Background technology
Infantile respiratory tract infection repeatedly is the common clinical frequently-occurring disease, and the cause of disease is many to be caused by cause pathogeny imcrobe infection, causes that the pathogenic microorganism that the child has a fever mainly contains antibacterial, virus and mycoplasma, chlamydia.Modern medicine thinks that definite pathogenesis still imperfectly understands, and is the result of many factors comprehensive function, one of major reason that immunologic hypofunction is considered to fall ill.Therapeutic Method research to child's diseases caused by exogenous pathogenic factor fevers in prior art is roughly (1) Physical temperature-lowering, as warm water or alcohol bath, ice bag cooling, normal saline enema etc.; (2) drug cooling, as medicines such as oral antipyretic, Metamizole nasal drip or intramuscular injection, intravenous drip dexamethasone, take simultaneously the antibiont medicine and treat infection; (3) herbal treatment: as oral Chinese medicine preparation, the external application of Chinese medicine etc.
Ibuprofen (Ibuprofen) is the clinical common Western medicine medicine that is used for the treatment of infantile fever, and ibuprofen has another name called Ibuprofen, is Non-steroidanalgetic drug.Its antiinflammatory, analgesia, refrigeration function are respond well, and untoward reaction is less.Extensive use in the world, become one of global best-selling over-the-counter drug at present, and aspirin, acetaminophen are listed as the large pillar product of antipyretic analgesic three together.Except Chinese Pharmacopoeia records, also be incorporated into the multinational pharmacopeia such as American and Britain, day.Ibuprofen goes on the market in Britain early than nineteen sixty-eight, and the manufacturer is Britain the Boots Co. PLC, and commodity are called Brufen.Because it has rheumatism and analgesic analgesic curative effect concurrently, and toxicity is low, all is better than aspirin and acetaminophen at aspects such as curative effect and side effect, thereby market enlarges rapidly.Ibuprofen has its oneself characteristic in clinical practice, be all antipyretic safely and effectively, and during higher than 39.2 ℃, ibuprofen is than more effective with the acetaminophen of dosage, and fever time is longer at body temperature; Large 16~32 times than aspirin of its analgesic activities, antipyretic effect similar to aspirin but the effect than more lasting; Lighter to the gastrointestinal side effect, easily tolerance, be that in this type of medicine, gastrointestinal irritation is minimum; Its untoward reaction is fewer and light than aspirin.Most NSAIDS medicine only has peroral dosage form for pain relieving.When the patient can not take oral formulations, injection gave ibuprofen and can for the patient, ease the pain and fever symptoms fast.
Yet all there is more defect in above-mentioned therapeutic modality, Physical temperature-lowering or simple Chinese medicine effect are poor, and the reduction body temperature by can not be efficiently and effectively, occur again soon after bringing down a fever that body temperature gos up, and the body temperature fluctuation is larger.Antibiotic therapy mainly adopts oral administration or intramuscular injection, the large approach of intravenous drip two.The infant oral antibiotic often can cause gastrointestinal reaction, the serious toxic and side effects such as also can cause allergic reaction, simultaneously infant take medicine more bothersome, the difficulty or ease operation, intramuscular injection or intravenous drip antibiotic, have a big risk, operation easier is high, the infant uneasiness of crying and screaming, the utmost point is mismatched.
Motherland's medical science is thought: children's's internal organs are tender and lovely, and the skin hedge is not close, defend outer function solid, and cold warming up do not known self-regulated in addition, weather cataclysm during Chang Yinsi, and changes in temperature are not normal, and exopathogen is taken advantage of a weak point and is sent out as primary disease; Because children's is " pure-yang constituent " " YANG often being in excess, YIN often being in shortage ", the diseases caused by exogenous pathogenic factor seasonal pathogen, be easy to heat-transformation again, therefore clinical the most common with heat syndrome, bringing down a fever rapidly is its primary treatment purpose." Plain Questions five is hidden and generated a piece of writing " thinks that lung spleen deficiency of kidney-QI is the key of its morbidity, and " all gas persons, all belong to lung." lung governing qi, department breathes, and the whole body mechanism of qi is had to important regulating action.The insufficiency of vital energy and blood of lung, defend QI-insufficiency, therefore spontaneous perspiration, easily diseases caused by exogenous pathogenic factor.Children's's the spleen tending to insufficiency usually, weakness of the spleen and stomach, the fortune of receiving is not normal, the biochemical weary source of QI and blood, inability of earth to generate metal, lung qi are also empty, are easy to diseases caused by exogenous pathogenic factor.Diseases caused by exogenous pathogenic factor repeatedly, prolonged illness is impairment of the kidney, and kidney is the root of Yuanyang, and deficiency of kidney-QI more causes lung spleen deficiency.Form vicious cycle.As can be seen here, the treatment primary disease should the lung benefiting strengthening spleen, tonifying kidney, benefiting QI for strengthening the superficies.Take QI invigorating as main, the kidney qi abundance, the strong fortune of taste, building up the spleen to supplement the lung, the mutual generation between metal and water functional rehabilitation is normal.
Summary of the invention
The purpose of this invention is to provide a kind for the treatment of both the principal and secondary aspects of a disease, have no side effect, safe ready, cheap Chinese medicine and western medicine compound preparation, its objective is in order to solve the treatment infantile respiratory tract infection repeatedly, overcome single ibuprofen and easily repeatedly wait obviously deficiency, reach the purpose for the treatment of both the principal and secondary aspects of a disease.
The present application people is according to forefathers' experience and oneself medical practice for many years, by the research to Chinese medicine, and in conjunction with dialectical demonstration, in many ways collect the length of many families, seek therapeutic regimen, for the tender body of children's, not normal to changes in temperature, exopathogen is taken advantage of a weak point and is sent out, and the diseases caused by exogenous pathogenic factor seasonal pathogen, be easy to heat-transformation, the disease of repeated infection, the present invention adopts the Chinese crude drug of different properties, has carried out the science compatibility, has stronger antiviral, antipyretic and anti-inflammatory, enhancing human body immunity effect;
For realizing above-mentioned purpose of the present invention, the technical solution used in the present invention is as follows:
A kind of pharmaceutical composition for infantile respiratory tract infection repeatedly:
It is characterized in that obtaining 5 parts of ibuprofen, 20 parts of Radix Bupleuri, 20 parts of Rhizoma Coptidis, 18 parts of Rhizoma Dioscoreaes, 15 parts, Folium Bambusae, 15 parts of Radix Zanthoxylis, 15 parts of the Radixs Astragali, 12 parts of the Rhizoma Pinelliaes, 10 parts of Fructus Trichosanthis, 10 parts of the Radixs Angelicae Dahuricae, 5 parts, Flos Carthami, 5 parts of Radix Curcumaes, 3 parts of Pericarpium Granatis, 3 parts, Radix Glycyrrhizae by the preparation of following weight proportioning raw material.
The above-mentioned raw materials medicine is prepared to capsule, tablet or suspensoid according to conventional pharmaceutical methods after adding the pharmaceutic adjuvants such as starch or edible cellulose.
Wherein the preferred preparation method of suspensoid is:
The preparation of the concentrated liquid of tradition Chinese medicine: get Chinese medicine ingredients in crude drug and (namely get 20 parts of Radix Bupleuri, 20 parts of Rhizoma Coptidis, 18 parts of Rhizoma Dioscoreaes, 15 parts, Folium Bambusae, 15 parts of Radix Zanthoxylis, 15 parts of the Radixs Astragali, 12 parts of the Rhizoma Pinelliaes, 10 parts of Fructus Trichosanthis, 10 parts of the Radixs Angelicae Dahuricae, 5 parts, Flos Carthami, 5 parts of Radix Curcumaes, 3 parts of Pericarpium Granatis, 3 parts, Radix Glycyrrhizae.) decoct three merging filtrates, be condensed into relative density and be 1.1 concentrated solution;
The concentrated liquid of tradition Chinese medicine of preparation, ibuprofen are added in excipient substance, make it suspendible, be configured to solution, further sterilizing, packing, sealing, the rear packing of inspection and get final product.
Technical solutions according to the invention are on the clinical experience basis of Chinese traditional treatment infantile common cold heating, in conjunction with the compound preparation with the Chinese medicine and western medicine combination of modern pharmacy achievement development.The present invention adopts the Chinese crude drug of different properties, has carried out the science compatibility with traditional western medicine composition, can reach desirable therapeutic effect, and lasting medicine, is not easy repeatedly, the advantage such as toxic and side effects is little.
The present invention has following advantage:
The cat fever curative effect of combination of Chinese and Western medicine medicine is good, and fever is not easy repeatedly, and toxic and side effects is little.
Preparation technology's simple possible of medicine of the present invention, and cheap, can be applicable to large-scale industrialized production.
The present invention improves on existing ibuprofen suspension basis, by a large amount of experiments, added the Chinese herbal medicine of suitable species and dosage, adopt peculiar methods to prepare, obtain the splendid pharmaceutical composition of effect, bring down a fever and greatly be better than existing ibuprofen suspension with analgesic effect.
The present invention, by the choose reasonable to medicine components, proportioning, has obtained desirable therapeutic effect, has both met the requirement of state-promulgated pharmacopoeia to relevant drug dose, can guarantee good therapeutic effect, non-evident effect again.
The specific embodiment
Embodiment 1
Preparation 1000ml pharmaceutical composition of the present invention
A kind of pharmaceutical composition for infantile respiratory tract infection repeatedly, it is characterized in that principal agent is added in excipient substance, make it suspendible, be configured to solution, sterilizing, packing, described principal agent is prepared from by following crude drug: ibuprofen 5g, Radix Bupleuri 20g, Rhizoma Coptidis 20g, Rhizoma Dioscoreae 18g, 15 parts, Folium Bambusae, Radix Zanthoxyli 15g, Radix Astragali 15g, Rhizoma Pinelliae 12g, Fructus Trichosanthis 10g, Radix Angelicae Dahuricae 10g, Flos Carthami 5g, Radix Curcumae 5g, Pericarpium Granati 3g, Radix Glycyrrhizae 3g.
Preparation method is:
1 Chinese medicine extraction liquid preparation:
Get Radix Bupleuri 20g, Rhizoma Coptidis 20g, Rhizoma Dioscoreae 18g, Folium Bambusae 15g, Radix Zanthoxyli 15g, Radix Astragali 15g, Rhizoma Pinelliae 12g, Fructus Trichosanthis 10g, Radix Angelicae Dahuricae 10g, Flos Carthami 5g, Radix Curcumae 5g, Pericarpium Granati 3g, Radix Glycyrrhizae 3g, decoct with water three times, add each time 5 times of water gagings, soak, decoct, filter; 1.10~1.15 concentrated solution when discarded medicinal residues, merging filtrate, reduction vaporization are concentrated into relative density and are 60~70 ℃.
2 ibuprofen slurry preparations
Get Sorbitol solution 100g, glycerol 100g, sodium carboxymethyl cellulose 1g, stirred 10 minutes, is heated to 70 ℃, until this colloid becomes hydrate fully.Then this hydrate is chilled to 45 ℃, adds Tween 80 3g, when being cooled to 30 ℃, continued to mix approximately 15 minutes, then add ibuprofen 5g, continue to be uniformly mixed 15 minutes;
3 prepare suspension
Get 150mL water, slowly add arabic gum 1.5g, mix and approximately made to become hydrate in 25 minutes, add microcrystalline Cellulose, make suspension;
4 finished product preparations
In suspension, slowly add sucrose 500g, and mix 15 minutes, then add carmine 0.005g, ibuprofen slurry prepared by Chinese medicine extraction liquid prepared by the 1st step and the 2nd step slowly adds, and mixes 15 minutes.Add successively sodium benzoate 2.5g, disodiumedetate 0.5g, citric acid 1.425g, Fructus Citri Limoniae essence 1.6g, adding distil water, to 1000ml, gets product again.
Embodiment 3
One, toxicity test:
The healthy SD rat is adopted in this experiment, the drug dose gradient of oral administration embodiment 1 preparation is 0.1ml/kg and 0.5ml/kg, successive administration 30 days, through within 1 week, growth of animal state, movable diet, hematology, blood biochemical are learned during observing the rat administration and after drug withdrawal, organs and tissues structure and routine urinalysis etc. all have no significant effect, show that clinical drug safety is reliable.
Two, analgesic experiment:
BALB/c mouse acetic acid is caused to the effect of writhing response: 60 of BALB/c mouse, male and female half and half, average weight are 19.5g, are divided at random 2 groups, are respectively normal saline group, embodiment 1 medicine group; Be administered once every day, dosage is that (experimental group gives medicine to 0.25ml/kg, matched group gives the normal saline of equivalent weight), gastric infusion is 3 days continuously, in the last gastric infusion after 1 hour, lumbar injection 0.6% glacial acetic acid 0.2ml/ only, observes mouse writhing number of times in 20min, the results are shown in Table 1.
Table 1 mouse writhing number of times statistics
Group |
Mice number (only) |
Writhing number of times (30min) |
The normal saline group |
30 |
32.7 |
Embodiment 1 |
30 |
6.9 |
Conclusion: by mouse writhing, test and can find, medicine prepared by the present invention can obviously ease pain
The experiment of bringing down a fever
The fever model is set up: 60 of kunming mices, male and female half and half, 26-28g/ are only, be divided at random three groups, take temperature, subcutaneous injection 2 respectively, the 4-dinitrophenol, 30mg/kg, make fever model, 0.5 after hour, detect body temperature, it is that (experimental group gives medicine to 0.25ml/kg that the while gavage gives drug dose, the normal saline group gives the normal saline of equivalent weight, matched group is commercially available ibuprofen suspension, 0.25ml/kg), detects body temperature after 15 minutes.Concrete data see table 2.
The bring down a fever effect of table 2 medicine to mice
Embodiment 1 effect of bringing down a fever is better than conventional ibuprofen suspension.
Embodiment 5
Case
Type: totally 60 examples, male 28 examples wherein, female's 32 examples, 8 months-5 years old age, 3 years old 4 months mean age.Be divided at random two groups, every group of 30 people, take commercially available ibuprofen suspension for first group, takes embodiment 1 for second group and prepare medicine.
Clinical symptoms: because of affection of exogenous wind-cold, the cold symptoms such as the nasal obstruction then occurred, watery nasal discharge, cough, 38.0 ℃-40.3 ℃ of body temperature, patient's flushed face with red ears, the uneasiness of crying and screaming.
Therapeutic Method: two groups on the basis of the conventional therapies such as antibiotic, antiviral, liquid make-up, Physical temperature-lowering, matched group is taken commercially available ibuprofen suspension, 1 group of suspension of taking embodiment 1 preparation of embodiment, 0.25ml/kg, 24h is no more than 4 times, and be 3 days two groups of courses for the treatment of.
Efficacy assessment standard: recovery from illness: heating paresthesia is after treatment, and children's recovers normally fully, within two weeks without body temperature phenomenon repeatedly.Take a turn for the better: the infant heating paresthesia disappears, and the cold symptoms such as nasal obstruction, watery nasal discharge, cough do not take a turn for the better fully, and body temperature phenomenon was repeatedly arranged within two weeks.Invalid: the state of an illness is without any improvement.Concrete data see table.
Visible, compound preparation of the present invention improves greatly than single Motrin cure rate.
Yin, the female, 3 years old, while having a bath, to catch a cold, cat fever continues the week more than one, the rear infant anorexia of having an injection of infusing, food is received and is not changed.Sometimes readme stomachache, be hard and dry.When medical, 38.1 ℃ of body temperature, still cough intermittently.Disease see spirit still can, watery nasal discharge, colour of the tongue is micro-red, greasy in yellow fur, the fingerprint purple.Give embodiment 1 suspension of preparation, 0.25ml/kg, 24h are no more than 4 times, after one day, start a fever of the body and subtract, and brothers turn temperature, and two is just unobstructed logical without hindrance, and spirit is slightly shaken, pharyngalgia only, lip profit mouthful and; Continued to take 3 days, body temperature is normal, and spiritual amelioration, cough caused by the disorders of throat are coughed only, lip profit mouthful and, know hungry rope food, two is just unobstructed logical without hindrance.Continue to take a course for the treatment of, return to one's perfect health, diet is normal.Follow up a case by regular visits to half a year without recurrence.A week is observed in drug withdrawal, and rehabilitation as before.
Chen, the man, 5 years old, at kindergarten, infect flu, the infant cough is more than, medical after two weeks, still cough, and flu intermittently, heating, cough is more than, has expectorant to be difficult for bringing up, and coughs night heavily, is paroxysmal, companion's vomiting sputum or food.Receive can, large dry stool, urine is many.Disease see spirit still can, watery nasal discharge, pharynx is red and swollen large, colour of the tongue is micro-red, greasy in yellow fur, the fingerprint purple.Disease belongs to the cough due to common cold, inside has damp and hotly, gives the embodiment suspension of 1 preparation, and 0.25ml/kg, 24h are no more than 4 times, after 2 days, start slight sweating, a fever of the body subtracts, and brothers turn temperature, and two is just unobstructed logical without hindrance, and spirit is slightly shaken, after 5 days, body temperature E is normal, spiritual amelioration, pharyngalgia only, lip profit mouthful and, know hungry rope food.A week is observed in drug withdrawal, and rehabilitation as before.Follow up a case by regular visits to without recurrence.
Although, above with general explanation and the specific embodiment, this case having been done to detailed explanation, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, the modification of doing without departing from theon the basis of the spirit of the present invention or improvement, all belong to the scope of protection of present invention.