CN1244336C - Infantile antipyretic - Google Patents
Infantile antipyretic Download PDFInfo
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- CN1244336C CN1244336C CN 02159199 CN02159199A CN1244336C CN 1244336 C CN1244336 C CN 1244336C CN 02159199 CN02159199 CN 02159199 CN 02159199 A CN02159199 A CN 02159199A CN 1244336 C CN1244336 C CN 1244336C
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Abstract
The present invention discloses infantile antipyretic which is a medicinal preparation prepared from bupleurum root, scutellaria root, sweet wormwood herb, cassia twig, schizonepeta spike and menthol according to a certain preparation process. The medicine has favorable functions of removing heat and resisting inflammatory.
Description
Technical field
The present invention relates to a kind of children's antipyretic medicine, belong to the field of Chinese medicines.
Background technology
The child is the future of motherland, and there are 300,000,000 children in China, guarantees that it grows up healthy and sound, and is significant to multiplying and being prosperous of the Chinese nation.According to the clinical data statistics, acute upper respiratory tract infection is the modal disease of department of pediatrics, accounts for more than 80% of Pediatric Clinic amount, generates heat to being that its modal clinical symptoms, persistent fever can cause a series of untoward reaction such as the interior regulatory function disorder of body.Therefore, especially should take active and effective treatment measure to infantile acute upper respiratory infection with heating person.
Present known infantile acute upper respiratory infection is about to be by due to the viral infection more than 90%, and Western medicine has direct actor still rare to viral infection, the new variety of Chinese patent drugs of domestic treatment infantile acute upper respiratory infection of having put on market already, mostly be relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, antipyretic and antidotal type, it is still rare than the powerhouse that children's is gone up the common clinical manifestation intermingling cold and heat card of sense specific aim.Therefore, carry out children's in a deep going way and go up the research of sense therapeutics, the suitable children's of exploitation goes up outside the sense intermingling cold and heat pattern of syndrome and uses Chinese patent medicine, and to enriching the tcm treatment according to syndrome differentiation content, the performance Chinese medicine is gone up the therapeutic advantage of feeling to children's, is of great practical significance undoubtedly.
Summary of the invention
The invention provides a kind of children's antipyretic medicine.
The present invention also provides preparation method.
Medicine of the present invention is that the feedstock production with following weight ratio forms:
Radix Bupleuri 300-700 Radix Scutellariae 100-400 Herba Artemisiae Annuae 100-300
Ramulus Cinnamomi 100-300 Herba Schizonepetae 100-300 Mentholum 0.5-3
The above-mentioned raw materials weight ratio of preparation medicine of the present invention is preferably:
Radix Bupleuri 400-600 Radix Scutellariae 200-300 Herba Artemisiae Annuae 100-200
Ramulus Cinnamomi 100-200 Herba Schizonepetae 100-200 Mentholum 0.5-2
The material medicine optimum weight ratio of preparation medicine of the present invention is:
Radix Bupleuri 500 Radix Scutellariaes 250 Herba Artemisiae Annuaes 150 Ramulus Cinnamomi 150 Herba Schizonepetaes 150 Mentholums 1
The above-mentioned raw materials medicine can prepare clinical medicament commonly used according to the preparation process of routine, for example, and pill, tablet, capsule, oral liquid, masticatory, unguentum, syrup, aerosol, suppository, soft capsule, drop pill, topical agent etc.In the middle of the preparation process, can add drug excipient commonly used.
Preparation method is:
1. according to the above-mentioned raw materials prescription, get Radix Bupleuri, Herba Artemisiae Annuae, Ramulus Cinnamomi, the Herba Schizonepetae four Chinese medicine adds 10 1 14 times of water gagings, adds thermal distillation 4-6 hour, collects distillate, divides and gets volatile oil, and is standby.Decocting liquid filters, medicinal residues add 6-9 times of water gaging again and decocted 0.5-1 hour, filter, and merge decocting liquid, be evaporated to about 1.09 (50 ℃) of relative density, add ethanol after the cooling and make and contain alcohol amount and reach 70-80%, cold preservation 24 hours filters, (60-70 ℃ of decompression filtrate recycling ethanol,-0.08Mpa), be concentrated into relative density and be about 1.25 (60 ℃), standby.
2. get baikal skullcap root decoction pieces, adding 8-12 times of water gaging respectively decocts 1-3 time, each 0.5-2 hour, filter the back medicinal liquid and add 2mol/L hydrochloric acid accent pH to 1.0-2.0,70-90 ℃ is incubated 20-50 minute, leaves standstill centrifugal (4000rpm) after 12 hours, and precipitation adds 6-8 times of water gaging and stirs evenly, transfer pH to 7.0～7.5 with 40% sodium hydroxide solution, add equivalent ethanol again and stir moltenly, filter, filtrate adds 2mol/L hydrochloric acid and transfers pH to 1.0～2.0, fully stir, be heated to 50-70 ℃, be incubated 20-50 minute, left standstill 12 hours, centrifugal (4000rpm), precipitation washes with water to pH and is about 5.0, continues to be washed till pH with ethanol and to be about 7.0, obtains the baicalin crude product, add 70% ethanol 120ml and make suspension, standby.
Above crude drug adds Mentholum, and mix homogeneously adds the refined shape agent of medicine again and makes pill, tablet, capsule, oral liquid, masticatory, unguentum, syrup, aerosol, soft capsule, suppository, drop pill or topical agent.
The discrimination method and the content assaying method of medicine of the present invention are as follows:
[discrimination method]:
(1) get medicine 5g of the present invention, add petroleum ether 10ml, extraction, inclining supernatant, and the low temperature water-bath volatilizes, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Ramulus Cinnamomi control medicinal material lg, the 20ml that adds diethyl ether, and supersound process 20 minutes filters, and filtrate volatilizes naturally, and residue adds ethyl acetate 2ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" 2000 editions appendix VIB of Chinese pharmacopoeia) test, draw control medicinal material solution 4uL, need testing solution 8uL put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, be developing solvent with petroleum ether (60～90 ℃)-ethyl acetate (17: 3), launch, take out, dry, spray is with 2,4 dinitrophenyl hydrazine ethanol test solution, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical orange speckle.
(2) get said method (1) the item residue behind Petroleum ether extraction down, add ethyl acetate 10ml, extraction, inclining supernatant, and low temperature water bath method, residue add ethyl acetate 2ml makes dissolving, as need testing solution.Other gets Herba Artemisiae Annuae control medicinal material 1g, the 20ml that adds diethyl ether, and supersound process 20 minutes filters, and filtrate volatilizes naturally, and residue adds ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" 2000 editions appendix VIB of Chinese pharmacopoeia) test, draw control medicinal material solution 4uL, need testing solution 8uL, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, be developing solvent with chloroform-methanol (15: 1), launch, take out, dry, put that (365nm) inspects under the ultra-violet lamp, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sky blue fluorescence speckle.
(3) get Herba Schizonepetae control medicinal material 1g, the 20ml that adds diethyl ether, ultrasonic 20 minutes, filter, filtrate low temperature volatilizes, and residue adds ethyl acetate 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" 2000 editions one appendix VI B of Chinese pharmacopoeia) test, draw control medicinal material solution 8uL, said method (1) item is need testing solution 8uL down, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, with petroleum ether (60～90 ℃)-ethyl acetate-formic acid (9: 1: 0.1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 0.05% vanillin, 105 ℃ dry by the fire to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical punctation.
(4) get medicine 5g of the present invention, add the 30ml saturated sodium-chloride water solution and stir, filter, get filtrate 20ml, twice (20ml 15ml), discards ether solution to extracted with diethyl ether, water liquid three (20ml of water saturation n-butanol extraction, 15ml 15ml) merges n-butyl alcohol liquid, low temperature water bath method, residue adds methanol 2ml, as test sample liquid.Other gets Radix Bupleuri control medicinal material 1g, add methanol 20ml, ultrasonic 20 minutes, filter, filtrate low temperature evaporate to dryness, residue adds ethanol 1ml makes dissolving, and medical material solution in contrast is according to thin layer chromatography (" 2000 editions appendix VIB of Chinese pharmacopoeia) test, draw control medicinal material solution 8uL, need testing solution 12uL, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, be developing solvent with chloroform-methanol (4: 1), saturated 10 minutes of strong aqua ammonia, launch, take out, dry, put that (365nm) inspects under the ultra-violet lamp, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sky blue fluorescence speckle, spray 20% sodium hydroxide ethanol liquid fluorescence speckle and strengthen.
Content assaying method: measure according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2000).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-water-phosphoric acid (47: 53: 0.2) is a mobile phase, and the detection wavelength is 280nm, and number of theoretical plate calculates by baicalin should be not less than 2000.
The preparation of reference substance solution: precision takes by weighing the glycosides reference substance that is dried to constant weight at 105 ℃, adds methanol and makes the solution that every 1ml contains 20ug, promptly.
The preparation of need testing solution: get this product 1g, the accurate title, decide, and adds methanol 30ml, it is ultrasonic that (250W 40KHz) 40 minutes, moves in the 100ml measuring bottle, add methanol to scale, shake up, filter, get subsequent filtrate 1ml, put in the 10ml measuring bottle, add methanol, shake up to scale, filter (0.45 μ m) with microporous filter membrane and filter, promptly.
Algoscopy: accurate respectively reference substance and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Record the every 1g of medicine of the present invention according to said method and contain Radix Scutellariae with baicalin (C
21H
18O
11) meter, must not be less than 16.0mg.
Adopt medicine of the present invention that children's is gone up sense heating (syndrome of superficies cold and interior heat) clinical cure-remarkable-effectiveness rate and reach 75%, total effective rate reaches 86.67%
Following pharmacodynamic experiment data has further confirmed the antiinflammatory action of bringing down a fever of medicine of the present invention.
Experimental exampleCure mainly relevant main pharmacodynamics research with function
Be subjected to the reagent thing
Title: children's antipyretic extractum
Children's antipyretic extractum small dose group (hereinafter to be referred as low dose): content: every g contains crude drug amount 1.5g, lot number: 20010406.
Dosage group in the children's antipyretic extractum (hereinafter to be referred as middle dosage): content: every g contains crude drug amount 3g, lot number: 20010406.
The heavy dose of group of children's antipyretic extractum (hereinafter to be referred as heavy dose): content: every g contains crude drug amount 6g, lot number: 20010406.
Acetaminophen: Jinan, Shandong Yongning pharmaceutical Co. Ltd produces, lot number: 200010201
Aspirin: Jinan, Shandong Yongning pharmaceutical Co. Ltd produces, lot number: 19990101
Test reagent
2,2, 4-dinitrophenol: reagent three factories in Shanghai City produce, lot number: 891218
Dimethylbenzene: chemical reagent work of Qilu Petroleum Chemistry Co. Inst. produces, lot number: 911112
Typhoid Vi Polysaccharide Vaccine: Beijing Tiantan Bio-pharmaceuticals goods limited company produces, lot number: 2001030201.
Yeast: yeast factory in Yantai produces.
Influenza virus A type solution: provide by Shandong Prov. Sanitation and Antiepidemic Station.
Liquid paraffin: Jining City's chemical institute is produced, lot number: 20001027.
Experimental animal
Animal, strain, source: kunming mouse, WISTER rat provide by Shandong University's animal center.The animal quality certification number: Shandong animal matter word 200001002,200001003.Rabbit is a new zealand purebred rabbit, provides animal by Shandong Prov. Sanitation and Antiepidemic Station, and the animal quality certification number is: 200001007.
Feedstuff: test Mus, test rabbit full-valence pellet feed are provided operative norm: GB19424-94 by Shandong Province's animal center.
Raise: the conventional raising, room temperature is controlled at 22-26 ℃
Test method and result
One, children's antipyretic extractum is to the influence of heating
1. the influence of children's antipyretic extractum to generating heat due to the skim milk
Select 50 of the normal rabbit of body temperature (body temperature is 38～39.2 ℃), be divided into 5 groups at random, every rabbit vein injection skim milk 2ml/kg, behind the 3h, every rabbit gives normal saline as negative control, and the administration group is children's antipyretic extractum low dose, middle dosage, heavy dose respectively, the oral 1% acetaminophen 5ml/kg of positive controls (dosage is equivalent to 10 times of clinical consumption), survey rabbit anus temperature respectively at 15min, 0.5h, 1h, 2h, 3h, 4h after the administration, experimental result sees Table 1:
Table 1: children's antipyretic extractum is to the influence of generating heat due to the skim milk (X ± SD) (℃)
| Group | Normal body temperature | Pyrogenicity body temperature | 15min | Body temperature after the administration | ||||
| 0.5h | 1h | 2h | 3h | 4h | ||||
| The heavy dose of group of dosage group acetaminophen group in the normal saline group small dose group | 38.81±0.32 38.80±0.28 38.69±0.37 38.87±0.27 38.73±0.32 | 40.04±0.24 39.95±0.26 39.87±0.19 40.02±0.27 39.82±0.29 | 40.45±0.25 40.15±0.23 ※ 40.16±0.21 ※ 40.06±0.21 ※※ 40.21±0.21 | 40.75±0.48 40.44±0.26 40.42±0.28 40.32±0.31 ※ 40.33±0.21 ※ | 41.03±0.53 40.63±0.22 ※40.63±0.25 ※40.66±0.29 ※40.55±0.21 ※ | 41.25±0.51 40.77±0.24 ※ 40.66±0.28 40.68±0.30 40.68±0.29 ※ | 41.33±0.50 41.03±0.26 40.97±0.26 40.80±0.33 ※ 40.88±0.34 ※ | 41.41±0.50 41.19±0.38 40.97±0.36 41.08±0.31 41.04±0.44 |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
From test as can be seen: the onset of children's antipyretic extractum refrigeration function is than very fast, little, in, heavy dose of just can onset at 15min, heavy dose can be kept 3h.Onset time, acetaminophen was fast.
2. children's antipyretic extractum is to the influence of rat fever due to the yeast
Select 50 of the normal rats of body temperature (body temperature is 36.6～38.3 ℃), body weight 200-250g, be divided into 5 groups at random, every group 10, every rat back subcutaneous injection 10% yeast 1ml/100g, after 3 hours, every rat is distinguished administration children's antipyretic extractum low dose, middle dosage, heavy dose, the oral 0.5% acetaminophen 1ml/100g of positive controls (dosage is equivalent to 10 times of clinical consumption), survey rat anus temperature respectively at 15min, 0.5h, 1h, 2h, 3h, 4h after the administration, experimental result sees Table 2:
Table 2: children's antipyretic extractum is to the influence of rat fever due to the yeast (X ± SD) (℃)
| Group | Normal body temperature | Pyrogenicity body temperature | 15min | Body temperature after the administration | ||||
| 0.5h | 1h | 2h | 3h | 4h | ||||
| The heavy dose of group of dosage group acetaminophen group in the normal saline group small dose group | 37.33±0.52 37.49±0.47 37.45±0.50 37.36±0.25 37.27±0.42 | 38.63±0.47 38.67±0.37 38.72±0.44 38.68±0.26 38.64±0.30 | 38.87±0.42 38.56±0.41 38.46±0.44 ※ 38.53±0.23 ※ 38.55±0.30 | 39.04±0.32 38.59±0.40 ※38.66±0.48 38.52±0.47 ※※38.74±0.33 | 39.21±0.21 38.99±0.33 38.84±0.42 ※38.68±0.39 ※※38.82±0.39 ※ | 39.29±0.19 39.14±0.28 39.08±0.32 38.83±0.36 ※※39.12±0.34 | 39.34±0.34 39.00±0.43 39.19±0.19 ※38.90±0.36 ※39.10±0.18 | 39.06±0.41 38.73±0.36 38.79±0.34 38.84±0.31 38.95±0.26 |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
3. children's antipyretic extractum is to the influence of rat fever due to the typhoid fever paratyphoid fever
Selecting of rat with rat fever test due to the yeast, every rats by intraperitoneal injection typhoid fever-Vi polysaccharide vaccine 0.25ml/100g gets rat pyrogenicity body temperature behind the 1h, and rat administration at this moment, and administration volume, method are ditto tested, and experimental result sees Table 3:
Table 3: children's antipyretic extractum is to the influence of rat fever due to the typhoid fever paratyphoid fever (X ± SD) (℃)
| Group | Normal body temperature | Pyrogenicity body temperature | 15min | Body temperature after the administration | ||||
| 0.5h | 1h | 2h | 3h | 4h | ||||
| The heavy dose of group of dosage group acetaminophen group in the normal saline group small dose group | 37.79±0.47 37.52±0.52 37.74±0.29 37.58±0.52 37.61±0.51 | 38.79±0.54 38.59±0.52 38.88±0.23 38.69±0.40 38.87±0.42 | 39.38±0.60 38.75±0.51 ※38.88±0.26 ※38.79±0.44 ※38.96±0.34 | 39.63±0.51 38.85±0.42 ※ 39.06±0.24 ※※ 38.93±0.28 ※ 39.08±0.34 ※ | 39.62±0.42 38.87±0.45 39.07±0.34 39.14±0.33 39.14±0.33 ※ | 89.61±0.36 38.95±0.42 ※※39.08±0.35 ※39.28±0.26 ※39.14±0.29 ※※ | 39.48±0.34 38.84±0.31 ※※ 39.06±0.46 39.13±0.33 39.18±0.27 | 39.44±0.32 38.9±0.45 ※※38.91±0.65 ※38.97±0.40 ※39.13±0.29 ※ |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
4. children's antipyretic extractum is to 2, the influence of fever in rabbits due to the 2, 4-dinitrophenol
Rabbit selects processing with heat run due to the skim milk, every tame rabbit back subcutaneous injection 2, and 2, 4-dinitrophenol 30mg/g gets rat pyrogenicity body temperature behind the 1h, and rabbit administration at this moment, and administration volume, method are with heat run due to the skim milk.Result of the test sees Table 4:
Table 4: children's antipyretic extractum is to 2, the influence of fever in rabbits due to the 2, 4-dinitrophenol (X ± SD) (℃)
| Group | Normal body temperature | Pyrogenicity body temperature | 15min | Body temperature after the administration | ||||
| 0.5h | 1h | 2h | 3h | 4h | ||||
| The heavy dose of group of dosage group acetaminophen group in the normal saline group small dose group | 38.24±0.36 38.75±0.32 38.74±0.30 38.58±0.42 37.61±0.34 | 40.37±0.56 40.49±0.53 40.33±0.62 40.32±0.52 40.69±0.42 | 40.34±0.48 39.97±0.42 39.85±0.49 ※ 39.87±0.42 ※ 40.15±0.59 | 40.20±0.37 39.84±0.40 39.69±0.46 ※ 39.83±0.32 ※ 39.94±0.51 | 40.11±0.29 39.76±0.24 ※ 39.69±0.39 ※ 39.73±0.21 ※※ 39.67±0.37 ※ | 39.65±0.31 39.43±0.28 39.45±0.30 ※39.33±0.21 ※39.31±0.38 ※ | 39.29±0.26 39.14±0.30 39.16±0.30 39.02±0.28 ※ 39.15±0.43 | 39.17±0.27 38.98±0.21 39.04±0.30 38.92±0.24 39.05±0.33 |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
From test as can be seen: the onset of children's antipyretic extractum refrigeration function is than very fast, in, heavy dose of just can onset at 15min, acetaminophen just can have significant difference at 1h.
Two, children's antipyretic extractum antiinflammatory action test
Get 50 of Kunming mouses, body weight 18-22g, be divided into 5 groups at random, every group 10, the outside evenly is coated with dimethylbenzene 0.25ul in every mouse right ear, 1.5h the back is children's antipyretic extractum low dose, middle dosage, heavy dose respectively, and oral 0.25% aspirin 0.2ml/10g (dosage is equivalent to 10 times of clinical consumption), behind 30min after the administration, put to death mice, two ears about cutting, card punch with diameter 7mm is laid auricle in identical position, and scales/electronic balance weighing calculates inhibition percentage rate (matched group difference-experimental group difference/matched group difference) experimental result and sees Table 5:
Table 5: the influence of inflammatory effect due to the children's antipyretic extractum xylol (X ± SD)
| Group | Number of animals | Auris dextra-left ear (mg) | Suppress percentage rate |
| The heavy dose of group of dosage group aspirin in the saline group matrix group small dose group | 10 10 10 10 10 10 | 8.48±1.73 7.32±1.57 4.31±1.12 ※※ 3.22±1.15 ※※ 3.39±1.83 ※※ 6.63±2.30 ※ | 13.6 49.7 62.4 60.4 22.6 |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
From test as can be seen: children's antipyretic extractum antiinflammatory action is remarkable, little, in, heavy dose of antiinflammatory action has significant difference, what anti-dimethylbenzene caused oozes out significantly better than aspirin.
Three, children's antipyretic extractum is to the exponential influence of influenza infection lung
Get 50 of healthy mices, male and female half and half are divided into 5 groups at random, draw about 15 LD of influenza virus A liquid of dilution under the shallow fiber crops of ether with the 0.25ml syringe
50About 0.15ml collunarium, every day, every mice gave normal saline, children's antipyretic extractum low dose, middle dosage, heavy dose respectively then, every day 4 times, continuous 4 days, cutd open mice extremely in the 4th day, open the thoracic cavity and take out full lung and weigh, calculate lung index (lung weight/mice body weight) and suppression ratio (the average lung index of the average lung index/matched group of the average lung index-experimental group of matched group) experimental result and see Table 6:
Table 6: children's antipyretic extractum is to the influence of influenza virus pulmonary infection (X ± SD)
| Group | Number of animals | The lung index | Suppress percentage rate |
| The heavy dose of group of dosage group aspirin group in the normal saline group matrix group small dose group | 10 10 10 10 10 10 | 1.84±0.25 1.78±0.21 1.65±17 ※ 1.61±0.23 ※ 1.54±0.16 ※※ 1.64±0.13 ※ | 3.3 10.3 12.5 16.3 10.9 |
Compare ※ P＜0.05, ※ ※ P＜0.01 with the normal saline group
From test as can be seen: children's antipyretic extractum has the increase of pulmonary's weight that tangible reduction influenza virus causes, reduces the exponential effect of pulmonary infection.
By above-mentioned experiment as can be seen: children's antipyretic extractum has tangible refrigeration function, can reduce skim milk, yeast, typhoid fever-Vi polysaccharide vaccine, 2, the heating due to the 2, 4-dinitrophenol; Have tangible antiinflammatory action, can reduce dimethylbenzene induced mice auricle edema rate; Have tangible antivirus action, the increase of pulmonary's weight that the reduction influenza virus causes reduces the pulmonary infection index, and pharmacodynamic action and function cure mainly and match.
Preferred forms
Embodiment 1
Radix Bupleuri 300g Radix Scutellariae 100g Herba Artemisiae Annuae 100g Ramulus Cinnamomi 100g Herba Schizonepetae 100g Mentholum 0.5g
Method for making:
Get Radix Bupleuri in the above prescription, Herba Artemisiae Annuae, Ramulus Cinnamomi, the Herba Schizonepetae four Chinese medicine adds 12 times of water gagings, adds thermal distillation 5 hours, collects distillate, collects the about 1000ml of re-distilled liquid, divides and gets volatile oil, and is standby.Decocting liquid filters, medicinal residues add 8 times of water gagings again and decocted 0.5 hour, filter, and merge decocting liquid, be evaporated to about 1.09 (50 ℃) of relative density, add ethanol after the cooling and make and contain alcohol amount and reach 80%, cold preservation 24 hours filters, (60-70 ℃ of decompression filtrate recycling ethanol,-0.08Mpa), be concentrated into relative density and be about 1.25 (60 ℃), standby.
Get baikal skullcap root decoction pieces, add 10 times of water gagings respectively and decoct 3 times, each 1 hour, filter the back medicinal liquid and add 2mol/L hydrochloric acid accent pH to 1.0 ~ 2.0,80 ℃ are incubated 30 minutes, leave standstill centrifugal (4000rpm) after 12 hours, precipitation adds 6-8 times of water gaging and stirs evenly, and transfers pH to 7.0～7.5 with 40% sodium hydroxide solution, adding equivalent ethanol again stirs molten, filter, filtrate adds 2mol/L hydrochloric acid and transfers pH to 1.0～2.0, fully stirs, be heated to 60 ℃, be incubated 30 minutes, left standstill 12 hours, centrifugal (4000rpm), precipitation washes with water to pH and is about 5.0, continuing is washed till pH with ethanol and is about 7.0, obtains the baicalin crude product
The above-mentioned raw materials medicine adds Mentholum, and mix homogeneously is made oral liquid.
Embodiment 2
The above-mentioned raw materials weight ratio of preparation medicine of the present invention is preferably:
Radix Bupleuri 600g Radix Scutellariae 300g Herba Artemisiae Annuae 200g Ramulus Cinnamomi 200g Herba Schizonepetae 200g Mentholum 2g
Described crude drug mixes to be pulverized, and crosses 100 mesh sieves, adds an amount of refined honey, makes honeyed pill.
Embodiment 3
Radix Bupleuri 700g Radix Scutellariae 400g Herba Artemisiae Annuae 300g Ramulus Cinnamomi 300g Herba Schizonepetae 300g Mentholum 3g
Press embodiment 1 gained raw material, add the Mentholum of medical starch and pulverizing, mix homogeneously, pelletize, tabletting is made tablet.
Embodiment 4
Radix Bupleuri 400g Radix Scutellariae 200g Herba Artemisiae Annuae 100g Ramulus Cinnamomi 100g Herba Schizonepetae 100g Mentholum 0.5g presses embodiment 1 gained raw material, adds Mentholum and appropriate amount of auxiliary materials is made granule.
Claims (8)
1, a kind of children's antipyretic medicine is characterized in that it is that crude drug with following weight ratio is prepared from:
Radix Bupleuri 300-700 Radix Scutellariae 100-400 Herba Artemisiae Annuae 100-300
Ramulus Cinnamomi 100-300 Herba Schizonepetae 100-300 Mentholum 0.5-3.
2, antipyretic according to claim 1 is characterized in that the weight ratio of crude drug is:
Radix Bupleuri 400-600 Radix Scutellariae 200-300 Herba Artemisiae Annuae 100-200
Ramulus Cinnamomi 100-200 Herba Schizonepetae 100-200 Mentholum 0.5-2.
3, antipyretic according to claim 1 is characterized in that the weight ratio of crude drug is:
Radix Bupleuri 500 Radix Scutellariaes 250 Herba Artemisiae Annuaes 150 Ramulus Cinnamomi 150 Herba Schizonepetaes 150 Mentholums 1.
4, according to the arbitrary described antipyretic of claim 1-3, it is characterized in that also adding drug excipient.
5, according to the arbitrary described antipyretic of claim 1-3, the dosage form that it is characterized in that this medicine is a kind of in pill, tablet, capsule, oral liquid, masticatory, unguentum, syrup, aerosol, soft capsule, suppository, drop pill or the topical agent.
6,, it is characterized in that this method is following steps according to the preparation method of the arbitrary described antipyretic of claim 1-3:
Get Radix Bupleuri, Herba Artemisiae Annuae, Ramulus Cinnamomi, Herba Schizonepetae four flavor crude drug add 10-14 times of water gaging, add thermal distillation 4-6 hour, collect distillate, divide and get volatile oil, and are standby; Decocting liquid filters, medicinal residues add 6-9 times of water gaging again and decocted 0.5-1 hour, filter, merge decocting liquid, be evaporated to 50 ℃ of relative densities about 1.09, adding ethanol after the cooling makes the alcohol amount of containing reach 70-80%, cold preservation 24 hours filters decompression filtrate recycling ethanol, be concentrated into 60 ℃ of relative densities and be about 1.25, standby;
Get Radix Scutellariae, add 8-12 times of water gaging respectively and decoct 1-3 time, each 0.5-2 hour, filter the back medicinal liquid and add 2mol/L hydrochloric acid accent pH to 1.0-2.0,70-90 ℃ is incubated 20-50 minute, it is centrifugal to leave standstill after 12 hours 4000rpm, and precipitation adds 6-8 times of water gaging and stirs evenly, with 40% sodium hydroxide solution accent pH to 7.0～7.5, adding equivalent ethanol again stirs molten, filter, filtrate adds 2mol/L hydrochloric acid and transfers pH to 1.0～2.0, fully stirs, be heated to 50-70 ℃, be incubated 20-50 minute, left standstill 12 hours, 4000rpm is centrifugal, precipitation washes with water to pH and is about 5.0, continuation is washed till pH with ethanol and is about 7.0, obtains the baicalin crude product, and is standby;
Above-mentioned gained material adds Mentholum, and mix homogeneously adds drug excipient again and makes pill, tablet, capsule, oral liquid, masticatory, unguentum, syrup, aerosol, soft capsule, suppository, drop pill or topical agent.
7,, it is characterized in that this method is following steps according to the preparation method of the described antipyretic of claim 6:
Get Radix Bupleuri, Herba Artemisiae Annuae, Ramulus Cinnamomi, Herba Schizonepetae four flavor crude drug add 12 times of water gagings, add thermal distillation 5 hours, collect distillate, divide and get volatile oil, and are standby; Decocting liquid filters, medicinal residues add 8 times of water gagings again and decocted 0.5 hour, filter, and merge decocting liquid, be evaporated to 50 ℃ of relative densities about 1.09, add ethanol after the cooling and make and contain alcohol amount and reach 80%, cold preservation 24 hours filters, filtrate is at 60-70 ℃, decompression recycling ethanol under the-0.08Mpa condition is concentrated into 60 ℃ of relative densities and is about 1.25, and is standby;
Get Radix Scutellariae, add 10 times of water gagings respectively and decoct 3 times, each 1 hour, filter the back medicinal liquid and add 2mol/L hydrochloric acid accent pH to 1.0～2.0,80 ℃ are incubated 30 minutes, it is centrifugal to leave standstill after 12 hours 4000rpm, and precipitation adds 6-8 times of water gaging and stirs evenly, with 40% sodium hydroxide solution accent pH to 7.0～7.5, adding equivalent ethanol again stirs molten, filter, filtrate adds 2mol/L hydrochloric acid and transfers pH to 1.0～2.0, fully stirs, be heated to 60 ℃, be incubated 30 minutes, left standstill 12 hours, 4000rpm is centrifugal, precipitation washes with water to pH and is about 5.0, continuation is washed till pH with ethanol and is about 7.0, obtains the baicalin crude product, and is standby;
Above-mentioned gained material adds Mentholum, and mix homogeneously is made oral liquid.
8,, it is characterized in that being one or more the method in the middle of the following method according to the discrimination method of the arbitrary described antipyretic of claim 1-3:
(1) get medicine 5g of the present invention, add petroleum ether 10ml, extraction, inclining supernatant, and the low temperature water-bath volatilizes, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Ramulus Cinnamomi control medicinal material 1g, 20ml adds diethyl ether, supersound process 20 minutes, filter, filtrate volatilizes naturally, and residue adds ethyl acetate 2ml makes dissolving, medical material solution in contrast, according to thin layer chromatography test, draw control medicinal material solution 4 μ L, need testing solution 8 μ L put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, with petroleum ether-ethyl acetate is developing solvent at 17: 3, launch, take out, dry, spray is with 2,4-dinitrophenylhydrazine ethanol test solution, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical orange speckle;
(2) get said method (1) the item residue behind Petroleum ether extraction down, add ethyl acetate extraction, inclining supernatant, the low temperature water bath method, residue adds ethyl acetate 2ml makes dissolving, as need testing solution, other gets Herba Artemisiae Annuae control medicinal material 1g, and 20ml adds diethyl ether, supersound process 20 minutes, filter, filtrate volatilizes naturally, and residue adds ethyl acetate 1ml makes dissolving, medical material solution in contrast, according to the thin layer chromatography test, draw control medicinal material solution 4 μ L, need testing solution 8 μ L, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, with chloroform-methanol is developing solvent at 15: 1, launches, and takes out, dry, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sky blue fluorescence speckle;
(3) get Herba Schizonepetae control medicinal material 1g, the 20ml that adds diethyl ether, ultrasonic 20 minutes, filter, filtrate low temperature volatilizes, and residue adds ethyl acetate 1ml makes dissolving, in contrast medical material solution; Test according to thin layer chromatography, draw control medicinal material solution 8 μ L, said method (1) is need testing solution 8 μ L down, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, with petroleum ether-ethyl acetate-formic acid is developing solvent at 9: 1: 0.1, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 0.05% vanillin, 105 ℃ dry by the fire to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical punctation;
(4) get medicine 5g of the present invention, add the 30ml saturated sodium-chloride water solution and stir, filter, get filtrate 20ml, extracted with diethyl ether is respectively 20ml and 15ml for twice, discards ether solution, water liquid is respectively 20ml three times with the water saturation n-butanol extraction, 15ml and 15ml merge n-butyl alcohol liquid, the low temperature water bath method, residue adds methanol 2ml, as test sample liquid, other gets Radix Bupleuri control medicinal material 1g, adds methanol 20ml, ultrasonic 20 minutes, filter, filtrate low temperature evaporate to dryness, residue add ethanol 1ml makes dissolving, medical material solution in contrast, according to the thin layer chromatography test, draw control medicinal material solution 8 μ L, need testing solution 12 μ L, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.5% sodium carboxymethyl cellulose, with chloroform-methanol is developing solvent at 4: 1, and saturated 10 minutes of strong aqua ammonia launches, take out, dry, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sky blue fluorescence speckle, spray 20% sodium hydroxide ethanol liquid fluorescence speckle and strengthen;
(5) according to the high effective liquid chromatography for measuring content of baicalin, wherein chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-water-phosphatase 24 is a mobile phase at 7: 53: 0.2, and the detection wavelength is 280nm, and number of theoretical plate calculates by baicalin should be not less than 2000;
The preparation of reference substance solution: precision takes by weighing the baicalin reference substance that is dried to constant weight at 105 ℃, adds methanol and makes the solution that every 1ml contains 20 μ g, promptly;
The preparation of need testing solution: get this product 1g, the accurate title, decide, and adds methanol 30ml, 250W, ultrasonic 40 minutes of 40KHz, move in the 100ml measuring bottle, add methanol, shake up, filter, get subsequent filtrate 1ml to scale, put in the 10ml measuring bottle, add methanol, shake up, filter with 0.45 μ m microporous filter membrane, promptly to scale;
Accurate respectively reference substance and each 20 μ l of need testing solution of drawing inject chromatograph of liquid, measure, and record the every 1g of above-mentioned gained medicine and contain Radix Scutellariae in baicalin, must not be less than 16.0mg.
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| CN 02159199 CN1244336C (en) | 2002-12-30 | 2002-12-30 | Infantile antipyretic |
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| CN 02159199 CN1244336C (en) | 2002-12-30 | 2002-12-30 | Infantile antipyretic |
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| CN1244336C true CN1244336C (en) | 2006-03-08 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102327349A (en) * | 2011-09-23 | 2012-01-25 | 蔡敏泽 | Infant quick-acting antipyretic powder |
| CN102552404A (en) * | 2011-12-30 | 2012-07-11 | 苏州爱斯欧蒂生物科技有限公司 | Antipyretic |
| CN102793876B (en) * | 2012-09-05 | 2013-10-30 | 成都中医药大学 | Pharmaceutical composition for treating fever caused by unknown reason as well as preparation method and application of pharmaceutical composition |
| CN103954724B (en) * | 2014-04-28 | 2015-05-27 | 四川逢春制药有限公司 | Method for detecting Jingfang granules |
| CN104189609B (en) * | 2014-09-19 | 2017-05-17 | 商丘爱己爱牧生物科技股份有限公司 | Veterinary Chinese herbal medicine compound preparation for relieving fever |
| CN109030699B (en) * | 2018-06-26 | 2020-09-18 | 哈尔滨市康隆药业有限责任公司 | Sugar-free cold cough relieving granule quality detection method |
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