Summary of the invention
Object of the present invention, is to provide a kind of compound Chinese medicinal preparation for the treatment of anaphylactoid purpura, and the present invention has heat-clearing and toxic substances removing, removing heat from blood, blood stasis dispelling effect, and allergic purpura is had to good curative effect.
Another object of the present invention, is to provide a kind of method prepared by the Chinese medicine compound of anaphylactoid purpura for the treatment of of preparing.
The technical scheme adopting is:
Treating a compound Chinese medicinal preparation for anaphylactoid purpura, is to be prepared into by Chinese crude drug Radix Arnebiae (Radix Lithospermi) 100-370g, Herba Taraxaci 100-500g, Cortex Moutan 100-250g, Cortex Dictamni 100-230g, Radix Paeoniae Alba 100-300g, Herba Ecliptae 100-300g, Herba Cirsii 100-500g, Radix Achyranthis Bidentatae 75-300g, Radix Glycyrrhizae 50-240g, Radix Rehmanniae 100-400g and Poria 100-400g.
Treat a preparation method for the compound Chinese medicinal preparation of anaphylactoid purpura, comprise following processing step:
1, get Radix Rehmanniae 100-400g and Poria 100-400g decocts with water 2-3 time, add 6-8 times of water gaging at every turn, decoct 1-1.5 hour at every turn, merge decoction liquor, filter, filtrate is concentrated into the clear paste that relative density is 1.05-1.10 at 60 ℃;
2, get ethanol extraction 2-3 time that Radix Arnebiae (Radix Lithospermi) 100-370g, Herba Taraxaci 100-500g, Cortex Moutan 100-250g, Cortex Dictamni 100-230g, Radix Paeoniae Alba 100-300g, Herba Ecliptae 100-300g, Herba Cirsii 100-500g, Radix Achyranthis Bidentatae 75-300g and Radix Glycyrrhizae 50-240g are 90% by mass concentration, add 6-8 at every turn and doubly measure ethanol, difference reflux, extract, 1-1.5 hour, merge extractive liquid,, filter, after filtrate backflow ethanol, be concentrated into the clear paste that at 60 ℃ of temperature, relative density is 1.05-1.10;
3, the clear paste of combining step 1 and step 2 gained, is evaporated to the thick paste that at 60 ℃ of temperature, relative density is 1.15-1.25, then adds appropriate dextrin and aspartame, mixes, and dry, pulverize into fine powder, by setting granularity, granulates, and obtains.
Function: heat-clearing and toxic substances removing blood stasis dispelling.
Cure mainly: anaphylactoid purpura.
Dose: below 10 years old, each 10g, every day 3 times, more than 10 years old, each 20g, every day 3 times.
Beneficial effect of the present invention:
Anaphylactoid purpura, because sickness rate is high, renal damage is serious, has become the important multiple disease of serious harm child and juvenile healthy and life.Though domestic, there is the bibliographical information that adopts Chinese medicine compound decoction or decoct treatment anaphylactoid purpura, be developed into there is not yet of new Chinese medicine (VI class).We are engaged in the clinical treatment and nearly 30 years of research of anaphylactoid purpura, understanding based on motherland's medical science to primary disease, established removing toxic substances, removing heat from blood, the method of anaphylactoid purpura is treated in the ruling by law of blood stasis dispelling, and on the basis of having carried out a large amount of clinical applications, screen active drug taste, form effectively fixedly experience prescription, and on the basis of Chinese medicine decoction, carried out technological innovation, make Tournefortia monrana granules preparation, and carried out scientific and normal multicenter clinical observation clinical, confirm that this Chinese medicine compound has removing toxic substances, removing heat from blood, blood stasis dispelling effect, relief of symptoms in the short period of time, Shorten the Treatment Process, reduce Relapse rate, reduce the probability of happening of renal damage, and the disconnected effect in rank without hormone.The present invention has good application prospect, has great Social benefit and economic benefit.
The specific embodiment
Embodiment mono-
Treating a compound Chinese medicinal preparation for anaphylactoid purpura, is to be prepared into by Chinese crude drug Radix Arnebiae (Radix Lithospermi) 367g, Herba Taraxaci 239g, Cortex Moutan 239g, Cortex Dictamni 239g, Radix Paeoniae Alba 239g, Herba Ecliptae 239g, Herba Cirsii 239g, Radix Achyranthis Bidentatae 184g, Radix Glycyrrhizae 239g, Radix Rehmanniae 239g and Poria 239g.
Embodiment bis-
Treating a compound Chinese medicinal preparation for anaphylactoid purpura, is to be prepared into by Chinese crude drug Radix Arnebiae (Radix Lithospermi) 370g, Herba Taraxaci 500g, Cortex Moutan 250g, Cortex Dictamni 230g, Radix Paeoniae Alba 300g, Herba Ecliptae 300g, Herba Cirsii 500g, Radix Achyranthis Bidentatae 300g, Radix Glycyrrhizae 200g, Radix Rehmanniae 400g and Poria 400g.
Embodiment tri-
Treating a compound Chinese medicinal preparation for anaphylactoid purpura, is to be prepared into by Chinese crude drug Radix Arnebiae (Radix Lithospermi) 100g, Herba Taraxaci 100g, Cortex Moutan 100g, Cortex Dictamni 100g, Radix Paeoniae Alba 100g, Herba Ecliptae 100g, Herba Cirsii 100g, Radix Achyranthis Bidentatae 75g, Radix Glycyrrhizae 50g, Radix Rehmanniae 100g and Poria 100g.
Embodiment tetra-
Treating a compound Chinese medicinal preparation for anaphylactoid purpura, is to get SHENGHUANG ground 239g and Poria 239g decocts with water secondary, adds 8 times of water gagings at every turn, each decocts 1.0 hours, and collecting decoction filters, being concentrated into relative density is the clear paste of 1.05-1.10 (60 ℃), and another device is collected.Get Radix Arnebiae (Radix Lithospermi) 367g, Herba Taraxaci 239g, Cortex Moutan 239g, Cortex Dictamni 239g, Radix Paeoniae Alba 239g, Herba Ecliptae 239g, Herba Cirsii 239g, 90% ethanol extraction secondary for Radix Achyranthis Bidentatae 184g and Radix Glycyrrhizae 239g, add 8 times of amounts at every turn, each reflux, extract, 1 hour, merge extractive liquid, filter, filtrate recycling ethanol is also concentrated into the clear paste that relative density is 1.05-1.10 (60 ℃), merge with above-mentioned clear paste, being evaporated to relative density is the thick paste of 1.15~1.25 (60 ℃), add dextrin appropriate (about 550g), aspartame appropriate (about 20g), mix, dry, be ground into fine powder, granulate, make 1000g, obtain.
Clinical research:
The routine clinical analysis of clearing away heat and cooling blood blood stasis dispelling treatment anaphylactoid purpura 75.
1 data and method
1.1 clinical data all cases are in January, 2008~2009 year December hospital outpatient case.Man's 45 examples, female's 30 examples, M-F is 1.5: 1.5-7 year 21 examples, 7-14 year 49 examples, 14 years old 5 example of >.22 examples of falling ill spring, summers 25 example, autumns 9 example, winters 19 example.
1.2 case selection
(1) Western medicine diagnose standard: formulate with reference to the diagnostic criteria about anaphylactoid purpura in < < practical paidonosology > >
[1].
(2) tcm diagnosis and dialectical standard: with reference to the diagnostic criteria about purpura in the < < of State Administration of Traditional Chinese Medicine traditional Chinese medical science disease Standardization of diagnosis and curative effect > >, formulate
[2].
Wind heat is hindered network type: disease sees that onset is anxious, and ecchymosis color is scarlet, and two lower limb are symmetrical, or have gargalesthesia, with heating, excessive thirst etc., red tip of the tongue, yellow and thin fur, floating and rapid pulse.
Heat in blood is hindered network type: disease sees that erythra color is scarlet, and two lower limb are symmetrical, many and intensive, a little merges in flakes, and an awful ache in the belly, dysphoria, and constipation, oliguria with reddish urine, can be with epistaxis, red tongue, tongue fur is white thick greasy or yellow greasy.
All cases all meets Chinese and western medicine diagnostic criteria.
1.3 Therapeutic Method
Chinese traditional treatment: heat-clearing and toxic substances removing blood stasis dispelling, purple red water decoction, ingredients: Radix Arnebiae (Radix Lithospermi), Herba Taraxaci, Cortex Moutan, Cortex Dictamni, the Radix Paeoniae Alba, Herba Ecliptae, Herba Cirsii, Radix Achyranthis Bidentatae, Radix Glycyrrhizae, Radix Rehmanniae, Poria etc. for side.5
+-7 years old, each 50ml, twice of every day is oral, and 7
+-10 years old, each 80ml, twice of every day is oral; 10
+more than year, each 100ml, twice of every day is oral.And coordinate oral vitamin C, rutin etc., one month course for the treatment of.In outer court, use hormonotherapy, continued oral prednisone, 1mg/kg.d, gradation is oral, and decrement is to drug withdrawal.
1.4 efficacy assessment standard
With reference to the < < of State Administration of Traditional Chinese Medicine traditional Chinese medical science disease Standardization of diagnosis and curative effect > >, judge
[2].Cure: purpura is all disappeared, simultaneous phenomenon disappears, and it is normal that lab testing indices recovers; Effective: skin purpura disappears or obviously reduces, and General Symptoms alleviates, and laboratory indices is clearly better; Invalid: skin purpura does not move back or moves back and recurs, and lab testing is without improvement.Total effective rate=(curing number of cases+effective number of cases)/total number of cases.
1.5 follow-up method
Finish the course for the treatment of in 3 months, check weekly routine urinalysis 1 time, after three months, a routine urinalysis of check in every 2 weeks, follows up a case by regular visits to 6 months, and take hematuria, albuminuria is the terminal event of evaluation of renal infringement.
2 results
2.1 clinical treatment result clinical cure 55 examples, effective 14 examples, invalid 6 examples, cure rate 73.3%, obvious effective rate 18.7%, effective percentage is 92%.
There are urine examination abnormal change 7 examples in 2.2 Follow-up results, asymptomatic proteinuria 1 example wherein, and simple hematuria 5 examples, asymptomatic proteinuria, albuminuria 1 example, secondary kidney damage is 9%.
Result shows: adopt the purple red water decoction of Chinese medicine of removing toxic substances cooling blood and removing stasis method screening, the treatment to anaphylactoid purpura, determined curative effect.The probability of happening of its Follow-up results renal damage is starkly lower than bibliographical information.National industry public welfare project has been listed in research in, is carrying out the RCT research of the red granule therapy anaphylactoid purpura of clinical purple.
List of references
[1] Hu Yamei, Jiang Zaifang, Zhu Futang, etc.Practical paidonosology [M] .7 version.Beijing: People's Health Publisher, 2002:689.
[2] State Administration of Traditional Chinese Medicine.Traditional Chinese medical science disease Standardization of diagnosis and curative effect [S]. Nanjing: publishing house of Nanjing University, 1994:18.
Experimentation:
Purple red granule Expermental research on main pharmacodynamics
Summary object to the red granule Pharmacodynamics of purple effect study.Method adopts models of passive skin irritability of rats reaction experiment, the experiment of DNBC induced mice delayed hypersensitive reaction, observes purple red granule to allergic impact; Rat paw edema experiment due to the capillary permeability experiment of employing acetic acid induced mice abdominal cavity, Ovum Gallus domesticus album, observes purple red granule antiinflammatory action.The purple red granule of result can obviously suppress models of passive skin irritability of rats reaction, suppresses DNBC induced mice delayed hypersensitive reaction; Reduce acetic acid induced mice capillary permeability, suppress rat paw edema due to Ovum Gallus domesticus album.The purple red granule of conclusion has antiallergic action, antiinflammatory action.
Purple red granule is comprised of 11 taste medical materials such as Radix Arnebiae (Radix Lithospermi), Cortex Moutan, the Radix Rehmanniae, has removing toxic substances removing heat from blood, blood stasis dispelling effect.Be used for the treatment of anaphylactoid purpura.For its effect and clinical practice, this medicine has been carried out to Pharmacodynamic test of active extract herein.
One, experiment purpose
Observe purple red granule and cure mainly relevant Pharmacodynamics effect with function, for the clinical practice of this medicine provides reference.
Two, experiment material
Tested medicine: purple red granule, is provided lot number by Shenyang Pharmaceutical University:, specification: 9g/ bag, 2.702g crude drug/g, Chinese medicine positive control drug Callicarpa nudiflora sheet, Hainan Jiuzhitang Maedicine Co., Ltd produces, lot number: 900820, specification: 24/close, 0.5g (dry extract)/sheet; Western medicine positive control drug prednisone acetate tablets, Tianjin Tianyao Pharmaceutical Co., Ltd. produces, lot number: 090603, specification: 20 slices/bottle, 50mg/ sheet.
Animal subject: SPF level white mice, be purchased from Chinese Medical Sciences University's Experimental Animal Center, credit number: SCXK-(the Liao Dynasty) 2008-0005, SPF level rat, is purchased from Test Animal Centre, Academy of Military Medical Sciences, P.L.A, credit number: SCXK-(army) 2007-004.
Experimental situation: Liaoning Chinese Medicine Institute's Experimental Animal Center.Credit number: SYXK (the Liao Dynasty) 2007-0010.Laboratory temperature: 20 ℃~23 ℃, humidity level: 50%~60%.
Instrument: 721 spectrophotometers, Shanghai San analytical tool factory produces.PV-200 toes capacity measurer, Chengdu TME Technology Co., Ltd. produces.
Reagent: azovan blue, lot number: 20070207, Chemical Reagent Co., Ltd., Sinopharm Group produces.2.4-dinitrochlorobenzene, Military Medical Science Institute's medical supply station provides, lot number: 991223.Acetone, Tianjin Chemical Co., Ltd.'s all generations produces.Lot number: 20050408.Acetic acid, Kaiyuan chemical reagent factory produces, lot number: 900812.
Statistical method: all mean ± standard deviations for data
represent.Between group, relatively with t, check.
Three, test method and result
The impact (1) of 1 purple red granules in rats passive cutaneous anaphylaxis, PCA (PCA)
1.1 antiserum preparations: get 10 of body weight 100~120g male rats, except 3 intravenous injection normal saline, all the other 7 intravenous injections, 1% fresh-laid egg clear liquids, by 50mg/kg, while lumbar injection 4%A1
2(SO
4)
3only, after sensitization, the 12nd day venous blood collection, centrifugal for gel 2mL/, separation of serum, and-20 ℃ of preservations, standby in 2 weeks.
1.2 antiserum inoculations and antigen are attacked
Get 70 of body weight 180~220g male rats, by body weight, divide 7 groups at random, blank (equal-volume distilled water), model control group (equal-volume distilled water), the purple basic, normal, high dosage group of red granule (6.57g crude drug/kg, 13.13g crude drug/kg, 26.26g crude drug/kg), Western medicine positive control drug prednisone acetate tablets group (3.6mg/kg), Chinese medicine positive control drug Callicarpa nudiflora sheet group (0.54g dry extract/kg).Gastric infusion, every day 1 time, continuous 7 days, administration the 6th day, in back part of animal center line both sides, lose hair or feathers respectively, above-mentioned antiserum is become after 1:8 dilution factor with normal saline dilution, at each group rat back depilation place intradermal injection antiserum 0.1ml/ point, 48h after sensitization (30min after last administration) carries out antigen attack, each only organizes rat intravenous injection 0.5% azovan blue protein injection liquid (including 1ml% fresh-laid egg clear liquid) 1ml/, after 30min, de-neck is put to death rat, skin of back locus coeruleus skin graft is cut, shred, add in acetone one normal saline (7: 3) mixed solution 5mL and soak, next day is centrifugal, get supernatant, with 721 spectrophotometers, at 610nm wavelength place, measure its trap (0D value), the significance of comparing difference between group, calculate inhibition percentage.The results are shown in Table 1.
The impact of the purple red granule of table 1 on PCA reaction
* P < 0.05 (with model control group ratio) * * P < 0.01 (with model control group ratio)
From table 1, the middle and high dosage group of purple red granule (13.13g crude drug/kg, 26.26g crude drug/kg) optical density value is starkly lower than model control group, compares difference significance (P < 0.05) with model control group.Show that purple red granule can reduce locus coeruleus and form, suppress models of passive skin irritability of rats reaction and occur.
2 impacts of purple red granule on DNCB induced mice delayed hypersensitive reaction
(1)
Get 60 of white mice, male.By body weight, divide 6 groups at random, blank group (equal-volume distilled water), the purple basic, normal, high dosage group of red granule (9.48g crude drug/kg, 18.96g crude drug/kg, 37.92g crude drug/kg), Western medicine positive control drug prednisone acetate tablets group (5.2mg/kg), Chinese medicine positive control drug Callicarpa nudiflora sheet group (0.78 dry extract/kg).Gastric infusion, successive administration 9 days.First administration second day mouse back subcutaneous injection 1.25%2.4 dinitrochlorobenzene acetone soln (DNCB) 20 μ l/ sensitization, after last administration 1 hour, only on mouse right ear two sides, smear 1.25%DNBC acetone solution 20 μ l/, 24h after attacking, mice is put to death in cervical vertebra dislocation, with diameter 8mm card punch, in left and right ear same area, lay auricle, weigh, the weight difference of left and right auricle of take is swelling.The difference of each administration group of statistical disposition and model control group.The results are shown in Table 2.
The impact of the purple red granule of table 2 on DNCB induced mice delayed hypersensitive reaction
* P < 0.05 (with blank group ratio) * * P < 0.01 (with blank group ratio)
From table 2, the purple basic, normal, high dosage group of red granule (9.48 crude drugs/kg, 18.96g crude drug/kg, 37.92g crude drug/kg) ear swelling degree is starkly lower than blank group, compares difference significance (P < 0.05) with blank group.Show that purple red granule can suppress DNBC induced mice ear swelling.
The impact of 3 purple red granule Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeabilities
(2)
Get 60 of white mice, body weight 18~22g, female, hero half and half, grouping and dosage are with experiment 2, gastric infusion, every day 1 time, continuous 7 days, after last administration 30min, equal tail vein injection 0.5% azovan blue normal saline solution 0.1ml/10g body weight, every lumbar injection 0.6% acetic acid 0.2ml immediately, after 20min, de-neck is put to death, and cuts off abdominal part, with 6ml normal saline, divides and washs abdominal cavity for several times, suction pipe sucking-off cleaning mixture, adds normal saline to 10ml after merging.Put into the centrifugal 15min of centrifuge 3000rpm, get supernatant and with spectrophotometer, at 590nm place, measure optical density value, the significance of comparing difference between group.And obtain suppression ratio.
The results are shown in Table 3.
The impact of the purple red granule Dichlorodiphenyl Acetate induced mice of table 3 abdominal cavity capillary permeability
* P < 0.05 (with blank group ratio) * * P < 0.01 (with blank group ratio)
From table 3, the middle and high dosage group of purple red granule (18.96g crude drug/kg, 37.92g crude drug/kg) optical density value is starkly lower than blank group, compares difference significance (P < 0.05) with blank group.Show that purple red granule can obviously suppress Evans blue seepage discharge, reduce capillary permeability.
4 impacts on rat paw edema due to Ovum Gallus domesticus album
(1)
Get 60 of rats, body weight 160~200g, male, by body weight, be divided at random 6 groups, blank (equal-volume distilled water), the purple basic, normal, high dosage group of red granule (6.57g crude drug/kg, 13.13g crude drug/kg, 26.26g crude drug/kg), Western medicine positive control drug prednisone acetate tablets group (3.6mg/kg), Chinese medicine positive control drug Callicarpa nudiflora sheet group (0.54g dry extract/kg).Successive administration 7 days, experiment is front at every oiliness stroke one clear horizontal line for the left back pawl ankle of rat, first measure the normal Mus corpus unguis of each Mus long-pending, after last administration 30min, each Mus, left back foot plantar subcutaneous injection 10% egg white solution 0.1ml/ only causes inflammation, cause scorching 1h, 2h, 4h, 6h afterwards and measure each Mus toes volume, it is swelling that each Mus causes the sufficient volume difference in scorching front and back, respectively organizes the difference of swelling.The results are shown in Table 4.
The impact of the purple red granule of table 4 on rat paw edema due to Ovum Gallus domesticus album
* P < 0.05 (with blank group ratio) * * P < 0.01 (with blank group ratio)
From table 4, the purple basic, normal, high dosage group of red granule (6.57g crude drug/kg, 13.13g crude drug/kg, 26.26g crude drug/kg) 1~6h paw swelling after causing inflammation is starkly lower than model control group, compare difference significance (P < 0.05, P < 0.01) with model control group.Show that purple red granule has remarkable inhibitory action to rat paw edema due to Ovum Gallus domesticus album.
3 conclusions
Models of passive skin irritability of rats (PCA) reaction experiment result shows, the middle and high dosage group of purple red granule (13.13g crude drug/kg, 26.26g crude drug/kg) optical density value is starkly lower than model control group, compare difference significance (P < 0.05) with model control group, show that purple red granule can reduce locus coeruleus and form, suppress models of passive skin irritability of rats reaction and occur, there is the effect of anti-I type allergy.DNBC induced mice delayed hypersensitive reaction experimental result shows, the purple basic, normal, high dosage group of red granule (9.48 crude drugs/kg, 18.96g crude drug/kg, 37.92g crude drug/kg) ear swelling degree is starkly lower than blank group, compare difference significance (P < 0.05) with blank group, show that purple red granule has anti-delayed (IV type) allergy effect.
Acetic acid induced mice abdominal cavity capillary permeability experimental result shows, the purple middle and high dosage group of red granule (18.96g crude drug/kg, 37.92g crude drug/kg) optical density value is starkly lower than blank group, compare difference significance (P < 0.05) with blank group, show that purple red granule can obviously suppress azovan blue seepage discharge, reduce capillary permeability; Due to Ovum Gallus domesticus album, rat paw edema experimental result shows, the purple basic, normal, high dosage group of red granule (6.57g crude drug/kg, 13.13g crude drug/kg, 26.26g crude drug/kg) 1~6h paw swelling after causing inflammation is starkly lower than model control group, compare difference significance (P < 0.05 with model control group, P < 0.01), show that purple red granule can significantly suppress rat paw edema due to Ovum Gallus domesticus album, has antiinflammatory action.
List of references
1. Li Yi Kui, etc. herbal pharmacology experimental methodology [M]. second edition. Shanghai science tech publishing house, 2006:744,875,774
2. Qi Chen. herbal pharmacology research methodology [M]. People's Health Publisher, 1993,305.