CN101366731A - Propolis flavone, preparation method and uses in treating diabetes - Google Patents
Propolis flavone, preparation method and uses in treating diabetes Download PDFInfo
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- CN101366731A CN101366731A CNA2008100512517A CN200810051251A CN101366731A CN 101366731 A CN101366731 A CN 101366731A CN A2008100512517 A CNA2008100512517 A CN A2008100512517A CN 200810051251 A CN200810051251 A CN 200810051251A CN 101366731 A CN101366731 A CN 101366731A
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Abstract
The invention provides propolis flavone, which is extracted through a novel method, has a propolis flavone component differing from the prior art, and is used for treating diabetes. A novel process for preparing the propolis flavone is characterized in that the total flavone content of obtained propolis which is calculated on the basis of chrysin is not less than 50 percent; the chrysin content can not be lower than 6.0 percent; the propolis is low in heavy metal content (lower than 5 ppm) and low in the amount of pesticide residue (lower than 10 ppb); and pharmaceutical preparation of the propolis is used for treating diabetes.
Description
Technical field
The invention provides a kind of propolis flavone, extract, have propolis flavone component different and in the past, be used for treatment of diabetes, belong to traditional Chinese medical science pharmaceutical technology field by new method.
Background technology
Propolis is that Apis gives birth to resinae material and the endocrine complex compound of Apis that the branch axillalry bud is gathered from the collagen plant.The chemical constituent of propolis is very complicated, and by chromatograph and mass spectral analysis, the flavone that has separated affirmation at present just has kind more than 20.At present, both at home and abroad the bibliographical information for the propolis pharmacological action mainly is its blood fat reducing, blood sugar lowering, antiinflammatory, antibiotic, antiviral, antioxidation, antitumor, enhance immunity, the research of vessel softening and aspect such as purify the blood.And show that for the blood sugar lowering Mechanism Study of propolis its balance blood sugar function derives from its energy activating cell, promote tissue regeneration.Diabetes are mainly because the islet cells pathological changes causes hypoinsulinism to cause.Take propolis and help repairing islet cells, recover the normal secretory function of insulin.
About propolis flavone be used for the treatment of aspect such as diabetes be reported in the present invention finish before report not; Propolis flavone is a kind of mixture of total flavones, having the total flavones of treatment diabetes, also is to separate first to obtain, and process is simple, suitable, active strong, the purity high (more than 50%) of the total flavones part of extracting is a kind of new method that industrialization is produced that is suitable for.
Summary of the invention
The invention provides a kind of propolis flavone, extract, have propolis flavone component different and in the past by new method.
The present invention also provides the preparation technology of propolis flavone, is suitable for industrialization production.
The present invention further discloses the purposes of propolis pyrite in preparation treatment diabetes medicament, be used for the treatment of diseases such as diabetes.
Propolis flavone of the present invention, available following method obtains:
Get propolis medicinal material ,-4～4 ℃ freezing 4～6 hours, be ground into coarse powder, mix with the ethanol of propolis weight sixth, put in the extractor, extracting pressure 20～30MPa, extraction temperature is 40～60 ℃, extracts 3 ~ 5 hours; It is 6.0～7.0MPa that separating still is pressed; Decompression and solvent recovery gets extract; 70～90 ℃, drying under reduced pressure is ground into fine powder, promptly.
Propolis flavone of the present invention is that yellowish-brown is to brown ceramic powder; Special fragrance is arranged, puckery.Foundation is the thin layer chromatography discrimination method of reference substance with propolis control medicinal material and chrysin.This product loss on drying, residue on ignition, microbial limit are checked.Adopt spectrophotography to measure total flavone content in propolis, chrysin content adopts high effective liquid chromatography for measuring.Regulation this product loss on drying must not be higher than 9.0%, and residue on ignition must not be higher than 1.0%, and general flavone content is no less than 50.0% in chrysin, and chrysin content must not be lower than 6.0%.Microbial limit is up to specification.
Propolis flavone of the present invention has the component of blood sugar lowering isoreactivity, is applied in the preparation treatment diabetes medicament.
Press practice of pharmacy, propolis flavone of the present invention can be prepared into the various clinical pharmaceutical dosage form as treatment of diseases medicines such as diabetes, oral formulations is selected from any in drop pill, tablet, capsule, pill, granule, suspensoid, the oral liquid.
Medicine of the present invention preferably contains 1%-99% propolis flavone and 99%-1% excipient (medicine that comprises other compatibility), preferably contain 30%-80% propolis flavone and 70%-20% pharmaceutical excipient (comprising the medicine that other compatibility is used), preferably contain 60%-70% propolis flavone and 40%-30% excipient (comprising the medicine that other compatibility is used).
Adjuvant in the medicine of the present invention is meant conventional excipient, as solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent etc.The medicine that other compatibility in the medicine of the present invention is used, the propolis flavone that refers to effective dose is certain medicine material, again compatibility other can allow the Chinese medicine or the chemical drugs that share.
Propolis flavone pharmaceutical preparation of the present invention has diseases such as treatment diabetes, is to be confirmed by following effect experiment.
Summary is under 80-320mg/kg dosage, and repeatedly gavaging the hyperglycemia that propolis flavone causes epinephrine, glucose, streptozotocin and alloxan all has tangible reduction effect, and tangible dose-effect relationship is arranged.But the animal euglycemia there is not obvious influence.
Purpose research propolis flavone hypoglycemic activity.
The medicine propolis flavone is provided by Jilin Academy of Chinese Medicine Sciences dosage form research chamber.TANGNIAOLE JIAONANG is produced by Dongfeng Pharmaceutical Industry Co., Ltd., Jilin, specification: 0.3g/ grain, lot number: 20070301.Be made into desired concn with distilled water during experiment.Streptozotocin and alloxan are Sigma company product.
The animal Kunming mouse, body weight 18-22g, the male and female dual-purpose, the animal quality quality certification is numbered: 10-5112 is provided by Univ. of Farming and Stockbreeding, PLA's Experimental Animal Center.
All through " t " check, the result represents with X ± SD in statistical result.
Result of the test
One, propolis flavone is to the influence of mice euglycemia
Get 50 of male and female half and half mices, be divided into 5 groups at random by body weight, be respectively blank group (10ml/kg), TANGNIAOLE JIAONANG group (2g/kg), three dosage groups of propolis flavone (320,160 and 80mg/kg), in 7 days every day gastric infusion once, irritate the long-pending 10ml/kg that is of body of stomach, after the last administration 1 hour, mice socket of the eye vein was got blood, surveys blood glucose with glucose oxidase method.The result shows that propolis flavone does not have obvious influence to the mice euglycemia.Above-mentioned each treated animal blood glucose meansigma methods is respectively 6.14 ± 1.295; 6.27 ± 1.495; 6.05 ± 1.623; 5.87 ± 2.101; 6.88 ± 1.450mmol/L.
Two, propolis flavone causes the influence of mice hyperglycemia to glucose
Get 180 of male and female half and half mices, be divided into 6 groups at random by body weight, be respectively blank group (10ml/kg water), model control group (10ml/kg water), TANGNIAOLE JIAONANG group (2g/kg), three dosage groups (320 of propolis flavone, 160 and 80mg/kg), in 7 days every day gastric infusion once, irritate the long-pending 10ml/kg that is of body of stomach, fasting is 5 hours before the last administration, after the last administration 1 hour, except that the blank group, all the other respectively organize equal lumbar injection glucose 2g/kg, respectively at behind the injectable dextrose monohydrate 0.5,1 and 2 hour, every treated animal is put to death 10 (male and female half and half), get blood, survey blood glucose with glucose oxidase method.The result shows: propolis flavone can obviously reduce the hyperglycemia that glucose causes in 0.5 and 1 hour behind injectable dextrose monohydrate.See Table 1.
Table 1 propolis flavone causes the influence of mice hyperglycemia to glucose
Annotate: compare * P＜0.05 with model control group
Three, propolis flavone causes the influence of mice hyperglycemia to epinephrine
Grouping and administration experiment two together.Difference is last administration (non-fasting) after 1 hour, and except that the blank group, all the other respectively organize equal lumbar injection epinephrine 250ug/kg, respectively at the injection epinephrine after 0.5,1 and 2 hour, every treated animal is put to death 10 (male and female half and half), get blood, survey blood glucose with glucose oxidase method.The result shows: propolis flavone all can obviously reduce the hyperglycemia that epinephrine causes in observed time range, and is the most remarkable with effect in 0.5 hour especially.See Table 2.
Table 2 propolis flavone causes the influence of mice hyperglycemia to adrenal gland's disposition
Annotate: compare * P＜0.05 with model control group; * P＜0.01; * * P＜0.001
Four, propolis flavone causes the influence of mice hyperglycemia to streptozotocin
90 of male mices are got 10 at random as the blank group, and all the other mouse tail vein injection streptozotocin (with the preparation of 0.05M citric acid pH4.5 solution, using immediately in the 4C ice bath) 200mg/kg causes diabetes model.Inject back 72 hours mice socket of the eye veins and get blood survey blood glucose, deletion does not cause the diabetes model, and the person (surveys preceding fasting 12 hours, blood glucose value is lower than 11.11mmol/L), continue to employ mice and be divided into 5 groups at random, 10 every group, in 7 days, be administered once every day by dosage shown in the table 3, after the last administration 2 hours,, the socket of the eye vein is got blood, surveys blood glucose with ortho-aminotoluene method (ultramicro method).The result shows: dosage group and high dose group cause that to streptozotocin the mice hyperglycemia has tangible reduction effect in the propolis flavone.See Table 3.
Table 3 propolis flavone causes the influence of mice hyperglycemia to streptozotocin
Annotate: compare * P＜0.05 with model control group; * P＜0.01
Five, propolis flavone causes the influence of mice hyperglycemia to alloxan
120 of male mices are got 20 at random as the blank group, and all the other mouse tail vein injection alloxan 70mg/kg cause diabetes model, then, are divided into 6 groups at random, and 20 every group.Injected back second day, and began to be administered once every day by dosage shown in the table 4, respectively at injection back 14 days and 21 days, after administration on the same day 2 hours, every group of mice put to death 10 respectively, gets blood, with glucose oxidase method survey blood glucose.The result shows: under used dosage, alloxan is caused that the mice hyperglycemia has tangible reduction effect, and obvious dose-effect relationship is arranged.See Table 4.
Table 4, propolis flavone cause the influence of mice hyperglycemia to alloxan
Annotate: compare * P＜0.05 with model control group; * P＜0.01; * * P＜0.001
3. conclusion
Above-mentioned experimental result shows: repeatedly irritate stomach and give the blood sugar content that propolis flavone can significantly reduce the hyperglycemia mice due to glucose and the epinephrine, the blood sugar content of normal mouse is not then had obvious influence.Streptozotocin and alloxan are the beta Cell of islet kill agent, optionally damage beta Cell of islet, cause artificial diabetes, gavaging the animal blood glucose that propolis flavone can significantly reduce due to streptozotocin and the alloxan raises, and action intensity is strengthened with the increase of dosage, existing tangible dose-effect relationship, the prompting propolis flavone may have the beta Cell of islet restitution that promotes animal injury.Above-mentioned pharmacodynamics test provides certain pharmacology's foundation for the clinical practice propolis flavone.
The specific embodiment
By following examples the present invention is described for example further, and do not limit the present invention in any way, under the prerequisite that does not deviate from technical solution of the present invention, any change or change that those of ordinary skills that the present invention did are realized easily all will fall within the claim scope of the present invention.
Embodiment 1
Get propolis medicinal material, 4 ℃ freezing 5 hours, be ground into coarse powder, mix with the ethanol of propolis sixth weight, put in the extractor, extracting pressure 25MPa, extraction temperature is 50 ℃, extracts 4 hours.Separating still is pressed and is 6.5MPa.Decompression and solvent recovery gets extract.Drying under reduced pressure (80 ℃ 0.05MPa), are ground into fine powder, promptly.
Embodiment 2
Get propolis ,-4 ℃ freezing 4 hours, be ground into coarse powder, mix with the ethanol of propolis weight sixth, put in the extractor, extracting pressure 30MPa, extraction temperature is 40 ℃, extracts 3 hours; Separating still is pressed and is 6.0MPa; Decompression and solvent recovery gets extract; 90 ℃, drying under reduced pressure is ground into fine powder, promptly.
Embodiment 3
Get propolis, 0 ℃ freezing 6 hours, be ground into coarse powder, mix with the ethanol of propolis weight sixth, put in the extractor, extracting pressure 25MPa, extraction temperature is 60 ℃, extracts 3 hours; Separating still is pressed and is 7.0MPa; Decompression and solvent recovery gets extract; 80 ℃, drying under reduced pressure is ground into fine powder, promptly.
Embodiment 4
The preparation of drop pill
Propolis total flavones 83g and 3 times amount polyethylene glycol 6000 through mixing, fusing, drip and make, cool off, blot and make drop pill.Other project should meet 2000 editions drop pill projects of Pharmacopoeia of People's Republic of China relevant requirements.
Embodiment 5
The preparation of tablet
Propolis flavone raw material 150g, medical starch 100g, mix homogeneously is used an amount of alcohol granulation, through the pelletizing machine granulate, tabletting, every 0.25g, oral, each 1-2, twice of every day.Other project should meet 2000 editions tablet projects of Pharmacopoeia of People's Republic of China relevant requirements.
Embodiment 6
The preparation of capsule
Propolis flavone raw material 150g, medical starch 150g, mix homogeneously, the capsule of packing into No. 1, every 0.30g, each oral 1-2, twice of every day.Other project should meet 2000 editions capsule projects of Pharmacopoeia of People's Republic of China relevant requirements.
Embodiment 7
The preparation of granule
Propolis flavone raw material 150g, starch 450g, mix homogeneously is used an amount of alcohol granulation, and drying, granulate, packing are promptly.Oral, a 6g, twice on the one.Other project should meet 2000 editions granule projects of Pharmacopoeia of People's Republic of China relevant requirements.
Claims (5)
1. propolis flavone, available following method obtains:
Get propolis medicinal material ,-4～4 ℃ freezing 4～6 hours, be ground into coarse powder, mix with the ethanol of propolis weight sixth, put in the extractor, extracting pressure 20～30MPa, extraction temperature is 40～60 ℃, extracts 3 ~ 5 hours; It is 6.0～7.0MPa that separating still is pressed; Decompression and solvent recovery gets extract; Drying under reduced pressure is ground into fine powder, promptly.
2. the preparation method of the described propolis flavone of claim 1, it is characterized in that: get propolis medicinal material ,-4～4 ℃ are freezing 4～6 hours, be ground into coarse powder, mix, put in the extractor with the ethanol of propolis weight sixth, extracting pressure 20～30MPa, extraction temperature is 40～60 ℃, extracts 3 ~ 5 hours; It is 6.0～7.0MPa that separating still is pressed; Decompression and solvent recovery gets extract; Drying under reduced pressure is ground into fine powder, promptly.
3. the described propolis flavone of claim 1 is preparing the purposes for the treatment of in the diabetes medicament.
4. the pharmaceutical preparation that utilizes the described propolis pyrite of claim 1 to be prepared into is characterized in that containing propolis total flavones and one or more pharmaceutically admissible excipient for the treatment of effective dose, or can with the other medicines of propolis flavone prescription.
5. pharmaceutical preparation according to claim 4 is characterized in that said medicine is the dosage form of oral formulations.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100512517A CN101366731B (en) | 2008-10-08 | 2008-10-08 | Propolis flavone, preparation method and uses in treating diabetes |
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| CN2008100512517A CN101366731B (en) | 2008-10-08 | 2008-10-08 | Propolis flavone, preparation method and uses in treating diabetes |
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| CN101366731A true CN101366731A (en) | 2009-02-18 |
| CN101366731B CN101366731B (en) | 2012-11-28 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103054907A (en) * | 2012-12-05 | 2013-04-24 | 天津隆顺榕发展制药有限公司 | Propolis flavonoid extractive and preparation method thereof |
| CN103845607A (en) * | 2013-11-27 | 2014-06-11 | 吉林省中医药科学院 | Compound traditional Chinese medicinal preparation for preventing and treating diabetes mellitus and preparation method thereof |
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2008
- 2008-10-08 CN CN2008100512517A patent/CN101366731B/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103054907A (en) * | 2012-12-05 | 2013-04-24 | 天津隆顺榕发展制药有限公司 | Propolis flavonoid extractive and preparation method thereof |
| CN103054907B (en) * | 2012-12-05 | 2014-10-15 | 天津隆顺榕发展制药有限公司 | Propolis flavonoid extractive and preparation method thereof |
| CN103845607A (en) * | 2013-11-27 | 2014-06-11 | 吉林省中医药科学院 | Compound traditional Chinese medicinal preparation for preventing and treating diabetes mellitus and preparation method thereof |
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| CN101366731B (en) | 2012-11-28 |
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Granted publication date: 20121128 Termination date: 20131008 |