CN105663380A - Method for preparing traditional Chinese medicine composition for treating prostatitis - Google Patents
Method for preparing traditional Chinese medicine composition for treating prostatitis Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine composition for treating prostatitis, and relates to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition is prepared from ladybell roots, white mustard seeds, all-grass of dischidia chinensis Champ. ex Benth., black fovea snails, roots of oenothera erythrosepala borb, folium turpiniae, herba conyzae and salix leaves. The traditional Chinese medicine composition reduces the level of TNF-alpha and IL-8 in the prostate tissue of a patient to perform the treating function on chronic abacterial prostatitis, reduces the level of inflammatory reaction, and thus promotes the remediation of the prostate tissue structure.
Description
The application be Weicon, applicant Shandong biological medicine Science and Technology Ltd. propose application for a patent for invention (denomination of invention is: a kind of Chinese medicine composition and application thereof treating prostatitis, application number is: 2014104612187, and the applying date is: on September 12nd, 2014) point case application.
Technical field
The invention belongs to technical field of Chinese medicine, it relates to a kind of method of Chinese medicine composition preparing treatment prostatitis.
Background technology
Chronic nonbacterial prostatitis is a kind of common male urinary surgical disease, mainly shows as pelvis area pain, it is seen that in perineum, penis, crissum portion, urethra, pubis portion and lumbosacral region position. Paruria can show as urgent urination, frequent micturition, odynuria and enuresis nocturna and increase. Due to chronic pain obstinate, patients ' life quality declines, and the symptom of possibility sexual disorders, anxiety, depression, insomnia, hypomnesis. Current clinical multiplex microbiotic, anodyne are treated, but microbiotic, anodyne have certain side effect, and therapeutic process patient is very painful.
Chronic prostatitis treatment is had advantage by motherland's medical science. The methods such as classical method mainly includes oral medicinal herb, external application sticks, herbal enema and suppository rectal administration, make a general survey of current treatment thoughts and method, taking promoting blood circulation and removing blood stasis, clearing heat and promoting diuresis is treating stranguria, kidney tonifying etc. is generally used in the treatment of clinical chronic prostatitis as therapeutic rules. Further, Chinese medicine prostatitis, has the advantages such as cheap and easy to get, untoward reaction is little, therefore becomes current one of research focus and trend.
Summary of the invention
Modern medicine is thought, in the special anatomical structure of the pathogenesis of chronic nonbacterial prostatitis and prostate gland, Posterior urethral smooth muscle spasm, prostate gland, the factor such as urine reflux, cytokine mediated immune response is relevant, and wherein cytokine effect is further remarkable. The present inventor, on the basis of cytokine theory, uses the method for motherland's medical science, have found the novel method of a treatment chronic nonbacterial prostatitis. Based on this methods for the treatment of, it is an object of the invention to provide the Chinese medicine composition of a kind of resistance prostatitis and application thereof.
In order to realize the object of the present invention, contriver, by a large amount of experimental study and persistent exploration, finally obtains following technical scheme:
A kind of Chinese medicine composition treating prostatitis, comprising Chinese medical extract and pharmaceutical excipient, described Chinese medical extract is prepared from through water extraction and alcohol precipitation method by the traditional Chinese medicinal material raw materials of following weight part: Root of Upright Ladybell 9-15 part, White Mustard Seed 9-15 part, stone melon seeds 17-24 part, sea Cassia tora 10-18 part, root of Redsepal Eveningprimrose 20-30 part, leaf of Turpinia pomifera (Roxb) D O. 20-30 part, gold Radix Gentianae 9-15 part, willow leaf 6-10 part.
Preferably, the Chinese medicine composition for the treatment of prostatitis as mentioned above, described Chinese medical extract is prepared from through water extraction and alcohol precipitation method by the traditional Chinese medicinal material raw materials of following weight part: Root of Upright Ladybell 11-13 part, White Mustard Seed 11-13 part, stone melon seeds 19-21 part, sea Cassia tora 13-15 part, root of Redsepal Eveningprimrose 23-26 part, leaf of Turpinia pomifera (Roxb) D O. 23-26 part, gold Radix Gentianae 11-13 part, willow leaf 7-9 part.
In a most preferred embodiment of the present invention, Chinese medical extract as above is prepared from through water extraction and alcohol precipitation method by the traditional Chinese medicinal material raw materials of following weight part: Root of Upright Ladybell 12 parts, White Mustard Seed 12 parts, 20 parts, stone melon seeds, sea Cassia tora 14 parts, root of Redsepal Eveningprimrose 25 parts, leaf of Turpinia pomifera (Roxb) D O. 25 parts, gold Radix Gentianae 12 parts, willow leaf 8 parts.
Preferably, the Chinese medicine composition of above-mentioned treatment prostatitis is oral preparations. Again further preferably, described oral preparations comprises oral liquid, granule, Tablet and Capsula agent.
By the preparation method of the compound granule that above-mentioned each Chinese medicinal materials preparation cost is invented, comprise the steps: to take and clean clean Root of Upright Ladybell 9-15 part, White Mustard Seed 9-15 part, stone melon seeds 17-24 part, sea Cassia tora 10-18 part, root of Redsepal Eveningprimrose 20-30 part, leaf of Turpinia pomifera (Roxb) D O. 20-30 part, gold Radix Gentianae 9-15 part, willow leaf 6-10 part, merge, boiling twice, merge decocting liquid, it is evaporated to medicinal extract, adding ethanol makes alcohol content reach 70-80% (v/v), stir, leave standstill, filter, filtrate decompression be condensed into relative density when 65 DEG C be 1.20-1.30, and reclaim ethanol, obtain concentrated solution, by concentrated solution lyophilize, pulverized 80 order sieves, obtain cream powder clearly, dropping in trough type mixing machine by clear cream powder together with pharmaceutically acceptable auxiliary material, stir, slowly add tackiness agent while stirring, to making softwood, granulate with 12 order stainless steel sifts, forced air drying under 60 DEG C of conditions, takes out, cools and obtain granule.
It should be noted that, what the Chinese medicine composition of the present invention adopted in preparation process traditional Chinese medicinal material raw materials source is as follows: Root of Upright Ladybell selects Campanulaceae adenophora tetraphyllaAdenophoratetraphylla(Thunb.) Fisch.Dry root. White Mustard Seed selects cress sinapsis albaSinapisalbaL.Dry seed. Trailing plants section eye tree nelumbium eye tree lotus selected by stone melon seedsDischidiachinensisChamp.exBenth.Dry full grass. Sea Cassia tora selects top shell section animal Chlorostoma nigerrima (Gmelin)Chlorostomanigerrinma(Gmelin)Shell. Root of Redsepal Eveningprimrose selects Oenotheraceae root of Redsepal EveningprimroseOenotheraerythrosepalaBorbDry root. Leaf of Turpinia pomifera (Roxb) D O. selects Fruit of Bumalda Bladdernut section plant sharp point Turpinia pomifera(Roxb) D O.Turpiniaarguta(Lindl.) Seem. ［ OchrantheargutaLindl. ］Dry leave. Gold Radix Gentianae selects the dry full grass of the little bitter wormwood artemisia ConyzabliniiLevl. of the false fluffy platymiscium of composite family. Willow leaf selects Salicaceae plant weeping willowSalixbabylonicaL.Dry leave.
The secretion of cytokine is the important factor that inflammation occurs tissue, and TNF-α and IL-8 proinflammatory gene representation play a part extremely important in the immunomodulatory of body and the pathogenic process of chronic nonbacterial prostatitis. Inflammation can produce TNF-α under the effects such as infection, toxin, wound, these cytokines can increase chemokine such as the expression of IL-8, body tissue is caused by respective mechanism and damages and cause pain by expression product, and regulation and control inflammatory factor can react by inflammation-inhibiting indirectly. Therefore the present inventor selects TNF-α in prostata tissue, IL-8 level as the comparison index treated by chronic nonbacterial prostatitis rat, found that: compared with sham operated rats, in model control group rat prostate tissue TNF-α and IL-8 level increase (P< 0.01);Compared with model control group, adopt TNF-α and IL-8 level in the treatment group rat prostate tissue of Chinese medical extract intervention of the present invention significantly reduce (P< 0.01). Therefore, present invention also offers a kind of pharmaceutical applications, that is: the application of above-mentioned Chinese medical extract in the medicine of preparation treatment chronic nonbacterial prostatitis.
Compared with prior art, by reducing, TNF-α and IL-8 level in patient's prostata tissue play the therapeutic action to chronic nonbacterial prostatitis to the Chinese medicine composition of the present invention, reduce inflammatory reaction degree, thus promote the reparation of prostata tissue structure.
Embodiment
The following is the preparation embodiment of Chinese medicine composition of the present invention and test of pesticide effectiveness example, the technical scheme of the present invention is done and describes further, but protection scope of the present invention is not limited to these embodiments.
The preparation of embodiment 1 granule
Get the raw materials ready: Root of Upright Ladybell 1.2kg, White Mustard Seed 1.2kg, stone melon seeds 2.0kg, sea Cassia tora 1.4kg, root of Redsepal Eveningprimrose 2.5kg, leaf of Turpinia pomifera (Roxb) D O. 2.5kg, gold Radix Gentianae 1.2kg, willow leaf 0.8kg.
Preparation: take by recipe quantity and clean clean above-mentioned Chinese medicinal materials, merge, pulverize, boiling twice, add water 10 times amount into medicinal material weight for the first time, decoct and boil 2h, add water 8 times amount into medicinal material weight for the second time, decoct and boil 1h, merge decocting liquid, 0.07MPa, the medicinal extract that relative density is 1.15 it is evaporated at 65 DEG C of temperature, (v/v) ethanol makes alcohol content reach 75% (v/v) to add 95%, stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density, and reclaim ethanol, obtain concentrated solution, by concentrated solution lyophilize, dried object pulverized 80 order sieves, obtain cream powder clearly, claim qinghuo reagent powder 10g, lactose 80g, Microcrystalline Cellulose 80g, Xylo-Mucine 15g, drop in trough type mixing machine, stir 20 minutes, slowly add 55% ethanol (volumetric concentration is the aqueous ethanolic solution of 55%) while stirring, to making softwood, granulating with 12 order stainless steel sifts, forced air drying under 60 DEG C of conditions, takes out, cool and obtain granule, by every bag of 10g packaging.
The preparation of embodiment 2 granule
Get the raw materials ready: Root of Upright Ladybell 1.5kg, White Mustard Seed 1.2kg, stone melon seeds 1.8kg, sea Cassia tora 1.8kg, root of Redsepal Eveningprimrose 2.0kg, leaf of Turpinia pomifera (Roxb) D O. 3.0kg, gold Radix Gentianae 1.0kg, willow leaf 1.0kg.
Preparation: take by recipe quantity and clean clean above-mentioned traditional Chinese medicinal material raw materials, merge, pulverize, boiling twice, add water 10 times amount into medicinal material weight for the first time, decoct and boil 2h, add water 8 times amount into medicinal material weight for the second time, decoct and boil 1h, merge decocting liquid, 0.07MPa, the medicinal extract that relative density is 1.15 it is evaporated at 65 DEG C, (v/v) ethanol makes alcohol content reach 75% (v/v) to add 95%, stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density, and reclaim ethanol, obtain concentrated solution, by concentrated solution lyophilize, pulverized 80 order sieves, obtain cream powder clearly, claim qinghuo reagent powder 10g, lactose 80g, Microcrystalline Cellulose 80g, Xylo-Mucine 15g, drop in trough type mixing machine, stir 20 minutes, slowly add 55% ethanol (volumetric concentration is the aqueous ethanolic solution of 55%) while stirring, to making softwood, granulating with 12 order stainless steel sifts, forced air drying under 60 DEG C of conditions, takes out, cool and obtain granule, by every bag of 10g packaging.
The clinical trial of chronic nonbacterial prostatitis rat model is studied by embodiment 3 Chinese herbal granules
Only, initial physique amount 210-250g, freely take food, drink water and keep 12h light and shade alternate illumination, room temp 18～25 DEG C, humidity 45%-65%, ventilate good, test front this feeding environment adaptation 1 week 2 month female SD rat 6O.Random digits table is adopted to be divided into each 2O of model control group, treatment group and sham operated rats only. After taking abdominal injection 10% chloral hydrate anesthesia rat, in abdomen median incision under aseptic condition, expose both sides seminal vesicle and prostate gland, sham operated rats rat is in prostate gland side leaf injecting normal saline 0.2mL/ only, all the other rats are injected to prostate gland side leaf respectively with 25% XIAOZHILING ZHUSHEYE 0.2mL, close abdomen. Chronic nonbacterial prostatitis model can be formed after 5 weeks. Pathological change is inflammatory cell infiltration in gland body, and secretory product reduces, and gland chamber is blocked, reduced, interstitial fibrosis. 5th day each group of tested material starting the following dosage of correspondingly gavage after art: model control group is physiological saline 10mL/kg; Sham operated rats is physiological saline 10mL/kg; Treatment group is that the clear clear cream powder of cream powder 0.75g/kg(prepared by embodiment 1 is dissolved in physiological saline). Respectively organize all by 1 time/d administration, totally 5 weeks.
Being put to death by disconnected for rat neck after last administration 60min, isolate prostata tissue, shred, the ratio adding physiological saline 400 μ L in every 100mg prostata tissue is mixed even. Draw 20 μ L suspensions, add white blood cell count(WBC) liquid 0.38mL, mixed even, fill pond, cell counting count board counts the total white blood cells in the block plaid of 4, corner. ELISA kit detects TNF-α, IL-8 expression amount in rat blood serum and prostata tissue homogenate.
The generalized case of rat is observed in administration after terminating, model control group rat is compared with sham operated rats rat, movable minimizing, the sparse tarnish of hair; Treatment group rat is compared with model control group rat, and hair is relatively glossy, and generalized case still may be used. In modeling process, unexpected dead 1 for the treatment of group, dead 2 of model control group.
In addition, in each group rat prostate tissue, TNF-α and IL-8 level statistic the results are shown in Table 1. By the test-results of table 1 it may be seen that compared with sham operated rats, in model control group rat prostate tissue TNF-α and IL-8 level increase (P< 0.01). Compared with model control group, treatment group rat TNF-α and IL-8 level significantly reduce (P< 0.01).
Table 1 is respectively organized TNF-α and IL-8 level in rat prostate tissue and is compared
| Group | Sample size | TNF-α (ng/L) | IL-8(ng/L) |
| Sham operated rats | 20 | 3.71±0.46 | 24.15±2.94 |
| Model control group | 18 | 149.28±1.02★★ | 98.20±17.33★★ |
| Treatment group | 19 | 12.40±1.69▼▼ | 37.09±5.18▼▼ |
Model control group compares with sham operated rats,★ P< 0.05;★★ P< 0.01; Treatment group compares with model control group,▼ P< 0.05,▼▼ P< 0.01.
Each group rat leukocyte counting statistics the results are shown in Table 2. By the test statistics result of table 2 it may be seen that sham operated rats is significantly lower than other two groups; The quantity of leucocyte for the treatment of group significantly declines, compare with model control group have significant difference (P< 0.01).
Rat leukocyte respectively organized by table 2 and the little body number of Blood phospholipid compares
| Group | Sample size | White corpuscle (109Individual) |
| Sham operated rats | 20 | 1.80±0.21 |
| Model control group | 18 | 9.49±1.13★★ |
| Treatment group | 19 | 4.37±0.66▼▼ |
Model control group compares with sham operated rats,★ P< 0.05;★★ P< 0.01;
Treatment group compares with model control group,▼ P< 0.05,▼▼ P< 0.01.
Claims (2)
1. prepare the method for the Chinese medicine composition for the treatment of prostatitis for one kind, it is characterised in that obtain by following processing step:
(1) the clean following traditional Chinese medicinal material raw materials of cleaning is taken by weight: Root of Upright Ladybell 15 parts, White Mustard Seed 12 parts, 18 parts, stone melon seeds, sea Cassia tora 18 parts, root of Redsepal Eveningprimrose 20 parts, leaf of Turpinia pomifera (Roxb) D O. 30 parts, gold Radix Gentianae 10 parts, willow leaf 10 parts;
(2) above raw material is merged, pulverize, boiling twice, add water 10 times amount into medicinal material weight for the first time, decoct and boil 2h, add water 8 times amount into medicinal material weight for the second time, decoct and boil 1h, merge decocting liquid, 0.07MPa, the medicinal extract that relative density is 1.15 it is evaporated at 65 DEG C of temperature, adding 95%v/v ethanol makes alcohol content reach 75%v/v, stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density, and reclaim ethanol, obtain concentrated solution, by concentrated solution lyophilize, dried object pulverized 80 order sieves, obtain cream powder clearly,This Chinese medicine composition obtained on the basis of clear cream powder.
2. the method for the Chinese medicine composition of prostatitis is treated in preparation according to claim 1, it is characterised in that: described Chinese medicine composition is oral preparations, and described oral preparations is oral liquid, granule, tablet or capsule.
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