CN103721074A - Pharmaceutical composition and preparation method and application thereof - Google Patents
Pharmaceutical composition and preparation method and application thereof Download PDFInfo
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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, be specifically related to a kind of pharmaceutical composition for the treatment of diabetes.
Background technology
Diabetes (diabetes) are by inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, free radical toxin, the various virulence factors of Nervous and Mental Factors etc. act on body and cause hypoinsulinism, insulin resistant etc. and cause sugar, protein, fat, a series of metabolism disorder syndromes such as power and water Xie Zhi, clinically take hyperglycemia as main feature, can there is polyuria in model case, polydipsia, polyphagia, the performance such as become thin, i.e. " three-many-one-little " symptom, diabetes (blood glucose) cause complication once control bad meeting, cause kidney, eye, the exhaustion pathological changes at the positions such as foot, and cannot cure.The traditional Chinese medical science thinks that diabetes are due to positive QI-insufficiency, and feelings will is hindered, and poison is evil to cause a disease, and blood stasis is for suffering from, and expectorant is turbid to be pented up etc. and to cause.Aspect the treatment of diabetes, doctor trained in Western medicine mainly adopts insulin injection or simple utilization hypoglycemic medicine, long-term insulin injection can cause islet function to be degenerated this is the method for drinking poison to quench thirst.Along with the progress of medical science and people are to the going deep into of diabetes understanding, find that generation, the development of diabetes, especially type Ⅱdiabetes mellitus and chronic complicating diseases thereof has number of mechanisms to participate in.Treatment by Chinese herbs disease often Chinese medicine compound is passed through too many levels, multipath, many target spots, act on the multiple internal organs of whole body, system, by number of mechanisms, play a role, the pathomechanism that just in time participates in morbidity with the multimachine system of type Ⅱdiabetes mellitus and chronic complicating diseases of diabetes coincide.Therefore, the control of type Ⅱdiabetes mellitus and chronic complicating diseases of diabetes should be the advantage place of Chinese medicine.
The effects such as modern study shows, Herba Dendrobii extract has nourishing YIN and clearing away heat, the stomach reinforcing that promotes the production of body fluid, nourishing the lung to arrest cough, improving eyesight are kept fit, can be by regulating the hormonal readiness performance hypoglycemic activity of pancreatic islet alpha, β emiocytosis, and have in pancreas and the outer hypoglycemic mechanism of action of pancreas.In Semen Trigonellae, 4-hydroxyisoleucine, saponin also have good hypoglycemic activity.
Now have no Herba Dendrobii, Semen Trigonellae are coordinated to the report that is used for the treatment of diabetes.
Summary 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 Herba Dendrobiis, 2～4 parts of Semen Trigonellaes.
Preferably, described compositions is the preparation being prepared from by the raw material of following weight proportioning: 10 parts of Herba Dendrobiis, 3 parts of Semen Trigonellaes.
Described Herba Dendrobii is the stem of the orchid family Dendrobium Sw Dendrobium nobile Dendrobium nobile Lindl., Herba Dendrobii Dendrobium aurantiacum Rchb.f.var.denneanum, drumstick Dendrobium chrysotoxum Lindl or Diffuse Coptosapelta Dendrobium fimbriatum Hook..
Described compositions is take the crude drug of Herba Dendrobii, Semen Trigonellae, water extract or extractive with organic solvent as effective ingredient, adds the preparation that pharmaceutically acceptable adjuvant is prepared from.
Described preparation is oral formulations.
Described preparation is powder, unguentum, granule, tablet, capsule, oral liquid or drop pill.
The present invention prepares the method for aforementioned pharmaceutical composition, and it comprises following steps:
(1) according to aforementioned proportioning, weighting raw materials Herba Dendrobii, Semen Trigonellae;
(2) Semen Trigonellae is pulverized as coarse powder, added the alcohol reflux of 30-95%, filter, by filtrate concentrate drying, obtain Semen Trigonellae ethanol extract;
(3) Herba Dendrobii is pulverized as coarse powder, added water reflux, extract,, filter, by filtrate concentrate drying, obtain Herba Dendrobii water extraction;
(4) Semen Trigonellae ethanol extract step (2) being obtained mixes with the Herba Dendrobii water extract of step (3), adds that pharmaceutically acceptable adjuvant or complementary composition are prepared into pharmaceutically conventional preparation.
In step (2), the concentration of ethanol is 75%, and the consumption of ethanol is 11 times of Semen Trigonellae coarse powder, and reflux, extract, number of times is 3 times, and each time of extracting is 120min.
In step (3), the consumption of water is 11 times of Herba Dendrobii coarse powder, and reflux, extract, number of times is 3 times, and each time of extracting is 120min.
The present invention finally provides the purposes of aforementioned pharmaceutical composition in the medicine of preparation treatment diabetes.Preferably, described diabetes are type Ⅱdiabetes mellitus.
Pharmaceutical composition of the present invention can effectively be treated diabetes, fill a prescription precise and appropriate, flavour of a drug are few, toxic and side effects is little, and preparation method is simple, easy to use, for clinical treatment diabetes provide a kind of new selection, under same dose, the two effect being used in combination is significantly better than two kinds of medicines to be used separately, illustrates that they have brought into play the effect of Synergistic.
Obviously, according to foregoing of the present invention, according to ordinary skill knowledge and the customary means of this area, not departing under the above-mentioned basic fundamental thought of the present invention prerequisite, can also make modification, replacement or the change of other various ways.
The specific embodiment of form by the following examples, is described in further detail foregoing of the present invention again.But this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following example.All technology realizing based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Take Herba Dendrobii 10g, Semen Trigonellae 3g.Herba Dendrobii is ground into coarse powder, adds the water of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, obtains Herba Dendrobii water extract.Semen Trigonellae is ground into coarse powder, adds 75% ethanol of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, obtains Semen Trigonellae ethanol extract.
Herba Dendrobii water extract is mixed with Semen Trigonellae ethanol extract, then make the medicine of required dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill or syrup.Wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Sw Dendrobium nobile Dendrobium nobile Lindl..
The preparation of embodiment 2 pharmaceutical compositions of the present invention
Get Herba Dendrobii 7g, Semen Trigonellae 2g.According to the method for embodiment 1, prepare Herba Dendrobii water extract and Semen Trigonellae ethanol extract.
Herba Dendrobii water extract is mixed with Semen Trigonellae ethanol extract, then make the medicine of required dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill or syrup.Wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Herba Dendrobii Dendrobium aurantiacum Rchb.f.var.denneanum.
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Get Herba Dendrobii 13g, Semen Trigonellae 4g.According to the method for embodiment 1, prepare Herba Dendrobii water extract and Semen Trigonellae ethanol extract.
Herba Dendrobii water extract is mixed with Semen Trigonellae ethanol extract, then make the medicine of required dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill or syrup.Wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Herba Dendrobii Dendrobium officinale Kimura et Migo.
The preparation of embodiment 4 pharmaceutical compositions of the present invention
Get Herba Dendrobii 10g, Semen Trigonellae 3g.According to the method for embodiment 1, prepare Herba Dendrobii water extract and Semen Trigonellae ethanol extract.
Herba Dendrobii water extract is mixed with Semen Trigonellae ethanol extract, then make the medicine of required dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill or syrup.Wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Sw drumstick Dendrobium chrysotoxum Lindl.
The preparation of embodiment 5 pharmaceutical compositions of the present invention
Get Herba Dendrobii 8g, Semen Trigonellae 2.5g.According to the method for embodiment 1, prepare Herba Dendrobii water extract and Semen Trigonellae ethanol extract.
Herba Dendrobii water extract is mixed with Semen Trigonellae ethanol extract, then make the medicine of required dosage form, as: granule, tablet, hard capsule, oral liquid, soft capsule, drop pill or syrup.Wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Diffuse Coptosapelta Dendrobium fimbriatum Hook..
By concrete pharmacodynamic experiment, prove beneficial effect of the present invention below:
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 Semen Trigonellae 3g, Herba Dendrobii 10g is that primary raw material is made, and wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Dendrobium nobile Dendrobium nobile Lindl., and preparation method is as follows:
Semen Trigonellae: get the coarse powder of parch Semen Trigonellae, add 75% ethanol of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, yield of extract is 15%;
Herba Dendrobii: get the coarse powder of Herba Dendrobii, add the water of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, yield of extract is 9%;
Above-mentioned Semen Trigonellae ethanol extract and Herba Dendrobii water extract are mixed and be get final product.
1.2 laboratory animal
SD rat (clean level, purchased from reach large biological company limited in Chengdu for ♂, 180～200g).
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. Sig-ma product, is 1.5% with the fresh compound concentration of normal saline before experiment.
2 experimental techniques
This experimental animal feeding, in pharmacological evaluation animal observation ward of Chengdu University of Traditional Chinese Medicine, starts prospective adaptation environment 3 days in experiment, normally gives diet and water.Only get male (180～200g) SD rat 9O, lumbar injection Alloxan (alloxan) 150mg/kg, injection 4d, fasting 8h, detects blood glucose (note is below measured before animal blood glucose the equal fasting 8h of animal in experiment).
Choose 50 of the qualified rat models of hyperglycemia (blood glucose is greater than 10mmol/L) and be divided at random dosage group, Semen Trigonellae+Herba Dendrobii low dose group, single Herba Dendrobii group, single Semen Trigonellae group in model group, positive group, Semen Trigonellae+Herba Dendrobii high dose group, Semen Trigonellae+Herba Dendrobii.The healthy SD rat of separately getting the not modeling of 10 same batch is blank group.Gastric infusion 30d continuously, Normal group, model control group animal give isometric(al) 20ml/kg normal saline.All the other group dosages every day are as follows:
The grouping of table 1 animal and dosage
Observation index: in administration 10d, 20d, 30d tail venous blood sampling mensuration blood glucose respectively.In administration 20d, 23d, get respectively hematometry serum islet rope.Experimental data represents with x ± S, and statistics SPSS13.0 software processes for data, checks with t between group.
3 experimental results
After administration, respectively organize blood sugar level and insulin content respectively as shown in following table 2, table 3.
Table 2 blood sugar level (mmol/L)
| Group | Before administration | After administration 10 days | After administration 20 days | After administration 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 ** |
| Compositions is low | 15.24±1.08 | 14.73±1.42 | 12.14±2.02 * | 11.35±2.04 * |
| In compositions | 16.01±1.73 | 12.55±1.19 * | 9.78±1.95 **﹟▼ | 8.25±1.29 *﹟﹟▼▼ |
| Combination object height | 15.72±2.01 | 12.63±1.56 * | 11.47±1.38 ** | 9.74±1.71 *﹟▼ |
| Herba Dendrobii | 15.36±1.09 | 14.02±1.53 | 12.18±1.55 * | 11.99±2.02 * |
| Semen Trigonellae | 15.41±1.45 | 14.38±1.94 | 12.22±1.72 * | 12.01±1.09 * |
Note: with model group comparison,
*p < 0.05,
*p < 0.01; With the comparison of Herba Dendrobii group:
﹟p < 0.05,
﹟ ﹟p < 0.01; With the comparison of Semen Trigonellae group:
▼p < 0.05,
▼ ▼p < 0.01;
As shown in table 2, after rat injection Aloxan4d, blood sugar content raises, and relatively has significant difference (P<0.01) to illustrate that Alloxan causes diabetes model success with blank group.
After administration, positive group rat blood sugar obviously declines, after administration 10d, 20d, 30d, more all there is significant difference (p<0.01 or p<0.05) with model group, illustrate that it is feasible adopting Alloxan to cause diabetes model evaluation medicine hypoglycemic activity.
After administration, single Herba Dendrobii group, single Semen Trigonellae group rat blood sugar all decline, and after administration 20d, 30d, more all have significant difference (p<0.05) with model group.
After administration, the basic, normal, high dosage group of present composition rat blood sugar all progressively declines, wherein, low dose group is in administration after 20 days, 30 days, with model group relatively there were significant differences p<0.05), middle and high dosage group is in administration after 10 days, 20 days, 30 days, and relatively there were significant differences (p<0.01 or p<0.05) with model group, illustrates that the present composition can effectively reduce blood glucose.
With single Herba Dendrobii group, the comparison of single Semen Trigonellae group, in the present composition, the blood sugar level of high dose group after administration is lower, wherein, middle dosage group is at administration 20d, after 30d with single Herba Dendrobii group, relatively there were significant differences (p<0.01 or p<0.05) for single Semen Trigonellae group, the blood sugar level of high dose group 30d after administration and single Herba Dendrobii group, relatively there were significant differences (p<0.05) for single Semen Trigonellae group, illustrate that the present invention combines use by Herba Dendrobii with Semen Trigonellae, the two has brought into play the effect of Synergistic.
Table 3 serum insulin content (mU/L)
| Group | Before administration | After administration 10 days | After administration 20 days | After administration 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 ** |
| Compositions is low | 13.84±1.09 | 11.03±1.68 ** | 10.73±1.28 **▼ | 10.03±1.68 **▼ |
| In compositions | 13.93±1.20 | 11.56±2.09 * | 10.56±1.07 **﹟▼ | 9.75±2.09 **﹟▼ |
| Combination object height | 13.97±1.15 | 10.71±1.08 ** | 10.27±1.21 **﹟▼ | 9.81±1.08 **﹟▼ |
| Herba Dendrobii | 14.03±1.14 | 13.11±1.06 | 12.17±1.38 * | 11.85±1.12 ** |
| Semen Trigonellae | 13.88±1.12 | 13.02±1.19 | 12.67±1.14 * | 12.01±1.33 * |
Note: with model group comparison,
*p < 0.05,
*p < 0.01; With the comparison of Herba Dendrobii group:
﹟p < 0.05,
﹟ ﹟p < 0.01; With the comparison of Semen Trigonellae group:
▼p < 0.05,
▼ ▼p < 0.01;
As shown in table 3, after rat injection Aloxan (150mg/kg) 4d, serum insulin content continues to raise, and relatively has significant difference (P<0.01) with blank group, illustrates that Alloxan causes the success of type Ⅱdiabetes mellitus model.
After administration, positive group rat blood serum insulin content obviously declines, after administration 10d, 20d, 30d, more all there is significant difference (p<0.01 or p<0.05) with model group, illustrate that it is feasible adopting Alloxan to cause the effect of diabetes model evaluation drug treatment of diabetic.
After administration, single Herba Dendrobii group, single Semen Trigonellae group rat blood serum insulin level all decline, and after administration 20d, 30d, more all have significant difference (p<0.01 or p<0.05) with model group.
After administration, the basic, normal, high dosage group of present composition rat blood serum insulin level all obviously declines, and after administration 10d, 20d, 30d, more all has significant difference (p<0.01 or p<0.05) with model group.
With single Herba Dendrobii group, the comparison of single Semen Trigonellae group, the present composition is low, in, the serum insulin content of high dose group after administration is lower, wherein, low dose group is at administration 20d, after 30d, there were significant differences (p<0.05) with the serum insulin levels of single Semen Trigonellae group, in, high dose group is at administration 20d, after 30d, all there were significant differences (p<0.05) with the serum insulin levels of single Herba Dendrobii group and single Semen Trigonellae group, illustrate that the present invention combines use by Herba Dendrobii with Semen Trigonellae, the two has brought into play the effect of Synergistic.
From the above results, the each dosage group of pharmaceutical composition of the present invention all can reduce blood glucose and serum insulin levels, can effectively treat diabetes.Simultaneously, under same dose, the effect of the blood sugar reducing function of pharmaceutical composition of the present invention and reduction serum insulin, all significantly be better than Herba Dendrobii and Semen Trigonellae and use separately (p<0.01 or p<0.05), illustrate that each component in medicine of the present invention brought into play the effect of Synergistic.
The checking of test example 2 pharmaceutical composition blood sugar reducing function of the present invention
1, experiment material
1.1 Experimental agents
Pharmaceutical composition of the present invention, by Semen Trigonellae 3g, Herba Dendrobii 10g is that primary raw material is made, and wherein, described Herba Dendrobii is the stem of the orchid family Dendrobium Dendrobium nobile Dendrobium nobile Lindl., and preparation method is as follows:
Semen Trigonellae: get the coarse powder of parch Semen Trigonellae, add 75% ethanol of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, yield of extract is 15%;
Herba Dendrobii: get the coarse powder of Herba Dendrobii, add the water of 11 times, reflux, extract, 3 times, 120min/ time, filter paper filtering, merging filtrate, is evaporated to every 100ml and is equivalent to crude drug in whole 50g, refrigerator cold-storage 12 hours, lyophilization, yield of extract is 9%;
Above-mentioned Semen Trigonellae ethanol extract and Herba Dendrobii water extract are mixed and be get final product.
1.2 laboratory animal
SPF level Wistar rat is male, and body weight is (180-200) g.
1.3 experiment reagent
Streptozotocin (STZ), high-calorie feed, metformin.
2, experimental technique
Normal feedstuff adaptability was fed after 1 week, in 100 rats, take table of random number method, extracted 10 as blank group; All the other rats all feed with high-calorie feed (wherein containing 10.0% Adeps Sus domestica, 20.0% sucrose, 2.5% cholesterol, 1.0% cholate, 66.5% conventional feed).Within the 5th week, with the disposable left side of low dosage (25mg/kg) STZ (being dissolved in 0.1mmol/L citrate buffer solution, pH4.4) hypogastric region, inject, and continue high caloric diet and feed, normally drinking-water.After the 7th week rat fasting 12h, by 2g/kg body weight, fill with and feed 20%D-glucose solution, all 0,120min blood glucose respectively >=7.8 and (or) >=rat of 11.0mmol/L is modeling success.
Select 50 of the successful rats of modeling to be divided at random dosage group in model group, metformin group, Semen Trigonellae+Herba Dendrobii low dose group, Semen Trigonellae+Herba Dendrobii, Semen Trigonellae+Herba Dendrobii high dose group, single Herba Dendrobii group, single Semen Trigonellae group rat, each 10 by body weight numbering; Within the 2nd day, start gavage, blank group, model group give isopyknic normal saline; Metformin group is given metformin 70mg/ (kgd); The high, medium and low dosage group of Semen Trigonellae+Herba Dendrobii is given Semen Trigonellae+Herba Dendrobii 1500,1000,500mg/ (kgd); Single Herba Dendrobii group, single Semen Trigonellae group rat give respectively Herba Dendrobii, Semen Trigonellae 1500mg/ (kgd).Each group all continues to feed with high-calorie feed.
The grouping of table 4. animal and dosage
After the 11st week each group rat fasting 12h, lumbar injection 2% pentobarbital sodium normal saline solution 40mg/kg anesthesia, tail venous blood sampling is measured blood glucose, serum insulin and C peptide content.
SPSS13.0 statistical software processing for data acquisition.The all data of technical data represent with x ± s; Between group, mean relatively adopts one factor analysis of variance check, and P<0.05 or P<0.01 are for there being statistical significance.
3, experimental result
(1) blood sugar test result is as shown in table 5:
Impact (X ± the s of table 5 compositions on blood glucose.mmol／L)
Note: with model group comparison,
*p < 0.05,
*p < 0.01; With the comparison of Herba Dendrobii group:
﹟p < 0.05,
﹟ ﹟p < 0.01; With the comparison of Semen Trigonellae group:
▼p < 0.05,
▼ ▼p < 0.01.
Adopt after the inventive method modeling, animal blood glucose level raises, and relatively has significant difference (P<0.01) with blank group, illustrates that streptozotocin causes diabetes model modeling success.
After administration, compared with model group, positive group rat blood sugar level obviously declines (p<0.05), illustrates that it is feasible adopting urea assistant rhzomorph to cause diabetes model evaluation medicine hypoglycemic activity.
After administration, single Herba Dendrobii group, single Semen Trigonellae group rat blood sugar level all decline, and more all have significant difference (p<0.05) with model group.
After administration, the basic, normal, high dosage group of present composition rat blood sugar level all obviously declines, more all there is significant difference (p<0.05) with model group, illustrate that pharmaceutical composition of the present invention can effectively reduce serum insulin levels, can treat diabetes.
With single Herba Dendrobii group, the comparison of single Semen Trigonellae group, obviously lower (p<0.05) of blood sugar level after the administration of the basic, normal, high dosage group of the present composition, illustrate that the present invention combines use by Herba Dendrobii with Semen Trigonellae, the two has brought into play the effect of Synergistic.
(2) serum insulin content testing result is as shown in table 6:
Impact (X ± the s of table 6 compositions on insulin.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 ** |
| Compositions is low | 13.79±1.17 | 10.13±1.12 *▼ |
| In compositions | 13.83±1.05 | 9.76±1.11 *﹟▼ |
| Combination object height | 13.98±1.12 | 10.52±1.18 *▼ |
| Herba Dendrobii | 13.87±1.16 | 11.74±1.06 * |
| Semen Trigonellae | 14.04±1.21 | 12.86±1.13 * |
Note: with model group comparison,
*p < 0.05,
*p < 0.01; With the comparison of Herba Dendrobii group:
﹟p < 0.05,
﹟ ﹟p < 0.01; With the comparison of Semen Trigonellae group:
▼p < 0.05,
▼ ▼p < 0.01.
As shown in table 6, adopt after the inventive method modeling, serum insulin content raises, and relatively has significant difference (P<0.01) with blank group, illustrates that streptozotocin causes type Ⅱdiabetes mellitus model modeling success.
After administration, positive group rat blood serum insulin level obviously declines, and more all has significant difference (p<0.01) with model group, illustrates that it is feasible adopting urea assistant rhzomorph to cause the effect of diabetes model evaluation drug treatment of diabetic.
After administration, single Herba Dendrobii group, single Semen Trigonellae group rat blood serum insulin level all decline, and more all have significant difference (p<0.05) with model group.
After administration, the basic, normal, high dosage group of present composition rat blood serum insulin level all obviously declines, more all there is significant difference (p<0.05) with model group, illustrate that pharmaceutical composition of the present invention can effectively reduce serum insulin levels, can treat diabetes.
With single Herba Dendrobii group, the comparison of single Semen Trigonellae group, obviously lower (p<0.05) of serum insulin content after the administration of the basic, normal, high dosage group of the present composition, illustrate that the present invention combines use by Herba Dendrobii with Semen Trigonellae, the two has brought into play the effect of Synergistic.
(3) serum C peptide content detection result is as shown in table 7:
Table 7 compositions is on 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 ** |
| Compositions is low | 583.3±69.2 * |
| In compositions | 513.6±91.4 *﹟▼ |
| Combination object height | 501.2±78.4 *﹟▼ |
| Herba Dendrobii | 631.6±68.9 * |
| Semen Trigonellae | 657.7±58.3 * |
Note: with model group comparison,
*p < 0.05,
*p < 0.01; With the comparison of Herba Dendrobii group:
﹟p < 0.05,
﹟ ﹟p < 0.01; With the comparison of Semen Trigonellae group:
▼p < 0.05,
▼ ▼p < 0.01;
As shown in table 7, adopt after the inventive method modeling, the content of rat blood serum C peptide raises, and relatively has significant difference (P<0.01) with blank group, illustrates that streptozotocin causes type Ⅱdiabetes mellitus model modeling success.
After administration, positive group rat blood serum C peptide level obviously declines, and more all has significant difference (p<0.01) with model group, illustrates that it is feasible adopting urea assistant rhzomorph to cause the effect of diabetes model evaluation drug treatment of diabetic.
After administration, single Herba Dendrobii group, single Semen Trigonellae group rat blood serum C peptide level all decline, and more all have significant difference (p<0.05) with model group.
After administration, the basic, normal, high dosage group of present composition rat blood serum C peptide level all obviously declines, and more all has significant difference (p<0.05) with model group.
With single Herba Dendrobii group, the comparison of single Semen Trigonellae group, serum C peptide content after the administration of the basic, normal, high dosage group of the present composition is lower, wherein, there were significant differences (p<0.05) for the Serum C-peptide of middle and high dosage group and single Semen Trigonellae group, single Herba Dendrobii group, illustrate that the present invention combines use by Herba Dendrobii with Semen Trigonellae, the two has brought into play the effect of Synergistic.
Experimental result explanation, the 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.Simultaneously, under same dose, pharmaceutical composition blood sugar lowering of the present invention, the effect that reduces serum insulin content and reduce C peptide content are all significantly better than Herba Dendrobii and Semen Trigonellae and use separately (p<0.05), illustrate that each component in medicine of the present invention brought into play the effect of Synergistic.
To sum up, the present invention chooses Semen Trigonellae and Herba Dendrobii is used in combination, and is used for the treatment of the determined curative effect of diabetes, fills a prescription precise and appropriate, flavour of a drug are few, toxic and side effects is little, and preparation method is simple, easy to use, simultaneously, under same dose, the two effect being used in combination is significantly better than two kinds of medicines to be used separately, illustrates that they have brought into play the effect of Synergistic.
Claims (10)
1. a pharmaceutical composition, is characterized in that: it is the preparation being prepared from by the crude drug of following weight proportioning: 7～13 parts of Herba Dendrobiis, 2～4 parts of Semen Trigonellaes.
2. pharmaceutical composition according to claim 1, is characterized in that: the preparation that it is prepared from by the crude drug of following weight proportioning: 10 parts of Herba Dendrobiis, 3 parts of Semen Trigonellaes.
3. pharmaceutical composition according to claim 1 and 2, is characterized in that: described Herba Dendrobii is the stem of the orchid family Dendrobium Sw Dendrobium nobile Dendrobium nobile Lindl., Herba Dendrobii Dendrobium aurantiacum Rchb.f.var.denneanum, drumstick Dendrobium chrysotoxum Lindl or Diffuse Coptosapelta Dendrobium fimbriatum Hook..
4. according to the pharmaceutical composition described in claim 1～3 any one, it is characterized in that: described compositions is take the crude drug of Herba Dendrobii, Semen Trigonellae, water extract or extractive with organic solvent as effective ingredient, adds the preparation that pharmaceutically acceptable adjuvant is prepared from.
5. pharmaceutical composition according to claim 4, is characterized in that: described preparation is oral formulations;
Preferably, described preparation is powder, unguentum, granule, tablet, capsule, oral liquid or drop pill.
6. a method of preparing pharmaceutical composition described in claim 1～5 any one, is characterized in that: it comprises following steps:
(1) according to proportioning described in claim 1～5 any one, weighting raw materials Herba Dendrobii, Semen Trigonellae;
(2) Semen Trigonellae is pulverized as coarse powder, added the alcohol reflux of 30-95%, filter, by filtrate concentrate drying, obtain Semen Trigonellae ethanol extract;
(3) Herba Dendrobii is pulverized as coarse powder, added water reflux, extract,, filter, by filtrate concentrate drying, obtain Herba Dendrobii water extract;
(4) step (2) gained Semen Trigonellae ethanol extract is mixed with step (3) gained Herba Dendrobii water extract, add that pharmaceutically acceptable adjuvant or complementary composition are prepared into pharmaceutically conventional preparation.
7. method according to claim 6, is characterized in that: in step (2), the concentration of ethanol is 75%, and the consumption of ethanol is 11 times (v/w) of Semen Trigonellae coarse powder, and reflux, extract, number of times is 3 times, and each time of extracting is 120min.
8. method according to claim 6, is characterized in that: in step (3), the consumption of water is 11 times (v/w) of Herba Dendrobii coarse powder, and reflux, extract, number of times is 3 times, and each time of extracting is 120min.
9. the purposes of claim 1～5 any one pharmaceutical composition in the medicine of preparation treatment diabetes.
10. purposes according to claim 9, is characterized in that: described diabetes are type Ⅱdiabetes mellitus.
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