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CN1985947B - Fire-clearing zhimai dripping pill and its preparing method - Google Patents

Fire-clearing zhimai dripping pill and its preparing method Download PDF

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CN1985947B
CN1985947B CN200510122491A CN200510122491A CN1985947B CN 1985947 B CN1985947 B CN 1985947B CN 200510122491 A CN200510122491 A CN 200510122491A CN 200510122491 A CN200510122491 A CN 200510122491A CN 1985947 B CN1985947 B CN 1985947B
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clearing
zhimai
fire
dripping pill
extractum
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CN1985947A (en
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张志华
佟永领
苏文琴
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Jinyao Darentang Group Co ltd No 6 Chinese Medicine Factory
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No6 Chinese Medicine Factory Tianjin Zhongxin Pharmaceutical Industry Group Co Ltd
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Abstract

The present invention is fire-clearing Zhimai dripping pill prepared with andrographis herb, cape jasmine and ophiopogon root, and its preparation process. The preparation process includes the following steps: alcohol reflux extracting andrographis herb, mixing with active carbon, alcohol reflux to decolorize to obtain extractun I; alcohol reflux extracting cape jasmine and ophiopogon root, concentrating the extracted liquid while recovering alcohol, extracting the concentrate with organic solvent and concentrating to obtain extractum II; mixing polyglycol, extractun I and extractum II, and making dripping pill with the mixture. The fire-clearing Zhimai dripping pill has the features of high bioavailability, small dosage, less toxic side effect, high curative effect and fast acting.

Description

Fire-clearing zhimai dripping pill and preparation method thereof
Technical field
The present invention relates to a kind of Chinese patent medicine drop pill and preparation method thereof, particularly relate to a kind of fire-clearing zhimai dripping pill and preparation method thereof.
Background technology
" heat-clearing and toxic substances removing " class Chinese patent medicine has the large market demand, and such Chinese patent medicine has stronger antibiosis and antiviral functions, and good effect, and toxic and side effects is little, therefore have the laudatory title of " green antibiotic " clinically.Wherein fire-clearing zhimai class medicine has heat-clearing and toxic substances removing, removing heat from blood repercussive effect, is mainly used in treatment laryngopharynx swelling and pain, heating, toothache and conjunctival congestion.Because the fire-clearing zhimai class preparation of selling is tablet, capsule or pill in the market, therefore the part patient dysphagia just might occur or take inconvenient problem when taking the medicine of these dosage forms, and these bioavailability of medicament are often not high, and onset is slow.
Summary of the invention
In order to address the above problem, the object of the present invention is to provide a kind of rapid-action, bioavailability is high and the fire-clearing zhimai dripping pill of taking convenience.
Another object of the present invention is to provide a kind of method for preparing fire-clearing zhimai dripping pill.
In order to achieve the above object, fire-clearing zhimai dripping pill provided by the invention mainly is made up of following weight proportion raw material component:
Herba Andrographis 600-1000 part Fructus Gardeniae 80-120 part 80-120 Radix Ophiopogonis part.
The weight proportion of each raw material components is preferably in the described fire-clearing zhimai dripping pill:
100 parts of 800 portions of Fructus Gardeniaes of Herba Andrographis 100 parts of Radix Ophiopogonis
The preparation method of described fire-clearing zhimai dripping pill is to carry out according to the following step order:
A. will join according to the Herba Andrographis after the said ratio weighing and be reflux, extract, in 70~95% ethanol of 12~20 times of its weight 1~3 time, each 1~3 hour, then extracting solution being merged the back reclaims ethanol and is condensed into thick extractum, thick extractum is mixed according to 1: 0.5~3 ratio with active carbon, decolour with 70~95% alcohol refluxs, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 50~95% ethanol of 6~10 times of its gross weights 1~3 time according to joining the Fructus Gardeniae after the said ratio weighing, Radix Ophiopogonis, each 1~3 hour, then extracting solution being merged back recovery ethanol and being concentrated into relative density is 1.05~1.30 (80 ℃), be that any organic solvent merges the back with extract and reclaims solvent and concentrate and obtain extractum 2 above-mentioned concentrated solution extraction 1~4 time in n-butyl alcohol, ethyl acetate, butanone or the chloroform of 0.5~1 times of concentrated solution gross weight with weight;
C. with weight Polyethylene Glycol-4000, Polyethylene Glycol-6000 or both mixture heating and melting in water-bath of 1~9 times of extractum 1,2 gross weight, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball promptly to can be made into fire-clearing zhimai dripping pill provided by the invention.
Concentration of alcohol is preferred 95% among the described step a, and consumption is 16 times of Herba Andrographis weight, extraction time 2 times, and each 2 hours, the weight ratio of thick extractum and active carbon was 1: 0.5~1.5, preferred 1: 1.
Concentration of alcohol preferred 70% among the described step b, consumption is Fructus Gardeniae, Radix Ophiopogonis 10 times of gross weight, reflux, extract, 2 times, each 2 hours, 80 ℃ of relative densities that concentrate the back extracting solution down are 1.05~1.12, during organic solvent extraction for the first time consumption be 1 times of concentrated solution gross weight, its complementary degree is 0.5 times of concentrated solution gross weight, and preferred n-butyl alcohol.
Preferred 4: 1 of the ratio of Polyethylene Glycol among the described step c-4000, Polyethylene Glycol-6000 or both mixture and extractum 1,2 gross weights.
Described drop pill can also wrap film-coat.
Described film-coat material is an Opadry.
Fire-clearing zhimai dripping pill provided by the invention and preparation method thereof is as carrier the dissolution of the lactone composition that is insoluble in water in the Herba Andrographis to be improved with Polyethylene Glycol greatly, thereby helps the absorption of medicine, and can improve bioavailability.In addition, dosage is little, volume is little, toxic and side effects is little and efficient, quick-acting, long lasting characteristics because drops has, thereby rapid-action, taking convenience and evident in efficacy, thereby can satisfy the demand of extensive patients.
The specific embodiment
Below in conjunction with embodiment fire-clearing zhimai dripping pill provided by the invention and preparation method thereof is elaborated.
Embodiment 1:
A. will join according to the Herba Andrographis after the optimum ratio weighing and be reflux, extract, in 95% ethanol of 16 times of its weight 2 times, each 2 hours, then extracting solution being merged the back reclaims ethanol and is condensed into thick extractum, thick extractum is mixed according to 1: 1 ratio with active carbon, decolour with 95% alcohol reflux, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 70% ethanol of 10 times of its gross weights 2 times according to joining the Fructus Gardeniae after the optimum ratio weighing, Radix Ophiopogonis, each 2 hours, then extracting solution being merged back recovery ethanol and being concentrated into relative density is 1.08 (80 ℃), with n-butyl alcohol above-mentioned concentrated solution is extracted 4 times, for the first time consumption is 1 times of concentrated solution gross weight, all the other are 0.5 times for 3 times, extract is merged the back reclaim n-butyl alcohol and concentrate and obtain extractum 2;
C. with weight Polyethylene Glycol-6000 heating and melting in water-bath of 4 times of extractum 1,2 gross weights, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball, promptly can be made into fire-clearing zhimai dripping pill provided by the invention with Opadry bag film-coat after the assay was approved.
Embodiment 2:
A. will join according to the Herba Andrographis after the optimum ratio weighing and be reflux, extract, in 70% ethanol of 20 times of its weight 3 times, each 1 hour, then extracting solution being merged the back reclaims ethanol and is condensed into thick extractum, thick extractum is mixed according to 1: 0.5 ratio with active carbon, decolour with 85% alcohol reflux, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 80% ethanol of 8 times of its gross weights 3 times according to joining the Fructus Gardeniae after the optimum ratio weighing, Radix Ophiopogonis, each 1 hour, then extracting solution being merged back recovery ethanol and being concentrated into relative density is 1.10 (80 ℃), with ethyl acetate above-mentioned concentrated solution is extracted 3 times, for the first time consumption is 1 times of concentrated solution gross weight, all the other are 0.5 times for 2 times, extract is merged the back reclaim ethyl acetate and concentrate and obtain extractum 2;
C. with weight Polyethylene Glycol-6000 heating and melting in water-bath of 6 times of extractum 1,2 gross weights, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball promptly to can be made into fire-clearing zhimai dripping pill provided by the invention.
Embodiment 3:
A. will join according to the Herba Andrographis after the optimum ratio weighing and be reflux, extract, in 85% ethanol of 12 times of its weight 1 time 2 hours, then extracting solution is reclaimed ethanol and be condensed into thick extractum, thick extractum is mixed according to 1: 1.5 ratio with active carbon, decolour with 85% alcohol reflux, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 95% ethanol of 6 times of its gross weights 1 time 3 hours according to joining the Fructus Gardeniae after the optimum ratio weighing, Radix Ophiopogonis, then extracting solution being reclaimed ethanol and being concentrated into relative density is 1.11 (80 ℃), with butanone above-mentioned concentrated solution is extracted 2 times, for the first time consumption is 1 times of concentrated solution gross weight, the 2nd time is 0.5 times, extract is merged the back reclaim butanone and concentrate and obtain extractum 2;
C. with weight Polyethylene Glycol-6000 heating and melting in water-bath of 2 times of extractum 1,2 gross weights, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball promptly to can be made into fire-clearing zhimai dripping pill provided by the invention.
Embodiment 4:
A. will join according to the Herba Andrographis after the optimum ratio weighing and be reflux, extract, in 90% ethanol of 15 times of its weight 1 time 2 hours, then extracting solution is reclaimed ethanol and be condensed into thick extractum, thick extractum is mixed according to 1: 3 ratio with active carbon, decolour with 85% alcohol reflux, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 50% ethanol of 8 times of its gross weights 1 time 3 hours according to joining the Fructus Gardeniae after the optimum ratio weighing, Radix Ophiopogonis, then extracting solution being reclaimed ethanol and being concentrated into relative density is 1.09 (80 ℃), with n-butyl alcohol above-mentioned concentrated solution is extracted 3 times, for the first time consumption is 1 times of concentrated solution gross weight, all the other are 0.5 times for 2 times, extract is merged the back reclaim n-butyl alcohol and concentrate and obtain extractum 2;
C. with weight Polyethylene Glycol-6000 heating and melting in water-bath of 8 times of extractum 1,2 gross weights, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball promptly to can be made into fire-clearing zhimai dripping pill provided by the invention.
Embodiment 5:
Preparation method is with embodiment 1, unique different be that the Polyethylene Glycol among the step c-6000 usefulness Polyethylene Glycol-4000 is replaced.
Embodiment 6:
Preparation method is with embodiment 1, unique different be to be that 1: 20 Polyethylene Glycol-4000 and Polyethylene Glycol-6000 mixture replaces with the Polyethylene Glycol among the step c-6000 usefulness ratio.
Fire-clearing zhimai dripping pill provided by the invention is dark-brown, every heavy 40mg of ball, and every gram drop pill is equivalent to 4.16 gram crude drugs.
In order to verify the drug effect of fire-clearing zhimai dripping pill provided by the invention, with commercially available fire-clearing zhimai capsule (0.25g/ grain, every is equivalent to 1 gram crude drug), indometacin (25mg/ capsule), water-soluble (bamyl (aspirin) of aspirin, 0.5g/ sheet) and yeast tablet (every contains dry yeast 0.5g) medicine and this medicine has been carried out multinomial animal experiments such as analgesia, antiinflammatory in contrast, the result is as follows:
One, experimental animal
1. Kunming mouse, body weight 21-28g, male and female have concurrently, available from laboratory animal research institute of Beijing Chinese Academy of Medical Sciences breeding field, the quality certification number: SCXK11-00-006 (secondary).
2.Wistar rat, available from laboratory animal research institute of Beijing Chinese Academy of Medical Sciences breeding field, the quality certification number: SCXK11-00-006 (secondary).
3. test chamber condition secondary animal experiment chamber, 22 ± 2 ℃ of temperature, humidity 55 ± 15%, natural illumination.Large and small Mus is all raised in the clean cabinet of animal, drinks the clean water through purification utensil; Feedstuff is available from laboratory animal research institute of Chinese Academy of Medical Sciences breeding field.
4. the statistical procedures measurement data is represented with X ± SD, and result of the test is T-check and X with the Yukms statistical analysis software 2Check.
Two, method and result
1. analgesic test
1.1 mice acetic acid twisting method
Select 50 of healthy mices for use, male and female half and half, body weight 23 ± 2 grams.Mice is divided into 5 groups at random, 10 every group.Wherein the 1st group is the matched group that only gives the equivalent normal saline, the 2nd~4 group is fire-clearing zhimai dripping pill 0.1,0.3 of the present invention, 1.0g crude drug/kg dosage group, the 5th group then for to give fire-clearing zhimai capsule 1g the positive controls of crude drug/kg, each organize every day oral administration once, successive administration 5 days.Each treated animal after the last administration 1 hour in lumbar injection 0.6% acetum 0.2mL/20g body weight.Inject to rise in back 5 minutes and begin to observe and write down the number of times that writhing response appears in mice in the 20min, the average and the standard deviation of each treated animal writhing response number of times are carried out the statistics comparison, and obtain and turn round the body suppression ratio, the results are shown in Table 1.
Medicine Dichlorodiphenyl Acetates such as table 1. fire-clearing zhimai dripping pill cause the influence of mouse writhing reaction times
Figure G2005101224918D00061
Compare with the normal saline matched group: * * P<0.01
The result shows that fire-clearing zhimai dripping pill 0.3,1.0g crude drug/kg dosage group can obviously reduce by 0.6% acetic acid induced mice writhing response number of times, with the normal saline matched group notable difference are arranged relatively, show that this product has significant analgesia role.Fire-clearing zhimai dripping pill 1.0g crude drug/kg dosage group is compared the no marked difference of effect with the fire-clearing zhimai capsule with dosage.
2. antiinflammatory test
2.1 fire-clearing zhimai dripping pill Dichlorodiphenyl Acetate (HAc) causes the influence of mice capillary permeability
Animal grouping and administration cause the mouse writhing reaction test with acetic acid.The mice of turning round after the observation of body number of times finishes is injected acetic acid 30 minutes in the abdominal cavity after the blue normal saline solution 0.1mL/10g of mouse tail vein injection 0.5% ivens body weight, after 20 minutes the dislocation of mice cervical vertebra is put to death, opening the abdominal cavity then divides several to wash the abdominal cavity with the 6mL normal saline, the cleaning mixture sucking-off merges the back and adds normal saline to 10mL, and under the rotating speed of 3000rpm centrifugal 15 minutes, get supernatant and measure absorbance in the 590nm wavelength, check the absorbance that compares each administration group and matched group with t, the results are shown in Table 2.
Medicine Dichlorodiphenyl Acetates such as table 2. fire-clearing zhimai dripping pill cause the influence of mice capillary permeability
Compare with the normal saline matched group: * * P<0.01
The result shows, the absorbance of fire-clearing zhimai dripping pill 0.3,1.0g crude drug/kg dosage group and fire-clearing zhimai capsule 1.0g crude drug/kg control group mice abdominal cavity cleaning mixture is starkly lower than matched group, shows that fire-clearing zhimai dripping pill can obviously suppress increasing of H+ induced mice abdominal cavity capillary permeability.Fire-clearing zhimai dripping pill 1.0g crude drug/kg dosage group and fire-clearing zhimai capsule relatively act on no marked difference with dosage.
2.2 fire-clearing zhimai dripping pill is to the influence of mice gingiva inflammation
Select 50 of healthy mices for use, male and female half and half, body weight 28 ± 2 grams.Mice is divided into 5 groups at random, every group 10, the single cage of every mice is raised, and takes the photograph the material amount every day of measuring every animal before formal test begins in advance, take the photograph the material amount every day and represent to take the photograph material g/10g body weight, METHOD FOR CONTINUOUS DETERMINATION 3 days also causes the material amount of normally taking the photograph before scorching with its meansigma methods as mice.The 1st group is the matched group that gives the equivalent normal saline, and the 2nd~4 group is fire-clearing zhimai dripping pill 0.1,0.3,1.0g crude drug/kg dosage group, and the 5th group then is fire-clearing zhimai capsule 1.0g crude drug/kg positive controls.The same day was used etherization with mice in test, and injection 2.5% formalin causes inflammation, every side 40 μ L under front tooth both sides gingival mucosa on the mice.Each test group began administration the scorching same day in causing, every day oral administration once, successive administration 5 days, measure and respectively organize the body weight of mice and take the photograph the material amount every day during the administration, the result represents to take the photograph material g/10g body weight, and each group mice is caused the material amount of taking the photograph of scorching back every day compare respectively with before causing inflammation, relatively cause the difference that scorching back each group every day is taken the photograph the material amount simultaneously, the results are shown in Table 3.
The influence that medicines such as table 3. fire-clearing zhimai dripping pill are taken the photograph the material amount to gingiva inflammation mice
With cause scorching before △: P<0.05 relatively; △ △: P<0.01
Compare *: P<0.05 with matched group; *: P<0.01
The result shows, after causing inflammation the 1st, 2 day of fire-clearing zhimai dripping pill 0.3,1.0g crude drug/kg dosage group can obviously increase the material amount of taking the photograph that causes scorching mice, with matched group and before causing inflammation significant difference is arranged more all, show that fire-clearing zhimai dripping pill 0.3,1.0g crude drug/kg dosage group have the obvious suppression effect to the gingiva inflammation.Fire-clearing zhimai dripping pill 1.0g crude drug/kg dosage group is compared with dosage with the fire-clearing zhimai capsule, and the former is fast than the latter onset time, but overall antiphlogistic effects does not have marked difference.
2.3 fire-clearing zhimai dripping pill is to the influence of rat paw inflammation
Select 60 of healthy rats for use, body weight 190 ± 15g, male, be divided into 6 groups at random, 10 every group.Wherein the 1st group is the matched group that gives the equivalent normal saline, and the 2nd group is indometacin 10mg/kg matched group, in test oral administration on the same day once; The 3rd group is that fire-clearing zhimai drips capsule 1.0g crude drug/kg matched group; The 4th~6 group then is fire-clearing zhimai dripping pill 0.5g, 1.0g, 2.0g crude drug/kg dosage group, 4 groups of equal continuous oral administrations in back 7 days.After the last administration immediately at the subcutaneous injection 1% carrageenin solution 0.1ml of the right sufficient sole of the foot of every rat, and with the lace cord of 0.8mm diameter around the rat paw girth, observe then respectively organize rat paw cause scorching before, cause 1,2,4,6,8 and 24 hour the paw swelling in scorching back, so that the rat paw girth difference before and after scorching is as paw swelling, carry out statistical with matched group, and calculate the inflammation suppression ratio, the results are shown in Table 4.
Medicines such as table 4. fire-clearing zhimai dripping pill are to the influence of rat paw inflammation
Figure G2005101224918D00091
Compare with matched group: * P<0.05, * * P<0.01.
The result shows, fire-clearing zhimai dripping pill 0.5g, 1.0g, 2.0g crude drug/kg dosage group all have the obvious suppression effect to the rat paw inflammation, wherein fire-clearing zhimai dripping pill 2.0g, 1.0g crude drug/kg dosage group can present certain effect difference in 1~8 hour after administration, fire-clearing zhimai dripping pill 1.0g crude drug/kg compares with fire-clearing zhimai capsule Isodose, 1 hour swelling degree of the paw of the former administration is starkly lower than the latter, 4~24 hours a little higher than again latter of the former swelling degree of the paw, but both did not relatively have marked difference.
2.4 fire-clearing zhimai dripping pill is to the influence of rat leukocyte migration
Get 60 of healthy rats, male and female half and half, body weight 180 ± 20g is divided into 6 groups at random, 10 every group.Wherein the 1st group is the matched group that gives the equivalent normal saline, and the 2nd group is aspirin 100mg/kg matched group, continuous oral administration 2 days; The 3rd group is that fire-clearing zhimai drips capsule 1.0g crude drug/kg matched group; The 4th~6 group then is fire-clearing zhimai dripping pill 0.5g, 1.0g, 2.0g crude drug/kg dosage group, 4 groups of equal continuous oral administrations in back 5 days, administration volume 2ml/kg.Behind administration the 4th day and positive drug first day in the back of every rat cropping, and under the sterile working, inject the 5ml air to form round balloon to its back, inject 1.5%CMC-Na sterilized solution 5ml with sterile syringe next day in the rat back capsule in the last administration, and draw each 0.1ml of CMC-Na liquid in the capsule respectively at 3 hours and 7.5 hours, be injected into the dyeing 2 minutes and dripping on cell counting count board of being mixed in the blue dye liquor of magnificent cresol of 3ml then, count leukocyte count down in mirror, be scaled total white blood cells in each capsule again.Respectively 3,7.5 hours leukocyte counts of 2 are carried out the t test, the results are shown in Table 5.
Medicines such as table 5. fire-clearing zhimai dripping pill are to the influence of rat leukocyte migration
Figure G2005101224918D00101
Compare with matched group: * P<0.05, * * P<0.01.
The result shows, under the stimulation of CMC-Na, fire-clearing zhimai dripping pill 1.0g, 0.5g crude drug/kg dosage group is starkly lower than matched group 7.5 hours numeration of leukocyte, 2.0g crude drug/kg dosage group all was starkly lower than matched group at 3 and 7.5 hours, compared significant difference with matched group, showing that fire-clearing zhimai dripping pill provided by the invention has can obviously suppress the aggregation of leukocyte in the inflammation kitchen range.Fire-clearing zhimai dripping pill 1.0 crude drugs/kg and fire-clearing zhimai capsule Isodose compare, and the former is higher than the latter 3 hours numeration of leukocyte, then is lower than the latter at 7.5 hours countings, and both are close for overall function.
2.5 fire-clearing zhimai dripping pill is to the influence of yeast pyrogenicity rat
Select 70 of male and healthy rats for use, body weight 200 ± 20g evenly is divided into 7 groups, 10 every group.Wherein the 1st, 2 group is blank group and the model control group that gives the equivalent normal saline; The 3rd group is aspirin group 100mg/kg matched group, in test oral administration on the same day once; The 4th group is fire-clearing zhimai capsule 1.0g crude drug/kg matched group, and the 5th~7 group is fire-clearing zhimai dripping pill 0.5g, 1.0g, 2.0g crude drug/kg dosage group, 4 groups of equal continuous oral administrations in back 7 days, once a day., but freely drink water to each treated animal fasting in preceding 12 hours of last administration.The same day was surveyed body temperature 2 times in 1 hour at interval to each treated animal in test, get its meansigma methods as basal body temperature, except that the blank group, each treated animal is subcutaneous injection 18% yeast suspension behind neck all, volume is 1ml/100gbw, each treated animal is administered once when body temperature significantly raise in back 4 hours in injection, measures after the administration 1,2,3,4,5,6,24 hour rat temperature, difference and matched group with body temperature value before and after the administration carry out the comparison same period (t test), the results are shown in Table 6.
Medicines such as table 6. fire-clearing zhimai dripping pill are to the influence of yeast pyrogenicity rat
Compare with matched group: * P<0.05, * * P<0.01.
The result shows that fire-clearing zhimai dripping pill 1.0g, 2.0g crude drug/kg dosage group can obviously present cooling effect in 1~24 hour in administration, and there were significant differences with the matched group comparison same period.0.5g crude drug/kg dosage group only has cooling effect in administration after 1 hour.Fire-clearing zhimai dripping pill 1.0g crude drug/kg dosage group and fire-clearing zhimai capsule matched group compare with dosage, and the former all is better than the latter in onset time and cooling effect.
Except that animal experiment, the applicant utilize fire-clearing zhimai dripping pill to treatment acute pharyngitis (wind-heat syndrome) effectiveness, safety, at random, double blinding, dual analog and multicenter carried out clinical verification.Going into to organize case in this test is 240 examples, and with Qinghuozhimaipian medicine in contrast, the statistical result of its therapeutic evaluation is: fire-clearing zhimai dripping pill cure rate provided by the invention is 30.5%, cure-remarkable-effectiveness rate is 82.2%, total effective rate is 98.3%, it is better than Qinghuozhimaipian, does not find any untoward reaction simultaneously.
In sum, fire-clearing zhimai dripping pill provided by the invention has certain inhibitory action for the red and swollen heat pain symptom of inflammation, relatively present tangible antipyretic-antalgic, antiphlogistic pharmacological action with matched group, so in full accord with heat-clearing and toxic substances removing, the removing heat from blood detumescence effect of this medicine.

Claims (6)

1. fire-clearing zhimai dripping pill preparation method, it is characterized in that: described fire-clearing zhimai dripping pill preparation method is to carry out according to the following step order:
A. will join according to the Herba Andrographis after the said ratio weighing and be reflux, extract, in 70~95% ethanol of 12~20 times of its weight 1~3 time, each 1~3 hour, then extracting solution being merged the back reclaims ethanol and is condensed into thick extractum, thick extractum is mixed according to 1: 0.5~3 ratio with active carbon, decolour with 70~95% alcohol refluxs, filter, filtrate recycling ethanol also concentrates and obtains extractum 1;
B. will be reflux, extract, in 50~95% ethanol of 6~10 times of its gross weights 1~3 time according to joining the Fructus Gardeniae after the said ratio weighing, Radix Ophiopogonis, each 1~3 hour, then extracting solution being merged the back under 80 ℃ temperature is 1.05~1.30 with receiving ethanol and being concentrated into relative density, be that any organic solvent merges the back with extract and reclaims solvent and concentrate and obtain extractum 2 above-mentioned concentrated solution extraction 1~4 time in n-butyl alcohol, ethyl acetate, butanone or the chloroform of 0.5~1 times of concentrated solution gross weight with weight;
C. with weight Polyethylene Glycol-4000, Polyethylene Glycol-6000 or both mixture heating and melting in water-bath of 1~9 times of extractum 1,2 gross weight, add above-mentioned extractum 1,2 then, splash in the refrigerative liquid paraffin after fully mixing, collect drop pill, remove liquid coolant, select ball promptly to can be made into fire-clearing zhimai dripping pill provided by the invention.
2. fire-clearing zhimai dripping pill preparation method according to claim 1, it is characterized in that: concentration of alcohol is 95% among the described step a, and consumption is 16 times of Herba Andrographis weight, extraction time 2 times, each 2 hours, the weight ratio of thick extractum and active carbon was 1: 0.5~1.5.
3. fire-clearing zhimai dripping pill preparation method according to claim 1, it is characterized in that: concentration of alcohol is 70% among the described step b, consumption is Fructus Gardeniae, Radix Ophiopogonis 10 times of gross weight, reflux, extract, 2 times, each 2 hours, 80 ℃ of relative densities that concentrate down the back extracting solution were 1.05~1.12, during organic solvent extraction for the first time consumption be 1 times of concentrated solution gross weight, its complementary degree is 0.5 times of concentrated solution gross weight, and organic solvent is a n-butyl alcohol.
4. fire-clearing zhimai dripping pill preparation method according to claim 1 is characterized in that: Polyethylene Glycol among the described step c-4000, Polyethylene Glycol-6000 or both mixture are 4: 1 with the ratio of extractum 1,2 gross weights.
5. fire-clearing zhimai dripping pill preparation method according to claim 1 is characterized in that: described drop pill can also wrap film-coat.
6. fire-clearing zhimai dripping pill preparation method according to claim 5 is characterized in that: described thin film farming material is an Opadry.
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US20090117209A1 (en) * 2007-11-02 2009-05-07 Hutchison Medipharma Enterprises Limited Andrographis paniculata extract

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