CN100500174C - Medicine composition used for lowering blood-sugar, preparation method and use thereof - Google Patents
Medicine composition used for lowering blood-sugar, preparation method and use thereof Download PDFInfo
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- CN100500174C CN100500174C CNB2005100206912A CN200510020691A CN100500174C CN 100500174 C CN100500174 C CN 100500174C CN B2005100206912 A CNB2005100206912 A CN B2005100206912A CN 200510020691 A CN200510020691 A CN 200510020691A CN 100500174 C CN100500174 C CN 100500174C
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- semen trigonellae
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Abstract
A hypoglycemic Chinese medicine for treating diabetes is prepared from feungreak seed and mulberry leaf.
Description
Technical field
The present invention relates to a kind of hypoglycemic pharmaceutical composition that is used for, particularly, relate to Chinese medicine and be pharmaceutical composition that feedstock production forms and its production and use.
Background technology
Diabetes are commonly encountered diseases, frequently-occurring disease, and its number of patients is just along with the change of the raising of living standards of the people, the aging of population, life style and improving of diagnostic techniques and increase sharply.Adopted nature crowd, stratified cluster sampling method by WHO standard in 1994,20-75 years old 42751 people of China 11 provinces and cities carried out Epidemiological study, found that diabetes prevalence is 3.21%, impaired glucose tolerance (IGT) prevalence is 4.76%.WHO1997 annual report, the whole world have 1.35 hundred million diabeticss approximately, predict will rise to 300,000,000 in 2005.Diabetes have become the third-largest non-infective disease after cardiovascular, tumor, are the worldwide hygienic issues of serious threat human health.
Traditional hypoglycemic medicine mainly comprises sulphanylureas and biguanides, and its hypoglycemic effect is for 60%-70% diabetics, and blood glucose can be controlled preferably; But these medicines but have certain side effect: gastrointestinal tract, liver function to patient have certain infringement, particularly can bring out hypoglycemia.So extract active component from plant, the blood sugar lowering medicine of research and development good effect, few side effects just becomes a focus.
Semen Trigonellae is the mature seed of pulse family annual herb plant Semen Trigonellae, and China is among the people to be used for warming the kidney to invigorate YANG, cold relieving with Semen Trigonellae more, and treatment is suffered from a deficiency of the kidney and caused the card of part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels cold type of pain, is fabulous tonic and nutriment; In some countries such as India, mediterranean country and North Americas it is used as flavoring agent and appetizer.Pharmacological research shows both at home and abroad in recent years: Semen Trigonellae has effects such as blood sugar lowering, blood fat reducing, antitumor, and its active component steroidal saponin, flavone and glycosides, alkaloid, organic acid and oils and fats etc. cause lot of domestic and foreign expert's concern.Yet hypoglycemic activity composition of Semen Trigonellae and mechanism of action also are not very clear and definite; There is report to claim 4 monohydroxy isoleucine in the Semen Trigonellae extract that thereby B cell is had the effect that stimulation reaches blood sugar lowering.Folium Mori are the leaf of Moraceae deciduous tree plant mulberry, in the Ancient Times in China medicine books with regard to useful Folium Mori as the quench one's thirst record of (and being modern diabetes) of Drug therapy, put down in writing Folium Mori in the Compendium of Material Medica " juice fries in shallow oil Dai Ming, can only quench one's thirst " modern pharmacological research finds: compositions such as the Folium Mori alkali that contains in the Folium Mori, polysaccharides of Folium Mori all have the effect of blood sugar lowering, blood fat reducing.Have report to claim: the ecdysterone that contains in the Folium Mori (Ecdysterone) belongs to phytoecdysone ecdyson, can promote that glucose changes glycogen into, thereby reaches the effect of blood sugar lowering.
Chinese patent application CN 1480462A discloses a kind of Semen Trigonellae extract that extracts and production method and preparation from Semen Trigonellae, can be used for the treatment of the adjusting of diabetes to blood glucose and blood fat; It is the health-care tea made of mulberry leaves of primary raw material with Folium Mori and Folium Camelliae sinensis that Chinese patent application CN 1513336A has announced a kind of, can be used for the daily health caring of diabetics.Still be difficult Semen Trigonellae at present, Folium Mori are the relevant report that feedstock production becomes hypoglycemic drug.
Summary of the invention
Technical scheme of the present invention provides a kind of hypoglycemic pharmaceutical composition that is used for, and another technical scheme of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of hypoglycemic pharmaceutical composition that is used for, it is by containing the medicament that the following weight proportion raw material is prepared from:
1～5 part of Semen Trigonellae, 1～6 part on Folium Mori.
Wherein, said Semen Trigonellae, Folium Mori all use Chinese crude drug or the decoction pieces that meets Chinese Pharmacopoeia and local medical material standard.Semen Trigonellae derives from: the mature seed of leguminous plant Semen Trigonellae Trigonella foenum-graecum L.; Folium Mori derive from: the leaf of moraceae plants mulberry morus Alba L..
Further, it is the medicament that is prepared from by the following weight proportion raw material:
1～5 part of Semen Trigonellae, 1～6 part on Folium Mori.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
1～2 part of Semen Trigonellae, 1～3 part on Folium Mori.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
1 part of Semen Trigonellae, 1～3 part on Folium Mori.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
1 part of Semen Trigonellae, 1.1 parts on Folium Mori
Described pharmaceutical composition is to be active component by Semen Trigonellae water or alcohol extract, Folium Mori water or alcohol extract, adds the medicament that acceptable accessories or complementary composition are prepared from.
The per unit preparation contains the 4-hydroxyisoleucine and is no less than 5mg in the described medicament.Adopt the HPLC-ELSD method to detect.
Adopt the conventional formulation technology in present medical industry field, the feedstock production in the above-mentioned prescription can be become capsule, tablet, granule, pill, soft capsule.
Production method of the present invention is as follows:
1, gets Semen Trigonellae, add the alcohol reflux of 50%-95%, reclaim ethanol, get extractum liquid; Immersion by cation exchange resin, is used the ammonia eluting, and eluent concentrates, and gets extract;
2, get Folium Mori, decoct with water extraction, filtration concentrates, and adds ethanol and makes with extra care, and filters, and filter residue and drying gets extract powder;
3, the extract with 1 step mixes with 2 step extracts, adds adjuvant pharmaceutically commonly used and is prepared into preparation pharmaceutically commonly used.
The extraction process of Semen Trigonellae is alcohol extraction, ammonia elution processes among the present invention; what Folium Mori used is the water extract-alcohol precipitation process for refining; those skilled in the art can take different extracting method according to the contained effective ingredient of each raw material, and for example: the extraction that Semen Trigonellae carries out combination of fenugreek gum earlier waits these variations all to belong to protection scope of the present invention.
As long as adopted the composition of raw materials of medicine of the present invention, but make pharmaceutical formulation, the health food that any other patients uses, all within protection scope of the present invention.
Medicine material Semen Trigonellae of the present invention, Folium Mori compatibility use, the effect of performance Synergistic, and drug effect is reliable, and the medicine of preparation is stable, and controllability is strong, for clinical hypoglycemic drug provides a kind of new selection.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment one
Take by weighing each materials of weight proportions: 1 part of Semen Trigonellae, 1.1 parts on Folium Mori; Get Semen Trigonellae, 80% alcohol reflux that adding 5-10 doubly measures 1-3 time, each 1-3 hour, merge extractive liquid, filtered, and concentrating under reduced pressure reclaims ethanol, gets extractum liquid; Extractum liquid by cationic resin, is used the ammonia eluting, and eluent concentrates, and drying under reduced pressure (temperature is 50-80 ℃) is pulverized, and gets extract powder; Get Folium Mori, the water extraction that adding 8-12 doubly measures 1-3 time, each 0.5-2 hour, merge extractive liquid, filtered, being concentrated into proportion is 1.10-1.20, and adding ethanol is 80% to carry out precipitate with ethanol to containing the alcohol amount, and standing over night is filtered, filtering residue drying under reduced pressure (temperature is 60-80 ℃) is pulverized, and gets extract powder; Behind above two extract powder mixings, granulate with one-step-granulating method, be wetting agent with water, inlet temperature 60-80 ℃, leaving air temp 40-60 ℃, get granule, packing gets the granule product; Also granule can be incapsulated the capsule product.
Embodiment two
Take by weighing each materials of weight proportions: 2 parts of Semen Trigonellae, 3 parts on Folium Mori; After being processed into granule by the method for embodiment one, add proper amount of lubricating agent and disintegrating agent again, tabletting, every 0.45g-0.55g, the high-efficiency coating machine coating, packing gets the tablet product.
Embodiment three
Take by weighing each materials of weight proportions: 3 parts of Semen Trigonellae, 2.5 parts on Folium Mori; After being processed into extract powder by the method for embodiment one, behind two kinds of extract powder mixings, add vegetable oil or Polyethylene Glycol that 1-2 doubly measures, grind evenly with colloid mill after, with soft capsule mechanism soft capsule, packing gets the soft capsule product.
Embodiment four
Take by weighing each materials of weight proportions: 3 parts of Semen Trigonellae, 4 parts on Folium Mori; After being processed into extract powder by the method for embodiment one, behind two kinds of extract powder mixings, adding Mel and water and make soft material, use the pellet processing machine pill, cold drying, packing get the pill product.
Embodiment five
Take by weighing each materials of weight proportions: 4 parts of Semen Trigonellae, 3 parts on Folium Mori; After being processed into granule by the method for embodiment one, add proper amount of lubricating agent and disintegrating agent again, tabletting, every 0.48g-0.56g, the high-efficiency coating machine coating, packing gets the tablet product.
Embodiment six
Take by weighing each materials of weight proportions: 3 parts of Semen Trigonellae, 2.5 parts on Folium Mori, be processed into extract powder by the method for embodiment one after, behind lotus flavone powder mixing, add vegetable oil or Polyethylene Glycol that 1-2 doubly measures, after grinding evenly with colloid mill, with soft capsule mechanism soft capsule, packing gets the soft capsule product.
Embodiment seven
Take by weighing each materials of weight proportions: 4 parts of Semen Trigonellae, 3 parts on Folium Mori; By the method for embodiment one be processed into behind the extract powder and mountain Semen phaseoli radiati powder, astragaloside powder mixes evenly after, granulate with one-step-granulating method, be wetting agent with water, inlet temperature 60-80 ℃, leaving air temp 40-60 ℃, granule, packing gets the granule product; Also granule can be incapsulated the capsule product.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
By drug effect contrast screening experiment, estimate the pharmacodynamics of Semen Trigonellae extract, Folium Mori extract and prescription.Animal model is the diabetes model rat due to the alloxan.
Test material
Medicine
Raw material prescription: Semen Trigonellae 5000g, Folium Mori 5500g
Method for making: get Semen Trigonellae and add 70% alcohol reflux 3 times, each 1 hour, filter, concentrating under reduced pressure reclaims ethanol, and cationic resin on the extractum liquid is used the ammonia eluting, and concentrating under reduced pressure final vacuum drying or spray drying get extract powder, and the order number is that 60 ~ 100 orders are standby; Go dried leaves to decoct with water 2 times, each 1 hour, merging filtrate, be concentrated into 1:1 (the 1g crude drug is equivalent to 1ml) and add 95% ethanol and make and contain alcohol amount and reach 80%, low temperature was placed 24 hours, leached precipitation, drying under reduced pressure gets the polysaccharides of Folium Mori extract powder, and the order number is that 60 ~ 100 orders are standby.Will more than each get fine powder and mix, granulate, cross 40 mesh sieves, 1000 of No. 0 capsules are loaded in dry back, every is equivalent to crude drug 10.4g.
Table 1: single-dose is to the influence of the blood glucose of the hyperglycemic rat due to the alloxan:
Annotate: each administration group and model group compare, * P＜0.05
Table 2: successive administration is to the influence of diabetes model rat blood sugar due to the alloxan:
Annotate: each administration group and model group compare, * P＜0.05
Wherein, the Folium Mori extract hypoglycemic activity is in bibliographical information, 300mg/kg, Semen Trigonellae extract 30mg/kg all are the effective doses on the bibliographical information, pharmaceutical formulation group 60mg/kg of the present invention is tested in contrast, and as can be seen from the test results: Folium Mori and Semen Trigonellae extract all have hypoglycemic activity.With model group relatively, Folium Mori have hypoglycemic activity, but DeGrain.Semen Trigonellae has hypoglycemic activity, but the blood glucose downward trend is bad, and when single-dose, between 3 hours and 5 hours, during successive administration, between the 3rd week and the 4th week, blood glucose falls afterwards earlier and rises.And the prescription group, not only hypoglycemic activity is obvious, and the blood glucose downward trend is fine.Two assembly are described than using, hypoglycemic activity obviously is better than using separately each material medicine, has brought into play the effect of Synergistic.
Claims (7)
1, a kind ofly be used for hypoglycemic pharmaceutical composition, it is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
1～2 part of Semen Trigonellae, 1～3 part on Folium Mori;
Wherein
A, get Semen Trigonellae, add the alcohol reflux of 50%-95%, reclaim ethanol, extractum liquid; Immersion by cation exchange resin, use the ammonia eluting, and eluent is concentrated, drying under reduced pressure, pulverize extract powder;
B, get Folium Mori, decoct with water extraction, filter, concentrate, it is refining to add ethanol, filter, the filtering residue drying under reduced pressure, pulverize extract powder;
C, a step extract powder with the b step is mixed, the adjuvant that adding is pharmaceutically used always is prepared into described medicament.
2, pharmaceutical composition according to claim 1 is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
1 part of Semen Trigonellae, 1～3 part on Folium Mori.
3, pharmaceutical composition according to claim 2 is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
1 part of Semen Trigonellae, 1.1 parts on Folium Mori.
4, pharmaceutical composition according to claim 1 is characterized in that: the per unit preparation contains the 4-hydroxyisoleucine and is no less than 5mg in the described medicament.
5, pharmaceutical composition according to claim 1 is characterized in that: described medicament is capsule, tablet, granule, pill or soft capsule.
6, a kind of method for preparing the described pharmaceutical composition of claim 1, it is made up of following steps:
A, get Semen Trigonellae, add the alcohol reflux of 50%-95%, reclaim ethanol, extractum liquid; Immersion by cation exchange resin, use the ammonia eluting, and eluent is concentrated, drying under reduced pressure, pulverize extract powder;
B, get Folium Mori, decoct with water extraction, filter, concentrate, it is refining to add ethanol, filter, the filtering residue drying under reduced pressure, pulverize extract powder;
C, a step extract powder with the b step is mixed, the adjuvant that adding is pharmaceutically used always is prepared into described medicament.
7, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment diabetes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100206912A CN100500174C (en) | 2005-04-11 | 2005-04-11 | Medicine composition used for lowering blood-sugar, preparation method and use thereof |
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| CNB2005100206912A CN100500174C (en) | 2005-04-11 | 2005-04-11 | Medicine composition used for lowering blood-sugar, preparation method and use thereof |
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| CN100500174C true CN100500174C (en) | 2009-06-17 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101336974B (en) * | 2008-08-07 | 2012-05-23 | 华中科技大学同济医学院附属同济医院 | Blood sugar and fat reducing traditional Chinese medicine with function of comprehensively adjusting body metabolism and preparation method thereof |
| CN102885897A (en) * | 2012-10-10 | 2013-01-23 | 湖北省宏源药业有限公司 | Composition having auxiliary blood sugar level reducing function and method for preparing same |
| CN109156733A (en) * | 2018-09-05 | 2019-01-08 | 江苏道诚生物科技有限公司 | A kind of fenugreek compound metformin and its preparation process |
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