CN1663606A - Medicine for treating radiation diseases - Google Patents
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- CN1663606A CN1663606A CN 200410104431 CN200410104431A CN1663606A CN 1663606 A CN1663606 A CN 1663606A CN 200410104431 CN200410104431 CN 200410104431 CN 200410104431 A CN200410104431 A CN 200410104431A CN 1663606 A CN1663606 A CN 1663606A
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Abstract
The present invention is a medicine for treating radiation diseases, especially a medicine prepared by biological preparation and Chinese traditional medicine for treating radiation diseases. It is characterized in that it mainly includes Alpha-mannan peptides 10-40%, and free radical removing Chinese traditional medicine 60-90%. The medicine includes Alpha-mannan peptides 10-40%, free radical removing Chinese traditional medicine 10-60%, and strengthening middle-burner and benefit vital energy Chinese traditional medicine 10-50%. The medicine includes Alpha-mannan peptides 10-40%, free radical removing Chinese traditional medicine 10-50%, strengthening middle-burner and benefit vital energy Chinese traditional medicine 10-40%, activating blood and removing stasis Chinese traditional medicine 10-30%. The medicine is a capsule prepared by biological preparation and Chinese traditional medicine, and combines the current medicine with traditional medicine, and plays their cooperating function, and has unique curative effect for the damnification caused by radiation and has no toxic and side effect, and can be taken conveniently.
Description
Affiliated technical field
The invention belongs to a kind of medicine of radiotherapy disease, particularly biological preparation and the Chinese medicine about a kind of radiotherapy disease cooperates the medicine of making.
Background technology
Radiation sickness is that human body suffers evenly or the more equably damage that causes of total irradiation of heavy dose of strong penetrating power ray.Be divided into acute radiation sickness and chronic radiation disease according to exposure time length and irradiation number of times.Acute radiation sickness is meant that human body is subjected to the caused systemic disease of one or many high-dose irradiation in the short time (normally a few days); Chronic radiation disease is meant continuous in a long time or is interrupted the effects of ionizing radiation that is subjected to super equivalent dose limit value, reaches the systemic disease of the multisystem infringement that causes after certain accumulated dose.Radiation sickness can be caused that external exposure radiation sickness mainly is caused by X ray, gamma-rays or neutron current irradiation by external exposure or internal radiation; Internal radiation radiation sickness then is to cause owing to radioactive substance enters in the body.
The pathogeny of radiation sickness can reduce:
(1) to the effect of molecule: ray directly acts on biomacromolecule, after macromole absorbs energy, excites, ionization, cause chemical bond rupture, generate macromolecular radical, the destruction that causes the large number of biological macromolecular structure, as act on nucleic acid and cause gene mutation, chromosomal aberration; Act on aminoacid protein structure is destroyed, influence activity of proteins, the function of enzyme and receptor etc.; Act on unsaturated fatty acid and can cause the membrane structure damage, influence the generation of mitochondrial oxidative phosphorylation and adenosine triphosphate.
(2) influence of pair cell: cell to the sensitivity of ionizing radiation with cell generation cycle length relevant, proliferating cycle is short in the ionizing radiation sensitivity.As hematopoietic stem cell, small intestinal pit cell, spermatogonium, idiophase cell cycle such as follicular cell, lens epithelial short, to the radiation sensitive height, after than low dose exposure apoptosis takes place promptly.
(3) to the influence of histoorgan:
1. the hemopoietic organ is the main target organ of ionizing radiation, the radiosensitivity of stem cell is very high, and irradiation back myeloid element multiplication capacity obviously is subjected to press down, and its polychromatophilic erythroblast and lymphocyte influence are the earliest, granulocyte and megalokaryocyte take second place, and blood sinus also has obvious destruction.
2. lymphocyte is extremely sensitive to ionizing radiation, and tissue lymph's cells such as spleen, thymus, lymph node and intestinal lymph filter born of the same parents reduce or complete obiteration, and body's immunity descends, and easily causes to infect to take place.
3. blood coagulation system can be activated behind high-dose irradiation in early days, the platelet aggregation increased response, viscosity of blood raises, high blood coagulation occurring sexually revises, cause small thrombosis and microcirculation disturbance, generate deficiency owing to consumption of coagulation factors increases, thrombocytopenia, aggregation capability reduce, and often cause hemorrhage syndrome.
4. digestive system is the most responsive to ionizing radiation with small intestinal, is followed successively by esophagus, stomach, colon, rectum, oral cavity.
5. antepituitary increases according to back initial stage secretory cell in the hormonal system, and secretory function strengthens, and decrescence moves back after a few days.Adrenal cortex and thyroid function irradiation back strengthens, after decrescence a little less than.Gonad is very sensitive to ray, and irradiation can produce permanent sterile.
6. nervous system early stage cerebral cortex excitement after irradiation has symptoms such as agitation, fear, headache, insomnia, enters inhibitory stage later on.
7. what the radiation damage of skin occurred earlier is little vasodilation, and may be with edema and epidermis cell regression.
Summary of the invention
The medicine that the purpose of this invention is to provide a kind of radiotherapy disease, this medicine is a kind of with biological preparation and the compounded capsule of Chinese medicine, it is to modern medicine and traditional medicine science, combine cleverly, bring into play both synergism, unique curative effect is played in the radiation-induced damage of ceremony, and have no side effect taking convenience.
Technical scheme of the present invention is: design a kind of medicine of radiotherapy disease, it is characterized in that: it mainly comprises α-mannatide 10-40%, removes radical type Chinese medicine 60-90%.
Described medicine includes α-mannatide 10-40%, removes radical type Chinese medicine 10-60%, invigorating the spleen and replenishing QI class Chinese medicine 10-50%.
Described medicine includes α-mannatide 10-40%, removes radical type Chinese medicine 10-50%, invigorating the spleen and replenishing QI class Chinese medicine 10-40%, blood circulation promoting and blood stasis dispelling class Chinese medicine 10-30%.
Described α-mannatide 10-40%, removing radical type Chinese medicine 10-30%, invigorating the spleen and replenishing QI class Chinese medicine 5-20%, blood circulation promoting and blood stasis dispelling class Chinese medicine 10-20%, nourishing the liver and kidney class Chinese medicine 10-30%.
Described removing radical type Chinese medicine has Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Poria, Fructus Schisandrae Chinensis, Radix Ginseng, Radix Codonopsis, the Radix Astragali, Fructus Ligustri Lucidi, Cornu Cervi Pantotrichum, Cordyceps, Herba Epimedii, Semen Cuscutae, Fructus Corni; Invigorating the spleen and replenishing QI class Chinese medicine has Radix Codonopsis, Rhizomadioscoreae, the Radix Astragali, Radix Ginseng, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Rehmanniae Preparata; Described blood circulation promoting and blood stasis dispelling class Chinese medicine has Semen Persicae, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae, Radix Salviae Miltiorrhizae, Pollen Typhae, Olibanum, Myrrha, Rhizoma Corydalis etc.; Rhizoma sparganic, Rhizoma Curcumae; Described nourishing the liver and kidney class Chinese medicine has Radix Rehmanniae Preparata, mountain cornel, Rhizoma Dioscoreae, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Tribuli, Folium Mori, Herba Ecliptae, the Radix Paeoniae Alba, Rhizoma Polygonati, Radix Glycyrrhizae.
Include α-mannatide 270g, Rhizoma Chuanxiong 50g, Radix Salviae Miltiorrhizae 50g, Radix Angelicae Sinensis 50g, Radix Polygoni Multiflori 50g, Poria 80g, Fructus Schisandrae Chinensis 80g, Radix Ginseng 30g, Radix Codonopsis 50g, Radix Astragali 50g, Fructus Ligustri Lucidi 50g, Cornu Cervi Pantotrichum 30g, Cordyceps 30g, Herba Epimedii 30g, Semen Cuscutae 50g, Fructus Corni 50g among the every 1000g of described medicine.
Include α-mannatide 260g, Rhizoma Chuanxiong 40g, Radix Salviae Miltiorrhizae 40g, Radix Polygoni Multiflori 30g, Poria 40g, Fructus Schisandrae Chinensis 50g, Fructus Ligustri Lucidi 40g, Cornu Cervi Pantotrichum 20g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 40g, Fructus Corni 40g, Radix Codonopsis 80g, Rhizomadioscoreae 20g, Radix Astragali 80g, Radix Ginseng 80g, Radix Glycyrrhizae 20g, Radix Angelicae Sinensis 60g, Radix Rehmanniae Preparata 20g among the every 1000g of described medicine.
Include α-mannatide 260g among the every 1000g of described medicine, Radix Salviae Miltiorrhizae 30g, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 40g, Fructus Ligustri Lucidi 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 50g, Rhizomadioscoreae 20g, Radix Astragali 40g, Radix Ginseng 50g, Radix Rehmanniae Preparata 30g, Semen Persicae 20g, Radix Angelicae Sinensis 20g, Fructus Aurantii 20g, Rhizoma Chuanxiong 20g, Radix Bupleuri 20g, Flos Carthami 20g, Radix Achyranthis Bidentatae 20g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 20g, Radix Glycyrrhizae 20g, Radix Salviae Miltiorrhizae 10g, Pollen Typhae 10g, Olibanum 10g, Myrrha 20g, Rhizoma Corydalis 20g, rhizoma sparganic 10g, Rhizoma Curcumae 20g.
Include α-mannatide 260g among the every 1000g of described medicine, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 30g, Rhizomadioscoreae 20g, Radix Astragali 20g, Radix Ginseng 20g, Radix Rehmanniae Preparata 20g, Semen Persicae 20g, Fructus Aurantii 15g, Radix Bupleuri 10g, Flos Carthami 15g, Radix Achyranthis Bidentatae 10g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 15g, Radix Salviae Miltiorrhizae 15g, Pollen Typhae 5g, Olibanum 10g, Myrrha 15g, Rhizoma Corydalis 10g, rhizoma sparganic 10g, Rhizoma Curcumae 10g, Radix Rehmanniae Preparata 10g, mountain cornel 10g, Rhizoma Dioscoreae 20g, Fructus Ligustri Lucidi 10g, Fructus Lycii 20g, Rhizoma Gastrodiae 10g, Radix Angelicae Dahuricae 10g, Radix Polygoni Multiflori 10g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 30g, Radix Angelicae Sinensis 30g, Fructus Tribuli 10g, Folium Mori 20g, Herba Ecliptae 10g, Radix Paeoniae Alba 10g, Rhizoma Polygonati 10g, Radix Glycyrrhizae 30g.
Characteristics of the present invention are: α-mannatide is a kind of biological response modifier, has enhancing human body immunity power, hemopoietic, and the protection gastrointestinal tract is avoided damage, and the activity of energy endocrine regulation system makes it to be in poised state; Chinese medicines such as Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis have invigorating the spleen and replenishing QI, and invigorating QI to consolidate the body surface resistance is enriched blood and invigorated blood circulation, the effect that nourishes blood; Chinese medicines such as Semen Persicae, Radix Notoginseng, Squama Manis have detumescence and apocenosis, dissipating blood stasis hemostasis, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain; Chinese medicine such as Fructus Lycii, Radix Glycyrrhizae has nourishing the liver and kidney, replenishing vital essence to improve eyesight, invigorating the spleen and replenishing QI, heat-clearing toxin-expelling functions; Chinese medicine such as vitamin C, Folium Ginkgo has extremely strong radical scavenging activity, and can activate the antioxidant reductase of body.This side is the Chinese medicine and western medicine compound preparation, and collaborative mutually between each composition, effect is unique.
The specific embodiment
Because the present invention is carried recoverable space craft (spacecraft or retrievable satellite) with the Alpha-hemolytic streptococcus strain, utilize the comprehensive function of factors such as little in the space (zero) gravity, cosmic ray, alternating magnetic field, fine vacuum, hyperpyrexia deep cooling, make the dna double chain structure fracture of bacterial strain, genome is reset, thereby produces new bacterial strain.After returning ground, bacterial strain through space treatment is cultivated and screened, by studying contents such as its morphological characteristic, cultural characteristic, biochemical reactions, metabolite, hereditary character and protein expression, hereditary stability, pilot scale production target, optimize the stable strain of plus variant, inherited character wherein, the medicine of the ulcerative colitis that after cultivation and fermentation, obtains medical treatment.This strain in China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation, is numbered CGMCCNo.1082.
Particularly Alpha-hemolytic streptococcus D33 bacterial strain behind ground screening, separation and the purification, selects higher, the secreted mannan peptide content of fermentation unit higher high yield, quality strains T33 strain through space treatment mutation.By Institute of Microorganism, Academia Sinica whole-cell protein SDS-polyacrylamide gel (SDS-PAGE) analysis of T33 bacterial strain and D33 bacterial strain and the genomic DNA restricted enzyme cutting analysis (RFLP/PFGE) of bacterial strain are compared, can prove that its gene of T33 bacterial strain that space mutagenesis and ground filter out has variation.This mutant strain is stable in heredity, stronger production adaptability is arranged, the mannan peptide content that is produced by its fermentation improves, content of peptides improves 3 to 5 times than national standard (80%), institute for drug control, Xi'an sample presentation is measured and is reached 271.6%, and fermentation content on average exceeds more than three times than matched group product content.This strain is through the spaceship-carried space flight of Shenzhou series of spacecraft, and further screening and culturing breeding forms stable hereditary property, the tangible high-yield highly-effective strain of variation features to strain by BeiJing ZhongKe Institute of Micro-biology of institute and biology department of Northwest University.The mannan peptide content of α in the every fermentation unit of this strain-space flight strain production has improved more than several times.(the material 1 of seeing Appendix: science and technology bureau Shaanxi Province, Shaanxi Province scientific and technological achievement assay certificate material
Adnexa material 2: the mannatide that the space flight strain is produced is produced bacterial strain and is carried notarization through " No. three, divine boat " airship.
Adnexa material 3: the mannatide that the space flight strain is produced is produced bacterial strain and is returned ground screening report through the lift-launch of " No. three, divine boat " airship
Adnexa material 4: Microbe Inst., Chinese Academy of Sciences produces the form Physiology and biochemistry probation report book of bacterial strain and ground contrast bacterium about the mannatide that " No. three, divine boat " airship carries the production of space flight strain
Adnexa material 5: Microbe Inst., Chinese Academy of Sciences produces SDS-PAGE and the RFLP/PFGE Analysis and Identification statement of bacterial strain and ground contrast bacterium about the mannatide that " No. three, divine boat " airship carries the production of space flight strain
Adnexa material 6: the mannatide oral liquid examining report that institute for drug control, Shaanxi Province " No. three, divine boat " space flight strain is produced
Adnexa material 7: scientific and technological novelty assessment report copy
Adnexa material 8: notice is accepted in China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation culture presevation)
Strain improvement: on the basis of Alpha-hemolytic streptococcus growth rhythm, selected than the proper growth strain in period, adopt the plate growth bacterium colony, immerse methods such as the bacteria suspension in other material, germ-carrying sand, carry " No. three, divine boat " spacecraft on March 25th, 2002.Carried out 6 days 0 18 hours flying at space track (200 kilometers of perigee altitudes, 350 kilometers of altitude of the apogees) at rail.The specific condition of space mainly is presented as special environments such as microgravity, fine vacuum, high radiation, alternating magnetic field.The strain of outer-space flight be placed in one with the diverse environment of tellurian ecological environment in, the electronics, proton and the mental retardation heavy particle that mainly comprise coming self-magnetic field to capture; Cosmic ray such as proton, particle and heavier high energy heavy particle from the milky way galaxy; From the proton of sun magnetic storm and heavy particle etc.These particles act on the dna double chain structure in the microbial cell nuclear, can cause double-strand break.Microgravity, high vacuum environment can make the base sequence of DNA recombinate, promptly genomic reorganization and variation.The new bacterial strain that the variation back produces, variation in various degree all can take place in its morphological characteristic, cultural characteristic, biochemical reactions, metabolite, hereditary character and protein expression, pilot scale production target etc.After ground is returned in spacecraft, through further screening, only optimize wherein 0.2% plus variant and the stable bacterial strain of inherited character, make the production strain through cultivation.This strain that after spaceship-carried mutation, selects December in 2003 29 days by China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation, be numbered CGMCCNo.1082.
Experiment and middle trial production result show, stable on inherited character through the novel space strain behind the space mutagenesis, stronger production adaptability is arranged, the mannan peptide content that is produced by its fermentation improves, content of peptides improves 3 to 5 times than national standard (80%), institute for drug control, Xi'an sample presentation is measured and is reached 271.6%, and fermentation content on average exceeds more than three times than matched group product content, and fermentation period shortens greatly.
Preparation method:
The space flight strain is produced the preparation process of mannatide:
The mannatide of space flight strain of the present invention production is by following method preparation: the space strain preparation--purify, and final production goes out mannatide by one grade fermemtation--second order fermentation-----fermentation liquid.
1. space strain preparation:
With through the Alpha-hemolytic streptococcus of space mutagenesis breeding meticulous selection-breeding as producing strain.
A. inclined-plane seed culture medium: Carnis Bovis seu Bubali cream 0.5%, yeast extract 0.6%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%, agar 3%, sheep blood 8%; PH7.4.
121 ℃ of inclined-plane seed culture medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
Unpacking strain cryovial with aseptic broth bouillon dilution, inserts the blood inclined-plane under aseptic condition, the rearmounted 38 ℃ of constant temperature culture of inoculation 30 hours.
B. meat soup seed culture medium: Carnis Bovis seu Bubali cream 0.5%, yeast extract 0.6%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%; PH7.4.
121 ℃ of meat soup seed culture medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
With cultured slant strains under aseptic condition by 9% inoculum concentration, insert in the meat soup seed culture medium 38 ℃ of constant temperature culture 30 hours.
2. sweat:
Fermentation medium: Carnis Bovis seu Bubali cream 0.4%, yeast extract 0.5%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%.
121 ℃ of fermentation medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
A. one grade fermemtation jar: with good meat soup strain under aseptic condition by 10% inoculum concentration, insert first class seed pot, 29 ℃ of constant temperature culture 30 hours, tank pressure was no more than 0.02Mpa, ventilation is advisable can stir culture fluid, fully stirs continuously.
B. second order fermentation jar: with the one grade fermemtation culture fluid under aseptic condition by 20% inoculum concentration, insert fermentation tank, 29 ℃ of constant temperature culture 70 hours, tank pressure is 0.02Mpa not, jar is put in deactivation.Deactivation is adopted to heat and is made the fermentation liquid temperature reach 100 ℃, is incubated 60 minutes, and cooling is left standstill.
3. leaching process:
A, fermentation liquid concentrate, and make concentrated solution volume and fermentating liquid volume ratio be controlled at 1: 15-1: 20 or be determined by circumstances.
The concentrated solution of b, fermentation liquid adds 80-99% ethanol, and the volume ratio is controlled at 1: 1.5-1: 5.5 or be determined by circumstances.Fully stir leave standstill after, centrifugal removal supernatant, the precipitation dissolved in distilled water, accent pH5.0 obtains lysate and lysate is left standstill.
C, the more centrifugal removal impurity of lysate is obtained supernatant, accurately measure the clear liquid volume, calculate required amount of alcohol by the supernatant stereometer, adjust pH slowly joins ethanol in the supernatant, and fully stirs, and leaves standstill the centrifugal removal supernatant in back and obtains precipitate.
D, precipitate reuse dissolved in distilled water are transferred pH, and centrifugal, supernatant adds ethanol precipitation again.Such technology repeatable operation to intermediate detection qualified till, the precipitate that obtains is the mannatide crude product that the space flight strain is produced.Vacuum drying 3-8 hour, promptly obtain the mannan peptide product that the space flight strain is produced.
The check of the product that said method obtains:
[character] this product is white or little yellow amorphous powder; Odorless, tasteless.
This product is easily molten in water, and is insoluble in ethanol, chloroform and acetone.
Specific optical rotation: get this product, accurate claim surely, be dissolved in water and be diluted to the solution that contains IOmg among every 1ml approximately, measure (two appendix vIE of Chinese Pharmacopoeia version in 2000) in accordance with the law, specific optical rotation is+70 ℃ to+80 ℃.
[discriminating] 1, get this product 10mg, add water 0.5ml and make dissolving, add a-naphthols alcoholic solution (5-100) 1ml, shake up, slowly add sulphuric acid 0.5ml along tube wall, after several minutes, the interface is aubergine.
2, get this product, add water and make the solution that contains 1mg among every 1ml, get about 10ul point on filter paper, dry, fix with dehydrated alcohol, put high salpeter solution (get periodic acid 1.2g, add water 30ml dissolving after.Add 0.2mol/L sodium acetate solution 1.5ml and ethanol 100ml, mixing promptly.Put the dark place and preserve, can use the several months) the middle immersion 5 minutes, take out, wash with 70% alcoholic solution, (get potassium iodide 5g, sodium thiosulfate 5g adds water 100ml and makes dissolving to put reducing solution, add ethanol 150ml, 2mol/L hydrochloric acid solution 2.5ml again, with adding, face the time spent and join with stirring) the middle immersion 5 minutes, take out, wash with 70% alcoholic solution, put in the pinkish red industry sulphuric acid test solution and soaked about 30 minutes, take out, (get sodium pyrosulfite 0.4g with sodium metabisulfite solution, add hydrochloric acid 1ml, being dissolved in water makes into 100ml, promptly), and flushing, dry, the place should be aubergine at the filter paper point sample.
3, get test sample and reference substance is an amount of, add respectively the chlorination sodium injection make contain 1mg among every 1ml solution as need testing solution and reference substance solution, press the test of mannatide immunogenicity determining method, test sample and contrast QC should all not have haemolysis to be taken place.
[inspection] 1, acidity: get this product, add water and make the solution that contains 10mg among every 1ml, measure (two appendix VIH of Chinese Pharmacopoeia version in 2000) in accordance with the law, pH value should be 3.0-5.0.
2, trap: get this product, add water and make the solution that contains 0.4mg among every 1ml, according to spectrophotography (two appendix VIA of Chinese Pharmacopoeia version in 2000), wavelength place at 260nm, its trap must not be greater than 0.25, and at the wavelength place of 280nm, its trap must not be greater than 0.20.
3, total nitrogen: get this product, measure according to N2 method (two appendix VIID second methods of Chinese Pharmacopoeia version in 2000).Press dry product and calculate, contain total nitrogen and should be 0.8-2.0%.
4, immunogenicity: get test sample and reference substance is an amount of, add the chlorination sodium injection respectively and make the solution that contains 10mg among every 1ml, make 1: 2,1: 4,1: 8,1: 16,1: 32,1: 64,1: 128,1: 256 diluent as need testing solution and reference substance solution with phosphate buffer respectively again, check in accordance with the law (attached mannatide immunogenicity determining method) that the least concentration of the insoluble blood vessel of test sample should be higher than more than a times of reference substance respective concentration.
5, loss on drying is got this product, is dried to constant weight at 105 ℃, subtracts weight loss and must not cross 5.0% (two appendix VIIIL of Chinese Pharmacopoeia version in 2000).
6, heavy metal is got this product, at 1.0g, checks that in accordance with the law (Chinese Pharmacopoeia version VIIIH in 2000) contains heavy metal and must not cross 20/1000000ths.
7, the undue toxicity gets this product, adds the chlorination sodium injection and makes the solution that contains 0.5mg among every 1ml, checks (Chinese Pharmacopoeia version appendix in 2000 XIC) in accordance with the law.Press the intravenous injection administration, should (injection) up to specification.
[assay]
1. the preparation of reference substance solution
Precision takes by weighing through 105 ℃ of D-mannose reference substance 0.1g that are dried to constant weight and puts in the 100ml measuring bottle, is dissolved in water and is diluted to scale.Shake up; Precision is measured 5ml, puts in the measuring bottle of 100ml, adds water to scale, shakes up.Contain mannose 50ug among every 1ml.
2. need testing solution is equipped with
It is an amount of to get this product, and accurate the title decides, and is dissolved in water and makes the solution that contains 40ug among every 1ml.
3. the preparation of standard curve
Precision takes by weighing reference substance solution 0,0.2,0.4,0.6,0.8,1.0ml, puts respectively in the tool plug test tube, respectively adds water to 1.0ml, adds 3% phenol solution 1.0ml again, shakes up, and pours sulphuric acid 4.5ml, shakes up, and is positioned over room temperature, is blank with 0 pipe.Measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000) at the wavelength place of 490nm.To corresponding trap, calculate regression equation with mannose ug number.
4. algoscopy
Precision is measured need testing solution 1.0ml, operates from " adding 3% phenol solution 1.0ml again " under the sighting target directrix curve preparation in accordance with the law, measures trap, by the regression equation calculation mannose content.
Mannatide immunogenicity determining method (complement combined techniques);
1, test solution
A. phthalate buffer (pH7.2)
Get sodium chloride 8.5g, sodium hydrogen phosphate 0.565g and potassium dihydrogen phosphate 0.135g, add water to 1000ml and make its dissolving, add 10% Adlerika 1ml, shake up.
B.1% sheep erythrocyte suspension
The preparation of sheeps blood erythrocyte: (get glucose 20.5g, sodium citrate 8.0g, sodium chloride 4.2g in filling equivalent A Shi liquid by sheep jugular vein sterile blood sampling, citric acid 5.5g, add water to 1000ml and make dissolving, 100 ℃ the sterilization 30 minutes) sterile chamber in, 4 ℃ of preservations.
The preparation of 1% sheeps blood erythrocyte suspension: it is an amount of to get above-mentioned sheeps blood erythrocyte, and with sodium chloride injection washing three times, each centrifugal 5 minutes (2000 rev/mins), sheeps blood erythrocyte is amassed in pressure, makes 1% sheeps blood erythrocyte suspension with sodium chloride injection.Get suspension, make need testing solution for 20 times with the sodium chloride injection dilution, other gets 20 times of equivalent suspension thin ups as blank solution, according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000), wavelength place at 541nm measures, its trap should be 0.65-0.70, should regulate the concentration of 1% sheep erythrocyte suspension as overrun.
C. hemolysin and sensitization sheeps blood erythrocyte
The preparation of hemolysin: get above-mentioned hematocrit sheeps blood erythrocyte, make 25% sheeps blood erythrocyte suspension with sodium chloride injection.Get 1 of rabbit, the above-mentioned sheeps blood erythrocyte suspension of intravenous injection, once a day, and totally seven times, first three time 3ml, back three 5ml, last inject blood sampling in back seven days.Separation of serum, 56 ℃ of deactivations in .30 minute, packing is preserved below 0 ℃.
The mensuration of amboceptor unit: it is an amount of to get hemolysin, add phosphate buffer and make 1: 1000,1: 2000,1: 3000,1: 4000,1: 5000,1: 6000,1: 7000,1: 8000,1: 9000,1: 10000 diluent respectively, respectively getting 0.1ml puts in the test tube, add 1% Sanguis caprae seu ovis cell suspension 0.1ml, shake up, add dilution factor and be 1: 30 guinea pig serum (complement) 0.2ml and phosphate buffer 0.2ml, shake up, 37 ℃ of insulations 30 minutes, the high dilution of complete hemolysis pipe is 1 unit hemolysin.
The preparation of sensitization sheeps blood erythrocyte: before facing usefulness, the sheeps blood erythrocyte suspension with 2% mixes with 2 unit haemolysis rope equal-volumes, and 37 ℃ are incubated 15 minutes promptly.
Complement: get the Cavia porcellus more than three, the heart blood sampling, centrifugalize serum is preserved below 0 ℃.
The mensuration of complement unit: it is an amount of to get complement, add phosphate buffer, make 1: 40,1: 60,1: 80,1: 100,1: 120,1: 140,1: 160,1: 180 diluent respectively, respectively get 0.2ml and put in the test tube, add the 0.2ml phosphate buffer, shake up, 37 ℃ of insulations are after 30 minutes, add sensitization sheeps blood erythrocyte 0.2ml respectively, shake up, 37 ℃ are incubated 30 minutes again.The high dilution of complete hemolysis pipe is the complement of 1 unit.
Antibody: it is an amount of to get the mannatide reference substance, add the chlorination sodium injection and make the reference substance solution immunizing rabbit that contains 10mg among every 1ml, the next day adopt ear vein injection reference substance solution once.Inject for the first time 0.2ml, for the second time respectively inject 0.5ml to the 5th time, respectively inject 1.0ml the 6th time to the tenth time, the tenth once respectively injects 2.0ml to the 15 time, and last is injected blood sampling in back three days, centrifugalize serum, 56 ℃ of deactivations in following 30 minutes, (before facing usefulness, needing 56 ℃ of deactivations once more in 30 minutes) preserved in packing below 0 ℃.
The mensuration of antibody unit: it is an amount of to get antibody, add phosphate buffer and make 1: 2,1: 4,1: 8,1: 16,1: 32.1: 64,1: 128 diluent respectively, respectively getting 0.1ml puts in the test tube, add mannatide reference substance solution 0.1ml and the 2 complement 0.2ml of unit, shake up, place more than 4 hours in 4-8 ℃, put 37 ℃ of insulations 30 minutes, the high dilution of insoluble blood vessel is 1 unit antibody.Establish antigen simultaneously and (do not add antibody, replace with the 0.1ml phosphate buffer), antibody (do not add antigen, replace with the 0.1ml phosphate buffer), complement (do not add antigen, antibody, replace with the 0.2ml phosphate buffer) control tube, more than three kinds of control tube haemolysis entirely; The sensitization sheeps blood erythrocyte that other establishes (do not add antigen, antibody and complement, replace with the 0.4ml phosphate buffer) control tube is haemolysis not.
2, immunogenicity determining method
It is an amount of to get rapid glycopeptide reference substance of manna and test sample, make the reference substance solution and the need testing solution of variable concentrations according to the regulation under the medicine item, respectively getting 0.1ml puts in the test tube, add the 2 antibody 0.1ml of unit and the 2 complement 0.2m1. of unit shake up, more than 4 hours, put 37 ℃ of insulations 30 minutes in 4-8 ℃ of placement, add sensitization sheeps blood erythrocyte 0.2ml, shake up, 37 ℃ are incubated 30 minutes again.Observe the haemolysis situation of each pipe, the least concentration of insoluble blood vessel is represented the immunogenicity of mannatide.Establish antigen simultaneously and (do not add antibody, replace with the 0.1ml phosphate buffer), antibody (do not add antigen, replace with the 0.1ml phosphate buffer), complement (do not add antigen, antibody, replace) control tube with the 0.2ml phosphate buffer, more than three kinds of control tube haemolysis entirely: the sensitization sheeps blood erythrocyte that other establishes (do not add antigen, antibody and complement, replace with the 0.4ml phosphate buffer) control tube is haemolysis not.
Embodiment 1 gets above-mentioned α-mannatide 100mg, vitamin C 3g, and Folium Ginkgo 100g, Radix Codonopsis 120g, Radix Astragali 100g, Radix Angelicae Sinensis 100g, Semen Persicae 80g, Radix Notoginseng 80g, Squama Manis 80g, Fructus Lycii 150g, Radix Glycyrrhizae 100g makes the capsule grain, every 5g.
Preparation process: above decocting for Chinese herbal medicine → extraction medicine juice → filter and remove residue → carry out precipitate with ethanol is concentrated → dry again spraying → pulverizing → mix → granulate → quality inspection is qualified afterwards → carry out capsule filling → packing finished product with α-mannatide and vitamin C.
Concrete production method is pressed 2000 editions one capsular preparation technology of Pharmacopoeia of People's Republic of China and is carried out (Chinese Pharmacopoeia Commission compiles, and Chemical Industry Press publishes).
Just the medication composition is different with embodiment 1 for other embodiment, and other production process is identical.
Contain α-mannatide 270g, Rhizoma Chuanxiong 50g, Radix Salviae Miltiorrhizae 50g, Radix Angelicae Sinensis 50g, Radix Polygoni Multiflori 50g, Poria 80g, Fructus Schisandrae Chinensis 80g, Radix Ginseng 30g, Radix Codonopsis 50g, Radix Astragali 50g, Fructus Ligustri Lucidi 50g, Cornu Cervi Pantotrichum 30g, Cordyceps 30g, Herba Epimedii 30g, Semen Cuscutae 50g, Fructus Corni 50g among the medicine 1000g of embodiment 2.
Contain α-mannatide 260g, Rhizoma Chuanxiong 40g, Radix Salviae Miltiorrhizae 40g, Radix Polygoni Multiflori 30g, Poria 40g, Fructus Schisandrae Chinensis 50g, Fructus Ligustri Lucidi 40g, Cornu Cervi Pantotrichum 20g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 40g, Fructus Corni 40g, Radix Codonopsis 80g, Rhizomadioscoreae 20g, Radix Astragali 80g, Radix Ginseng 80g, Radix Glycyrrhizae 20g, Radix Angelicae Sinensis 60g, Radix Rehmanniae Preparata 20g among the medicine 1000g of embodiment 3.
Contain α-mannatide 260g among the medicine 1000g of embodiment 4, Radix Salviae Miltiorrhizae 30g, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 40g, Fructus Ligustri Lucidi 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 50g, Rhizomadioscoreae 20g, Radix Astragali 40g, Radix Ginseng 50g, Radix Rehmanniae Preparata 30g, Semen Persicae 20g, Radix Angelicae Sinensis 20g, Fructus Aurantii 20g, Rhizoma Chuanxiong 20g, Radix Bupleuri 20g, Flos Carthami 20g, Radix Achyranthis Bidentatae 20g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 20g, Radix Glycyrrhizae 20g, Radix Salviae Miltiorrhizae 10g, Pollen Typhae 10g, Olibanum 10g, Myrrha 20g, Rhizoma Corydalis 20g, rhizoma sparganic 10g, Rhizoma Curcumae 20g.
Include α-mannatide 260g among the embodiment 5 medicine 1000g, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 30g, Rhizomadioscoreae 20g, Radix Astragali 20g, Radix Ginseng 20g, Radix Rehmanniae Preparata 20g, Semen Persicae 20g, Fructus Aurantii 15g, Radix Bupleuri 10g, Flos Carthami 15g, Radix Achyranthis Bidentatae 10g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 15g, Radix Salviae Miltiorrhizae 15g, Pollen Typhae 5g, Olibanum 10g, Myrrha 15g, Rhizoma Corydalis 10g, rhizoma sparganic 10g, Rhizoma Curcumae 10g, Radix Rehmanniae Preparata 10g, mountain cornel 10g, Rhizoma Dioscoreae 20g, Fructus Ligustri Lucidi 10g, Fructus Lycii 20g, Rhizoma Gastrodiae 10g, Radix Angelicae Dahuricae 10g, Radix Polygoni Multiflori 10g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 30g, Radix Angelicae Sinensis 30g, Fructus Tribuli 10g, Folium Mori 20g, Herba Ecliptae 10g, Radix Paeoniae Alba 10g, Rhizoma Polygonati 10g, Radix Glycyrrhizae 30g.
The sick capsular toxicological study of radiotherapy of the present invention: 1. acute toxicity test: the once oral 50g of rabbit, do not see that dead and any untoward reaction takes place; 2. subacute toxicity test: rabbit oral 25g every day, continuous use was checked hepatic and renal function, hemogram and all no abnormal variation of each organs and tissues in 2 months; 3. the Cavia porcellus hypersensitive test is negative; 4. the deadly test of teratogenesis is all negative.
The animal pharmacodynamics test:
Experiment one: the influence that above-mentioned four kinds of compound capsules are stagnated the chmice acute hemopoietic function.
By observing BACB/C mice warp
60The pathological change of peripheral blood picture, myelogram, bone marrow, liver spleen behind Co ray one subtotal body irradiation, set up the animal model of the acute hemopoietic function stagnation that is fit to this experiment, and inquired into the therapeutical effect that four kinds of compound capsules of the present invention are stagnated acute hemopoietic function, the active drug that experimental result points out four kinds of compound capsules of the present invention all to can be used as the treatment hematopoietic disorder, and have no side effect.
1 materials and methods
1.1 material
(1) animal inbred line BACB/C mice is 1120, age in 8-12 week, body weight 18-20g, male and female half and half.Provide by Xi'an Jiaotong University Medical College's Experimental Animal Center.
(2) instrument S/SMEXDP-460 type peripheral blood is Japan and produces as detector, baker810 type platelet detector.
(3) detection and observation item liver, spleen, bone marrow pathological section; Myelogram, peripheral blood picture.
(4) medicine α-mannatide, four kinds of compound capsules of the present invention provide by our company; Oleum Hippophae is provided by Qin Yong Fructus Hippophae company limited.
1.2 method: 220 mices of (1) modelling freely drink water, and advance the lump food.Fasting 6-8h after
60Co ray one subtotal body irradiation, apart from 100cm, close rate 203.66rad/min, dosage 450rad, time 2min22s.Shine back (except that death) at 3d, 7d, 15d, 30d put to death 40 respectively, look into above-mentioned test item.
(2) the grouping mice is 900,
60Be divided into seven groups behind the Co roentgenization at random: I organizes simple normal saline matched group, II organizes first kind of compound capsule treatment group of the present invention, III organizes second kind of compound capsule treatment group of the present invention, IV organizes the third compound capsule treatment group of the present invention, V organizes the 4th kind of compound capsule treatment group of the present invention, VI organizes α-mannatide treatment group, VII group Oleum Hippophae treatment group.
(3) experimentation I group normal saline is only irritated stomach 0.2ml/, every day 2 times; II organizes first kind of compound capsule of the present invention and only irritates stomach 0.5g/, every day 2 times; III organizes second kind of compound capsule of the present invention and only irritates stomach 0.5g/, every day 2 times; IV group the third compound capsule of the present invention is only irritated stomach 0.5g/, every day 2 times; V organizes the 4th kind of compound capsule of the present invention and only irritates stomach 0.5g/, every day 2 times; VI group α-mannatide oral liquid is only irritated stomach 1ml/, every day 2 times; VII group Oleum Hippophae is only irritated stomach 0.2ml/, every day 2 times.Treatment 20d, 40d gets 40 respectively for every group behind the 60d, checks every index.Wherein beat the left back lower limb femoral shaft of mice bone marrow with No. 8 or No. 9 syringe needles, 10 μ l mice serums dilution back smear, Wright's staining in the 6h, microscope oil sem observation myelogram is got internal organs such as right femur of mice and liver spleen and is done the pathology inspection.
2 experimental results
2.1 model: model mice main organs pathological change: the 3d hepatic necrosis is remarkable, the regression of part cytopathy, and cell is cracked, karyopycnosis; Visible kitchen range sexual cell necrosis in the spleen medullary substance, mild fibrosis and hemosiderosis; Myelosis lowers, and hematopoietic cell reduces, blood sinus hyperemia, expansion.The regression of 7d hepatosplenomegaly portion, partial necrosis; Myelosis severe lowers, and hematopoietic cell obviously reduces, and non-hematopoietic cell increases, and blood sinus is obviously expanded, medium and small venectasia, hyperemia, hemorrhage.The 15d hepatic necrosis, residual have a streak hepatocyte, and the lamellar necrotic area is arranged in the spleen medullary substance; Bone marrow hematogenesis further worsens, and occurs fatty marrow individually.The 30d hepatocyte has slight hypertrophy, and there is the lamellar necrotic area at the edge, the downright bad point of lamellar is arranged, surrounding tissue part fibrosis in the spleen medullary substance; Myelosis lowers, and nucleated cell gos up to some extent, and blood sinus still has expansion, hyperemia.Different time mice peripheral blood picture changes after the modeling, sees Table 1.Different time mouse bone marrow cells picture changes after the modeling, sees Table 2.
The animal peripheral blood picture change of table 1 irradiation back (X ± SE)
| Time (d) | Number of animals (n) | ???WBC(×10 9/L) | ??RBC(×10 12/L) | ???HB(g/L) |
| ????0 | ????40 | ????5.2±0.5 | ????6.5±0.5 | ???13.1±0.2 |
| 3 moulds *Right * | ????40 ????40 | ????3.9±0.6 ????5.4±0.9 | ????4.7±1.1 ????6.9±0.7 | ???11.7±0.4 ???14.1±0.6 |
| 7 moulds *Right * | ????40 ????40 | ????3.9±0.7 ????5.4±0.7 | ????4.6±0.7 ????6.9±0.5 | ???11.6±0.5 ???13.8±1.1 |
| 15 moulds *Right * | ????40 ????40 | ????1.9±0.4 ????6.2±0.8 | ????3.8±1.1 ????6.3±1.0 | ???8.5±1.0 ???13.2±0.9 |
| 30 moulds *Right * | ????40 ????40 | ????3.3±1.1 ????5.9±1.0 | ????4.9±1.8 ????6.7±0.6 | ???11.2±0.4 ???13.0±2.3 |
Annotate: model group and matched group compare, P＜0.05.
The experimental data of table 1, table 2 shows: animal blood picture in the 7d of beginning descends gradually after the modeling, the amount of model group peripheral blood WBC, RBC and HB all obviously descends, with matched group significant difference is arranged, modeling 15d-30d hemopoietic function serious hindrance, the 30d bleeding from anus looks like to have the trend of rise; Modeling 3d, 7d, 15d, 30d, bone marrow smear model group grain are that cell and erythroid cells number average obviously reduce, and with matched group significant difference are arranged, and hyperplasia degree is from lowering, and severe lowers, and low in active, myelogram has the trend of rise behind the 30d.So hematopoietic disorder, advantage has been created in treatment to medicine, meets this requirement of experiment.
The animal bone marrow picture change of table 2 irradiation back (X ± SE)
| Time (d) | Number of animals (n) | Hyperplasia degree | Grain system (%) | Red system (%) |
| ????0 | ????40 | Obviously active | ????50.01±4.1 | ????18.2±6.5 |
| 3 moulds *Right * | ????40 ????40 | Lower obviously active | ????40.3±3.0 ????51.3±4.9 | ????16.2±5.4 ????18.9±5.2 |
| 7 moulds *Right * | ????40 ????40 | Severe lowers obviously active | ????40.6±4.2 ????53.1±5.8 | ????15.3±7.2 ????19.8±9.5 |
| 15 moulds *Right * | ????40 ????40 | Lower obviously active | ????32.8±9.2 ????50.1±4.9 | ????12.5±3.9 ????17.4±5.3 |
| 30 moulds *Right * | ????40 ????40 | Active obviously active | ????23.2±8.9 ????49.8±5.2 | ????16.8±5.3 ????18.3±9.3 |
Annotate: model group and matched group compare, P＜0.01.
2.2 drug effect is in the laboratory observation of model
Treatment back bone marrow pathological change: treatment 20dI group hemopoietic function of bone marrow further worsens, and occurs fatty marrow individually.II group-V group myelosis is active, and the nucleated cell number increases, and hematopoietic cell increases, and non-hematopoietic cell reduces, the more preceding improvement of bone marrow interstital blood sinus edema dilatation and congestion.VI group, VII group bone marrow pathological change degree are between last two kinds.
Treatment 40dI group myelosis lowers, and nucleated cell gos up to some extent, and blood sinus still has expansion, hyperemia.II group-V group myelosis is obviously active, and hematopoietic cell showed increased, blood sinus do not have obvious dilatation and congestion edema.VI group, VII group myelosis are enlivened, and the nucleated cell number increases, and hematopoietic cell increases, and the bone marrow interstital blood sinus still has the edema dilatation and congestion.
Treatment 60dI group bone marrow hematogenesis obviously recovers, and it is not obvious that the blood sinus dilatation and congestion is recovered.II group-VII group bone marrow hematogenesis recovers normal substantially.
Treat back animal peripheral blood picture variation and see Table 3, the animal bone marrow picture variation of treatment back sees Table 4.
The animal peripheral blood picture variation of table 3 treatment back (X ± SE)
| Grouping | Time (d) | Number of animals (n) | ??WBC(×10 9/L) | ??RBC(×10 12/L) | ??HB(g/L) |
| The I group | ??20 ??40 ??60 | ??40 ??40 ??40 | ??2.01±0.60 ??4.62±1.26 ??4.93±0.91 | ??4.27±0.98 ??6.12±0.85 ??6.09±0.68 | ??11.10±1.66 ??11.24±1.78 ??11.03±1.31 |
| The II group | ??20 ??40 ??60 | ??40 ??40 ??40 | ??4.47±1.12 ??8.05±0.99 ??6.66±0.71 | ??6.09±0.66 ??7.21±0.65 ??7.09±1.11 | ??12.68±1.63 ??13.55±1.25 ??12.6±0.99 |
| The III group | ??20 | ??40 | ??4.50±0.96 | ??6.15±1.01 | ??11.15±1.28 |
| ?40 ?60 | ????40 ????40 | ??8.06±1.30 ??6.69±2.10 | ??7.37±0.49 ??7.02±0.89 | ?12.07±0.96 ?13.49±0.61 | |
| The IV group | ?20 ?40 ?60 | ????40 ????40 ????40 | ??4.53±0.87 ??8.06±1.12 ??6.70±0.89 | ??6.18±0.97 ??7.39±0.64 ??7.13±0.56 | ?11.54±1.15 ?12.19±1.23 ?13.07±1.46 |
| The V group | ?20 ?40 ?60 | ????40 ????40 ????40 | ??4.55±0.78 ??8.10±1.02 ??6.74±1.22 | ??6.34±1.01 ??7.42±0.89 ??7.30±0.78 | ?11.67±1.35 ?12.56±1.46 ?13.68±1.39 |
| The VI group | ?20 ?40 ?60 | ????40 ????40 ????40 | ??3.21±0.34 ??6.14±1.03 ??5.24±0.41 | ??5.07±0.14 ??6.08±0.57 ??6.13±0.89 | ?11.07±0.89 ?11.79±1.03 ?11.56±1.38 |
| The VII group | ?20 ?40 ?60 | ????40 ????40 ????40 | ??3.07±0.40 ??6.25±0.89 ??5.30±0.46 | ??5.12±0.49 ??6.11±0.36 ??6.09±0.97 | ?11.47±1.06 ?11.89±0.76 ?11.46±0.97 |
The experimental data of table 3 shows: the amount of I group (being the normal saline matched group) peripheral blood WBC, RBC and HB is flat low than normal water, and the 40d-60d blood picture gos up to some extent; The amount of II group-V group (being four kinds of compound capsule treatment groups of the present invention) peripheral blood WBC, RBC and HB all significantly raises, and along with the reinforcement of capsule formula, curative effect is remarkable further; VI group (being α-mannatide oral liquid treatment group) peripheral blood picture has rise slightly than the I group, but not remarkable; VII group (being Oleum Hippophae treatment group) peripheral blood picture and the no significant difference of VI group.Illustrate that four kinds of compound capsules of the present invention have good therapeutical effect to radio-induced peripheral blood picture decline, list α-mannatide oral liquid and the Oleum Hippophae of being better than evident in efficacy.
The animal bone marrow picture variation of table 4 treatment back (X ± SE)
| Grouping | Time (d) | Number of animals (n) | Hyperplasia degree | Grain system (%) | Red system (%) |
| The I group | ??20 ??40 ??60 | ???40 ???40 ???40 | Severe lowers | ??13.22±1.89 ??17.23±3.80 ??19.39±4.83 | ??5.55±1.88 ??5.93±2.33 ??6.99±3.66 |
| The II group | ??20 ??40 ??60 | ???40 ???40 ???40 | Active obviously active obviously active | ??37.51±3.82 ??36.43±9.22 ??34.92±7.13 | ??16.61±3.22 ??13.13±1.89 ??12.28±3.52 |
| The III group | ??20 | ??40 | Active | ??39.31±1.89 | ??18.10±1.28 |
| ??40 ??60 | ??40 ??40 | Obviously active obviously active | ??40.03±2.88 ??40.36±9.32 | ??13.23±0.76 ??13.49±1.61 | |
| The IV group | ??20 ??40 ??60 | ??40 ??40 ??40 | Obviously active obviously active obviously active | ??41.25±1.23 ??41.32±1.64 ??40.89±0.97 | ??18.54±1.25 ??13.19±1.32 ??13.67±1.47 |
| The V group | ??20 ??40 ??60 | ??40 ??40 ??40 | Obviously active obviously active obviously active | ??42.38±1.01 ??43.06±1.34 ??42.17±1.36 | ??19.07±1.12 ??13.56±1.47 ??13.68±1.87 |
| The VI group | ??20 ??40 ??60 | ??40 ??40 ??40 | Active active | ??16.34±1.14 ??19.46±1.75 ??21.21±1.89 | ??7.17±0.39 ??7.68±1.34 ??8.06±1.47 |
| The VII group | ??20 ??40 ??60 | ??40 ??40 ??40 | Active active | ??16.74±1.49 ??20.03±2.11 ??21.89±1.97 | ??7.68±1.16 ??7.97±1.18 ??8.36±1.35 |
The experimental data of table 4 shows: the grain of I group (being the normal saline matched group) bone marrow is and is red is that hyperplasia degree is flat low than normal water, and 40d-60d myelosis degree is gone up to some extent; The grain system of II group-V group (being four kinds of compound capsule treatment groups of the present invention) bone marrow and red be that hyperplasia degree is significantly increased, and along with the reinforcement of capsule formula, curative effect is remarkable further; The grain of VI group (being α-mannatide oral liquid treatment group) bone marrow is and is red to be that hyperplasia degree has rise slightly than the I group, but not remarkable; The grain of VII group (being Oleum Hippophae treatment group) bone marrow is and is red to be hyperplasia degree and the no significant difference of VI group.Illustrate four kinds of compound capsules of the present invention to the grain system of radio-induced bone marrow and red be that hyperplasia degree descends good therapeutical effect is arranged, evident in efficacyly be better than single α-mannatide oral liquid and Oleum Hippophae used.
The sick capsular clinical efficacy checking of radiotherapy of the present invention: Wang, man, 54 years old, certain provincial hospital cardiac catheter chief physician.Because of fatigue and weak, forgetful, sexual function obviously reduces, and peripheral white blood cell reduces 3 years, is admitted to hospital in February, 2004.The patient was engaged in the work of cardiovascular interventional radiology in 1986 to 2004, it is estimated, it is 2.21Sv that the individual is subjected to according to the accumulated dose equivalent.Be engaged in before the radiation work healthyly, began to occur being engaged in fatigue and weak behind the radiation work in 1991, peripheral white blood cell one is crossed the property minimizing, can recover after the rest, so treat.Above-mentioned symptom increases the weight of after calendar year 2001, and occur forgetful, irritability sometimes, personality is unusual, sexual function obviously reduces, and checks that blood picture peripheral red blood cells number is 3.50 * 10
12/ L, leukocyte count are 1.50 * 10
12/ L.Have a medical check-up: T36.5 ℃, P80 time/minute, BP16/10Kpa.Refreshing clear, development nutrition is good, cardiopulmonary (-), and abdomen is flat soft, and the liver spleen does not touch; Point shape canescence muddiness under the capsule of back, the visible cavity of right eye are found in the bicrystal slit lamp examination; Skin examination finds that left forearm skin is dry slightly, and defurfuration is arranged, obscure boundary, the slight hyperkeratosis of dermal pathology inspection prompting epidermis.Lab testing: peripheral red blood cells, leukopenia, distortion; Semen efamination finds, the sperm mortality rate is up to 60%, accidental deformity, and motoricity is general; Endocrine dysfunction; Immunologic function reduction etc.Take this compound capsule, once a day, each one, logotype is after one month, and subjective symptoms is obviously improved, and spiritual complexion is good, and sleep is good.Continued to take medicine three months, and checked and find that RBC number is 7.50 * 10 in the blood
12/ L, leukocyte count are 4.50 * 10
12/ L recovers normal level substantially, and sperm motility power is strengthened, and mortality rate is lower than 5%, and passive protective physical fitness obviously strengthens.Followed up a case by regular visits to 1 year, each systemic-function of body is normal.
The sick capsular clinical efficacy statistics of radiotherapy of the present invention: 30 exception irradiation chronic radiation disease patients' data is collected in this research, male's 19 examples wherein, women's 11 examples, accepted raytime the shortest 4 years, the longest 29 years, the individual is subjected to shine the accumulated dose equivalent from 1.6Sv-5.95Sv, and the cardinal symptom performance is broadly divided into three classes, i.e. hemocyte quantity minimizing type (20 example), immunologic function inhibition type (10 example).All patients take compound capsule of the present invention, once a day, each one, logotype one month.Found that: 20 routine hemocyte quantity minimizing type patient medication proerythrocyte numbers are 2.0-3.5 * 10
12/ L, leukocyte count are 0.9-1.5 * 10
9/ L, platelet count are 30-60 * 10
9/ L, medication after one month 19 routine patient's RBC number be 7.0-10 * 10
12/ L, leukocyte count are 4.0-5.5 * 10
9/ L, platelet count are 80-95 * 10
9/ L, only 1 routine patient's blood cell count changes little; IgG is 6-8g/L in the preceding blood of 10 routine immunologic function inhibition type patient medications, obviously on the low side than normal value (8-15g/L), the IgG fluctuation range is surveyed in medication after one month, and it is 10-13g/L that 9 routine patients are arranged, obviously obviously raising and recovery are normal, and only 1 routine patient does not have significant change.The statistics total effective rate is 93.3%.
Confirm that through collecting the patient medical record data further investigation conclusion summary of taking medicine in a large number this Chinese medicine and western medicine compound capsule has: the hemopoietic function that 1. stimulates bone marrow, recover peripheral hemogram, the clinical symptoms that causes because of hematopoietic disorder there is comprehensive improvement effect, as fatigue and weak, dizzy headache, sleep disorder, hypomnesis etc.; 2. activate the cellular immunization and the humoral immune function of body, improve the immunity of body, evident in efficacy to the various infection that ionizing radiation causes; 3. reduce bleeding tendency; 4. eliminate injury of gastrointestinal tract, recover its physiological function; 5. regulate the activity of hypothalamus-hypophysis-target gland axle, make the functional rehabilitation of adrenal cortex, thyroid and gonad normal; 6. the neural excitement of coordination center-inhibition activity improves languishment, and spirit is indifferent, agitation etc.; 7. thoroughly treat skin lesion such as edema, hemorrhage etc.
Claims (9)
1, a kind of medicine of radiotherapy disease is characterized in that: it mainly comprises α-mannatide 10-40%, removes radical type Chinese medicine 60-90%.
2, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: described medicine includes α-mannatide 10-40%, removes radical type Chinese medicine 10-60%, invigorating the spleen and replenishing QI class Chinese medicine 10-50%.
3, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: described medicine includes α-mannatide 10-40%, removes radical type Chinese medicine 10-50%, invigorating the spleen and replenishing QI class Chinese medicine 10-40%, blood circulation promoting and blood stasis dispelling class Chinese medicine 10-30%.
4, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: described α-mannatide 10-40%, removing radical type Chinese medicine 10-30%, invigorating the spleen and replenishing QI class Chinese medicine 5-20%, blood circulation promoting and blood stasis dispelling class Chinese medicine 10-20%, nourishing the liver and kidney class Chinese medicine 10-30%.
5, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: described removing radical type Chinese medicine has Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Poria, Fructus Schisandrae Chinensis, Radix Ginseng, Radix Codonopsis, the Radix Astragali, Fructus Ligustri Lucidi, Cornu Cervi Pantotrichum, Cordyceps, Herba Epimedii, Semen Cuscutae, Fructus Corni; Invigorating the spleen and replenishing QI class Chinese medicine has Radix Codonopsis, Rhizomadioscoreae, the Radix Astragali, Radix Ginseng, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Rehmanniae Preparata; Described blood circulation promoting and blood stasis dispelling class Chinese medicine has Semen Persicae, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae, Radix Salviae Miltiorrhizae, Pollen Typhae, Olibanum, Myrrha, Rhizoma Corydalis etc.; Rhizoma sparganic, Rhizoma Curcumae; Described nourishing the liver and kidney class Chinese medicine has Radix Rehmanniae Preparata, mountain cornel, Rhizoma Dioscoreae, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Tribuli, Folium Mori, Herba Ecliptae, the Radix Paeoniae Alba, Rhizoma Polygonati, Radix Glycyrrhizae.
6, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: include α-mannatide 270g, Rhizoma Chuanxiong 50g, Radix Salviae Miltiorrhizae 50g, Radix Angelicae Sinensis 50g, Radix Polygoni Multiflori 50g, Poria 80g, Fructus Schisandrae Chinensis 80g, Radix Ginseng 30g, Radix Codonopsis 50g, Radix Astragali 50g, Fructus Ligustri Lucidi 50g, Cornu Cervi Pantotrichum 30g, Cordyceps 30g, Herba Epimedii 30g, Semen Cuscutae 50g, Fructus Corni 50g among the every 1000g of described medicine.
7, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: include α-mannatide 260g, Rhizoma Chuanxiong 40g, Radix Salviae Miltiorrhizae 40g, Radix Polygoni Multiflori 30g, Poria 40g, Fructus Schisandrae Chinensis 50g, Fructus Ligustri Lucidi 40g, Cornu Cervi Pantotrichum 20g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 40g, Fructus Corni 40g, Radix Codonopsis 80g, Rhizomadioscoreae 20g, Radix Astragali 80g, Radix Ginseng 80g, Radix Glycyrrhizae 20g, Radix Angelicae Sinensis 60g, Radix Rehmanniae Preparata 20g among the every 1000g of described medicine.
8, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: include α-mannatide 260g among the every 1000g of described medicine, Radix Salviae Miltiorrhizae 30g, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 40g, Fructus Ligustri Lucidi 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 50g, Rhizomadioscoreae 20g, Radix Astragali 40g, Radix Ginseng 50g, Radix Rehmanniae Preparata 30g, Semen Persicae 20g, Radix Angelicae Sinensis 20g, Fructus Aurantii 20g, Rhizoma Chuanxiong 20g, Radix Bupleuri 20g, Flos Carthami 20g, Radix Achyranthis Bidentatae 20g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 20g, Radix Glycyrrhizae 20g, Radix Salviae Miltiorrhizae 10g, Pollen Typhae 10g, Olibanum 10g, Myrrha 20g, Rhizoma Corydalis 20g, rhizoma sparganic 10g, Rhizoma Curcumae 20g.
9, the medicine of a kind of radiotherapy disease according to claim 1 is characterized in that: include α-mannatide 260g among the every 1000g of described medicine, Radix Polygoni Multiflori 20g, Poria 30g, Fructus Schisandrae Chinensis 30g, Cornu Cervi Pantotrichum 10g, Cordyceps 20g, Herba Epimedii 20g, Semen Cuscutae 30g, Fructus Corni 20g, Radix Codonopsis 30g, Rhizomadioscoreae 20g, Radix Astragali 20g, Radix Ginseng 20g, Radix Rehmanniae Preparata 20g, Semen Persicae 20g, Fructus Aurantii 15g, Radix Bupleuri 10g, Flos Carthami 15g, Radix Achyranthis Bidentatae 10g, Radix Paeoniae Rubra 10g, Radix Rehmanniae 10g, Radix Platycodonis 15g, Radix Salviae Miltiorrhizae 15g, Pollen Typhae 5g, Olibanum 10g, Myrrha 15g, Rhizoma Corydalis 10g, rhizoma sparganic 10g, Rhizoma Curcumae 10g, Radix Rehmanniae Preparata 10g, mountain cornel 10g, Rhizoma Dioscoreae 20g, Fructus Ligustri Lucidi 10g, Fructus Lycii 20g, Rhizoma Gastrodiae 10g, Radix Angelicae Dahuricae 10g, Radix Polygoni Multiflori 10g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 30g, Radix Angelicae Sinensis 30g, Fructus Tribuli 10g, Folium Mori 20g, Herba Ecliptae 10g, Radix Paeoniae Alba 10g, Rhizoma Polygonati 10g, Radix Glycyrrhizae 30g.
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| CN102357230A (en) * | 2011-11-01 | 2012-02-22 | 山东大学 | Traditional Chinese medicine preparation for treating radiation encephalopathy |
| CN102861164A (en) * | 2011-07-04 | 2013-01-09 | 中国人民解放军第二军医大学 | Chinese medicine composition for controlling radiation, its preparation method and application |
| CN104800692A (en) * | 2015-04-27 | 2015-07-29 | 陶俊荣 | Chinese material medicine preparation for alleviating side effects from radiation therapy and preparation method |
| CN104940567A (en) * | 2015-07-22 | 2015-09-30 | 单裕清 | Chinese material medicine preparation for treating mild hemopoietic acute radiation sickness and preparation method thereof |
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| CN1084403A (en) * | 1993-07-02 | 1994-03-30 | 利国威 | Radioprotector and production technology thereof |
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| CN1172952C (en) * | 2003-03-31 | 2004-10-27 | 成都利尔药业有限公司 | Mannosan peptide and its prepn and use |
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| CN102861164A (en) * | 2011-07-04 | 2013-01-09 | 中国人民解放军第二军医大学 | Chinese medicine composition for controlling radiation, its preparation method and application |
| CN102357230A (en) * | 2011-11-01 | 2012-02-22 | 山东大学 | Traditional Chinese medicine preparation for treating radiation encephalopathy |
| CN102357230B (en) * | 2011-11-01 | 2012-11-14 | 山东大学 | A traditional Chinese medicine preparation for treating radiation encephalopathy |
| CN104800692A (en) * | 2015-04-27 | 2015-07-29 | 陶俊荣 | Chinese material medicine preparation for alleviating side effects from radiation therapy and preparation method |
| CN104940567A (en) * | 2015-07-22 | 2015-09-30 | 单裕清 | Chinese material medicine preparation for treating mild hemopoietic acute radiation sickness and preparation method thereof |
| CN105617357A (en) * | 2016-03-02 | 2016-06-01 | 刘存兵 | Medicine composition used for nursing during stomach radiation injury pseudo-recovery period and preparation method thereof |
| CN105726776A (en) * | 2016-03-03 | 2016-07-06 | 郑州大学 | Traditional Chinese medicine for alleviating bone marrow inhibition reaction caused by paclitaxel chemotherapy |
| CN108452190A (en) * | 2018-06-27 | 2018-08-28 | 桐城市泰安中药材种植专业合作社 | A kind of anti-fatigue health-product containing and its processing method |
| CN112716998A (en) * | 2020-12-31 | 2021-04-30 | 天津中医药大学第一附属医院 | Traditional Chinese medicine preparation for treating pulmonary hypertension |
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