CN104523852A - Anti-cold traditional Chinese medicine composition and application thereof - Google Patents

Anti-cold traditional Chinese medicine composition and application thereof Download PDF

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Publication number
CN104523852A
CN104523852A CN201410797732.8A CN201410797732A CN104523852A CN 104523852 A CN104523852 A CN 104523852A CN 201410797732 A CN201410797732 A CN 201410797732A CN 104523852 A CN104523852 A CN 104523852A
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parts
chinese medicine
medicine composition
endotoxin
traditional chinese
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CN104523852B (en
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高申
宋洪杰
全山丛
胡晋红
石力夫
王世祥
王卓
杨樟卫
朱德增
陈方剑
胡叶帅
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Second Military Medical University SMMU
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • A61K36/195Strobilanthes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315Isatis, e.g. Dyer's woad
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535Perilla (beefsteak plant)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538Schizonepeta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634Forsythia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Abstract

The invention relates to an anti-cold traditional Chinese medicine composition and an application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 25-35 parts of honeysuckle flower, 25-35 parts of weeping forsythia capsule, 50-70 parts of indigowoad root, 25-35 parts of bistort rhizome, 6-14 parts of mulberry leaf, 6-14 parts of purple perilla and 5-15 parts of fineleaf schizonepeta herb. Verified by in-vitro experiments, the traditional Chinese medicine composition disclosed by the invention has an effect of inhibiting endotoxin; verified by in-vivo animal experiments, the traditional Chinese medicine composition can be used for significantly inhibiting fever processes of domestic rabbits caused by the endotoxin; and verified by clinical experiments, the traditional Chinese medicine composition has significant curative effects on cold fever and acute tonsillitis, so that the traditional Chinese medicine composition disclosed by the invention has wide application prospects in an aspect of treating or alleviating diseases or clinical symptoms caused by the endotoxin.

Description

A kind of Chinese medicine composition of anti-flu and application thereof
[technical field]
The present invention relates to technical field of Chinese medicines, specifically, relate to a kind of Chinese medicine composition and application thereof of anti-flu.
[background technology]
Flu is modal acute infections of respiratory tract disease, and incidence rate is higher, and adult is annual to be occurred 2 ~ 4 times, and child's incidence rate is higher, and annual 6 ~ 8 times, the whole year all can fall ill, and winter-spring season is more.Divide by paathogenic factor, flu can be divided into bacillary flu and viral influenza.Bacillary flu common sympton comprises heating, fear of cold, headache, laryngopharynx swelling and pain etc., often causes acute tonsillitis, acute pharyngolaryngitis etc. further.Bacterial endotoxin is a kind of endemic element in gram-negative bacteria cell wall, after antibacterials kill pathogenic bacterium, thalline can produce endotoxin, endotoxin is exogenous pyrogen, it can activate neutrophilic granulocyte etc., make it to discharge a kind of endogenous pyrogen, act on thermotaxic centre and cause heating, lipoid A is its biological active center, causing playing an important role in the processes such as septic shock, systemic inflammatory response syndrome and multiple organ dysfunction syndrome, be also cause gram-negative bacteria main causes of death.Therefore about focus that the research of Endotfoxin antagonist is world's biomedical research always.
The traditional Chinese medical science is thought flu is that Therapeutic Principle is generally dispelling wind pathogens, induces sweat and bring down a fever because of the disease being main clinical manifestation with headache, nasal obstruction, nasal mucus, sneeze, aversion to wind and cold, heating, floating pulse etc. caused by exopathogen invasion and attack human body.This series products market being used for the treatment of cold symptoms is more, as Radix Isatidis granules, antitoxic bolus of honeysuckle flower and forsythia and SHUANGHUANGLIAN KOUFUYE etc., but some product is as being added with the compositions such as acetaminophen, chlorphenamine maleate and VC in VC YINQIAO sheet, 999 Ganmaoling Granules, they are also easy to cause gastrointestinal upset, dripping sweat, the untoward reaction such as drowsiness while treatment cold symptoms, even there will be the untoward reaction that Liver and kidney toxicity etc. is serious.
For better treating flu and other pathological process of being caused by endotoxin, need that a kind of toxic and side effects is little badly, the pure Chinese medicinal preparation of safety well Be very effective simultaneously.
[summary of the invention]
The object of the invention is for deficiency of the prior art, a kind of Chinese medicine composition of anti-flu is provided.
Of the present invention again one object be that the purposes of described Chinese medicine composition is provided.
For realizing above-mentioned first object, the technical scheme that the present invention takes is:
A Chinese medicine composition for anti-flu, it is made up of the crude drug of following weight portion: Flos Lonicerae 25-35 part, Fructus Forsythiae 25-35 part, Radix Isatidis 50-70 part, Rhizoma Bistortae 25-35 part, Folium Mori 6-14 part, Folium Perillae 6-14 part, Herba Schizonepetae 5-15 part.
Preferably, described Chinese medicine composition is made up of the crude drug of following weight portion: Flos Lonicerae 28-32 part, Fructus Forsythiae 28-32 part, Radix Isatidis 55-65 part, Rhizoma Bistortae 28-32 part, Folium Mori 8-12 part, Folium Perillae 8-12 part, Herba Schizonepetae 8-12 part.
More preferably, described Chinese medicine composition is made up of the crude drug of following weight portion: Flos Lonicerae 30 parts, Fructus Forsythiae 30 parts, Radix Isatidis 60 parts, Rhizoma Bistortae 30 parts, 10 parts, Folium Mori, Folium Perillae 10 parts, Herba Schizonepetae 10 parts.
The dosage form of described Chinese medicine composition is capsule, granule, tablet or mixture.
For realizing above-mentioned second object, the technical scheme that the present invention takes is:
As above the application of arbitrary described Chinese medicine composition in the disease medicament of preparation treatment endotoxin initiation.
As above the application of arbitrary described Chinese medicine composition in the medicine of preparation treatment endotoxin-induced fever.
As above the application of arbitrary described Chinese medicine composition in the bacillary flu of preparation treatment.
As above the application of arbitrary described Chinese medicine composition in preparation treatment acute tonsillitis or acute pharyngolaryngitis.
As above the application of arbitrary described Chinese medicine composition in preparation treatment septic shock, systemic inflammatory response syndrome or multiple organ dysfunction syndrome.
Herein, described Radix Isatidis is a kind of Chinese crude drug.
The invention has the advantages that:
1, the present invention by vivo test two kinds of technique study of the in vitro tests and endotoxin fever model that produce agglutination between endotoxin and tachypleus amebocyte lysate the anti-endotoxin effect of Chinese medicine composition of the present invention, result shows, Chinese medicine composition of the present invention has good anti-endotoxin effect, the process of the fever in rabbits that can significantly suppress endotoxin to cause, and confirm that Chinese medicine composition of the present invention has significant curative effect for cold, fever and acute tonsillitis by clinical experiment.
Those skilled in the art will know that, endotoxin in gram-negative bacteria cell wall is exogenous pyrogen, organism fever can be caused, and then initiation various diseases, the cold symptoms such as such as heating, fear of cold, headache, the upper respiratory tract infection such as acute tonsillitis, acute pharyngolaryngitis, serious will cause septic shock, systemic inflammatory response syndrome and multiple organ dysfunction syndrome.In addition, for all pathological processes of human or animal, every process having gram-negative bacteria to participate in, then the endotoxin discharged by gram-negative bacteria can increase the weight of clinical symptoms, and this clinical symptoms is not limited only to heating, also comprises the cascade reaction caused by heating.Chinese medicine composition of the present invention is as the effective antagonist of endotoxin, and the above-mentioned symptom caused for treatment or alleviation endotoxin all can produce certain effect.
2, Chinese medicine composition of the present invention is pure Chinese medicinal preparation, has no side effect, and safety is good.
3, Chinese medicine composition flavour of a drug number of the present invention is few, and cost is low, is convenient to preparation.
[accompanying drawing explanation]
Accompanying drawing 1 is the impact that Chinese medicine composition induced by endotoxin of the present invention causes fever in rabbits.
[detailed description of the invention]
Below in conjunction with accompanying drawing, detailed description of the invention provided by the invention is elaborated.
The preparation (one) of embodiment 1 Chinese medicine composition of the present invention
Flos Lonicerae 30 parts, Fructus Forsythiae 30 parts, Radix Isatidis 60 parts, Rhizoma Bistortae 30 parts, 10 parts, Folium Mori, Folium Perillae 10 parts, Herba Schizonepetae 10 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (two) of embodiment 2 Chinese medicine composition of the present invention
Flos Lonicerae 25 parts, Fructus Forsythiae 35 parts, Radix Isatidis 50 parts, Rhizoma Bistortae 35 parts, 6 parts, Folium Mori, Folium Perillae 14 parts, Herba Schizonepetae 5 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (three) of embodiment 3 Chinese medicine composition of the present invention
Flos Lonicerae 35 parts, Fructus Forsythiae 25 parts, Radix Isatidis 70 parts, Rhizoma Bistortae 25 parts, 14 parts, Folium Mori, Folium Perillae 6 parts, Herba Schizonepetae 15 parts, add water after preimpregnation and decoct twice, time is respectively 2h, 1h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 50%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (four) of embodiment 4 Chinese medicine composition of the present invention
Flos Lonicerae 25 parts, Fructus Forsythiae 25 parts, Radix Isatidis 70 parts, Rhizoma Bistortae 35 parts, 6 parts, Folium Mori, Folium Perillae 6 parts, Herba Schizonepetae 15 parts, add water after preimpregnation and decoct twice, time is respectively 1.5h, 2h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 70%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (five) of embodiment 5 Chinese medicine composition of the present invention
Flos Lonicerae 35 parts, Fructus Forsythiae 35 parts, Radix Isatidis 50 parts, Rhizoma Bistortae 25 parts, 14 parts, Folium Mori, Folium Perillae 14 parts, Herba Schizonepetae 5 parts, add water after preimpregnation and decoct four times, time is respectively 1.5h, 1h, 1h, 1h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (six) of embodiment 6 Chinese medicine composition of the present invention
Flos Lonicerae 25 parts, Fructus Forsythiae 25 parts, Radix Isatidis 50 parts, Rhizoma Bistortae 35 parts, 14 parts, Folium Mori, Folium Perillae 14 parts, Herba Schizonepetae 15 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 0.5h, filter, merging filtrate, is evaporated to relative density and is about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (seven) of embodiment 7 Chinese medicine composition of the present invention
Flos Lonicerae 28 parts, Fructus Forsythiae 32 parts, Radix Isatidis 55 parts, Rhizoma Bistortae 32 parts, 8 parts, Folium Mori, Folium Perillae 12 parts, Herba Schizonepetae 8 parts, add water after preimpregnation and decoct three times, time is respectively 2h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 65%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (eight) of embodiment 8 Chinese medicine composition of the present invention
Flos Lonicerae 32 parts, Fructus Forsythiae 28 parts, Radix Isatidis 65 parts, Rhizoma Bistortae 28 parts, 12 parts, Folium Mori, Folium Perillae 8 parts, Herba Schizonepetae 12 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (nine) of embodiment 9 Chinese medicine composition of the present invention
Flos Lonicerae 28 parts, Fructus Forsythiae 28 parts, Radix Isatidis 55 parts, Rhizoma Bistortae 28 parts, 12 parts, Folium Mori, Folium Perillae 8 parts, Herba Schizonepetae 12 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 75%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation (ten) of embodiment 10 Chinese medicine composition of the present invention
Flos Lonicerae 32 parts, Fructus Forsythiae 32 parts, Radix Isatidis 55 parts, Rhizoma Bistortae 32 parts, 12 parts, Folium Mori, Folium Perillae 8 parts, Herba Schizonepetae 8 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 55%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).
The preparation of embodiment 11 Chinese medicine composition tablet/capsule of the present invention
The arbitrary described Chinese medicine composition raw material of Example 1-10, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).Add pharmaceutical aids, vacuum drying, pulverize and granulate, be pressed into tablet or fill encapsulated dose.
The preparation of embodiment 12 Chinese medicinal composition granules of the present invention
The arbitrary described Chinese medicine composition raw material of Example 1-10, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).Add suitable pharmaceutical aids, granulate, dry, granulate, obtains granule, subpackage 13g/ bag.
The preparation of embodiment 13 Chinese medicine composition mixture of the present invention
The arbitrary described Chinese medicine composition raw material of Example 1-10, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C).Add suitable pharmaceutical aids, make mixture.
The Effect study of embodiment 14 Chinese medicine composition induced by endotoxin of the present invention
From in vitro and in vivo antiendotoxin two parts, Chinese medicine composition of the present invention is furtherd investigate respectively.This experiment adopts the method producing agglutination between endotoxin and tachypleus amebocyte lysate, the antiendotoxic effect of Chinese medicine composition of the present invention under investigating conditions in vitro.By copying endotoxin-induced fever in rabbits model, observing Chinese medicine composition of the present invention to the refrigeration function of endotoxin-induced fever in rabbits, investigating the antiendotoxic effect of Chinese medicine composition of the present invention under condition in body.
1. material and instrument
1.1 reagent
Chinese medicine composition thick paste (containing crude drug 6.97g/ml, the Changhai hospital department of the Chinese Academy of Sciences of Second Military Medical University, PLA makes by oneself) prepared by embodiment 1; Bacterial endotoxin working standard (Nat'l Pharmaceutical & Biological Products Control Institute, 140EU/ props up, lot number: 150601-201070); Bacterial endotoxin national standard (Nat'l Pharmaceutical & Biological Products Control Institute, 10000EU/ props up, lot number: 150600-200707); Tachypleus amebocyte lysate (Zhanjiang Andusi Biology Co., Ltd., sensitivity: 0.25EU/ml, product batch number: 1212012); Baterial endotoxin test use water (Zhanjiang Andusi Biology Co., Ltd., product batch number: 1209200); Aspirin Enteric-coated Tablets (Bayer Health Care Manufacturing S.r.l.100mg/ sheet, lot number: BJ09890).
1.2 animal
(male and female are use all, female without pregnant, body weight 1.5-2.5kg, body temperature 38.8-39.6 DEG C, and The 2nd Army Medical College Experimental Animal Center provides, credit number: SYXK (Shanghai) 2007-0003 for New Zealand white rabbit; SYXK (army) 2007-024).
1.3 instrument
01J2003-4 type vertical pressure steam sterilizer cylinder (East Asia, Shanghai pressure vessel manufacturing company limited, production code member: B4427); BT124S electronic balance (Beijing Sai Duolisi Instrument Ltd.); DL-720A ultrasonic cleaner (the letter Instrument Ltd. in Shanghai); HWS24 type electric-heated thermostatic water bath (Shanghai-permanent scientific instrument company limited); XNC-1 type bacteria endotoxin detector (development of the one five five hospital); Eddy mixer (Shanghai first medical college instrument plant); The glass apparatus such as test tube, suction pipe is 250 DEG C of sterilizing 3h in baking oven all.
2. the Antiendotoxin Effect method and result
2.1 external the Antiendotoxin Effect
2.1.1 sample preparation
Chinese medicine composition thick paste 0.0656g, 0.0318g, 0.0142g of Example 1 preparation respectively, 3% polyoxyethylene sorbitan monoleate hydrotropy of water preparation is checked by tachypleus amebocyte lysate, obtain the sample liquid that concentration is respectively 32.80mg/ml, 15.90mg/ml, 7.10mg/ml, 121 DEG C of sterilizing 30min.
2.1.2 the preparation of endotoxin liquid
Endotoxin (140EU/ props up), after dissolving, gets 1ml (100EU/ml) tachypleus amebocyte lysate and checks that water is diluted to 10ml, obtain the endotoxin liquid of 10EU/ml with tachypleus amebocyte lysate inspection use water 1.4ml.
2.1.3 experimentation
Establish following group to test respectively, each concentration operation repetitive 2 is managed.(1) get basic, normal, high three each 0.5ml of concentration samples liquid respectively and put into centrifuge tube, add 10EU/ml endotoxin titer 0.5ml, mixing, put 55 ± 2 DEG C of warm 30min of water-bath, let cool to room temperature, get the above-mentioned solution of 0.2ml and be added in tachypleus amebocyte lysate ampoule, mixing.(2) get the endotoxin solution that 0.2ml has prepared, be added in tachypleus amebocyte lysate ampoule, dissolve mixing, do positive control; (3) directly dissolve tachypleus amebocyte lysate with 0.2ml tachypleus amebocyte lysate inspection water and do negative control; (4) diluent contrast is done with 0.5ml 3% polyoxyethylene sorbitan monoleate by dissolving tachypleus amebocyte lysate after the process same with sample.By above-mentioned pipe simultaneously in 37 ± 1 DEG C of incubation 60min.
Taken out gently from thermostat by test tube and slowly reverse 180 °, if form gel in pipe, and gel is indeformable, not from tube wall slippage person be the positive; Do not form gel, or formed gel not solid, distortion and from tube wall slippage person be feminine gender.
2.1.4 result
Negative control does not produce gel, and the contrast of positive control, diluent forms gel with tachypleus amebocyte lysate, illustrates that EXPERIMENTAL DESIGN is reasonable.Sample liquid and the tachypleus amebocyte lysate of basic, normal, high three kinds of concentration do not produce gel, illustrate that Chinese medicine composition thick paste of the present invention has in vitro and suppress endotoxin effect.
The Antiendotoxin Effect in 2.2 bodies
2.2.1 rabbit prepares
Conform rabbit before experiment 3d, and single cage is raised, and freely drinks water, and inserts rectum 7cm, test and get body temperature based on average 3 times with digital thermometer.Choose basal body temperature (39.0 ± 0.5) DEG C rabbit and be used for experiment.25 rabbit are divided into 5 groups at random: dosage group (1.74g/kg), compositions low dose group (0.87g/kg) in model group, aspirin group (0.20g/kg), compositions high dose group (3.48g/kg), compositions.
2.2.2 endotoxin preparation
The endotoxin normal saline dilution of 10000EU is become the concentrated solution of 1000EU/ml.Facing the used time becomes 80EU/ml with normal saline dilution.
2.2.3 model is prepared
Each group of rabbit gastric infusion respectively, model group is to equal-volume normal saline, and the high, medium and low dosage group of compositions and aspirin group are filled with respectively with relative medicine.After administration 30min, in auricular vein injection of LPS 65EU/kg, after auricular vein injection of LPS, respectively survey body temperature once every half an hour, survey 4 hours altogether.Finally deduct the meansigma methods (DT) of regular using warming therapy difference as vertical coordinate using body temperature after medicine, the corresponding time is as abscissa.
2.2.4 result
The results are shown in Table 1 and Fig. 1.As can be seen from table 1 and Fig. 1, compare with model group, aspirin group and compositions high, medium and low dosage group have obvious anti-endotoxin effect, can find out, along with the increasing of composition dosage, the degree that rabbit body temperature declines also increases, and the anti-endotoxin effect of compositions high dose group is the strongest, and substantially returns to normal body temperature after 4h.
The clinical trial of embodiment 15 traditional Chinese medicine composition for treating flu of the present invention, acute tonsillitis
1, clinical data
Gather clinical medical having bacillary cold symptoms and include clinical experiment in acute tonsillitis symptom, concrete diagnostic criteria is: leukocyte raises, fever, and headache is weak, pharyngalgia, and pharyngeal mucosa and tonsil hyperemia, tonsil has purulent secretion.Collect case 150 example altogether, be divided into 3 groups at random, respectively organize patient age, sex, body temperature has comparability.
2, Therapeutic Method
Chinese drug-treated group of the present invention: Chinese medicine composition thick paste (containing crude drug 6.97g/ml) 5ml prepared by Example 1, converts two volumes warm boiled water, every day three times.
Matched group one: prepare following Chinese medicine composition thick paste: Flos Lonicerae 30 parts, Fructus Forsythiae 30 parts, Radix Isatidis 60 parts, Rhizoma Bistortae 30 parts, 10 parts, Folium Mori, Folium Perillae 10 parts, Ramulus Cinnamomi 10 parts, add water after preimpregnation and decoct three times, time is respectively 1.5h, 1h, 1h, filtration, merging filtrate, be evaporated to relative density and be about 1.15 (40-50 DEG C), add ethanol to full liquid alcohol content 60%, leave standstill more than 12h, get supernatant and reclaim ethanol, get the clear paste that relative density is 1.28-1.32 (50-60 DEG C), containing crude drug 6.97g/ml.Get thick paste 5ml, convert two volumes warm boiled water, every day three times.
Matched group two: take White Cloud Mountain Banlangen Granule, 10g/ wraps, every day three times, each 1 bag.
3, curative effect determinate standard
A) effective: treatment 2d internal heat generation, pharyngalgia, weak transference cure, pharyngeal mucosa and tonsil hyperemia alleviate, and tonsil purulent secretion disappears; B) effective: treatment 2 ~ 3d internal heat generation disappears, pharyngalgia, the symptom such as weak are clearly better, pharyngeal mucosa and tonsil congested, tonsil purulent secretion obviously alleviates or disappears; C) invalid: treatment 3d patients symptomatic and sign, without obviously alleviating, even increase the weight of.
4, clinical effectiveness
The statistical result of each test group comparitive study is in table 2.Result shows, Chinese medicine composition of the present invention compares respectively with the total effective rate of matched group one and matched group, all there is statistical significance (P<0.05), show that Chinese medicine composition effect of the present invention is better than the Chinese medicine composition of Banlangen Granule and matched group one use, illustrate that compatibility of the present invention is precise and appropriate.In prescription of the present invention, Herba Schizonepetae, Folium Perillae are pungent and warm medicine for relieving the exterior syndrome, but temperature and not dry, not only contributing to expelling pathogenic factors from the exterior induces sweat, and can prevent the medicine of a cold nature from making fur inaccessible too on the contrary, and heresy must not be separated, and belongs to the medicine compatibility method opposed each other and yet also complement each other.Flos Lonicerae, the pungent table that cools completely of Fructus Forsythiae in side, heat-clearing and toxic substances removing, based on clearing away lung-heat, simultaneously also has expelling pathogenic factors from the exterior effect, and the wind heat that the wind heat in lung and visitor can be made to defend point in flesh table, goes out by showing thoroughly reaching of gas; Folium Mori can assist clearing away lung-heat in Flos Lonicerae, Fructus Forsythiae, outer loose exterior heat; Radix Isatidis, Rhizoma Bistortae strengthen the effect of heat-clearing and toxic substances removing, the laryngopharynx swelling and pain etc. that treatment pathogenic heat causes; Full prescription compatibility defines the dispelling wind pathogens of self uniqueness, function of bringing down a fever of inducing sweat.Therefore can be used for treatment cold, fever, fear of cold, headache, laryngopharynx swelling and pain etc. and by upper respiratory tract infection such as flu induced Acute tonsillitis, acute pharyngolaryngitises.
The therapeutic effect of each test group flu of table 2, acute tonsillitis
Group Effective Effectively Invalid Total effective rate
Chinese drug-treated group of the present invention 25 22 3 94.0%
Matched group one 13 24 13 74.0%
Matched group two 16 23 11 78.0%
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite not departing from the inventive method; can also make some improvement and supplement, these improve and supplement and also should be considered as protection scope of the present invention.

Claims (9)

1. a Chinese medicine composition for anti-flu, is characterized in that, it is made up of the crude drug of following weight portion: Flos Lonicerae 25-35 part, Fructus Forsythiae 25-35 part, Radix Isatidis 50-70 part, Rhizoma Bistortae 25-35 part, Folium Mori 6-14 part, Folium Perillae 6-14 part, Herba Schizonepetae 5-15 part.
2. Chinese medicine composition according to claim 1, it is characterized in that, it is made up of the crude drug of following weight portion: Flos Lonicerae 28-32 part, Fructus Forsythiae 28-32 part, Radix Isatidis 55-65 part, Rhizoma Bistortae 28-32 part, Folium Mori 8-12 part, Folium Perillae 8-12 part, Herba Schizonepetae 8-12 part.
3. Chinese medicine composition according to claim 2, is characterized in that, it is made up of the crude drug of following weight portion: Flos Lonicerae 30 parts, Fructus Forsythiae 30 parts, Radix Isatidis 60 parts, Rhizoma Bistortae 30 parts, 10 parts, Folium Mori, Folium Perillae 10 parts, Herba Schizonepetae 10 parts.
4. Chinese medicine composition according to claim 1, is characterized in that, the dosage form of described Chinese medicine composition is capsule, granule, tablet or mixture.
5. the application of the arbitrary described Chinese medicine composition of claim 1-4 in the medicine of the disease of preparation treatment endotoxin initiation.
6. the application of the arbitrary described Chinese medicine composition of claim 1-4 in the medicine of preparation treatment endotoxin-induced fever.
7. the application of the arbitrary described Chinese medicine composition of claim 1-4 in the bacillary flu of preparation treatment.
8. the application of the arbitrary described Chinese medicine composition of claim 1-4 in preparation treatment acute tonsillitis or acute pharyngolaryngitis.
9. the application of the arbitrary described Chinese medicine composition of claim 1-4 in preparation treatment septic shock, systemic inflammatory response syndrome or multiple organ dysfunction syndrome.
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