CN102688283B - 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 PDFInfo
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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
Technical field
The present invention relates to a kind of Chinese medicinal capsule for the treatment of lupus erythematosus and preparation method thereof, belong to Chinese traditional compound medicine technical field.
Background technology
Systemic lupus erythematosus (sle) (Systemic lupus erythematosus, SLE) be a kind of autoimmunity of multisystem, refractory disease of serious harm human health of invading, involve the multiple 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 the kidney rate of getting involved is almost 100%, shows as albuminuria, hematuria, cylinderuria etc.Lupus nephritis (lupus Nephritis, LN) is as modal Secondary cases kidney disease, and the end stagerenaldisease being caused by it (ESRD) is SLE patient's the reason of mainly dying of illness.At present, according to Chinese system lupus erythematosus research cooperative groups (CSTAR) 2011 annual reports, the average prevalence in the whole world is 12～39,/10 ten thousand, and population of China prevalence is 30～70,/10 ten thousand, is only second to Black people 1,00/,100,000, occupies global second.Therefore, the control of SLE is seemed to particularly important, the at present treatment of SLE is take glucocorticoid and immunosuppressant as main, 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 are subject among the peoplely effectively to inspire with Tripterygium Wilfordii Hook quasi-wind gateway, the first treatment research for lupus erythematosus by Radix Tripterygii Wilfordii, is characterized in instant effect in the world, effect is strong.But alone Radix Tripterygii Wilfordii there will be stomach discomfort, the leukopenia that female patients menoxenia and a few patients occur etc.Then further developed the compound preparation three rattan mixture of Radix Tripterygii Wilfordii, through treating various lupus erythematosus, confirmed that curative effect is significantly improved, side effect incidence rate also decreases.The routine various patients with SLE of three rattan mixture clinical treatments 302, 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 there is no the side effect of corticosteroid hormone.Through several groups of controlled observations, three rattan mixture are compared with generally acknowledging the Radix Tripterygii Wilfordii that has good therapeutic effect, and its curative effect is learned processing by statistics, is obviously better than matched group.In addition three rattan mixture not only can be treated lupus erythematosus, and dermatomyositis, rheumatoid arthritis, psoriasis, vasculitis, lichen planus etc. more than ten are planted to disease also there is good curative effect, feasibility and reproducible, only, with my institute's applicable cases among a small circle, treat thousands of patients.
Three rattan mixture are by Radix Tripterygii Wilfordii, Caulis Spatholobi, Caulis Sargentodoxae three taste 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, improves microcirculation, and regulating menstruation etc. all have good curative effect.The length of this medicine collection three medicines, complements each other, and to reach raising curative effect, reduces side effect, and long with not waning through the clinical practices of more than ten years, clinical practice has proved the superiority of above-mentioned prescription.
The preparation method adopting due to three rattan mixture is decocting ethanol precipitation, the preparation that adds appropriate sucrose to make, complicated component, quality is wayward, and the holding time is shorter, not portable, clinical efficacy is also unstable, therefore three rattan mixture is carried out to preparation reform, has invented solid preparation " three liana rubber capsules ", this capsule have taking convenience, dosage accurately, be easy to carry, curative effect advantages of higher.
Summary of the invention
The object of this invention is to provide a kind of Chinese medicinal capsule for the treatment of lupus erythematosus and preparation method thereof, it can overcome three rattan mixture quality and be difficult for guaranteeing, easily go mouldy, not portative shortcoming, in effective ingredient enrichment, quality control, storage time, carry and the aspect such as curative effect is better than three rattan mixture.
In order to achieve the above object, the present invention is optimized the preparation technology of three rattan mixture, a kind of Chinese medicinal capsule for the treatment of lupus erythematosus is provided, has it is characterized in that, its raw material packet is containing Radix Tripterygii Wilfordii 15～45 weight portions, Caulis Spatholobi 15～45 weight portions and Caulis Sargentodoxae 15～45 weight portions of peeling root.
The present invention also provides the preparation method of the Chinese medicinal capsule of above-mentioned treatment lupus erythematosus, it is characterized in that, concrete steps are:
The first step: take 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 ℃ dry, makes dry powder, packs in No. 0 capsule, must treat the Chinese medicinal capsule of lupus erythematosus.
Preferably, in the described first step, the weight ratio of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root is 1: 1: 1.
Principle of the present invention is as follows:
Adopt orthogonal experiment to select the extraction process of Radix Tripterygii Wilfordii, Caulis Spatholobi and Caulis Sargentodoxae:
Radix Tripterygii Wilfordii is removed the peel to root, Caulis Spatholobi and Caulis Sargentodoxae and be ground into respectively coarse powder, with extraction time, 3 factors of concentration of alcohol and extraction time, each factor is divided into 3 levels, use orthogonal trial experimental technique, take triptolide in Radix Tripterygii Wilfordii (triptolide) as index, obtain three rattan extractum of 3 kinds of different extraction processes.For the screening of lupus erythematosus animal model.Determine the extraction process of three liana rubber capsules according to drug effect and chemical result of study.
Orthogonal design is investigated Radix Tripterygii Wilfordii peeling root extraction conditions
Orthogonal experiment design method and result:
Table 1 orthogonal test factor level table
Application L9 (3
4) orthogonal table investigates the content of extractum extracted amount and triptolide.Result shows that desirable 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:
Technique 1: take Caulis Sargentodoxae, Caulis Spatholobi and the Radix Tripterygii Wilfordii peeling root of identical weight, decoct with water secondary, collecting decoction, filters, filtrate is concentrated, cooling, under agitation adds ethanol, makes to reach 60vol% containing alcohol amount, fully stir, leave standstill, get supernatant reclaim under reduced pressure to dry, to obtain final product.(note: this preparation method is the technique of three rattan mixture.)
Technique 2: take 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 filtrate is concentrated, and dry, obtains Radix Tripterygii Wilfordii dry extract.The Caulis Sargentodoxae and the Caulis Spatholobi that take identical weight, decoct with water secondary, and collecting decoction filters, and filtrate is concentrated, cooling, under agitation adds ethanol, makes to reach 60vol% containing alcohol amount, leaves standstill, and gets supernatant reclaim under reduced pressure to dry, merges and get final product with Radix Tripterygii Wilfordii dry extract.
Technique 3: take 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 filtrate is concentrated into dry, to obtain final product.
The content of main effective ingredient triptolide (triptolide) in the extractum that 3 kinds of techniques of employing high effective liquid chromatography for measuring are made, result shows: technique 2 and technique 3, triptolide extraction efficiency is high, and content is more approaching, and Caulis Sargentodoxae and Caulis Spatholobi do not affect the mensuration of triptolide.
The preliminary experiment of three liana rubber capsule pharmacodynamicss:
Evaluate the observation of 3 kinds of different extraction processes on the impact of MRL/lpr lupus mouse.The extract and the anti-lupus that found that 3 kinds of different extraction processes of three rattans are dispersed in the albuminuria aspect of improving MRL/lpr lupus mouse, (intervention experiment the 28th day) for the second time, (0.663 ± 0.364) g/24h with the high dose group of technique 3 from intervening drops to (0.405 ± 0.150) g/24h, compared with model group (0.803 ± 0.03) g/24h, 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 comparison, difference there are no significant meaning (P > 0.05); Aspect the improving of anti-ds-DNA antibody level, (intervention experiment the 28th day) for the second time, each pharmaceutical intervention group (A～F group) compares with model J group, P=0.026, difference has significance, and the high dose group of three kinds of techniques is compared with model group, and difference all has significance (P=0.033), wherein obvious with the improvement of 3 groups of techniques, with (13.266 ± 5.256) gl from intervening
-1drop to (6.267 ± 3.694) gl
-1, (33.967 ± 15.992) gl compared with model group
-1, P=0.049; (intervention experiment the 56th day) for the third time, each treatment group and model group comparison, 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 techniques.
Through above-mentioned chemistry and pharmacodynamic study, determine the preparation method of the Chinese medicinal capsule of following treatment lupus erythematosus:
The Caulis Sargentodoxae, Caulis Spatholobi and the Radix Tripterygii Wilfordii peeling root that adopt same weight, add 6 times of amount 90% ethanol, and 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 ℃ are dry, obtain three rattan dry powder, pack in No. 0 capsule, obtain three liana rubber capsules.
Compared with prior art, advantage of the present invention is:
1, preparation method of the present invention can extract in three kinds of crude drug effectively to the medicable composition for the treatment of lupus erythematosus, and prepared capsule has better drug effect than former three rattan mixture (technique 1);
2, the capsule formulation that prepared by the present invention, can control quality effectively, takes with easy to carry, and the storage time is longer.
Accompanying drawing explanation
Fig. 1 is the Renal Pathological Analysis figure of J group mice in embodiment 4;
Fig. 2 is the Renal Pathological Analysis figure of A group mice in embodiment 4;
Fig. 3 is the Renal Pathological Analysis figure of B group mice in embodiment 4;
Fig. 4 is the Renal Pathological Analysis figure of C group mice in embodiment 4;
Fig. 5 is the Renal Pathological Analysis figure of D group mice in embodiment 4;
Fig. 6 is the Renal Pathological Analysis figure of E group mice in embodiment 4;
Fig. 7 is the Renal Pathological Analysis figure of F group mice in embodiment 4;
Fig. 8 is the Renal Pathological Analysis figure of I group mice in embodiment 4.
The specific embodiment
For the present invention is become apparent, hereby with preferred embodiment, the present invention is described in further detail.
Embodiment 1: Chinese medicinal capsule for the treatment of lupus erythematosus and preparation method thereof
Learnt from else's experience identify each 32 kilograms of the Radix Tripterygii Wilfordii (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, the extraction pot of putting into 1 ton mixes, add the 90vol% ethanol (576 kilograms) of 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, obtain 5.98 kilograms of three rattan fluid extracts.
Add 1.3 kilograms, dextrin, mix, 80 ℃ dry, beats powder, obtains 5.32 kilograms, three rattan dry powder, packs in No. 0 capsule, and every fills 0.44 gram, prepares altogether 12060, three liana rubber capsule, fills 45/bottle, inside puts into dry bag, sealing.(closing 4.02 kilograms of dry extracts, yield 4.18%).
Embodiment 2: Chinese medicinal capsule for the treatment of lupus erythematosus and preparation method thereof
Learnt from else's experience identify each 32 kilograms of the Radix Tripterygii Wilfordii (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, the extraction pot of putting into 1 ton mixes, add the 90vol% ethanol (576 kilograms) of 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, obtain 6.09 kilograms of three rattan fluid extracts.
Add 1.3 kilograms, dextrin, mix, 80 ℃ dry, beats powder, obtains 5.39 kilograms, three rattan dry powder, packs in No. 0 capsule, and every fills 0.44 gram, prepares altogether 12210, three liana rubber capsule, fills 45/bottle, inside puts into dry bag, sealing.
Embodiment 3: Chinese medicinal capsule for the treatment of lupus erythematosus and preparation method thereof
Learnt from else's experience identify each 32 kilograms of the Radix Tripterygii Wilfordii (totally 96 kilograms) of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, the extraction pot of putting into 1 ton mixes, add the 90vol% ethanol (576 kilograms) of 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, obtain 5.91 kilograms of three rattan fluid extracts.
Add 1.3 kilograms, dextrin, mix, 80 ℃ dry, beats powder, obtains 5.25 kilograms, three rattan dry powder, packs in No. 0 capsule, and every fills 0.44 gram, prepares altogether 11910, three liana rubber capsule, fills 45/bottle, inside puts into dry bag, sealing.
Chemistry and the pharmacodynamic study of 4: three kinds of extraction processes of embodiment
Technique 1: take each 500 grams of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, add 8 times of water gagings and decoct secondaries, each 2 hours, collecting decoction, filtered, and it is 1.25g/cm that filtrate is concentrated into relative density
3(60 ℃), are cooled to 40 ℃, under agitation slowly add the ethanol of 2 times of weight, make to reach 60vol% containing alcohol amount, fully stir, and leave standstill 24 hours, get supernatant reclaim under reduced pressure to dry, obtain dry extract, are diluted with water to 150ml.Be equivalent to 1ml=10g crude drug.
Technique 2: 500 grams of the Radix Tripterygii Wilfordiis of peeling root add 6 times of weight, 90% alcohol reflux 2 hours, and backflow filters, and filtrate is concentrated, and the dry Radix Tripterygii Wilfordii dry extract that obtains.Each 500 grams 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 filtrate is concentrated into relative density
3(60 ℃), are cooled to 40 ℃, under agitation slowly add the ethanol of 2 times of weight, make to reach 60vol% containing alcohol amount, fully stir, leave standstill 24 hours, get supernatant reclaim under reduced pressure to dry, merge with Radix Tripterygii Wilfordii dry extract, obtain dry extract, be diluted with water to 150ml, be equivalent to 1ml=10g crude drug.
Technique 3: take each 500 grams of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root, add 6 times of weight 90vol% ethanol, reflux, extract, 2 hours, filters, and filtrate is concentrated, and dry, obtains dry extract, is diluted with water to 150ml.Be equivalent to 1ml=10g crude drug.
The content of main effective ingredient triptolide (triptolide) in the extractum that 3 kinds of techniques of employing high effective liquid chromatography for measuring are made.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
-1; Sample 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.Result is as follows:
Table 2HPLC method is measured triptolide (TP) extraction ratio of 3 kinds of extraction processes
Result shows: technique 2 and technique 3, triptolide extraction efficiency is high, and more approaching, and Caulis Sargentodoxae and Caulis Spatholobi do not affect the mensuration of first element.
The preliminary experiment of the pharmacodynamics of 3 kinds of different extraction process products therefroms:
Evaluate the impact of 3 kinds of different extraction processes on MRL/lpr lupus mouse:
Method: under SPF level closed state, normal forage feed, after totally 20 weeks, is divided into 8 groups by body weight by 40 MRL/lpr mices at random; Be divided into respectively technique 1 high dose group (A group, 0.44g crude drug/10g), low dose group (B group, 0.11g crude drug/10g); Technique 2 high dose group (C group, 0.44g crude drug/10g), low dose group (D group, 0.11g crude drug/10g); Technique 3 high dose group (E group, 0.44g crude drug/10g), low dose group (F group, 0.11g crude drug/10g); Anti-lupus fall apart positive controls (I group, 0.022g pill/10g) and model group (J group, normal saline 0.1ml/10g).Raise 8 weeks continuously each mouse stomach capacity 0.1ml/10g; Every day 1 time.Separately get 5 C57BL/6 Normal groups; Take normal saline.After starting, experiment starting point weighed every 3～5 days until test while end; During administration, examine the appetite of mice, the situation such as variation, activity of hair.In (0 day) before experiment, experiment (4 weeks) and while finishing (8 weeks) point get eye socket posterior vein blood for 3 times, leave and take the frozen standby survey anti-ds-DNA antibody of serum; Collect twenty-four-hour urine liquid with metabolic cage at every turn, measure for twenty-four-hour urine protein quantification.And test while end 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 Pathological change (HE dyeing).Adopt SPSS13.0 statistical analysis software.
1 ordinary circumstance is observed as a result: before experiment starts, respectively organize mice diet, activity, body weight indifference, appearance fur is moist.Along with passage of time, respectively organize the gradual change of mice fur withered, and have and come off, be not in good state, weight loss, the enlargement of axillary lymph knot is obvious etc.When therapeutic intervention 28 days, respectively organize mice and start appearance activity and reduce, slow, fur comes off and increases gradually, and occurs the phenomena of mortality etc.After 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 each group 24h urine protein detection by quantitative:
Difference (P > 0.05) that between front each group of (A, B, C, D, E, F, I, J) the mice 24h urine protein of pharmaceutical intervention is quantitative, relatively there are no significant, illustrates between eight groups and has comparability; All there is significant difference (P < 0.05) and contrast with C57BL/6 to compare, wherein A, B, C, D, E, F, I, J group are compared with matched group, and P value is respectively 0.02,0.011,0.046,0.02,0.02,0.046,0.046 and 0.046.In table 3.
Table 3 each group MRL/lpr lupus mouse 24h urine protein Quantitative Comparison (X ± S, g/24h, n=4～5)
For the second time, intervention effect the 28th day, difference that between A group and B, D, E, F, I group, there are no significant, but A group and relatively P=0.034 of C group, difference that between B group and A, C, D, E, F, I, J group, there are no significant, C group and B, F, difference that between I group, there are no significant, C group and relatively P=0.034 of D group, C group and relatively P=0.034 of J group, and D group and A, B, E, F, I, equal zero difference between J group, E group and A, B, D, F, equal zero difference between I group, E group and relatively P=0.021 of C group, E group and relatively P=0.034 of J group, F group and A, B, C, D, E, I, equal zero difference between J group, I group and A, B, C, D, E, F, equal zero difference between J group, J group and B, D, F, equal zero difference between I group, J group and relatively P=0.05 of A group, for the third time, intervention effect the 56th day, A～F group/I organizes relatively, P=0.813, no significant difference, same A-F group/J organizes relatively, P=0.147, no significant difference.
3 anti-ds-DNA antibody level comparisons:
Each group mice serum equal no difference of science of statistics of anti-ds-DNA antibody level (P=0.779) before pharmaceutical intervention, illustrate between each group and have comparability, but there is significant difference (P=0.0010) compared with Normal group, wherein I～J group is compared with normal control, P=0.006, the foundation that model is described is correct.Intervene three rattan mixture groups and the loose group of the anti-lupus of the positive control mice anti-ds-DNA antibody level that after 28 days prepared by various technique and be starkly lower than model group (normal saline matched group) (P=0.026), and be wherein that Radix Tripterygii Wilfordii, Caulis Sargentodoxae, Caulis Spatholobi alcohol extraction medicine group are the most obvious with 3 groups of techniques, anti-ds-DNA antibody level the most obviously high dose group (13.266 ± 5.256) gl from intervening that declines
-1drop to (6.267 ± 3.694) gl
-1, low dose group (33.5 ± 17.526) gl from intervening
-1drop to (16.0 ± 20.648) gl
-1; And for the third time, respectively organize comparing difference not statistically significant (P > 0.05), in table 4
The comparison of the each group of table 4 MRL/lpr lupus mouse anti-ds-DNA antibody level (X ± S, g.l
-1, n=4～5)
For the second time, intervention effect the 28th day, A-F group compares with I group, P=0.535, no significant difference; And A-F group compares with J group, P=0.026, difference has significance; E and I comparison, P=0.127, no significant difference; The high dose group of three kinds of techniques is compared with model group, and difference all has significance (P=0.033), and E and J comparison, P=0.049, difference has significance.For the third time, intervention effect the 56th day, A～F/I comparison, P=0.718, no significant difference; Same A～F/J comparison, P=0.584, no significant difference; E and I comparison, P=0.374, no significant difference; And E and J comparison, P=0.121, there are no significant for difference.
4 each group mouse kidney pathological changes: model group presents the pathological change of typical spontaneous lupus nephritis without pharmaceutical intervention (J group), visible capillary endothelial cell hypertrophy, a large amount of inflammatory cell infiltrations, and there is granulomatous formation; lesion degree is the most serious in 8 groups, as shown in Figure 1; 1 group of (A high dose group) visible slight hypertrophy of minority capillary endothelial cell of technique, part capillary lumen is slightly aobvious narrow, and inflammatory cell infiltration is comparatively obvious with blood vessel and blood vessel wall, as shown in Figure 2; 1 group of (B low dose group) point capillary endothelial cell hypertrophy of technique, tube chamber is slightly aobvious narrow, and vascular inflammation is obvious compared with A group, as shown in Figure 3; Technique 2 (C high dose group) vascular inflammation pathological changes is obvious compared with A group, more inflammatory cell infiltration, as shown in Figure 4; Technique 2 (D low dose group) extent of disease is obvious compared with C group, more inflammatory cell infiltration, as shown in Figure 5; Technique 3 (E high dose group) inflammatory cell infiltration, Endovascular erythrocyte oozes out, as shown in Figure 6; Technique 3 (F low dose group) blood vessel fibrinoid necrosis, Granuloma formation, manages all inflammatory cells and infiltrates in a large number, assemble agglomerating, as shown in Figure 7; The anti-lupus a small amount of periangiitis disease of the positive controls cellular infiltration that falls apart, special mess is assembled 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 MRL/lpr lupus mouse, (intervention experiment the 28th day) for the second time, (0.663 ± 0.364) g/24h with the high dose group of technique 3 from intervening drops to (0.405 ± 0.150) g/24h, compared with model group (0.803 ± 0.03) g/24h, 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 comparison, difference there are no significant meaning (P > 0.05); Aspect the improving of anti-ds-DNA antibody level, (intervention experiment the 28th day) for the second time, each pharmaceutical intervention group (A～F group) compares with model J group, P=0.026, difference has significance, and the high dose group of three kinds of techniques is compared with model group, and difference all has significance (P=0.033), wherein obvious with the improvement of 3 groups of techniques, with (13.266 ± 5.256) gl from intervening
-1drop to (6.267 ± 3.694) gl
-1, (33.967 ± 15.992) gl compared with model group
-1, P=0.049; (intervention experiment the 56th day) for the third time, each treatment group and model group comparison, 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 techniques.
3 kinds of different extraction process extracts of three vine formulations at intervention experiment for the second time, intervene the 28th day, all can improve the anti-ds-DNA antibody level of MRL/lpr lupus mouse, the most obvious with technique 3; And three vine formulations high dose group of technique 3 can be improved albuminuria, and certain " amount-effect " and the relation of " timeliness " are shown.
Through above-mentioned chemistry and pharmacodynamic study, the preparation method that the present invention treats the Chinese medicinal capsule of lupus erythematosus can extract raw material the effective elements of the medicine effectively, has higher drug effect.
On the basis of technique 3, in order to be further prepared into oral capsule, meet the technological requirement of large production, three rattan medical materials are after 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.After breaking into powder after dry, make effective ingredient even again, be easily divided in Capsules, the capsule finished product weight differential of making is little, guarantees that the quality of capsule meets the regulation of Chinese Pharmacopoeia.
Claims (2)
1. a Chinese medicinal capsule for the treatment of lupus erythematosus, is characterized in that, its raw material packet is containing Radix Tripterygii Wilfordii 15～45 weight portions, Caulis Spatholobi 15～45 weight portions and Caulis Sargentodoxae 15～45 weight portions of peeling root, and its preparation method is:
The first step: take 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 ℃ dry, makes dry powder, packs in No. 0 capsule, must treat the Chinese medicinal capsule of lupus erythematosus.
2. the Chinese medicinal capsule for the treatment of lupus erythematosus as claimed in claim 1, is characterized in that, in the described first step, the weight ratio of the Radix Tripterygii Wilfordii of Caulis Sargentodoxae, Caulis Spatholobi and peeling root is 1:1:1.
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| CN201210197227.0A CN102688283B (en) | 2012-06-15 | 2012-06-15 | Chinese traditional medicine capsule for treating lupus erythematosus and preparation method thereof |
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| CN102688283B true CN102688283B (en) | 2014-07-02 |
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| WO2014153685A1 (en) * | 2013-03-29 | 2014-10-02 | Li Daihong | Chinese medicine capsule for treating lupus erythematosus |
| CN105617024B (en) * | 2016-02-22 | 2019-12-13 | 广西梧州制药（集团）股份有限公司 | a Chinese medicinal composition for treating psoriasis, and its preparation method |
| 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 |
| CN112114126B (en) * | 2020-08-13 | 2023-03-24 | 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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| CN101919993A (en) * | 2010-08-06 | 2010-12-22 | 朱五元 | Medicament for treating psoriasis |
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| 秦万章.《我院30年雷公藤治疗红斑狼疮的研究现状及展望》.《第五届全国雷公藤学术会议论文汇编》.2008,1-11. * |
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