus Ligustri Lucidi and Fructus Mume at first in proportion respectively, and respectively adds 6 times of decoctings respectively and boil the 1st time 2-5 hour 2 times; The 2nd time 0.5-3 hour, merge each component and each time decocting liquid, filter, filtrating is concentrated into relative density 1.0～1.2; Add ethanol, stir, leave standstill, get supernatant and reclaim ethanol; Continue to be condensed into relative density and be 1.3～1.5 extractum, further spray drying, extract powder, add an amount of excipient substance except that sucrose; Mixing is granulated, and promptly gets granular pattern treatment type 2 diabetes mellitus pharmaceutical composition.
Preparation of drug combination method as the treatment type 2 diabetes mellitus of second aspect present invention takes by weighing the Radix Astragali, Ganoderma, Fructus Ligustri Lucidi and Fructus Mume in proportion respectively, and respectively adds 6 times of decoctings respectively and boil the 1st time 2-5 hour 2 times; The 2nd time 0.5-3 hour, merge each component and each time decocting liquid, filter, filtrating is concentrated into extractum; Spray drying adds starch, uses 85% alcohol granulation, drying; 18 mesh sieve granulate add carboxymethyl starch sodium and magnesium stearate, mixing, tabletting; Coating, packing promptly gets tablet form treatment type 2 diabetes mellitus pharmaceutical composition.
Preparation of drug combination method as the treatment type 2 diabetes mellitus of second aspect present invention takes by weighing the Radix Astragali, Ganoderma, Fructus Ligustri Lucidi and Fructus Mume in proportion respectively, and respectively adds 6 times of decoctings respectively and boil 2 times; The 1st time 2-5 hour, the 2nd time 0.5-3 hour, merge each component and each time decocting liquid; Filter, filtrating is concentrated into extractum, spray drying; Get extract powder, encapsulated, promptly get capsule-type treatment type 2 diabetes mellitus pharmaceutical composition.
Preparation of drug combination method as the treatment type 2 diabetes mellitus of second aspect present invention; Take by weighing the Radix Astragali, Ganoderma, Fructus Ligustri Lucidi and Fructus Mume in proportion respectively; Cleaning and removing impurities is ground into fine powder after the oven dry, excessively mix homogeneously behind 100～200 mesh sieves; The fill capsule promptly gets capsule-type treatment type 2 diabetes mellitus pharmaceutical composition.
Preparation of drug combination method of the present invention is not limited to above-mentioned disclosed several kinds, can also be other known methods that industry technical staff is known.
The present invention is divided into treatment group and matched group at random with 60 routine cases; Wherein, 30 examples are organized in treatment, matched group 30 examples; The treatment group is in former Western medicine glucose-lowering treatment; Add treatment type 2 diabetes mellitus pharmaceutical composition of the present invention, matched group then continues former Western medicine glucose-lowering treatment and adds placebo simultaneously, the March course of treatment.
One, the clinical symptoms change of diabetics before and after the treatment:
The result shows: pharmaceutical composition of the present invention can obviously improve patient's symptom, and its improvement rate is apparently higher than matched group (P＜0.05), and concrete numerical value is seen table 1.
Clinical symptoms improvement rate relatively before and after the table 1 liang group treatment
Annotate: relatively preceding with treatment,
*P＜0.05; Compare between two groups of treatment back groups,
△P＜0.05.
Two, empty stomach, 2 hours after the meal blood glucose, glycolated hemoglobins change before and after the treatment:
The result shows: treatment group fasting glucose, after the meal 2h blood glucose all than taking a turn for the better (P＜0.01) before the treatment, matched group only fasting glucose improves (P＜0.05), treatment group simultaneously reduce fasting glucose and after the meal 2h blood glucose all be superior to matched group (P＜0.05; P＜0.01); The treatment group reduces glycolated hemoglobin and is superior to matched group (P＜0.05), and concrete numerical value is respectively referring to table 2 and table 3.
Before and after the treatment of table 2 liang group on an empty stomach and 2 hours after the meal blood glucose value (mmol/L) (x ± S) relatively
Notes: two groups of treatment backs are relatively preceding with treatment
*P＜0.05;
*P＜0.01; The treatment back is relatively between two groups:
△P＜0.05.
Comparison before and after the treatment of table 3 glycolated hemoglobin (x ± S)
Annotate: compare behind two groups of internal therapies with before the treatment
*P＜0.01; Compare between two groups of treatment back groups:
△P＜0.05
Three, two groups of ultra sensitive C-reactive proteins in treatment front and back change:
The result shows: decline (P＜0.05) is in various degree all arranged before and after treatment group and the treatment of control group; Treatment group decline degree is superior to matched group (P＜0.05), and concrete numerical value is referring to table 4.
Table 4 surpasses comparison before and after the sensitive C-reactive protein treatment (x ± S)
Annotate: compare behind two groups of internal therapies with before the treatment
*P＜0.05; Compare between two groups of treatment back groups:
△P＜0.05.
Four, two groups of treatment front and back FPIs (FINS), insulin resistance index (HOMA-IR) compares:
The result shows: treatment back treatment group and matched group FINS and HOMA-IR all have reduction (P＜0.05); The treatment group all is superior to matched group (P＜0.05) reducing insulin level and improve insulin resistance index, and concrete numerical value is referring to table 5.
Table 5 FPI, and the comparison before and after C peptide and the insulin resistance index treatment (X ± S)
Annotate: compare before and after two groups of treatments
*P＜0.05,
*P＜0.01; Compare between two groups after the treatment:
△P＜0.05,
△ △P＜0.01.
Each medicine material that the present invention adopted, its pharmacological action is distinguished as follows:
The Radix Astragali: sweet in the mouth, warm in nature, return spleen, lung meridian, have tonifying Qi and lifting yang, quench the thirst, benefit is defended consolidating superficial resistance, the effect of expelling pus and promoting granulation, inducing diuresis to remove edema, logical blood circulation regulating, popular meridians.Radix Astragali main component contains number of chemical compositions such as Saponin, polysaccharide, flavone, several amino acids and trace element, in addition, has in the report Radix Astragali and also contains compositions such as folic acid, linolenic acid, choline.Modern pharmacological research finds that the Radix Astragali can increase liver glycogen, and carbohydrate metabolism is had regulating action; Astragalus polysaccharides can strengthen the serine phosphorylation PKB expression of insulin stimulating, thereby improves insulin resistant.The Radix Astragali is Wheat Protein also, and ability enhancement of SOD and GSH-Px are active, alleviate the Radical Metabolism disorder.
Ganoderma: the little acid of sweet in the mouth, property is flat, and GUIXIN, lung, liver, kidney channel have the beneficial motive, pacify smart soul, tonifying liver QI invigorating, hard muscles and bones, strengthening by means of tonics, life lengthening, sharp joint, control deaf curative effect.The complex chemical composition of Ganoderma, kind surplus separation has obtained 100 from Ganoderma at present, totally 10 big types: polysaccharide, triterpenes, ucleosides, furans, sterols, alkaloids, aminoacid protein class, oils, inorganic ions, organic germanium etc.Pharmacological research shows; Ganoderma all has tangible regulating action to diabetes rat sugar, disorders of lipid metabolism; And can obviously reduce microdose urine protein excretion rate and the morphological abnormalities of early diabetic nephropathy rat, and the diabetes rat body weight is obviously increased, renal index reduces; Total serum protein, albumin increase, and Ganoderma has certain effect to the diabetic mice early nephropathy.Thereby ganoderan can help glucose transport to go into the B cell through promoting the proteic expression of islet cells GLUT2, promotes the metabolism of glucose, causes the outer Ca of islet cells
2+In stream and play the effect that pancreotropic hormone discharges.
Fructus Ligustri Lucidi: sweet in the mouth, hardship, cool in nature.Return liver, kidney channel.Main effect, nourishing the liver and kidney, black hair makes eye bright.Mainly contain terpenoid, flavonoid, plain type of phenylpropyl alcohol and some alcohol, phenolic compound in the Fructus Ligustri Lucidi platymiscium.Oleanolic acid wherein, five rings such as maloic acid three mushrooms compositions are the main effective ingredient of Ligustrum plant.Fructus Ligustri Lucidi has prevention and therapeutical effect to hyperglycemia, and two kinds of effective ingredient of contained ursolic acid and oleanolic acid all have blood sugar reducing function, can obviously increase diabetes model Hepar Mus glycogen content and blood sugar lowering; Fructus Ligustri Lucidi also has the enhance immunity active function, gives mouse stomach with the Fructus Ligustri Lucidi decoct, can make the mouse immune organ, and thymus and spleen weight obviously increase, and oleanolic acid can increase macrophage and lymphocytic function; In preventing and treating the experiment of hyperlipemia and atherosclerosis, can blood fat reducing concentration.
Fructus Mume: sour in the mouth, puckery is flat.Return liver, spleen, lung, large intestine channel.Main effect: promoting the production of body fluid to quench thirst, astringing lung-QI and relieving cough, relieving diarrhea with astringents, relieving pain by calming ascaris.Fructus Mume is that the ripe or maturescent fruit of rose department plant plum processes through the method for smoking or smoking.Fructus Mume contains rich organic acid, sterols, aminoacid volatile oil, lipoid, has effects such as antibacterial, anthelmintic, antitumor, antiallergic.
The pharmaceutical composition of type 2 diabetes mellitus of the present invention can effectively reduce empty stomach, post-prandial glycemia, glycolated hemoglobin, and the state that effectively reduces inflammation has a better role to type 2 diabetes mellitus patient's insulin resistant tool.
The specific embodiment
For technological means, creation characteristic that the present invention is realized, reach purpose and effect and be easy to understand and understand, below in conjunction with instantiation, further set forth the present invention.
Embodiment 1
Raw material takes by weighing by following weight proportion:
10 parts of the Radixs Astragali, 10 parts of Ganodermas, 10 parts of Fructus Ligustri Lucidi, 10 parts of Fructus Mumes.
Get above medicine, add 6 times of decoctings and boil 2 times, the 1st time 3 hours, the 2nd time 2 hours, merge each each time of component decocting liquid; Filter, filtrating is concentrated into relative density 1.2, adds ethanol, stirs, and leaves standstill; Get supernatant and reclaim ethanol, be condensed into extractum, spray drying gets extract powder; Add an amount of excipient substance except that sucrose, mixing is granulated, and promptly gets granular pattern treatment type 2 diabetes mellitus pharmaceutical composition of the present invention.Three times on the one, each 4.
Embodiment 2
Raw material takes by weighing by following weight proportion:
30 parts of the Radixs Astragali, 10 parts of Ganodermas, 15 parts of Fructus Ligustri Lucidi, 10 parts of Fructus Mumes.
Get above medicine, add 6 times of decoctings and boil 2 times, the 1st time 3 hours, the 2nd time 2 hours, collecting decoction filtered, and filtrating is concentrated into extractum, and spray drying gets extract powder, and is encapsulated, promptly got capsule-type treatment type 2 diabetes mellitus pharmaceutical composition of the present invention.Three times on the one, each 4 capsules.
Embodiment 3
Raw material takes by weighing by following weight proportion:
30 parts of the Radixs Astragali, 30 parts of Ganodermas, 15 parts of Fructus Ligustri Lucidi, 15 parts of Fructus Mumes.
Get above medicine,, be ground into fine powder after the oven dry the raw material cleaning and removing impurities, mix homogeneously behind mistake 100～200 mesh sieves, last fill capsule promptly gets capsule-type treatment type 2 diabetes mellitus pharmaceutical composition of the present invention.Three times on the one, each 4 capsules.
Embodiment 4
Raw material takes by weighing by following weight proportion:
60 parts of the Radixs Astragali, 30 parts of Ganodermas, 30 parts of Fructus Ligustri Lucidi, 30 parts of Fructus Mumes.
Get above medicine, add 6 times of decoctings and boil 2 times, the 1st time 3 hours, the 2nd time 2 hours, collecting decoction; Filter, filtrating is concentrated into extractum, and spray drying adds starch, uses 85% alcohol granulation; Drying, 18 mesh sieve granulate add carboxymethyl starch sodium and magnesium stearate, mixing; Tabletting, coating, packing promptly gets tablet form treatment type 2 diabetes mellitus pharmaceutical composition of the present invention.Three times on the one, each 4.
Embodiment 5
Raw material takes by weighing by following weight proportion:
Radix Astragali 40g, Ganoderma 30g, Fructus Ligustri Lucidi 20g, Fructus Mume 10g.
With the Impurity removal of above-mentioned each raw material, all medicines of receiving add 500 milliliters in water in marmite, soaked 30 minutes, decoct half an hour earlier, and potion on the one is taken at twice.
More than show and described ultimate principle of the present invention and principal character and advantage of the present invention.The technical staff of the industry should understand; The present invention is not restricted to the described embodiments; That describes in the foregoing description and the description just explains principle of the present invention; Under the prerequisite that does not break away from spirit and scope of the invention, the present invention also has various changes and modifications, and these variations and improvement all fall in the scope of the invention that requires protection.The present invention requires protection domain to be defined by appending claims and equivalent thereof.
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| CN102600384B (en) * | 2012-03-05 | 2014-07-30 | 广州蓝韵医药研究有限公司 | Bamboo shoot product for treating diabetes mellitus and preparation method thereof |
| CN105213861A (en) * | 2015-11-07 | 2016-01-06 | 李树霞 | A kind of Chinese medicine and preparation method for the treatment of type 2 diabetes mellitus |
| CN106138757A (en) * | 2016-08-25 | 2016-11-23 | 陈红专 | A kind of pharmaceutical composition treating type Ⅱdiabetes mellitus and preparation method thereof |
| CN107669860A (en) * | 2017-09-26 | 2018-02-09 | 河南大学 | A kind of Chinese medicine composition and its application with blood sugar reducing function |
| CN110652590B (en) * | 2018-06-29 | 2023-03-24 | 上海复浩生物科技有限公司 | Traditional Chinese medicine compound for treating diabetes and preparation method and application thereof |
| CN111956747A (en) * | 2020-09-02 | 2020-11-20 | 陈爱红 | A pharmaceutical composition for treating type 2 diabetes and preparation method thereof |
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| CN1726967A (en) * | 2005-07-26 | 2006-02-01 | 浙江省中药研究所 | Chinese materia medica preparation for treating diabetic nephropathy, and preparation method |
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