CN103721074B - Pharmaceutical composition and preparation method and application thereof - Google Patents
Pharmaceutical composition and preparation method and application thereof Download PDFInfo
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- CN103721074B CN103721074B CN201410019246.3A CN201410019246A CN103721074B CN 103721074 B CN103721074 B CN 103721074B CN 201410019246 A CN201410019246 A CN 201410019246A CN 103721074 B CN103721074 B CN 103721074B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8984—Dendrobium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
Abstract
The invention discloses a pharmaceutical composition. The pharmaceutical composition is a preparation prepared from the following raw materials in parts by weight: 7-13 parts of dendrobe and 2-4 parts of fenugreek. The invention also discloses a preparation method and application of the pharmaceutical composition. The pharmaceutical composition can obviously reduce the blood glucose level of the body, serum insulin content and serum C-peptide content, can effectively treat the diabetes and has high practical application value.
Description
Technical field
The present invention relates to drug world is and in particular to a kind of pharmaceutical composition treating diabetes.
Background technology
Diabetes (diabetes) are by inherent cause, immunologic function disorder, microorganism infection and its toxin, free radical poison
Element, the various virulence factors of mental element etc. act on the sugar that body leads to hypoinsulinism, insulin resistance etc. and cause,
A series of metabolic disorder syndrome such as protein, fat, water and electrolyte, clinically with hyperglycaemia as main feature, typical case's disease
Example may occur in which diuresis, many drinks, the performance such as eats more, becomes thin, i.e. " three-many-one-little " symptom, and diabetes (blood sugar) are once control bad meeting
Cause complication, lead to the exhaustion pathology at the positions such as kidney, eye, foot, and cannot cure.The traditional Chinese medical science thinks that diabetes are due to healthy tendency not
Foot, feelings will hindered, and poison is evil to cause a disease, and hemostasis is trouble, and phlegm is turbid to be pented up etc. and to cause.In terms of the treatment of diabetes, doctor trained in Western medicine is mainly adopted
With insulin injection or simple utilization hypoglycemic medicine, long term injections insulin islet function can be led to degenerate this is to drink poison to quench thirst
Method.Progress with medical science and people go deep into diabetes understanding, find diabetes, especially patients with type Ⅰ DM and its
The generation of chronic complicating diseases, development have number of mechanisms to participate in.Treatment by Chinese herbs disease is often that Chinese medicine compound prescription passes through too many levels, many ways
Footpath, Mutiple Targets, are acted on the multiple internal organs of whole body, system, are played a role by number of mechanisms, just with patients with type Ⅰ DM and glycosuria
The pathomechanism that many mechanism of sick chronic complicating diseases participate in morbidity coincide.Therefore, patients with type Ⅰ DM and chronic complicating diseases of diabetes
Preventing and treating should be Chinese medicine advantage be located.
Modern study shows, Herba Dendrobii extract have nourishing Yin and clearing heat, the beneficial stomach that promotes the production of body fluid, moisten the lung and relieve the cough, improving eyesight salubrity the effects such as,
Can by adjusting the hormonal readiness performance hypoglycemic activity of pancreatic islet alpha, the secretion of β cell, and have in pancreas and the outer hypoglycemic work of pancreas
Use mechanism.In faenum graecum, 4-hydroxyisoleucine, saponin(e also have preferable hypoglycemic activity.
Now have no and the stem of noble dendrobium, faenum graecum are coordinated the report being used for treating diabetes.
Content of the invention
The invention provides a kind of new hypoglycemic medicine composition and its production and use.
Pharmaceutical composition of the present invention, it is the preparation being prepared from by the raw material of following weight proportioning: 7～13 parts of the stem of noble dendrobium,
2～4 parts of faenum graecum.
Preferably, described composition is the preparation being prepared from by the raw material of following weight proportioning: 10 parts of the stem of noble dendrobium, faenum graecum
3 parts.
The described stem of noble dendrobium is orchid family Dendrobium Sw HERBA DENDROBII dendrobium nobile lindl., Herba Dendrobii
Dendrobium aurantiacum rchb.f.var.denneanum, drumstick dendrobium chrysotoxum lindl
Or the stem of tasselled dendrobium fimbriatum hook..
Described composition is with the stem of noble dendrobium, the crude drug of faenum graecum, water extract or extractive with organic solvent as active ingredient,
The preparation being prepared from plus pharmaceutically acceptable auxiliary material.
Described preparation is oral formulations.
Described preparation is powder, paste, granule, tablet, capsule, oral liquid or dripping pill.
The method that the present invention prepares foregoing pharmaceutical composition, it comprises the steps of:
(1) according to aforementioned proportioning, the bulk drug stem of noble dendrobium, faenum graecum are weighed；
(2) faenum graecum is pulverized as meal, plus the alcohol reflux of 30-95% extracts, and filters, filtrate concentrate drying obtains calabash
Reed bar alcohol extract；
(3) stem of noble dendrobium is pulverized as meal, add water refluxing extraction, filter, filtrate concentrate drying obtains stem of noble dendrobium water and extracts；
(4) the faenum graecum alcohol extract that step (2) obtains is mixed with the stem of noble dendrobium water extract of step (3), add and pharmaceutically may be used
The auxiliary material accepting or complementary composition are prepared into the preparation pharmaceutically commonly used.
In step (2), the concentration of ethanol is 75%, and the consumption of ethanol is 11 times of faenum graecum meal, and refluxing extraction number of times is
3 times, the time extracted every time is 120min.
In step (3), the consumption of water is 11 times of stem of noble dendrobium meal, and refluxing extraction number of times is 3 times, and the time extracted every time is
120min.
The present invention finally provides purposes in the medicine of preparation treatment diabetes for the foregoing pharmaceutical composition.Preferably,
Described diabetes are patients with type Ⅰ DM.
Pharmaceutical composition energy effectively treatment diabetes of the present invention, formula is precise and appropriate, and flavour of a drug are few, and toxic and side effect is little, preparation method
Simply, easy to use, it is that clinical treatment diabetes provide a kind of new selection, under same dose, the two is applied in combination
Effect is significant is used alone better than two kinds of medicines, illustrates that they have played the effect of Synergistic.
Obviously, the above according to the present invention, according to ordinary technical knowledge and the customary means of this area, without departing from
Under the premise of the present invention above-mentioned basic fundamental thought, modification, replacement or the change of other various ways can also be made.
The specific embodiment of form by the following examples, remakes further specifically to the above of the present invention
Bright.But this scope being interpreted as the above-mentioned theme of the present invention should not be only limitted to Examples below.All based on the above of the present invention
The technology realized belongs to the scope of the present invention.
Specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Weigh stem of noble dendrobium 10g, faenum graecum 3g.The stem of noble dendrobium is ground into meal, adds 11 times of water, refluxing extraction 3 times,
120min/ time, Filter paper filtering, merging filtrate, it is evaporated to every 100ml and be equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours,
Freeze-drying, obtains stem of noble dendrobium water extract.Faenum graecum is ground into meal, adds 11 times of 75% ethanol, refluxing extraction 3 times,
120min/ time, Filter paper filtering, merging filtrate, it is evaporated to every 100ml and be equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours,
Freeze-drying, obtains faenum graecum alcohol extract.
Stem of noble dendrobium water extract is mixed with faenum graecum alcohol extract, then makes the medicine of required formulation, such as: be granule, tablet, hard
Capsule, oral liquid, soft capsule, dripping pill or syrup.Wherein, the described stem of noble dendrobium is orchid family Dendrobium Sw HERBA DENDROBII
The stem of dendrobium nobile lindl..
The preparation of embodiment 2 pharmaceutical composition of the present invention
Take stem of noble dendrobium 7g, faenum graecum 2g.Method according to embodiment 1 prepares stem of noble dendrobium water extract and faenum graecum alcohol extract.
Stem of noble dendrobium water extract is mixed with faenum graecum alcohol extract, then makes the medicine of required formulation, such as: be granule, tablet, hard
Capsule, oral liquid, soft capsule, dripping pill or syrup.Wherein, the described stem of noble dendrobium is orchid family Dendrobium Herba Dendrobii dendrobium
The stem of aurantiacum rchb.f.var.denneanum.
The preparation of embodiment 3 pharmaceutical composition of the present invention
Take stem of noble dendrobium 13g, faenum graecum 4g.Method according to embodiment 1 prepares stem of noble dendrobium water extract and faenum graecum alcohol extract.
Stem of noble dendrobium water extract is mixed with faenum graecum alcohol extract, then makes the medicine of required formulation, such as: be granule, tablet, hard
Capsule, oral liquid, soft capsule, dripping pill or syrup.Wherein, the described stem of noble dendrobium is orchid family Dendrobium dendrobium candidum dendrobium
The stem of officinale kimura et migo.
The preparation of embodiment 4 pharmaceutical composition of the present invention
Take stem of noble dendrobium 10g, faenum graecum 3g.Method according to embodiment 1 prepares stem of noble dendrobium water extract and faenum graecum alcohol extract.
Stem of noble dendrobium water extract is mixed with faenum graecum alcohol extract, then makes the medicine of required formulation, such as: be granule, tablet, hard
Capsule, oral liquid, soft capsule, dripping pill or syrup.Wherein, the described stem of noble dendrobium is orchid family Dendrobium Sw drumstick dendrobium
The stem of chrysotoxum lindl.
The preparation of embodiment 5 pharmaceutical composition of the present invention
Take stem of noble dendrobium 8g, faenum graecum 2.5g.Method according to embodiment 1 prepares stem of noble dendrobium water extract and faenum graecum alcohol extract.
Stem of noble dendrobium water extract is mixed with faenum graecum alcohol extract, then makes the medicine of required formulation, such as: be granule, tablet, hard
Capsule, oral liquid, soft capsule, dripping pill or syrup.Wherein, the described stem of noble dendrobium is orchid family Dendrobium tasselled dendrobium
The stem of fimbriatum hook..
Below by way of concrete pharmacodynamic experiment proof beneficial effects of the present invention:
The checking of test example 1 pharmaceutical composition blood sugar reducing function of the present invention
1 experiment material
1.1 Experimental agents
Pharmaceutical composition of the present invention, by faenum graecum 3g, stem of noble dendrobium 10g is made up of primary raw material, and wherein, the described stem of noble dendrobium is orchid family
The stem of Dendrobium HERBA DENDROBII dendrobium nobile lindl., preparation method is as follows:
Faenum graecum: take the meal of frying fenugreek, add 11 times of 75% ethanol, refluxing extraction 3 times, 120min/ time, filter
Paper filters, and merging filtrate is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, freeze-drying, medicinal extract
Yield is 15%；
The stem of noble dendrobium: take the meal of the stem of noble dendrobium, add 11 times of water, refluxing extraction 3 times, 120min/ time, Filter paper filtering, merge and filter
Liquid, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, freeze-drying, yield of extract is 9%；
Above-mentioned faenum graecum alcohol extract and the mixing of stem of noble dendrobium water extract are obtained final product.
1.2 animal used as test
Sd rat (♂, 180～200g, cleaning grade reach large biology Co., Ltd purchased from Chengdu).
1.3 experiment reagent
Diamicron (gliclazide, gliclazid in tablets i), French Les Laboratoires servier, the co-production of Tianjin Hua Jin pharmaceutical factory.
Aloxan (alloxan), U.S.'s sig ma product, use physiological saline Fresh concentration to be 1.5% before experiment.
2 experimental techniques
This experimental animal feeding, in pharmacological evaluation animal observation ward of Chengdu University of Traditional Chinese Medicine, adapts to environment before experiment starts
3 days, normally give diet and water.Only take male (180～200g) sd rat 9o, lumbar injection alloxan (alloxan)
150mg/kg, injection 4d, fasting 8h, detection blood sugar (note, before measuring animal blood glucose in below testing, animal equal fasting 8h).
Choose the qualified rat model of hyperglycaemia (blood sugar is more than 10mmol/l) 50 to carry out being randomly divided into model group, the positive
Group, faenum graecum+stem of noble dendrobium high dose group, faenum graecum+stem of noble dendrobium middle dose group, faenum graecum+stem of noble dendrobium low dose group, single stem of noble dendrobium group, list
Taste faenum graecum group.10 healthy sd rats with the non-modeling of batch are separately taken to be blank group.Continuous gavage is administered 30d, normally right
Give isometric(al) 20ml/kg physiological saline according to group, model control group animal.It is as follows that remaining organizes daily dosage:
Table 1 animal packet and dosage
Observation index: in administration 10d, 20d, 30d tail vein measuring blood sugar of blood extracting respectively.Take respectively in administration 20d, 23d
Hematometry serum islet rope.Experimental data is represented with x ± s, data statistics spss13.0 software processing, is checked with t between group.
3 experimental results
After administration, each group blood sugar level and insulin content are respectively as shown in table 2 below, table 3.
Table 2 blood sugar level (mmol/l)
| Group | Before administration | It is administered latter 10 days | It is administered latter 20 days | It is administered latter 30 days |
| Blank group | 6.34±1.97** | 6.41±1.49** | 6.53±1.70** | 6.64±1.55** |
| Model group | 15.53±2.11 | 15.20±2.01 | 14.96±1.85 | 14.63±1.78 |
| Positive group | 15.15±2.17 | 12.37±1.49** | 10.79±1.90** | 9.79±1.69** |
| Composition is low | 15.24±1.08 | 14.73±1.42 | 12.14±2.02* | 11.35±2.04* |
| In composition | 16.01±1.73 | 12.55±1.19* | 9.78±1.95* | 8.25±1.29* |
| Composition is high | 15.72±2.01 | 12.63±1.56* | 11.47±1.38** | 9.74±1.71* |
| The stem of noble dendrobium | 15.36±1.09 | 14.02±1.53 | 12.18±1.55* | 11.99±2.02* |
| Faenum graecum | 15.41±1.45 | 14.38±1.94 | 12.22±1.72* | 12.01±1.09* |
Note: compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with stem of noble dendrobium group:?P ＜ 0.05,??P ＜ 0.01；With calabash
Reed bar group compares:▼P ＜ 0.05,▼▼P ＜ 0.01；
As shown in table 2, rat injection aloxan4d after, blood-sugar content raise, compare with blank group have significant difference (p <
0.01) illustrate that alloxan causes diabetes model success.
After administration, positive group rat blood sugar is decreased obviously, and after administration 10d, 20d, 30d, compares with model group and all has significantly
Sex differernce (p < 0.01 or p < 0.05), illustrates that it is feasible for causing diabetes model to evaluate medicine hypoglycemic activity using alloxan.
After administration, single stem of noble dendrobium group, single faenum graecum group rat blood sugar all decline, after administration 20d, 30d, with model group ratio
More all there is significant difference (p < 0.05).
After administration, the present composition basic, normal, high dosage group rat blood sugar all progressively declines, and wherein, low dose group is being given
Medicine 20 days, after 30 days, the p < 0.05 that compares with model group that there were significant differences), middle and high dosage group was in administration 10 days, 20 days, 30 days
Afterwards, compare with model group that there were significant differences (p < 0.01 or p < 0.05), illustrate that the present composition can effectively reduce blood sugar.
Compare with single stem of noble dendrobium group, single faenum graecum group, the middle and high dosage group of present composition blood sugar water upon administration
Flat lower, wherein, middle dose group compare that there were significant differences after administration 20d, 30d with single stem of noble dendrobium group, single faenum graecum group (p <
0.01 or p < 0.05), high dose group upon administration the blood sugar level of 30d compare with single stem of noble dendrobium group, single faenum graecum group have aobvious
Write difference (p < 0.05), illustrate that the stem of noble dendrobium is used in combination with faenum graecum by the present invention, the two has played the effect of Synergistic.
Table 3 serum insulin content (mu/l)
| Group | Before administration | It is administered latter 10 days | It is administered latter 20 days | It is administered latter 30 days |
| Blank group | 9.20±1.09** | 9.18±1.13** | 9.21±1.04** | 9.22±1.05** |
| Model group | 13.94±1.11 | 13.97±1.15 | 14.23±1.45 | 14.94±1.10 |
| Positive group | 14.01±1.05 | 11.56±1.52* | 10.25±1.71** | 9.56±1.71** |
| Composition is low | 13.84±1.09 | 11.03±1.68** | 10.73±1.28**▼ | 10.03±1.68**▼ |
| In composition | 13.93±1.20 | 11.56±2.09* | 10.56±1.07* | 9.75±2.09* |
| Composition is high | 13.97±1.15 | 10.71±1.08** | 10.27±1.21* | 9.81±1.08* |
| The stem of noble dendrobium | 14.03±1.14 | 13.11±1.06 | 12.17±1.38* | 11.85±1.12** |
| Faenum graecum | 13.88±1.12 | 13.02±1.19 | 12.67±1.14* | 12.01±1.33* |
Note: compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with stem of noble dendrobium group:?P ＜ 0.05,??P ＜ 0.01；With calabash
Reed bar group compares:▼P ＜ 0.05,▼▼P ＜ 0.01；
As shown in table 3, after rat injection aloxan (150mg/kg) 4d, serum insulin content persistently raises, with blank
Group compares significant difference (p < 0.01), illustrates that alloxan causes the success of patients with type Ⅰ DM model.
After administration, positive group rat blood serum insulin content is decreased obviously, after administration 10d, 20d, 30d, with model group ratio
More all there is significant difference (p < 0.01 or p < 0.05), illustrate to cause diabetes model to evaluate drug therapy glycosuria using alloxan
Disease effect is feasible.
After administration, single stem of noble dendrobium group, single faenum graecum group rat blood serum insulin level all decline, after administration 20d, 30d,
Compare with model group and all have significant difference (p < 0.01 or p < 0.05).
After administration, the present composition basic, normal, high dosage group rat blood serum insulin level is all decreased obviously, administration
After 10d, 20d, 30d, compare with model group and all have significant difference (p < 0.01 or p < 0.05).
Compare with single stem of noble dendrobium group, single faenum graecum group, the basic, normal, high dosage group of present composition blood upon administration
Clear insulin content is lower, wherein, serum insulin level after administration 20d, 30d, with single faenum graecum group for the low dose group
There were significant differences (p < 0.05), blood after administration 20d, 30d, with single stem of noble dendrobium group and single faenum graecum group for the middle and high dosage group
All there were significant differences (p < 0.05) for clear insulin level, illustrates that the stem of noble dendrobium is used in combination by the present invention with faenum graecum, the two performance
The effect of Synergistic.
Understand from the above, each dosage group of pharmaceutical composition of the present invention all can reduce blood sugar and serum insulin water
Flat, being capable of effectively treatment diabetes.Meanwhile, under same dose, the blood sugar reducing function of pharmaceutical composition of the present invention and reduce serum pancreas
The effect of island element, is all significantly better than the stem of noble dendrobium and faenum graecum is used alone (p < 0.01 or p < 0.05), illustrates each in medicine of the present invention
Component has played the effect of Synergistic.
The checking of test example 2 pharmaceutical composition blood sugar reducing function of the present invention
1st, experiment material
1.1 Experimental agents
Pharmaceutical composition of the present invention, by faenum graecum 3g, stem of noble dendrobium 10g is made up of primary raw material, and wherein, the described stem of noble dendrobium is orchid family
The stem of Dendrobium HERBA DENDROBII dendrobium nobile lindl., preparation method is as follows:
Faenum graecum: take the meal of frying fenugreek, add 11 times of 75% ethanol, refluxing extraction 3 times, 120min/ time, filter
Paper filters, and merging filtrate is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, freeze-drying, medicinal extract
Yield is 15%；
The stem of noble dendrobium: take the meal of the stem of noble dendrobium, add 11 times of water, refluxing extraction 3 times, 120min/ time, Filter paper filtering, merge and filter
Liquid, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, freeze-drying, yield of extract is 9%；
Above-mentioned faenum graecum alcohol extract and the mixing of stem of noble dendrobium water extract are obtained final product.
1.2 animal used as test
Spf level wistar rat male, body weight is (180-200) g.
1.3 experiment reagent
Streptozotocin (stz), high-calorie feed, melbine.
2nd, experimental technique
After basal feed adaptability is fed 1 week, in 100 rats, extract 10 as blank group with random digits table；
Remaining rat all feed with high-calorie feed (wherein contain 10.0% lard, 20.0% sucrose, 2.5% cholesterol, 1.0% cholate,
66.5% conventional feed).5th week with low dosage (25mg/kg) stz (being dissolved in 0.1mmol/l citrate buffer solution, ph4.4) once
Property on the left of lower abdomen injection, and continue high caloric diet feed, normal water.After 7th week Rat Fast 12h, by 2g/kg body weight
Feed 20%d- glucose solution, all 0,120min blood sugar respectively >=7.8 and (or) >=11.0mmol/l rat be modeling one-tenth
Work(.
The successful rat of modeling 50 is selected only to be randomly divided into model group, melbine group, the faenum graecum+stem of noble dendrobium by body weight numbering
Low dose group, faenum graecum+stem of noble dendrobium middle dose group, faenum graecum+stem of noble dendrobium high dose group, single stem of noble dendrobium group, single faenum graecum group rat,
Each 10；2nd day starts gavage, and blank group, model group give isopyknic physiological saline；Melbine group gives melbine
70mg/(kg·d)；The high, medium and low dosage group of faenum graecum+stem of noble dendrobium give faenum graecum+stem of noble dendrobium 1500,1000,500mg/ (kg d)；Single
Taste stem of noble dendrobium group, single faenum graecum group rat give the stem of noble dendrobium, faenum graecum 1500mg/ (kg d) respectively.Each group all continues to feed with high heat
Feed.
Table 4. animal packet and dosage
After 11st week each group Rat Fast 12h, lumbar injection 2% yellow Jackets normal saline solution 40mg/kg anaesthetizes,
Tail vein measuring blood sugar of blood extracting, serum insulin and c peptide content.
Data adopts spss13.0 statistical software to process.The all data of technical data are represented with x ± s；Between group, mean compares
Using one-way analysis of variance inspection, p < 0.05 or p < 0.01 is statistically significant.
3rd, experimental result
(1) blood glucose test results are as shown in table 5:
Impact (x ± s to blood sugar for table 5 composition.Mmol/l)
Note: compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with stem of noble dendrobium group:?P ＜ 0.05,??P ＜ 0.01；With calabash
Reed bar group compares:▼P ＜ 0.05,▼▼P ＜ 0.01.
After the inventive method modeling, animal blood glucose level raise, compare with blank group have significant difference (p <
0.01), illustrate that Streptozotocin causes diabetes model modeling success.
After administration, compared with model group, positive group rat blood sugar level is decreased obviously (p < 0.05), illustrates to help bacterium using urea
It is feasible that element causes diabetes model to evaluate medicine hypoglycemic activity.
After administration, single stem of noble dendrobium group, single faenum graecum group rat blood sugar level all decline, compare with model group all have aobvious
Write sex differernce (p < 0.05).
After administration, the present composition basic, normal, high dosage group rat blood sugar level is all decreased obviously, and compares with model group
All there is significant difference (p < 0.05), illustrate that pharmaceutical composition of the present invention can effectively reduce serum insulin level, Ke Yizhi
Treat diabetes.
Compare with single stem of noble dendrobium group, single faenum graecum group, the blood sugar after the administration of the present composition basic, normal, high dosage group
Level considerably lower (p < 0.05), illustrates that the stem of noble dendrobium is used in combination by the present invention with faenum graecum, the two has played the work of Synergistic
With.
(2) serum insulin content testing result is as shown in table 6:
Impact (x ± s to insulin for table 6 composition.mu/l))
| Group | Before administration | After administration |
| Blank group | 9.12±1.03** | 9.01±1.01** |
| Model group | 13.09±1.08 | 13.90±1.12 |
| Positive group | 14.21±1.14 | 9.75±1.23** |
| Composition is low | 13.79±1.17 | 10.13±1.12*▼ |
| In composition | 13.83±1.05 | 9.76±1.11* |
| Composition is high | 13.98±1.12 | 10.52±1.18*▼ |
| The stem of noble dendrobium | 13.87±1.16 | 11.74±1.06* |
| Faenum graecum | 14.04±1.21 | 12.86±1.13* |
Note: compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with stem of noble dendrobium group:?P ＜ 0.05,??P ＜ 0.01；With calabash
Reed bar group compares:▼P ＜ 0.05,▼▼P ＜ 0.01.
As shown in table 6, after using the inventive method modeling, serum insulin content raises, and compares with blank group and has significantly
Sex differernce (p < 0.01), illustrates that Streptozotocin causes patients with type Ⅰ DM model modeling success.
After administration, positive group rat blood serum insulin level is decreased obviously, compare with model group all have significant difference (p <
0.01), illustrate that it is feasible for causing diabetes model to evaluate drug treatment of diabetic effect using urea assistant rhzomorph.
After administration, single stem of noble dendrobium group, single faenum graecum group rat blood serum insulin level all decline, and compare equal with model group
There is significant difference (p < 0.05).
After administration, the present composition basic, normal, high dosage group rat blood serum insulin level is all decreased obviously, with model
Group more all has significant difference (p < 0.05), illustrates that pharmaceutical composition of the present invention effectively can reduce serum insulin level,
Diabetes can be treated.
Compare with single stem of noble dendrobium group, single faenum graecum group, the serum after the administration of the present composition basic, normal, high dosage group
Insulin content considerably lower (p < 0.05), illustrates that the stem of noble dendrobium is used in combination by the present invention with faenum graecum, the two has played collaborative increasing
The effect of effect.
(3) serum c peptide content testing result is as shown in table 7:
Table 7 composition is to cp(c peptide) impact (x ± s.Mg/l))
| Group | After administration |
| Blank group | 341.6±49.1** |
| Model group | 740.3±74.2 |
| Positive group | 628.4±86.8** |
| Composition is low | 583.3±69.2* |
| In composition | 513.6 ± 91.4* |
| Composition is high | 501.2 ± 78.4* |
| The stem of noble dendrobium | 631.6±68.9* |
| Faenum graecum | 657.7±58.3* |
Note: compare with model group, * p ＜ 0.05, * * p ＜ 0.01；Compare with stem of noble dendrobium group: p ＜ 0.05, p ＜ 0.01；With
Faenum graecum group compares: p ＜ 0.05, p ＜ 0.01；
As shown in table 7, after using the inventive method modeling, the content of rat blood serum c peptide raises, compare with blank group have aobvious
Write sex differernce (p < 0.01), illustrate that Streptozotocin causes patients with type Ⅰ DM model modeling success.
After administration, positive group rat blood serum c peptide level is decreased obviously, compare with model group all have significant difference (p <
0.01), illustrate that it is feasible for causing diabetes model to evaluate drug treatment of diabetic effect using urea assistant rhzomorph.
After administration, single stem of noble dendrobium group, single faenum graecum group rat blood serum c peptide level all decline, and being compared with model group is all had
Significant difference (p < 0.05).
After administration, the present composition basic, normal, high dosage group rat blood serum c peptide level is all decreased obviously, with model group ratio
More all there is significant difference (p < 0.05).
Compare with single stem of noble dendrobium group, single faenum graecum group, the serum c after the administration of the present composition basic, normal, high dosage group
Peptide content is lower, wherein, middle and high dosage group and single faenum graecum group, the serum c peptide level of single stem of noble dendrobium group there were significant differences (p
< 0.05), illustrate that the stem of noble dendrobium is used in combination by the present invention with faenum graecum, the two has played the effect of Synergistic.
Experimental result illustrates, each dosage group of pharmaceutical composition of the present invention all can effectively reduce blood sugar level, reduces serum
Insulin content and c peptide content, can treat diabetes.Meanwhile, under same dose, pharmaceutical composition hypoglycemic of the present invention, reduction
The effect of serum insulin content and reduction c peptide content is all significantly better than the stem of noble dendrobium and faenum graecum is used alone (p < 0.05), explanation
In medicine of the present invention, the effect of Synergistic has been waved in each group distribution.
To sum up, the present invention chooses faenum graecum and the stem of noble dendrobium is applied in combination, for treating the determined curative effect of diabetes, formula essence
When, flavour of a drug are few, and toxic and side effect is little, and preparation method is simple, easy to use, meanwhile, under same dose, the two effect being applied in combination
Fruit is significantly better than two kinds of medicines and is used alone, and illustrates that they have played the effect of Synergistic.
Claims (9)
1. a kind of pharmaceutical composition with function of reducing blood sugar it is characterised in that: it by following weight proportioning bulk drug prepare and
The preparation becoming: 10 parts of the stem of noble dendrobium, 3 parts of faenum graecum；
Described composition is with the alcohol extract of the water extract of the stem of noble dendrobium and faenum graecum as active ingredient, adds pharmaceutically acceptable auxiliary
Expect the preparation being prepared from.
2. pharmaceutical composition according to claim 1 it is characterised in that: the described stem of noble dendrobium be orchid family Dendrobium Sw Jin Chai
Stem of noble dendrobium dendrobium nobile lindl., Herba Dendrobii dendrobium aurantiacum
Rchb.f.var.denneanum, drumstick dendrobium chrysotoxum lindl or tasselled dendrobium
The stem of fimbriatum hook..
3. pharmaceutical composition according to claim 1 it is characterised in that: described preparation be oral formulations.
4. pharmaceutical composition according to claim 3 it is characterised in that: described preparation be powder, paste, granule, piece
Agent, capsule, oral liquid or dripping pill.
5. a kind of method preparing Claims 1 to 4 any one described pharmaceutical composition it is characterised in that: it comprises as follows
Step:
(1) according to proportioning described in Claims 1 to 4 any one, the bulk drug stem of noble dendrobium, faenum graecum are weighed；
(2) faenum graecum is pulverized as meal, plus the alcohol reflux of 30-95% extracts, and filters, filtrate concentrate drying obtains cucurbit
Bar alcohol extract；
(3) stem of noble dendrobium is pulverized as meal, add water refluxing extraction, filter, filtrate concentrate drying obtains stem of noble dendrobium water extract；
(4) step (2) gained faenum graecum alcohol extract is mixed with step (3) gained stem of noble dendrobium water extract, add pharmaceutically acceptable
Auxiliary material be prepared into pharmaceutically commonly use preparation.
6. method according to claim 5 it is characterised in that: in step (2), the concentration of ethanol is 75%, the use of ethanol
Measure 11 times (v/w) for faenum graecum meal, refluxing extraction number of times is 3 times, the time extracted every time is 120min.
7. method according to claim 6 it is characterised in that: in step (3), the consumption of water is 11 times of stem of noble dendrobium meal
(v/w), refluxing extraction number of times is 3 times, and the time extracted every time is 120min.
8. purposes in the medicine of preparation treatment diabetes for the Claims 1 to 4 any one pharmaceutical composition.
9. purposes according to claim 8 it is characterised in that: described diabetes are patients with type Ⅰ DM.
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| CN201410019246.3A CN103721074B (en) | 2014-01-15 | 2014-01-15 | Pharmaceutical composition and preparation method and application thereof |
| PCT/CN2014/071593 WO2015106467A1 (en) | 2014-01-15 | 2014-01-27 | Pharmaceutical composition and preparation method and use thereof |
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| CN201410019246.3A CN103721074B (en) | 2014-01-15 | 2014-01-15 | Pharmaceutical composition and preparation method and application thereof |
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