Summary of the invention
The purpose of this invention is to provide a kind of with the Chinese herbal medicine be raw material make have relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing and be used for the medicine of wind-heat cold.
Medicine of the present invention is made (in parts by weight) by following component:
12.5 parts of Fructus Forsythiae 600-650 parts, Herba Taraxaci 600-650 part, Radix Scutellariae 480-520 part, Flos Lonicerae 350-400 part, Radix Isatidis 350-700 part, dextrin 240-400 part, cyclamate.
Medicine optimum weight of the present invention (part) proportioning:
625 parts of Fructus Forsythiaes, 625 parts of Herba Taraxacis, 500 parts of Radix Scutellariaes, 375 parts of Flos Loniceraes, 375 parts of Radix Isatidis, 300 parts in dextrin, 12.5 parts of cyclamates.
Process for preparing medicine of the present invention comprises following process:
(1) Fructus Forsythiae adds 5 times of water of its weight, distills 3.5 hours, extracts volatile oil, and aqueous solution after the distillation and medicinal residues are collected stand-by respectively;
(2) get Herba Taraxaci, Radix Scutellariae, Flos Lonicerae, Radix Isatidis mixing, add 10 times of water of its weight, decocted 1.5 hours, filter, filtrate collection is stand-by;
(3) step (1) Fructus Forsythiae medicinal residues and step (2) filtering residue are merged, add 8 times of water of its weight, decocted 1.5 hours, filter, get filtrate;
(4) filtrate of the aqueous solution of step (1) and step (2), (3) is mixed, through the clear paste that to be evaporated to 50 ℃ of relative densities be 1.25-1.30;
(5) clear paste of step (4) becomes dried cream through drying under reduced pressure, dried cream and sweet close element are ground into fine powder, add the lake essence again, mixing is made granule with an amount of 70-80% ethanol with medicated powder, 60 ℃ of oven dry, granulate sprays into the volatile oil that step (1) obtains, mixing, airtight 10 minutes, the granule that makes carried out packing.
Described cyclamate should meet Food Additives Used in China GB2098 regulation.
Described lake essence should meet " Chinese pharmacopoeia, two 1099 pages of regulations about dextrin in 2000.
Drug administration method of the present invention: every day 3 times, each one bag (8 gram/bag), take half an hour after the meal at every turn, 3 days courses of treatment.
Advantage of the present invention and effect:
Medicine of the present invention (connecting the Pu granule to call compound recipe in the following text) is a Sugarless type, is to be made by Chinese herbal medicine such as Fructus Forsythiae, Herba Taraxacis, has the effect of relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, is specially adapted to treat cold of wind-heat syndrome.Show by pharmacodynamic study: medicine of the present invention has antiviral, antibiotic, analgesic, antiinflammatory, analgesic activity; The result shows by toxicologic study, and medicine acute toxicity test of the present invention and long term toxicity test are not seen toxic reaction; Show that by clinical test results clinical drug curative effect obvious effective rate of the present invention is 85.1%, total effective rate is 97.35%.
Be medicine effect test of the present invention, toxicity test and clinical trial situation below:
One. the test of pesticide effectiveness
1. antivirus action:
The extracorporeal antivirus effect test: connecting the Pu granule by cell culture test proof compound recipe has tangible antivirus action to respiratory syncytial virus (RSV) and III type parainfluenza virus (parainrlu III).Compound recipe connects the Pu granule minimum effective drug concentration of respiratory syncytial virus is 0.078mg/ml, its therapeutic index (TI) 64 for (MTC); Minimum effective drug concentration to III type parainfluenza virus is 0.156mg/ml, and therapeutic index is 32, and is approximate with the result of the test of contrast medicine SHUANGHUANGLIAN KOUFUYE.
Interior resisting virus test: give by per os that influenza virus infection mice compound recipe connects the Pu granule test of pesticide effectiveness, prove that compound recipe connects the Pu granule very tangible interior resisting virus (first 1 type FM is arranged
1Mus lung adapted strain) infection effect is tried continuous 6 days oral administered compounds of mice and connected Pu granule medicinal liquid, not only can significantly reduce mouse death rate, and can obviously reduce mouse lung pathological changes rate, and is approximate with the result of the test of contrast medicine SHUANGHUANGLIAN KOUFUYE.
2. antibacterial action:
In-vitro antibacterial test: result of the test shows that compound recipe connects the Pu granule to gram positive bacteria: staphylococcus aureus, streptococcus pneumoniae all have obvious bacteriostasis, minimal inhibitory concentration (MTC) is respectively 32mg/ml, 64mg/ml, be better than contrasting the medicine SHUANGHUANGLIAN KOUFUYE, and not obvious to the effect of A type Hemolytic streptococcus, MJC is 512mg/ml.
Antibacterial tests in the body: result of the test shows: irritate stomach with 3.9g/kg, 7.8g/kg, 3 dosage of 15.6g/kg and give white mice; every day 1 time; continuous 7 days, to clinical SEPARATION OF GOLD Staphylococcus aureus, streptococcus pneumoniae, A type hemolytic hammer infecting mouse all had protective effect.Compare with matched group, high dose group has highly significant protective effect (P=8.8 * 10 to the staphylococcus aureus infecting mouse
-3), senior middle school amount fine horse has highly significant and significant protective effect (P=8.8 * 10 to streptococcus pneumoniae
-3, P<0.05), high dose group has significant protective effect (P<0.05) to A type hemolytic streptococcal infection mice.
3. refrigeration function
Compound recipe connects the Pu granule has remarkable refrigeration function to the beer yeast fever in rabbit, and wherein after the administration of 11.2g/kg dosage group one hour, relatively there were significant differences for administration group and matched group, and highly significant difference was arranged on the the 2nd, 3 hour.Compound recipe connects the Pu granule has obviously analgesic (cooling) effect to triple vaccine pyrogenicity rabbit, is wherein tried rabbit after the administration of 11.2g/kg dosage group in 1 hour and begins cooling, and cooling in 2 hours is the most obvious, with matched group highly significant difference is arranged relatively.
4. antiinflammatory action:
Compound recipe connects the Pu granule to based on the acute inflammation that is caused by dimethylbenzene and carrageenin that oozes out obvious inhibitory action being arranged, and wherein 15.6g/kg, 7.8g/kg and matched group relatively have highly significant difference and significant difference.
5. analgesic activity:
Compound recipe connects Pu granule 15.6g/kg, 7.8g/kg senior middle school dosage group Dichlorodiphenyl Acetate causes the mouse writhing reaction obvious inhibitory action, and relatively there were significant differences with matched group, and 15.6g/kg group PARA FORMALDEHYDE PRILLS(91,95) causes pain the highly significant inhibitory action.
Two. toxicity test
1. compound recipe connects the acute toxicity test of Pu granule
It is 240g (crude drug)/kg to the white mice maximum dosage-feeding that compound recipe connects Pu granule (Sugarless type) filling stomach, and the quite clinical adult of this dosage intends using 240 times of dosage, and (by the body weight conversion, lumbar injection is to the LD of white mice
50Be 30.2g (crude drug)/kg).
2. compound recipe connects Pu extractum filling stomach to rat test in three months
Connect Pu extractum for 90 days compound recipes of Wistar rat with 125g/kg.d, 65.5g/kg.d, 31.2g/kg.d (crude drug amount) continuous irrigation stomach, each administration group to tried rat outward appearance, behavior, body weight gain, the just situation of drinking-water, two of ingesting, every index of hematology (erythrocyte sum, hemoglobin, total white blood cells and classification, when platelet count and blood coagulation), blood biochemistry checking index (AST, ALT, ALP, GLU, Crea, Y-Bil, TP, ALB, T-CHO, BUN), system become celestial and histopathologic examination all do not have obvious influence.Show by this long term toxicity test: it is safe by the clinical dosage application that compound recipe connects Pu extractum.
Three. clinical trial
04 month in November, 2002 in 2002 was carried out the research of III clinical trial phase to it, the clinical efficacy and the safety that compound recipe are connected Pu granule therapy flu (wind-heat syndrome) are further estimated, test is adopted at random, positive drug parallel control, multiple center clinical study method, contrasts with SHUANGHUANGLIAN KOUFUYE.Observe patient's 403 examples altogether, wherein 302 examples, matched group 101 examples are organized in treatment.
Result of the test: clinical efficacy: it is 85.10% that compound recipe connects Pu granule test group obvious effective rate, and total effective rate is 97.35%; SHUANGHUANGLIAN KOUFUYE matched group obvious effective rate is 81.19%, and total effective rate is 94.06%.The body temperature curative effect: it is 85.66% that compound recipe connects Pu granule test group obvious effective rate, and total effective rate is 94.67%; SHUANGHUANGLIAN KOUFUYE matched group obvious effective rate is 81.93%, and total effective rate is 92.77%.The tcm symptom curative effect: compound recipe connects Pu granule test group obvious effective rate 87.09%, total effective rate 97.35%; SHUANGHUANGLIAN KOUFUYE matched group obvious effective rate is 83.17%, and total effective rate is 94.06%.
Compound recipe connects the Pu granule can improve every tcm symptoms such as flu (wind-heat syndrome) patient heating, pharyngalgia, distending pain in the head, nasal obstruction, the turbid tears of stream effectively.Relatively, credit is analysed by statistics, and significant differences (P<0.05) is arranged before and after himself.
It is 6.556 hours average onset time to the abnormal body temperature patient that compound recipe connects the Pu granule, and the average analgesic time is 15.522 hours.
In the clinical trial,, do not find obvious toxic-side effects, do not see obvious adverse reaction by to blood, urine, just routine and the heart, liver, renal function lab testing.Be two model cases below:
Case 1 (Provincial Medicine Research Institute, Jilin, random number are No. 33)
The patient X that makes pottery, man, 20 years old.Because of heating, headache 21 hours, went to a doctor on 04 12nd, 2002.
T38.8 ℃ of body temperature is surveyed in the conscious heating of patient during prescription on individual diagnosis, pharyngalgia companion distending pain in the head, and cough, two just transfer.Red tongue with thin and yellow fur, floating and rapid pulse.Have a medical check-up: BP90-60mmkg, HR90 time/minute, rule is neat, pharyngeal mucous membrane hyperemia (+), Chest X-rays (-), ECG (-).
This patient meets compound recipe and connects Pu granule III clinical trial phase inclusion criteria.Sign Informed Consent Form voluntarily.Give compound recipe at random and connect Pu granule clinical application (the medicine numbering is test group No. 33).Instructions about how to take medicine: compound recipe connects the Pu granule, and each 1 bag, every day 3 times, warm boiled water after meal.
Took medicine 2 hours, patient heating is disappeared (T37.0 ℃) fully, and distending pain in the head takes a turn for the better, and adheres to taking medicine patient's conscious malaise symptoms complete obiterations such as pharyngalgia nasal obstruction of generating heat 3 days.
Patient's symptom integral is 16 minutes before taking medicine, and takes medicine back 0 minute.Patient's compliance is good during the clinical research, has no adverse reaction.Security inspection all normal (hematuria just, hepatic and renal function, ECG).
Efficacy determination: recovery from illness.Body temperature onset time: 1.5 hours.The analgesic time: 2 hours.
Case 2 (the Huaxi Hospital Attached to Sichuan Univ random number is No. 52)
Patient Tan XX, woman, 47 years old.Because of heating, pharyngalgia, headache 36 hours, went to a doctor on 06 14th, 2002.
T38.1 ℃ of body temperature is surveyed in the conscious heating of patient during prescription on individual diagnosis, pharyngalgia companion distending pain in the head, and nasal obstruction flows turbid tears.Aversion to wind, cough, two just transfer.Red tongue with thin and yellow fur, floating and rapid pulse.Have a medical check-up: BP105/75mmkg, HR90 time/minute, rule is neat, pharyngeal mucous membrane hyperemia (++), Chest X-rays (-), ECG (-).
This patient meets compound recipe and connects Pu granule III clinical trial phase inclusion criteria.Sign Informed Consent Form voluntarily.Give compound recipe at random and connect Pu granule clinical application (the medicine numbering is test group No. 52).Instructions about how to take medicine: compound recipe connects the Pu granule, and each 1 bag, every day 3 times, warm boiled water after meal.
Took medicine 3.5 hours, patient heating is disappeared (T36.6 ℃) fully, and distending pain in the head, cough take a turn for the better, and adheres to taking medicine patient's conscious malaise symptoms complete obiterations such as pharyngalgia nasal obstruction of generating heat 3 days.
Patient's symptom integral is 18 minutes before taking medicine, and takes medicine back 0 minute.Patient's compliance is good during the clinical research, has no adverse reaction.Security inspection all normal (hematuria just, hepatic and renal function, ECG).
Efficacy determination: recovery from illness.Body temperature onset time: 2 hours.The analgesic time: 3 hours.