CN102100814A - Method for preparing nanometer traditional Chinese medicine for treating severe asthma and production method thereof - Google Patents

Abstract

The invention relates to a method for preparing a nanometer traditional Chinese medicine for treating severe asthma and a production method thereof. The nanometer traditional Chinese medicine comprises the following raw materials in part by weight: 10 to 20 parts of radish seed, 10 to 20 parts of shizandra berry, 15 to 30 parts of malaytea scurfpea, 6 to 12 parts of common threewingnut root and the like. The production process comprises the following steps of: ultrasonic extracting, microwave extracting, supersonic crushing, nanometer grinding, mixing, filling and the like. In the method, the nanometer traditional Chinese medicine has the synergetic and multi-targeting effects of nanometer medicaments. Products have the effects of concurrent treatment of lung, spleen, kidney and liver, tonification and purgation in combination and the like by treatment methods of warming yang, keeping strong and healthy, replenishing qi to invigorate spleen, warming lung to eliminate cold, resolving sputum, relieving asthma, dispelling dampness, resolving sputum, tonifying kidney, holding qi and the like. The nanometer traditional Chinese medicine has good effect of treating the severe asthma, can enhance the immunity in human bodies and does not have toxic or side effects.

Description

A kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma

Technical field

The present invention relates to a kind of treatment severe asthma nanometer Chinese medicine, the invention still further relates to this medication preparation and production method.

Background technology

The whole world has 1,500,000,000 people to suffer from asthma approximately, in state-owned 1,000 ten thousand～2,000 ten thousand patients, with between twenty and fifty and the child is in the majority.Become the main chronic disease of serious harm people ' s health.Its prevention has become the Chinese and western medicine current focus of attention of author clinically with treatment.

Doctor trained in Western medicine pathology confirms that bronchial mucosa has eosinophilic granulocyte and lymphocytic infiltration in early days.The bronchia smooth muscle has slight plumpness.Along with PD, and can have bronchus, bronchia mucous secretion to increase, the damage of basement membrane thickened degeneration and ciliated epithelial cell, variation such as come off.Late period can concurrent obstructive emphysema.Asthma continues the visible sticky expectorant bolt of outbreak and blocks bronchia and bronchioles, causes local pulmonary atelectasis, and emphysema finally can cause chronic pulmonary heart disease.Violent disease appearing at regular intervals can concurrent pneumothorax.

Differential diagnosis in tcm: the main pathological factor that causes primary disease is an expectorant, so-called " asthma is specially main in expectorant ", diseases caused by exogenous pathogenic factor, diet, imbalance after being ill, feelings will internal injury, fatigue etc. all are risk factors.The traditional Chinese medical science thinks, the syndrome of dyspnea is meant because being invaded by exogenous pathogen accumulates in expectorant is turbid, disorder of emotion and cause abnormal rising of lung-QI, and losing a surname Yu falls, or the prolonged illness deficiency of vital energy, loses in taking the photograph to receive, with dyspnea.Asthma should be deficiency in origin and excess in superficiality at the pathogenesis of acute stage, and mark is real to be wind, expectorant, gas, the stasis of blood, and deficiency in origin is the lung qi deficiency of YIN-blood.Asthma gradually reaches the liver spleen just at lung, and with the passing of time heart kidney is got involved.Disease develops into the serious stage, not only lung spleen kidney is all empty, in lonely sun desires to take off, have influence on the heart, all empty as lung spleen kidney, then the motive, heart-yang can not be agitated the blood vessels operation more, the blood clots absorbing stagnates and meeting color, color of the lip, fingernail are livid purple, dyspnea and sweating very then occurs and cause and take off, the dangerous symptom of exhaustion of YIN YANG-depletion, this is the clinical findings status asthmaticus.

The common lung of primary disease, spleen, kidney tool void, about the cause of disease of the syndrome of dyspnea, say as " danxi's experiential therapy is breathed heavily ": " institute of six climate exopathogens seven emotions hinders, the action of being satiated with food, and the visceral-qi discord, the breath of breathing, must not declare freely is dyspnea with rapid respiration.The all empty weak people of spleen kidney are also arranged, all can breathing heavily." Ming Dynasty's Zhang Jingyue reduces deficiency and excess two cards to the syndrome of dyspnea, " Jing Yue's complete work dyspnea with rapid and short breath " said: " the excess-dyspnea person has heresy, and excess of pathogen is also; Dyspnea due to deficiency person naivete, first deficiency of vital energy also." comprised the syndrome of dyspnea that causes " breath of breathing must not be declared smooth " by the strongly fragrant lung of cold-phlegm in the excess-dyspnea.About the formation of cold-phlegm, mainly be because the diseases caused by exogenous pathogenic factor cold-evil, the visitor is in internal organs or innate deficiency of YANG in the body, can not be warm and give birth to endogenous cold, or both have both at the same time, and influences the gasification of internal organs to water liquid, make that water liquid transfers, compress generation obstacle, so that water liquid stops and the generation phlegm retention poly-.Cold-evil and phlegm retention are handed over resistance, and lung qi is stopped up stagnant, thus see side of body rib distension, abnormal rising of lung-QI, so see dyspnea with rapid and short breath, stagnation of phlegm air flue, gas touch its expectorant, so see gurgling with sputum such as water bird sound.Kidney governing inspiration is led by lung though breathe, and the gas of suction must descend and in kidney, is taken the photograph for it by kidney qi and receives.Confirmed that insufficiency of kidney-YANG is the most basic pathomechanism of primary disease, the control asthma attack is worked as with the kidney invigorating warming YANG improving inspiration by invigorating kidney-QI for wanting." Lei Zheng Zhi Cai? asthma " cloud: " the lung being the dominator of QI, the kidney being the root of QI. lung the master give vent to anger, kidney governing inspiration, negative and positive intersect, breathing be and. if come in and go out abnormal ascending-descending of QI. here this breathes heavily work " has been illustrated the outbreak of asthma and the substantial connection of lung kidney.

Phlegm retention volt lung is long-standing of asthma, in view of the above should ancestor's traditional Chinese medical science, and " sick phlegm retention person is when " serving as to treat rule with warm medicine and it.The generation of expectorant this in asthenia of both the spleen and kidney, the void of spleen kidney, it comes also gradually, it goes also slow, and this is that asthma is controlled repeatly repeatly and sent out the reason place that prolonged difficulty heals, the product of advocating to use temperature male wind-supplying kidney strengthen patient's body constitution to consolidate, and " healthy energy is deposited interior " could really break off the perennial root of asthma.In addition, pathological changes such as stagnation of liver-QI QI rising in reverse order, liverzang-fire attacking lung, the ring of wind rocking clock, stagnated phlegm impairing the lung also can appear in liver, lung two dirty functional disorders, thereby cause the generation of asthma.

The disease being located in YANG position person, invigorating YANG presses down cloudy; Sick cloudy person, cloudy with sunization.So emphasize when controlling in opinion " control but hold up kidney-Yang, inside and outside two heresies all can be gone out, and are not control heresy and real control heresy also ".The yang deficiency most important point be exactly in the Gu of burnt temper protect the growth of temper.Sun is born in the liver spleen, and spleen falls into and edema with the liver involved does not rise, and wet is declining, and the no the source of vital function of sun, the root that spleen falls into is because of declining in the wet kidney qi of soil, and what soil wet trembles with fear by coming from water.The root that spleen falls into is because of the deficiency of kidney-QI that wets in soil, and kidney qi is to close the gas of Tibetan, and irritability rises, and the liter of Yuanyang is moving will to lean on liver, and in Yuanyang rose, beneath kidney qi can not be closed the Tibetan, and Yuanyang will down be let out, and this is the phenomenon that a kind of spleen falls into.It is moving that the irritability desire will rise the liter of Dalai's temper, do not foster middle soil, do not rise the spleen sun, and the wet infra that stagnates of stopping up of water, the gas of edema with the liver involved can not be from rising, then must under let out.Bronchial asthma patient's decline variation then shows as the deficiency of YIN, yang deficiency, the deficiency of vital energy, blood deficiency, QI and blood deficiency, final vital organs of the human body tool void, negative and positive tool void, patient death.

Chinese herbal medicine China has become the important object of new drug development exploitation, the one matter of Chinese herbal medicine, active substance group and Chinese medicine nanometer powder have special advantages, two-ways regulation function that it is remarkable and less toxicity, side effect have obtained the generally approval of world medical circle, the effect of main Chinese medicine in this prescription:

Ramulus Cinnamomi, nature and flavor suffering, sweet, temperature.Return spleen, heart channel, relieving the exterior syndrome by diaphoresis, promoting the flow of QI-blood by warming the meridian, activating YANG and prormoting functioning of QI, diuresis.Active ingredient contains Oleum Cinnamomi, mainly contains cinnamic aldehyde, Cortex cinnamomi japonici (Ramulus Cinnamomi) acetic acid fat etc.Pharmacological research has inhibitory action to external to tumor cell, and Oleum Cinnamomi has spleen invigorating, spasmolytic, analgesia, cardiotonic.Be used for that Deficiency and coldness of spleen and stomach, fortuneization mistake department, mental disorder stagnate, blood stasis congelation, cold and stagnate, the cancer of qi depression to blood stasis, cardiopalmus, limb swelling etc.The Ramulus Cinnamomi ethanol extract can suppress escherichia coli, bacillus subtilis and staphylococcus aureus external, and valid density is 25mg/ml or following; Staphylococcus albus, dysentery bacterium, typhoid fever and paratyphoid fever bacillus, streptococcus pneumoniae, aerobacteria, Bacillus proteus, anthrax bacillus, Salmonella enteritidis, vibrio cholera etc. also there is inhibitory action.Ramulus Cinnamomi decoct (1: 20) has inhibitory action to the first type capital 68-1 of section strain of influenza Asia and Orphan virus.Influenza virus there is inhibitory action, better with 70% pure preserved material effect.

Radix Morindae Officinalis, property is sweet, suffering, tepor is returned kidney, Liver Channel.Function with cure mainly: reinforcing the kidney and supporting YANG, muscle bone strengthening, remove wind damp eliminating, bone and muscle strengthening.Be used for rheumatic arthralgia, soft, the few abdomen cold type of pain of muscles and bones flaccidity, sexual impotence cold womb etc.Radix Morindae Officinalis the kidney warming sun and fall dry, but exorcising training Yuanyang, ailment said due to cold or exposure is gone, then defend not strong, Wei Buqiang can with flourish and, Rong Wei peace, cooperate Rhizoma Atractylodis Macrocephalae spleen invigorating dehumidifying and in, to change the taste kidney raw, cooperates the Ramulus Cinnamomi sweet and pungent flavors inducing perspiration and pertaining to yang; Radix Morindae Officinalis can reduce patient's acidophil absolute counting, and level is eliminated airway inflammation, thereby played warming and recuperating the kidney-YANG, the helping inspiration to relieve asthma effect. improve patient's symptom and pulmonary function.Iridoid has 29 in the Radix Morindae Officinalis platymiscium, and wherein aglycon is 3, up to the present, has separated from the Radix Morindae Officinalis platymiscium and the chemical constituent type that identifies mainly contains anthraquinone, iridoid, oligosaccharide, polysaccharide etc.Iridoid has wide biological activity, and pharmacological research shows, iridoid has pharmacological actions widely such as antibiotic, antioxidation, antimutagenic, antitumor, anti-inflammatory analgesic in the Radix Morindae Officinalis platymiscium.The citrifolinin B Wheat Protein that contains in the Morinda Citifolia leaf, the concentration of 30 μ mol can be removed the DPPH free radical.Radix Morindae Officinalis water extract can improve the antineoplastic immune function of tumor mice.

The Rhizoma Pinelliae, its acrid in the mouth warm in nature is returned spleen, stomach, lung meridian.Effect mainly contains stopping nausea and vomiting by lowering the adverse flow of QI, reduces phlegm and exempt from drink, dissolving lump and resolving mass, invigorating spleen and reinforcing stomach, removing obstruction in the collateral to relieve pain, and clinical practice is very extensive.The logical three warmers of transferring of the Rhizoma Pinelliae, acrid in the mouth warm in nature looses, and assistant Ramulus Cinnamomi cold expelling opening lung-energy promptly by the cold strong defensive QI weak nutrient QI that causes of ailment said due to cold or exposure (sun is floating cloudy weak), only to induce sweat, is assistant.Should be fried boiling earlier when using Rhizoma Pinelliae and be advisable in 30 minutes, avoid side effect such as mouthful fiber crops.Contain multiple compositions such as alkaloid, cupreol, polysaccharide, aminoacid, volatile oil, pinellin and inorganic elements in the Rhizoma Pinelliae.Expert report has been arranged Rhizoma Pinelliae Pharmacological action study progress points out that the Rhizoma Pinelliae can be applicable to antitussive, antiulcer, tranquilizing soporific, detoxifcation antiinflammatory and blood pressure lowering in clinical, conforms to substantially with the effect of drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.The processed product total alkaloids of the Rhizoma Pinelliae can suppress the chronic myelogenous leukemia cell.The polysaccharide that extracts from the Rhizoma Pinelliae can strengthen the phagocytic function of reticuloendothelial system, suppresses the generation and the propagation of tumor.Further observe and show that the precipitation part of pinellin 30% ammonium sulfate has the stronger effect that impels apoptosis of tumor cells.Rhizoma Pinelliae total alkaloids all has tangible antagonism effect to multiple inflammatory animal model.Rare alcohol of the Rhizoma Pinelliae or water diffuse out liquid zoopery mice with tumor hepatocarcinoma (HCA), murine sarcoma S180 and human cervical carcinoma (HeLa) cell are all had the obvious suppression effect.

Radix Angelicae Sinensis, sweet in the mouth, suffering, warm in nature.GUIXIN, liver, lung, spleen channel.Effect: benefiting blood and regulating blood circulation, menstruction regulating and pain relieving is moisturized laxation.Cure mainly amenorrhea stomachache, the lump in the abdomen knot is poly-, metrorrhagia, and headache due to deficiency of blood, dizzy, flaccidity syndrome and arthralgia syndrome, the dryness of the intestine dyschezia, heavy after the bloody dysentery, ulcer sores, injury from falling down.Domestic and international many scholars have carried out comparatively studying in great detail to the pharmacological action of Radix Angelicae Sinensis.Radix Angelicae Sinensis composition n-butene husband's lactone and ligustilide have relaxation effect to tracheal smooth muscle, the bronchial asthma that can cause antihistamine-acetylcholine.Radix Angelicae Sinensis has obvious effect to body immune system, hemopoietic system, also demonstrates better curative effect at aspects such as antiinflammatory, antitumor in addition.Angelica lactone can be by the immunosuppressive action of different approaches antagonism chemical factor initiation.

The Radix Astragali is sweet, temperature.Return lung, spleen channel.Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.It is weak to be used for the deficiency of vital energy, anorexia and loose stool, and sinking of QI of middle-JIAO, the chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst for a long time and do not hold back, the blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Can treat multiple chronic disease etc., its mechanism may realize by the human body immunity improving function.The Radix Astragali can improve body's immunological function and the quality of making the life better. and astragalus polysaccharides can play the effect that suppresses tumor by strengthening the mouse cell immune level. and astragalus root contains 2 ', 4 '-dihydroxy-5,6-dimethoxy isoflavone, kumatakenin, choline, betanin, polysaccharide, glucuronic acid and micro-folic acid.The effective ingredient F3 of Radix Astragali promoting immunity shows that patient's lymphocyte function is had the effect of completeness immune restoration in external XGVHR test, can demonstrate the immunosuppressant phenomenon that whole reverses cause because of cyclophosphamide in vivo in the animal model test, the prompting astragalus root components may be a biological response modifier that gets a good chance of in immunization therapy.The another kind of composition Hedysamn polysaccharide of the Radix Astragali can significantly improve mouse macrophage phagocytic index and E-garland formation rate, and showing has the effect that improves non-specific immunity and cellular immunity.The Radix Astragali can also be treated other disease of immune system, especially viral infection, chronic disease is had special effect.

The Rhizoma Atractylodis Macrocephalae, property bitter but sweet flavor, temperature.Return spleen, the heart, stomach, tri-jiao channel.Spleen reinforcing stomach reinforcing dampness and in, tonify deficiency is stopped up stagnate-closed, and is slowly soft, can enter into the ground of Zhiyin, can go the yin channel cold-damp, in the wood gas dryness-transformation, effect is defended tenaciously in wind-transformation; Cure mainly deficient QI of the spleen and stomach, anorexia, the asthenia weak breath, deficiency-distension is had loose bowels, phlegm retention, edema, jaundice, arthralgia chiefly caused by damp pathogen, dysuria, dizziness, spontaneous perspiration is spleen QI invigorating first key medicine.It is not dry with getting its spleen invigorating that the Rhizoma Atractylodis Macrocephalae is given birth to, and frying with dampness strength then increases, parching to brown then be used in spleen wet have cold, so the general deficiency of the spleen causing weakness of QI Rhizoma Atractylodis Macrocephalae.The Rhizoma Atractylodis Macrocephalae has vasorelaxation action." book on Chinese herbal medicine can compile ": the spleen being adverse to dampness, domination of damp pathogen then gas must not executing, and Tianjin what by life? so say: the bladder person, the mansion of body fluid, here gasification then can go out.Wet with the Rhizoma Atractylodis Macrocephalae to remove it, then be so incensed that circumfluence and the body fluid life." Bencao Jingshu ": art, its gas virtue is strong, and its sweet in the mouth is dense, and the pure sun of its property is for removing medicine on the migratory arthralgia, the superb work of peace taste." herbal classic " water-damp from the earth is felt the skin and flesh muscles and bones of then victimizing.Dead flesh person, noxious dampness is invaded muscle also.Convulsion person, wind and cold take advantage of a weak point in opponent's defence the visitor due to the liver,spleen,kidney also.Subcutaneous ulcer person, taste void and humid-heat stagnation are also.As above all diseases there's no one who doesn't or isn't form by wind and cold is wet, and the Rhizoma Atractylodis Macrocephalae has the merit except that this three heresy, so the disease due to it of dispelling.The Rhizoma Atractylodis Macrocephalae can strengthen the phagocytic function of reticuloendothelial system, and when leukopenia, the Rhizoma Atractylodis Macrocephalae has leukogenic effect.The Rhizoma Atractylodis Macrocephalae can also improve lymhocyte transformation rate and natural Flos Rosae Rugosae formation rate, promotes cellular immune function, and obviously increases IgG.Illustrate that the Rhizoma Atractylodis Macrocephalae has the effect of strengthening the spleen and stomach, strong health and disease resistance enhancemen.The Rhizoma Atractylodis Macrocephalae has the obvious suppression effect to platelet aggregation.

Flos Magnoliae is a diaphoretic medicine commonly used, its warm in nature, acrid in the mouth, attach to the lung and stomach meridians, effect with dispersing wind and cold, clearing the nasal passage, the effect that Flos Magnoliae volatile oil (VOMbP) has significant antianaphylaxis airway inflammation, be in particular in: 1. can obviously prolong drawing of sensitized animal breathes heavily incubation period, alleviates the symptom of the early stage phase reaction of asthma.2. can suppress asthma animal phase in late period blood circulation and air flue eosinophilic granulocyte's (EOS) increase and infiltration, inflammatory cells such as antagonism EOS.

Contained theophylline can relaxing smooth muscle in the Folium Camelliae sinensis rich in selenium, so in order to treat bronchial asthma.Trace element-selenium can effectively prevent and treat asthma.Studies show that: asthma patient is after selenium supplement, and clinical symptoms all can take a turn for the better, and cough alleviates, amount of expectoration reduces, wheezing sound reduces or disappearance in the lung, pulmonary function is significantly improved, and especially SAO obviously alleviates, and selenium has important meaning to prevention and treatment asthma.The extract of Radix Tripterygii Wilfordii has the effect that reduces the animal model in asthma airway reactivity, and Tripterygium glycosides has the obvious suppression effect to asthmatic patient Th2 production of cytokines, is the important mechanisms of treatment asthma.

Fructus Psoraleae is the legumes psoraleae fruit, and is warm in nature, acrid in the mouth, the kidney invigorating yang deficiency, the effect of tool reinforcing the kidney and supporting YANG.Cure mainly the cold diarrhea of suffering from a deficiency of the kidney, frequent micturition, sexual impotence, chills and pain of the waist and kness, deficiency and coldness is breathed with cough.Modern study shows that Fructus Psoraleae has blood vessel dilating, increases myocardial contraction, and is antibiotic, the effect of estrogen sample, and Fructus Psoraleae total coumarins is to all there being incubation period of allergic asthma and histamine asthma significant prolongation effect (P＜0.01 and P＜0.05); Significantly reduce animal dead rate (P＜0.05).Fructus Psoraleae total coumarins can directly be expanded the guinea pig bronchial smooth muscle, and can be shunk by the bronchial smooth muscle that histamine causes by antagonism.Fructus Psoraleae total coumarins has Zhichuan effect preferably, and asthma is had tangible antagonism.

The Rhizoma Belamcandae clearing throat, the lung qi dispersing eliminating phlegm, Rhizoma Belamcandae extract has obvious clinical efficacy to the senile asthma patient, and to take off granule relevant with suppressing the eosinophilic granulocyte.The senile asthma patient adds when carrying out conventional therapy and uses the Rhizoma Belamcandae decoction, obviously shorten than the conventional therapy group course of disease, clinical symptom remission is very fast, main lung function index FEV1 and PEF obviously improve, improvement significantly is better than the conventional therapy group to ECP, illustrates that Rhizoma Belamcandae extract has the obvious treatment effect to the senile asthma patient.Herba Ephedrae depressed lung-energy dispersing, Herba Ephedrae have lax bronchial smooth muscle of expansion and antiinflammation.Ephedroxane helps disappearing of respiratory inflammation in the Herba Ephedrae, and Herba Ephedrae water extract, ethanol extract can suppress sensitive media and discharge.The Rhizoma Belamcandae Herba Ephedrae can be improved the pulmonary function of asthmatic patient, can reduce endothelin level, blood plasma viscosity level.

A little less than the gas yang deficiency the important endogenous cause of ill that asthma is shown effect repeatedly, Radix Astragali benefiting QI for strengthening the superficies among the we.Radix Angelicae Sinensis sweet in the mouth suffering, warm in nature, can enrich blood with activating QI.Radix Glycyrrhizae has raise immunity, anti-allergic effects and antiasthmatic effect.Ramulus Cinnamomi focuses on harmonizing yingfen and weifen two gas, and square Ramulus Cinnamomi acrid-sweet flavor temperature is gone into spleen, heart channel, and Xin Wen disperses, suffering is opened lung qi, promoting the flow of QI-blood by warming the meridian, activate yang and cloudy activating QI, diuresis; Ramulus Cinnamomi, Radix Angelicae Sinensis, Herba Ephedrae (processed), Fructus Schisandrae Chinensis Chinese medicine etc. can reduce asthmatic patient air flue eosinophilic granulocyte quantity, reduces ECP's level and reduces the reactivity of air flue, thereby effectively prevent and reduce the outbreak of asthma.Have the effect that strengthens patient's peripheral blood lymphocyte acceptor quantity. can correct too high receptor affinity again simultaneously, can avoid, receptor stimulating agent and the bronchorelaxing activity that causes because of life-time service.The Radix Peucedani effective ingredient is mainly Coumarins, and Radix Peucedani has antipyretic-antalgic, the wind heat clearing function looses; Clinical be used for the treatment of cough due to pathogenic wind-heat, expectorant dyspnea of heat type full, cough up phlegm yellow thick etc.Fructus Perillae sending down the abnormal ascending QI Dingchuan, promoting the circulation of QI reduces phlegm.The Rhizoma Pinelliae connects three warmers.Gecko the kidney invigorating lung benefiting improving inspiration by invigorating kidney-QI.Pheretima has antiasthmatic effect, and bronchus is had significant diastole effect.Fructus Schisandrae Chinensis convergence lung qi.The Herba Houttuyniae heat-clearing and toxic substances removing.The Poria air making-up and spleen enlivening.Drying dampness to eliminate phlegm such as Fructus Perillae, the Rhizoma Atractylodis Macrocephalae, tonifying speen and tonifying kidney, promoting the circulation of QI reduces phlegm.Ramulus Cinnamomi temperature compensation kidney the yang aspect of yang.

Novelty and breakthrough that the present invention has essence are to have found out the key point that treatment severe asthma nanometer Chinese medicine Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of treatment severe asthma nanometer Chinese medicine " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano-powder that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.

See that further the present invention is that the employing sun is developed a kind of treatment severe asthma nanometer Chinese medicine greater than cloudy theory, proves according to the novelty assessment report conclusion, the present domestic reported literature that has the utilization sun to research and develop the nanometer tcm product greater than the moon theory of not seeing.

This prescription drug effect and function and sun six cloudy four treatment mechanism focus on training mend eliminating evil, Wen Huaxuan looses, the respectful lung of expectorant, giving consideration to both the incidental and fundamental.This prescription has temperature male wind-supplying kidney, replenishing QI to invigorate the spleen, training unit invigorating YANG, sets upright effects such as timid heresy, liver and kidney tonifying, warming YANG to expel cold, spleen invigorating dehumidifying, heart tonifying lung benefiting, heat-clearing and toxic substances removing, nourishing YIN and benefiting blood, clearing away phlegm damp eliminating, removing food stagnancy and dispersing accumulation, the dampness of relieving oedema or abdominal distension through diuresis or purgation.Be used for the serious symptom bronchial asthma, the bronchial asthma patient is recovered gradually.Can strengthen patient's body's immunity, duration of efficacy is long, and late result is stable, the cure rate height, and without any toxic and side effects.

Summary of the invention:

Purpose of the present invention is exactly in order to solve the above-mentioned problems in the prior art, and a kind of treatment severe asthma nanometer Chinese medicine preparation and production method thereof are provided.

Purpose of the present invention is achieved through the following technical solutions:

A kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: this nanometer Chinese medicine raw materials of effective components and weight proportion---

Semen Raphani 10-20 part, Fructus Schisandrae Chinensis 10-20 part, Fructus Psoraleae 15-30 part, Radix Tripterygii Wilfordii 6-12 part, Radix Peucedani 10-20 part, Ramulus Cinnamomi 8-16 part, Radix Astragali 30-60 part, Pheretima 15-30 part, Rhizoma Pinelliae 6-12 part, Radix Glycyrrhizae 5-10 part, Poria 10-20 part, Radix Angelicae Sinensis 15-30 part, Fructus Perillae 10-20 part, Gecko 1-2 part, Flos Magnoliae 10-20 part, Rhizoma Belamcandae 15-30 part, tea rich in selenium 6-12 part, Rhizoma Atractylodis Macrocephalae 20-40 part, Radix Morindae Officinalis 15-30 part, Herba Ephedrae (processed) 5-10 part, Herba Houttuyniae 15-30 part.

Above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: the weight proportion of described each raw material is---

Semen Raphani 10-18 part, Fructus Schisandrae Chinensis 10-18 part, Fructus Psoraleae 15-25 part, Radix Tripterygii Wilfordii 6-10 part, Radix Peucedani 12-18 part, Ramulus Cinnamomi 8-12 part, Radix Astragali 35-50 part, Pheretima 18-25 part, Rhizoma Pinelliae 6-10 part, Radix Glycyrrhizae 5-8 part, Poria 12-18 part, Radix Angelicae Sinensis 18-25 part, Fructus Perillae 12-18 part, Gecko 1-1.5 part, Flos Magnoliae 12-18 part, Rhizoma Belamcandae 18-25 part, tea rich in selenium 8-10 part, Rhizoma Atractylodis Macrocephalae 20-30 part, Radix Morindae Officinalis 18-25 part, Herba Ephedrae (processed) 5-8 part, Herba Houttuyniae 15-25 part.

Further, above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: the weight proportion of described each raw material is---

15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

Further, above-mentioned a kind of treatment severe asthma nanometer Chinese medicine, wherein: the present invention adopts sun greater than yin, yang six cloudy four theoretical this prescription of research and development and nanometer Chinese medicines.Medicine is become medicine support material medicine with preparing carriers, crude drug can be a nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, one or more combinations in the microcapsule etc., the final prepared end product that goes out can be a tablet, pill, powder, suppository, granule, membrane, capsule, microcapsule, effervescent, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral solution, dosage forms such as plaster.

Again further, above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: said Chinese medicine is rich in organic selenium.The drug carrier material that the present invention selects for use, adjuvant, colloid, activating agent, help Emulsion, excipient substances such as dispersant can be gelatin, albumin and starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid and cyanoacrylate, the semisolid poe, triglyceride is (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride is (as glyceryl monostearate, contain list, two, the synthetic glyceride of triglyceride), steroidal class (cholesterol etc.), Polyethylene Glycol, wax class (microcrystalline wax, whale ester type waxes), erythrocyte, Montmorillonitum, in the bentonite etc. one or more.

A kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, it may further comprise the steps:

Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.

Step 2: get 25% each Chinese medicine micropowder and mix immersion 1-2 days with the 30%-90% alcohol-water solution that 6-12 doubly measures, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, and recovered alcohol gets extract with standby.

Step 3: get 25% various medicine micropowder, adopt the high-frequency ultrasonic of independent research to disperse the pulverizing extraction equipment to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz-120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.

Step 4: get 10% each Chinese medicine micropowder, adopt the swing nanon ball-mill of independent research to grind 4-16 hour, obtain the nano powder that particle size distribution is the 50-1000 nanometer, standby.

Step 5: get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.

Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.

Step 7: the said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.

Step 8: by " preparation part of standards code requirement in the Chinese pharmacopoeia is got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, microcapsule one or more and mixed.

Step 9: in GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.

Step 10: the end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.

Above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced breaking method, extracting method and technology.

Further, above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: the medicine monomer in the described step 6, active substance, effective site technology of preparing, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.

Further, above-mentioned a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, wherein: the dissimilar crude drug such as nanoparticle that adopt the different pharmaceutical adjuvant to be prepared in the described step 7, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.

Again further, above-mentioned a kind of nanometer Chinese medicine for the treatment of severe asthma prepares and production method, and wherein: its key point is according to the nanometer particle size difference of crude drug and the property of medicine and uses the different of carrier, can produce the gentle controlled capability of different targeting.

The outstanding substantive distinguishing features and the obvious improvement of technical solution of the present invention is mainly reflected in:

Novelty and breakthrough that the present invention has essence are to have found out the key point that treatment severe asthma nanometer Chinese medicine Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of treatment severe asthma nanometer Chinese medicine " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano-powder that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.

See that further the present invention is that the employing sun is developed a kind of treatment severe asthma nanometer Chinese medicine greater than cloudy theory, proves according to the novelty assessment report conclusion, the present domestic reported literature that has the utilization sun to research and develop the nanometer tcm product greater than the moon theory of not seeing.Prescription is to adopt sun to make main dialectical opinion greater than yin, yang six cloudy four theories to control method, pays attention to the collaborative idea of human body integral, pays attention to selenium-enriched nano medicine Synergistic treatment scheme.Emphasize that the vital organs of the human body, the four stages in the course of an epidemic febrile disease, body fluid marrow are in harmonious proportion with mending, the cold warm medicine of a cold nature of heat and with, inside and outside administration develop simultaneously, the midnight-noon and ebb-flow doctrine QI and blood flows to the position medication of timesharing branch.This prescription is by setting upright timid heresy, monarch reasonable compatibility, and the Chinese medicine of will filling a prescription is taken four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Nanometer Chinese medicine is made film former be attached to the affected part, can and need not inject, strengthened the biological activity of single variety behind the prescription nanorize, reach the purpose of enhancing immunity, treatment serious symptom bronchial asthma by the direct absorption of skin.This prescription is taken for a long time and is had no side effect, be fit to various crowd's enhancing immunity, improve human body antitumor, anti-virus ability, various tumor patients, viral infection patient are all had therapeutical effect, and the mode of production has then been gathered the integration that high-frequency ultrasonic extracts advanced technologies such as disperseing crushing technology, microwave extracting technology of preparing, supersonic speed dry technology, the grinding of efficient physical nanoscale.The prescription theory is to be based upon on a large amount of traditional Chinese medical science works, pharmacology of Chinese materia medica, pharmacodynamics, toxicology, biotechnology, modern pharmaceutical technology, high frequency ultrasound wave technology, microwave-assisted extraction technique, the nanotechnology scheduling theory, is many interdisciplinary technology set.This shows that the present invention has substantive technical characterstic and significant technological progress, its application prospect is boundless.

Purpose of the present invention, advantage and characteristics will make an explanation by the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical solution of the present invention, and all technical schemes of taking to be equal to replacement or equivalent transformation and forming all drop within the scope of protection of present invention.

The specific embodiment

A kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma, its special feature is: making the raw materials of effective components composition is by weight ratio---

Semen Raphani 10-20 part, Fructus Schisandrae Chinensis 10-20 part, Fructus Psoraleae 15-30 part, Radix Tripterygii Wilfordii 6-12 part, Radix Peucedani 10-20 part, Ramulus Cinnamomi 8-16 part, Radix Astragali 30-60 part, Pheretima 15-30 part, Rhizoma Pinelliae 6-12 part, Radix Glycyrrhizae 5-10 part, Poria 10-20 part, Radix Angelicae Sinensis 15-30 part, Fructus Perillae 10-20 part, Gecko 1-2 part, Flos Magnoliae 10-20 part, Rhizoma Belamcandae 15-30 part, tea rich in selenium 6-12 part, Rhizoma Atractylodis Macrocephalae 20-40 part, Radix Morindae Officinalis 15-30 part, Herba Ephedrae (processed) 5-10 part, Herba Houttuyniae 15-30 part.

With regard to the present invention's one preferred embodiment, described each raw material can adopt following weight proportion:

15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

Again further, treatment severe asthma nanometer Chinese medicine of the present invention can be fast in the gastrointestinal disintegrate, in water, in the body solid dispersion good, absorb rapidly fully, bioavailability is good, stronger targeting and tunneling are arranged, effective ingredient pharmacological action effect is significantly higher than conventional formulation.

Production method of the present invention may further comprise the steps: gets each prepared slices of Chinese crude drugs pretreatment, inserts pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, and standby.Get 25% each Chinese medicine micropowder and mix immersion 1-2 days with the 30%-90% alcohol-water solution that 6-12 doubly measures, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, and recovered alcohol gets extract with standby.Get 25% various medicine micropowder, adopt the high-frequency ultrasonic of independent research to disperse the pulverizing extraction equipment to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.Get 10% each Chinese medicine micropowder, adopt the swing nanon ball-mill of independent research to grind 4-16 hour, obtain the nano powder that particle size distribution is the 50-1000 nanometer, standby.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.With above-mentioned gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.The said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.By " preparation part of standards code requirement in the Chinese pharmacopoeia is got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, microcapsule one or more and mixed.In GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.The end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.

" embodiment one "

Press the following crude drug of preceding method preparation:

Extractum, nanoparticle, microcapsule, nanoparticle.

It makes the raw materials of effective components composition---

15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

Its manufacture process is as follows:

In GMP10000 level toilet with extractum, nanoparticle, microcapsule, nanoparticle in 4: 2: 2: after 2 ratios are mixed, adopt latest edition " Chinese pharmacopoeia preparation part hard capsule standard, do not add adjuvant, antiseptic, adopt fully-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.

" embodiment two "

Press the following crude drug of preceding method preparation:

Water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion, nanometer suspension liquid.

It makes the raw materials of effective components composition---15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

Its manufacture process is as follows:

In GMP10000 level toilet with water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion, nanometer suspension liquid in 5: 1: 1: after ratio was mixed in 2: 1, adopt latest edition " Chinese pharmacopoeia preparation part soft capsule standard, do not add adjuvant, antiseptic, adopt full-automatic soft capsule filling machine packing soft capsule, make soft capsule.Carry out several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.

" embodiment three "

Press the following crude drug of preceding method preparation:

Extractum, solid lipid nanoparticle, nano-emulsion.

It makes the raw materials of effective components composition---15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

Its manufacture process is as follows:

After in the GMP10000 level toilet extractum, solid lipid nanoparticle, nano-emulsion being mixed in 4: 3: 3 ratios, " Chinese pharmacopoeia preparation part membrane standard, filmogen adopts polyvinyl alcohol, makes membrane to adopt latest edition.Adorn box again, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.Every membrane area size is the 2-40 square centimeter, and content of dispersion is the 1.2-5 gram, and every medicine film pasted 12-72 hour, pasted the medicine position: positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.

By above-mentioned text description as can be seen: novelty and breakthrough that the present invention has essence are to have found out the key point that treatment severe asthma nanometer Chinese medicine Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of treatment severe asthma nanometer Chinese medicine " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano-powder that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.

This prescription is collaborative, the many targeted therapies scheme of employing selenium-enriched nano Chinese medicine.Used Chinese medicine mostly is rich in the high-activity nano organic selenium, the one matter monomer of the contained existing Chinese medicine of raw material of Chinese medicine, the effective part group that Chinese medicine is arranged again also has the nano-powder of Chinese medicine and micro-powder and Chinese medicine extract, concentrated solution, concentrates and invade cream, volatile wet goods.Have anti-airway allergy inflammation, airway hyperreactivity, enhancing immune function of human body, antiviral and antiphlogistic effect.Dialectical opinion is controlled and is adopted sun to make main rationale greater than cloudy theoretical, positive six cloudy four therapies, pay attention to the human body integral idea, emphasize that the vital organs of the human body, the four stages in the course of an epidemic febrile disease, body fluid marrow are in harmonious proportion with mending, the cold warm medicine of a cold nature of heat and develop simultaneously, flow to the position medication of timesharing branch by the midnight-noon and ebb-flow doctrine QI and blood with, inside and outside administration.Can directly or indirectly suppress the infiltration of inflammatory cells such as lymphocyte, thereby suppress airway inflammation, reduce airway hyperreactivity.

Further, these various rich selenium Chinese medicine nanometer particle size major parts of filling a prescription are the granule of 40～250 nanometers, the nanometer Chinese medicinal granule has tunnel-effect, cells such as penetrable lung, liver, spleen, strengthen nanometer selenium, Chinese medicine one matter and Chinese medicine active substance group attack, infected tissue is recovered gradually virus, inflammatory cell.This prescription and effective ingredient treatment serious symptom bronchial asthma thereof realize that by many target spots, multipath, too many levels the theoretical basis of this prescription selenium-enriched nano Chinese medicine and effective ingredient thereof will be opened up new approach for treatment serious symptom bronchial asthma.The preparation of we's Nano medication, ultrasonic extraction Chinese medicine technology advanced person, the dosage form novelty, used effective ingredient is clear and definite, and medicine effect has obtained admitting of modern medicine, and these will promote the development of China's Chinese medicine industry.

Claims (10)

1. a nanometer Chinese medicine for the treatment of severe asthma prepares and production method, it is characterized in that: this prescription raw materials of effective components and weight proportion---Semen Raphani 10-20 part, Fructus Schisandrae Chinensis 10-20 part, Fructus Psoraleae 15-30 part, Radix Tripterygii Wilfordii 6-12 part, Radix Peucedani 10-20 part, Ramulus Cinnamomi 8-16 part, Radix Astragali 30-60 part, Pheretima 15-30 part, Rhizoma Pinelliae 6-12 part, Radix Glycyrrhizae 5-10 part, Poria 10-20 part, Radix Angelicae Sinensis 15-30 part, Fructus Perillae 10-20 part, Gecko 1-2 part, Flos Magnoliae 10-20 part, Rhizoma Belamcandae 15-30 part, tea rich in selenium 6-12 part, Rhizoma Atractylodis Macrocephalae 20-40 part, Radix Morindae Officinalis 15-30 part, Herba Ephedrae (processed) 5-10 part, Herba Houttuyniae 15-30 part.

2. a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma according to claim 1, it is characterized in that: the weight proportion of described each raw material is---

Semen Raphani 10-18 part, Fructus Schisandrae Chinensis 10-18 part, Fructus Psoraleae 15-25 part, Radix Tripterygii Wilfordii 6-10 part, Radix Peucedani 12-18 part, Ramulus Cinnamomi 8-12 part, Radix Astragali 35-50 part, Pheretima 18-25 part, Rhizoma Pinelliae 6-10 part, Radix Glycyrrhizae 5-8 part, Poria 12-18 part, Radix Angelicae Sinensis 18-25 part, Fructus Perillae 12-18 part, Gecko 1-1.5 part, Flos Magnoliae 12-18 part, Rhizoma Belamcandae 18-25 part, tea rich in selenium 8-10 part, Rhizoma Atractylodis Macrocephalae 20-30 part, Radix Morindae Officinalis 18-25 part, Herba Ephedrae (processed) 5-8 part, Herba Houttuyniae 15-25 part.

3. according to described a kind of preparation of nanometer Chinese medicine and the production method thereof for the treatment of severe asthma of claim 1.2, it is characterized in that: the optimum weight proportioning of described each raw material is---

15 parts of Semen Raphanis, 15 parts of Fructus Schisandrae Chinensis, 20 parts of Fructus Psoraleaes, 8 parts of Radix Tripterygii Wilfordiis, 15 parts of Radix Peucedanis, 10 parts of Ramulus Cinnamomi, 40 parts of the Radixs Astragali, 20 parts of Pheretimas, 8 parts of the Rhizoma Pinelliaes, 6 parts in Radix Glycyrrhizae, 15 parts of Poria, 20 parts of Radix Angelicae Sinensis, 15 parts of Fructus Perillaes, 1 part of Gecko, 15 parts of Flos Magnoliaes, 20 parts of Rhizoma Belamcandae, 10 parts of tea rich in selenium, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Radix Morindae Officinaliss, 8 parts of Herba Ephedrae (processed), 20 parts of Herba Houttuyniae.

4. according to claim 1 or 2 or 3 an any described a kind of preparation of nanometer Chinese medicine and production methods thereof for the treatment of severe asthma, it is characterized in that: the present invention adopts sun greater than yin, yang six cloudy four theoretical this prescription of research and development and nanometer Chinese medicines.Medicine is become medicine support material medicine with preparing carriers, crude drug can be a nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, one or more combinations in the microcapsule etc., the final prepared end product that goes out can be a tablet, pill, powder, suppository, granule, membrane, capsule, microcapsule, effervescent, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral solution, dosage forms such as plaster.

5. according to claim 1 or 2 or 3 or 4 an any described a kind of preparation of nanometer Chinese medicine and production methods thereof for the treatment of severe asthma, it is characterized in that: said Chinese medicine is rich in organic selenium.The drug carrier material that the present invention selects for use, adjuvant, colloid, activating agent, help Emulsion, excipient substances such as dispersant can be gelatin, albumin and starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid and cyanoacrylate, the semisolid poe, triglyceride is (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride is (as glyceryl monostearate, contain list, two, the synthetic glyceride of triglyceride), steroidal class (cholesterol etc.), Polyethylene Glycol, wax class (microcrystalline wax, whale ester type waxes), erythrocyte, Montmorillonitum, in the bentonite etc. one or more.

6. a nanometer Chinese medicine for the treatment of severe asthma prepares and production method, it is characterized in that may further comprise the steps:

Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.

Step 2: get 25% each Chinese medicine micropowder and mix immersion 1-2 days with the 30%--90% alcohol-water solution that 6-12 doubly measures, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, and recovered alcohol gets extract with standby.

Step 3: get 25% various medicine micropowder, adopt the high-frequency ultrasonic of independent research to disperse the pulverizing extraction equipment to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.

Step 4: get 10% each Chinese medicine micropowder, adopt the swing nanon ball-mill of independent research to grind 4-16 hour, obtain the nano powder that particle size distribution is the 50-1000 nanometer, standby.

Step 5: get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.

Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.

Step 7: the said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.

Step 8: by " preparation part of standards code requirement in the Chinese pharmacopoeia is got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, microcapsule one or more and mixed.

Step 9: in GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.

Step 10: the end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.

7. a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma according to claim 6; it is characterized in that: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced breaking method, extracting method and technology.

8. a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma according to claim 7; it is characterized in that: the medicine monomer in the described step 6, active substance, effective site technology of preparing; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.

9. a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma according to claim 8; it is characterized in that: the dissimilar crude drug such as nanoparticle that adopt the different pharmaceutical adjuvant to be prepared in the described step 7; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.

10. a kind of preparation of nanometer Chinese medicine and production method thereof for the treatment of severe asthma according to claim 9, it is characterized in that: its key point is the different and property of medicine and use the different of carrier according to the nanometer particle size of crude drug, can produce the different targeting controlled capability that eases up.