CN102688283A - Chinese traditional medicine capsule for treating lupus erythematosus and preparation method thereof - Google Patents

Chinese traditional medicine capsule for treating lupus erythematosus and preparation method thereof Download PDF

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CN102688283A
CN102688283A CN2012101972270A CN201210197227A CN102688283A CN 102688283 A CN102688283 A CN 102688283A CN 2012101972270 A CN2012101972270 A CN 2012101972270A CN 201210197227 A CN201210197227 A CN 201210197227A CN 102688283 A CN102688283 A CN 102688283A
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lupus erythematosus
capsule
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radix tripterygii
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秦万章
杨春欣
王强
沈熊
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Zhongshan Hospital Fudan University
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Abstract

The invention discloses a Chinese traditional medicine capsule for treating lupus erythematosus and a preparation method of the Chinese traditional medicine capsule. The Chinese traditional medicine capsule for treating lupus erythematosus is characterized in that the raw materials comprise 15-45 parts by weight of peeled thunder god vine with removed roots, 15-45 parts by weight of leatherleaf milletia and 15-45 parts by weight of sargentgloryvine stem. The invention also provides a preparation method of the Chinese traditional medicine capsule for treating lupus erythematosus. According to the invention, the effective ingredients of the three raw material medicines can be effectively extracted, and the prepared capsule has a better effect than the original three-rattan mixture; and the quality can be effectively controlled, the capsule is convenient to take and carry, and the storage time is longer.

Description

A kind of Chinese medicinal capsule of treating lupus erythematosus and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicinal capsule of treating lupus erythematosus and preparation method thereof, belong to the Chinese traditional compound medicine technical field.
Background technology
Systemic lupus erythematosus (sle) (Systemic lupus erythematosus; SLE) be a kind of LADA of multisystem, refractory disease of serious harm human health of invading; Involve a plurality of important organs of whole body such as kidney, the heart, brain, kidney is one of its modal involved organs.According to relevant kidney biopsy data statistics, SLE patient's renal involvement rate is almost 100%, shows as albuminuria, hematuria, cylinderuria etc.(lupus Nephritis is LN) as modal Secondary cases kidney disease, by its ESRD that causes (ESRD) reason of mainly dying of illness that then is SLE patient for lupus nephritis.At present, according to Chinese systemic lupus erythematosus (sle) research cooperative groups (CSTAR) 2011 annual reports, the average prevalence in the whole world is 12~39,/10 ten thousand, and the population of China prevalence is 30~70,/10 ten thousand, is only second to Black people 1,00/,100,000, occupies second in the whole world.Therefore, the control of SLE is seemed particularly important, the treatment of SLE is main with glucocorticoid and immunosuppressant at present, but their side effect is very obvious; For activeness LN, hormone and cell toxicity medicament treatment are effective, but prolonged application can produce comparatively serious toxic and side effects.
Last century the eighties, we receive among the peoplely effectively to inspire with Radix Tripterygii Wilfordii treatment quasi-wind gateway, at first Radix Tripterygii Wilfordii are used for the treatment research of lupus erythematosus in the world, are characterized in instant effect, effect is strong.But list stomach discomfort can occur with Radix Tripterygii Wilfordii, the leukopenia that female patients menoxenia and few patients occur etc.Further developed the compound preparation three rattan mixture of Radix Tripterygii Wilfordii then, through the various lupus erythematosus of treatment, confirmed that curative effect is significantly improved, the side effect incidence rate also decreases.Three rattan mixture clinical treatments, 302 routine various lupus erythematosus patients, total effective rate 95.4%, obvious effective rate is 50%, is mainly reflected in various clinical symptoms and improves, lab index and dysimmunity also take an evident turn for the better, and have alternative hormone, a functions of hormones of successively decreasing.This medicine has antiinflammatory action and regulates immunologic function, and does not have the side effect of corticosteroid hormone.Through several groups of controlled observations, three rattan mixture have the Radix Tripterygii Wilfordii of better curative effect to compare with generally acknowledged, and its curative effect obviously is superior to matched group through statistical procedures.Three rattan mixture not only can be treated lupus erythematosus in addition; And kind of disease surplus dermatomyositis, rheumatoid arthritis, psoriasis, vasculitis, the lichen planus etc. ten also there is better curative effect; Feasibility and good reproducibility; Only, treated thousands of patients with my institute applicable cases among a small circle.
Three rattan mixture are by Radix Tripterygii Wilfordii, Caulis Spatholobi, Caulis Sargentodoxae three flavor medicine prescriptions.Radix Tripterygii Wilfordii has blood circulation promoting and blood stasis dispelling, heat clearing away, removing heat from blood, anti-inflammation detumescence effect.Caulis Sargentodoxae mainly contains heat-clearing and toxic substances removing, function of promoting blood circulation to disperse blood clots, can improve cardiac function, and antiinflammatory and inhibition antibody form, and also can suppress phosphodiesterase, improve the level of cAMP.Caulis Spatholobi mainly contains and enriches blood, promoting the circulation of blood, promoting blood flow to regulate menstruation function, and it contains Sanguis Gallus domesticus alcohol, can improve patient's leukocyte count, microcirculation improvement, and conditioning menstruations etc. all have better curative effect.The length of this medicine collection three medicines complements each other, and reaching the raising curative effect, reduces side effect, and the clinical practice surplus ten year is long with not waning, and clinical practice has proved the superiority of above-mentioned prescription.
Because the method for preparing that three rattan mixture adopt is the decocting ethanol precipitation, adds the preparation that an amount of sucrose is processed, complicated component; Quality is wayward, and the holding time is shorter, and is not portable; Clinical efficacy is also unstable, therefore three rattan mixture is carried out the preparation reform, has invented solid preparation " three liana rubber capsules "; This capsule have taking convenience, dosage accurately, be easy to carry the curative effect advantages of higher.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicinal capsule of treating lupus erythematosus and preparation method thereof; It can overcome three rattan mixture quality and be difficult for guaranteeing; Go mouldy easily, not portative shortcoming is in effective ingredient enrichment, quality control, storage time, carry and aspect such as curative effect is superior to three rattan mixture.
In order to achieve the above object; The present invention optimizes the preparation technology of three rattan mixture; A kind of Chinese medicinal capsule of treating lupus erythematosus is provided, has it is characterized in that, its raw material comprises Radix Tripterygii Wilfordii 15~45 weight portions, Caulis Spatholobi 15~45 weight portions and Caulis Sargentodoxae 15~45 weight portions of removing the peel root.
The present invention also provides the method for preparing of the Chinese medicinal capsule of above-mentioned treatment lupus erythematosus, it is characterized in that, concrete steps are:
The first step: take by weighing Radix Tripterygii Wilfordii 15~45 weight portions of Caulis Sargentodoxae 15~45 weight portions, Caulis Spatholobi 15~45 weight portions and peeling root, mix, add the 90vol% ethanol of 6 times of weight; Reflux, extract, 2 hours; Filter, filtrate recycling ethanol, being concentrated into relative density is 1.28~1.30g/cm 3, obtain fluid extract;
Second step: add dextrin 0.6-1.8 weight portion, mix, 80 ℃ of dryings are processed dry powder, in No. 0 capsule of packing into, promptly get the Chinese medicinal capsule of treating lupus erythematosus.
Preferably, the weight ratio of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root is 1: 1: 1 in the described first step.
Principle of the present invention is following:
Adopt orthogonal experiment to select the extraction process of Radix Tripterygii Wilfordii, Caulis Spatholobi and Caulis Sargentodoxae:
Radix Tripterygii Wilfordii is removed the peel root, Caulis Spatholobi and Caulis Sargentodoxae pulverize separately become coarse powder; With extraction time; 3 factors of concentration of alcohol and extraction time, each factor is divided into 3 levels, with orthogonal table contrived experiment method; With triptolide in the Radix Tripterygii Wilfordii (triptolide) is index, obtains three rattan extractum of 3 kinds of different extraction processes.Supply the screening of lupus erythematosus animal model.Confirm the capsular extraction process of three rattans according to the drug effect and the result of study of chemistry.
Orthogonal design is investigated Radix Tripterygii Wilfordii peeling root extraction conditions
Orthogonal experiment design method and result:
Table 1 orthogonal test factor level table
Figure BDA00001768488400031
Use L9 (3 4) orthogonal table investigates the content of extractum extracted amount and triptolide.The result shows that ideal extraction conditions is: the 90vol% ethanol extraction of 6 times of weight 1 to 2 hour.
According to above-mentioned result of study, draft following 3 kinds of extraction processes, concrete steps are referring to embodiment 4:
Technology 1: take by weighing Caulis Sargentodoxae, Caulis Spatholobi and the Radix Tripterygii Wilfordii peeling root of identical weight, the decocte with water secondary, collecting decoction filters; Filtrating concentrates, and cooling under agitation adds ethanol, makes to contain the alcohol amount and reach 60vol%; Fully stir, leave standstill, get the supernatant reclaim under reduced pressure, promptly get to doing.(annotate: this method for preparing is the technology of three rattan mixture.)
Technology 2: take by weighing with the Radix Tripterygii Wilfordii of Caulis Sargentodoxae identical weight and remove the peel root, add 6 times of weight 90vol% alcohol reflux 2 hours, backflow filters, and filtrating concentrates, and dry, promptly gets the Radix Tripterygii Wilfordii dry extract.Take by weighing the Caulis Sargentodoxae and the Caulis Spatholobi of identical weight, the decocte with water secondary, collecting decoction filters, and filtrating concentrates, and cooling under agitation adds ethanol, makes to contain the alcohol amount and reach 60vol%, leaves standstill, and gets the supernatant reclaim under reduced pressure to doing, and merges with the Radix Tripterygii Wilfordii dry extract promptly to get.
Technology 3: take by weighing Caulis Sargentodoxae, Caulis Spatholobi and the Radix Tripterygii Wilfordii peeling root of identical weight, add 6 times of weight 90vol% ethanol, reflux, extract, 2 hours filters, and filtrating is concentrated into dried, promptly gets.
The content of main effective ingredient triptolide (triptolide) in the extractum that 3 kinds of technologies of employing high effective liquid chromatography for measuring are processed; The result shows: technology 2 and technology 3; The triptolide extraction efficiency is high; And content is more approaching, and Caulis Sargentodoxae and Caulis Spatholobi do not influence the mensuration of triptolide.
The preliminary experiment of three liana rubber capsule pharmacodynamicss:
Estimate of the observation of 3 kinds of different extraction processes to the influence of MRL/lpr lupus mouse.The result finds that the extract and the anti-lupus of 3 kinds of different extraction processes of three rattans are dispersed in the albuminuria aspect of improving the MRL/lpr lupus mouse; (intervention experiment the 28th day) for the second time; High dose group with technology 3 drops to (0.405 ± 0.150) g/24h from intervening preceding (0.663 ± 0.364) g/24h; G/24h compares with model group (0.803 ± 0.03), and difference has significance (P=0.034), and other groups are improved all not obvious; (intervention experiment the 56th day) for the third time, each treatment group and model group relatively, difference there are no significant meaning (P>0.05); Aspect the improving of serum anti ds-DNA antibody horizontal, (intervention experiment the 28th day) for the second time, each pharmaceutical intervention group (A~F group) and model J group are relatively; P=0.026; Difference has significance, and the high dose group of three kinds of technologies is compared with model group, and difference all has significance (P=0.033); Wherein obvious with the improvement of 3 groups of technologies, with (13.266 ± 5.256) gl before intervene -1Drop to (6.267 ± 3.694) gl -1, compare (33.967 ± 15.992) gl with model group -1, P=0.049; (intervention experiment the 56th day) for the third time, each treatment group and model group relatively, difference there are no significant meaning (P>0.05); The pathological change of different its kidneys of group is also different, also obvious with the improvement of 3 groups of technologies.
Through above-mentioned chemistry and pharmacodynamic study, the method for preparing of the Chinese medicinal capsule of the treatment lupus erythematosus below having confirmed:
Adopt Caulis Sargentodoxae, Caulis Spatholobi and the Radix Tripterygii Wilfordii peeling root of same weight, add 6 times of amount 90% ethanol, reflux, extract, 2 hours filters, filtrate recycling ethanol, and being concentrated into relative density is 1.28~1.30 (g/cm 3), add dextrin, mix, 80 ℃ of dryings, three rattan dry powder, in No. 0 capsule of packing into, promptly get three liana rubber capsules.
Compared with prior art, advantage of the present invention is:
1, method for preparing of the present invention can extract in three kinds of crude drug the medicable composition of treatment lupus erythematosus effectively, and prepared capsule has better drug effect than former three rattan mixture (technology 1);
2, the capsule formulation of the present invention's preparation, control of quality is taken with easy to carry effectively, and the storage time is longer.
Description of drawings
Fig. 1 is the kidney pathology analysis chart of J group mice among the embodiment 4;
Fig. 2 is the kidney pathology analysis chart of A group mice among the embodiment 4;
Fig. 3 is the kidney pathology analysis chart of B group mice among the embodiment 4;
Fig. 4 is the kidney pathology analysis chart of C group mice among the embodiment 4;
Fig. 5 is the kidney pathology analysis chart of D group mice among the embodiment 4;
Fig. 6 is the kidney pathology analysis chart of E group mice among the embodiment 4;
Fig. 7 is the kidney pathology analysis chart of F group mice among the embodiment 4;
Fig. 8 is the kidney pathology analysis chart of I group mice among the embodiment 4.
The specific embodiment
For making the present invention more obviously understandable,, the present invention is done further explain now with preferred embodiment.
Embodiment 1: Chinese medicinal capsule of treatment lupus erythematosus and preparation method thereof
Learnt from else's experience identify the Radix Tripterygii Wilfordii each 32 kilograms (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root; The extraction pot of putting into 1 ton mixes; The 90vol% ethanol (576 kilograms) that adds 6 times of weight, reflux, extract, 2 hours, extracting solution filters; Filtrate recycling ethanol, and to be concentrated into relative density be 1.287g/cm 3, get 5.98 kilograms of three rattan fluid extracts.
Add 1.3 kilograms in dextrin, mix, 80 ℃ of dryings are beaten powder, 5.32 kilograms in three rattan dry powder, in No. 0 capsule of packing into, adorn 0.44 for every and restrain, prepare 12060 in three liana rubber capsules altogether, adorn 45/bottle, in put into dry bag, seal.(closing 4.02 kilograms of dry extracts, yield 4.18%).
Embodiment 2: Chinese medicinal capsule of treatment lupus erythematosus and preparation method thereof
Learnt from else's experience identify the Radix Tripterygii Wilfordii each 32 kilograms (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root; The extraction pot of putting into 1 ton mixes; The 90vol% ethanol (576 kilograms) that adds 6 times of weight, reflux, extract, 2 hours, extracting solution filters; Filtrate recycling ethanol, and to be concentrated into relative density be 1.293g/cm 3, get 6.09 kilograms of three rattan fluid extracts.
Add 1.3 kilograms in dextrin, mix, 80 ℃ of dryings are beaten powder, 5.39 kilograms in three rattan dry powder, in No. 0 capsule of packing into, adorn 0.44 for every and restrain, prepare 12210 in three liana rubber capsules altogether, adorn 45/bottle, in put into dry bag, seal.
Embodiment 3: Chinese medicinal capsule of treatment lupus erythematosus and preparation method thereof
Learnt from else's experience identify the Radix Tripterygii Wilfordii each 32 kilograms (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root; The extraction pot of putting into 1 ton mixes; The 90vol% ethanol (576 kilograms) that adds 6 times of weight, reflux, extract, 2 hours, extracting solution filters; Filtrate recycling ethanol, and to be concentrated into relative density be 1.281g/cm 3, get 5.91 kilograms of three rattan fluid extracts.
Add 1.3 kilograms in dextrin, mix, 80 ℃ of dryings are beaten powder, 5.25 kilograms in three rattan dry powder, in No. 0 capsule of packing into, adorn 0.44 for every and restrain, prepare 11910 in three liana rubber capsules altogether, adorn 45/bottle, in put into dry bag, seal.
The chemistry and the pharmacodynamic study of 4: three kinds of extraction processes of embodiment
Technology 1: take by weighing each 500 gram of Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, add 8 times of water gagings and decoct secondary, each 2 hours, collecting decoction filtered, and it is 1.25g/cm that filtrating is concentrated into relative density 3(60 ℃) are cooled to 40 ℃, under agitation slowly add the ethanol of 2 times of weight, make the alcohol amount of containing reach 60vol%, fully stir, and leave standstill 24 hours, get the supernatant reclaim under reduced pressure to doing, dry extract, thin up is to 150ml.Be equivalent to the 1ml=10g crude drug.
Technology 2: Radix Tripterygii Wilfordii 500 grams of peeling root add 6 times of weight, 90% alcohol reflux 2 hours, and backflow filters, and filtrating concentrates, and drying obtains the Radix Tripterygii Wilfordii dry extract.Each 500 gram of Caulis Sargentodoxae and Caulis Spatholobi add 8 times of water gagings and decoct secondary, and each 2 hours, collecting decoction filtered, and it is 1.25g/cm that filtrating is concentrated into relative density 3(60 ℃) are cooled to 40 ℃, under agitation slowly add the ethanol of 2 times of weight, make the alcohol amount of containing reach 60vol%; Fully stir, left standstill 24 hours, get the supernatant reclaim under reduced pressure, merge with the Radix Tripterygii Wilfordii dry extract to doing; Get dry extract, thin up is equivalent to the 1ml=10g crude drug to 150ml.
Technology 3: the Radix Tripterygii Wilfordii that takes by weighing Caulis Sargentodoxae, Caulis Spatholobi and peeling root respectively 500 restrains, and adds 6 times of weight 90vol% ethanol, and reflux, extract, 2 hours filters, and filtrating concentrates, and drying, gets dry extract, and thin up is to 150ml.Be equivalent to the 1ml=10g crude drug.
The content of main effective ingredient triptolide (triptolide) in the extractum that 3 kinds of technologies of employing high effective liquid chromatography for measuring are processed.Chromatographic condition chromatographic column: Agilent Zobrax SB-C18 post (5 μ m, 4.6mm * 250); Mobile phase: methanol-0.05% (volumetric concentration) trifluoroacetic acid (volume ratio is 50: 50); Detect wavelength: 221nm; Column temperature: 30 ℃; Flow velocity: 0.8mLmin -1Sample size: 10 μ L; Measure according to above-mentioned chromatographic condition, theoretical cam curve is not less than 3000 in triptolide, and triptolide and other components all can reach baseline separation.The result is following:
Table 2HPLC method is measured triptolide (TP) extraction ratio of 3 kinds of extraction processes
Figure BDA00001768488400061
The result shows: technology 2 and technology 3, the triptolide extraction efficiency is high, and more approaching, and Caulis Sargentodoxae and Caulis Spatholobi do not influence the mensuration of first element.
The preliminary experiment of the pharmacodynamics of 3 kinds of different extraction process products therefroms:
Estimate of the influence of 3 kinds of different extraction processes to the MRL/lpr lupus mouse:
Method: normal forage feed after totally 20 weeks, is divided into 8 groups by body weight with 40 MRL/lpr mices at random under the SPF level closed state; Be divided into technology 1 high dose group (A group, 0.44g crude drug/10g), low dose group (B group, 0.11g crude drug/10g) respectively; Technology 2 high dose group (C group, and 0.44g crude drug/10g), low dose group (the D group, the 0.11g crude drug/10g); Technology 3 high dose group (E group, and 0.44g crude drug/10g), low dose group (the F group, the 0.11g crude drug/10g); Anti-lupus loose positive controls (I group, 0.022g pill/10g) and model group (J organizes, normal saline 0.1ml/10g).Raised for 8 weeks each mouse stomach capacity 0.1ml/10g continuously; Every day 1 time.Other gets 5 C57BL/6 normal control groups; Take normal saline.Beginning the back in the experiment starting point whenever weighed at a distance from 3~5 days when experiment finishes; During administration, examine the situation such as variation, activity of appetite, the hair of mice.Before the experiment in (0 day), the experiment (4 week) (8 week) branch when finishing get eye socket posterior vein blood 3 times, leave and take that serum is frozen surveys anti-ds-DNA antibody fully; Collect twenty-four-hour urine liquid with metabolic cage at every turn, be used for the twenty-four-hour urine protein quantification and measure.And test when finishing and leave and take kidney etc., observe twenty-four-hour urine protein quantification (coomassie brilliant blue staining method mensuration), serum anti double stranded dna antibody (the anti-ds dna antibody) level (detection of ELISA method) of different groups and observe kidney pathological change (HE dyeing).Adopt the SPSS13.0 statistical analysis software.
1 ordinary circumstance is observed as a result: before the experiment beginning, each organizes mice diet, activity, body weight indifference, and the appearance fur is moist.As time passes, it is withered that each organizes the gradual change of mice fur, and have and come off, be not in good state, and weight loss, the enlargement of axillary lymph knot is obvious etc.Therapeutic intervention is in the time of 28 days, and each is organized mice and begins appearance activity minimizing, and slow, fur comes off and increases gradually, and the phenomena of mortality etc. occur.Behind the therapeutic intervention 56 days, animal dead situation, 1 of B group, 1 of C group, 1 of F group, 1 of I group, 1 of NS matched group J group.
2 respectively organize 24h urine protein detection by quantitative:
Difference (P>0.05) that relatively there are no significant between preceding each group (A, B, C, D, E, F, I, J) the mice 24h urine protein of pharmaceutical intervention was quantitative, explaining between eight groups has comparability; Significant difference is all arranged (P<0.05) and compare with C57BL/6 contrast, wherein A, B, C, D, E, F, I, J group are compared with matched group, and the P value is respectively 0.02,0.011,0.046,0.02,0.02,0.046,0.046 and 0.046.See table 3.
Table 3 is respectively organized MRL/lpr lupus mouse 24h urine protein Quantitative Comparison (X ± S, g/24h, n=4~5)
Figure BDA00001768488400071
Figure BDA00001768488400081
For the second time, intervention effect the 28th day, difference that there are no significant between A group and B, D, E, F, the I group, but the A group compares P=0.034 with the C group; Difference that there are no significant between B group and A, C, D, E, F, I, the J group; Difference that there are no significant between C group and B, F, the I group, C group and D group is P=0.034 relatively, and C group and J group be P=0.034 relatively, and equal zero difference between D group and A, B, E, F, I, the J group; Equal zero difference between E group and A, B, D, F, the I group, the E group is organized relatively P=0.021 with C, and E organizes with the J group and compares P=0.034; Equal zero difference between F group and A, B, C, D, E, I, J organize, equal zero difference between I group and A, B, C, D, E, F, the J group, equal zero difference between J group and B, D, F, the I group; The J group compares P=0.05 with the A group, for the third time, and intervention effect the 56th day; A~F group/I organizes relatively, P=0.813, and difference does not have significance; Same A-F group/J group compares, P=0.147, and difference does not have significance.
3 serum anti ds-DNA antibody horizontals compare:
Respectively organize the mice serum equal no difference of science of statistics of anti-ds-DNA antibody horizontal (P=0.779) before the pharmaceutical intervention; Explain between each group comparability is arranged; But compared significant difference (P=0.0010) with the normal control group; Wherein I~J group is compared with normal control, P=0.006, and the foundation that model is described is correct.The three rattan mixture groups and the diffusing group of the anti-lupus of the positive control mouse anti ds-DNA antibody horizontal of intervening various prepared after 28 days are starkly lower than model group (normal saline matched group) (P=0.026); And be that Radix Tripterygii Wilfordii, Caulis Sargentodoxae, Caulis Spatholobi alcohol extraction medicine group are the most obvious with 3 groups of technologies wherein, anti-ds-DNA antibody horizontal the most obvious high dose group (13.266 ± 5.256) gl before intervene that descends -1Drop to (6.267 ± 3.694) gl -1, low dose group is from intervening preceding (33.5 ± 17.526) gl -1Drop to (16.0 ± 20.648) gl -1And for the third time, each organizes comparing difference not statistically significant (P>0.05), sees table 4
Table 4 is respectively organized MRL/lpr lupus mouse serum anti ds-DNA antibody horizontal relatively (X ± S, g.l -1, n=4~5)
Figure BDA00001768488400082
Figure BDA00001768488400091
For the second time, intervention effect the 28th day, the A-F group compares with the I group, P=0.535, difference does not have significance; And the A-F group compares with the J group, P=0.026, and difference has significance; E and I compare, P=0.127, and difference does not have significance; The high dose group of three kinds of technologies is compared with model group, and difference all has significance (P=0.033), and E and J are relatively, P=0.049, and difference has significance.For the third time, intervention effect the 56th day, A~F/I compares, P=0.718, difference does not have significance; Same A~F/J compares, P=0.584, and difference does not have significance; E and I compare, P=0.374, and difference does not have significance; And E and J are relatively, P=0.121, and there are no significant for difference.
4 respectively organize the mouse kidney pathological change: model group presents the pathological change of typical spontaneous lupoid acne nephritis without pharmaceutical intervention (J group); It is thus clear that the capillary endothelial cell hypertrophy, a large amount of inflammatory cell infiltrations, and granulomatous formation is arranged; lesion degree is the most serious, as shown in Figure 1 in 8 groups; 1 group of (A high dose group) visible slight hypertrophy of minority capillary endothelial cell of technology, it is narrow that the part capillary lumen shows slightly, and inflammatory cell infiltration is comparatively obvious, as shown in Figure 2 with blood vessel and blood vessel wall; Technology 1 group (B low dose group) is divided the capillary endothelial cell hypertrophy, and it is narrow that tube chamber shows slightly, and vascular inflammation than the A group obviously, and is as shown in Figure 3; Technology 2 (C high dose group) vascular inflammation pathological changes is obvious than the A group, and more inflammatory cell infiltration is as shown in Figure 4; Technology 2 (D low dose group) extent of disease is obvious than the C group, and more inflammatory cell infiltration is as shown in Figure 5; Erythrocyte oozes out in technology 3 (E high dose group) inflammatory cell infiltration, lumen of vessels, and is as shown in Figure 6; Technology 3 (F low dose group) blood vessel fibrinoid necrosis, granuloma forms, and manages all inflammatory cells and soaks in a large number, assembles agglomerating, as shown in Figure 7; The anti-lupus a small amount of periangiitis disease of the positive controls cellular infiltration that looses, the gathering of special mess property is agglomerating, and the relative J group of pathological changes is light, as shown in Figure 8.
Interpretation of result: the extract of 3 kinds of different extraction processes of three vine formulations and anti-lupus are dispersed in the albuminuria aspect of improving the MRL/lpr lupus mouse; (intervention experiment the 28th day) for the second time; High dose group with technology 3 drops to (0.405 ± 0.150) g/24h from intervening preceding (0.663 ± 0.364) g/24h; G/24h compares with model group (0.803 ± 0.03), and difference has significance (P=0.034), and other groups are improved all not obvious; (intervention experiment the 56th day) for the third time, each treatment group and model group relatively, difference there are no significant meaning (P>0.05); Aspect the improving of serum anti ds-DNA antibody horizontal, (intervention experiment the 28th day) for the second time, each pharmaceutical intervention group (A~F group) and model J group are relatively; P=0.026; Difference has significance, and the high dose group of three kinds of technologies is compared with model group, and difference all has significance (P=0.033); Wherein obvious with the improvement of 3 groups of technologies, with (13.266 ± 5.256) gl before intervene -1Drop to (6.267 ± 3.694) gl -1, compare (33.967 ± 15.992) gl with model group -1, P=0.049; (intervention experiment the 56th day) for the third time, each treatment group and model group relatively, difference there are no significant meaning (P>0.05); The pathological change of different its kidneys of group is also different, also obvious with the improvement of 3 groups of technologies.
3 kinds of different extraction process extracts of three vine formulations are in the second time of intervention experiment, promptly intervene the 28th day, all can improve the serum anti ds-DNA antibody horizontal of MRL/lpr lupus mouse, the most obvious with technology 3; And three vine formulations high dose group of technology 3 can be improved albuminuria, and have shown certain " amount-effect " and the relation of " timeliness ".
Through above-mentioned chemistry and pharmacodynamic study, the method for preparing that the present invention treats the Chinese medicinal capsule of lupus erythematosus can extract the raw material the effective elements of the medicine effectively, has higher drug effect.
On the basis of technology 3; In order further to be prepared into oral capsule, meet the technological requirement of big production, three rattan medical materials are behind alcohol reflux; Filtrate recycling ethanol obtains fluid extract and just can add the glitch-free pharmaceutic adjuvant dextrin of drug effect, is convenient to mix homogeneously.Make effective ingredient even after breaking into powder after the drying again, be divided in easily in the Capsules, the capsule finished product weight differential of processing is little, guarantees that the quality of capsule meets the regulation of Chinese Pharmacopoeia.

Claims (3)

1. a Chinese medicinal capsule of treating lupus erythematosus is characterized in that, its raw material comprises Radix Tripterygii Wilfordii 15~45 weight portions, Caulis Spatholobi 15~45 weight portions and Caulis Sargentodoxae 15~45 weight portions of removing the peel root.
2. the method for preparing of the Chinese medicinal capsule of the described treatment lupus erythematosus of claim 1 is characterized in that, concrete steps are:
The first step: take by weighing Radix Tripterygii Wilfordii 15~45 weight portions of Caulis Sargentodoxae 15~45 weight portions, Caulis Spatholobi 15~45 weight portions and peeling root, mix, add the 90vol% ethanol of 6 times of weight; Reflux, extract, 2 hours; Filter, filtrate recycling ethanol, being concentrated into relative density is 1.28~1.30g/cm 3, obtain fluid extract;
Second step: add dextrin 0.6-1.8 weight portion, mix, 80 ℃ of dryings are processed dry powder, in No. 0 capsule of packing into, promptly get the Chinese medicinal capsule of treating lupus erythematosus.
3. the method for preparing of the Chinese medicinal capsule of treatment lupus erythematosus as claimed in claim 2 is characterized in that, the weight ratio of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root is 1: 1: 1 in the described first step.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105636605A (en) * 2013-03-29 2016-06-01 李代虹 Chinese medicine capsule for treating lupus erythematosus
CN105617024A (en) * 2016-02-22 2016-06-01 广西梧州制药(集团)股份有限公司 Traditional Chinese medicine composition for treating psoriasis and preparation method thereof
CN106706815A (en) * 2017-03-17 2017-05-24 复旦大学附属中山医院 Method for detecting content of traditional Chinese medicine composition three-vine capsule
CN112114126A (en) * 2020-08-13 2020-12-22 川北医学院 Diagnostic marker for systemic lupus erythematosus and application thereof

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CN101919993A (en) * 2010-08-06 2010-12-22 朱五元 Medicament for treating psoriasis

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105636605A (en) * 2013-03-29 2016-06-01 李代虹 Chinese medicine capsule for treating lupus erythematosus
CN105617024A (en) * 2016-02-22 2016-06-01 广西梧州制药(集团)股份有限公司 Traditional Chinese medicine composition for treating psoriasis and preparation method thereof
CN106706815A (en) * 2017-03-17 2017-05-24 复旦大学附属中山医院 Method for detecting content of traditional Chinese medicine composition three-vine capsule
CN112114126A (en) * 2020-08-13 2020-12-22 川北医学院 Diagnostic marker for systemic lupus erythematosus and application thereof

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