CN103768308A - Medicament composition for treating upper respiratory infections and preparation method thereof - Google Patents
Medicament composition for treating upper respiratory infections and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicament composition for treating upper respiratory infections and a preparation method thereof and belongs to the technical scheme of traditional Chinese medicine preparations. The medicament composition comprises the following raw materials in parts by weight: 40-50 parts of ephedrine, 20-30 parts of liquorice, 20-40 parts of radix isatidis, 10-20 parts of radix bupleuri, 5-10 parts of pinellia ternate, 5-10 parts of scutellaria baicalensis, 10-20 parts of dandelion, 5-10 parts of dried orange peel, 3-5 parts of platycodon grandiflorum, 4-8 parts of menthol, 3-5 parts of saposhnidoviae radix, 6-12 parts of fructus forsythia, 10-15 parts of hindu datura flower, 10-15 parts of semen brassicae and 30-50 parts of dextrin. Through drug synergism, the medicament composition is capable of effectively treating upper respiratory infections and relieving uncomfortable syndromes; meanwhile, as pinellia ternate is separately extracted, the extraction yield of ephedrine is effectively improved; menthol is treated through an ultrafiltration membrane, impurities are removed, thus the stability of ephedrine in a finished product is remarkably improved.
Description
Technical field
The invention discloses a kind of pharmaceutical composition that is used for the treatment of upper respiratory tract infection and preparation method thereof, belong to Chinese medicine preparation technical scheme.
Background technology
Upper respiratory tract infection refers to from nasal cavity to the acutely inflamed general name between throat, is modal infectious disease.How to be caused by virus, after antibacterial infects and is often secondary to viral infection.These disease four seasons, any age all can fall ill, and by containing the virulent spittle, droplet, or propagate through the apparatus polluting.Motherland's medical science is to infectious disease, particularly the understanding to respiratory infectious disease and prevent and treat with a long history.Before more than 2,000 years, Han dynasty Zhang Zhongjing just has relevant discussion to go out side by side the side's of control medicine.
Although it is of a great variety to treat in the market the Chinese patent medicine of upper respiratory tract infection disease, exist large such as dosage, effect duration is short, the inapparent problem of curative effect.
Summary of the invention
The object of the invention is: a kind of Chinese medicine composition that is used for the treatment of upper respiratory tract infection is provided.Technical scheme is:
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material by weight: 40～50 parts, Herba Ephedrae, 20～30 parts, Radix Glycyrrhizae, 20～40 parts of Radix Isatidis, 10～20 parts of Radix Bupleuri, 5～10 parts of the Rhizoma Pinelliaes, 5～10 parts of Radix Scutellariaes, 10～20 parts of Herba Taraxacis, 5～10 parts of Pericarpium Citri Reticulataes, 3～5 parts of Radix Platycodoniss, 4～8 parts of Mentholums, 3～5 parts of Radix Saposhnikoviaes, 6～12 parts of Fructus Forsythiaes, 10～15 parts of Flos Daturaes, 10～15 parts of Semen Sinapis Albaes, 30～50 parts, dextrin.
Herba Ephedrae has relievings asthma, and antitussive, removes expectorant, diaphoresis, and diuresis, antiinflammatory, antipyretic, the effect of excited maincenter.
Radix Glycyrrhizae is for asthma and cough.Can be alone, also can the application of compatibility other drug.As control the ERCHEN TANG of cough due to damp-phlegm; Control the Linggan Wuwei Jiangxin Tang of cold-phlegm cough with asthma; Control the sangxing decoction of dry stool phlegm cough; Control pyretic toxicity and cause the Radix Platycodonis decoction of the stench purulent sputum of lung abscess cough and spit; Control the Radix Glycyrrhizae Rhizoma Zingiberis soup of cough and spit saliva foam etc.The also Chang Peiwu application of another cough due to pathogenic wind-heat, cough due to wind and cold, phlegm heat cough.
Radix Isatidis has heat clearing away, removing toxic substances, removing heat from blood, effect of sore-throat relieving.
Effect that Radix Bupleuri has comprises: 1. antipyretic, effective ingredient: volatile oil (eugenol, acid, r-undecanoic acid lactone and to methoxybenzene diketone), saikoside (sapogenin A).Effect: heating due to typhoid fever, paratyphoid fever vaccine, escherichia coli liquid, fermented milk, yeast etc. is had to trivial solution heat effect; And can make animal normal body temperature decline.Saikosaponin decoct 2g/kg is to rabbit gavage, to all having obvious refrigeration function with the heating that vaccine and temperature thorn cause.2. antiinflammatory, effective ingredient: saponin.Effect: swollen and desmoplastic inflammation all has inhibitory action to ankle joint due to multiple proinflammatory agent.Saikoside 300mg/kg lumbar injection, can suppress the rat paw edema that carrageenin, 5-hydroxy tryptamine, histamine cause, suppresses rat granuloma swollen, can make adrenal gland's hypertrophy, atrophy of thymus gland simultaneously; Inflammation-inhibiting is organized histamine release and leukoplania.3. Promote immunity function, effective ingredient: Bupleurum chinense polysaccharide.Effect: phagocytic function strengthens, Natural killer activity strengthens, and improves special viral antibody titre, improves lymphocyte and turns core rate, improves skin delayed hypersensitivity reaction.
The Rhizoma Pinelliae can drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.Control damp-phlegm cold drink, vomiting, regurgitation, cough with asthma abundant expectoration, chest and diaphragm distension, syncope due to accumulation of phlegm headache, dizzy sleeplessness.Outer subduing inflammation., vomiting regurgitation dizzy for abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, interior expectorant, breast gastral cavity painful abdominal mass are vexed, globus hystericus disease; Raw with external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI.
Radix Scutellariae heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive, blood pressure lowering.For hygropyrexia, fever disease in summer vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, high hot excessive thirst, heat in blood is told nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.
Herba Taraxaci heat-clearing and toxic substances removing, diuresis eliminating stagnation.Control acute mastitis, lymphadenitis, scrofula, furuncle carbuncle toxin, acute conjunctivitis, cold, fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection.
Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
The functions such as Radix Platycodonis has lung qi dispersing, eliminates the phlegm, sore-throat relieving, evacuation of pus, cure mainly the symptom such as cough with copious phlegm, laryngopharynx swelling and pain.
Herba Menthae brain-capacity optionally stimulates the Cold receptor of human body skin or mucosa, produces sense of cold reflection and creeping chill, causes skin mucosa vasoconstriction (in fact skin keeps normal); Also can cause contraction to the blood vessel of deep tissue in addition, and produce therapeutical effect.External can antiinflammatory, pain relieving, and antipruritic, blood circulation promoting, alleviates edema etc.; For oral administration can alleviate local inflammation (pharyngolaryngitis) and treatment flu in compound preparation, and have stomach invigorating, wind dispelling effect.
Radix Saposhnikoviae expelling pathogenic wind from the body surface, removing dampness to relieve pain, spasmolytic, antipruritic.Cure mainly: affection of exogenous wind-cold; Headache general pain; Rheumatic arthralgia; Joint is ached; Stomachache is had loose bowels; Discharging fresh blood stool; Tetanus; Rubella pruritus; Skin infection from the beginning of.
The pharmacological action such as that Fructus Forsythiae has is antibacterial, heart tonifying, diuresis, town are told, is the Chinese medicine of heat-clearing and toxic substances removing, cures mainly calentura from the beginning of symptom, its bacteriostasis and Flos Lonicerae broadly similars such as, anemopyretic cold, heating, vexed, laryngopharynx swelling and pain, acute nephritis, carbuncle sore tumefacting virus.
Flos Daturae antiasthmatic-antitussive; Narcotic analgesic; Spasmolytic is only jerked.For asthma and cough; Coldness and pain in the epigastrium; Rheumatic arthralgia; Epilepsy; Infantile convulsion; Surgical anesthesia.
Semen Sinapis Albae warming the lung eliminating phlegm promoting the circulation of QI, mammary gland eliminating stagnation removing obstruction in the collateral to relieve pain.Breath with cough for cold-phlegm, distending pain in the chest and hypochondrium, the stagnant meridians of expectorant, joint numbness, pain, phlegm-damp oozing in the body, carbuncle of yin nature toxic swelling.
Another object of the present invention has been to provide a kind of preparation method of the above-mentioned pharmaceutical composition that is used for the treatment of upper respiratory tract infection, comprises the steps:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water of 10～12 times of above medical material gross weights, decoct 2～4 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 8～10 times of Rhizoma Pinelliae weight, decoct 1～3 hour, elimination residue, obtains lixiviating solution;
The 3rd step, get Mentholum, add the water of 8～10 times of Mentholum weight, decoct 0.5～1 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters, and obtains ultrafiltrate;
The 4th step, thick paste, lixiviating solution, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.25～1.39;
The 5th step, extract is mixed homogeneously with dextrin, granulate, dry, make.
In the 1st described step, the shared volume ratio of ethanol of ethanol water is 40%～50%.
The molecular cut off optimum of described ultrafilter membrane is 200,000～400,000.
In the 5th described step, granulation is to pass through wet granulation.
Beneficial effect
The present invention, by each herbal medicine synergism, can effectively treat the infection of upper respiratory tract, and alleviate malaise symptoms; Meanwhile, by the Rhizoma Pinelliae is separately extracted, effectively improve the extract yield of ephedrine, Mentholum has been processed by ultrafilter membrane, removed impurity, improved significantly the stability of finished product Ephedrine.
The specific embodiment
Below in conjunction with specific embodiment, the present invention is further described, so that those skilled in the art more understands the present invention, but does not therefore limit the present invention.
Embodiment 1
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material: Herba Ephedrae 40kg, Radix Glycyrrhizae 20kg, Radix Isatidis 20kg, Radix Bupleuri 10kg, Rhizoma Pinelliae 5kg, Radix Scutellariae 5kg, Herba Taraxaci 10kg, Pericarpium Citri Reticulatae 5kg, Radix Platycodonis 3kg, Mentholum 4kg, Radix Saposhnikoviae 3kg, Fructus Forsythiae 6kg, Flos Daturae 10kg, Semen Sinapis Albae 10kg, dextrin 30kg.
Preparation method is:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water (the shared volume ratio of ethanol of ethanol water is 40%) of 10 times of above medical material gross weights, decoct 2 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 8 times of Rhizoma Pinelliae weight, decoct 1 hour, elimination residue, obtains lixiviating solution;
The 3rd step, get Mentholum, add the water of 8 times of Mentholum weight, decoct 0.5 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters (molecular cut off of ultrafilter membrane is 200,000), obtains ultrafiltrate;
The 4th step, thick paste, lixiviating solution, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.25;
The 5th step, extract is mixed homogeneously with dextrin, wet granulation, dry, make.
Embodiment 2
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material: Herba Ephedrae 50kg, Radix Glycyrrhizae 30kg, Radix Isatidis 40kg, Radix Bupleuri 20kg, Rhizoma Pinelliae 10kg, Radix Scutellariae 10kg, Herba Taraxaci 20kg, Pericarpium Citri Reticulatae 10kg, Radix Platycodonis 5kg, Mentholum 8kg, Radix Saposhnikoviae 5kg, Fructus Forsythiae 12kg, Flos Daturae 15kg, Semen Sinapis Albae 15kg, dextrin 50kg.
Preparation method is:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water (the shared volume ratio of ethanol of ethanol water is 50%) of 12 times of above medical material gross weights, decoct 4 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 10 times of Rhizoma Pinelliae weight, decoct 3 hours, elimination residue, obtains lixiviating solution;
The 3rd step, get Mentholum, add the water of 10 times of Mentholum weight, decoct 1 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters (molecular cut off of ultrafilter membrane is 400,000), obtains ultrafiltrate;
The 4th step, thick paste, lixiviating solution, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.39;
The 5th step, extract is mixed homogeneously with dextrin, wet granulation, dry, make.
Embodiment 3
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material: Herba Ephedrae 45kg, Radix Glycyrrhizae 25kg, Radix Isatidis 30kg, Radix Bupleuri 15kg, Rhizoma Pinelliae 7kg, Radix Scutellariae 7kg, Herba Taraxaci 15kg, Pericarpium Citri Reticulatae 7kg, Radix Platycodonis 4kg, Mentholum 6kg, Radix Saposhnikoviae 4kg, Fructus Forsythiae 8kg, Flos Daturae 12kg, Semen Sinapis Albae 12kg, DEXTRIN kg.
Preparation method is:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water (the shared volume ratio of ethanol of ethanol water is 45%) of 11 times of above medical material gross weights, decoct 3 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 9 times of Rhizoma Pinelliae weight, decoct 2 hours, elimination residue, obtains lixiviating solution;
The 3rd step, get Mentholum, add the water of 9 times of Mentholum weight, decoct 0.7 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters (molecular cut off of ultrafilter membrane is 300,000), obtains ultrafiltrate;
The 4th step, thick paste, lixiviating solution, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.30;
The 5th step, extract is mixed homogeneously with dextrin, wet granulation, dry, make.
Reference examples 1
Reference examples 1 is with the difference of embodiment 3: the Rhizoma Pinelliae extracts with other raw material in the 1st step simultaneously, particularly as follows:
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material: Herba Ephedrae 45kg, Radix Glycyrrhizae 25kg, Radix Isatidis 30kg, Radix Bupleuri 15kg, Rhizoma Pinelliae 7kg, Radix Scutellariae 7kg, Herba Taraxaci 15kg, Pericarpium Citri Reticulatae 7kg, Radix Platycodonis 4kg, Mentholum 6kg, Radix Saposhnikoviae 4kg, Fructus Forsythiae 8kg, Flos Daturae 12kg, Semen Sinapis Albae 12kg, DEXTRIN kg.
Preparation method is:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, the Rhizoma Pinelliae, add the ethanol water (the shared volume ratio of ethanol of ethanol water is 45%) of 11 times of above medical material gross weights, decoct 3 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get Mentholum, add the water of 9 times of Mentholum weight, decoct 0.7 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters (molecular cut off of ultrafilter membrane is 300,000), obtains ultrafiltrate;
The 3rd step, thick paste, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.30;
The 5th step, extract is mixed homogeneously with dextrin, wet granulation, dry, make.
Reference examples 2
Reference examples 2 is with the difference of embodiment 3: Mentholum, after decocting, does not filter by ultrafilter membrane, particularly refers to:
Be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material: Herba Ephedrae 45kg, Radix Glycyrrhizae 25kg, Radix Isatidis 30kg, Radix Bupleuri 15kg, Rhizoma Pinelliae 7kg, Radix Scutellariae 7kg, Herba Taraxaci 15kg, Pericarpium Citri Reticulatae 7kg, Radix Platycodonis 4kg, Mentholum 6kg, Radix Saposhnikoviae 4kg, Fructus Forsythiae 8kg, Flos Daturae 12kg, Semen Sinapis Albae 12kg, DEXTRIN kg.
Preparation method is:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water (the shared volume ratio of ethanol of ethanol water is 45%) of 11 times of above medical material gross weights, decoct 3 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 9 times of Rhizoma Pinelliae weight, decoct 2 hours, elimination residue, obtains lixiviating solution I;
The 3rd step, get Mentholum, add the water of 9 times of Mentholum weight, decoct 0.7 hour, elimination residue, obtains lixiviating solution II;
The 4th step, by thick paste, lixiviating solution I, lixiviating solution II, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.30;
The 5th step, extract is mixed homogeneously with dextrin, wet granulation, dry, make.
Content test
The HPLC detection method of the content (in ephedrine hydrochloride) of ephedrine is as follows:
According to high effective liquid chromatography for measuring, take octadecylsilane chemically bonded silica as filler, take acetonitrile-0.1% phosphoric acid solution (containing 0.1% triethylamine), (3:97) as mobile phase, detection wavelength is 205nm.Number of theoretical plate calculates and should be not less than 4000 by ephedrine hydrochloride.Get ephedrine hydrochloride reference substance appropriate, accurately weighed, the hydrochloric acid solution that adds 0.1mol/L is made the solution of every 1ml containing 45 μ g, obtains reference substance solution.Get this product under content uniformity item, porphyrize, gets 1g, accurately weighed, add 10ml distilled water and strong ammonia solution 0.5ml, with ether extraction 5 (30ml, 30ml, 20ml, 20ml, 20ml), merge ether solution, add ethanol solution hydrochloride (1 → 20) 2ml, mix, low temperature reclaims solvent to dry, and residue adds ethanol 5ml to be made to dissolve, and is transferred in 25ml measuring bottle, add 0.1mol/L hydrochloric acid solution and be diluted to scale, shake up, obtain need testing solution.Accurate reference substance solution and the each 10 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures, and the results are shown in following table.
To carry out long-term stable experiment under listing terms of packing, 25 ℃ ± 2 ℃ of temperature, relative humidity, 60% ± 5%, samples respectively detection level at 0,3,6,9,12,18,24 the end of month.
Table 1 content and stability test result
| ? | Embodiment 1 | Embodiment 2 | Embodiment 3 | Reference examples 1 | Reference examples 2 |
| 0th month Content of Ephedrine With % (w/w) | 0.16 | 0.17 | 0.20 | 0.10 | 0.19 |
| Stable content % (w/w) | ? | ? | ? | ? | ? |
| 3 months | 0.16 | 0.17 | 0.20 | 0.09 | 0.17 |
| 6 months | 0.16 | 0.17 | 0.20 | 0.08 | 0.15 |
| 9 months | 0.15 | 0.16 | 0.20 | 0.08 | 0.14 |
| 12 months | 0.15 | 0.16 | 0.19 | 0.08 | 0.13 |
| 18 months | 0.15 | 0.16 | 0.19 | 0.07 | 0.12 |
| 24 months | 0.14 | 0.16 | 0.19 | 0.07 | 0.11 |
As can be seen from the table, in reference examples 1, because the Rhizoma Pinelliae is to extract with other component simultaneously, its ingredient containing has had influence on the leaching of ephedrine, makes its content lower; In reference examples 2, owing to Mentholum not being carried out to membrane separation for removing impurities, the impurity wherein containing is brought into product, had influence on the long-term storing stability of ephedrine, after the preservation of 24 months, the content of ephedrine declines obviously.
The test of pesticide effectiveness
1. separate heat test
Body weight 160-200g and body temperature are changed to the female rats random packet that is no more than 0.3 ℃, every group 10, gavage gives granule medicament (200mg/kg), aspirin 0.3g/kg (positive group) and the equivalent normal saline (matched group) of embodiment 1-3 gained respectively, after every Mus administration 30min in back subcutaneous injection 2,2, 4-dinitrophenol 1ml/100g (25mg/kg), respectively at after injection, 60,90,120,150,180min is measured in the same method each Mus anus temperature, result of the test is as shown in table 2.
Table 2 causes the impact of rat fever on 2,4-DNP
With relatively * p < 0.05 of model group
From table data can find out, the solution thermal effect of granule provided by the invention is better than positive group, and the successful of embodiment 3 is better than embodiment 1 and embodiment 2.
2. analgesic test
Get 40 of the female white mice of body weight 20 ± 2g, be divided at random: blank group (normal saline), positive drug group (aspirin 0.15g/kg), pharmaceutical composition high dose group of the present invention (200mg/kg), medicinal granule low dose group of the present invention (100mg/kg) is by after above-mentioned dosed administration, inject 0.6% glacial acetic acid 0.1mL/10g respectively at 30 minutes pneumoretroperitoneums, writhing number of times in 10 minutes after record injection algogen, statistical result is as shown in table 3.
Table 3 writhing number of times statistical result (X ± S)
| Group | Writhing number of times |
| Blank group | 51.3±4.7 |
| Positive drug group | 6.3±1.2* |
| High dose group | 12.4±2.1* |
| Low dose group | 17.8±2.3* |
With relatively * p < 0.05 of blank group
Result of the test shows that positive drug medicine group of the present invention and extract high dose group can significantly reduce the writhing response number of times of acetic acid induced mice, and low dose group can reduce the writhing response number of times of acetic acid induced mice, has good analgesia effect.
3. antiinflammatory test
Get body weight and be the male mice random packet of 23-26 gram, every group 10, gavage gives medicinal granule 200mg/kg of the present invention and 100mg/kg, prednisone 10mg/kg (positive group) and equivalent normal saline (matched group) respectively, once a day, continuous three days, be only evenly coated with dimethylbenzene 0.005ml/ to for after last administration 40 minutes the left ear of animal.Causing scorching latter 30 minutes execution animals, the rustless steel punching pin that is 8mm with diameter takes off left and right same area auricle, weighs, and is calculated as follows swelling and inhibitory rate of intumesce, and result is as shown in table 4.
Swelling=(left auricle weight-auris dextra sheet weight)
Inhibitory rate of intumesce=(1-administration group swelling/matched group swelling) × 100%
Table 4 xylol causes the impact of mice auricle swelling
| Group | Swelling (mg) | Suppression ratio % |
| Model group | 12.43±1.85 | ? |
| Positive drug group | 7.61±1.11* | 38.8 |
| High dose group | 8.26±1.23* | 33.5 |
| Low dose group | 8.44±1.32* | 32.1 |
With relatively * p < 0.05 of model group
Result demonstration, drug particles high dose group of the present invention, low dose group and prednisone group all can suppress xylene value mice ear, relatively have significant difference with matched group, show that pharmaceutical composition of the present invention has obvious antiinflammatory action.
4. In vitro Bactericidal Experiments
The part test result of the minimum inhibitory concentration (MIC) of pharmaceutical composition of the present invention is as shown in table 5-1 and table 5-2.
The MIC (mg/ml) (twice test meansigma methods) of table 5-1 to clinical isolates strain
| Clinical isolates strain | ? |
| Staphylococcus aureus | 2.5 |
| Escherichia coli | 5.0 |
| Diplococcus pneumoniae | >5.0 |
| Bacillus cloacae | 5.0 |
| Acinetobacter calcoaceticus | >5.0 |
| Kerekou pneumonia hundred Salmonellas | 2.5 |
| Streptococcus | 1.25 |
The MIC of table 5-2 to reference culture
| To reference culture | ? |
| Staphylococcus aureus | 2.5 |
| Escherichia coli | 5.0 |
| Bacillus pumilus | 5.0 |
| Bacillus subtilis | 5.0 |
| Micrococcus luteus | 2.5 |
Result shows: medicinal granule of the present invention all demonstrates and has certain bacteriostasis the common pathogen of clinical separation.
5. mice ammonia is drawn to the impact of coughing
Get 56 of male mouse of kunming, body weight 15-17g, be divided at random: blank group (normal saline), positive drug group benproperine phosphate 0.05g/kg), drug particles high dose group of the present invention (200mg/kg), drug particles low dose group of the present invention (100mg/kg) is by after above-mentioned dosed administration, administration volume is 20ml/kg body weight, mice is administration in batches, and 7 every batch, every group of each 1 mice.Each batch of mice accepted ammonia spraying in bell jar after 4 hours in administration, when spraying stops, take out immediately mice, then observes and record the number of times of coughing in the incubation period and 5 minutes of mouse cough.The results are shown in Table 6
Table 6 draws the impact (X ± S) of coughing incubation period and cough number of times due to mice ammonia
| Group | Incubation period (s) | Cough number of times (inferior/5min) |
| Blank group | - | 64.33±13.45 |
| Positive drug group | 51.3±12.4 | 7.32±3.42* |
| High dose group | 49.7±11.4 | 2.46±0.45* |
| Low dose group | 48.5±12.1 | 3.78±0.52* |
With relatively * p < 0.05 of blank group
Chinese medicine preparation of the present invention is used in 2006 to 2012 the routine patients of clinical observation upper respiratory tract infection 120, and clinical report is as follows:
1, physical data
In 120 routine patients, women's 60 examples, male's 60 examples, at minimum 7 years old of age, maximum 67 years old, the course of disease was many at 1 day to 7 days, 43.2 years old mean age.
2, diagnostic criteria
Reference " traditional Chinese medical science disease Standardization of diagnosis and curative effect ":
Primary symptom: (1) fever of the body, (2) aversion to wind; Inferior disease: (1) pharyngalgia, (2) are thirsty, (3) cough, (4) sweating, (5) nasal obstruction
Watery nasal discharge.The micro-Huang of thin white fur of tongue or BOHUANG, floating and rapid pulse or sliding number.Possess 2 of primary symptoms and time disease more than 2 or 2, possess above-mentioned tongue pulse condition person simultaneously.
3, Therapeutic Method
Granule, every day three times, each 10g, 5 days per courses for the treatment of
4, therapeutic outcome:
4.1 references " traditional Chinese medical science disease Standardization of diagnosis and curative effect ":
Cure: cardinal symptom, sign are alleviated completely or substantially, it is normal that objective indicator is recovered;
Effective: cardinal symptom, sign are obviously alleviated, objective indicator approaches normal;
Effective: cardinal symptom, sign take a turn for the better, and objective indicator makes moderate progress;
Invalid: cardinal symptom, sign are unchanged, objective indicator changes not obvious or increases the weight of.
4.2 results: in 120 routine patients, cure 95 examples (79.2%), effective 16 examples (13.3%), effective 7 examples (5.8%), invalid 2 examples (1.7%), total effective rate is 98.3%.
Below model case:
Case 1
Man, 8 years old, continuous three days sneeze, cough, taken the standing coldrex inefficacy of family, and have a fever the 4th day night suddenly, takes temperature 39.5 ℃.On inspection, this child's pars oralis pharyngis redness, antiadoncus is taken Chinese medicinal granule of the present invention in adopting the measure of control body temperature, takes two days, every day three times, each 10g, transference cure, recovers normal.
Case 2
Women, 36 years old, pharyngalgia, photophobia, sheds tears, and eye is itched, is generated heat, and 38.5 ℃ of body temperature check and find the obviously hyperemia of pharyngeal cavity and binding film, and routine blood test numeration of leukocyte reduces, and percentage of lymphocyte increases.Take Chinese medicinal granule provided by the invention, every day three times, each 10g, after 1 day, temperature recovery is normal, takes 3 days, and transference cure, recovers normal.
Claims (5)
1. be used for the treatment of a pharmaceutical composition for upper respiratory tract infection, include following raw material by weight: 40～50 parts, Herba Ephedrae, 20～30 parts, Radix Glycyrrhizae, 20～40 parts of Radix Isatidis, 10～20 parts of Radix Bupleuri, 5～10 parts of the Rhizoma Pinelliaes, 5～10 parts of Radix Scutellariaes, 10～20 parts of Herba Taraxacis, 5～10 parts of Pericarpium Citri Reticulataes, 3～5 parts of Radix Platycodoniss, 4～8 parts of Mentholums, 3～5 parts of Radix Saposhnikoviaes, 6～12 parts of Fructus Forsythiaes, 10～15 parts of Flos Daturaes, 10～15 parts of Semen Sinapis Albaes, 30～50 parts, dextrin.
2. a method of preparing the pharmaceutical composition that is used for the treatment of upper respiratory tract infection claimed in claim 1, comprises the steps:
The 1st step, get Herba Ephedrae, Radix Glycyrrhizae, Radix Isatidis, Radix Bupleuri, Radix Scutellariae, Herba Taraxaci, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Saposhnikoviae, Fructus Forsythiae, Flos Daturae, Semen Sinapis Albae, add the ethanol water of 10～12 times of above medical material gross weights, decoct 2～4 hours, after elimination residue, decocting liquid is reclaimed to ethanol, obtain thick paste;
The 2nd step, get the Rhizoma Pinelliae, add the water of 8～10 times of Rhizoma Pinelliae weight, decoct 1～3 hour, elimination residue, obtains lixiviating solution;
The 3rd step, get Mentholum, add the water of 8～10 times of Mentholum weight, decoct 0.5～1 hour, elimination residue, sends extracting solution into ultrafilter membrane and filters, and obtains ultrafiltrate;
The 4th step, thick paste, lixiviating solution, ultrafiltrate are merged, stir, be evaporated to the extract that the relative density at 80 ℃ is 1.25～1.39;
The 5th step, extract is mixed homogeneously with dextrin, granulate, dry, make.
3. the method for the pharmaceutical composition for the preparation for the treatment of upper respiratory tract infection according to claim 2, is characterized in that: in the 1st described step, the shared volume ratio of ethanol of ethanol water is 40%～50%.
4. the method for the pharmaceutical composition for the preparation for the treatment of upper respiratory tract infection according to claim 2, is characterized in that: the molecular cut off of described ultrafilter membrane is 200,000～400,000.
5. the method for the pharmaceutical composition for the preparation for the treatment of upper respiratory tract infection according to claim 2, is characterized in that: in the 5th described step, granulation is to pass through wet granulation.
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| CN105617095A (en) * | 2016-01-27 | 2016-06-01 | 朱德密 | Oral liquid for acute upper respiratory infection in children and preparation method |
| CN106728164A (en) * | 2017-02-15 | 2017-05-31 | 成都市飞龙水处理技术研究所青白江第分所 | A kind of Chinese medicine composition for treating the infection of the upper respiratory tract and tonsillitis |
| WO2022217319A1 (en) * | 2021-04-14 | 2022-10-20 | Liquim Pty Ltd | Composition for prophylaxis against pathogens and methods of use |
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