CN104623388B - A kind of Chinese medicine composition of systemic lupus erythematosus and preparation method thereof - Google Patents
A kind of Chinese medicine composition of systemic lupus erythematosus and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine compositions of systemic lupus erythematosus, it is made of the component of following parts by weight：15 30 parts of Cornu Bubali slice, 20 30 parts of oldenlandia diffusa, 10 20 parts of Radix Rehmanniae, 10 15 parts of Fructus Forsythiae, 10 20 parts of Radix Paeoniae Alba, 10 20 parts of the root bark of tree peony, 10 15 parts of bark of ash, 15 20 parts of rhizoma imperatae, 10 15 parts of rhizoma atractylodis macrocephalae.The invention also discloses the preparation method and applications of the Chinese medicine composition of above-mentioned systemic lupus erythematosus.There is inventive formulation good inhibition autoantibody to generate, immune complex is formed, inhibit type Ⅲ allergy, analgesia, anti-inflammatory effect, clinical therapeutic efficacy is apparent, and effect is better than the clear particle of lupus of early-stage study, and prescription is simplified, dose is reduced, toxic herb caulis sinomenii in the side of eliminating, therefore the clear particle of lupus considers there is greater advantage to inventive formulation from safe and effective angle than before.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of using Chinese medicine as systemic lupus erythematosus made of raw material
Chinese medicine composition and preparation method thereof.
Background technology
Systemic loupus erythematosus (SLE) is a kind of typical systemic autoimmune disease, body will produce it is a variety of from
Body antibody and with Multisystem damage symptom, usually with the systems such as fever, arthralgia, fash and kidney, blood, nervous centralis by
Tire out for main clinical manifestation.Currently, hormone, immunosuppressor are still to treat the main means of SLE.But hormone is a twolip
Sword, this kind of drug, which is taken for a long time, while inhibiting inflammation, mitigating disease activity can lead to serious adverse reaction such as：Body
Metabolic disorder etc..And the characteristics of Chinese medicine is that long term administration toxic side effect is smaller, therefore Chinese medicine has oneself in treatment lupus erythematosus
Advantage.
Inventor has applied for a patent 201110155223.1 in 2011, and is authorized, and which disclose one
Chinese medicine composition of the kind for systemic lupus erythematosus, it includes the component of following parts by weight：12~30 parts of cornu bubali,
9~15 parts of radix rehmanniae recen, 10~30 parts of oldenlandia diffusa, 5~10 parts of Radix Rhapontici seu Radix Echinopsis, 6~12 parts of moutan bark, 6~12 parts of radix paeoniae rubra process stiff silkworm
5~10 parts, 3~10 parts of bark of ash, 6~15 parts of caulis sinomenii, 9~15 parts of RHIZOMA POLYGONATI PREPARATA, 6~12 parts of rhizoma atractylodis macrocephalae, 3~9 parts of dried orange peel.But
Caulis sinomenii in the formula belongs to toxic herb in People's Republic of China's toxic herb voluminous dictionary, increases clinical application
Security risk.
Invention content
Technical problem to be solved by the invention is to provide a kind of Chinese medicine composition of systemic lupus erythematosus, the groups
Side is the improvement side of Chinese patent 201110155223.1, is recognized pathogenesis of systemic lupus erythematosus mechanism based on theory of traditional Chinese medical science
Knowledge and principle of reatment, in conjunction with the clinical experience of this disease of diagnosis and treatment for many years, repeated screening, the Chinese medicine compound prescription developed meticulously.
The present invention also technical problems to be solved are to provide the preparation method of above-mentioned Chinese medicine composition.
In order to solve the above technical problems, the technical solution adopted by the present invention is as follows：
A kind of Chinese medicine composition of systemic lupus erythematosus, it is made of the component of following parts by weight：Cornu bubali
15-30 parts of piece, 20-30 parts of oldenlandia diffusa, 10-20 parts of Radix Rehmanniae, 10-15 parts of Fructus Forsythiae, 10-20 parts of Radix Paeoniae Alba, 10-20 parts of the root bark of tree peony,
10-15 parts of bark of ash, 15-20 parts of rhizoma imperatae, 10-15 parts of rhizoma atractylodis macrocephalae.
The Chinese medicine composition of above-mentioned systemic lupus erythematosus is preferably made of the component of following parts by weight：Buffalo
15 parts of cornual plate, 20 parts of oldenlandia diffusa, 10 parts of Radix Rehmanniae, 10 parts of Fructus Forsythiae, 10 parts of Radix Paeoniae Alba, 10 parts of the root bark of tree peony, 10 parts of bark of ash, rhizoma imperatae 15
Part, 10 parts of rhizoma atractylodis macrocephalae.
Cornu bubali is monarch drug in a prescription in side, and the salty hardship of cornu bubali taste, cold in nature, converge to heart and liver channels, function is clearing heat and detoxicating, cool blood, arresting convulsion.
Oldenlandia diffusa, Radix Rehmanniae, Fructus Forsythiae, Radix Paeoniae Alba, the root bark of tree peony are ministerial drug in side.Oldenlandia diffusa sweet and slightly bitter taste, cold in nature, function heat-clearing profit
Wet, removing toxicity for eliminating carbuncles.Radix rehmanniae recen sweet-bitter flavor, cold in nature, the thoughts of returning home, liver and kidney channel, function clearing heat and cooling blood, nourishing Yin and promoting production of body fluid；Fructus Forsythiae bitter, property
It is slightly cold, function is clearing heat and detoxicating, subduing inflammation；Cloudy, soft liver analgesic is held back in Radix Paeoniae Alba bitter acid, cold nature, blood-nourishing；Root bark of tree peony acrid flavour is bitter, and property is micro-
It is cold, function clearing heat and cooling blood, promoting blood circulation to remove blood stasis.All medicines play the effect of clearing heat and detoxicating, cool blood dissipates the stasis of blood, nourishing Yin and promoting production of body fluid altogether, to reinforce monarch drug in a prescription
Therapeutic effect.Bark of ash in side, rhizoma imperatae, rhizoma atractylodis macrocephalae, etc. be adjuvant.Bark of ash has the function of dispelling wind and eliminating dampness, removes obstruction in channels to relieve pain；
Imperata rhizome heat-clearing diuretic, cooling blood and hemostasis；Rhizoma atractylodis macrocephalae has the function of replenish qi to invigorate the spleen eliminating dampness, regulating qi-flowing for harmonizing stomach, to care for burnt taste in shield.
The all medicine compatibilities of we have effects that clearing heat and promoting diuresis, removing toxicity for eliminating carbuncles, nourishing Yin and promoting production of body fluid, strengthening vital QI to eliminate pathogenic factors (our effect).
The preparation method of the Chinese medicine composition of above-mentioned systemic lupus erythematosus, it includes the following steps：
(1) prepared slices of Chinese crude drugs are respectively prepared according to concocted specification in each bulk pharmaceutical chemicals in formula；
(2) prepared slices of Chinese crude drugs root bark of tree peony of formula ratio is used into extraction by steam distillation Paeonol, the another device storage of Paeonol, medicine
Slag is spare；
(3) by the prepared slices of Chinese crude drugs Cornu Bubali slice of formula ratio, every time plus 6~10 times of weight water, heating extraction 2~3 times, often
Secondary 1~2 hour, merges gained extracting solution, be concentrated into relative density 1~1.2, obtain cornu bubali extracting solution；
(4) prepared slices of Chinese crude drugs bark of ash, Radix Paeoniae Alba, Fructus Forsythiae, oldenlandia diffusa, rhizoma atractylodis macrocephalae and the step (2) of formula ratio is taken to obtain
The root bark of tree peony dregs of a decoction merge, and add the ethanol water of 4~8 times of weight to extract 2~3 times, 1~1.5 hour every time, merge gained extraction
Liquid is concentrated under reduced pressure into no alcohol taste, obtains hybrid medicine extracting solution I；
(5) prepared slices of Chinese crude drugs Radix Rehmanniae, the rhizoma imperatae for taking formula ratio add the water heating extracting 3 times of 6~10 times of weight, every time 1~
1.5 hours, merges gained extracting solution, be concentrated into relative density 1~1.2, add 95%v/v ethanol waters to containing alcohol into liquid
Amount reaches 60%v/v, and refrigeration stands 24~48 hours, filtration, filtrate recycling ethanol to no alcohol taste, until relative density 1~1.2, obtains
Hybrid medicine extracting solution II；
(6) merge step (3) obtained cornu bubali extracting solution, the hybrid medicine extracting solution I that step (4) obtains, step (5)
Obtained hybrid medicine extracting solution II, add the Paeonol that step (2) obtains to get.
In ethanol water described in step (4), ethanol content 60%v/v.
Method of the pharmaceutically acceptable customary adjuvant according to conventional Chinese medicine preparation is added in the finished product that step (6) obtains
It is prepared into common peroral dosage form, including oral solution, granule, capsule or effervescent tablet.
The Chinese medicine composition of above-mentioned systemic lupus erythematosus answering in preparing medicament for treating systemic lupus erythematosus
With.
Inventive formulation has effects that clearing heat and promoting diuresis, removing toxicity for eliminating carbuncles, nourishing Yin and promoting production of body fluid, strengthening vital QI to eliminate pathogenic factors, can alleviate erythema wolf
Sore patient generates heat, tired, weak, and weight declines, and albuminuria, cutaneous manifestations are arthralgia, alopecia, thunder based on butterfly erythema
The symptoms such as Nuo Shi phenomenons, photosensitized reaction, irregular menstruation, dry, night sweat restore the effect of major immunological index.
Experimental study shows：
1. medicine can reduce MRL/lpr mice serums Anti-hCG action, Anti-nucleosome antibodies level, Urine proteins are reduced
It is quantitative, mitigate the deposition of IgG, IgA type immune complex.
2. inhibiting rabbit type Ⅲ allergy, inhibit the formation of CIC ELISA, inhibit the effect of complement activity, alleviates
Skin occur bleeding, hyperemia, discoloration phenomena such as.
3. Dichlorodiphenyl Acetate induced mice writhing response has apparent analgesic activity.
4. can inhibit acetic acid induced mice abdominal cavity capillary permeability to increase, there is certain anti-inflammatory effect.
5. clinical data is shown：Lupus recovering particles, which have, alleviates lupus erythematosus disease human hair heat, tired, weak, constitution
Amount declines, and albuminuria, cutaneous manifestations are based on butterfly erythema, and arthralgia, alopecia, Raynaud's phenomenon, photosensitized reaction, menstruation are not
The symptoms such as tune, dry, night sweat improve blood routine (leucocyte, blood platelet), Urine proteins and major immunological index (immune globulin
White G (IgG), anti-ds-DNA antibody) effect.
We are specific to the Chinese medicine preparation of systemic loupus erythematosus, have considered the disease of systemic loupus erythematosus
Cause, pathogenic characteristic, the good medicine of the systemic lupus erythematosus of development.Compared with early-stage study, current prescription medicine is simplified,
Clinical people's dosage is reduced.We by clinic application, have systemic loupus erythematosus good curative effect, total effective rate to reach
87.5%, clinic does not find any toxic side effect.
Advantageous effect：Inventive formulation compared with the disclosed formula (i.e. the clear particle of lupus) of patent 201110155223.1,
In pharmacological evaluation, present invention large dosage group reduction MRL/lpr mouse Anti-hCG action is horizontal, Anti-nucleosome antibodies are horizontal,
IgG, IgA fluorescence intensity；The effect of dermoreaction degree is reduced and improves to Arthus reaction rabbit anteserum immune complex contents
It is better than the clear particle large dosage group of lupus, the clear particle large dosage group of lupus is suitable with middle dosage effect of the present invention.In clinical efficacy
On, to anti-ds-DNA antibody on lupus erythematosus Case treatment, the effect of the reduction present invention of IgG content is apparently higher than clear of lupus
Grain dosage group.
There is inventive formulation good inhibition autoantibody to generate, immune complex is formed, inhibit type Ⅲ allergy,
Analgesia, anti-inflammatory effect, clinical therapeutic efficacy is apparent, and effect is better than the clear particle of lupus of early-stage study, and prescription is simplified,
Dose is reduced, toxic herb caulis sinomenii in the side of eliminating, thus inventive formulation than before the clear particle of lupus from safe and effective angle
Degree considers there is greater advantage.
Specific implementation mode
According to following embodiments, the present invention may be better understood.However, as it will be easily appreciated by one skilled in the art that real
It applies content described in example and is merely to illustrate the present invention, without sheet described in detail in claims should will not be limited
Invention.
Embodiment 1：
A kind of drug of systemic lupus erythematosus, is made of the bulk pharmaceutical chemicals of following deal：
15 parts of Cornu Bubali slice, 20 parts of oldenlandia diffusa, 10 parts of Radix Rehmanniae, 10 parts of Fructus Forsythiae, 10 parts of Radix Paeoniae Alba, 10 parts of the root bark of tree peony, bark of ash
10 parts, 15 parts of rhizoma imperatae, 10 parts of rhizoma atractylodis macrocephalae.
Embodiment 2：
A kind of drug of systemic lupus erythematosus, is made of the bulk pharmaceutical chemicals of following deal：
20 parts of Cornu Bubali slice, 25 parts of oldenlandia diffusa, 15 parts of Radix Rehmanniae, 15 parts of Fructus Forsythiae, 15 parts of Radix Paeoniae Alba, 15 parts of the root bark of tree peony, bark of ash
15 parts, 20 parts of rhizoma imperatae, 15 parts of rhizoma atractylodis macrocephalae.
Embodiment 3：
A kind of drug of systemic lupus erythematosus, is made of the bulk pharmaceutical chemicals of following deal：
30 parts of Cornu Bubali slice, 30 parts of oldenlandia diffusa, 20 parts of Radix Rehmanniae, 15 parts of Fructus Forsythiae, 20 parts of Radix Paeoniae Alba, 20 parts of the root bark of tree peony, bark of ash
15 parts, 20 parts of rhizoma imperatae, 15 parts of rhizoma atractylodis macrocephalae.
Embodiment 4：The preparation of granule.
The formula of embodiment 1 is prepared as follows：
(1) prepared slices of Chinese crude drugs are respectively prepared according to concocted specification in each bulk pharmaceutical chemicals in formula；
(2) prepared slices of Chinese crude drugs root bark of tree peony of formula ratio is used into extraction by steam distillation Paeonol, the another device storage of Paeonol, medicine
Slag is spare；It is spare with cyclodextrin package paeonol inclusion compound.
(3) by the prepared slices of Chinese crude drugs cornu bubali of formula ratio every time plus 10 times of weight water, heating extraction 2 times, 2 hours every time,
Merge gained extracting solution, is concentrated into relative density 1.1, obtains cornu bubali extracting solution；
(4) prepared slices of Chinese crude drugs bark of ash, Radix Paeoniae Alba, Fructus Forsythiae, oldenlandia diffusa, rhizoma atractylodis macrocephalae and the step (2) of formula ratio is taken to obtain
The root bark of tree peony dregs of a decoction merge, and add the 60%v/v ethanol waters of 6 times of weight to extract 2 times, 1.5 hours every time, merge gained extracting solution,
It is concentrated under reduced pressure into no alcohol taste, obtains hybrid medicine extracting solution I；
(5) prepared slices of Chinese crude drugs Radix Rehmanniae, the rhizoma imperatae for taking formula ratio, add the water heating extracting 3 times of 8 times of weight, 1 hour every time,
Merge gained extracting solution, be concentrated into relative density 1.1, into liquid plus 95%v/v ethanol waters to alcohol content reaches 60%v/
V, refrigeration stand 24 hours, filtration, filtrate recycling ethanol to no alcohol taste, until relative density 1.1, obtains hybrid medicine extracting solution II；
(6) merge step (3) obtained cornu bubali extracting solution, the hybrid medicine extracting solution I that step (4) obtains, step (5)
Obtained hybrid medicine extracting solution II, is concentrated into thick medicinal extract, dry, and dextrin is added, and mixing is pelletized, dry, and cyclodextrin packet is added
Paeonol inclusion compound, mixing are wrapped up in, granule is made in packaging.
Embodiment 5：The preparation of capsule.
The formula of embodiment 2 is prepared as follows：
(1) prepared slices of Chinese crude drugs are respectively prepared according to concocted specification in each bulk pharmaceutical chemicals in formula；
(2) prepared slices of Chinese crude drugs root bark of tree peony of formula ratio is used into extraction by steam distillation Paeonol, the another device storage of Paeonol, medicine
Slag is spare；It is spare with cyclodextrin package paeonol inclusion compound.
(3) water of 10 times of weight, heating extraction 3 prepared slices of Chinese crude drugs cornu bubali of formula ratio is added every time 2 hours every time, to close
And gained extracting solution, it is concentrated into relative density 1.1, obtains cornu bubali extracting solution；
(4) prepared slices of Chinese crude drugs bark of ash, Radix Paeoniae Alba, Fructus Forsythiae, oldenlandia diffusa, rhizoma atractylodis macrocephalae and the step (2) of formula ratio is taken to obtain
The root bark of tree peony dregs of a decoction merge, and add the 60%v/v ethanol waters of 6 times of weight to extract 2 times, 1.5 hours every time, merge gained extracting solution,
It is concentrated under reduced pressure into no alcohol taste, obtains hybrid medicine extracting solution I；
(5) prepared slices of Chinese crude drugs Radix Rehmanniae, the rhizoma imperatae for taking formula ratio, add the water heating extracting 3 times of 8 times of weight, 1 hour every time,
Merge gained extracting solution, be concentrated into relative density 1.1, into liquid plus 95%v/v ethanol waters to alcohol content reaches 60%v/
V, refrigeration stand 24 hours, filtration, filtrate recycling ethanol to no alcohol taste, until relative density 1.1, obtains hybrid medicine extracting solution II；
(6) merge step (3) obtained cornu bubali extracting solution, the hybrid medicine extracting solution I that step (4) obtains, step (5)
Obtained hybrid medicine extracting solution II, is concentrated into thick medicinal extract, dry, and cyclodextrin is added and wraps up paeonol inclusion compound, mixing is added
Dextrin is pelletized, dry, filled hard capsules, capsule is made in packaging.
Embodiment 6：The therapeutic effect of MRL/lpr spontaneity lupus erythematosus mouse.
(1) animal：
12 week old C57BL/6J mouse 10, weight 18-22g are carried by Shanghai Slac Experimental Animal Co., Ltd.
For 12 weeks female MRL/lpr mouse 60, weight 18-22g are provided by Department of Immunology of Department Of Medicine, Peking University propagating and breeding.
(2) drug and reagent：
Anti-ds-DNA antibody, Anti-nucleosome antibodies ELISA detection kit：Purchased from BPB biomedical companies of the U.S., lupus
Recovering particles (embodiment 4 is prepared), are provided, lot number 120918 by Nanjing University of Traditional Chinese Medicine.The clear particle of lupus is (according to patent
The method of 201110155223.1 embodiments 5 is prepared), it is provided by Nanjing University of Traditional Chinese Medicine, lot number 100726.
(3) instrument：Microplate reader：U.S.'s Bio-Tek models：SyneRgy HT fluorescence microscopes：Japanese Olympus
(4) experimental method：
Random point 6 groups：(1) model group：Give isometric(al) distilled water；(2) prednisone group：0.01g/kg, (3) lupus health
Grain small dose group：9g (crude drug)/kg；(4) lupus recovering particles middle dose group：18g (crude drug)/kg (5) lupus recovering particles large dosage
Group：36g (crude drug)/kg；(6) the clear particle large dosage group of lupus：45.6g (crude drug)/kg gastric infusions, administered volume 0.2ml/
10g, successive administration 60 days detect on the 61st day.Retroorbital venous clump takes blood, 3000r/min to centrifuge 10min, serum is taken, for resisting
The measurement of ds-DNA antibody, Anti-nucleosome antibodies.Mouse cervical dislocation is put to death, takes kidney and fixation rapidly, it is low using nephridial tissue
Warm frozen section, direct immunofluorescence labelling method carry out Immunofluorescence test.
(4) detection project：
(1) serum Anti-ds-DNA antibodies, the measurement of Anti-nucleosome antibodies：Using ELISA detections anti-ds-DNA antibody, anti-core
Corpusculum antibody level is strictly operated by kit specification.
(2) direct immunofluorescence：Observe nephridial tissue IgG, IgA immune complex deposit.Fluorescence intensity judges："-" height,
Low power lens is not shown, is denoted as 0 point；" ± " high power lens indistinctly has display, remembers 0.5 point；"+" low power lens mays be seen indistinctly, high power lens
Down as it can be seen that 1 point of note；It is under " ++ " low power lens as it can be seen that clear under high power lens, remember 2 points；It is clear under " +++ " low power lens, it shines under high power lens
Eye remembers 3 points；It is dazzling under " ++++" low power lens, it is dazzling under high power lens, remember 4 points.
(5) experimental result：
(1) influence of the lupus recovering particles to mice serum Anti-hCG action, Anti-nucleosome antibodies, IgG, IgA fluorescence intensity
Influence (IU/ of the 1 lupus recovering particles of table to MRL/lpr mice serums Anti-hCG action, Anti-nucleosome antibodies level
L)
Compared with normal group##P<0.01, compared with model group, * P<0.05
Anti-hCG action level after each medicine group (removing small dose group) treatment is substantially less than model group (P<0.05),
Anti-nucleosome antibodies after each medicine group (removing small dose group) treatment are substantially less than model group (P<0.05), lupus recovering particles
There are no significant between each medicine group difference (P>0.05), the clear particle large dosage group Anti-hCG action of lupus and Anti-nucleosome antibodies
Effect be not so good as lupus recovering particles large dosage group, it is suitable with lupus health middle dosage effect.
Comparison of the 2 lupus recovering particles of table to MRL/lpr mouse IgGs, IgA fluorescence intensities
Compared with model group, * P<0.05
As it can be seen that model group murine glomerular blood vessel is in the profile of uneven grain shape fluorescent color under fluorescence microscope,
In mesangial region, fluorescence, the linear fluorescence of capillary wall, medullary substance renal tubule and interstitial area have IgG, IgA fluorescence antibody in the form of sheets
IgG, IgA are obviously deposited.Each medication group (removing small dose group) glomerulus and interstitial area fluorescence antibody deposition are reduced, and intensity is weaker,
With model group there were significant differences (P<0.05), but between each medicine group there was no significant difference (P>0.05), the clear particle large dosage of lupus
Group effect is suitable with lupus health middle dosage effect.
(6) conclusion：
Erythematosus Disease is a kind of autoimmune disease, and the disorderly of cellular immunity is characterized in that in SLE immunologys
It is disorderly hyperfunction with humoral immunity, various autoantibodies and immune complex deposit are caused, the multiple organs of body are damaged.This experimental study
It was found that lupus recovering particles, can reduce MRL/lpr mice serums Anti-hCG action level, reduce Anti-nucleosome antibodies level, subtract
The deposition of light IgG, IgA type immune complex, improves renal lesions, to play the role of delaying progression of the disease.And the medicine
Without significant difference (P compared with hormone>0.05), the effect of lupus clear particle large dosage group Anti-hCG action and Anti-nucleosome antibodies
Fruit is not so good as lupus recovering particles large dosage group, suitable with lupus health middle dosage effect.
Embodiment 5：Lupus recovering particles influence III type of rabbit abnormal (Arthus) reaction.
(1) animal：
Healthy rabbits, 60, half male and half female, weight 2.0-2.5kg, by Shanghai Slac Experimental Animal Co., Ltd.
It provides.
(2) drug and reagent：
Freund's complete adjuvant, ovalbumin：It is sigma companies of the U.S., lupus recovering particles (embodiment 4 is prepared)：
Nanjing University of Traditional Chinese Medicine provides, lot number 120918；The clear particle of lupus is (according to the method for 201110155223.1 embodiment 5 of patent
It is prepared), it is provided by Nanjing University of Traditional Chinese Medicine, lot number 100726.
(3) preparation of reagents：
Ovalbumin-Freund's complete adjuvant reference《Pharmacological experimental methodology》It prepares, i.e., is dissolved in 0.5g/L ovalbumins
Ovalbumin-Freund's complete adjuvant is made with equivalent Freund's complete adjuvant mixing in physiological saline.
(4) experimental method：
It presses《Pharmacological experimental methodology》, every rabbit intramuscular injection 1ml ovalbumins-Freundps Freund's complete adjuvants one weekly
Secondary sensitization, continuous surrounding.The last sensitization same day, rabbit are randomly divided into 6 groups, i.e. (1) model group：Give isometric(al) distilled water；(2)
Prednisone group：0.0025g/kg, (3) lupus recovering particles small dose group：2.28g (crude drug)/kg；(4) lupus recovering particles middle dosage
Group：4.56g (crude drug)/kg, (5) lupus recovering particles large dosage group：9.12g (crude drug)/kg, the clear particle large dosage group of (6) lupus：
11.4g (crude drug)/kg, every group 10.Each group was administered in the last sensitization same day by setting dosage or physiological saline, continuous 10d.The
10 days 1% ovalbumins of family's rabbit back intracutaneous injection (antigen attack), every injection volume are 0.2ml.Observe following index:(1)
Each group Rabbit Femoral Artery takes blood for 24 hours for antigen attack, and the content of Circulating Immune Complexes in Sera is measured by polyethylene glycol method.(2) anti-
The grading answered：According to《Pharmacological experimental methodology》Standard grading, i.e., +++：The apparent congested, bleedings of 2 or 5h, are in plocoid；
Apparent hemorrhagic discoloration for 24 hours.++：2 or 5h moderate hyperemia bleedings are in patch shape；Moderate hemorrhagic changes colour for 24 hours.+：2 or 5h is slight
Congested, bleeding；24 hyporrheas change colour.—：2h or reactionless for 24 hours.
(5) result：
Lupus recovering particles influence Circulating Immune Complexes in Sera after Arthus reaction rabbit-anti original attacks for 24 hours.
The influence of rabbit anteserum immune complex is reacted Arthus after 3 each group medication of table
Compared with model group, * P<0.05,**P<0.01
The above result shows that：Prednisone group, middle and high dosage group rabbit anteserum CIC ELISA content are substantially less than mould
Type group (P<0.05), each dosage group of lupus recovering particles is compared with prednisone group, no significant difference (P>0.05), show lupus health
Grain can inhibit the formation of Circulating Immune Complexes in Sera after Arthus reaction rabbit-anti original attacks for 24 hours.The clear particle large dosage group of lupus
Arthus reaction effects are inhibited to be not so good as lupus recovering particles large dosage group, it is suitable with lupus health middle dosage effect.
Dermoreaction degree compares after the attack of 4 each group rabbit-anti original of table
It is shown by dermoreaction degree (hyperemia, bleeding etc.) result：The prednisone group extent of reaction is more clear, lupus recovering particles
As dosage is bigger, the extent of reaction is more clear, and the model group extent of reaction is most heavy, and prednisone group and lupus recovering particles have mitigation to react
The effect of degree, the clear particle large dosage effect of lupus are suitable with lupus health middle dosage effect not as good as lupus recovering particles large dosage group.
(6) conclusion
Arthus belongs to type Ⅲ allergy, and there are III types (to be immunized multiple in Patients with SLE pathogenesis
Close object type) hypersensitivity, it is that antigen antibody complex deposits and have complement and granulocyte to participate in caused inflammation within the organization
Disease is reacted, and lupus recovering particles generate inhibiting effect to type Ⅲ allergy, inhibits the formation of CIC ELISA, inhibits complement
Active effect, alleviate skin occur bleeding, hyperemia, discoloration phenomena such as.The clear particle large dosage effect of lupus is not as good as lupus health
Particle large dosage group is suitable with lupus health middle dosage effect.
Embodiment 6：The anti-inflammatory and analgesic effect of lupus recovering particles.
One, the influence of Dichlorodiphenyl Acetate induced mice writhing assay
(1) animal：Kunming mouse：18-22g, half male and half female, Shanghai Slac Experimental Animal Co., Ltd. carry
For.
(2) drug agent reagent：
Lupus recovering particles (embodiment 4 is prepared)：Nanjing University of Traditional Chinese Medicine provides, lot number：120918；The clear particle of lupus
(being prepared according to the method for 201110155223.1 embodiment 5 of patent), is provided, lot number by Nanjing University of Traditional Chinese Medicine
100726.Aspirin：Astra Pharmaceuticals Pty Ltd., lot number：20121105；Glacial acetic acid：Nanjing chemical reagent factory, batch
Number：110721
(3) experimental method：
Take Kunming mouse 60, ♀,It is fifty-fifty, 18-22g of weight, random point 6 groups：(1) model group：Give isometric(al)
Distilled water；(2) aspirin group：600mg/kg, (3) lupus recovering particles small dose group：9g (crude drug)/kg；(4) lupus recovering particles
Middle dose group：18g (crude drug)/kg；(5) lupus recovering particles large dosage group：36g (crude drug)/kg；(6) the clear particle large dosage of lupus
Group：45.9g (crude drug)/kg, administration volume is 10ml.kg-1.Administration 3 days.After last dose 45min, each mouse is injected intraperitoneally
0.6% acetum 0.1ml/10g, the writhing response number occurred in 15min after observation injection (abdomen indent, stretching, extension hind leg,
Buttocks is raised), and calculate analgesia percentage.It the results are shown in Table 5.
The influence of 5 lupus recovering particles Dichlorodiphenyl Acetate induced mice writhing number of table
Compared with model group,*P<0.05,**P<0.01。
The above experimental result is shown：Aspirin group and each dosage group Dichlorodiphenyl Acetate induced mice writhing response of lupus recovering particles
There is obvious protective function, (the P compared with model group<0.05), have obviously to mouse writhing reaction times caused by chemically pain
Inhibiting effect, illustrate that lupus recovering particles have apparent analgesic activity to chemically pain.Big dose of the clear particle of analgesic activity lupus
The suitable lupus recovering particles large dosage group of amount group effect.
Two, mouse peritoneal capillary permeability is tested.
(1) animal：ICR mouse, male, 18-22g, Nantong University's Experimental Animal Center provide.
(2) drug and reagent：
Lupus recovering particles (embodiment 4 is prepared)：Nanjing University of Traditional Chinese Medicine provides, lot number：120918；The clear particle of lupus
(being prepared according to the method for 201110155223.1 embodiment 5 of patent), is provided, lot number by Nanjing University of Traditional Chinese Medicine
100726。
Aspirin：Astra Pharmaceuticals Pty Ltd., lot number：20121107
Evans blue：China Medicine's lot number：100213
(3) experimental method：
ICR male mices 60, weight 18-22g are randomly divided into 5 groups, every group 10 by weight.(1) model group：It gives
Isometric distilled water；(2) aspirin group：600mg/kg；(3) lupus recovering particles small dose group：9g (crude drug)/kg；(4) wolf
Sore health middle dose group:18g (crude drug)/kg；(5) lupus recovering particles large dosage group:36g (crude drug)/kg；(6) the clear particle of lupus
Large dosage of group：45.9g (crude drug)/kg administered volume 10ml/kg, each dosage group same day gastric infusion of lupus recovering particles 3 days, last
After 45min is administered, animal fasting 12h before testing, the glacial acetic acid 0.1mL/10g of each group ip in mice 0.6%, blank control group ip lifes
Manage brine.After 30min, the Yi Wensilan normal saline solutions 0.1mL/10g of tail iv1%.After 20min, mouse cervical dislocation is put to death,
Abdominal cavity is cut off, abdominal cavity is rinsed with 6mL physiological saline score time, collects flushing liquor and be settled to 10mL.Peritoneal fluid is pressed
3000r/min centrifuges 10min, takes supernatant, and absorbance is surveyed at 590nm.It the results are shown in Table 6.
6 lupus recovering particles of table act on (X ± SD) to mouse peritoneal capillary permeability
Compared with model group,*P<0.05,**P<0.01。
Above the experimental results showed that：In aspirin and lupus recovering particles, large dosage of group can fight acetic acid induced mice abdomen
Chamber capillary permeability increases, with the more significant difference (P of model group<0.05) it is certain anti-, to illustrate that lupus health has
Inflammation effect.The clear particle large dosage group of antiinflammatory efficacy lupus is suitable with lupus recovering particles large dosage group effect.
Conclusion：By the above anti-inflammatory and antalgic the experimental results showed that：Lupus recovering particles turn round mouse caused by chemically pain
Precursor reactant number has apparent inhibiting effect, generates analgesic effect；It can inhibit the capillary for inhibiting glacial acetic acid to induce simultaneously
Permeability increases, and has certain anti-inflammatory effect, prompts the pain inflammation that lupus recovering particles can improve caused by Erythematosus Disease anti-
It answers.The clear particle large dosage group of anti-inflammatory and analgesic potency lupus is suitable with lupus recovering particles large dosage group effect.
Embodiment 7：Clinical data：
Selection meets SLE diagnosis lupus recovering particles treatment group 40, the clear granule therapy group of lupus sore 40.Age 15~50
(30.2 ± 3.7) year；A month of average course of disease (10.8 ± 5.4).3 oral, oral drugs dosage 1.83g of lupus recovering particles point
(crude drug)/kg, 3 oral, oral drugs dosage 2.28g (crude drug)/kg of the clear particle of lupus point.With 3 months for 1 course for the treatment of.
(1) Symptom Observation：Main clinical manifestation:Lupus erythematosus disease human hair heat, tired, weak, weight declines, albumen
Urine, cutaneous manifestations are arthralgia, alopecia, Raynaud's phenomenon, photosensitized reaction, irregular menstruation, dry, night sweat based on butterfly erythema
Etc. symptoms, evaluation criteria referring to《Chinese medicine (new drug) guideline of clinical investigations》.
(2) blood routine after observation patient treatment, urine protein content situation of change：White blood cell count(WBC), platelet count,
Urine proteins.Using routine analysis of blood instrument HF-3800, dying method with coomassie brilliant blue detects albumen.
(3) amynologic index is observed：1. immunoglobulin G (IgG, IgA)：Step riel biology Co., Ltd production IgG,
IgA kits detect.2. anti-dsDNA antibody (anti-ds-DNA antibody)：The anti-ds- produced with Mai Ruier biologies Co., Ltd
DNA antibody kit, IL-4 cell factor ELISA detection kits are provided purchased from upper sea blue base biology Co., Ltd；Instrument：Enzyme
It marks instrument and is purchased from Bio-Rad companies of the U.S..
(4) experimental result：
(1) Symptom Observation：Clinical remission is generated heat after the treatment of lupus recovering particles, tired, weak, and weight declines, albuminuria,
Blood urine.Cutaneous manifestations are that also may occur in which plate-like erythema, fingers and palms portion and first week erythema, whelk etc., joint based on butterfly erythema
Bitterly, alopecia, Raynaud's phenomenon, photosensitized reaction, irregular menstruation, dry, night sweat 20, part are alleviated 15, invalid 5, are always had
Efficiency 87.5%, the clear particle of lupus alleviate 20, partly alleviation 12, invalid 8, effective percentage 80%.
(2) blood routine and Urine proteins detection：
Table 7
(3) to the influence of amynologic index：
8 pretherapy and post-treatment major immunological index of table changes (X ± SD)
Compared with before treatment：**P<0.01
Observation alleviates lupus erythematosus disease human hair heat, tired, weak, weight the results show that lupus recovering particles can improve
Decline, albuminuria, cutaneous manifestations be butterfly erythema based on, arthralgia, alopecia, Raynaud's phenomenon, photosensitized reaction, irregular menstruation,
The symptoms such as dry, night sweat and patient's blood routine, Urine proteins and major immunological index IgG, anti-ds-DNA antibody, IL-4
Restore.
Conclusion：Lupus recovering particles clinic has the effect of good treatment Erythematosus Disease.Lupus health dosage group dialogue
The improvement of cell count, platelet count, Urine proteins, IL-4 is suitable with the clear particle dosage group of lupus, but to anti-ds-DNA antibody,
The clear particle dosage group effect of IgG content lupus is not as good as lupus recovering particles dosage group.
Claims (6)
1. a kind of Chinese medicine composition of systemic lupus erythematosus, which is characterized in that it by following parts by weight component system
At：15-30 parts of Cornu Bubali slice, 20-30 parts of oldenlandia diffusa, 10-20 parts of Radix Rehmanniae, 10-15 parts of Fructus Forsythiae, 10-20 parts of Radix Paeoniae Alba, the root bark of tree peony
10-20 parts, 10-15 parts of bark of ash, 15-20 parts of rhizoma imperatae, 10-15 parts of rhizoma atractylodis macrocephalae.
2. the Chinese medicine composition of systemic lupus erythematosus according to claim 1, which is characterized in that it by weighing as follows
The component of amount number is made：15 parts of Cornu Bubali slice, 20 parts of oldenlandia diffusa, 10 parts of Radix Rehmanniae, 10 parts of Fructus Forsythiae, 10 parts of Radix Paeoniae Alba, the root bark of tree peony
10 parts, 10 parts of bark of ash, 15 parts of rhizoma imperatae, 10 parts of rhizoma atractylodis macrocephalae.
3. the preparation method of the Chinese medicine composition of systemic lupus erythematosus described in claim 1, which is characterized in that it is wrapped
Include following steps：
(1) prepared slices of Chinese crude drugs are respectively prepared according to concocted specification in each bulk pharmaceutical chemicals in formula；
(2) extraction by steam distillation Paeonol, the another device of Paeonol is used to store the prepared slices of Chinese crude drugs root bark of tree peony of formula ratio, the dregs of a decoction are standby
With；
(3) by the prepared slices of Chinese crude drugs Cornu Bubali slice of formula ratio, every time plus the water of 6~10 times of weight, heating extraction 2~3 times, every time 1
~2 hours, merges gained extracting solution, be concentrated into relative density 1~1.2, obtain cornu bubali extracting solution；
(4) root bark of tree peony for taking prepared slices of Chinese crude drugs bark of ash, Radix Paeoniae Alba, Fructus Forsythiae, oldenlandia diffusa, rhizoma atractylodis macrocephalae and the step (2) of formula ratio to obtain
The dregs of a decoction merge, and add the ethanol water of 4~8 times of weight to extract 2~3 times, 1~1.5 hour every time, merge gained extracting solution, subtract
Pressure is concentrated into no alcohol taste, obtains hybrid medicine extracting solution I；
(5) prepared slices of Chinese crude drugs Radix Rehmanniae, the rhizoma imperatae for taking formula ratio add the water heating extracting 3 times of 6~10 times of weight, and every time 1~1.5
Hour, merge gained extracting solution, be concentrated into relative density 1~1.2, adds 95%v/v ethanol waters to alcohol content into liquid
Up to 60%v/v, refrigeration stands 24~48 hours, filtration, filtrate recycling ethanol to no alcohol taste, until relative density 1~1.2, obtains mixed
Composite medicine extracting solution II；
(6) merge step (3) obtained cornu bubali extracting solution, the hybrid medicine extracting solution I that step (4) obtains, step (5) to obtain
Hybrid medicine extracting solution II, add the Paeonol that step (2) obtains to get.
4. preparation method according to claim 3, which is characterized in that in the ethanol water described in step (4), ethyl alcohol contains
Amount is 60%v/v.
5. preparation method according to claim 3, which is characterized in that the finished product that step (6) obtains, addition pharmaceutically may be used
The customary adjuvant of receiving is prepared into common peroral dosage form, including oral solution, granule, glue according to the method for conventional Chinese medicine preparation
Wafer or effervescent tablet.
6. the Chinese medicine composition of systemic lupus erythematosus described in claim 1 is preparing systemic lupus erythematosus medicine
Application in object.
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