Summary of the invention
The purpose of this invention is to provide a kind of oral formulations and preparation method thereof with immunological regulation, radiation-resisting functional.
To be raw material with rhodiola root, sealwort, the Radix Astragali, the fruit of Chinese wolfberry, sea-buckthorn, green tea form through scientific composition is refining with reference to the modern pharmacological research achievement oral formulations of the present invention.
Rhodiola root is Tibetan medicine commonly used, and its main active ingredient has multiple compositions such as rhodioside, polysaccharide, protein, flavone compound, alkaloid.Modern pharmacological research shows, rhodiola root have immunological regulation, antifatigue, anti-anoxic, radioresistance, antibiotic, suppress effects such as blood sugar rising, preventing tumor.Zoopery proves that rhodiola root can obviously promote the increase of mouse thymus and spleen weight.To the phagocytic function test of mouse reticuloendothelial system, prove that rhodiola root can strengthen the speed of cleaning up of mouse vein colloid carbon granules, the phagocytic function of reticuloendothelial system there is obvious humidification.In addition, the experiment proved that the contained polysaccharide of rhodiola root can significantly improve survival rate to being subjected to according to mouse, and hemopoietic system is also had obvious protective effect, its significant degree can be compared with the positive drug Benzalkonium, and this seldom sees in Chinese medicine and natural drug.
Sealwort has the medicine-food two-purpose function.The sealwort beginning is stated from " Mingyi Bielu ", motherland's medical science thinks that sealwort has good enriching yin and nourishing kidney, the effect of invigorating the spleen and benefiting qi, thereby be usually used in nourishing and fit keeping function and treatment is suffered from a deficiency of the kidney and weakness of the spleen and the stomach disease, and think that the nourishing effect of sealwort is main relevant with the promotion functions of immune system.Modern pharmacology studies have shown that sealwort has multiple beneficial such as delaying senility, regulate immunity in the effect of health.Sealwort contains sibiricoside, polysaccharide, quinones and various trace elements, and wherein Siberian solomonseal rhizome polysaccharide (PSP) is one of important component of sealwort bioactivator.
Experiment in vitro shows that Siberian solomonseal rhizome polysaccharide has the moderate excitation to normal person's lymphocyte transformation, and immunologic hypofunction patient's lymphocyte transformation is then had the height excitation.Zoopery shows, giving the immunology that coarse solomon's seal polysaccharide carries out with the filling stomach studies confirm that, coarse solomon's seal polysaccharide can make mouse thymus, spleen weight increase, can obviously strengthen mouse carbon particle clearance speed, to mouse reticuloendothelial system phagocytic function, tangible activation and humidification are arranged, improve the humoral immunity level of animal spleen t-cell sum and external source thymus-dependent antigen, Rhizoma Polygonati extract can promote mouse spleen lymphocyte to transform.Result of study shows that sealwort has immunoloregulation function.
Zoopery shows, to whole body
60Co radiation gamma mouse, Siberian solomonseal rhizome polysaccharide can obviously resist
60The minimizing of the blood cell count that the Co gamma-rays causes, and can make red blood cell C
3The b acceptor is spent askew rate and immune complex rosette rate to shine more merely obviously to increase, and the hematopoiesis function of radiation injury mouse is had significant protective effect.
The chemical composition of the Radix Astragali mainly contains multiple compositions such as saponin(e, polysaccharide.Motherland's medical science record Radix Astragali has multiple effects such as nourishing, dampness removing, pain relieving, calmness.Modern pharmacological research shows that the Radix Astragali has diuresis, step-down, antibiotic, radioresistance, enhancing immunologic function and makes effects such as cAMP in plasma increases.Zoopery shows, astragalus polyose is to having favorable protection and therapeutic action by the kidney function damage due to the microwave, and the chromosome damage that can repair by INDUCED BY MICROWAVE IRRADIATION promptly has antimutagenic effect.
The chemical composition of the fruit of Chinese wolfberry mainly contains LBP-X, betaine, carotenoid and various trace elements.Wherein LBP-X has the promotion immunization, is one of main active of matrimony vine.In addition, the experiment proved that LBP-X can be alleviated the leucocyte minimizing that radiotherapy causes, increases the periphery blood T lymphocyte number, adjusts patient's immunocyte ratio, and significant radiation resistance is arranged.
Mainly contain materials such as flavones, linoleic acid, vitamin E, phytosterol in the sea-buckthorn, show through zoopery, what hippophae rhamnoides can significantly improve mouse macrophage engulfs percentage and phagocytic index, strengthen macrophage lysosomal acid phosphatase nonspecific esterase activity, the effect of the macrophage function of enhancing is arranged.In addition, sea-buckthorn can significantly improve GY
60The survival rate of Co radiation exposure mouse can improve spleen hemopoietic focus number, and bone marrow nucleated cell digital display work is increased.Can significantly reduce bone marrow smear and incarnadine the cell micronucleus rate, strengthen protective action chmice acute radiation sickness.
Mainly contain Tea Polyphenols class, alkaloids, the anthropoid required various trace elements of multivitamin in the green tea.Experimental results show that green tea has tangible radiation resistance, its main mechanism of action is that Tea Polyphenols class, lipopolysaccharides and vitamin E and C contained in the green tea can poison the generation detoxication to the peroxidating that the caused free radical of radiation is caused, especially tea polyphenolic compounds can be anti-oxidant and be removed free radical, play the effect that prevents the radiation infringement, thereby reach the radioresistance effect.In addition, the contained Tea Polyphenols class of green tea can play oxidation resistant effect in the present invention, thereby has increased the stability of product.
The reasonable combination coordinated of above-mentioned each raw material can make oral formulations of the present invention have significant immunological regulation and radiation-resisting functional.
Oral formulations of the present invention mainly is to be made by the raw material of following weight parts:
Rhodiola root 0.1-5 part
Sealwort 0.1-5 part
Radix Astragali 0.1-10 part
Fruit of Chinese wolfberry 0.1-5 part
Sea-buckthorn 0.1-5 part
Green tea 0.1-5 part
Oral formulations of the present invention can adopt the conventional method of Chinese medicine preparation to make any conventional oral preparations.
Used auxiliary material is the raw material of following weight portion during the preparation oral liquid:
Xylitol 0.1-5 part
Potassium sorbate 0.01-2 part
The preparation method that above-mentioned each raw material components is made oral formulations of the present invention is:
(1) chooses rhodiola root, sealwort, the Radix Astragali, the fruit of Chinese wolfberry, sea-buckthorn, the green tea that conforms to quality requirements, clean standby;
(2) above-mentioned raw materials is put into extractor, the decocting that adds 6 times of weight boils 2-3 time, each 1-2 hour, merges extract refrigeration after 300 eye mesh screens filter and handles;
(3) get supernatant after the extract centrifugal treating with refrigeration, supernatant liquid filtering is got oral formulations of the present invention.
Required auxiliary material commonly used adopted common process to can be made into any peroral dosage form commonly used when oral formulations of the present invention added the preparation different dosage form, as oral liquid, soft capsule, hard shell capsules, granule, tablet etc.
Oral formulations of the present invention shows through effect experiment, toxicological experiment and stability experiment, remarkable, nontoxic, the good stability of its effect, and take confirmation through majority and have immunological regulation, radiation-resisting functional really, improve the health, and the health food that can eat for a long time.Have reasonable recipe, craft science easily is absorbed by the body, the bioavilability height; The complete maturation of preparation method; Characteristics such as prescription is unique, and immunological regulation, radiation-resisting functional are remarkable, and taking dose is little.
Concrete experiment method
Below in conjunction with embodiments of the invention the present invention is further described, but the present invention is not limited to embodiment, those of ordinary skills do some modification, still in protection domain of the present invention.
Embodiment 1-5: prepare oral formulations oral liquid of the present invention, the weight proportion of each raw material components sees the following form.
Embodiment number | Rhodiola root (kg) | Sealwort (kg) | The Radix Astragali (kg) | The fruit of Chinese wolfberry (kg) | Sea-buckthorn (kg) | Green tea (kg) | Xylitol (kg) | Potassium sorbate (kg) |
1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.01 |
2 | 0.3 | 0.5 | 0.9 | 0.4 | 0.2 | 0.2 | 0.4 | 0.02 |
3 | 1.0 | 2.0 | 5.0 | 2.0 | 0.5 | 2.0 | 2.0 | 0.08 |
4 | 3.0 | 3.0 | 8.0 | 4.0 | 1.0 | 3.0 | 3.0 | 1.50 |
5 | 5.0 | 5.0 | 10.0 | 5.0 | 5.0 | 5.0 | 5.0 | 2.00 |
Preparation method's following (with embodiment 2 is the example explanation, and other is substantially the same manner as Example 2 except that raw material consumption difference):
(1) chooses raw material
Choose satisfactory rhodiola root 0.3kg, sealwort 0.5kg, Radix Astragali 0.9kg, fruit of Chinese wolfberry 0.4kg, sea-buckthorn 0.2kg, green tea 0.2kg, clean standby.
(2) extract raw material
Above-mentioned each raw material is put into extractor, and the decocting that adds 6 times of weight boils 2 times, is respectively 2 hours, 1.5 hours at every turn, merges extract, and 4-0 ℃ of refrigeration is handled after 300 eye mesh screens filter.
(3) preparation feed liquid
Extract after the refrigeration is added in the centrifuge, and 2000 rev/mins of centrifugal treating of rotating speed 10 minutes are got supernatant then and are filtered with plate frame filter, filter the back and add sorbierite 0.4kg, potassium sorbate 0.02kg, add distilled water again to ormal weight, stir evenly, place.
(4) embedding
With the feed liquid embedding for preparing in 100 bottles of 100ml oral liquid bottles.
(5) sterilization
The oral liquid that embedding is good adopted 100 ℃ of water vapour flowing steam sterilizations 30 minutes.
(6) quality inspection
Test by company standard to semi-finished product in the sterilization back.
(7) packing
After the assay was approved, in the carton of packing into, seal seal, be finished product.
Used each bulk drug of present embodiment should meet " 2000 editions requirements of Chinese pharmacopoeia.Green tea can be selected the commercially available Xihu Longjing Tea that meets national standard, Mount Huang Mao Feng, dongting biluchun (tea) etc.
Every bottle of net content 100ml of oral formulations oral liquid of the present invention, every bottle contains thick polysaccharide and is no less than 100mg.
Using method is oral, every day 3 times, 1 bottle of every day.