CN107929445A - A kind of pharmaceutical composition for treating the infection of the upper respiratory tract and preparation method thereof - Google Patents
A kind of pharmaceutical composition for treating the infection of the upper respiratory tract and preparation method thereof Download PDFInfo
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- CN107929445A CN107929445A CN201711231564.6A CN201711231564A CN107929445A CN 107929445 A CN107929445 A CN 107929445A CN 201711231564 A CN201711231564 A CN 201711231564A CN 107929445 A CN107929445 A CN 107929445A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
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- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
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- General Health & Medical Sciences (AREA)
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a kind of pharmaceutical composition for treating the infection of the upper respiratory tract, is by weight (1 3) by cotton rose leaf extract and Flos Eriocauli extract：1 composition.Present invention firstly discovers that cotton rose leaf extract and Flos Eriocauli extract, which are applied in combination, can play the infection of the upper respiratory tract extraordinary therapeutic effect, there is the effects such as significant antiviral, sterilization, antipyretic, anti-inflammatory, analgesia.Animal experiment shows that the influence that can substantially eliminate paraxylene cause mice auricle swelling is applied in combination in cotton rose leaf extract and Flos Eriocauli extract；There is obvious antipyretic effect to escherichia coli pyrogenicity rabbit.Clinical test shows that pharmaceutical composition of the invention is notable to the therapeutic effect of the infection of the upper respiratory tract, reliable effect, mild in medicine property and, do not occur toxic side effect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for treating the infection of the upper respiratory tract and preparation method thereof, belongs to pharmaceutical preparation skill
Art field.
Background technology
The infection of the upper respiratory tract refers to that respiratory tract more than annular cartilage infects, its incidence is high, and crowd is generally susceptible,
Especially old and weak and childhood more diseases have basic chronic patient, and complication rate is high.In initial infection, patients with respiratory tract
Mucous membrane congestion and edema, polymorphonuclear granulocyte and lymphocyte infiltration mucous membrane so that respiratory tract endocrine increases.Granulocyte enters
After mucus, mucus will become purulence.With the development of the course of disease, dry cough occurs in patient, and produces viscous phlegm.This viscous phlegm can be because
Its viscosity is very big and is not easy to discharge, and great pain is brought to patient.
The infection of the upper respiratory tract is a kind of multiple disease, the various originals for causing whole body or the reduction of respiratory tract local defense function
Cause, such as suffers from cold, drenches with rain, abrupt change of climate, fatigue can make original be present in virus that the is upper respiratory tract or being invaded from the external world
Or bacterium breeds rapidly, so as to induce this disease.It is difficult clinically to find out it since the risk factor of the infection of the upper respiratory tract is very much
The cause of disease and etiological treatment.In this case, doctor can use antibiotic to patient mostly.Although clinically this disease is normal
Bacterium infection is mixed with, but long-time service antibiotic is uneconomic behavior, and the increase of bacterial drug resistance can be caused.
The traditional Chinese medical science thinks that all diseases of the flu caused by the infection of the upper respiratory tract, it is because more based on ailment said due to cold or exposure.Ailment said due to cold or exposure for suffer from, often with
Conjunction hot in the six external factors which cause diseases, cold, wet and cause a disease, wherein wind-heat is closed evil, for one of common disease of clinic.Traditional Chinese medicine is in relieving the exterior syndrome with drugs pungent in flavor and warm in property, Xin Liang
Inducing diaphoresis and strengthening vital QI to eliminate pathogenic factors etc. have its outstanding advantage, and the report of associated treatment medicine is also more, such as：Fructus forsythiae antidotal tablet, double Huangs
Even oral liquid, heat-clearing spirit electuary, chaihu oral liquid, trollflower electuary, children Fengreqing oral liquid, GANMAO QINGRE JIAONANG etc..But
Since the pathology and disease mechanism of the infection of the upper respiratory tract is complicated, TCM Syndrome Type is more, and the method for syndrome differentiation of use is also more numerous and complicated, for its rules for the treatment of
There has been no unified understanding；In addition, the Chinese medicine of the existing treatment infection of the upper respiratory tract is by several tastes even tens of taste bulk pharmaceutical chemicals mostly
The big compound of composition, compound Study on mechanism is complicated, and active ingredient is indefinite, and the internationalization for being unfavorable for Chinese medicine is promoted；And
The cost of medicine is also higher.Therefore, researching and developing a kind of prescription, simply, safely and effectively the Chinese medicine of the treatment infection of the upper respiratory tract is non-
It is often necessary.
Cottonrose hibiscus leaf (Folium HibisicMutabilis), is the drying of Malvaceae lotus category machaka cotton rose
Leaf.Now some researches show that：Cottonrose hibiscus leaf energy cool blood, removing toxic substances, detumescence, analgesic；It is mainly used for treatment to be burdened with tongue red, scald, hot eyes
The diseases such as swelling and pain, traumatic injury.
Pipewort (Flos Eriocauli.) is the cephaloid of Eriocaulaceae annual herb pipewort dry zone scape
Sequence.Now some researches show that：Pipewort energy expelling wind and clearing away cold, improving eyesight；It is mainly used for treating the diseases such as blind sparrow, headache, dentalgia.
But there has been no on cottonrose hibiscus leaf and pipewort the combination report in terms of respiratory tract infection in the treatment at present.
The content of the invention
For the above-mentioned prior art, the object of the present invention is to provide a kind of pharmaceutical composition for treating the infection of the upper respiratory tract and
Its preparation method.
To achieve the above object, the present invention uses following technical proposals：
The first aspect of the present invention, there is provided cotton rose leaf extract and Flos Eriocauli extract are preparing treatment upper respiratory tract sense
Purposes in the medicine of dye.
The cotton rose leaf extract is prepared by the following method：
Cottonrose hibiscus leaf is added water to cook 2-4 times, when each 1-3 is small, merges decoction liquor, decoction liquor is concentrated into relative density
For 1.15-1.25 (50 DEG C of surveys), ethanol is added, alcohol content is sufficiently stirred, is filtered, filtrate salt up to 50% (volume fraction)
Acid solution tune pH to 2-3,80 DEG C of insulation 30min, stands 12h, collects precipitation, and be washed till with 50% ethanol (volume fraction)
PH4.0, it is dry, up to cotton rose leaf extract.
The Flos Eriocauli extract is prepared by the following method：
Pipewort dry, pulverize, extracting in water, collect Aqueous extracts, concentrated；Aqueous extracts after concentration are crossed into macropore
Resin is adsorbed, first with the ethanol elution of 10-20% (volume fraction), the impurity for being dissolved in polar solvent is removed, discards；80- is used again
The ethanol elution of 95% (volume fraction), collects eluent, drying after ethanol is recycled, up to Flos Eriocauli extract.
The second aspect of the present invention, there is provided a kind of pharmaceutical composition for treating the infection of the upper respiratory tract, described pharmaceutical composition
It is by weight (1-3) by above-mentioned cotton rose leaf extract and Flos Eriocauli extract：1 composition.
Preferably, described pharmaceutical composition is by weight being 2 by cotton rose leaf extract and Flos Eriocauli extract：1 group
Into.
The preparation method of the cotton rose leaf extract and Flos Eriocauli extract is same as above.
The third aspect of the present invention, there is provided a kind of pharmaceutical preparation for treating the infection of the upper respiratory tract, by the medicine group of the present invention
Compound and pharmaceutically acceptable carrier are prepared.
Term " pharmaceutically acceptable carrier " used in the present invention refers to not eliminate medicine group of the present invention
The biological activity of compound or the material of property.This kind of material be applied to individual do not cause undesirable biological action or
Not with harmful way with interacting comprising any component in its composition.
" pharmaceutically acceptable carrier " in the present invention include any and all solvent, decentralized medium, coating material,
Surfactant, antioxidant, preservative (such as antiseptic, antifungal agent), isotonic agent, absorption delaying agent, salt, preservative,
Drug stabilizing agent, adhesive, excipient, disintegrant, lubricant, sweetener, flavouring, dyestuff etc. or its combination.
The pharmaceutical composition of the present invention can be the form for the general medicament that oral or non-oral routes are applied.Namely
To say, pharmaceutical composition of the invention can be applied by the various oral or non-oral modes for clinical practice, but to take orally shape
Formula is as preferred.Wherein, the solid pharmaceutical preparation for orally administering can use the forms such as tablet, pill, pulvis, granule, capsule；
Liquid preparation for orally administering includes：Oral liquid, supensoid agent, interior solution, emulsion, syrup etc..The medicine of the present invention
Composition can also be applied through non-oral routes.For this reason, it can be used aseptic aqueous solution that injection etc. is made.
Beneficial effects of the present invention：
For Chinese medicine compound prescription because being played an important role in its more chemical active principle in the treatment respiratory tract infection, the present invention is first
Secondary discovery, cotton rose leaf extract and Flos Eriocauli extract, which are applied in combination, can play the infection of the upper respiratory tract extraordinary control
Therapeutic effect, has the effects such as significant antiviral, sterilization, antipyretic, anti-inflammatory, analgesia.Animal experiment shows, cotton rose leaf extract
The influence that paraxylene causes mice auricle swelling can substantially be eliminated by being applied in combination with Flos Eriocauli extract；Escherichia coli is caused
Hot rabbit has obvious antipyretic effect.Clinical test shows, the therapeutic effect of pharmaceutical composition of the invention to the infection of the upper respiratory tract
Significantly, reliable effect, mild in medicine property and, do not occur toxic side effect.
The present invention is also by largely testing the use determined between cotton rose leaf extract and Flos Eriocauli extract component
Amount proportioning, makes said composition play good synergistic effect.By repeatedly experimental study find, cotton rose leaf extract and
Weight ratio between Flos Eriocauli extract is (1-3)：Unexpected synergistic effect can be further produced when 1, synergy is bright
Aobvious, the weight ratio particularly between cotton rose leaf extract and Flos Eriocauli extract is 2：When 1, action effect is especially pronounced.
In the pharmaceutical composition of the treatment infection of the upper respiratory tract of the present invention, each raw material components are an organic wholes, are lacked
One can not.Inventor has found in R＆D process, reduces any one of aforementioned pharmaceutical compositions raw material components, or with
The bulk pharmaceutical chemicals of similar pharmacological property are replaced the raw material components of pharmaceutical composition of the present invention, then pharmaceutical composition is integrally to upper breathing
The therapeutic effect of road infection significantly reduces；Other raw material components, medicine are further added by the basis of the pharmaceutical composition of the present invention
The overall effect of compositions does not improve significantly, or even the situation that the overall effect for having pharmaceutical composition reduces occurs.
Embodiment
Below by instantiation, the present invention will be further elaborated, it should explanation, the description below be only for
Explain the present invention, its content is not defined.
Embodiment 1：
(1) preparation of cotton rose leaf extract
Cottonrose hibiscus leaf is added water to cook 3 times, the addition of water for cottonrose hibiscus leaf 8 times of weight (i.e. in every gram of cottonrose hibiscus leaf
Add 8 grams of water), every time 2 it is small when, merge decoction liquor, decoction liquor be concentrated into relative density as 1.15-1.25 (50 DEG C of surveys),
Ethanol is added, alcohol content is sufficiently stirred up to 50% (volume fraction), is filtered, filtrate is with 2mol/L hydrochloric acid solution tune pH to 2-
3,80 DEG C of insulation 30min, stand 12h, collect precipitation, and are washed till pH4.0 with 50% ethanol (volume fraction), dry, up to wood
Folium Hibisci Mutabilis extract.
(2) preparation of Flos Eriocauli extract
Pipewort dry, pulverize and (cross 40 mesh sieves), (i.e. the addition of water is the 8 of pipewort to the water of 8 times of weight of addition
Times), decoct extraction, every time 2 it is small when, extract 2 times, collect Aqueous extracts, be concentrated into relative density for 1.15 (50 DEG C of surveys)；Will
Aqueous extracts after concentration cross HPD450 type macroporous absorbent resins, first with the ethanol elution of 10% (volume fraction) of 4 times of volumes, remove
Remove to be dissolved in the impurity of polar solvent, discard；Again with 80% ethanol elution of 6 times of volumes, eluent is collected, is done after recycling ethanol
It is dry, up to Flos Eriocauli extract.
It is 2 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, up to the upper respiratory tract is treated
The pharmaceutical composition of infection.
Aforementioned pharmaceutical compositions are prepared into oral liquid in conventional manner.
Embodiment 2：
The preparation method of cotton rose leaf extract and Flos Eriocauli extract is the same as embodiment 1.
It is 1 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, up to the upper respiratory tract is treated
The pharmaceutical composition of infection.
Embodiment 3：
The preparation method of cotton rose leaf extract and Flos Eriocauli extract is the same as embodiment 1.
It is 3 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, up to the upper respiratory tract is treated
The pharmaceutical composition of infection.
Comparative example 1：
The preparation method of cotton rose leaf extract and Flos Eriocauli extract is the same as embodiment 1.
It is 4 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, and obtains pharmaceutical composition.
Comparative example 2：
The preparation method of cotton rose leaf extract and Flos Eriocauli extract is the same as embodiment 1.
It is 1 by weight by cotton rose leaf extract and Flos Eriocauli extract：2 are mixed, and obtain pharmaceutical composition.
Comparative example 3：
(1) preparation of cotton rose leaf extract
Cottonrose hibiscus leaf is added water to cook 3 times, the addition of water for cottonrose hibiscus leaf 8 times of weight (i.e. in every gram of cottonrose hibiscus leaf
Add 8 grams of water), every time 2 it is small when, merge decoction liquor, it is dry, up to cotton rose leaf extract.
(2) preparation of Flos Eriocauli extract
Pipewort dry, pulverize and (cross 40 mesh sieves), add absolute ethyl alcohol (the i.e. addition of absolute ethyl alcohol of 8 times of weight
For 8 times of pipewort), decoct extraction, every time 2 it is small when, extract 2 times, collect extracting solution, be concentrated and dried, up to pipewort extract
Thing.
It is 2 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, and obtains pharmaceutical composition.
Comparative example 4：
(1) preparation of cotton rose leaf extract
Cottonrose hibiscus leaf dry, pulverize and (cross 40 mesh sieves), add absolute ethyl alcohol (the i.e. addition of absolute ethyl alcohol of 10 times of weight
Measure as 10 times of cottonrose hibiscus leaf), decoct extraction, every time 2 it is small when, extract 2 times, collect extracting solution, extracting solution is concentrated and dried, i.e.,
Obtain cotton rose leaf extract.
(2) preparation of Flos Eriocauli extract
By the pipewort methanol of 8 times of weight (i.e. the addition of methanol is 8 times of pipewort) extraction 3 times, 2 is small every time
When, merge extracting solution；Extracting solution is concentrated, it is dry, up to Flos Eriocauli extract.
It is 2 by weight by cotton rose leaf extract and Flos Eriocauli extract：1 is mixed, and obtains pharmaceutical composition.
Test example 1：Pharmacological toxicity is tested
1st, acute toxicity test：
The rat oral gavage of weight 200g ± 10g is selected to carry out mtd test, the oral administration gavage embodiment of the present invention 1
Pharmaceutical composition, under 242.6g crude drugs/kg dosage (equivalent to clinical intend daily dosage 400 times of adult), mouse after administration
There is light activity to reduce, 1 it is small when or so recover normal, continuous observation 7 days after administration, none animal dead, its overall health of patients,
Diet, to take the photograph water, urine and body weight increase normal, test result indicates that：The Chinese medicine composition acute toxicity of the present invention is low, clinical
Drug safety.
2nd, long term toxicity test：
Select SD rats, if high, medium and low three dosage groups, give respectively various concentrations (18.0,6.0,2.0g crude drugs/
Kg the pharmaceutical composition of the embodiment of the present invention 1), daily gavage once, continuous 90 days；Separately set a blank control group.Last is given
After medicine 24 it is small when each group live kill 1/2 animal (half male and half female), remaining 1/2 animal continue observation 2 weeks after work kills, observed during experiment
Appearance, general behavior, food ration, the changes of weight of animal, after administration 90 days and be discontinued 2 weeks progress hematologies and blood biochemical,
The index checkings such as urine biochemistry, organ coefficient, Histopathology.
Test result indicates that：It is equal to the food-intake and body weight increase of rat with various dose to rat continuous oral 90 days
Without influence.Do not find that overt toxicity acts on to hepatic and renal function.To blood routine, blood biochemistry, urine biochemistry and marrow piece etc. not
See and significantly affect, no significant difference compared with the control group between each group, prompts the dosage of the Chinese medicine composition clinical practice of the present invention
Security is higher.
Test example 2：Pharmacological effect is tested
1st, anti-inflammation test：
The male mice for taking weight to be 23-26 grams is grouped at random, every group 10, and gavage gives the embodiment of the present invention 1 respectively
Pharmaceutical composition 4g crude drugs/kg (test group), comparative example 1 prepare pharmaceutical composition 4g crude drugs/kg (control group 1), contrast
Pharmaceutical composition 4g crude drugs/kg (control groups prepared by pharmaceutical composition 4g crude drugs/kg (control group 2) of the preparation of example 2, comparative example 3
3), pharmaceutical composition 4g crude drugs/kg (control group 4), prednisone 10mg/kg (positive controls) and equivalent prepared by comparative example 4
Physiological saline (blank control group), once a day, continuous three days, gives the left ear even spread diformazan of animal in 40 minutes after the last administration
Benzene 0.005ml/ only, puts to death animal in 30 minutes after inflammation is caused, left and right same area ear is removed with the stainless steel punching pin of a diameter of 8mm
Piece, weighs, and swelling is calculated as follows, and the results are shown in Table 1.
Swelling=(left auricle weight-auris dextra piece weight)
Table 1：Pharmaceutical composition paraxylene of the present invention causes the influence of mice auricle swelling
| Group | Swelling (mg) |
| Test group | 4.3±1.5 |
| Control group 1 | 6.9±2.0 |
| Control group 2 | 7.2±2.4 |
| Control group 3 | 8.4±2.8 |
| Control group 4 | 7.8±1.9 |
| Positive controls | 7.0±2.5 |
| Blank control group | 11.2±1.9 |
As can be seen from Table 1, pharmaceutical composition of the invention can substantially eliminate paraxylene and cause mice auricle swelling
Influence, with control group 1-4 significant differences.
2nd, antipyretic effect is tested：
Take health large ear rabbit, 3d before experiment, every under 22-25 DEG C of room temperature, humidity 55%-65%, ventilated environment
Animal anus temperature is surveyed when 1 is small 1 time totally 4 times, adapt to animal, and animal of the Thermal preference fluctuation range in the range of 0.4 DEG C is standby
With.
Animal is randomly divided into 4 groups by weight size during experiment, is respectively physiological saline group, test group, control group 1, right
According to group 2, control group 3 and control group 4.Rabbit anus temperature is surveyed with computer digital clinical thermometer 1 time, survey 3 times altogether, it is flat to ask for it every 30min
Average is the animal basal body temperature.By 1ml/kg administration rabbit auricular vein injection inactivation escherichia coli pyrogenicity, and before pyrogenicity
Gastric infusion, pharmaceutical composition 6g prepared by test group gastric infusion embodiment 1 give birth at twice within 30 minutes after 30min and pyrogenicity
Medicine/kg, pharmaceutical composition 6g crude drugs/kg prepared by control group 1-4 difference gastric infusion comparative examples 1-4, physiological saline group gavage
The physiological saline of equivalent.30,60,120,240 and 360min surveys rabbit anus temperature 5 times respectively after pyrogenicity, when calculating each group rabbit is each
Anus temperature and the difference of basal body temperature after section treatment, take statistics processing, the results are shown in Table 2.
Table 2：Different periods Temperature changing situation after each group treatment of animals
As can be seen from Table 2, pharmaceutical composition of the invention has obvious antipyretic effect to escherichia coli pyrogenicity rabbit, its
Positive effect of bringing down a fever is better than control group 1-4, and antipyretic effect is more longlasting.
3rd, analgesic test：
The female small white mouse 40 of 20 ± 2g of weight is taken, is randomly divided into：Blank control group (physiological saline), positive controls
(aspirin 0.15g/kg), test group (pharmaceutical composition of embodiment 1,4g crude drugs/kg), (medicine of comparative example 1 of control group 1
Compositions, 4g crude drugs/kg), control group 2 (pharmaceutical composition of comparative example 2,4g crude drugs/kg), control group 3 (comparative example 3
Pharmaceutical composition, 4g crude drugs/kg) and control group 4 (pharmaceutical composition of comparative example 4,4g crude drugs/kg)；Every group 10, by above-mentioned
After dosage administration, 0.6% glacial acetic acid 0.1mL/10g is injected respectively at 30 minutes pneumoretroperitoneums, record is injected after algogen 10 minutes
Interior writhing number, statistical result are as shown in table 3.
Table 3：Influence of the pharmaceutical composition of the present invention to mouse writhing number
| Group | Writhing number |
| Blank control group | 51.2±3.6 |
| Positive controls | 5.4±1.8 |
| Test group | 6.2±1.6 |
| Control group 1 | 16.8±4.5 |
| Control group 2 | 24.3±4.3 |
| Control group 3 | 30.4±3.8 |
| Control group 4 | 26.7±4.6 |
As can be seen from Table 3, the writhing number as caused by algogen can be greatly decreased in pharmaceutical composition of the invention, its
Analgesic effect is substantially better than control group 1-4, suitable with positive controls effect.
Above-mentioned experiment shows that the pharmaceutical composition of the embodiment of the present invention 1 will be shown for the therapeutic effect of the infection of the upper respiratory tract
Write the pharmaceutical composition prepared better than comparative example 1- comparative examples 4.Illustrate cotton rose leaf extract in the pharmaceutical composition of the present invention
It is that conventional adjustment institute is getable that consumption proportion with Flos Eriocauli extract, which is not, in pharmaceutical composition of the invention, wooden cottonrose hibiscus
The consumption proportion of Rong's leaf extract and Flos Eriocauli extract is determined according to the various Considerations such as its character of medicinal material, compatibility relationship
, for composition overall drug effect play the role of it is very important.In addition, cotton rose leaf extract and Flos Eriocauli extract
Performance of the preparation method for its drug effect also functions to very crucial effect, preparation method using the present invention to cottonrose hibiscus leaf and
The active ingredient of pipewort is extracted, its therapeutic effect to the infection of the upper respiratory tract is optimal.
Test example 3：Clinical test
1. general information：
The children 120 of 6-14 Sui of the selection with the infection of the upper respiratory tract, and the adult 120 of 18-60 Sui, respectively with
Machine is divided into three groups, is test group, Chinese medicine control group and western medicine group respectively.
2. case inclusive criteria：
According to《Chinese medical disease Standardization of diagnosis and curative effect》, primary symptom：(1) body heat, (2) foul wind；Minor symptom：(1) pharyngalgia, (2) are thirsty,
(3) cough, (4) sweating, (5) nasal obstruction runny nose.Thin white fur of tongue is micro- yellow or thin Huang, superficial and rapid pulse or sliding number.
Possess primary symptom 2 and minor symptom 2 or more than 2, be provided simultaneously with above-mentioned tongue vein as person.
3. treatment method：
Western medicine group gives micronomicin injection for treating, and by specification uses or follows the doctor's advice, and 7 days are 1 course for the treatment of.
Chinese medicine control group gives Shuanghuanglian oral liquid treatment, and three times a day, children organize each 5ml, each 10ml of adult group,
7 days are 1 course for the treatment of.
Treatment group is practiced the oral liquid treatment of the preparation of example 1, and three times a day, children organize each 5ml, and adult group is each
10ml, 7 days are 1 course for the treatment of.
4. curative effect determinate standard：
According to chilly, high fever, nasal obstruction, runny nose, headache, pharyngalgia, dry cough, general weakness, face red, the congested water of pharynx nasalis
Swollen, lung lower part has a small amount of bubble or wheezing sound, secondary bacterial infection to have yellow dense phlegm, pectoralgia, total white blood cells, neutrophil leucocyte
The improvement degree such as increase and be divided into healing, effective, effective or invalid.
Cure：More than 95% original symptom substantially mitigates；
It is effective：More than 75% original symptom substantially mitigates；
Improve：More than 50% original symptom substantially mitigates；
It is invalid：Less than 50% original symptom mitigates or entirely without mitigation.
5. result：
Clinical test through one western medicine group, Chinese medicine control group and treatment group course for the treatment of, its result is respectively such as table 4 and table
Shown in 5.
Table 4:Children organize clinical trial results
| Group | Cure | It is effective | Improve | It is invalid | Total effective rate (%) |
| Western medicine group | 12 | 14 | 11 | 3 | 92.5 |
| Chinese medicine control group | 10 | 13 | 12 | 5 | 87.5 |
| Treatment group | 21 | 16 | 3 | 0 | 100 |
Table 5：Adult group clinical trial results
| Group | Cure | It is effective | Improve | It is invalid | Total effective rate (%) |
| Western medicine group | 10 | 16 | 10 | 4 | 90 |
| Chinese medicine control group | 12 | 10 | 12 | 6 | 85 |
| Treatment group | 24 | 11 | 4 | 1 | 97.5 |
As a result as can be seen that compared with western medicine group and Chinese medicine control group, medicine composite for curing using the present invention
After the infection of the upper respiratory tract, clinical effective rate significantly improves, and can alleviate clinical symptoms in the short time, illustrates the medicine of the present invention
Compositions have good therapeutic effect to the infection of the upper respiratory tract, to a certain extent instead of western medicine respiratory tract infection,
Reducing reduces immunity caused by abuse of antibiotics, the problems such as developing immunity to drugs；And the pharmaceutical composition of the present invention uses peace
Entirely, the generation having no adverse reaction, to the few side effects of body, has staple market value.
The foregoing is only a preferred embodiment of the present invention, but protection scope of the present invention be not limited thereto,
It is any to be familiar with those skilled in the art in the technical scope of present disclosure, technique according to the invention scheme and its invention
Design is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (6)
1. the purposes of cotton rose leaf extract and Flos Eriocauli extract in the medicine for preparing the treatment infection of the upper respiratory tract.
2. purposes as claimed in claim 1, it is characterised in that the cotton rose leaf extract is prepared by the following method：
Cottonrose hibiscus leaf is added water to cook 2-4 times, when each 1-3 is small, merges decoction liquor, decoction liquor is concentrated into relative density is
1.15-1.25, adds ethanol, alcohol content is sufficiently stirred up to 50%, filters, and filtrate is with hydrochloric acid solution tune pH to 2-3,80 DEG C
30min is kept the temperature, stands 12h, collects precipitation, and pH4.0 is washed till with 50% ethanol, it is dry, up to cotton rose leaf extract.
3. purposes as claimed in claim 1, it is characterised in that the Flos Eriocauli extract is prepared by the following method：
Pipewort dry, pulverize, extracting in water, collect Aqueous extracts, concentrated；Aqueous extracts after concentration are crossed into macroporous absorption
Resin, first with the ethanol elution of 10-20%, removes the impurity for being dissolved in polar solvent, discards；The ethanol elution of 80-95% is used again,
Eluent is collected, drying after ethanol is recycled, up to Flos Eriocauli extract.
4. a kind of pharmaceutical composition for treating the infection of the upper respiratory tract, it is characterised in that described pharmaceutical composition is by claim 1 institute
The cotton rose leaf extract and Flos Eriocauli extract stated are by weight (1-3)：1 composition.
5. pharmaceutical composition as claimed in claim 4, it is characterised in that described pharmaceutical composition is as described in claim 1
Cotton rose leaf extract and Flos Eriocauli extract are 2 by weight：1 composition.
6. a kind of pharmaceutical preparation for treating the infection of the upper respiratory tract, it is characterised in that the pharmaceutical preparation is by 4 or 5 institute of claim
The pharmaceutical composition and pharmaceutically acceptable carrier stated are prepared.
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|---|---|---|---|---|
| CN101716199A (en) * | 2009-12-31 | 2010-06-02 | 浙江工业大学 | Method for extracting flavonoids from leaves of cotton rose hibiscus |
| CN102961463A (en) * | 2012-11-14 | 2013-03-13 | 贵州百灵企业集团制药股份有限公司 | Process for preparing Ganqing granules |
| CN104491224A (en) * | 2014-12-21 | 2015-04-08 | 哈尔滨金玉科技开发有限公司 | Traditional Chinese medicine composition for treating upper respiratory tract infection |
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2017
- 2017-11-29 CN CN201711231564.6A patent/CN107929445A/en active Pending
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|---|---|---|---|---|
| CN101716199A (en) * | 2009-12-31 | 2010-06-02 | 浙江工业大学 | Method for extracting flavonoids from leaves of cotton rose hibiscus |
| CN102961463A (en) * | 2012-11-14 | 2013-03-13 | 贵州百灵企业集团制药股份有限公司 | Process for preparing Ganqing granules |
| CN104491224A (en) * | 2014-12-21 | 2015-04-08 | 哈尔滨金玉科技开发有限公司 | Traditional Chinese medicine composition for treating upper respiratory tract infection |
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