CN1255146C - Medicine composition for treating uppe respiration channel infetion and its preparing process - Google Patents
Medicine composition for treating uppe respiration channel infetion and its preparing process Download PDFInfo
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Abstract
The present invention relates to medicinal composition for treating upper respiratory tract infections and an industrialization applied preparation method thereof. The medicinal composition is mainly composed of the ethanol and water extracts of glossy privet fruits, milkvetch roots, red sage roots. The medicinal composition has the functions of treating both manifestation and root causes on acute and chronic laryngopharyngitis, trachitis, tonsillitis, etc., particularly chronic pharyngitis with complicated disease symptoms by nourishing with clearing, supplementing with removing, nourishing yin, benefiting vital energy, resolving phlegm and dispelling stasis. A modern extraction technology and pharmacological experiments are used by the present invention, and the specific treatment ideas of multiple target point and the cooperative treatment of whole body regulation and local lesion treatment of traditional Chinese medicine are specifically presented with characteristics.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of treatment upper respiratory tract infection that comes from Chinese medicine and preparation method thereof.
Background technology
Upper respiratory tract infection often causes inflammation such as trachea, throat and tonsil, and normal and overall health of patients is closely related.Treat the Chinese patent medicine of upper respiratory tract infection in the market, can be divided into two big classes: have based on the heat-clearing and toxic substances removing sore-throat relieving, this type of Drug therapy upper respiratory tract infection curative effect is relatively poor; Have based on clearing away heat and nourishing YIN to wet one's whistle, this type of medicine is better to hyperactivity of deficient fire person curative effect, but to having the deficiency of vital energy concurrently, particularly expectorant coagulate, the syndrome of blood stasis person, curative effect is not good enough.The medicine that lacks treatment upper respiratory tract infection such as taking into account the deficiency of vital energy, blood stasis on the existing market.
Summary of the invention
The technical problem to be solved in the present invention is to utilize the Chinese medicine traditional theory, Chinese medicine composition with synergistic treatment upper respiratory tract infection is provided, it both had inhibitory action to oozing out in early days with the later stage granulation tissue hyperplasia of causing of inflammation, but again antiallergic, enhance immunity, antibacterial, improve hemorheology, anticoagulant, promote the production of body fluid and moisturize and activating QI to eliminate phlegm, thereby simultaneously at anti-infective, take into account the deficiency of vital energy particularly expectorant coagulate, the adjustment of blood stasis etc., reach treating both the principal and secondary aspects of a disease.
Technical scheme of the present invention is as follows:
A kind of pharmaceutical composition for the treatment of upper respiratory tract infection, it mainly is made up of the extract of the medical material gained of following quality component:
2～4 parts of Fructus Ligustri Lucidi, 0.5～2 part of the Radix Astragali, 0.5～2 part of Radix Salviae Miltiorrhizae, 1～3 part of Herba Euphorbiae Helioscopiae.
A kind of method for preparing aforementioned pharmaceutical compositions is characterized in that being made up of following steps:
Step 1, get Fructus Ligustri Lucidi, the Radix Astragali, Radix Salviae Miltiorrhizae, add 85～95% ethanol extractions 2～4 times with the ratio of 3～5 liters every kilogram of the gross masses of three kinds of medical materials by the quality component of aforementioned pharmaceutical compositions, each 1～2 hour, filter, alcohol extract,
Step 2, the medicinal residues of the alcohol extraction of step 1 gained and the Herba Euphorbiae Helioscopiae of quality component are merged, with the ratio extracting in water of 8～15 liters every kilogram of crude drug gross masses 1～3 time, each 1～3 hour, filter, relative density is 1.03～1.10 during condensed water extract to 65 ℃, and adding ethanol is 40～50% to containing the alcohol amount, leave standstill, filter, get supernatant
The alcohol extract of step 3, combining step one and the supernatant of step 2 reclaim ethanol, concentrate, and drying gets extract powder, promptly gets pharmaceutical composition of the present invention.
The preparation of aforementioned pharmaceutical compositions, it is that pharmaceutical composition is mixed with acceptable carrier on the pharmaceutics, the preparation oral formulations.
The preparation of aforementioned pharmaceutical compositions, it is to mix accepting carrier on pharmaceutical composition and the pharmaceutics, the oral formulations of making comprises granule, tablet, capsule, drop pill or oral liquid.
The preparation method of the granule of aforementioned pharmaceutical compositions, it is that extract powder is mixed with additives, adds the granule that 70～80% ethanol are made pharmaceutical composition in right amount.
The preparation method of the oral liquid of aforementioned pharmaceutical compositions, it is that extract powder is water-soluble, adds correctives, makes the oral liquid of pharmaceutical composition.
The preparation method of the hard capsule of aforementioned pharmaceutical compositions, it is that extract powder is mixed with additives, incapsulates, and makes the hard capsule of pharmaceutical composition.
The preparation of soft capsule method of aforementioned pharmaceutical compositions, it is that extract powder and soft capsule adjuvant commonly used is mixed, and is sealed in the soft capsule material of being made by gelatin, makes the soft capsule of pharmaceutical composition.
The preparation method of the tablet of aforementioned pharmaceutical compositions, it is that extract powder and tablet adjuvant lubricant commonly used, disintegrating agent, adhesive etc. are mixed, tabletting is made the tablet of pharmaceutical composition.
The preparation method of the drop pill of aforementioned pharmaceutical compositions, it is that extract powder and drop pill adjuvant commonly used is mixed, and drips system, makes the drop pill of pharmaceutical composition.
The present invention's Fructus Ligustri Lucidi is a principal agent, the merit of getting its tonifying the lung kidney first, because the lung kidney is the dirty of primary and secondary, the moon of lung kidney can nourish mutually, and kidney yin must be mended, and then lung yin must be grown, and throat is foster from being moistened.The hardship of holding concurrently in the Fructus Ligustri Lucidi nourishing is let out cool clear, is the product of clear benefits, benefit and oiliness, but not only nourishing YIN but also the clearind deficient heat of can holding concurrently.The gas that is aided with Radix Astragali harmonizing the spleen and stomach makes qi-blood-body fluid biochemistry active, and " building up the spleen to supplement the lung " is to help the merit of Fructus Ligustri Lucidi nourishing, bring out the best in each other with Fructus Ligustri Lucidi nourishing kidney lung moistening, on the other hand, but the Radix Astragali itself is with regard to the direct subsidy lung qi, lung qi must be mended, and " hundred passes are unobstructed ", body fluid is defeated often to be furnished with.Not only all diseases of the deficiency of vital energy can be removed, and throat also can be moistened foster.Assistant is with the Herba Euphorbiae Helioscopiae dissipating phlegm and resolving masses.Because upper respiratory tract infection is pharyngeal often an expectorant sense that stagnates, pharyngeal mucosa is with secretions, and lymph foilicie hyperplasia or lateral pharyngeal band enlargement often show as the time of " expectorant knot ", so use the Herba Euphorbiae Helioscopiae dissipating phlegm and resolving masses.Assistant is with the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling.Four flavor Chinese medicines share, and residence is clear in supporting, having of invigorating middle warmer, and the merit of Replenishing QI and nourishing YIN, dissipating phlegm and removing blood stasis is played in treating both the principal and the secondary aspects of a disease at the same time altogether, accompanies respiratory tract infection on the expectorant blood coagulation stasis of blood so be applicable to deficiency of both QI and YIN.
Experimental data proves: pharmaceutical composition of the present invention can suppress the mice auricular concha swelling due to capillary permeability increase of acetic acid induced mice abdominal cavity and the Oleum Tiglii, illustrates that early stage oozing out has inhibitory action to inflammation for it.Pharmaceutical composition of the present invention can also significantly suppress the rat granulation tissue hyperplasia that cotton balls brings out, and points out its connective tissue proliferation to chronic inflammatory disease that depression effect is arranged.
The hemorheology experiment confirm, pharmaceutical composition of the present invention can reduce whole blood viscosity and the plasma viscosity of rat, and can prolong KPTT, reduce fibrinogenic content, suppressing external thrombus forms, hematoblastic gathering there is extremely strong inhibitory action, therefore, the absorption that help to regulate microcirculation, promotes the focus local inflammation.This is to upper respiratory tract infection, and especially the treatment of pharyngolaryngitis has promotion and synergism.
Pharmaceutical composition of the present invention can suppress the take off granule of mastocyte under antigen is attacked very significantly and react, and suppresses to be discharged by the mastocyte that antigen causes the effect of sensitive media, thus the symptom of reducing inflammation.
Behind the mouse infection Sendai virus, immune complex sharply increases in the serum, the ability that erythrocyte is removed immune complex reduces, pharmaceutical composition of the present invention can improve infection Sendai virus mouse red blood cell garland formation rate, strengthen the ability of removing immune complex in the circulation, help the removing of interior microbial infection of body and pathological product.The mouse T cell esterase dyeing rate that infects Sendai virus obviously descends, the effect that the periphery blood T cell esterase rate that pharmaceutical composition of the present invention has the antagonism Sendai virus to cause descends.There is a certain amount of esterase on fully-developed T lymphocyte film surface, and its content and function are proportionate, and this just shows that pharmaceutical composition of the present invention has the effect of the T of enhancing cell function.
Extracorporeal bacteria inhibitor test shows that pharmaceutical composition of the present invention all has inhibitory action in various degree to Jia Xingrongxuexinglianqiujun, beta hemolysis type streptococcus, staphylococcus aureus, Staphylococcus albus, mlicrococcus catarrhalis
Rat blood capillary method and the phenol red method of mice trachea excretion prove that all pharmaceutical composition of the present invention has certain promoting the production of body fluid to moisturize effect with activating QI to eliminate phlegm, and this pharmacological action has embodied pharmaceutical composition of the present invention has therapeutical effect to upper respiratory tract infection such as acute and chronic pharyngolaryngitis and tracheitis.
In a word, pharmaceutical composition of the present invention is to upper respiratory tract infection, as acute and chronic pharyngitis, tracheitis, tonsillitis etc., especially to the chronic pharyngitis of disease complexity, effect with treating both the principal and secondary aspects of a disease, the present invention utilizes modern extraction process and pharmacological evaluation, and the distinctive many target spots of Chinese medicine, whole body are regulated the treatment theory of working in coordination with mutually with the local lesion treatment particularly, show to characteristic.
The specific embodiment
The pharmaceutical composition of embodiment 1. treatment upper respiratory tract infection of the present invention and the preparation of granule thereof
Get Fructus Ligustri Lucidi 1000 gram, the Radix Astragali 500 grams, Radix Salviae Miltiorrhizae 500 grams and add 8000 milliliters 90% soak with ethanol 4 hours, reflux, extract, 1.5 hours repeats to extract three times, filters while hot, merges three times alcohol extract, the reservation alcohol extract.Medicinal residues and Herba Euphorbiae Helioscopiae 700 grams merge, and add 27000 ml waters and soak 4 hours, decoct 2 hours, so extract 2 times, merge aqueous extract, filtration, filtrate is concentrated into relative density 1.05 (65 ℃ of heat are surveyed), cooling adds ethanol and makes and contain alcohol amount and reach 45%, staticly settles, get supernatant, supernatant and above-mentioned alcohol extract merge, and reclaim ethanol, concentrating under reduced pressure, vacuum drying is pulverized, get extract powder, be the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
Get 1 part of extract powder, 1 part of sucrose, 0.5 part in dextrin and an amount of 75% ethanol, the system granule, drying, granulate, packing promptly gets the granule of the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition of embodiment 2. treatment upper respiratory tract infection of the present invention and the preparation of hard capsule thereof
Get Fructus Ligustri Lucidi 650 gram, the Radix Astragali 200 grams, Radix Salviae Miltiorrhizae 200 grams, add 3150 milliliter of 85% soak with ethanol 4 hours, reflux, extract, 1.5 hours, filtered while hot is collected alcohol extract, and medicinal residues repeat to merge three times alcohol extract with 85% alcohol reflux 2 times again, and alcohol extract is continued to employ.Medicinal residues and Herba Euphorbiae Helioscopiae 400 grams of getting alcohol extraction merge, and add 11600 ml waters and soak 5 hours, decoct 1.5 hours, so extract 3 times, merge decocting liquid, filter, be concentrated into relative density 1.03 (65 ℃ of heat are surveyed). cooling, add ethanol to containing alcohol amount 40%, after staticly settling, keep supernatant.Supernatant and alcohol extract are merged, and decompression recycling ethanol concentrates, and drying is pulverized, and gets extract powder, is the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
Get 1 part of extract powder, 1 part of sucrose, 1 part in dextrin, mixing incapsulates, and is the hard capsule of the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition of embodiment 3. treatment upper respiratory tract infection of the present invention and the preparation of oral liquid thereof
Get Fructus Ligustri Lucidi 200 gram, the Radix Astragali 200 grams, Radix Salviae Miltiorrhizae 200 grams, add 3000 milliliter of 95% soak with ethanol 4 hours, reflux, extract, 1.5 hours, filtered while hot is collected alcohol extract, and medicinal residues repeat to merge 2 times alcohol extract with 95% alcohol reflux 1 time again, and alcohol extract is continued to employ.Medicinal residues and Herba Euphorbiae Helioscopiae 100 grams of getting alcohol extraction merge, and add 10500 ml waters and soak 5 hours. and decocted 1 hour, and filtered, be concentrated into relative density 1.10 (65 ℃ of heat are surveyed), cooling adds ethanol to containing alcohol amount 50%, after staticly settling, keeps supernatant.Supernatant and alcohol extract are merged, and decompression recycling ethanol concentrates, and drying is pulverized, and gets extract powder, is the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition of treatment upper respiratory tract infection of the present invention is water-soluble, add correctives, sterilization, fill promptly gets the oral liquid of the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition of embodiment 4. treatment upper respiratory tract infection of the present invention and the preparation of tablet thereof
Get Fructus Ligustri Lucidi 600 gram, the Radix Astragali 250 grams, Radix Salviae Miltiorrhizae 250 grams, add 3500 milliliter of 90% soak with ethanol 5 hours, reflux, extract, 2 hours, filtered while hot is collected alcohol extract, and medicinal residues repeat to merge 2 times alcohol extract with 90% alcohol reflux 2 hours again, and alcohol extract is continued to employ.Medicinal residues and Herba Euphorbiae Helioscopiae 400 grams of getting alcohol extraction merge, and add 10000 ml waters and soak 5 hours, decoct each 1.5 hours 3 times, merge decocting liquid, filter, be concentrated into relative density 1.05 (65 ℃ of heat are surveyed), cooling, add ethanol to containing alcohol amount 45%, leave standstill, filter, keep supernatant.Supernatant and alcohol extract are merged, reclaim ethanol, concentrate, drying is pulverized, and gets extract powder, is the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
Above-mentioned extract powder and tablet adjuvant commonly used such as lubricant, disintegrating agent, adhesive etc. are mixed, and tabletting is made the tablet of the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition and the preparation of soft capsule thereof of embodiment 5. treatment upper respiratory tract infection of the present invention
Get Fructus Ligustri Lucidi 550 grams, the Radix Astragali 200 grams, Radix Salviae Miltiorrhizae 150 grams add 4000 milliliter of 90% soak with ethanol 4 hours, reflux, extract, 3 times, each 1.5 hours, filtered while hot merged 3 times alcohol extract, keep alcohol extract, medicinal residues and Herba Euphorbiae Helioscopiae 300 grams merge, and add 9000 ml waters and soak 4 hours, decoct 2 times, each 2 hours, collecting decoction, filter, filtrate is concentrated into relative density 1.05 (65 ℃ of heat are surveyed), cooling, add ethanol to containing alcohol amount 45%, leave standstill, filter, supernatant and above-mentioned alcohol extract are merged, reclaim ethanol, concentrating under reduced pressure, vacuum drying is pulverized, get extract powder, be the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
Above-mentioned extract powder and soft capsule adjuvant commonly used is mixed, be sealed in the soft capsule material of making by gelatin, promptly make the medicinal composition soft capsule of treatment upper respiratory tract infection of the present invention.
The pharmaceutical composition of embodiment 6. treatment upper respiratory tract infection of the present invention and the preparation of drop pill thereof
Get Fructus Ligustri Lucidi 650 grams, the Radix Astragali 250 grams, Radix Salviae Miltiorrhizae 250 grams add 5000 milliliter of 85% ethanol extraction 2 times, each 2 hours, filtered while hot merges 2 times alcohol extract, keeps alcohol extract, medicinal residues and Herba Euphorbiae Helioscopiae 350 grams merge, and add 11000 ml waters and decoct each 3 hours 3 times, collecting decoction, filter, filtrate is concentrated into relative density 1.10 (65 ℃ of heat are surveyed), cooling, add ethanol to containing alcohol amount 50%, leave standstill, filter, supernatant and above-mentioned alcohol extract are merged, reclaim ethanol, concentrating under reduced pressure, vacuum drying is pulverized, get extract powder, be the pharmaceutical composition of treatment upper respiratory tract infection of the present invention.
Above-mentioned extract powder and drop pill adjuvant commonly used is mixed, splash in the not miscible condensed fluid, promptly get the medicament composition dropping pills of treatment upper respiratory tract infection of the present invention.
Each dosage form of the pharmaceutical composition of the prepared treatment upper respiratory tract infection of the present invention of above embodiment has essentially identical drug effect.
The antiinflammatory action of the pharmaceutical composition of embodiment 7. treatment upper respiratory tract infection of the present invention
Normal experiment has been studied it Oleum Tiglii is brought out the influence of mice auricular concha inflammation, brings out the influence of rat granulation tissue hyperplasia to the influence of mouse peritoneal capillary permeability, to cotton balls.
Pharmaceutical composition of the present invention prepares with the embodiment of the invention 1 method, and every bag 10 gram, every gram granule are equivalent to crude drug 1.83 grams. and be mixed with suspension with distilled water during experiment and use (down together).
Gold fruit drink, Chinese medicine two factories in Shanghai produce.
Animal, Kunming mouse, body weight 20 ± 2 grams, the SD rat, body weight 180 ± 20 grams, the male and female dual-purpose provides by Jiangsu Province's Experimental Animal Center, Soviet Union's (moving) matter 91004.
Sendai virus is provided by microorganism parasite teaching and research room of Nanjing University of Traditional Chinese Medicine, and the blood titre is 1: 320.
The chicken erythrocyte ,-4 ℃ are kept in the A Shi liquid, use in two weeks.
Get 40 mices, be divided into 4 groups at random, 10 every group.Positive controls gavages the gold fruit and drinks 20mL/kg, the administration group gavages that pharmaceutical composition of the present invention is little, heavy dose of (to be equivalent to crude drug 7.5g, 15g/kg respectively, this dosage is equivalent to equimultiple, the qdx of people's clinical medicine dose according to the conversion of body surface area ratio), the blank group gives the equivalent normal saline.Once a day, continuous three days, 30min after the last administration spread upon the positive and negative two sides of mice left side ear equably with 2% Oleum Tiglii 0.05mL, and auris dextra is contrast, behind the 4h, and cervical vertebra dislocation execution.With diameter is the auricle that the perforator of 8mm takes off ears, weighs, and obtains two ear weight differences, the results are shown in Table 1.
Table 1, pharmaceutical composition of the present invention bring out the influence of mice auricular concha inflammation to Oleum Tiglii
| Group | Route of administration | Dosage (g/kg) | Two ear weight differences (mg) | Suppression ratio (%) |
| Normal saline group medicine group gold of the present invention fruit drink group | Gavage | Isometric(al) 7.5 15.0 20mL/kg | 18.2±4.1 12.1±3.8** 9.7±3.3** 13.6±4.0** | 33.5 46.7 25.3 |
Compare with the normal saline group: * * P＜0.01
Get 40 of mices, be divided into 4 groups at random, 10 every group, positive controls gavages the golden 20mL/kg. administration group of really drinking and gavages pharmaceutical composition of the present invention little, heavy dose of (being equivalent to crude drug 7.5g, 15kg/kg respectively), and the blank group gives the equivalent normal saline.Once a day, continuous three days.After the last administration 1 hour, the blue 5mL/kg of each caudal vein injection 0.5%Evans, ip acetic acid 10mL/kg behind the 5min, at interval behind the 30min with the mice sacrificed by exsanguination.In 610nm place colorimetric, the results are shown in Table 2 with 754 type spectrophotometers.
Table 2, pharmaceutical composition of the present invention are to the influence of mouse peritoneal capillary permeability
| Group | Route of administration | Dosage (g/kg) | The blue concentration (mg/L) of Evans | Suppression ratio (%) |
| Normal saline group medicine group gold of the present invention fruit drink group | Gavage | Isometric(al) 7.5 15.0 20mL/kg | 9.5±2.0 5.4±2.6** 5.1±1.9** 5.8±2.7** | 43.2 46.3 38.9 |
Compare with the normal saline group: * * P＜0.01
Get 40 of rats, be divided into 4 groups at random, 10 every group, under aseptic condition, the back otch is implanted oxter, both sides, that mycin of local card-coating with sterilized cotton ball 20mg.From burying cotton balls same day, be administered once every day, and positive controls is irritated stomach gold fruit and drunk 8mL/kg, and the administration group gavages pharmaceutical composition of the present invention little, heavy dose of (being equivalent to crude drug 5g, 10g/kg respectively), and the blank group gives the equivalent normal saline.Continuous 8 days.The results are shown in Table 3.
Table 3, pharmaceutical composition of the present invention bring out the influence of rat granulation tissue hyperplasia to burying cotton balls
| Group | Route of administration | Dosage (g/kg) | Granuloma dry weight (mg) | Suppression ratio (%) |
| Normal saline group medicine group gold of the present invention fruit drink group | Gavage | Isometric(al) 5.0 10.0 8.0mL/kg | 80.2±11.7 54.7±13.2** 51.4±10.9** 57.8±10.6** | 31.8 35.7 27.9 |
Compare with the normal saline group: * * P＜0.01
The pharmaceutical composition of embodiment 8. treatment upper respiratory tract infection of the present invention is to Immune Effects
Experimentation its influence to rat cranial periosteum mast cell degranulation reaction (experimental technique is referring to Xie Qiangmin etc., " Zhejiang Province medical university journal " 1981; 10 (2): 83, a kind of new screening technique of crossing the sensitive media blocking medicine; " basis and clinical immunology ", Beijing medical college, People's Health Publisher, front page in 1981) and to infecting Sendai virus mouse red blood cell C
3bThe influence of garland formation and periphery blood T lymphocyte esterase dyeing rate.
By thanking to strong quick method, get 36 of Wistar rats, be divided into 4 groups at random, be that normal saline group, isoproterenol group (50 μ g/kg), pharmaceutical composition of the present invention (are amounted to crude drug 5g/kg for one group, be equivalent to the clinical equivalent amount), two groups of pharmaceutical compositions of the present invention (amount to crude drug 10g/kg, be equivalent to 2 times of clinical equivalent amounts), more than each medicine irritate stomach every day, the administration volume equates; The normal saline group is then irritated the equal-volume normal saline, and isoproterenol group rat is 5min before antigen (trichosanthin) is attacked, by tail intravenous injection isoproterenol 50 μ g/kg.Administration the 6th day with 1: 20 rat anti trichosanthin serum 0.1mL, the blue solution intravenous injection of Radix Trichosanthis ivens, is put to death rat behind the 30min, cut skull.The microscopic examination mastocyte calculates its particulate percentage rate that comes off, and the results are shown in Table 4.
The influence that table 4, pharmaceutical composition of the present invention react rat cranial periosteum mast cell degranulation
| Group | Dosage (g/kg) | Mast cell degranulation percentage rate (%) |
| Normal saline group medicine group of the present invention isoproterenol group | Isometric(al) 5.0 10.0 50 μ g/kg | 95.0±2.8 55.1±3.4** 39.2±1.7** 22.2±2.2** |
Compare with the normal saline group: * * P＜0.01
Adopt Guo Feng Chinese-French, with 1% sterilised yeast suspension, through filter paper filtering, recover original volume and boiled 20 minutes, add equivalent mice serum incubation 15 minutes, the centrifugal sensitization yeast that is made into uses liquid.
Get mice and give Sendai virus liquid 50 μ l from nasal cavity, behind infective virus the 2nd day is divided into 4 groups at random: normal saline group, little, the heavy dose of group of pharmaceutical composition of the present invention, positive control drug levamisole group.Every group 20.Each group is irritated stomach respectively and is given normal saline, pharmaceutical composition of the present invention, levamisole (0.195g/kg).Once a day, be total to administration 7 times.Other establishes the blank group.After the last administration 4 hours, mouse orbit was got blood, anticoagulant heparin, centrifuging and taking erythrocyte, get the sensitization yeast and use liquid and each 100 μ l mixing of Mus red cell suspension, incubation adds one of 2.5% glutaraldehyde then, and is fixing, with Rui Shi-Ji's nurse Sa dyeing, count 200 erythrocyte yeast garland numbers, calculate C
3bThe receptor rosette rate.The results are shown in Table 5.Other gets the blood push jack, immersed in 37 ℃ of warm liquid 30 minutes, and the dyeing of 1% peacock green, microscopy calculates T lymphocyte esterase dyeing rate, the results are shown in Table 6.
Table 5, pharmaceutical composition of the present invention are to infecting Sendai virus mouse red blood cell C
3bThe influence that garland forms
| Group | Number of animals | Dosage (g/kg) | C 3bGarland forms (%) |
| Blank group normal saline group medicine group of the present invention levamisole group | 20 20 20 20 20 | --isometric(al) 7.5 15.0 0.195 | 11.45±2.13 7.70±1.42## 8.70±1.30* 9.75±1.60** 11.50±2.51** |
Compare with the normal saline group: * P＜0.05; * P＜0.01; Compare with the blank group: ##P＜0.01
Table 6, pharmaceutical composition of the present invention are to infecting the Sendai virus mice
The influence of periphery blood T lymphocyte esterase dyeing rate
| Group | Route of administration | Dosage (g/kg) | T lymphocyte esterase dyeing rate (%) |
| Blank (uninfecting virus) physiological saline group medicine group of the present invention levamisol group | Gavage | --isometric(al) 7.5 15.0 0.195 | 40.6±4.4 27.4±2.3## 30.0±2.3 32.3±2.3** 35.3±3.3** |
Compare with the normal saline group: * * P＜0.01; With infected group not relatively: ##P＜0.01
The bacteriostatic test of the pharmaceutical composition of embodiment 9. treatment upper respiratory tract infection of the present invention
First type haemolysis type streptococcus, beta hemolytic streptococcus, staphylococcus aureus, Staphylococcus albus, mlicrococcus catarrhalis are carried out the bacteriostatic experiment of conventional method, the results are shown in Table 7.
Table 7, pharmaceutical composition bacteriostatic experiment result of the present invention (liquid tube method)
| Thalline | Drug regimen substrate concentration of the present invention (g/mL) | The medicine contrast | The bacterial strain contrast | ||||||
| 0.5 0.00781 | 0.25 | 0.125 | 0.0625 | 0.0313 | 0.0156 | ||||
| First type haemolysis type streptococcus beta hemolytic streptococcus staphylococcus aureus Staphylococcus albus mlicrococcus catarrhalis | - - - - - | - + - - - | + + - + - | + + - + - | + + + + + | + + + + + | + + + + + | + + + + + | - - - - - |
The function of promoting blood circulation to disperse blood clots of the pharmaceutical composition of embodiment 10. treatment upper respiratory tract infection of the present invention
Experimentation its influence to the rat blood rheological characteristic (experimental technique is referring to Deng Jiadong etc., " Hemorheology Study method and application thereof ", Beijing: Science Press, 1989,230; The Qi Chen chief editor, " herbal pharmacology research methodology ", People's Health Publisher, 1993,642) reach influence to formation of rabbit external thrombus and platelet aggregation rate, the results are shown in Table 8 to table 12.
Table 8, pharmaceutical composition of the present invention are to the influence of rat blood rheological characteristic
| Group | Dosage (g/kg) | Animal (n) | Whole blood viscosity | Plasma viscosity 153.60S | Erythrocyte sedimentation rate (mm/h) | Packed cell volume % | |
| Low (the 5.75S that cuts -1) (192.0S -1) | Height is cut | ||||||
| Normal saline group medicine group of the present invention aspirin group | Isometric(al) 5.0 10.0 0.3 | 11 11 11 11 | 40.02±10.06 27.65±9.13** 20.12±6.81*** 27.25±6.23** | 6.95±0.85 6.30±0.76 6.17±0.48* 6.04±0.53** | 3.16±0.53 2.46±0.55** 2.23±0.34*** 2.35±0.38** | 0.19±016 0.07±0.08 0.07±0.07 0.15±0.18 | 41.84±4.53 41.25±3.11 39.75±4.06 36.17±1.9* |
Compare with the normal saline group: * P＜0.05; * P＜0.01; * * P＜0.001
Table 9, pharmaceutical composition of the present invention are to rat KPTT, PT, fibrinogenic influence
| Group | Dosage (g/kg) | Number of animals (n) | KPTT (second) | PT (second) | Fibrinogen (mg/dl) |
| Normal saline group medicine group of the present invention aspirin group | Isometric(al) 5.0 10.0 0.3 | 11 11 11 11 | 29.18±8.64 29.09±9.13 39.06±10.60* 38.09±10.22* | 13.46±1.21 13.09±1.14 13.90±2.42 14.55±2.07 | 194.46±47.41 190.55±35.94 148.90±38.95* 135.50±46.36** |
Compare with the normal saline group: * P＜0.05; * P＜0.01
The influence that table 10, pharmaceutical composition of the present invention form external thrombus
| Group | Final concentration (g/mL) | Number of animals (n) | Thrombosis | ||
| Length (mm) | Weight in wet base (mg) | Dry weight (mg) | |||
| Normal saline group medicine group of the present invention aspirin group | Isometric(al) 23.8 11.9 5.95 0.45 | 10 10 10 10 10 | 47.9±7.16 22.6±6.42*** 33.8±6.68*** 39.85±9.75* 33.9±8.50*** | 68.63±14.58 36.13±8.48*** 55.9±9.01* 58.57±6.13 51.62±6.40** | 25.4±6.05 13.79±3.70** 19.49±5.38* 21.28±4.73 18.52±4.90* |
Each group is compared with the normal saline group: * P＜0.05; * P＜0.01; * * P＜0.001
Table 11, pharmaceutical composition of the present invention are to the influence of the inductive platelet aggregation of ADP
| Group | Final concentration (mg/mL) | Number of animals (n) | 1 minute aggregation rate (%) | Maximum agglutination rate (%) |
| Normal saline group medicine group of the present invention aspirin group | Isometric(al) 4.38 8.75 17.5 35.5 0.45 | 10 10 10 10 8 9 | 40.59±4.81 32.16±6.78** 30.58±6.00*** 20.78±2.34*** 13.11±3.69*** 33.82±5.07** | 60.85±3.17 51.89±7.19** 43.66±3.48*** 22.13±1.80*** 14.66±3.91*** 44.19±4.42** |
Each group is compared with the normal saline group: * * P＜0.01; * * P＜0.001
Table 12, pharmaceutical composition of the present invention are to the influence of collagen-induced platelet aggregation
| Group | Final concentration (mg/mL) | Number of animals (n) | 1 minute aggregation rate (%) | Maximum agglutination rate (%) |
| Normal saline group medicine group of the present invention aspirin group | Isometric(al) 4.38 5.65 11.90 23.80 0.30 | 10 10 10 10 10 10 | 27.04±5.52 24.66±4.37 9.58±3.52** 4.33±2.21*** 2.40±1.55*** 3.27±1.54*** | 53.41±3.67 50.51±4.21 43.83±2.28** 31.63±3.76*** 12.93±1.78*** 17.19±2.09*** |
Each group is compared with the normal saline group: * * P＜0.01; * * P＜0.001
The activating QI to eliminate phlegm effect of the pharmaceutical composition of embodiment 11. treatment upper respiratory tract infection of the present invention
Carried out pharmaceutical composition of the present invention to the phenol red effect of trachea excretion research and pharmaceutical composition of the present invention to the influence (capillary tube method) of rat expectoration amount (referring to the Qi Chen chief editor, " herbal pharmacology research methodology ", People's Health Publisher, 1993,642), the results are shown in Table 13.
The pharmaceutical composition of table 13, treatment upper respiratory tract infection of the present invention
The influence of and rat expectoration amount phenol red to mice trachea excretion
| Group | Route of administration | The phenol red excretion amount of mice | Rat sputum excretion amount | ||
| Dosage (g/kg) | Excretion amount (μ g/mL) | Dosage (g/kg) | Excretion amount (cm) | ||
| Normal saline group medicine group of the present invention compound Radix Glycyrrhizae mixture | Irritate stomach and irritate stomach filling stomach | Isometric(al) 7.0 14.0 28.0 20mL/kg | 3.26±0.96 4.19±1.05 5.53±1.64 ** 4.55±1.38 * 3.58±0.78 | Isometric(al) 2.5 5.0 10.0 20mL/kg | 2.39±0.86 2.46±0.90 3.37±0.88 * 3.68±0.72 ** 3.98±0.69 ** |
Compare with the normal saline group:
*P＜0.05,
*P＜0.01
Claims (9)
1, a kind of pharmaceutical composition for the treatment of upper respiratory tract infection is characterized in that basically being made up of the extract of the medical material gained of following quality component:
2～4 parts of Fructus Ligustri Lucidi, 0.5～2 part of the Radix Astragali, 0.5～2 part of Radix Salviae Miltiorrhizae, 1～3 part of Herba Euphorbiae Helioscopiae,
The extracting method of described extract is made up of following steps:
Step 1, get Fructus Ligustri Lucidi, the Radix Astragali, Radix Salviae Miltiorrhizae, add 85～95% ethanol extractions, filter with the ratio of 3～5 liters every kilogram of the gross masses of three kinds of medical materials by above-mentioned quality component, alcohol extract,
Step 2, the medicinal residues of the alcohol extraction of step 1 gained and the Herba Euphorbiae Helioscopiae of quality component are merged, ratio extracting in water with 8～15 liters every kilogram of crude drug gross masses, filter, relative density is 1.03～1.10 during condensed water extract to 65 ℃, adding ethanol is 40～50% to containing the alcohol amount, leaves standstill, and filters, get supernatant
The alcohol extract of step 3, combining step one and the supernatant of step 2 reclaim ethanol, concentrate, and drying gets extract powder.
2, according to the preparation of the described pharmaceutical composition of claim 1, it is characterized in that: pharmaceutical composition mixes with acceptable carrier on the pharmaceutics, the preparation oral formulations.
3, according to the preparation of the described pharmaceutical composition of claim 2, it is characterized in that: can accept carrier on pharmaceutical composition and the pharmaceutics and mix, the oral formulations of making comprises granule, tablet, capsule, drop pill or oral liquid.
4, according to the preparation method of the granule of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder is mixed with additives, add the granule that 70～80% ethanol are made pharmaceutical composition in right amount.
5, according to the preparation method of the oral liquid of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder is water-soluble, add correctives, make the oral liquid of pharmaceutical composition.
6, according to the preparation method of the hard capsule of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder is mixed with additives, incapsulate, make the hard capsule of pharmaceutical composition.
7, according to the preparation of soft capsule method of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder and soft capsule adjuvant commonly used is mixed, be sealed in the soft capsule material of making by gelatin, make the soft capsule of pharmaceutical composition.
8, according to the preparation method of the tablet of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder and tablet adjuvant lubricant commonly used, disintegrating agent, adhesive are mixed, and tabletting is made the tablet of pharmaceutical composition.
9, according to the preparation method of the drop pill of the described pharmaceutical composition of claim 3, it is characterized in that: extract powder and drop pill adjuvant commonly used are mixed, drip and make, make the drop pill of pharmaceutical composition.
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| CN101411782B (en) * | 2008-11-11 | 2011-06-08 | 南京同仁堂药业有限责任公司 | Pharmaceutical composition for treating acute pharyngitis and preparation method thereof |
| CN105055539B (en) * | 2015-09-10 | 2019-01-29 | 广西大学 | Chinese herbal medicine extract and preparation method thereof with antibacterial action |
| CN105853917B (en) * | 2016-04-29 | 2019-06-21 | 扬子江药业集团有限公司 | A kind of pharmaceutical composition and its preparation method and application for treating chronic pharyngitis |
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