CN101474367B - Pharmaceutical composition for reducing blood sugar - Google Patents
Pharmaceutical composition for reducing blood sugar Download PDFInfo
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- CN101474367B CN101474367B CN200810000003XA CN200810000003A CN101474367B CN 101474367 B CN101474367 B CN 101474367B CN 200810000003X A CN200810000003X A CN 200810000003XA CN 200810000003 A CN200810000003 A CN 200810000003A CN 101474367 B CN101474367 B CN 101474367B
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Abstract
The invention relates to a new pharmaceutical composition, in particular to a pharmaceutical composition consisting of corn silk and silkworm cocoon. The invention further relates to a method for preparing the composition and use of the composition in producing the drug for the prevention and treatment of Type II diabetes and related diseases.
Description
Technical field
The present invention relates to new pharmaceutical composition, particularly relate to the pharmaceutical composition of forming by Stigma Maydis and Bombyx bombycis.The invention further relates to the method for preparing said composition, and said compositions is used for preventing and treat the application of the medicine of type ii diabetes and relevant disease in production.
Technical background
Along with the raising onset diabetes rate of living standards of the people also is ascendant trend year by year.The bad multiple complications that causes of diabetics glycemic control is like cardio cerebrovascular affection, renal failure, blind, amputation etc.These complication are that the patient is disabled, lethal main cause.The interrelated data of World Health Organization (WHO) shows that the prevalence of diabetes, disability rate and case fatality rate reach the extent of injury to general health, has occupied the 3rd of Chronic Non-Communicable Diseases; The death that diabetes cause also occupies the 5th of world today's cause of death.The cause of the death of diabetics mainly is various complication, and wherein cerebrovascular accounts for 10%.Therefore, the diabetic cerebrovascular receives the increasing concern of Chinese scholars.Existing the diabetes and the aspects such as epidemiology, pathogenesis of depositing cerebrovascular are summarized (Wang Mingwei, diabetes and cerebrovascular, Chinese geriatrics magazine, 2007; 28 (8): 567).Present global diabetics has reached 1,800,000,000 left and right sides China has 3,000 ten thousand 3 approximately, according to investigations, among the crowd of China more than 45 years old, has 7%～8% to suffer from diabetes.Expect 2010, whole world diabetics will reach 2.4 hundred million people.The onset diabetes rate also increases year by year, and among the metropolitan adult crowd such as in Beijing, Shanghai, port and fringe, its sickness rate has reached about 10%, and China has become the 2nd the diabetes big country that is only second to India.Diabetes are one of important risk of cerebrovascular, and the ratio of diabetes complicated cerebrovascular is 4-10 a times of ND, and the diabetics dead because of cerebrovascular accounts for 10% of the total cause of the death of diabetics.The prevalence of report diabetics cerebrovascular such as Zhang Bin is 17.3%; Yin Ling etc. carry out the investigation of apoplexy risk factor to 923 routine diabeticss and show that the danger of diabetes apoplexy increases by 3.6 times (p＜0.01) than matched group.On age of onset, the cerebrovascular age of onset is lighter due to the diabetes, compares with the non-diabetic afflicted, and its cerebrovascular age of onset can shift to an earlier date 10～20 years.Also have the scholar to think that not only the sickness rate of diabetics apoplexy increases, impaired glucose tolerance patient stroke onset rate is also high 2 times than healthy subjects.Tuomilehto etc. were report (Prospective study of the middle-aged finnishpopulation.Stroke, 1996 in 1996; 27 (2): 210), diabetes combined cerebral infraction cause of the death statistics shows, accounts for 16% among the male, that the women accounts for 33% the cause of death is directly relevant with diabetes.
In recent years, the research of Chinese medicine prevention diabetes has obtained bigger progress, and in the traditional prescription of checking, a collection of new blood sugar lowering Chinese Traditional Medicines compositions is also developed and developed to many researcheres.For example, Chinese patent 00131808.X number the pharmaceutical composition of being made up of the Rhizoma Anemarrhenae, Radix Trichosanthis, Rhizoma Alismatis, Rhizoma Polygonati Odorati, Sha Yuan, Rhizomadioscoreae, Cortex Lycii, Cortex Mori, Stigma Maydis, Fructus Lycii is disclosed.A kind of hypoglycemic medicine composition of being made up of Cortex Mori, Fructus Mori, Folium Mori, Ramulus Mori, Bombyxmori Linnaeus, Stigma Maydis 6 flavor Chinese medicines is disclosed for Chinese patent 02122952.X number.Chinese patent discloses the pharmaceutical composition that comprises Stigma Maydis, Ganoderma, Fructus Momordicae charantiae, Radix Glycyrrhizae No. 200510109039.8.It is the pharmaceutical composition that raw material is processed that Chinese patent discloses for No. 200610036515.2 with the Radix Astragali, Hirudo, Stigma Maydis, Semen Euryales, Fructus Rosae Laevigatae, Herba Leonuri, Periostracum Cicadae, Fructus Crataegi.Yet these compositionss are all processed with extracting through simple infusion by multiple natural Chinese medicinal herb basically.Therefore, not only the composition relative complex prepares inconvenience, and is difficult to carry out more deep structure/drug efficacy study, also is unfavorable for the drug quality control and the modernization of Chinese medicine.
Summary of the invention
An object of the present invention is to provide the pharmaceutical composition of forming by Stigma Maydis and Bombyx bombycis.
Pharmaceutical composition preferred embodiment according to the present invention, wherein Stigma Maydis accounts for 33 to 67% (W/W) of total amount, and Bombyx bombycis accounts for 67 to 33% (W/W).
Pharmaceutical composition preferred embodiment according to the present invention wherein also can contain one or more and have same or similar active other drug composition.
Pharmaceutical composition preferred embodiment according to the present invention, wherein said other drug composition is selected from natural drug and chemical synthetic drug.
Pharmaceutical composition preferred embodiment according to the present invention wherein also can contain one or more pharmaceutically acceptable carrier or excipient.
Another object of the present invention provides the method for producing the pharmaceutical composition that is defined as above; This method comprises the water extract of the mixture that preparation Stigma Maydis and Bombyx bombycis make up by a certain percentage, then they is pressed proper proportion and one or more pharmaceutically acceptable carrier or mixed with excipients.
According to a preferred embodiment of the inventive method, wherein Stigma Maydis and Bombyx bombycis extract are the Stigma Maydis of suitable part by weight and the water extract of Bombyx bombycis.
According to a preferred embodiment of the inventive method, wherein Stigma Maydis accounts for 33 to 67% (W/W) of total amount, and Bombyx bombycis accounts for 67 to 33% (W/W).
A further object of the present invention provides the pharmaceutical composition that is defined as above is used for preventing and treat the medicine of diabetes and relevant disease in production application.
The present invention relates to the new pharmaceutical composition formed by Stigma Maydis and Bombyx bombycis.The invention further relates to the method for the said pharmaceutical composition of preparation, and the application of said pharmaceutical composition in the medicine of producing prevention and treatment diabetes and relevant disease.
Stigma Maydis (Stigma maydis) is the dry style and the stigma of grass family Semen Maydis plant corn, and it contains the number of chemical composition, like volatile oil, saponin, alkaloid, flavonoid, polysaccharide, cupreol, stigmasterol, allantoin, organic acid etc.The property flat, sweet in the mouth, have diuresis, expel the heat-evil, the effect of suppressing the hyperactive liver, function of gallbladder promoting, can be used for treating diseases such as nephritis, cholelithiasis, diabetes, jaundice, measles, hemotochyluria, blood spring, its water decoction has certain blood sugar reducing function.Modern pharmacological research shows that Stigma Maydis has effects such as blood sugar lowering, diuresis, hemostasis, blood pressure lowering.It is clinical that to be used to treat disease curative effects such as diabetes, chronic nephritis, urinary system calculus, urinary system infection, hypertension, metrorrhagia better.Modern experimentation shows: the Stigma Maydis water decoction can obviously reduce the alloxan diabetes mouse blood sugar, and the blood sugar reducing function of its 30g is similar with the effect of 100mg insoral.The Stigma Maydis water decoction has adrenolytic blood glucose increasing effect, and the Stigma Maydis water decoction does not have obvious influence to normal animal blood glucose.Can infer that thus the Stigma Maydis water decoction has the effect of biguanide antidiabetic medicament.
Pupa bombycis (Silkworm pupa) is a medicated diet homology Chinese medicine material, has very high nutrition and medical value.The Pupa bombycis aboundresources of China, output accounts for 80% of whole world total output, produces bright pupa per year more than 300,000 tons.In the ancient medicine classical works such as Compendium of Material Medica, all put down in writing Pupa bombycis and have promoting the production of body fluid to quench thirst, help digestion regulate the flow of vital energy, effect such as tonifying YANG, strengthening by means of tonics.Modern age, pharmaceutical research showed, Pupa bombycis has effects such as promoting lipid metabolism, the liver protecting, anticancer, diuresis and increases multiple functions such as intelligence, vision protection, slow down aging.Pupa bombycis hydrolysis aminoacids complex has the immune function of raising, the liver protecting, the strong effect of nutritious tonifying, the effect of androgen appearance, antitumor action and blood pressure lowering, hypoglycemic activity; Pupa bombycis unsaturated fatty acid particularly alpha-linolenic acid content is to maintain the life core substance that human brain is evolved, and has multiple functions such as the intelligence of growth, vision protection, slow down aging.The highly basic hydrolysis deacetylation product of Pupa bombycis chitin is chitosan, and chitin and chitosan have cholesterol reducing, human body immunity improving power, and blood pressure lowering, blood sugar lowering is strengthened the liver function.
The inventor is on the basis of being engaged in modernization of cmm for a long time; Theoretical and modern biochemical extraction process and pharmaceutical research method in conjunction with traditional Chinese medicine and pharmacy; With Stigma Maydis and Bombyx bombycis is the main raw material that extracts, and has successfully prepared the medicine with hypoglycemic activity.Pharmaceutical research is the result show, pharmaceutical composition of the present invention is blood sugar lowering effectively not only, and normal animal blood glucose is not had influence (referring to embodiment).Therefore, pharmaceutical composition of the present invention can be used as a kind of new hypoglycemic drug, is widely used in clinical.
In order to make each pharmaceutical composition of the present invention, can be according to conventional Chinese medicinal preparation method, (for example 1: 2 to 2: 1, W/W) collocation Stigma Maydis and Pupa bombycis were through the decocting effective component extracting by a certain percentage.Briefly, use Stigma Maydis and Pupa bombycis, be soaked in water 2 hours, change little fire after big fire is boiled and keep boiling to make liquid volume be reduced to the only about half of of crude drug amount weight in 2 hours with both mixing and after cleaning as initiation material.Cooling, sucking filtration are also collected filtrating.95% ethanol that in filtrating, adds proper volume, make in the extracting solution alcohol concentration be about 75%, 4 ℃ static 24 hours.Use multilamellar filter paper sucking filtration 2 times then, fully remove precipitate.Concentrate recovery ethanol with Rotary Evaporators, concentrate places surface plate to heat, and further removes ethanol and moisture, until there not being the alcohol flavor.Used the freeze dryer lyophilizing then 24 hours, and, thereby obtained pharmaceutical composition of the present invention again with one or more pharmaceutical carriers or mixed with excipients.
Pharmaceutical composition of the present invention contains the active ingredient of Stigma Maydis and Pupa bombycis, and one or more pharmaceutically acceptable carrier and/or diluent, and wherein Stigma Maydis accounts for the 67-33% of pharmaceutical composition gross weight, and Bombyx bombycis accounts for 33-67%.In case of necessity, pharmaceutical composition of the present invention also can contain one or more other active component with natural or chemosynthesis of same or similar effect.
Pharmaceutical research is the result show, pharmaceutical composition of the present invention not only can suppress to be tried the blood sugar increasing of animal effectively, and normal animal blood glucose is not had influence.Particularly, our experimental studies results proves that two kinds of primary activity compositions of pharmaceutical composition of the present invention have collaborative significantly hypoglycemic activity.Therefore, the blood sugar reducing function of pharmaceutical composition of the present invention significantly be superior to independent Stigma Maydis with or the hypoglycemic activity of Pupa bombycis.Pharmaceutical composition of the present invention not only can be used for prevention and treats diabetes, but also can be used for preventing and treating some other diseases relevant with the pathoglycemia rising.These diseases include but are not limited to obesity, hypertension, coronary heart disease, fatty liver and hyperlipidemia.
Possibly pharmaceutical composition of the present invention processed tablet, capsule, pill, powder agent, suppository and solution and suspending agent according to known method in the pharmaceuticals industry.Wherein preferably be suitable for capsule and tablet through gastrointestinal administration.When preparation is suitable for capsule, tablet, pill and the powder agent of oral administration, can use sucrose, lactose, galactose, corn starch, gelatin, microcrystalline Cellulose, carboxymethyl cellulose etc. as carrier or excipient.
In addition, also can use in the pharmaceuticals industry known method and auxiliary element that pharmaceutical composition of the present invention is processed the sharp suspending agent of the solution that is suitable for oral administration.In order to prepare solution or the suspending agent that is suitable for the outer administration of gastrointestinal tract, can use distilled water, water for injection, isotonic sodium chlorrde solution or low concentration (for example 1-100mM) phosphate buffered saline (PBS) (PBS) as carrier or diluent.Can in the preparation of these gastrointestinal tract external administrations, add one or more other auxiliary elements or additives, for example can use ascorbic acid as antioxidant, use sodium benzoate etc. are as antiseptic.In the preparation of these dosage forms, can also contain other appropriate solubilizing agent, disintegrating agent, lubricant, coloring agent, dispersant or surfactant.
Generally speaking, the oral administration dosage of pharmaceutical composition of the present invention is 0.1 to 5g crude drug/kg body weight/day, is preferably 0.1 to 500mg crude drug/kg body weight/day, is preferably 1 to 2g crude drug/kg body weight/day.Yet more definite dosage should be according to the character of disease to be treated or pathological state, the order of severity, patient's age, body weight, wait to treat patient factors such as the sensitivity of institute's medicament and administering mode are confirmed by the clinician.
Following examples are intended to further illustrate, rather than restriction the present invention.Under the prerequisite of spirit of the present invention and principle, all will fall into the present invention and await the reply in the claim scope inventing any change that indivedual technical steps carry out and changing
The specific embodiment
Embodiment 1: the preparation of hypoglycemic medicine composition of the present invention
(1) take by weighing Stigma Maydis 200g, Pupa bombycis 200g is after cleaning; Adding distil water 400ml soaked after 2 hours respectively, and big fire is boiled, and changed little fire and kept boiling to make liquid volume be about half the (about 300ml) of crude drug amount weight in 2 hours; Cooling, sucking filtration is also collected filtrating, in filtrating, adds 95% ethanol of proper volume; Make in the extracting solution alcohol concentration be about 75%, 4 ℃ static 24 hours.Collect supernatant,, fully remove precipitate with multilamellar filter paper sucking filtration 2 times.Concentrate recovery ethanol with Rotary Evaporators, concentrate places surface plate to heat, and further removes ethanol and moisture, to tasteless, uses the freeze dryer lyophilizing then 24 hours, gets Stigma Maydis water extract and Bombyx bombycis water extract.
(2) take by weighing Stigma Maydis 200g, Pupa bombycis 400g cleans the back and mixes, and adding distil water 900ml soaked 2 hours, and big fire is boiled then, changes little fire after boiling and keeps boiling 2 hours, makes liquid volume be reduced to half the (about 300ml) of crude drug amount weight.Cooling, sucking filtration are also collected filtrating, in filtrating, add 95% ethanol of proper volume, make in the extracting solution alcohol concentration be about 75%, 4 ℃ static 24 hours.Collect supernatant, use multilamellar filter paper sucking filtration 2 times then, fully remove precipitate.Concentrate recovery ethanol with Rotary Evaporators, concentrate places surface plate to heat, and further removes ethanol and moisture, uses the freeze dryer lyophilizing then 24 hours, obtains the freeze-dried powder of pharmaceutical composition of the present invention.
Can the dry powder that as above makes be prepared into the various various regular dosage forms that are suitable for administration outside gastrointestinal tract approach and gastrointestinal tract approach according to conventional method.For example, by aseptic the incapsulating of dry powder that conventional method will as above make, promptly obtain the pharmaceutical composition of the present invention of capsule formulation.The water for injection of aseptic adding appropriate amount in above-mentioned dry powder promptly obtains the pharmaceutical composition of the present invention of injection dosage form.
Embodiment 2: pharmaceutical composition of the present invention is to the blood sugar reducing function of the hyperglycemia animal of model induced by alloxan
Get 120 of kunming mices, male and female half and half, fasting 5 hours is freely drunk water, tail vein injection alloxan 75mg/Kg (having pushed away in 30 seconds), behind the 72h, fasting 12 hours is freely drunk water.Supraorbital margin is got blood, the laboratory animal of screening blood glucose value >=180mg/dL.Each group mice average blood sugar value is more or less the same is divided into 6 groups at random in 20mg/dL, i.e. high dose group, middle dose groups, low dose group, model group, positive group.Other gets normal mouse 20 and is the blank group.Behind the successive administration 20 days, fasting 12h freely drinks water, and supraorbital margin is got blood, surveys blood glucose value at wavelength 490nm place with glucose oxidase method, and data are carried out the analysis of t-test statistical test.Shown in the following tabulation 2 of result.
Table 1 pharmaceutical composition of the present invention is to the blood sugar reducing function (mg/dL)
of the hyperglycemia animal of model induced by alloxan
| Group | Quantity (only) | Blood glucose value (mg/dL) |
| The positive group model group of dose groups high dose group in the blank group low dose group | 20 20 20 20 20 20 | 79.94±7.54 139.46±40.97* 142.00±46.65* 174.23±36.89 136.66±34.10* 185.44±35.97 |
*Compare with model group P＜0.05.
Can find out from the result shown in the table 1, administration after the normal modeling, low dose group, middle dose groups, positive group and model group comparison successive administration after 20 days blood sugar concentration obviously reduce (p≤0.05).It is thus clear that pharmaceutical composition of the present invention has tangible blood sugar lowering effect.
Embodiment 3: drug regimen of the present invention and folk prescription Stigma Maydis and Bombyx bombycis single component extract compare the blood sugar reducing function of the hyperglycemia mice of model induced by alloxan
Get 80 of kunming mices, male and female half and half, fasting 5 hours is freely drunk water; Tail vein injection alloxan 75mg/Kg (having pushed away in 30 seconds), behind the 72h, fasting 12 hours is freely drunk water; Supraorbital margin is got blood, and the screening mice makes blood glucose value >=180mg/dL; Each is organized mice average blood sugar value and is more or less the same and is divided into 4 groups at random in 20mg/dL, male and female half and half, i.e. Stigma Maydis water extract administration group, Bombyx bombycis water extract administration group, the sharp model group of Stigma Maydis Bombyx bombycis mixed extract administration group.Other gets 20 of normal mouses (male and female half and half) and is the normal control group.Behind the successive administration 25 days, fasting 12h freely drinks water, and supraorbital margin is got blood, surveys blood glucose value at wavelength 490nm place with glucose oxidase method, and data are carried out the analysis of t-test statistical test.Shown in the following tabulation 1 of result.
Table 2 drug group of the present invention and thing to the blood sugar reducing function of the hyperglycemia animal of model induced by alloxan and with the comparison (mg/dL)
of single component extract for treating effect
| Group | Quantity (only) | Blood glucose value (mg/dL) |
| Normal control group model group Stigma Maydis water extract administration group Bombyx bombycis water extract administration group Stigma Maydis Bombyx bombycis mixed extract administration group | 20 20 20 20 20 | 75.86±5.73 188.29+40.15 150.34+36.56 189.23±27.41 128.25±28.32 * |
*Compare with model group in P＜0.01.
Can find out that from the result shown in the table 2 pharmaceutical composition of the present invention that comes into operation continuously (Stigma Maydis Bombyx bombycis mixed extract) is after 25 days, blood sugar concentration is compared with model group, difference highly significant (P＜0.01).After the medication, the blood sugar level of laboratory animal is recovered normal value basically.Our experimental result shows that the hypoglycemic effect of the water extract of Stigma Maydis and Bombyx bombycis compositions obviously is better than Stigma Maydis water extract or the Bombyx bombycis water extract that uses individually.This result clearly points out, and Stigma Maydis and Bombyx bombycis have significant collaborative hypoglycemic activity.Thereby, our the further resolution of developing compositions of the present invention and pushing it against industrialization that this result of experiment is firm.
Embodiment 4: pharmaceutical composition prevention administration of the present invention is to the blood sugar reducing function of the hyperglycemia animal of model induced by alloxan
Get 120 of kunming mices, male and female half and half are divided into 6 groups at random, i.e. blank group, high dose group, middle dose groups, low dose group, model group, positive group.The normal raising, high dose group, middle dose groups, low dose group successive administration be after 15 days, fasting 5 hours; Freely drink water, tail vein injection alloxan 75mg/Kg (having pushed away in 30 seconds) is behind the 72h; Fasting 12 hours is freely drunk water, and supraorbital margin is got blood; Survey blood glucose value at wavelength 490nm place with glucose oxidase method, the screening mice makes blood glucose value >=180mg/dL.Positive group beginning administration, fasting 12h freely drinks water after 15 days, gets blood in supraorbital margin, surveys blood glucose value at wavelength 490nm place with glucose oxidase method, and data are carried out the analysis of t-test statistical test.Shown in the following tabulation 3 of the result of experimentation.
Table 3 pharmaceutical composition prevention of the present invention administration is to the blood sugar reducing function (mg/dL)
of the hyperglycemia animal of model induced by alloxan
| Group | Quantity (only) | Blood glucose value (mg/dL) |
| The positive group model group of dose groups high dose group in the blank group low dose group | 20 20 20 20 20 20 | 80.93±7.16 131.16±20.06* 143.55±24.64 147.47±26.68 147.96±34.43 174.33±78.71 |
*Compare with model group P＜0.05.
Can find out that from the result shown in the table 3 mice prevention administration is after 30 days, low dose group and model group comparison blood sugar concentration obviously reduce (p≤0.05).Other groups compare with model group, and blood sugar concentration also has certain reduction trend (p≤0.2).It is thus clear that the compositions that Stigma Maydis and full pupa extract constitute can effectively prevent the blood sugar increasing of model induced by alloxan.
Claims (2)
1. pharmaceutical composition, it is to be active component with Stigma Maydis and Bombyx bombycis water extract, and contains one or more pharmaceutically acceptable carrier or excipient; Wherein said pharmaceutical composition prepares according to following method: 1: 2 to 2: 1 Stigma Maydis of part by weight and Bombyx bombycis are mixed, after cleaning, be soaked in water 2 hours; Change little fire after big fire is boiled and keep boiling to make liquid volume be reduced to the half the of crude drug amount weight in 2 hours, cooling, sucking filtration are also collected filtrating, in filtrating, add 95% ethanol of proper volume; Make in the extracting solution alcohol concentration be 75%, 4 ℃ static 24 hours, use multilamellar filter paper sucking filtration 2 times then; Fully remove precipitate, concentrate with Rotary Evaporators and reclaim ethanol, concentrate places surface plate to heat; Further remove ethanol and moisture; Until there not being the alcohol flavor, used the freeze dryer lyophilizing then 24 hours, again with one or more pharmaceutical carriers or mixed with excipients.
2. the pharmaceutical composition of claim 1 qualification is used for preventing and treating the application of the medicine of diabetes in production.
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| CN103005446A (en) * | 2012-12-22 | 2013-04-03 | 北华大学 | Functional food capable of decreasing blood sugar |
| CN104784568A (en) * | 2015-05-19 | 2015-07-22 | 黄芳 | Traditional Chinese medicine composition and acupuncture point combined acupuncture and moxibustion application for treating diabetes |
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| CN1394947A (en) * | 2001-07-09 | 2003-02-05 | 曹光荣 | Health-care wine and its production process |
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| CN1394947A (en) * | 2001-07-09 | 2003-02-05 | 曹光荣 | Health-care wine and its production process |
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| Title |
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| 敏涛等.妙用中草药-桃竹山玉饮.《精选妙用中草药常见内科疾病》.2006,第302页. * |
| 李文海等.糖尿病的治疗.《中医临症绝招》.1955,第275页. * |
| 秦艳芬.糖尿病.《广东凉茶》.2002,第54页. * |
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