CN104523793A - Viral cold treatment medicine and preparation method thereof - Google Patents

Abstract

The invention discloses a viral cold treatment medicine. Effective medicinal components of the medicine comprise, by weight, 0.2-2 parts of Alpine Yarrow Herb, 0.2-2 parts of isatis root and 0.2-2 parts of Folium Isatidis. The medicine is prepared through the following steps: adding water to Alpine Yarrow Herb, isatis root and Folium Isatidis, and decocting; mixing obtained decoctions, concentrating, adding ethanol to adjust the ethanol volume percentage content to 40-70%, standing, filtering, and carrying out reduced pressure treatment on the obtained filtrate to recover ethanol; and adding pharmaceutically acceptable auxiliary materials. Compared with simple anti-inflammatory and antiviral western medicines, the medicine disclosed in the invention has the advantages of anti-inflammatory and antiviral dual efficacies, extremely small toxic side effects, and definite therapeutic effect on viral colds, can obviously improve fever, throat dryness, nasal obstruction, deep-colored turbid snots, coughs, headache, thirst and other traditional Chinese medicinal symptoms, has a best improvement effect on the nasal obstruction, is suitable for children and adults, and is safe to use clinically.

Description

A kind of medicine for the treatment of viral influenza and preparation method thereof

Technical field

The invention belongs to field of medicaments, be specifically related to a kind of medicine for the treatment of viral influenza and preparation method thereof.

Background technology

Viral influenza is the common a kind of diseases of people, comprises common cold, influenza and viral pharyngitis etc., infects via nasal cavity mainly through air or hands contact.Influenza is the Acute respiratory infectious disease caused by influenza virus, and virus is present in the respiratory tract of patient, when patient's cough, sneeze through droplet infection.Because its infectiousness is strong, route of transmission is wayward, spread speed is fast, spread scope is wide, therefore more difficult control, endangers very large.Common cold is caused by rhinovirus, coronavirus and parainfluenza virus etc., and common cold wants much weak compared with influenza infectiousness, often occurs individually, when Abwehrkraft des Koepers declines, just easily ill.At present, treatment viral influenza many uses Western medicine, uses Western medicine to carry out anti-inflammation and sterilization, antiviral, and side effect is comparatively large, and have certain infringement to health anti-inflammation and sterilization is antiviral, sometimes also do not reach satisfied effect, cost is higher simultaneously.

Summary of the invention

The object of this invention is to provide medicine of a kind for the treatment of viral influenza be made up of Chinese medicine and preparation method thereof.

It is as follows that the present invention realizes the technical scheme that above-mentioned purpose adopts:

Treat a medicine for viral influenza, active drug composition is made up of 0.2-2 weight portion Herba Achilleae, 0.2-2 weight portion Radix Isatidis and 0.2-2 weight portion Folium Isatidis.

Further, described active drug composition is the water boiling and precipitation with ethanol thing of Herba Achilleae, Radix Isatidis and Folium Isatidis.

The preparation method of the medicine of above-mentioned treatment viral influenza, comprises the steps:

(1) add water to Herba Achilleae, Radix Isatidis and Folium Isatidis, decoct;

(2) decoction liquor merges concentrated, adds ethanol, regulates ethanol contend percentage composition to 40-70%, leaves standstill, filter, decompression filtrate recycling ethanol;

(3), after decompression filtrate recycling ethanol, add pharmaceutically acceptable adjuvant, make medicine.

Further, when step (1) decocts, solid-liquid ratio is 1:(6-12).

Further, temperature during decoction is 93-100 DEG C.

Accompanying drawing explanation

Fig. 1 is resisiting influenza virus result in medicine body of the present invention.

Fig. 2 is the suppression result that medicine of the present invention is verified mice.

Detailed description of the invention

Below in conjunction with embodiment and accompanying drawing, the present invention is described in further details.

Embodiment 1

Count by weight, get Herba Achilleae 0.2 part, Radix Isatidis 0.5 part, Folium Isatidis 0.4 part, this three tastes medical material is placed in extraction vessel, adds 6-12 times of water gaging, 93-100 DEG C decocts 2 times, each decocting time 2 hours, collecting decoction, filters, is cooled to room temperature, concentration of liquid medicine, to relative density 1.06-1.20, is cooled to room temperature; Add the ethanol that volume by volume concentration is 95% again, make alcohol volume content in medicinal liquid reach 50%, stir evenly, leave standstill 24 hours, filter, decompression filtrate recycling ethanol, and concentrated make thick paste, it is dry through wet granulation then to add the adjuvant such as dextrin, sucrose, makes granule.

Embodiment 2

Count by weight, get Herba Achilleae 2.0 parts, Radix Isatidis 2.0 parts, Folium Isatidis 2.0 parts, this three tastes medical material is placed in extraction vessel, adds 6-12 times of water gaging, 93-100 DEG C decocts 2 times, each decocting time 2 hours, collecting decoction, filters, is cooled to room temperature, concentration of liquid medicine, to relative density 1.06-1.20, is cooled to room temperature; Add the ethanol that volume by volume concentration is 95% again, make alcohol volume content in medicinal liquid reach 40%, stir evenly, leave standstill 24 hours, filter, decompression filtrate recycling ethanol, and concentrated make thick paste, it is dry through wet granulation then to add the adjuvant such as dextrin, sucrose, makes granule.

Embodiment 3

Count by weight, get Herba Achilleae 1.0 parts, Radix Isatidis 0.7 part, Folium Isatidis 0.5 part, this three tastes medical material is placed in extraction vessel, adds 6-12 times of water gaging, 93-100 DEG C decocts 2 times, each decocting time 2 hours, collecting decoction, filters, is cooled to room temperature, concentration of liquid medicine, to relative density 1.06-1.20, is cooled to room temperature; Add the ethanol that volume by volume concentration is 95% again, make alcohol volume content in medicinal liquid reach 70%, stir evenly, leave standstill 24 hours, filter, decompression filtrate recycling ethanol, and concentrated make concentrated solution, concentrated solution is prepared into extract powder through reduced vacuum drying again, adds adjuvant, and pharmaceutical methods makes tablet routinely.

Embodiment 4

Count by weight, get Herba Achilleae 1.0 parts, Radix Isatidis 2.0 parts, Folium Isatidis 2.0 parts, this three tastes medical material is placed in extraction vessel, adds 6-12 times of water gaging, 93-100 DEG C decocts 2 times, each decocting time 2 hours, collecting decoction, filters, is cooled to room temperature, concentration of liquid medicine, to relative density 1.06-1.20, is cooled to room temperature; Add the ethanol that volume by volume concentration is 95% again, make alcohol volume content in medicinal liquid reach 50%, stir evenly, leave standstill 24 hours, filter, decompression filtrate recycling ethanol, decoct extract obtained with 45% dense aqueous sucrose solution, pharmaceutical methods makes syrup routinely simultaneously.

Embodiment 5

Count by weight, get Herba Achilleae 2.0 parts, Radix Isatidis 1.3 parts, Folium Isatidis 1.6 parts, three taste medical materials are placed in 3 different extraction vessels respectively, add 6-12 times of water gaging respectively, each decoction twice, each decocting time 2 hours, filters, merges each decocting liquid, after mix homogeneously, be cooled to room temperature, concentration of liquid medicine, to relative density 1.06-1.20, is cooled to room temperature; Add the ethanol that volume by volume concentration is 95% again, make alcohol volume content in medicinal liquid reach 60%, stir evenly, leave standstill 24 hours, filter, decompression filtrate recycling ethanol, extracting solution after filtration suitably concentrates again, and selects as required to add correctives and antiseptic, makes oral liquid.

drug effect toxicological study

(1) inside and outside resisiting influenza virus effect

Test and be inoculated in people's laryngeal carcinoma epithelial cell HEP-2 cytopathogenic effect model (CPE) with influenza A virus (first H1N1 A/ capital anti-/ 262/95), observe thing of the present invention to the impact of CPE, calculate medium effective concentration IC50 and the selection index SI of thing of the present invention.

In Vitro Anti influenza virus is tested

In vivo in resisiting influenza virus experiment, with influenza A virus Mus lung adapted strain PR8 collunarium infecting mouse, oral thing of the present invention in infection the previous day, continuous 6 days, record infected death condition and the time-to-live of each group mice in latter 14 days.(experimental drug dosage arranges the dose,equivalent being all converted to mice with clinical application amount, and it is middle dosage that thing of the present invention gets dose,equivalent, and its 0.5 times is low dose of, and 2 times is heavy dose of, is respectively: 1,2 and 4 gkg ^-1d ^-1; Ribavirin: 0.06 gkg ^-1d ^-1; Antiviral granule is: 4.64gkg ^-1d ^-1.The results are shown in Figure 1.

Shown by the research of inside and outside resisiting influenza virus: thing clinical equivalent dosage of the present invention is 65% to PR8 infecting mouse Death prevention rate, and increase in life span is 67%, and lung index is 33%, has the resisiting influenza virus effect of good inside and outside.

(2) inside and outside bacteriostasis

Extracorporeal bacteria inhibitor test by test tube doubling dilution, measure thing of the present invention for the minimal inhibitory concentration (MIC) of staphylococcus aureus be 62.5, minimal bactericidal concentration (MBC) 125; To the minimal inhibitory concentration (MIC) of streptococcus pneumoniae be 7.8, minimal bactericidal concentration (MBC) 15.6.Known, thing of the present invention has good inhibitory action to staphylococcus aureus and streptococcus pneumoniae.

Extracorporeal bacteria inhibitor test: by experiment mice continuous oral thing of the present invention after 5 days, lumbar injection infection of staphylococcus aureus, statistics infects in 48h, and thing clinical equivalent dosage of the present invention is 33% to the Death prevention rate of staphylococcus aureus.Mice is with after thing prevention administration of the present invention by experiment, and lumbar injection coli-infection, statistics infects in 48h, and thing clinical equivalent dosage of the present invention is 44% to colibacillary Death prevention rate.

Shown by inside and outside bacteriostasis research: thing of the present invention has good inside and outside bacteriostasis.

(3) antiinflammatory, immunization

The suppression ratio that thing clinical equivalent dosage xylol of the present invention causes mice ear is 35%, obviously can suppress the ear swelling effect of mice caused by dimethylbenzene xylene, and strengthens with the inhibitory action that increases of concentration; Be 49% to mouse peritoneal capillary permeability suppression ratio, that can significantly suppress glacial acetic acid to cause mouse peritoneal capillary permeability increases effect, and strengthens (see figure 2) along with the inhibitory action that increases of concentration.Simultaneously by thing of the present invention on the test of Mouse IgM nucleus formation and the impact test on mice T and B lymphocyte proliferation effect, known its significantly can raise antibody horizontal in SRBC immune serum, and at 232 ~ 15000 μ gmL ^-1obvious inhibitory action is all had to the T/B lymphopoiesis of LPS/ConA induction in concentration range.

By showing antiinflammatory, immunization research: thing of the present invention has the effect of good antiinflammatory action and immunity moderation function.

(4) safety evaluatio research

Studies on acute toxicity: thing of the present invention is with maximum administration concentration, maximum administration volume, and to gavage in mice one day three times, namely in one day, maximum dosage-feeding MTD is 60 gkg ^-1d ^-1, within the observation period of regulation, there is not obvious acute toxic reaction in (286 times for adult's per kilogram of body weight consumption every day).Show that this preparation is without obvious acute toxicity, drug safety.

Cumulative toxicity is studied: get 120 Wistar rats and be divided into matched group, thing of the present invention 2.5,5,10 gkg at random ^-1d ^-1(being equivalent to 12,24,48 times of 70 kg adult per kilogram of body weight consumptions every day respectively) three dosage groups.Continuous gastric infusion 90 d, the indices such as administration group rat body weight, organ coefficient, hematology, blood biochemistry compares with matched group, is showed no the ANOMALOUS VARIATIONS relevant to administration; Histological examination also has no the pathological change relevant with drug effect.Point out thing of the present invention under this experiment condition without obvious accumulative toxicity.

clinical trial situation

Take antiviral granule as contrast, evaluate random, the double-blind of the Drug therapy of the present invention flu effectiveness of (anemopyretic) and safety, multicenter Parallel clinical trial, plan into group 440 example, wherein of the present invention group 330 example, matched group antiviral granule 110 example.

Clinical efficacy criterion is patient's cardinal symptom, sign (sneeze, nasal obstruction, watery nasal discharge, pharyngalgia, heating) and physical and chemical inspection etc. are index, and result of the test is as following table:

Tcm syndrome curative effect determinate standard is the indexs such as primary symptom, tongue fur, pulse condition, and result is as follows:

Clinical test results shows of the present invention group of Drug therapy flu (wind-heat syndrome) determined curative effect, obviously can improve body temperature, and simultaneously conventional to blood, urine, feces, the safe performance indexes such as electrocardiogram, hepatic and renal function has no adverse effects, and clinically has no untoward reaction, use safety.

Compared with simple antiinflammatory, antiviral Western medicine, medicine of the present invention has antiinflammatory, antiviral double effects, and toxic and side effects is minimum.Drug on viral sexuality of the present invention emits determined curative effect, and obviously can improve heating, parched throat, nasal obstruction, turbid nasal discharge, cough, headache, the tcm syndrome such as thirsty, it is best to the improvement effect of nasal obstruction, is applicable to child and adult's different crowd, Clinical practice safety.

Claims (5)

1. treat a medicine for viral influenza, active drug composition is made up of 0.2-2 weight portion Herba Achilleae, 0.2-2 weight portion Radix Isatidis and 0.2-2 weight portion Folium Isatidis.

2. treat the medicine of viral influenza according to claim 1, it is characterized in that, described active drug composition is the water boiling and precipitation with ethanol thing of Herba Achilleae, Radix Isatidis and Folium Isatidis.

3. treat the preparation method of the medicine of viral influenza described in claim 1, comprise the steps:

(1) add water to Herba Achilleae, Radix Isatidis and Folium Isatidis, decoct;

(2) decoction liquor merges concentrated, adds ethanol, regulates ethanol contend percentage composition to 40-70%, leaves standstill, filter, decompression filtrate recycling ethanol;

(3), after decompression filtrate recycling ethanol, add pharmaceutically acceptable adjuvant, make medicine.

4. the preparation method as requested described in 3, is characterized in that, when step (1) decocts, solid-liquid ratio is 1:(6-12).

5. the preparation method as requested described in 4, is characterized in that, temperature during decoction is 93-100 DEG C.