CN101279056B - Children's antipyretic granule - Google Patents
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Abstract
The invention relates to an antipyretic particle preparation for children and preparation thereof, particularly relates to a traditional Chinese particle preparation made from dyers woad leaf, isatis root, honeysuckle flower, fructus forsythiae, Cape jasmine, cortex moutan, root of large-flowered skullcap, herbal lophatheri, earthworm, polyphylla rhizoma paridis, radix bupleuri, cynanchum atratum, etc.
Description
Technical field:
The present invention relates to a kind of dispelling wind to relieve the exterior syndrome, the Chinese medicine Folium Isatidis is particularly used in the Chinese medicine granules of resolving toxin and disinhibiting the throat and preparation thereof, Radix Isatidis, and Flos Lonicerae, Fructus Forsythiae, Fructus Gardeniae, Cortex Moutan, Radix Scutellariae, Herba Lophatheri, Pheretima, Rhizoma Paridis, Radix Bupleuri, Radix Cynanchi Atrati is waited the Chinese medicine granules of processing.
Background technology:
The listing of children's antipyretic liquid preparation is arranged in the prior art,, produced instability, take inconvenience, defectives such as difficult quality control because said preparation technology and quality standard fall behind.
The present invention uses the modern Chinese medicine extractive technique through technological transformation, is equipped with special adjuvant and has processed the children's antipyretic granule agent, has overcome the defective of prior art.Invent granule, and its curative effect and quality have been studied, obtained beyond thought effect.
Summary of the invention:
The present invention provides a kind of Chinese medicinal granule preparation of treating fever of children, and said preparation is made up of pharmaceutically active substance and medicine acceptable carrier, and wherein said pharmaceutically active substance is processed by following Chinese medicine raw materials by weight proportion:
Chinese medicine preparation: Folium Isatidis 300g Radix Isatidis 180g Flos Lonicerae 180g
Fructus Forsythiae 180g Fructus Gardeniae 180g Cortex Moutan 180g
Radix Scutellariae 180g Herba Lophatheri 120g Pheretima 120g
Rhizoma Paridis 90g Radix Bupleuri 180g Radix Cynanchi Atrati 120g
Adjuvant of the present invention obtains through screening, cane sugar powder 500-524g preferably, dextrin 100-144g, 2% Mentholum ethanol liquid 5-20ml.Most preferred composition is: cane sugar powder 512g, dextrin 128g, correctives: 2% Mentholum ethanol liquid 10ml.
The method for preparing of Chinese medicine granules of the present invention is following: Cortex Moutan is extracted volatile ingredients such as paeonol; Radix Bupleuri, Fructus Forsythiae extract volatile oil, and above-mentioned medicinal residues mix decoction twice with Folium Isatidis, Radix Isatidis, Flos Lonicerae, Fructus Gardeniae, Radix Scutellariae, Herba Lophatheri, Pheretima, Rhizoma Paridis, Radix Cynanchi Atrati, add 10 times of amounts of water for the first time, decoct 1 hour; For the second time add 8 times of amounts of water, decocted 1 hour, collecting decoction filters; It is 1.08 (80 ℃) that filtrating is concentrated into relative density, adds equimultiple ethanol, leaves standstill, and gets supernatant concentration to thick paste; Add cane sugar powder, dextrin is an amount of, mixing is processed granule, drying; Spray into the Mentholum ethanol liquid 10ml of volatile ingredients such as above-mentioned volatile oil, paeonol and 2%, mixing is processed 1000g, promptly gets.
Its function of Chinese medicinal granule preparation of the present invention with cure mainly into:
Dispelling wind to relieve the exterior syndrome, the Chinese medicine granules of resolving toxin and disinhibiting the throat.Be used for infantile anemopyretic cold, fever and aversion to wind, headache conjunctival congestion, laryngopharynx swelling and pain, mumps, sore throat.
Below through experimental data beneficial effect of the present invention is described.
Granular preparation of the present invention is called children's antipyretic granule in experiment, is according to the preparation of the method for embodiment 1.
Children's antipyretic granule pharmacodynamics toxicologic study data: children's antipyretic granule shows through analgesic, analgesia, antiinflammatory, calmness, antiviral, antibacterial, toxicity test: the rabbit children's antipyretic extractum (containing crude drug 3g) of 3.0ml/kg body weight; Heating to due to typhoid fever, paratyphoid fever, the second polyvalent vaccine has the obvious cooling effect; 0.5ml/20g mice extractum dosage can make the pain valve raise after irritating stomach 1h; 0.5ml/20g mouse stomach has the obvious suppression effect to the inflammatory swelling due to the agar; 0.5ml/20g mouse stomach obviously prolongs the pentobarbital sodium hypnosis time, shows sedation.0.5ml/20g mouse stomach can suppress the pulmonary lesion that influenza virus causes, bacteriostatic experiment has certain inhibitory action to multiple upper respiratory tract pathogenic bacterium, and toxicity test is not seen obvious toxic-side effects.
One, experiment material
Children's antipyretic granule and extractum are supplied with by Weifang, Shandong pharmaceutical factory of traditional Chinese medicine Technology Development Department; (the Shanghai biological product are made with typhoid fever paratyphoid fever first and second polyvalent vaccines for pyrogenicity; Lot number 981102); Normal saline (production of Weifang pharmacy one factory) aspirin (pharmaceutical factory of Xinhua, lot number 971204) mice is the white II kind in Tianjin, and the rat kind is from Beijing Biological Product Inst..
Two, experimental technique and result
A) analgesic experiment: continuous three anus temperature of selecting 1.5-2.5kg are no more than 0.2 ℃ 48 of healthy rabbits, divide four groups at random, use the 1.0ml/kg body weight for every group; The quiet notes pyrogenicity of TAB was surveyed the anus temperature in per 30 minutes and is once surpassed 1 ℃ to fervescence, began medication 3.0ml/kg extractum respectively; 6.0ml/kg extractum, aspirin 100ml/kg, same volume (3.0ml) normal saline; Then, continue per hour to survey the anus temperature once, totally 5 times.Experimental result is seen table 1
Table 1, children's antipyretic granule is to the rabbit refrigeration function
Experimental result proves: normal saline group fervescence is maintained to 300 minutes, and children's antipyretic granule promptly began to produce antipyretic effect in 180 minutes, and its action time is similar with aspirin medicine matched group, and its action intensity is a little a little less than than aspirin.
A) analgesic experiment
Hot plate method: in 55 ℃ ± 0.1 ℃ super tepidarium, select and lick rear foot reaction.30 of the female healthy mices of the 18-22g that is no more than 30 seconds incubation period are divided into 3 groups at random, and every group of 10 marking serial numbers batch experiments are given mouse stomach with 0.5ml/20g extractum, measure mice behind the 1h and lick metapedes incubation period.Experimental result sees the following form 2.
Table 2, children's antipyretic granule is to the influence of mice pain valve
Experimental result: children's antipyretic granule can improve the pain valve of mice, shows certain analgesic activity, but than a little less than the dolantin.
B) antiinflammatory experiment:
Rat ankle edema method: choose 48 of 18-22g healthy mices, be divided into 4 groups at random, matched group; Aspirin level (0.1g/kg), and children's antipyretic granule two dose groups (0.5ml/20g, 1.0ml/20g); Irritate stomach respectively, behind the perfusion 1h, 10% agar solution 0.1ml is injected at the ankle middle part; Measure 0.5-6h ankle swelling degree respectively, the result sees the following form 3.
Table 3, children's antipyretic granule is to the influence of mice ankle edema.
Experiment shows, children's antipyretic granule has a significant effect to rat ankle edema due to the agar, shows tangible antiinflammatory action.
C) calm experiment:
Choose 30 of 18-22g healthy mices, male and female half and half are divided two groups at random; The first group is given antipyretic granule extractum 0.5ml/20g; The second group is given with the dosage normal saline, and difference lumbar injection 50mg/kg body weight pentobarbital sodium is observed the white mice righting reflex loss to recovery time after 30 minutes; Contrast it, the result sees the following form 4.
Table 4, children's antipyretic granule is to the influence of pentobarbital sodium hypnosis time
Experiment proof: children's antipyretic granule can obviously prolong the length of one's sleep of pentobarbital sodium to mice, shows tangible sedation.
D) antiviral experiment:
Choose 30 of 18-22g healthy mices, male and female half and half are divided into three groups at random; Began the .ig administration in preceding 1 day in infecting, continuous 5 days, during infection; Influenza virus FM1 with 15 LD50; The collunarium infecting mouse infects back dissection in the 4th day mice (weighing earlier) and gets lung observation pulmonary lesion degree, and weighs, and asks each Mus lung exponential quantity (100* lung weight/body weight) to compare.The lung exponential quantity is big more, and the pneumonopathy that expression virus causes becomes serious more.See the following form 5.
Table 5, children's antipyretic granule is to the influence of mice influenza property pneumonia
The experiment proof: the corresponding decline with the logarithmic increase of dosage of lung exponential quantity shows that the children's antipyretic granule of various dose all can suppress the pulmonary lesion that influenza virus causes.
E) bacteriostatic experiment:
2g/ml antipyretic granule extractum, the steel pipe method is done bacteriostatic test consequently: various respiratory road pathogenic bacterium are had inhibitory action.See table 6.
Table 6, children's antipyretic granule is to the effect of various pathogenic bacterium
F) acute toxicity testing:
Get 20 of 18-22g healthy mices, male and female half and half, every with 1.0ml/ children's antipyretic granule extractum (crude drug 2g) .ig administration; (the clinical consumption of behaving 133 times) observed for 1 week after the administration, and the laboratory animal activity freely; The figure unfolds, the fur light, and feed is normal; No animal dead is not also seen obvious adverse reaction.
G) long term toxicity test:
Select 60 of body weight 120 ± 10g rat, male and female half and half are divided 3 groups at random; Every group 20, establish pastille high dose group (bait pastille 3%), low dose group (bait pastille 1.5%); Matched group (normal bait) was raised for 12 weeks, observed toxic reaction, tested each treated animal and did not have death; Rat is loseed untoward reaction, inspection during stomach, liver, nephropathy reason do not have.
Liver: accidental have a slight cloudy swelling
Kidney: spheroid, Pi Shi bundle, proximal convoluted tubule epithelium, the equal no abnormality seen of a matter
Stomach: epithelium, basement membrane fiber, a matter is not all seen pathological changes.
Compare the no abnormality seen pathological changes with matched group, hepatic and renal function is seen table 7 in normal range.
Table 7
In addition, other organ heart of each treated animal, spleen, lung, intestinal, breast, gland etc. carry out tissue examination, also do not see pathological change.Experiment showed, that children's antipyretic granule is to the laboratory animal non-toxic reaction.
Three, brief summary
Children's antipyretic granule contains multiple heat and toxic materials clearing away medicine such as Folium Isatidis, Flos Lonicerae, Radix Bupleuri, Fructus Forsythiae, Radix Clerodenri Cyrtophylli; That reported literature has is analgesic, analgesia, antiinflammatory, calmness, antiviral, effect such as antibacterial; Children's antipyretic granule has good refrigeration function through the zoopery proof; Shown effects such as analgesia in various degree, antiinflammatory, antibacterial, antiviral, toxicity test is not seen its obvious toxic-side effects and untoward reaction, so think that children's antipyretic granule is a kind of heating agent of separating safely and effectively yet.
The children's antipyretic granule clinical research is summed up
Children's antipyretic granule is to be developed by Weifang pharmaceutical factory of traditional Chinese medicine, produces pure Chinese medicinal preparation for many years, is made up of ten multi-flavor medical materials such as Folium Isatidis, Radix Isatidis, Flos Lonicerae, Fructus Forsythiaes.Effect with dispelling wind to relieve the exterior syndrome, resolving toxin and disinhibiting the throat is mainly used in infantile anemopyretic cold clinically, fever and aversion to wind, headache conjunctival congestion, laryngopharynx swelling and pain, Zha rib, diseases such as sore throat.Through maternity & child care center, Weifang City, Shandong, Weifang Traditional Chinese Medicine Hospital, the People's Hospital of Weifang City, how tame clinical unit 500 routine clinical observations such as the 89 hospital of PLA prove that these article therapeutic effect is reliable.Existing 500 routine clinical efficacy situation are summed up reported as follows:
One, clinical data
(1), case is selected and is divided into groups
Case selection is diagnosed as 500 routine infants with fervescence such as infantile common cold fever, upper respiratory tract infection, tonsillitis according to " the new clinical research guideline of Chinese medicine " that Ministry of Health of the People's Republic of China in 1993 develops and publishes, and is divided into treatment group and matched group by randomly assigne.
The treatment group is 365 examples, and matched group is 135 examples.
1, age distribution (seeing table 1) is male's infant 282 examples wherein, women's infant 218 examples.
Table 1 500 routine case age distribution tables
| Group | Less than 1 years old routine % | 1-3 year example % | 3-5 year example % | Routine % more than 6 years old |
| The treatment group | 32 9.04 | 148 40.55 | 118 ?32.30 | 66 ?18.11 |
| Matched group | 12 8.89 | 57 ?42.22 | 40 29.63 | 26 ?19.26 |
Wherein the oldest 13 years old, minimum 3 months.
Health check-up situation when 2, going to a doctor
(1) body temperature situation (seeing table 2)
Body temperature situation statistical table when table 2 500 routine sufferer youngsters go to a doctor
| Group | Positive common practice % | Routine % more than 37 ℃ | Routine % more than 38 ℃ | Routine % more than 39 ℃ |
| The treatment group | 2 ?0.55 | 35 ?9.59 | 169 46.30 | 159 43.56 |
| Matched group | 1 ?0.74 | 14 ?10.37 | 56 ?41.48 | 64 ?47.41 |
(2) end blood leukocyte sum situation slightly
Did the treatment of blood routine examination in the 500 routine cases and organize 314 examples, blood exceeds normal person's 115 examples white the branch, matched group 108 examples, and blood exceeds normal person's 54 examples white the branch.
(3) state of an illness situation (seeing table 3)
Table 3 500 routine case disease situation statistical tables
| Group | Upper respiratory tract infection example % | The last sense complication example % that occurs together | Tonsillitis example % | Other disease example % |
| The treatment group | 313 ?85.75 | 16 ?4.38 | 15 ?4.11 | 21 5.76 |
| Matched group | 114 ?84.44 | 6 4.44 | 6 4.44 | 9 ?6.68 |
By can finding out in the last table, treatment group and matched group sex, age, disease situation are close basically, have comparability.
Two, Therapeutic Method
The method of administration and the course of treatment
The treatment group: children's antipyretic granule, Weifang pharmaceutical factory of traditional Chinese medicine product batch number 981108,5-10 year each bag, cut down according to the circumstance below 5 years old every day 3-4 time, after meal warm boiled water.
Matched group: GANMAO TUIRE KELI, Shanghai Chinese medicine three factories, lot number 980112,5-10 year each 1 bag, cut down according to the circumstance below 5 years old every day 2-3 time, after meal warm boiled water.
Three, criterion of therapeutical effect
Taking one week of this medicine is a course of treatment
Produce effects: body temperature obviously descends or reduces to normally, and symptom disappears or complete obiteration basically.
Take a turn for the better: body temperature descends, anesis.
Invalid: more preceding no change or increase the weight of after the medication.
Four, therapeutic outcome
(1), table 4 is relatively seen to clinical efficacy in the back two of taking medicine
Table 4 treatment group, matched group are taken medicine the back clinical efficacy relatively
| Disease | Group | Produce effects example % | Effective routine % | Invalid routine % |
| Upper respiratory tract infection | Treatment group n=313 matched group n=114 | 227 88.82 69 ?60.53 | 11 3.57 8 ?7.02 | 25 ?7.97 37 ?32.50 |
| The concurrent complication of last sense | Treatment group n=16 matched group n=6 | 10 ?62.50 4 66.67 | 3 ?18.75 1 ?16.67 | 3 18.75 1 16.67 |
| Tonsillitis | Treatment group n=15 matched group n=6 | 14 ?93.33 3 50.00 | 1 ?6.67 2 ?33.33 | 0 0 1 16.67 |
| Other | Treatment group n=21 matched group n=9 | 20 ?95.23 6 66.67 | 0 ?0.00 1 ?11.11 | 1 4.77 2 22.22 |
Last table 4 is visible, and two groups of clinical efficacies compare obvious effective rate treatment group 87.95%, matched group 60.74%.Total effective rate treatment group 92.05%.Through estimate method check P＜0.05 with ranking score, there were significant differences for both, and prompting treatment group is superior to matched group.
(2), body temperature situation of change contrast (table 5) after the produce effects case is taken medicine
From table, calculates and learn, the treatment group back body temperature of taking medicine reduces to normally that the required time is 2.46 days (meansigma methods), matched group 2.58 days (meansigma methods).From curative effect, treatment group and matched group no significant difference, and cooling-down effect is all obvious.
(3) side effect situation synopsis (table 6)
Table 6 side effect situation synopsis
From table, can find out that 365 examples are organized in treatment, side effect 5 examples take place, account for 1.37%, side effect 22 examples take place in matched group 135 examples, account for 16.29%, verify through X, and P＜0.01, difference has highly significant property meaning.So it is safer that children's antipyretic granule is used for the infantile common cold fever.
Five, model case
Example one: Ding Shaoqin, the woman, 7.5 months, went to a doctor in 3 days because of generating heat, have a medical check-up T38.9 ℃; P110 time/minute, R22 time/minute, tongue fur is white, and floating superficial venule of the index finger is livid purple, pharyngeal hyperemia; Blood WBC18600/cubic millimeter, N70%L30% gives children's antipyretic granule, and bag divided and took for 3 times every days 2; Body temperature descends very soon, N70%L30%, body temperature was 36.5 ℃ in second day, the 3rd day 36.3 ℃, side blood WBC13000/cubic millimeter; N70%L, 28%M1%, the 4th day blood WBC9800/cubic millimeter, N70%L30%, the body temperature hemogram is normally fully recovered.
Example two: Wang Tianhua, the man, 5 years old, accompanied painful dizzy prescription on individual diagnosis of pharynx in 2 days because of generating heat, have a medical check-up T39.6 ℃, P110 time/minute; R23 time/minute, body of the tongue is white, thick and greasy fur, and rapid pulse, pharyngeal hyperemia, tonsil is red big; Blood WBC15100/cubic millimeter, N78%L20%M2%, stool R, T Huang are rare, WBC+R, B, a little pyocyte of C+urine R, T, blood cell a little, wrap for children's antipyretic granule every days 3; Divide 3 usefulness, body temperature descends rapidly, and T was 37.3 ℃ in second day, the 3rd day T36.7 ℃, reduce to normal; WB ℃ of 8600/cubic millimeter N63%L36%M1% that had a blood test in the 3rd day, stool R, T Huang are rare, surplus (one), and hemogram and stool are all normal, and routine urinalysis is normally fully recovered.
Six, conclusion
1, children's antipyretic granule confirms through clinical observation; To upper respiratory tract infection; Diseases such as tonsillitis have tangible curative effect, and the disease that causes for bacteriovirus infection all has curative effect preferably, and are particularly rapid with other symptom curative effect of releasing to reducing fever infant body temperature.Its obvious effective rate reaches 87.95%, and total effective rate reaches 92.05%, is that present children's treats upper respiratory tract infection and the comparatively ideal Chinese patent medicine of cat fever.
2, children's antipyretic granule, rapid-action through clinical observation for many years, curative effect is definite rapidly; Side effect is also little, and is safe in utilization, and it is produced for many years by Weifang pharmaceutical factory of traditional Chinese medicine; Obtained tangible economic benefit and social benefit, its output value, profit increase progressively year after year, and with its reliable curative effect; The quality that guarantees has won social favorable comment, patient's favor.
Prescription of the present invention and method for making obtain through screening, and particularly most preferred prescription and method for making have solved operating difficulties in the process for preparation, make product more stable, are difficult for the moisture absorption, long shelf-life, and bioavailability improves, and the effect of existing preparation is more superior.
The specific embodiment:
Below further specify the present invention through embodiment, but not as limitation of the present invention.
Embodiment 1
[prescription] Folium Isatidis 300g Radix Isatidis 180g Flos Lonicerae 180g
Fructus Forsythiae 180g Fructus Gardeniae 180g Cortex Moutan 180g
Radix Scutellariae 180g Herba Lophatheri 120g Pheretima 120g
Rhizoma Paridis 90g Radix Bupleuri 180g Radix Cynanchi Atrati 120g
Adjuvant: cane sugar powder 512g, dextrin 128g, correctives: 2% Mentholum ethanol liquid 10ml.
[method for making] above 12 flavors extract Cortex Moutan volatile ingredients such as paeonol; Radix Bupleuri, Fructus Forsythiae extract volatile oil, and nine flavors such as above-mentioned medicinal residues and all the other Folium Isatidiss mix decoction twice, and each 1 hour, collecting decoction, filtration; It is 1.08 (80 ℃) that filtrating is concentrated into relative density, adds equimultiple ethanol, leaves standstill, and gets supernatant concentration to thick paste; Add cane sugar powder, dextrin is an amount of, mixing is processed granule, drying; Spray into the Mentholum ethanol liquid 10ml of volatile ingredients such as above-mentioned volatile oil, paeonol and 2%, mixing is processed 1000g, promptly gets.
Claims (2)
1. Chinese medicinal granule preparation of treating fever of children, wherein said preparation can be connect by pharmaceutically active substance and medicine
The carrier that receives is processed by following Chinese medicine raw materials by weight proportion:
Folium Isatidis 300g Radix Isatidis 180g Flos Lonicerae 180g
Fructus Forsythiae 180g Fructus Gardeniae 180g Cortex Moutan 180g
Radix Scutellariae 180g Herba Lophatheri 120g Pheretima 120g
Rhizoma Paridis 90g Radix Bupleuri 180g Radix Cynanchi Atrati 120g
Adjuvant: cane sugar powder 512g, dextrin 128g, correctives: 2% Mentholum ethanol liquid 10ml,
More than 12 the flavor, Cortex Moutan is extracted the paeonol volatile ingredient; Radix Bupleuri, Fructus Forsythiae extract volatile oil, and above-mentioned medicinal residues mix decoction twice with all the other Folium Isatidis nine flavors, and each 1 hour, collecting decoction filtered; Under 80 ℃ of conditions, filtrating and being concentrated into relative density is 1.08, adds equimultiple ethanol, leaves standstill, and gets supernatant concentration to thick paste; Add cane sugar powder, dextrin is an amount of, mixing is processed granule, drying; Spray into the Mentholum ethanol liquid 10ml of above-mentioned volatile oil, paeonol volatile ingredient and 2%, mixing is processed 1000g, promptly gets.
2. the method for preparing of the described Chinese medicinal granule preparation of claim 1, step is following:
Cortex Moutan is extracted the paeonol volatile ingredient; Radix Bupleuri, Fructus Forsythiae extract volatile oil, and above-mentioned medicinal residues mix decoction twice with Folium Isatidis, Radix Isatidis, Flos Lonicerae, Fructus Gardeniae, Radix Scutellariae, Herba Lophatheri, Pheretima, Rhizoma Paridis, Radix Cynanchi Atrati, add 10 times of amounts of water for the first time, decoct 1 hour; For the second time add 8 times of amounts of water, decocted 1 hour, collecting decoction filters; Under 80 ℃ condition, filtrating and being concentrated into relative density is 1.08, adds equimultiple ethanol, leaves standstill, and gets supernatant concentration to thick paste; Add cane sugar powder, dextrin is an amount of, mixing is processed granule, drying; Spray into the Mentholum ethanol liquid 10ml of above-mentioned volatile oil, paeonol volatile ingredient and 2%, mixing is processed 1000g, promptly gets.
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| CN105412683A (en) * | 2016-01-18 | 2016-03-23 | 黄庆辉 | Medicine for treating child wind-heat type common cold |
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| CN100362983C (en) * | 2005-11-10 | 2008-01-23 | 贵州益佰制药股份有限公司 | Chinese medicinal preparation for abating child fever and its preparation method |
| CN100388940C (en) * | 2005-11-21 | 2008-05-21 | 贵州益佰制药股份有限公司 | Quality control method of Chinese medicinal preparation for treating child hyperpyrexia |
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| CN100362983C (en) * | 2005-11-10 | 2008-01-23 | 贵州益佰制药股份有限公司 | Chinese medicinal preparation for abating child fever and its preparation method |
| CN100388940C (en) * | 2005-11-21 | 2008-05-21 | 贵州益佰制药股份有限公司 | Quality control method of Chinese medicinal preparation for treating child hyperpyrexia |
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