CN1444980A - Medicine for treating acute external affection heat disease and its preparing method - Google Patents
Medicine for treating acute external affection heat disease and its preparing method Download PDFInfo
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- CN1444980A CN1444980A CN 03114291 CN03114291A CN1444980A CN 1444980 A CN1444980 A CN 1444980A CN 03114291 CN03114291 CN 03114291 CN 03114291 A CN03114291 A CN 03114291A CN 1444980 A CN1444980 A CN 1444980A
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Abstract
A Chinese medicine in the form of powder-injection for treating acute cold, pneumonia, acute pneumonia, bronchitis, etc. is prepared from forsythia fruit and houttuynia through extracting, dispensing, and freeze drying. Its advantage is high curative effect.
Description
Affiliated technical field
The present invention relates to a kind of medicine for the treatment of acute fever caused by exogenous pathogenic factors, being specifically related to a kind of is the Chinese patent medicine of feedstock production with the Chinese herbal medicine, the invention still further relates to the preparation method of this medicine.
Background technology
Wind-warm lung-heat is to experience that the caused four seasons of wind heat pathogenic factor all have and be the acute fever caused by exogenous pathogenic factors of main clinical manifestation to generate heat, to cough, to cough up phlegm with the winter and spring pilosity.From clinical manifestation, be equivalent to the acute pulmonary infection diseases such as acute pneumonia, peribronchitis and acute bronchitis of doctor trained in Western medicine, be common clinical, frequently-occurring disease.It is evident in efficacy that antibiotic is treated bacterial pneumonia clinically at present, but the pneumonia that virus and Resistant strain cause is still having a strong impact on people's health, and the sick mortality rate of the pulmonary infection that gram negative bacteria causes is still up to about 50%.At present still based on simple analgesic, antiinflammatory, antibacterial, antiviral, medicine is based on sulphonamides and antibiotic to the acute pulmonary infection treatment of diseases for doctor trained in Western medicine, and treatment time is long, easily brings side effect.The traditional Chinese medical science has externally dressing, oral agents, absorbs slow, the unhappy defective of onset but exist, and is unfavorable for the treatment of acute illness.
Summary of the invention
The object of the present invention is to provide a kind of medicine for the treatment of acute fever caused by exogenous pathogenic factors, this medicine can be used for intravenous injection, and onset is rapid, the curative effect height.
Another object of the present invention is to provide the preparation method of this medicine.
A kind of medicine for the treatment of acute fever caused by exogenous pathogenic factors provided by the invention is the medicament of being made by the following weight Chinese medicinal raw materials:
Fructus Forsythiae 1, Herba Houttuyniae 1.
The above-mentioned medicine that is used for the treatment of acute fever caused by exogenous pathogenic factors can be made said multiple dosage form on the pharmaceutics, as injection, injectable powder, oral liquid, capsule or tablet.
Above-mentioned materials of weight proportions is made the method for medicine of the present invention, may further comprise the steps:
(1) gets Fructus Forsythiae, Herba Houttuyniae mixing, alcohol heating reflux with 70～80% extracts, it is 1.05～1.15 that extracting solution is evaporated to relative density, cold preservation, get supernatant and divide 4～6 extractions with the water saturated n-butyl alcohol of 4～8 times of amounts, reclaim under reduced pressure, concentrated, vacuum drying get Fructus Forsythiae and Herba Houttuyniae mixed extract;
(2) get the said extracted thing, add water, stirring and dissolving, cold preservation are got supernatant and are filtered with filter membrane, and filtrate decompression concentrates, vacuum drying gets dry extract;
(3) get dried cream and add the dissolving of injection water, add injection mannitol, adjust pH is 6.0～8.0, carries out ultrafiltration with ultrafilter membrane, collect ultrafiltrate, add the injection water to ormal weight, the reuse filtering with microporous membrane, be sub-packed in the cillin bottle, lyophilizing, jump a queue, gland, promptly get lyophilized injectable powder of the present invention.
Prescription of the present invention is effective Chinese medicine preparation of the evil wind-warm lung-heat disease of defending at lung of treatment.Wind-warm lung-heat disease is that the wind heat pathogenic factor violates lung, causes to defend gas and declared due to the respectful malfunction by strongly fragrant and lung.Treatment is worked as with heat-clearing and toxic substances removing, eliminating evil bringing down a fever." element ask the most pure virginity will discuss greatly " cloud: " wind is excessive in interior, controls with suffering flatly, and assistant is with sweetness and bitterness, with sweet slow it, loose it with suffering ...." the Herba Houttuyniae acrid in the mouth is slightly cold, and returns lung meridian, suffering can be dispersed the heat of lung heat clearing gas; cold then clearing away lung-heat is separated pyretic toxicity, and this product heat-clearing and toxic substances removing also can removing pus and relieving carbuncle; be good at through pathogenic heat with lung heat clearing, recently with controlling pneumonia, acute and chronic tracheitis, enteritis and urinary tract infection, better curative effect arranged all; Also have removing damp-heat in addition, the function of inducing diuresis for treating stranguria syndrome is a monarch drug at Fang Zhongyong.The Fructus Forsythiae bitter in the mouth is slightly cold, return lung, the heart, small intestine meridian, heat-clearing and toxic substances removing is eliminating evil, and kind clearing away heart-fire and the heat of the part of the body cavity above the diaphragm housing the heart and lungs that looses, can also eliminating fire and detoxication, the eliminating carbuncle eliminating stagnation, forefathers have the laudatory title of " persons particularly liable to develop skin infection's panacea ", virus there is stronger deactivation, and tool broad-spectrum antiseptic and the significantly effect of inhibition inflammatory exudation, with being ministerial drug.The two share, and pathogenic heat must be separated, and evil must the removing of poison played heat-clearing and toxic substances removing, eliminating evil effect of bringing down a fever altogether.
Medicine of the present invention has heat-clearing and toxic substances removing, eliminating evil antipyretic effect, curing mainly acute fever caused by exogenous pathogenic factors--heating, micro evil wind that-wind-warm lung-heat causes are cold, cough, cough up phlegm, thirsty, headache, nasal obstruction, tongue tip side of red, yellow and thin fur or HUANGBAI(sic) are held concurrently mutually, diseases such as floating and rapid pulse, and acute pulmonary infection diseases such as acute pneumonia, the peribronchitis person that sees the above-mentioned symptom.Show that through pharmacodynamics test medicine of the present invention has significant analgesic, antibiotic, antiviral and raising immunization, and pneumonia is had the good curing effect to acute pulmonary infections such as acute pneumonia, peribronchitises especially.
The present invention is further illustrated below in conjunction with embodiment and main pharmacological toxicology result of the test.
Embodiment 1
Get Fructus Forsythiae 4800g, Herba Houttuyniae 4800g, mixing extracts 2 times with 8 times of amount alcohol heating reflux of 75%, each 1 hour, filter, merging filtrate, it is 1.05～1.15 (50 ℃) that filtrate decompression is concentrated into relative density, cold preservation, get supernatant and divide 4 extractions, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol with the water saturated n-butyl alcohol of 4 times of amounts, concentrated solution gets Fructus Forsythiae and Herba Houttuyniae mixed extract in 65 ℃ of vacuum dryings.Get the said extracted thing, add water 2500ml, stir, dissolving, solution is in 4 ℃ of cold preservations 24 hours, gets supernatant and filters with the filter membrane of 0.45um, and solution decompression concentrates and then gets dry extract in 65 ℃ of vacuum dryings.Get dried cream and add injection water 2000ml dissolving, the injection mannitol that adds 45g, sodium hydroxide solution adjust pH with 40% is 6.0～8.0, with molecular cut off is that 3000 ultrafilter membrane carries out ultrafiltration, collects ultrafiltrate, adds the injection water to 2500ml, filtering with microporous membrane with 0.22um, be sub-packed in the cillin bottle, lyophilizing, jump a queue, gland, promptly get lyophilized injectable powder of the present invention.
Embodiment 2
Get Fructus Forsythiae 5100g, Herba Houttuyniae 5100g, mixing extracts 2 times with 9 times of amount alcohol heating reflux of 70%, each 1.5 hours, filter, merging filtrate, it is 1.05～1.15 (50 ℃) that filtrate decompression is concentrated into relative density, cold preservation, get supernatant and divide 5 extractions, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol with the water saturated n-butyl alcohol of 6 times of amounts, concentrated solution gets Fructus Forsythiae and Herba Houttuyniae mixed extract in 65 ℃ of vacuum dryings.Get the said extracted thing, add water 2500ml, stir, dissolving, solution is in 4 ℃ of cold preservations 24 hours, gets supernatant and filters with the filter membrane of 0.45um, and solution decompression concentrates and then gets dry extract in 65 ℃ of vacuum dryings.Get dried cream and add injection water 2000ml dissolving, the injection mannitol that adds 50g, sodium hydroxide solution adjust pH with 40% is 6.0～8.0, with molecular cut off is that 3000 ultrafilter membrane carries out ultrafiltration, collects ultrafiltrate, adds the injection water to 2500ml, filtering with microporous membrane with 0.22um, be sub-packed in the cillin bottle, lyophilizing, jump a queue, gland, promptly get lyophilized injectable powder of the present invention.The pharmacological toxicology test
1, Pharmacodynamic test of active extract: the main pharmacodynamics to lyophilized powder of the present invention has been carried out experimental study.Lyophilized powder 20g/L concentration group of the present invention has the effect of obvious suppression pathological changes caused by virus to the HSV-1 strain.In vivo test shows, adopts first
1Type influenza virus FM
1The strain infecting mouse is an animal model, and the compound houttuynin lyophilized powder infects lethal dose influenza virus mortality of mice to obviously reducing, and demonstrates the better protect effect; The mice pneumonia pathological changes that influenza virus is caused has the obvious suppression effect, can prolong the mice life span of influenza infection, can suppress proliferation of influenza virus.The in vitro tests of compound houttuynin lyophilized powder has in various degree inhibitory action to 6 kinds of representational pathogen and conditioned pathogen bacterial strain; Antibacterial tests shows in the body, and lyophilized powder ip5.2g/kg of the present invention, 10.4g/kg, 20.8g/kg dosage group can reduce staphylococcus aureus and attack mortality of mice (P＜0.01), the effect that have infection, watches for animals; Lyophilized powder of the present invention has the effect that the mice caused by dimethylbenzene xylene capillary permeability increases that suppresses; Also has the effect that rat paw edema forms that suppresses; Show that lyophilized powder of the present invention has certain bacteriostasis, especially staphylococcus aureus is had strong endogenous protective effect, and significantly antiinflammatory elimination swelling effect is arranged.Lyophilized powder iv1.3gKg of the present invention
-1, 2.6gKg
-1, 5.2gKg
-1The typhoid fever tetravaccine is caused rabbit fever models have remarkable refrigeration function, more rapid-action than the effect of gastric infusion approach, action effect is more obvious.Immunization experiment proof lyophilized powder of the present invention has activation and potentiation to the reticuloendothelial system phagocytic function; Can obviously improve the inductive circulating antibody level of sheep red blood cell, illustrate that lyophilized powder of the present invention has potentiation to the humoral immunity of organism system; (20.8g/kg, 10.4g/kg, 5.2g/kg iv) all have obvious inhibitory action to the inductive mice delayed hypersensitivity of DNFB to lyophilized powder of the present invention, show that lyophilized powder of the present invention can improve cell immune function of human body.Lyophilized powder Dichlorodiphenyl Acetate of the present invention in addition brings out time incubation period of mouse writhing reaction does not have influence, and high, middle dosage can obviously reduce turns round the body number of times in the 15min, and makes and the body number of animals do not occur turning round and increase.
2, general pharmacology test: observe the influence of lyophilized powder of the present invention to cardiovascular system, respiratory system and central nervous system.Experimental result shows that lyophilized powder of the present invention obviously reduces spontaneous activity in mice in 20.8g/kg and 41.6g/kg dosage range; Adopt blood pressure, heart rate, the electrocardiogram of ECG-6511 electrocardiograph and BL-410 biological function experimental system synchronous recording Canis familiaris L. and breathe parameters.The result shows that under 2.5g/kg, 10.0g/kg dosage, the compound houttuynin lyophilized powder is not seen obvious influence to each wave group of Sanguis Canitis pressure, heart rate, heart beat rhythm and electrocardiogram, and the Canis familiaris L. respiratory frequency and the degree of depth are not had obvious influence.Illustrate that lyophilized powder of the present invention does not have obvious harmful effect to central nervous system, the cardiovascular system respiratory system of unifying under therapeutic dose.
3, acute toxicity test: lyophilized powder normal saline solution of the present invention, by 1: 0.85 ratio diminishing method dilution between group, join be 3.4,2.89, three concentration of 2.46g/kg, 30 (♂ ♀ half and half) mices are divided 3 groups, by mice 0.2ml.10g
-1The body weight tail vein injection is administered once, i.e. per kilogram of body weight 68.0,57.8, three dosage groups of 49.1g crude drug/kg, and animal occurs deadly after the administration, and last dead animal recovers normal after 24 hours, puts to death animal on the 8th day.The anatomic observation main organs, it is as seen unusual all not have naked eyes, and the iv maximum tolerated dose is 57.8g/kg (is equivalent to approximately clinical consumption per day 173 times).Use in the original content one day to mouse peritoneal injection secondary or three times integral dose 136g.kg
-1Crude drug and 204g.kg
-1Crude drug, animal has the pain sample to turn round body action after the administration, and there have 13 mices to occur after be administered three times 2 hours to be dead, and dead animal recovers normal next day, observed and the anatomic observation no abnormality seen in continuous 7 days, the ip maximum tolerated dose is 136g/kg (being equivalent to 408 times of clinical consumption per days approximately).
4, rat long term toxication: intend lyophilized powder long term toxicity test of the present invention totally four groups of normal control group, high, medium and low three the dosage groups of lyophilized powder of the present invention (34.0g/kg, 17.0g/kg, 8.5g/kg) are set.With clinical day application dose criterion calculation, behave respectively 102,56,28 times of clinical effective dose of high, medium and low three the dosage groups of the lyophilized powder of the present invention of rat then; Matched group waits the capacity normal saline, and the test period is 30 days, adopts the rats by intraperitoneal injection administration.The result shows that each group there is no animal dead, animal activity, diet, stool, fur gloss situation there is no any unusual, rat body weight increases with age growth, obvious change is not seen in organ coefficient and normal group comparisons such as the rat heart, liver, spleen, lung, kidney, thyroid, adrenal gland, testis, uterus, brain, prostate.The convalescent period of the GRAM of dosage group, high dose group HGB and matched group are outside there were significant differences in the hematological indices, and other each groups there is no abnormal change.The blood parameters of surveying and normal control group relatively, GLU, TP, BUN have significant change, all the other every indexs there is no unusually.All rats are carried out system's postmortem, histopathologic slide, and each is organized, organ is no abnormal.Prompting compound houttuynin lyophilized powder dosage has good safety in the clinical scope of application.
5, dog long term toxicity test: lyophilized powder 12.0,6.0 of the present invention, three dosage of 3.0g crude drug/kg (large, medium and small), be equivalent to clinical 36,18.0,9.0 times, adopt the dilution of 5% glucose injection, press 10ml/kg volume (equal-volume is isoconcentration not), observed 21 days through the intravenous drip in continuous 30 days of Beagle dog and drug withdrawal convalescent period.
Heavy dose of group full distance test is after 6 dog intravenous drips.Principal character is behind the intravenous drip medicine in 15 minutes～between 1 hour, sialorrhea is in various degree arranged, and agitation is felt sick, vomiting (vomiting is food, laxativeness etc.) gastrointestinal symptom.In also accidental all Non Apparent Abnormalities of above-mentioned symptom, low dose and matched group (5% glucose injection) are arranged.Drug withdrawal is observed and be there is no in 21 days unusually.Urine routine examination no abnormality seen.Each self more all increases before organizing 30 days body weight of administration and medicine.Animal appearance is normal, active.
Preceding 2 times of medicine, administration 30 days, and drug withdrawal checked that the peripheral hemogram value was all in normal range, with matched group comparison no difference of science of statistics in 21 days; The bone marrow smear active proliferation, the no abnormality seen cell; Relatively its result is consistent before 10 index inspections of blood biochemical, each index and administration and between group, no abnormality seen.Electrocardioscopy is sinus rhythm, and P, QRS ripple are consistent with main ripple direction, and each wave voltage, time are normal; System becomes celestial and respectively organizes each main organs all not have naked eyes as seen unusual; Organ coefficient is learned by statistics to handle and be there is no difference; The histopathology heart, kidney,liver,spleen, lung, adrenal gland, thyroid, hypophysis, prostate, thymus, testis (epididymis), ovary, uterus, SDP gland,, brain (cerebellum), injection site vascular tissue check no abnormality seen.Drug withdrawal was observed 21 days, and each index of each dog is checked also no abnormality seen.
To sum up: lyophilized powder 17.0g/kg crude drug of the present invention has minimal irritation to the dog the intestines and stomach, and peripheral hemogram, each index of blood biochemical, electrocardiogram are not had influence, system's visible pathological changes of no naked eyes that becomes celestial, histopathological examination no abnormality seen, 21 days no abnormality seens of drug withdrawal.The dilution of appropriateness and a speed are at the following dosage of 12.0g/kg crude drug, and using animal is safe dose.
6, preparation security test: lyophilized powder of the present invention has been carried out blood vessel irritation, local irritation, haemolysis, irritated effect and pyrogen test, experimental result shows, each experimental result of compound houttuynin lyophilized powder all meets the requirement of safety of clinical administration regulation, illustrates that lyophilized powder of the present invention is a kind of safe injection.
Claims (4)
1, a kind of medicine for the treatment of acute fever caused by exogenous pathogenic factors is characterized in that it is the medicament of being made by the following weight proportion raw material:
Fructus Forsythiae 1, Herba Houttuyniae 1.
2, the medicine of the acute fever caused by exogenous pathogenic factors of treatment according to claim 1 is characterized in that described medicament is a said dosage form on any pharmaceutics.
3, the medicine of the acute fever caused by exogenous pathogenic factors of treatment according to claim 2 is characterized in that described medicament is an injectable powder.
4, the preparation method of the medicine of the acute fever caused by exogenous pathogenic factors of the described treatment of claim 3 may further comprise the steps:
(1) gets Fructus Forsythiae, Herba Houttuyniae mixing, alcohol heating reflux with 70～80% extracts, it is 1.05～1.15 that extracting solution is evaporated to relative density, cold preservation, get supernatant and divide 4～6 extractions with the water saturated n-butyl alcohol of 4～8 times of amounts, reclaim under reduced pressure, concentrated, vacuum drying get Fructus Forsythiae and Herba Houttuyniae mixed extract;
(2) get the said extracted thing, add water, stirring and dissolving, cold preservation are got supernatant and are filtered with filter membrane, and filtrate decompression concentrates, vacuum drying gets dry extract;
(3) get dried cream and add the dissolving of injection water, add injection mannitol, adjust pH is 6.0～8.0, carries out ultrafiltration with ultrafilter membrane, collect ultrafiltrate, add the injection water to ormal weight, the reuse filtering with microporous membrane, be sub-packed in the cillin bottle, lyophilizing, jump a queue, gland, promptly get lyophilized injectable powder of the present invention.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03114291 CN1444980A (en) | 2003-04-23 | 2003-04-23 | Medicine for treating acute external affection heat disease and its preparing method |
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| CN 03114291 CN1444980A (en) | 2003-04-23 | 2003-04-23 | Medicine for treating acute external affection heat disease and its preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939419B (en) * | 2005-09-26 | 2012-02-15 | 山东轩竹医药科技有限公司 | Medicinal composition with weeping forsythia and houttuynin sodium |
| CN104013717A (en) * | 2014-06-25 | 2014-09-03 | 南京华宽信息咨询中心 | Soft capsule for resisting pulmonary infection due to sendai virus |
| CN108201562A (en) * | 2016-12-20 | 2018-06-26 | 陆宇 | A kind of pain stop and anti-inflammation aerosol |
-
2003
- 2003-04-23 CN CN 03114291 patent/CN1444980A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939419B (en) * | 2005-09-26 | 2012-02-15 | 山东轩竹医药科技有限公司 | Medicinal composition with weeping forsythia and houttuynin sodium |
| CN104013717A (en) * | 2014-06-25 | 2014-09-03 | 南京华宽信息咨询中心 | Soft capsule for resisting pulmonary infection due to sendai virus |
| CN108201562A (en) * | 2016-12-20 | 2018-06-26 | 陆宇 | A kind of pain stop and anti-inflammation aerosol |
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