CN101357174B - Medicinal composition for treating diabetes - Google Patents
Medicinal composition for treating diabetes Download PDFInfo
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- CN101357174B CN101357174B CN2007100585759A CN200710058575A CN101357174B CN 101357174 B CN101357174 B CN 101357174B CN 2007100585759 A CN2007100585759 A CN 2007100585759A CN 200710058575 A CN200710058575 A CN 200710058575A CN 101357174 B CN101357174 B CN 101357174B
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- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a pharmaceutical compound used for treating diabetes, which is made of the following bulk drugs by weight portions: 3-15 portions of bupleurum, 3-15portions of white peony root, 3-15 portions of fruit of immature citron, 1-6 portions of Chinese rhubarb, and 1-6 portions of baikal skullcap; 3-15 portions of Chinese goldthread can be added or pinellia tuber, dark plum, trichosanthes root and berberine can be added. The compound is made by the following method: the bulk drugs are added with water for refluxing extraction to obtain an extract, the obtained extract is condensed and added with ethanol until the ethanol content reaches 65-75%, thus a mixture is obtained, the obtained mixture is filtrated to obtain a filtrate, vacuum concentration is carried out on the filtrate to obtain a thick paste, the obtained thick paste is dried into dry paste powder, and the dry paste powder is added with an adjuvant to obtain a pharmaceutically acceptable dosage form or is added with berberine and the adjuvant to obtain the pharmaceutically acceptable dosage form.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, be specifically related to a kind of pharmaceutical composition of treating diabetes and preparation method thereof.
Background technology
Diabetes are worldwide diseases of present serious harm human health.Diabetes are the lifelong diseases of a kind of chronic progressive external that caused by sugar, protein and fat metabolic disturbance in the body, and its characteristic features is hyperglycemia and glycosuria.This disease will cause heart and renal complication, blind and amputation.From observing clinically, the sickness rate of diabetes is being ascendant trend year by year in recent years.At present, the whole world has 1.5 hundred million diabeticss approximately, and the present diabetes number of China surpasses 4,000 ten thousand.In diabetes cases, minority is insulin dependent diabetes mellitus (IDDM) (an I type), and great majority are non-insulin-dependent diabetes mellitus (II type).Most diabetics need be taken medicine all the life.Research shows that insulin resistant and defect of insulin secretion are the bases of type ii diabetes morbidity, and insulin resistant appears at before the defect of insulin secretion.Therefore, alleviating insulin resistant, blood sugar control in early days is prevention and the key that delays type ii diabetes and complication incidence and development thereof.
Treating diabetes is main with chemical synthetic drug still at present, like sulfonamides, biguanides, glucosidase inhibitor, Lie Nai and euglycemic agent etc.But it is all bigger that these medicines are taken side effect for a long time.
Chinese medicine has long history aspect the diabetes preventing and treating, and the practice through several thousand has accumulated a large amount of invaluable experiences, has formed the unique academic system.The Chinese medicine ancient books and records have been put down in writing the Chinese medicine that much has the blood sugar lowering curative effect, like Rhizoma Alismatis, the Rhizoma Anemarrhenae, Radix Panacis Quinquefolii, Radix Puerariae, Radix Rehmanniae, pollen etc.Traditional TCM treatment of diabetes is to carry out the three types of diabetes opinion according to clinical symptoms to control.But there is not good treatment way in early days at impaired glucose tolerance phase and onset diabetes.
The diabetes spp traditional Chinese medical science category of " quenching one's thirst ".Ancient Chinese medicine doctor is many sets forth one's views with " deficiency of YIN is scorching ", branch upper, middle and lower three types of diabetes and distinguish from lung, stomach, kidney and to control.Clinical observation discovery, present most diabeticss do not have obviously " quenching one's thirst " symptom when morbidity or in morbidity back a period of time, so how not know and delay treatment.The how plain preference for fat and sweet food of inquiry medical history, fat or irascible temperament or depression; And go to a doctor often with gastral cavilty distension, dry mouth with bitter taste, constipation, irritated irritability or depression not freely, symptoms such as endurance, red tongue with yellow fur, slippery and rapid pulse not, often curative effect is not obvious to take the Chinese patent medicine of supplementing QI and nourishing YIN.Tracing it to its cause is the surfeit delicious food, and stomach mansion stasis influences the catharsis of liver, irritability stasis; Strongly fragrant and the heat-transformation of liver stomach, heat impairing vital QI, hear rate is cloudy.This is to save as this in hot and suffocating, and gas drink two is hindered and is mark, and interior-heat does not go, and gas is cloudy difficult multiple.The position head of this disease blames in the liver stomach, and accumulateing in hot and suffocating is the pathologic basis of diabetes, " soothing the stagnant liver ", " dampness accumulated in the spleen should be removed ", so when being main to dredge, promptly " must lie prostrate its institute and lead, and first its because of ".The quick clever dissipating depression of QI clearing stomach of sugar, nourishing YIN to lower pathogenic fire, purging FU-organs rushes down turbid, and treating both the principal and secondary aspects of a disease is hot and suffocating both clear, then the cloudy runback of gas." Standards of Diagnosis and Treatment diseases due to endogenous heat of ZANG FU organs " cloud: " road is loose and do not tie, body fluid is given birth to and not withered, QI and blood with and not puckery, then disease is controlled oneself.”
The clearing stomach of Therapeutic Method dissipating depression of QI, nourishing YIN to lower pathogenic fire, purging FU-organs rushes down turbid.
The inventor is a theoretical foundation with the traditional Chinese medical science " hot and suffocating " theory, discovers that the compositions of being made up of medical materials such as Radix Bupleuri, the Radix Paeoniae Alba, Fructus Aurantii Immaturus, Radix Et Rhizoma Rhei, Radix Scutellariaes has therapeutical effect preferably to diabetes.A kind of treatment type ii diabetes effective method and preparation are provided, to improve insulin resistant, blood sugar lowering; Alleviate the symptom of diabetics; The mitigate the disease progress improves patient's quality of life, reduces family and burden on society; Be mankind's service, thereby produce corresponding social benefit and economic benefit.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition of treating diabetes, it contains the raw medicinal herbs of following weight portion: Radix Bupleuri 3-15 part, 315 parts of the Radix Paeoniae Albas, Fructus Aurantii Immaturus 3-15 part, Radix Et Rhizoma Rhei 1-6 part, Radix Scutellariae 3-15 part.
Better, can also also contain Rhizoma Coptidis in the described compositions.The Rhizoma Coptidis clearing away stomach-heat can better clear Yu Xiere.The weight portion consumption of each raw medicinal herbs is: Radix Bupleuri 3-15 part, Radix Paeoniae Alba 3-15 part, Fructus Aurantii Immaturus 3-15 part, Radix Et Rhizoma Rhei 1-6 part, Radix Scutellariae 3-15 part, Rhizoma Coptidis 1-12 part.
Be preferably 9 parts of Radix Bupleuri, 15 parts of the Radix Paeoniae Albas, 9 parts of Fructus Aurantii Immaturuss, 3 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Scutellariaes, 5 parts of Rhizoma Coptidis.
In order to obtain better therapeutic effect, can also add the Rhizoma Pinelliae, Fructus Mume, Radix Trichosanthis in the pharmaceutical composition provided by the present invention, and berberine.The Rhizoma Pinelliae is the acrid thing, can disperse circulation of qi promoting; The acid of Fructus Mume property, yin fluid astringing promotes the production of body fluid, and acid is sweet to make; In conjunction with Radix Trichosanthis, can clearing away stomach-heat.Berberine (being commonly called as berberine Berberine) is the main effective ingredient in the Rhizoma Coptidis, and the content in Rhizoma Coptidis is about 4%～10%, and it extracts purification all than being easier to, and convenient sources is so add berberine to replace Rhizoma Coptidis.
Each parts by weight of raw materials consumption is: Radix Bupleuri 3-15 part, Radix Paeoniae Alba 3-15 part, Fructus Aurantii Immaturus 3-15 part, Radix Et Rhizoma Rhei 1-6 part, Radix Scutellariae 3-15 part, Rhizoma Pinelliae 1-12 part, Fructus Mume 5-20 part, Radix Trichosanthis 3-15 part, berberine 0.1-0.6 part.
Be preferably 12 parts of Radix Bupleuri, 9 parts of the Radix Paeoniae Albas, 9 parts of Fructus Aurantii Immaturuss, 3 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Scutellariaes, 6 parts of the Rhizoma Pinelliaes, 9 parts of Fructus Mumes, 9 parts of Radix Trichosanthis, 0.3 part of berberine.
Described pharmaceutical composition makes through following steps:
(1) said medical material adds the water reflux, extract; Extracting liquid filtering, concentrating under reduced pressure;
(2) concentrated solution adding ethanol is 65-75% to containing the alcohol amount, filters;
(3) filtrate decompression is condensed into extractum, and vacuum drying is processed dried cream powder;
(4) add adjuvant in the dried cream powder and process acceptable forms on the medicament; Perhaps in dried cream powder, add berberine, add again
Go into adjuvant and process acceptable forms on the pharmaceutics.
In the said step (1), preferably add water reflux, extract, twice, the water of each 10 times of its weight, each 1.5 hours.
In the said step (1), preferred extracting solution is concentrated into 1:1 (ratio of the initial medical material weight and the volume of concentrated solution).
In the said step (2), the concentration of alcohol of adding is preferably 90-100%, further is preferably 95%.Contain the alcohol amount and be preferably 70%.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into the preparation of any routine.For example the above-mentioned raw materials medicine is ground into powder and takes after mixing it with water, or process tablet or capsule oral, perhaps process injection etc.But these can not be used to limit protection scope of the present invention.
The specific embodiment
Further specify pharmaceutical composition of the present invention and beneficial effect thereof through embodiment and Test Example below, but not as limitation of the present invention.
The preparation of embodiment 1 tablet of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 10g, Radix Scutellariae 30g
5 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 90% ethanol to containing alcohol amount 65%, filters, and concentrating under reduced pressure becomes thick paste.75 ℃ of vacuum dryings are processed dried cream powder.
Add starch and process tablet.
The preparation of embodiment 2 capsules of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 12g, Radix Scutellariae 30g
5 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds dehydrated alcohol to containing alcohol amount 75%, filters, and concentrating under reduced pressure becomes thick paste.85 ℃ of vacuum dryings are processed dried cream powder.
Add lactose and process capsule.
The preparation of embodiment 3 concentrated pills of the present invention
Radix Bupleuri 27g, Radix Paeoniae Alba 45g, Fructus Aurantii Immaturus 27g, Radix Et Rhizoma Rhei 9g, Radix Scutellariae 27g
5 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 95% ethanol to containing alcohol amount 70%, filters, and concentrating under reduced pressure becomes thick paste.80 ℃ of vacuum dryings are processed dried cream powder.
Add microcrystalline Cellulose and process concentrated pill.
The preparation of embodiment 4 capsules of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 10g, Radix Scutellariae 30g, Rhizoma Coptidis 10g
6 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 90% ethanol to containing alcohol amount 65%, filters, and concentrating under reduced pressure becomes thick paste.80 ℃ of vacuum dryings are processed dried cream powder.
Add lactose and process capsule.
The preparation of embodiment 5 tablets of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 12g, Radix Scutellariae 30g, Rhizoma Coptidis 24g
6 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds dehydrated alcohol to containing alcohol amount 75%, filters, and concentrating under reduced pressure becomes thick paste.85 ℃ of vacuum dryings are processed dried cream powder.
Add starch and process tablet.
The preparation of embodiment 6 concentrated pills of the present invention
Radix Bupleuri 27g, Radix Paeoniae Alba 45g, Fructus Aurantii Immaturus 27g, Radix Et Rhizoma Rhei 9g, Radix Scutellariae 27g, Rhizoma Coptidis 15g
6 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 95% ethanol to containing alcohol amount 70%, filters, and concentrating under reduced pressure becomes thick paste.75 ℃ of vacuum dryings are processed dried cream powder.
Add microcrystalline Cellulose and process concentrated pill.
The preparation of embodiment 7 tablets of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 10g, Radix Scutellariae 30g, Rhizoma Pinelliae 10g, Fructus Mume 50g, Radix Trichosanthis 30g, berberine 1g
8 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 95% ethanol to containing alcohol amount 70%, filters, and concentrating under reduced pressure becomes thick paste.85 ℃ of vacuum dryings are processed dried cream powder.With the berberine mix homogeneously.
Add starch and process tablet.
The preparation of embodiment 8 capsules of the present invention
Radix Bupleuri 30g, Radix Paeoniae Alba 30g, Fructus Aurantii Immaturus 30g, Radix Et Rhizoma Rhei 12g, Radix Scutellariae 30g, Rhizoma Pinelliae 24g, Fructus Mume 40g, Radix Trichosanthis 30g, berberine 1.2g
8 medical materials were with 10 times of its weight water, reflux, extract, 2 times, each 1.5 hours.Extracting solution filters, and is evaporated to 1:1, adds 90% ethanol to containing alcohol amount 68%, filters, and concentrating under reduced pressure becomes thick paste.80 ℃ of vacuum dryings are processed dried cream powder.With the berberine mix homogeneously.
Add lactose and process capsule.
The preparation of embodiment 9 concentrated pills of the present invention
Radix Bupleuri 36g, Radix Paeoniae Alba 27g, Fructus Aurantii Immaturus 27g, Radix Et Rhizoma Rhei 9g, Radix Scutellariae 27g, Rhizoma Pinelliae 18g, Fructus Mume 27g part, Radix Trichosanthis 27g, berberine 0.9g.
8 medical materials were with 10 times of its weight water reflux, extract, 2 times each 1.5 hours, and extracting solution filters, and is evaporated to 1:1, adds 99% ethanol to containing alcohol amount 70%, filters, and concentrating under reduced pressure becomes thick paste.75 ℃ of vacuum dryings are processed dried cream powder.With the berberine mix homogeneously.
Add microcrystalline Cellulose and process concentrated pill.
Test Example 1
1. laboratory animal:
II level male SD rat, body weight 210-230g.
2. main agents and medicine:
Streptozotocin (Streptozotocin, STZ): U.S. sigma company, lot number 024K1211;
Steady milli type blood glucose meter (One-Touch Ultra): U.S. Lifescan company, number of registration 20032400735;
Anhydrous citric acid (C
6H
8O
7.H
2O): Tianjin chemical reagent one factory, lot number 011121;
Sodium citrate (Na
3C
6H
5O
7.2H
2O): Tianjin chemical reagent one factory, lot number 011219;
Metformin: the 250mg/ sheet, Tianjin Pacific Pharmaceutical Co., Ltd. produces, lot number 040121;
No. 1 side of the drug prescription of Test Example, No. 2 sides, No. 3 sides are respectively according to embodiment 3, embodiment 6 and the extract powder of embodiment 9 preparations or the mixture of extract powder and berberine.
3. model preparation:
The SD rat is divided into normal control group and diabetes modeling group at random.The fasting overnight of diabetes modeling group; Through lumbar injection STZ65mg/Kg (0.1mmol/l, PH4.4 citrate buffer solution are processed the solution of 2% (W/V)); The tail vein is got blood to survey blood glucose >=16.7mmol/L is the modeling success after 3 days, and the normal control group is injected isopyknic normal saline as contrast.
4. divide into groups and medication:
The diabetes rat of Cheng Mo is divided into model group according to blood sugar level pairing, groups such as No. 1 side, No. 2 sides, No. 3 sides and metformin, and beginning administration: No. 1 side's every rat oral gavage of group 10 times of (18g/Kg) medicinal liquids of dosage that are equivalent to be grown up; Every rat oral gavages of No. 2 side groups 10 times of (15.5g/Kg) medicinal liquids of dosage that are equivalent to be grown up; Every rat oral gavages of No. 3 side groups 10 times of (12g/Kg) medicinal liquids of dosage that are equivalent to be grown up; Every rat oral gavage of metformin group be equivalent to be grown up suspension of routine dose 10 times (125mg/Kg); The isodose distilled water of every rat oral gavage of normal control group and diabetic model group, the experimental session drinking-water of all freely ingesting.15 days experimental periods.
5. observation index and detection method:
Become mould to divide into groups back one week of adaptation, gastric infusion behind the detection blood glucose, once a day, medicine all is mixed with the suspension administration with distilled water.Administration the 7th, 14 days, fasting was 2 hours after the administration, and the tail vein is got blood and surveyed non-fasting glucose respectively, and blood glucose is measured with the one-touchultra blood glucose meter; Administration was put to death animal after 15 days; Fasting overnight before the sacrifice of animal, 1% chloral hydrate (0.4ml/100g) anesthesia, carotid artery is got blood and is surveyed blood glucose, four of blood fat (TG, TC, HDI-C, LDL-C); Blood fat adopts enzyme process (HITACHI7150, Automatic Analyzer).
6. statistical procedures:
(X ± SD) expression, two group difference significances adopt the t check to experimental data with mean ± standard deviation.
7. result
1) to the influence of STZ hyperglycemic rat blood glucose
The result sees table 1, and different prescription groups after 7,14 days, obviously descend the blood glucose of STZ hyperglycemic rat in administration (P < 0.01 or 0.05).No difference of science of statistics between metformin, prescription 1,2,3 each group (P>0.05).
Table 1. is respectively organized changes of blood glucose and comparison (the mmol/L n=10 of unit)
Annotate: compare with the normal control group:
*P<0.01; Compare with model group:
▲P<0.05,
▲ ▲P<0.01
2) to the influence of STZ hyperglycemic rat body weight
The result sees table 2, with the normal control group significant difference (P < 0.01) is arranged more all before different prescription groups, the administration of metformin group rat body weight, after the administration, but no difference of science of statistics between the metformin, prescription 1,2,3 each group (P>0.05).
Table 2. is respectively organized the variation and the comparison (unit: g n=10) of body weight
Annotate: compare with the normal control group:
*P<0.01
3) to the lipometabolic influence of STZ hyperglycemic rat
The result sees table 3, and No. 3 side group after 14 days, obviously descends the triglyceride levels of STZ hyperglycemic rat in administration, and HDL-C level significantly raise (P < 0.05).
Table 3. is respectively organized the variation and the comparison (the mg/dl n=10 of unit) of blood fat
Annotate: compare with the normal control group:
*P<0.05,
*P<0.01; Compare with model group:
▲P<0.05
Claims (6)
1. a pharmaceutical composition that is used to treat diabetes is characterized in that, is prepared by following method
(1) get the raw medicinal herbs of following weight portion: Radix Bupleuri 3-15 part, Radix Paeoniae Alba 3-15 part, Fructus Aurantii Immaturus 3-15 part, Radix Et Rhizoma Rhei 1-6 part, Radix Scutellariae 3-15 part, said medical material adds the water reflux, extract,, extracting liquid filtering, concentrating under reduced pressure;
(2) concentrated solution adding ethanol is 65-75% to containing the alcohol amount, filters;
(3) filtrate decompression is condensed into extractum, and vacuum drying is processed dried cream powder;
(4) add adjuvant in the dried cream powder and process acceptable forms on the medicament.
2. the described pharmaceutical composition of claim 1 is characterized in that adding water reflux, extract, twice in the step (1) water of each 10 times of its weight, each 1.5 hours.
3. the described pharmaceutical composition of claim 1 is characterized in that in the step (1), and the ratio that extracting solution is concentrated into the volume of initial medical material weight and concentrated solution is 1: 1.
4. the described pharmaceutical composition of claim 1 is characterized in that in the step (2), the concentration of alcohol of adding is 90-100%.
5. the described pharmaceutical composition of claim 1 is characterized in that in the step (2), the concentration of alcohol of adding is 95%.
6. the described pharmaceutical composition of claim 1 is characterized in that in the step (2), contains the alcohol amount and is preferably 70%.
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