Summary of the invention
The invention provides a kind of new pharmaceutical composition, said composition has the function of radioprotective, enhancing immunity.
Another object of the present invention provides the preparation method of aforementioned pharmaceutical compositions.
The present invention is achieved by the following technical solutions:
The present invention is made by the following weight parts proportion raw material:
Radix Ginseng 3-15 part, Radix Astragali 15-50 part, Fructus Schisandrae Chinensis 10-40 part, Radix Rhodiolae extract 5-30 part, Fructus Ligustri Lucidi 5-20 part, Fructus Lycii 8-20 part.
The preferred weight portion proportioning of described pharmaceutical composition is:
Radix Ginseng 4-7 part, Radix Astragali 20-30 part, Fructus Schisandrae Chinensis 15-20 part, Radix Rhodiolae extract 10-20 part, Fructus Ligustri Lucidi 7-15 part, Fructus Lycii 10-18 part.
Preparation of drug combination method of the present invention is as follows:
Get Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Rhodiolae extract, Fructus Ligustri Lucidi, Fructus Lycii in proportion, decoct with water, merge extractive liquid, concentrates, and adds appropriate amount of auxiliary materials, makes pharmaceutically acceptable oral formulations.
Pharmaceutical composition preferred manufacturing procedure of the present invention is as follows:
Get Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Radix Rhodiolae extract, Fructus Ligustri Lucidi, Fructus Lycii in proportion, adding for the first time 10 times of water gagings extracted 2 hours, adding for the second time 8 times of water gagings extracted 1.5 hours, adding 6 times of water gagings for the third time extracted 1.5 hours, merge extractive liquid,, being concentrated into relative density is 1.10-1.15, is about 60% to wherein adding ethanol to containing the alcohol amount then, stir, centrifugal, collect supernatant, concentrating under reduced pressure reclaims ethanol, add correctives, antiseptic then, mix homogeneously, ultrafiltration, sterilization, fill makes oral liquid.
In pharmaceutical composition of the present invention, the mechanism of action of each medicine is as follows:
Radix Ginseng: contain ginsenoside, nitrogen-containing compound, organic acid, polysaccharide and other multiple active components.Modern pharmacology shows that ginsenoside and ginseng polysaccharide can significantly improve body immunity, and the hemopoietic function of bone marrow is had protection and stimulation, also has antitumor, the anti-ageing effect of waiting for a long time.
The Radix Astragali: its main chemical compositions has saponin, polysaccharide etc.Modern pharmacological research shows, the Radix Astragali has effects such as diuresis, blood pressure lowering, antibiotic, radioprotective, enhancing immunity.
Fructus Schisandrae Chinensis: the peel of Fructus Schisandrae Chinensis and ripe the kind in the skin contain lignanoid, are the effective medicinal components of Fructus Schisandrae Chinensis, comprising multiple schizandrin, can promote body metabolism, share with Radix Ginseng, the Radix Astragali, strengthen the human body immunity.
Radix Rhodiolae: be Tibetan medicine commonly used, main effective ingredient is rhodioside, polysaccharide, protein, flavone compound, alkaloid etc.Modern pharmacological research shows that Radix Rhodiolae extract has effects such as the immunity of organisms of raising, resisting fatigue, anti-hypoxia, radioprotective, antiviral, preventing tumor.
Fructus Ligustri Lucidi: its active component has oleanolic acid, Fructus Ligustri Lucidi polysaccharide etc.Modern study proves the function of the cellular immunization that is significantly improved and improves the effect of life quality that also the leukopenia that chemicotherapy is caused has the rising effect, stimulates hemopoietic function of bone marrow, improves and promote hematopoietic function.
Fructus Lycii: its chemical constituent mainly contains lycium barbarum polysaccharide, betanin, carotenoid and various trace elements.Studies show that lycium barbarum polysaccharide has the effect that promotes immunity, also have and alleviate the leukopenia that causes because of chemicotherapy that adjust patient's immunocyte ratio, radioprotective etc. are effect significantly.
Below example illustrates beneficial effect of the present invention by experiment:
Experimental example:
1, main material
Animal: the ICR female mice, body weight 20-22g is provided by Military Medical Science Institute's Experimental Animal Center.
Irradiation capsule: wooden 30cm * 16cm * 3cm, base plate is fixed with iron sheet, be separated into 10 small rectangle spaces with iron sheet in the box, a mice is closed in each space, cover plate adopts the lucite of 1mm thickness, be with holes in each position, space, for mouse breathing, this lucite can be movable arbitrarily in chute.
Illuminate condition: accelerator, the X line, 10MEV, dosage 6GY, whole body shines together, range 100cm.
Instrument: 754-ultraviolet-uisible spectrophotometer.
Tried thing: the oral liquid of being made by pharmaceutical composition of the present invention.
2, experimental technique
Select 50 of healthy ICR mices, body weight 20-22g, female, nursing conformed in 4 days in laboratory animal room, numeration of leukocyte and classification are carried out in afterbody blood sampling in the 5th day, mice is divided equally 5 groups at random after recording normal data, 10 every group, positive controls (I), model group (II), oral liquid high dose group of the present invention (III), low dose group (IV), normal control group (V).(I) group press 45mg/kg dosage ig SHENGBAIAN PIAN, (III) and (IV) group ig oral liquid 0.4ml of the present invention, 0.2ml respectively, and (II) and (V) group difference ig distilled water 0.4ml, once a day.The feed of freely drinking water of experimental session mice, (I), (II), (III), (IV) group are carried out roentgen radiation x after ig5 days, each group is carried out ig later on, tracing observation leukocyte situation of change, each group is got half mouse assay serum hemolysin after 30 days, and second half measures macrophage phagocytic function, puts to death at last and weighs, spleen, thymus are got in dissection, calculate its internal organs Body Mass Index.
3, observation index
3.1 total white blood cells, the lymphocyte absolute number
3.2 serum hemolysin is measured
3.3 macrophage phagocytic function is measured
Phagocytic percentage: engulf macrophage number/200 * 100% of chicken red blood cell, phagocytic index: the average of each macrophage phagocytic chicken red blood cell.
3.4 spleen, thymus index: spleen, thymic weight mg/ body weight g
4, experimental result
4.1 oral liquid of the present invention is to the influence of roentgen radiation x murine interleukin sum and lymphocyte absolute number.Mice total white blood cells and lymphocyte absolute number behind the 6GY roentgen radiation x descend immediately, reduced as far as possible in the 3rd day according to the back, but the experimental group fall of ig oral liquid of the present invention are significantly less than model group, significant difference.Each irradiation group murine interleukin number begins to recover after 3 days, and the resume speed of the experimental group of ig oral liquid of the present invention is obviously faster than model group, and the most obvious with lymphocyte, returns to the pre-irradiation level after ten days.Normal control group total white blood cells and lymphocyte number in whole experiment are not seen significant change.Observe from whole experiment, illustrate that oral liquid of the present invention has the certain protection effect to the murine interleukin damage that roentgen radiation x causes.
4.2 oral liquid of the present invention is to the influence of roentgen radiation x mice serum hemolysin: see Table 1.
Table 1 oral liquid of the present invention to roentgen radiation x after the influence (X ± s) of mice serum hemolysin
Group |
Animal (only) |
Dosage |
Hemolysin content (OD) |
I |
5 |
Berbamine 45mg/kg |
2.159±0.102 |
II |
5 |
Distilled water 0.4ml |
1.611±0.408 |
III |
5 |
Oral liquid 0.4ml of the present invention |
2.307±0.064 |
IV |
5 |
Oral liquid 0.2ml of the present invention |
1.924±0.227 |
V (normal control group) |
5 |
Distilled water 0.4ml |
2.894±0.521 |
By table 1 as seen, shine the serum hemolysin content of the mice of ig oral liquid of the present invention after 30 days apparently higher than model group, there were significant differences for high dose group.
4.3 oral liquid of the present invention is to the influence of roentgen radiation x Turnover of Mouse Peritoneal Macrophages phagocytic function: see Table 2.
Table 2 oral liquid of the present invention is to the influence of roentgen radiation x Turnover of Mouse Peritoneal Macrophages phagocytic function (X ± s)
Group |
Animal (only) |
Dosage |
Engulf (%) |
Phagocytic index |
I |
5 |
Berbamine 45mg/kg |
20.1±5.7 |
0.35±0.22 |
II |
5 |
Distilled water 0.4ml |
11.9±5.5 |
0.20±0.13 |
III |
5 |
Oral liquid 0.4ml of the present invention |
28.8±9.6 |
0.47±0.21 |
IV |
5 |
Oral liquid 0.2ml of the present invention |
19.4±6.2 |
0.33±0.09 |
V (normal control group) |
5 |
Distilled water 0.4ml |
45.1±3.4 |
0.58±0.16 |
By table 2 as seen; after mice was subjected to roentgen radiation x, the peritoneal macrophage phagocytic function obviously reduced, and obviously was better than model group but ig tries its phagocytic function of mice of thing; significant difference illustrates that being tried thing damages the protective effect that any is arranged to the macrophage phagocytic function that roentgen radiation x causes.
4.4 tried thing to the influence of roentgen radiation x mouse spleen, thymic weight index: see Table 3.
Table 3 is tried thing to the influence of roentgen radiation x mouse spleen, thymic weight index (X ± s)
Rank |
Animal (only) |
Dosage |
Index and spleen index |
Thymus index |
I |
10 |
Berbamine 45mg/kg |
4.52±0.41 |
1.68±0.61 |
II |
10 |
Distilled water 0.4ml |
4.47±0.53 |
1.53±0.47 |
III |
10 |
Oral liquid 0.4ml of the present invention |
4.75±1.04 |
1.79±0.38 |
IV |
10 |
Oral liquid 0.2ml of the present invention |
4.71±1.98 |
1.64±0.55 |
V (normal control group) |
10 |
Distilled water 0.4ml |
5.39±0.55 |
2.41±0.83 |
By table 3 as seen, mice spleen, thymus index and normal control group after shining relatively are atrophy trend, and spleen, thymus index that ig is tried the thing mice are higher than model group, and increase and the index increase with dosage.
Above experimental result shows that the present composition has radioprotective, the effect of raise immunity.
Concrete embodiment
Below by the specific embodiment, foregoing of the present invention is described in further detail.
Embodiment 1:
Get 5 parts of Radix Ginsengs, 25 parts of the Radixs Astragali, 18 parts of Fructus Schisandrae Chinensis, 15 parts of Radix Rhodiolae extracts, 10 parts of Fructus Ligustri Lucidi, 15 parts of Fructus Lycii, adding for the first time 10 times of water gagings extracted 2 hours, adding for the second time 8 times of water gagings extracted 1.5 hours, adding 6 times of water gagings for the third time extracted 1.5 hours, merge extractive liquid,, being concentrated into relative density is 1.10-1.15, is about 55% to wherein adding ethanol to containing the alcohol amount then, stir, centrifugal, collect supernatant, concentrating under reduced pressure reclaims ethanol, add correctives, antiseptic then, mix homogeneously, ultrafiltration, sterilization, fill makes oral liquid.
Embodiment 2:
Get 7 parts of Radix Ginsengs, 22 parts of the Radixs Astragali, 15 parts of Fructus Schisandrae Chinensis, 17 parts of Radix Rhodiolae extracts, 8 parts of Fructus Ligustri Lucidi, 18 parts of Fructus Lycii, adding for the first time 10 times of water gagings extracted 2 hours, adding for the second time 8 times of water gagings extracted 1.5 hours, adding 6 times of water gagings for the third time extracted 1.5 hours, merge extractive liquid,, being concentrated into relative density is 1.10-1.15, is about 55% to wherein adding ethanol to containing the alcohol amount then, stir, centrifugal, collect supernatant, concentrating under reduced pressure reclaims ethanol, add correctives, antiseptic then, mix homogeneously, ultrafiltration, sterilization, fill makes oral liquid.