CN101940620A - Medicinal composition for treating diabetes mellitus and application thereof - Google Patents
Medicinal composition for treating diabetes mellitus and application thereof Download PDFInfo
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Abstract
The invention relates to a medicinal composition for treating diabetes mellitus and application thereof. The medicinal composition contains 20 to 200 parts of guava by weight, 0.01 to 0.2 part (converted to the weight of chromium) of medicinal compound containing chromium ions by weight, and 0.1 to 2 parts of evening primrose oil weight. The medicinal composition is a compound preparation combined by traditional Chinese herb and west medicine chromium picolinate to ensure that the two medicines can play the effect of synergy, so the medicinal composition not only has the advantages of accurate curative effect and quick response of the west medicine, but also can play the effects of harmonized medicines, compatibility between monarch and ministerial medicines, and abnormal metabolism balancing in human bodies in the traditional Chinese medicinal composition, and has the effect of treating both principal and secondary aspect of diabetes mellitus, hyperlipemia, in particular II-type diabetes mellitus with the hyperlipemia.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and application thereof for the treatment of diabetes.
Background technology
Raising along with living standards of the people, be accompanied by the variation of dietetic life, " affluenza " such as diabetes, hyperlipidemia, hypertension become serious in the world Chronic Non-Communicable Diseases after tumor, cardiovascular disease, and its sickness rate increases year by year, if can not be effectively controlled, its various secondary diseases, complication etc. are with the health of serious harm human body.For a long time, though the traditional Chinese medical science, Chinese medicine are started with from effecting a permanent cure, dialectical executing controlled, but from blood sugar lowering, blood fat still have gap fast and accurately, and the treatment of supplementation with insulin that doctor trained in Western medicine, Western medicine are taked or oral antidiabetic drug, lipid lowerers, though blood glucose, blood fat are controlled within the ideal scope, to diabetes, carrying out property blood vessel, nervous lesion, the blood vessel injury of hyperlipidemia etc. still do not have preventing and delay that it takes place, the effective measures of development.
Fructus psidii guajavae immaturus has the manual inseminating and loses to wild kind in areas such as China Fujian, Guangdong, Guangxi, Sichuan, Guizhou, Taiwan, be a kind of rich in natural resources.There are some researches show, be rich in flavone compound and polysaccharide compositions such as Quercetin in the Fructus psidii guajavae immaturus, compare with other Chinese medicine extract and have more excellent hypoglycemic effect.Also have and disclose the method that is used in combination with guava extract and some chemical classes medicines in some documents, but in order to play the effect identical with chemical medicine, the large usage quantity of common Chinese medicine extract, generally all more than 300g/kg, heavy dose of medication meeting increases production cost, the patient takes inconvenience, and large dose oral administration can bring a lot of side effect, brings great burden for intravital internal organs such as kidney, liver etc.Zoopery shows that the picked-up meeting of heavy dose of guava extract brings great side effect to gastrointestinal tract, and the symptom that occur feeling sick, vomiting, body weight significantly alleviates has increased patient's misery.And containing the Chinese medicine that several flavors to tens are distinguished the flavor of in traditional pure Chinese prescription, onset is slow, difficult quality control.
Summary of the invention
One of goal of the invention of the present invention is to provide a kind of pharmaceutical composition for the treatment of diabetes, and this pharmaceutical composition is a kind of can starting with from effecting a permanent cure, again the compound pharmaceutical composition of the Chinese medicine preparation of blood sugar lowering, blood fat and Western medicine preparation fast and accurately.
Technical scheme of the present invention is as follows:
A kind of medical compounds, the component that contains following parts by weight: guava extract 20-200 part, medicinal compound 0.01-0.2 part of containing chromium ion, Radix Oenotherae erythrosepalae oil 0.1-2 part, the wherein said content that contains the medicinal compound of chromium ion is the weight in chromium.
Preferably, the described medicinal compound that contains chromium ion is one or more in chromium picolinate, hydrochloric acid chromium, chromic oxide gel, chromium carbonate, chromic oxide and the Chlorizate chromium, preferably, the weight portion of Radix Puerariae extract is that the weight portion of 40-200, Radix Astragali extract is that the weight portion of 20-170, Fructus Momordicae charantiae extract is that the weight portion of 10-100, Radix Ophiopogonis is that the weight portion of 20-170, Folium Mori extract is 20-170.
Preferably, described pharmaceutical composition also comprises one or more in Radix Puerariae extract, Radix Astragali extract, Fructus Momordicae charantiae extract, Radix Ophiopogonis, the Folium Mori extract.
In the preferred embodiment of pharmaceutical composition of the present invention, said composition contains the component of following weight fraction:
Guava extract 50-100 part chromium picolinate 0.025-0.1 part
Radix Astragali extract 30-160 part Fructus Momordicae charantiae extract 10-100 part
Radix Ophiopogonis 30-160 part Radix Oenotherae erythrosepalae oil 0.15-1 part,
The parts by weight of wherein said chromium picolinate are with the cubage of chromium.
Preferably, described guava extract, Radix Puerariae extract, Radix Astragali extract, Fructus Momordicae charantiae extract and Folium Mori extract are respectively by Fructus psidii guajavae immaturus, Radix Puerariae, the Radix Astragali, Fructus Momordicae charantiae and Folium Mori after through alcohol extraction or water extraction, drying and crushing, and the effective ingredient that above-mentioned each extract comprises is Fructus psidii guajavae immaturus total flavonoid, Fructus psidii guajavae immaturus polysaccharide and Fructus psidii guajavae immaturus polyphenol, puerarin and Radix Puerariae flavone, astragalus polysaccharides, Charantin, Fructus Momordicae charantiae para-insulin, Fructus Momordicae charantiae para-insulin peptide class, Folium Mori alkaloid compounds.
The guava extract of pharmaceutical composition of the present invention is Fructus psidii guajavae immaturus meat extract and/or Folium Psidii Guajavae extract.
Preferably, also comprise pharmaceutically acceptable carrier auxiliary material, be prepared into medical dosage form or functional health product.Described carrier auxiliary material such as dextrin, lactose, amylum pregelatinisatum, excipient such as microcrystalline Cellulose, dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene is than disintegrating agents such as lattice alkane ketone, ethanol, starch slurry, sodium carboxymethyl cellulose, methylcellulose, binding agents such as ethyl cellulose, lubricants such as magnesium stearate, sodium stearate, sodium lauryl sulphate, the phospholipid surfactant, parabens, antiseptic such as benzoate, sucrose, correctivess such as stevioside, pectin, gelatin, polyoxyethylene, thickening agents such as polyvinyl alcohol, micropowder silica gel, fluidizer such as Pulvis Talci etc.
Preferably, described medical dosage form is oral liquid, powder, granule, micropill, capsule and tablet.Above-mentioned dosage form is the peroral dosage form any commonly used that the method for Chinese medicinal with routine is prepared into, as tablet, capsule, dispersible tablet, effervescent tablet, buccal tablet, chewable tablet, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation or oral liquid etc.
Two of goal of the invention of the present invention is to provide the application in the medicine of aforementioned pharmaceutical compositions in preparation treatment type ii diabetes.
Three of goal of the invention of the present invention is to provide the application of aforementioned pharmaceutical compositions in the medicine of preparation treatment high fat of blood.
Four of goal of the invention of the present invention is to provide aforementioned pharmaceutical compositions preparing treatment with the application in the medicine of the diabetes of hyperlipidemia.
Preparation of drug combination method of the present invention comprises the steps:
(1) carry with alcohol extraction or water according to conventional method and extract guava extract respectively, standby;
(2) according to above-mentioned prescription mixing guava extract, Radix Oenotherae erythrosepalae oil with contain chromium compound, add pharmaceutically acceptable pharmaceutic adjuvant, be prepared into medical dosage form or functional health product.
The extract of the Chinese medicinal components that adopts of the present invention can be carried or dipping, the reflux, extract, of alcohol extraction (comprising aqueous methanol, ethanol, propanol, ethylene glycol etc.) for water, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing, obtain the extract of each natural drug, can also can provide for oneself from direct purchase.
Radix Puerariae is the tuber of pulse family Herba Gelsemii Elegantis, by extraction, separation and evaluation to the Radix Puerariae main component, find that puerarin has blood sugar lowering, the expansion peripheral blood vessel, particularly effects such as coronary artery dilator blood vessel, anticoagulant, thereby had the treatment diabetes, and improved the peripheral nerve injury due to its microangiopathies and the effect of retinopathy and renal function pathological changes.Radix Puerariae extract has been broken through the single theory of treatment diabetes blood sugar lowering, is intended to repair patient's pancreas self-healing system in blood sugar lowering.The pancreas self-healing system is a self regulation and the endocrine system of balance, and when blood glucose was too high in the body, the pancreas self-healing system increased the secretion of insulin amount automatically, promotes the utilization synthetic and glucose of glycogen that blood glucose is reduced.In the time will hypoglycemia occurring, the pancreas self-healing system reduces the secretion of insulin amount again automatically, to keep the stable of blood glucose.But when pancreas is impaired when obstacle occurring, this steady statue will be broken, and it is unusual islet function to occur.As the islet function hyposecretion, insulin resistant, its result causes sugar, lipometabolic disorder---the ultimate principle of Here it is onset diabetes.The treatment diabetes restart the self-healing system of islets of langerhans as long as repair good impaired islet cells, allow patient's pancreas self-healing system running recover normal, the balance secretion of insulin, and diabetes could thoroughly rehabilitation.Radix Puerariae extract can be answered pancreas and be reformed, recover islet function exactly, promote the regeneration of B cell, make its excreting insulin normally, improve the state of hypoinsulinism, and swash the Insulin receptor INSR that in vivo is in resting state, and improve the sensitivity and the affinity of Insulin receptor INSR, improve the state of its " insulin resistant ".
In addition, the Radix Puerariae effective extract toxin expelling of invigorating blood circulation, so-called toxin expelling is removed the poison of intravital blood glucose exactly, the poison of lipid peroxide under the poison of blood fat and the free radical effect.These toxicants are intravital rubbish, are the bases that produces complication.Lipid peroxide in the blood plasma is that satisfied fatty acid is subjected to the free radical effect and forms in the body.The activity of the intravital superoxide dismutase of middle and elderly diabetic patient (we are accustomed to claiming SOD) reduces.Therefore it removes the ability drop of free radical, and lipid metabolic disorder causes microcirculation disturbance to cause blood flow to slow down simultaneously, and forms blood stasis.So-called prolonged illness in the traditional Chinese medical science that Here it is and the stasis of blood.Radix Puerariae extract can improve circulatory disturbance, makes blood stasis obstacle in the body, and blood stasis being improved invigorate blood circulation thus toxin expelling is the basis of complication prevention.
The Radix Astragali is the dry root of leguminous plant Radix Astagali or Radix Astragali.Its main component is astragalus polysaccharides class material, astragaloside, flavonoid and contains total amount and be about multiple compositions such as 1.23% 25 seed amino acids, 23 kinds of trace element (wherein ferrum, manganese, zinc, Se content are higher), folic acid, choline, linolenic acid.Astragalus polysaccharides because of its in enhancing human body immunity power. blood sugar lowering, there is stronger activity the defying age aspect and receives much concern.Studies show that astragalus polysaccharides has dual regulation.It can make the mouse blood sugar of glucose load obviously reduce, and also the mouse blood sugar that can obviously cause antiadrenergic drug raises and reacts, and it can also obviously resist the mouse experiment hypoglycemia that phenformin causes.But it does not have obvious influence to islets of langerhans disposition hypoglycemia.Astragalus polysaccharides is from regulating the metabolism aspect performance antidiabetic effect of liver.Liver is important digestive organs in the body, and it participates in keeping the stable of blood glucose by synthetic and decomposition glycogen.Abundant endoplasmic reticulum participates in proteic synthetic, secretion and steric configuration formation in the liver.If endoplasmic reticulum generation stress, cell will make some protein synthesis reduce, make some protein structures unusual, comprise that therefore the proteic quality and quantity of insulin and those assistance insulin actions all can be undesired, cause diabetes to take place.Astragalus polysaccharides alleviates the endoplasmic reticulum damage by improving the er stress of liver, increases the glycogen synthetase activity, increases insulin signaling albumen synthetic quantity and activity, thus the performance antidiabetic effect.
Fructus Momordicae charantiae contains steroid saponin such as Charantin, para-insulin peptide class and alkaloid, and these materials are given the balsam pear hypoglycemic activity.Charantin stimulates the release of insulin and hinders the formation of glucose in the blood flow, and this function may particularly play enormous function in the non-insulin-dependent diabetes mellitus treatment in diabetes.Fructus Momordicae charantiae effectively extract composition from suppress small intestinal mucosa to the absorption of glucose or directly play similar insulin be used for bringing into play blood sugar reducing function, modern medicine study is found, the composition that plays the blood sugar lowering effect in the Fructus Momordicae charantiae mainly is divided into two classes by its character: a class is an alkaloid, as Fructus Momordicae charantiae glucoside, Fructus Momordicae charantiae saponin etc.; Another kind of is protein and peptide, is maximum, the most significant part of blood sugar decreasing effect of content in the Fructus Momordicae charantiae.The exploitation of current bitter gourd sugar-reducing medicine mainly concentrates on separate preparation, character and the pharmacologically active of polypeptide and saponin and protects the research aspect.Having separated the Momordi glucose-reducing polypeptide that obtains has a variety of.Discover that Momordi glucose-reducing polypeptide can suppress the absorption of small intestinal mucosa to glucose; By strengthening the activity of muscle endoenzyme, glucose metabolism of acceleration bodies meat and utilization make the glucose metabolism balance, promote or improve insulin secretion, or directly play the effect of similar insulin, influence intravital carbohydrate metabolism process.
Radix Oenotherae erythrosepalae oil is the most important nutrient drug of finding this century.Seed oil-containing 20～30%, 70% is linoleic acid in the oil, 8～9% are the gamma-Linolenic acid of needed by human (can reduce the cholesterol of " bad " in the body, the prevention cardiovascular and cerebrovascular disease).Radix Oenotherae erythrosepalae oil can be treated multiple disease, regulate lipid material in the blood, diseases such as the coronary artery infraction that hypercholesterolemia, hyperlipidemia are caused, atherosis and cerebral thrombosis have significant curative effect, also can treat multiple sclerosis, diabetes, obesity, rheumatic arthritis and schizophrenia etc.Radix Oenotherae erythrosepalae oil contains abundant gamma-Linolenic acid (GLA), can be converted into PEG2, PGI2, PGF2a, has tangible blood fat reducing and antiplatelet aggregative activity.Gamma-Linolenic acid has tangible cholesterol reducing effect, and it is renderd a service to linoleic 163 times.Radix Oenotherae erythrosepalae oil can make high fat rat blood serum T-CHOL low-density lipoprotein cholesterol, C-VLDL reduce, and the high density cholesterol levels is significantly raise.The variation of HDL-C is because the high density lipoprotein subclasses cholesterol levels raises, and the outer cholesterol levels of high density lipoprotein subclasses does not have significant change.Cause hyperlipidemia pathology model for Wistar rats gavaged hyperlipidemia modeling agent or etherosulfuric acid, the result shows that Radix Oenotherae erythrosepalae oil and sodium salt thereof have stronger blood fat reducing and study of anti-atherogenic effect.This product can participate in the synthetic and balance of prostaglandin.Still the obviously effect of the synthetic thromboxane A2 (TXA2) of anticoagulant and platelet, thereby the ratio of change TXA2/PGI2, the effect with control thrombosis cardiovascular disease.Gamma-Linolenic acid has stimulation to brown adipose tissue, promotes the mitochondrial activity of brown fat acid, consumes too much heat and reaches certain fat-reducing effect.
Ecdysterone contained in the Folium Mori extract all has blood sugar reducing function to the inductive blood sugar increasing of several different methods, can promote that conversion of glucose is a glycogen, but not change intact animal's blood glucose.Discover that contained some aminoacid can stimulate secretion of insulin with blood sugar lowering in the Folium Mori.
Radix Ophiopogonis sweet Han Zhirun, the property that tool is cloudy gentle, the merit of YIN nourishing, be good at clearly supporting the wet weather of lung stomach and moisturize, can clear away heart-fire again through heat and relieving restlessness is to grow the tonification good medicine that has both clearly simply, be accessory drugs in this prescription, intravital surrounding tissue is reduced the opposing of insulin, impel islet cells to recover normal.
Pharmaceutical composition of the present invention is quality controllable, the trend that to have the fixing compound preparation of forming be the treatment diabetes, and chemicals often has the different side effect of weight, and drug combination can increase the incidence rate of side effect, brings hidden danger for the drug safety of extensive patients.For a change this situation all the time, attempts treating with botanical herbs clinically always.But when Chinese medicine uses separately,, exist onset slow, need the shortcoming of dialectical use under the experienced traditional Chinese medical science instructs though have certain hypoglycemic effect.Therefore, the present invention attempts Chinese medicine and Western medicine are combined, and avoids shortcoming separately, produces synergism simultaneously.The present invention attempts adding the chemicals that contains chromium first, when necessary elemental chromium lacks in additional diabetes human body, be surprised to find that it and can produce synergism between the effective ingredient of Chinese medicine extract such as Fructus psidii guajavae immaturus, glycometabolic each approach is started with in the body, played comprehensively, significantly, the effects of radical cure diabetes.
It is in the compositions of main pharmacodynamics composition that the medicinal compound that pharmaceutical composition of the present invention will contain chromium ion joins with the guava extract, the two has produced synergism efficiently surprised discovery, the adding of trace chromium ionic compound, to the main sugar-lowering components flavonoid in the guava extract and polysaccharide played purpose less than sensitization, greatly reduce the consumption of effective ingredient guava extract when obtaining identical drug effect, improved curative effect of medication, saved production cost, improved patient's compliance, reduce the untoward reaction of medicine and the generation of side effect, particularly alleviated the generation of gastrointestinal upset significantly.Simultaneously, at present diabetics usually with hyperlipidemia etc., the pathomechanism that hyperglycemia, hyperlipidemia etc. communicate, creatively add a certain proportion of Radix Oenotherae erythrosepalae oil, pharmacological evaluation shows that blood sugar reducing component and component for reducing blood fat also have synergism each other, blood glucose and blood fat can be reduced simultaneously, and have no adverse reaction, still do not have research report in this respect at present.
Pharmaceutical composition of the present invention, be with there being the Chinese herbal medicine extract of different pharmacological actions to combine according to a certain percentage with chemical classes medicine chromium picolinate, make compound preparation, each composition by to influence in the body glycometabolic each approach exert an influence play collaborative from effect, from producing hyperglycemia, each organ of hyperlipidemia, mechanism is started with, repair one by one and perfect, for example replenish the trace chromium element that lacks in the diabetes human body, to glycometabolic influence in the liver, reparation influence to pancreas, mucous membrane of small intestine is heavily absorbed the influence of glucose, replenish necessary aminoacid, many-sides such as linolenic acid play a role, produced beyond thought blood sugar lowering, consolidate, repair three bonded effects, fundamentally play blood sugar lowering, the effect of blood fat reducing, and the present invention has been carried out further checking in conjunction with pharmacological evaluation.Chinese medicine ingredients and western medicine composition are brought into play synergism, the determined curative effect of existing Western medicine, onset be advantage rapidly, can bring into play again in the Chinese medicine composition all medicines mutually and, the monarch and his subjects assist mutually, the effect of the abnormal metabolism in the balance human body is to diabetes, hyperlipidemia, especially play the effect for the treatment of both the principal and secondary aspects of a disease with the type ii diabetes of hyperlipidemia.With natural drug effective site is primary raw material, has the characteristic of hypotoxicity and low untoward reaction.By the suitableeest combination in the Chinese medicine compound, find the compositions ratio of optimum medicine efficacy, save cost, be convenient to clinical practice.Preparation technology is simple, and the composition of effective site is determined, is convenient to quantitatively help industrialized great production.
The specific embodiment
Introduce pharmaceutical composition of the present invention in detail below in conjunction with embodiment and test example.
Embodiment 1
In Fructus psidii guajavae immaturus, add 10 times of amount 50% alcoholic solution, dipping, reflux, extract, under 50 ℃, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain extract.
With the 50g guava extract, add 0.3g Radix Oenotherae erythrosepalae oil, 0.02g chromium picolinate (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000 preparations).
Embodiment 2
Add 10 times of amount 50% alcoholic solution Fructus psidii guajavae immaturus, dipping, reflux, extract, under 50 ℃, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain extract.
With the 100g guava extract, add 1g Radix Oenotherae erythrosepalae oil, 0.08g hydrochloric acid chromium (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000 preparations).
Embodiment 3
Prepare Powdered guava extract (can buy) 200g, adding 0.15g Radix Oenotherae erythrosepalae oil, 0.2g Chlorizate chromium (weight that is scaled chromium is calculated), mix homogeneously, add suitable amount of sucrose, starch and dextrin again, cross 100 mesh sieves, mixing, an amount of with starch slurry, make soft material, 12 orders are granulated, 55 ℃ of dryings, 16 order granulate, pack makes granule.
Embodiment 4
Prepare Powdered guava extract (can buy) 180g, adding 1.8g Radix Oenotherae erythrosepalae oil, 0.15g chromic oxide (weight that is scaled chromium is calculated), 0.03g hydrochloric acid chromium (weight that is scaled chromium is calculated), mix homogeneously, add suitable amount of sucrose, starch and dextrin again, cross 100 mesh sieves, mixing, an amount of with starch slurry, make soft material, 12 orders are granulated, 55 ℃ of dryings, 16 order granulate, pack makes granule.
Embodiment 5
In Fructus psidii guajavae immaturus, add 10 times of amount 50% alcoholic solution, dipping, reflux, extract, under 50 ℃, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain extract.
With the 80g guava extract, add 2g Radix Oenotherae erythrosepalae oil, 0.05g hydrochloric acid chromium (weight that is scaled chromium is calculated), 0.05 chromium carbonate (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000 preparations).
Embodiment 6
In Fructus psidii guajavae immaturus, add 10 times of amount 50% alcoholic solution, dipping, reflux, extract, under 50 ℃, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain extract.
With the 130g guava extract, add 0.11g Radix Oenotherae erythrosepalae oil, 0.15g chromium carbonate (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000 preparations).
Embodiment 7
The methanol and 50% alcoholic solution that respectively will be in Fructus psidii guajavae immaturus, the Radix Puerariae add 10 times of amounts 50%, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug
In 160g guava extract, 70g Radix Puerariae extract, add 1.5g Radix Oenotherae erythrosepalae oil, 0.15g chromium carbonate (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000 preparations).
Embodiment 8
The methanol and 50% alcoholic solution that respectively Fructus psidii guajavae immaturus, Radix Puerariae, the Radix Astragali are added 10 times of amounts 50%, 60 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug.
In 70g guava extract, 50g Radix Puerariae extract, 30g Radix Astragali extract, add 1.5g Radix Oenotherae erythrosepalae oil, 0.15g chromium carbonate (weight that is scaled chromium is calculated), mix homogeneously adds suitable amount of sucrose, starch and dextrin again, cross 100 mesh sieves, mixing, an amount of with starch slurry, make soft material, 12 orders are granulated, 55 ℃ of dryings, 16 order granulate, pack makes granule.
Embodiment 9,
Respectively with Fructus psidii guajavae immaturus, the Radix Astragali, Fructus Momordicae charantiae, add the methanol and 50% alcoholic solution of 10 times of amounts 50% in Radix Ophiopogonis, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug.
Guava extract 50g
Radix Astragali extract 45g
Fructus Momordicae charantiae extract 10g
Radix Ophiopogonis 35g
Radix Oenotherae erythrosepalae oil 0.3g
Chromium picolinate 0.05g
Preparation process: take by weighing each extract according to said ratio, add 0.3g Radix Oenotherae erythrosepalae oil, 0.05g chromium picolinate (weight that is scaled chromium is calculated), add an amount of excipient microcrystalline Cellulose, disintegrating agent carboxymethyl base Starch Sodium and hypromellose, magnesium stearate lubricant etc. again, cross 100 mesh sieves, mixing, with 75% ethanol system soft material, 12 mesh sieves are granulated, 55 ℃ of dryings 3 hours, 14 mesh sieve granulate, add micropowder silica gel, mixing, tabletting, both pharmaceutical composition tablet of the present invention (1000).
Embodiment 10,
The methanol and 50% alcoholic solution that respectively will be in Fructus psidii guajavae immaturus, the Radix Astragali, Fructus Momordicae charantiae, the Folium Mori add 10 times of amounts 50%, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug.
Guava extract 80g
Radix Astragali extract 45g
Folium Mori extract 55g
Radix Oenotherae erythrosepalae oil 0.5g
Chromium picolinate 0.09g
Preparation process: the extract that takes by weighing each component according to said ratio, add 0.5g Radix Oenotherae erythrosepalae oil, 0.09g chromium picolinate (weight that is scaled chromium is calculated), mix homogeneously adds suitable amount of sucrose, starch and dextrin again, cross 100 mesh sieves, mixing, an amount of with starch slurry, make soft material, 12 orders are granulated, 55 ℃ of dryings, 16 order granulate, pack makes granule.
Embodiment 11
Utilize the method for embodiment 5 to prepare pharmaceutical composition of the present invention.Difference is, is prescription according to following listed component:
Guava extract 65g
Radix Puerariae extract 200g
Fructus Momordicae charantiae extract 60g
Radix Ophiopogonis 80g
Radix Oenotherae erythrosepalae oil 0.7g
Chromium picolinate 0.1g
Embodiment 12
Utilize the method for embodiment 6 to prepare pharmaceutical composition of the present invention.Difference is, is prescription according to following listed component:
Guava extract 88g
Fructus Momordicae charantiae extract 80g
Folium Mori extract 90g
Radix Ophiopogonis 155g
Radix Oenotherae erythrosepalae oil 0.9g
Chromium carbonate 0.025g
Embodiment 13
Utilize the method for embodiment 6 to prepare pharmaceutical composition of the present invention.Difference is, is prescription according to following listed component:
Guava extract 100g
Radix Astragali extract 130g
Folium Mori extract 130g
Radix Ophiopogonis 115g
Radix Oenotherae erythrosepalae oil 0.6g
Hydrochloric acid chromium 0.065g
Embodiment 14,
To add 50% methanol and 20% propanol solution of 10 times of amounts in Fructus psidii guajavae immaturus, Radix Puerariae, the Radix Astragali, the Fructus Momordicae charantiae respectively, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug.
Guava extract 100g
Radix Puerariae extract 100g
Radix Astragali extract 80g
Radix Oenotherae erythrosepalae oil 1g
Chromic oxide gel 0.25g
Dried powder according to each natural drug extract of above-mentioned recipe quantity is a raw material, adds 1g Radix Oenotherae erythrosepalae oil, 0.25g chromium picolinate (weight that is scaled chromium is calculated), as principal agent; With the water-soluble adding glycerol of gelatin, transfer to suitable color, be incubated set aside for use (diluent) after the vacuumize degassing; Solubilizing agent PEG-400 (Polyethylene Glycol), antioxidant vitamin E, pH regulator agent phosphate buffer, dehydrated alcohol are added in the diluent, and principal agent is dissolved in wherein, both mix homogeneously; 50-60 ℃ of reduction vaporization removed ethanol, gets settled solution; The medicinal liquid for preparing is poured in the pellet processing machine, finalized the design, put drying, scrape and promptly get soft capsule preparation (1000 preparations).
Embodiment 15,
Preparation technology: add 60% alcoholic solution of 10 times of amounts with Fructus psidii guajavae immaturus, the Radix Astragali, Fructus Momordicae charantiae, in Radix Ophiopogonis, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug;
Guava extract 50g
Radix Astragali extract 70g
Fructus Momordicae charantiae extract 50g
Radix Ophiopogonis 64g
Radix Oenotherae erythrosepalae oil 0.5g
Hydrochloric acid chromium 0.05g
Dried powder with each natural drug extract of above-mentioned recipe quantity is a raw material, add 0.5g Radix Oenotherae erythrosepalae oil, 0.05g chromium picolinate (weight that is scaled chromium is calculated), add tartaric acid, sodium bicarbonate, sweeting agent, filler mixing, granulate with dehydrated alcohol, dry, add the lubricant mixing, tabletting prepares effervescent tablet (1000 preparations).
Embodiment 16,
Preparation technology: will be in Folium Psidii Guajavae, Fructus psidii guajavae immaturus sarcocarp, the Radix Astragali add 60% alcoholic solution of 10 times of amounts, 50 ℃ of dipping, reflux, extract, down, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing obtain the extract of each natural drug;
Folium Psidii Guajavae extract 80g
Fructus psidii guajavae immaturus meat extract 50g
Radix Astragali extract 45g
Radix Oenotherae erythrosepalae oil 0.9g
Chromium picolinate 0.07g
Dried powder with each natural drug extract of above-mentioned recipe quantity is a raw material, add 0.9g Radix Oenotherae erythrosepalae oil, 0.07g chromium picolinate (weight that is scaled chromium is calculated), add adjuvant, filler commonly used in the food, sieve, tabletting behind the mixing, make functional health product (1000 preparations).
Embodiment 17,
Add the water of 10 times of amounts and the mixed solution of 50% methanol solution (1: 1) with Folium Psidii Guajavae, Fructus psidii guajavae immaturus sarcocarp, Fructus Momordicae charantiae, Folium Mori, in Radix Ophiopogonis, dipping, reflux, extract, under 50 ℃, merge extractive liquid,, concentrating under reduced pressure, drying, pulverizing, obtain the extract of each natural drug, standby.
Folium Psidii Guajavae extract 100g
Fructus psidii guajavae immaturus meat extract 50g
Fructus Momordicae charantiae extract 10g
Folium Mori extract 35g
Radix Ophiopogonis 100g
Radix Oenotherae erythrosepalae oil 0.8g
Chromium picolinate 0.1g
Dried powder with each natural drug extract of above-mentioned recipe quantity is a raw material, add Radix Oenotherae erythrosepalae oil 0.8g, 0.1g chromium picolinate (weight that is scaled chromium is calculated), mix the back with ethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate and granulate, tabletting makes slow releasing tablet (1000 preparations).
The pharmaceutic adjuvant that uses in the various embodiments described above of the present invention all is a pharmaceutic adjuvant acceptable in the commonly used or medication preparation in the medication preparation as diluent, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler, antiseptic, stabilizing agent, correctives, thickening agent, fluidizer etc.The dosage form that the dosage form of pharmaceutical composition of the present invention is not limited to list in the foregoing description, also available conventional method is prepared into other common dosage forms, as tablet, capsule, dispersible tablet, buccal tablet, chewable tablet, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid etc.The extract of each Chinese medicinal components of the present invention can directly be bought from market, and its preparation method is also for pharmaceutical field water or pure extracting method commonly used, so not for a more detailed description herein.
One, experimental example
The present invention verifies further that by pharmacology, the test of pesticide effectiveness Chinese medicine compound compositions that adopts the present invention to make has hypoglycemic effect significantly, and the adding of chromium ion has reduced the consumption of effective medicinal ingredient significantly.
One, to Pharmacological action study
1, to the influence of normal mouse blood sugar (table 1), body weight and food ration (2):
Get 60 of normal mouses (23 ± 2g), be divided into 3 groups at random, 20 every group;
(1) pharmaceutical composition of the present invention (80mg guava extract+0.02mg chromium picolinate): give and 80mg/kg;
(2) guava extract: give and guava extract 300mg/kg;
(3) normal control group: give and normal saline;
Gastric infusion, continuous 10 days, 5h and 12h surveyed blood glucose after the last administration, and the result is as follows:
The influence of table 1 pair normal mouse blood sugar
The result shows that behind pharmaceutical composition group of the present invention and guava extract group mice fasting 5h and the 12h, blood sugar level is a little less than the normal control group, but no significant difference.
The influence of table 2 pair normal mouse body weight and food ration
| Group | Body weight average (g) | Food ration average (g/ day) |
| Pharmaceutical composition group of the present invention | 22±2g | 10±2g |
| The guava extract group | 16±2g | 4±2g |
| The normal control group | 24±2g | 12±3g |
The result shows, present composition group is approaching to the zest and the normal group of mouse GI tract, mice appetite no change, the body weight average and every day food ration average zero difference, but heavy dose of guava extract is big to the mouse GI tract stimulus effects, can be observed the mice inappetence, be a cup too low, the body weight average and every day the food ration average have significant difference.
2, to the influence of glucose sugar hyperglycemia mouse blood sugar
Test method: get normal mouse, be divided into 11 groups at random, 15 every group.Guava extract group administration 300mg/kg, pharmaceutical composition of the present invention (with test example 1) administration 80mg/kg, normal control group, model control group are given with distilled water, positive controls and are given and glipizide 5mg/kg, equal gastric infusion, continuous 10 days, last is irritated the preceding fasting 10h of stomach, after irritating stomach 1h, normal control group intraperitoneal injection of saline, all the other respectively organize lumbar injection glucose sugar 3g/kg, behind the 1h, the tail vein is surveyed blood glucose.
The result is as follows:
The influence of table 3 pair glucose hyperglycemia mouse blood sugar
| Group | Blood glucose value (mmol/L) |
| The normal control group | 5.13±0.73 |
| Model control group | 25.12±1.97 △△ |
| The glipizide group | 12.21±2.32 **△△ |
| Present composition group | 9.75±1.47 **△△ |
| The guava extract group | 15.69±2.47 **△△ |
Annotate:
*P＜0.05,
*P＜0.01. compares with the normal control group, △ P＜0.05, △ △ P＜0.01.
The result shows: lumbar injection glucose induction mouse blood sugar significantly raises (P＜0.01), and glipizide, the present composition, guava extract be the significantly rising of antagonism mouse blood sugar level all, and the blood sugar lowering rate of compositions of the present invention is better than other groups.
The influence of table 4 pair glucose hyperglycemia mice body weight and food ration
| Group | Body weight average (g) | Food ration average (g/ day) |
| The normal control group | 24±2g | 12±2g |
| Model control group | 25±2g | 15±2g |
| The glipizide group | 20±2g | 12±3g |
| Present composition group | 22±2g | 10±2g |
| The guava extract group | 16±2g | 4±2g |
The result shows, the present composition, glipizide are approaching to the zest and the normal group of mouse GI tract, mice appetite no change, the body weight average and every day food ration average zero difference, but heavy dose of guava extract is big to the mouse GI tract stimulus effects, can be observed the mice inappetence, be a cup too low, the body weight average and every day the food ration average have significant difference.
3, to the influence of adrenal gland's disposition hyperglycemia mouse blood sugar
Get 165 of normal mouses, grouping and administration are with above-mentioned glucose sugar hyperglycemia mouse blood sugar influence test item down.Fasting 10.5h before the last administration, behind the gastric infusion 0.5h, normal control group subcutaneous injection normal saline, other group subcutaneous injection epinephrines 1mg/kg, behind the 1h, the tail vein is surveyed blood glucose, and the result is as follows:
Table 5 compound is to the influence of adrenal gland's disposition hyperglycemia mouse blood sugar
Annotate:
*P＜0.05,
*P＜0.01. compares with the normal control group, △ P＜0.05, △ △ P＜0.01.
The result shows that subcutaneous injection epinephrine inducing mouse blood glucose significantly raises (P＜0.01), and glipizide, the present composition, guava extract be the significantly rising of antagonism mouse blood sugar level all, and the blood sugar lowering rate of compound is better than other groups.
4, chain is urinated blood sugar lowering, the effect for reducing blood fat of rhzomorph-diabetes rat
Test method: get the normal male rat, lumbar injection chain urine rhzomorph 180mg/kg causes diabetes model.Be divided into 9 groups at random, 13 every group.Present composition group administration 85.2mg/kg (80mg guava extract+0.2mg chromium picolinate+5mg Radix Oenotherae erythrosepalae oil), guava extract group administration 300mg/kg normal control group, model control group are given and distilled water, positive controls gives glipizide 5mg/kg, equal gastric infusion, after 3 weeks of administration, last is irritated the preceding fasting 2h of stomach, and 1h tail vein was surveyed blood glucose after last was irritated stomach, and the result is as follows:
Table 6 compound is urinated the influence of rhzomorph-rat diabetes, blood fat to chain
| Group | Blood glucose (mmol/L) | Triglyceride (mmol/L) |
| The normal control group | 5.19±0.53 | 0.89±0.12 |
| Model control group | 27.47±4.55 △△ | 4.21±1.16 △△ |
| The glipizide group | 19.35±1.76 **△△ | 3.92±0.96 **△△ |
| Present composition group | 17.75±2.92 **△△ | 1.32±1.17 **△△ |
| The guava extract group | 20.15±2.96 **△△ | 4.15±1.69 **△△ |
Annotate:
*P＜0.05,
*Compare with the normal control group in P＜0.01, △ P＜0.05, △ △ P＜0.01.
The result shows: glipizide, the present composition, guava extract all can reduce the mouse blood sugar level, and the blood sugar lowering rate of the present composition is better than other groups; The present composition can significantly reduce the mice blood lipid level, and guava extract, glipizide can reduce the mice blood lipid level slightly.
5, synergistic action effect experiment between each component in the pharmaceutical composition of the present invention:
Having set up high sugar induces rat insulin opposing model-SD rat to give normal diet (carbohydrate 60%, fat 11%, protein 29%) 4 weeks of nursing, rat is fed with high fructose feedstuff (fructose 66%, fat 12%, protein 22%), can become mould after spending for 4 weeks.
Be reference substance with commercially available rosiglitazone maleate sheet, XIAOKE JIANGTANG JIAONANG (guava extract capsule) then, with FPG (blood glucose), HbAlc (glycolated hemoglobin) is index, investigates the blood sugar reducing function of this product (pharmaceutical composition that adopts embodiment 1,2,7,8,9,10,14,15,16,17 is as test specimen).It the results are shown in Table 5.
The variation of the forward and backward blood glucose of table 7 treatment, glycolated hemoglobin
As seen from table, there is significant difference between each treatment group (experimental group), pharmaceutical composition of the present invention, because the drug combination of pharmaceutically active ingredient in each, reach the synergism that produces with the chemicals chromium picolinate that adds first, have significant hypoglycemic effect, compare with other Chinese medicine preparation that produce same effect, reduce the consumption of each component, reduced toxic and side effects.And the proportioning effect of each component more is better than other prescriptions in the pharmaceutical composition that makes of embodiment 9 as shown in Table 7.
Two, acute toxicity test
Test method: get 60 of mices, after the fasting 16 hours, be divided into 3 groups at random, each 10 of every group of male and female, by adult (body weight 65kg) 2.7g compound consumption calculating for each person every day, be converted into per kilogram of body weight 41.5mg every day, enlarge the administration of 100 times of disposable per os mouse stomaches with this dosage, in two weeks, observe and record poisoning symptom and death condition, calculate LD50 with the Bliss method.The result shows: 1. do not find poisoning symptom and death condition; 2. female, male its mouse oral LD50 is all greater than 4.15g/KGBW.Judge that according to acute toxicity grading criteria in " toxicological evaluation of food safety procedure and method " this compound belongs to the non-toxic type material.
The above only is preferred embodiment of the present invention, and is in order to restriction the present invention, within the spirit and principles in the present invention not all, any modification of being done, is equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. a pharmaceutical composition is characterized in that, contains the component of following parts by weight:
Guava extract 20-200 part is contained medicinal compound 0.01-0.2 part of chromium ion,
Radix Oenotherae erythrosepalae oil 0.1-2 part,
The wherein said content that contains the medicinal compound of chromium ion is the weight in chromium.
2. pharmaceutical composition according to claim 1 is characterized in that, the described medicinal compound that contains chromium ion is one or more in chromium picolinate, hydrochloric acid chromium, chromic oxide gel, chromium carbonate, chromic oxide and the Chlorizate chromium.
3. pharmaceutical composition according to claim 1 and 2, it is characterized in that, also contain in Radix Puerariae extract, Radix Astragali extract, Fructus Momordicae charantiae extract, Radix Ophiopogonis, the Folium Mori extract one or more in the said composition, wherein the weight portion of Radix Puerariae extract is that the weight portion of 40-200, Radix Astragali extract is that the weight portion of 20-170, Fructus Momordicae charantiae extract is that the weight portion of 10-100, Radix Ophiopogonis is that the weight portion of 20-170, Folium Mori extract is 20-170.
4. pharmaceutical composition according to claim 3 is characterized in that, said composition contains the component of following weight fraction:
Guava extract 50-100 part chromium picolinate 0.025-0.1 part
Radix Astragali extract 30-160 part Fructus Momordicae charantiae extract 10-100 part
Radix Ophiopogonis 30-160 part Radix Oenotherae erythrosepalae oil 0.15-1 part,
The parts by weight of wherein said chromium picolinate are with the cubage of chromium.
5. pharmaceutical composition as claimed in claim 3, it is characterized in that, described guava extract, Radix Puerariae extract, Radix Astragali extract, Fructus Momordicae charantiae extract and Folium Mori extract are respectively by Fructus psidii guajavae immaturus, Radix Puerariae, the Radix Astragali, Fructus Momordicae charantiae and Folium Mori are through alcohol extraction or water extraction, after the drying and crushing, described guava extract, Radix Puerariae extract, Radix Astragali extract, the active ingredient that Fructus Momordicae charantiae extract and Folium Mori extract comprise is respectively the Fructus psidii guajavae immaturus total flavonoid, Fructus psidii guajavae immaturus polysaccharide and Fructus psidii guajavae immaturus polyphenol, puerarin and Radix Puerariae flavone, astragalus polysaccharides, Charantin, Fructus Momordicae charantiae para-insulin and Fructus Momordicae charantiae para-insulin peptide class, the Folium Mori alkaloid compounds.
6. pharmaceutical composition as claimed in claim 1 is characterized in that, also comprises pharmaceutically acceptable carrier auxiliary material, is prepared into medical dosage form or functional health product.
7. pharmaceutical composition as claimed in claim 6, it is characterized in that described medical dosage form is tablet, capsule, dispersible tablet, effervescent tablet, buccal tablet, chewable tablet, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation or oral liquid.
8. pharmaceutical composition as claimed in claim 1, the application in the medicine of preparation treatment type ii diabetes.
9. pharmaceutical composition as claimed in claim 1, the application in the medicine of preparation treatment high fat of blood.
10. pharmaceutical composition as claimed in claim 1 is preparing treatment with the application in the medicine of the diabetes of hyperlipidemia.
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