CN102579620B - A kind of compositions causes the medicinal usage of histologic lesion at control plasticiser - Google Patents
A kind of compositions causes the medicinal usage of histologic lesion at control plasticiser Download PDFInfo
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Abstract
The invention provides the purposes that a kind of compositions causes in the medicine of histologic lesion at preparation control plasticiser.Described compositions is that silent board indigo plant difficult to understand supports sheet, and its composition is open in the patent of application number 03117070.6, and the active component be made up of natural amino acid, natural extract mixes with relevant auxiliary materials and forms.Compositions provided by the invention can alleviate and recover brain, the kidney of plasticiser to animal, the infringement of liver or testis tissue cell.Thus the infringement overcome because plasticiser brings to organs in adults such as human reproductive systems, cerebral nerve, kidneys, alleviate and recover the organ lesion that plasticiser causes human health, thus reach the diseases induced medicament purpose of control plasticiser.
Description
Technical field
The invention belongs to field of medical application, relate to a kind of compositions preparation effectively control plasticiser cause the purposes in the medicine of animal organ histologic lesion.The present composition can available protecting animal organ be organized, and reduces and overcome the injury that plasticiser causes it, thus reaches the diseases induced medicament purpose of control plasticiser.
Background technology
In April, 2011, in the island of Taiwan during hygiene department's routine examination at random food. and in a " clean first probiotic bacteria " powder, find phthalic acid two (2 one ethyl) own ester (DEHP), concentration is up to 600mg/kg.Trace discovery, in the mist generating agent that DEHP supplies from Yu Shen spice company.Through investigation further, a lot of Taiwan famous brand name beverage, health product, food are all subject to this supplier's mist generating agent contamination of products, relate generally to the 5 large based foods such as sports drink, fruit juice, tea-drinking, fruit jam fruit jelly, capsule ingot shape powdery.But along with investigation is goed deep into, even youngster's chapter is adjusted and is hidden syrup, plate is supervised the medicines such as root and also failed to escape by luck.This time contamination accident scale is rare greatly over the years, puts the cat among the canaries in Taiwan.
Mist generating agent is kasher additive in fact, generally add emulsifying agent by Petiolus Trachycarpi oil to mix, but because Petiolus Trachycarpi oil is expensive, price is five times of plasticiser, in current event, Taiwan evil mind manufacturer just replaces Petiolus Trachycarpi oil with cheap virose plasticiser, joins in mist generating agent, causes various beverages " contamination ".
In addition, plasticiser not only exists with in beverage and food, there is any one space of living with us.In fact, plasticiser is phthalic acid ester (being also phthalate ester) class material, this kind of material includes 200 number of chemical materials, this material is industrial is the macromolecular material auxiliary agent be widely used, in plastic processing, add this material, its pliability can be made to strengthen, easily process, all plastics in process of production, all can use this kind of material.Comprise all types of plastic container, toy for children, vinyl flooring and wallpaper, cleaning agent and personal-care supplies etc.
The disposable plastic fast food container of every day use, preservative film, the plastic bottle of dixie cup, the plastic bag of splendid attire hot soup common in life, heat food and plastic bowl etc. also can disengage plasticiser by trace, and the box lunch that supermarket is peddled is mainly with plastic casing splendid attire, as long as put into microwave-oven-heating, more can disengage plasticiser composition in a large number and incorporate in food.
Present most toy is all made of plastics, and in plastic toy, phthalic acid ester material extensively exists, and reason is that to the addition of the toy material cost of this plasticiser lower.Child at ordinary times with toy close contact, like toy to put into mouth, this is very large potential safety hazard to the health of child.
Find according to the study, about seventy percent cosmetics as nial polish, perfume, lipstick, emulsion, cream, hair jelly, bath oils etc. all contain phthalate, it product can be made to seem evenly, fragrance is denseer, is more easily absorbed by the skin.Wherein, the content of plasticizing agent of nial polish is the highest, and nial polish needs the plasticizer adding about 5%, makes film property better, and plays the effect of certain emulsifying thickening, and seeming lubricious has texture.In addition, cosmetics can add fixastive in the mill, have the composition of plasticiser in a lot of fixastive, because it can avoid the spice rapid release of interpolation, and perfume fragrance remaining time are extended.
Plasticiser kind nearly over one hundred kind, but use to obtain the compound of the most generally phthalate (DEHP), belong to industrial additive, colourless, tasteless, liquid.DEHP not only can not be added in food, does not even allow to be used in packaging for foodstuff.Although accidentally a small amount of absorption can not work the mischief to health, if human body is taken in for a long time can produce very serious consequence.
Because plasticiser has been prevalent in daily life, therefore increasing people focuses on sight in this problem of plasticiser toxicity.
The research team of life sciences system of platform Normal University assistant professor Shen Lin amber, Kaohsiung Medical University's environmental medicine research center professor's Ling Shuilong composition claims, from 16 kinds of different plasticisers, 5 kinds with remarkable toxicity have been found out more than a year, comprise ditridecyl phthalate (DEHP), phthalic acid ester (MEHP), dibutyl phthalate (DBP) etc., compare one by one, find that plasticiser directly can cause genotoxicity.
Research before confirms that plasticiser is Environmental Hormone, can cause reproductive system disease, and the report of research team finds, plasticiser toxicity also can endanger heart, liver and renal system, particularly the highest to the risk of cardiovascular disease harm, heart failure and arrhythmia may be caused.Next is hepatic disease, and the 3rd is diseases of urinary system, and fourth is only reproduction aspect disease.
Plasticiser is little via the dose comparison of contact skin, can be discharged in 48 hours by human body.But directly the edible Foods or drinks containing plasticiser, equals to enter digestive system from the oral cavity of people, and absorbed speed sooner, especially by after intestinal absorption, is just difficult to be discharged, meeting is accumulation toxin harmful to human constantly, also can pass through gene genetic, misfortune and the next generation.
Biology department of Hong Kong Baptist University is for further study with guinea pig, finds once to take the mouse of " plasticiser ", and the offspring under birth based on female, and can affect it and ovulates normally; Even if birth is lower male, its genitals's compared with normal little by 2/3rds, and sperm quantity also subtracts greatly, reflection " plasticiser " toxicity belongs to antiandrogen active, causes endocrine disturbance.Expert represents, research can be applied to it the mankind, and it is more womanlike to male influence that " plasticiser " is clisised in display for a long time.
The effect of plasticiser DEHP is similar to artificial hormone, can endanger male reproductive function and impel female precocious puberty, and long-term huge uptake can cause hepatocarcinoma.Because child is in the hormonal system Development of Reproductive System phase, DEHP can be larger to the potential hazard that child brings.Food Research Inst. of Taiwan Univ. professor Sun Luxi represents, plasticiser DEHP toxicity ratio tripolycyanamide poison 20 times, and long-term absorption can cause immunity and reproductive performance to decline.
Existing patent (CN1451426) discloses a kind of Pharmaceutical composition, has the advantageous combination effect for the treatment of following disease: sexual disorder, sexual impotence, hypoimmunity, confirmed fatigue and hepatic disfunction.Said composition has obvious effect to raising sexual function, and have no side effect, safety is high, can long-term taking, is the first-selected product that people improve quality of life and health care.Above-mentioned Pharmaceutical composition has obtained national health food authentication code (2006B0578), and name of product is that silent board indigo plant difficult to understand supports sheet, and health care is for improving anoxia endurance, having auxiliary protection function to chemical liver injury.
Research confirms, plasticiser, as a kind of environmental estrogens, all can have toxic action to a certain degree, especially with the most obvious to the toxicity of reproductive system to the different organs system comprising brain, liver, kidney and reproductive system:
1) cardiac toxicity: cause cellular edema, unclear transverse striation of muscle fiber or disappearance, part sarcoplasm dissolves, muscle fiber fracture etc.;
2) hepatotoxicity: cause liver congested, cellular edema, sinus hepaticus narrows, cell cavity, cell focal necrosis, cell infiltration etc.;
3) Toxicity of Kidney: cellular edema, interstitial is congested, and slightly to moderate hypertrophy, blood capillary tube chamber narrows, and glomerule blood flow is obstructed;
4) cerebral tissue toxicity: neurocyte edema, unclear or disappearance of neurocyte karyopycnosis, kernel etc.;
5) ovary tissue toxicity: ovarian atrophy, mature follicle and stimulate that follicle quantity significantly reduces, primary follicle and locking quantity significantly improves;
6) testis tissue toxicity: testis and epididymis Telatrophy, sperm quantity reduce, every day sperm production reduce, motility of sperm reduces, improper sperm quantity increases, contorted seminiferous tubules is thinning, spermatogenic cell layer reduce, sparse, testicular spermatogenic tubule comes off, testicular cell film destroy etc.
Correlational study also confirms, and filial generation is large/and the internal organs such as brain, testis, kidney, liver of mice can produce because of the pregnant Mus contact plasticiser of previous generation and damage phenomenon significantly.
Summary of the invention
The object of the present invention is to provide the purposes that a kind of compositions causes in the medicine of animal organ histologic lesion at preparation control plasticiser.Described compositions is that silent board indigo plant difficult to understand supports sheet, its composition is open in the patent of application number 03117070.6, by natural amino acid, the active component of natural extract composition mixes with relevant auxiliary materials and forms, wherein natural amino acid is ornithine and citrulline, the crude drug of natural extract is Fructus Jujubae, Semen Ginkgo and Radix Ginseng, its weight ratio is: ornithine: citrulline: Fructus Jujubae: Semen Ginkgo: Radix Ginseng equals 40:30:10:5:5, or ornithine: citrulline: Fructus Jujubae: Semen Ginkgo: Radix Ginseng equals 60:20:10:5:5, or ornithine: citrulline: Fructus Jujubae: Semen Ginkgo: Radix Ginseng equals 20:60:10:5:5, or ornithine: citrulline: Fructus Jujubae: Semen Ginkgo: Radix Ginseng equals 43:42:5:5:5.
Described plasticiser is the one in the just own ester (DNHP) of phthalic acid two (2-ethylhexyl) ester (DEHP), diisononyl phthalate (DINP), dibutyl phthalate (DBP), BBP(Butyl Benzyl Phthalate (BBP), diisooctyl phthalate (DIDP), dinoctyl phthalate (DOP), diisooctyl phthalate (DIOP), diethyl phthalate (DEP), diisobutyl phthalate (DIBP) or phthalic acid two.
Described animal organ's tissue refers to brain, kidney, the one in liver or testis.
The toxicity problem of plasticiser has caused the great attention of people, the invention discloses the foster sheet of silent board indigo plant difficult to understand and can alleviate and recover brain, the kidney of plasticiser to animal, the infringement of liver or testis tissue cell.Thus the infringement overcome because plasticiser brings to organs in adults such as human reproductive systems, cerebral nerve, kidneys, alleviate and recover the organ lesion that plasticiser causes human health, there is very strong originality and novelty, huge Social benefit and economic benefit can be brought.The present invention have studied from animal tissue's cellular level the silent board indigo plant of harm and described Pharmaceutical composition Austria thereof that plasticiser causes and supports sheet available protecting animal organ tissue; reduce and overcome the injury that plasticiser causes it, thus reach the diseases induced object of control plasticiser.
Accompanying drawing explanation
Fig. 1 is negative control group SD rat brain tissue paraffin section de in embodiment 1, and HE dyes, and result display negative control group rat neuronal cell form is normal, and large interstitial tissue of brain is normal.
Fig. 2 is model group SD rat brain tissue paraffin section de in embodiment 1, HE dyes, present cavity sample around result display model group rat neuronal cell, in large interstitial tissue of brain, occur that a large amount of fiber-like deposits, illustrate that DBP has obvious damaging action to rat brain tissue.
Fig. 3 is test group SD rat brain tissue paraffin section de in embodiment 1, HE dyes, result display is compared with model group, around rats in test groups cerebral tissue neuronal cell, cavity change is basic disappears, stroma fibrosis sample deposition degree alleviates, and the above results prompting board indigo plant difficult to understand silent supports the fibrosis sample deposition that sheet significantly can reduce the cerebral tissue caused because of DBP.
Fig. 4 is negative control group SD rat kidney tissue paraffin section de in embodiment 2, and HE dyes, and result display negative control group kidney of rats tubule, glomerule structure are normal.
Fig. 5 is model group SD rat kidney tissue paraffin section de in embodiment 2, and HE dyes, and result display model group kidney of rats Minute Tubule Structures is loose, and tube wall is obviously thinning, cannot find glomerule, illustrates that BBzP has obvious damaging action to rat kidney tissue.
Fig. 6 is test group SD rat kidney tissue paraffin section de in embodiment 2, HE dyes, result display is compared with model group, rats in test groups renal tubules clear in structure, tube wall thickening, glomerular injury is not obvious, and the above results prompting silent board indigo plant difficult to understand is supported sheet and significantly can be reduced the destruction of BBzP to renal tissue.
Fig. 7 is negative control group SD rat testis paraffin section in embodiment 3, and HE dyes, and result display negative control group rat testis contorted seminiferous tubules clear in structure, spermatogonium levels are rich, arrangement closely.
Fig. 8 is model group SD rat testis paraffin section in embodiment 3, and HE dyes, and result display model group rat testis contorted seminiferous tubules is out of shape, and tube chamber expands, and spermatogonium reduces in a large number, illustrates that DEHP has obvious damaging action to rat testis.
Fig. 9 is test group SD rat testis paraffin section in embodiment 3, HE dyes, result display model group is compared, rats in test groups testis tissue contorted seminiferous tubules structure is comparatively clear, caliber enlarged degree reduces, spermatogonium increases, and the above results illustrates that silent board indigo plant difficult to understand is supported sheet and significantly can be reduced the damaging action of DEHP to rat testis.
Detailed description of the invention
The present invention is further described in conjunction with the embodiments.Pharmaceutical composition described in below implementing is that silent board indigo plant difficult to understand supports sheet, and the name of product in State Food and Drug Administration's approval " national OTC certificate of approval ", authentication code is 2006B0578.
Embodiment 1: Pharmaceutical composition is to the protective effect of the cerebral lesion that dibutyl phthalate (Di-n-butylphthalate, DBP) causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 1.
Rat is dissected and takes out brain, and 4% neutral formalin is fixed, paraffin embedding, section, and conventional H E dyes, and observation by light microscope cerebral tissue Pathologic changes situation, slice map is see Fig. 1, Fig. 2, Fig. 3.
Fig. 1 result display negative control group rat neuronal cell form is normal, and large interstitial tissue of brain is normal.Fig. 2 result shows: present cavity sample around model group rats neuronal cell, occurs a large amount of fiber-like deposition (dark strip part, arrow indication) in large interstitial tissue of brain.Fig. 3 result shows: rats in test groups is compared with model group DBP group, and around neuronal cell, cavity change is basic disappears, and stroma fibrosis sample deposition degree alleviates (the dark strip part of arrow indication).
The above results shows, plasticiser (DBP) produces the effect of obvious fibrosis sample deposition to rat brain tissue, and test group gives silent board indigo plant difficult to understand simultaneously and supports the fibrosis sample deposition that sheet significantly can reduce the cerebral tissue caused because of DBP.
Embodiment 2: Pharmaceutical composition is to the protective effect of the renal tissue damage that butyl benzyl phthalate (butylbenzylphthalate, BBzP) causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 2.
Rat is dissected and takes out kidney, and 4% neutral formalin is fixed, paraffin embedding, section, and conventional H E dyes, and observation by light microscope renal histopathology situation of change, slice map is see Fig. 4, Fig. 5, Fig. 6.
Fig. 4 result shows: negative control group kidney of rats tubule, glomerule normal (arrow indication is glomerule, and circle indication is renal tubules structure).Fig. 5 result shows: model group renal tubules is loosely organized, and tube wall is obviously thinning, cannot find glomerule.Fig. 6 result shows: test group is renal tubules clear in structure compared with model group, tube wall thickening, glomerular injury not obvious (arrow indication is glomerule, and circle indication is renal tubules structure).
The above results is pointed out, and plasticiser (BBzP) obviously destroys kidney of rats tubule, glomerule structure, and test group gives silent board indigo plant difficult to understand and supports sheet, significantly can reduce the destruction of the renal tissue that BBzP causes.
Embodiment 3: Pharmaceutical composition is to the protective effect of the testis tissue damage that phthalic acid two (2-ethylhexyl) fat (Di (2-ethylhexyl) phthalate, DEHP) causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 3.
Rat is dissected and takes out testis, and 4% neutral formalin is fixed, paraffin embedding, section, and conventional H E dyes, and observation by light microscope testis tissue Pathologic changes situation, slice map is see Fig. 7, Fig. 8, Fig. 9.
Fig. 7 result shows: negative control group rat contorted seminiferous tubules clear in structure, spermatogonium levels are rich, and arrangement closely (circle is depicted as contorted seminiferous tubules structure, and wherein dark point is spermatogonium).Fig. 8 result shows: model group rats contorted seminiferous tubules is out of shape, and tube chamber expands, and spermatogonium reduces in a large number.Fig. 9 result shows: test group is compared with model group, and contorted seminiferous tubules structure is comparatively clear, and caliber enlarged degree reduces, and spermatogonium increases (circle is depicted as contorted seminiferous tubules structure, and wherein dark point is spermatogonium).
The above results shows, plasticiser (DEHP) can cause that testis tissue contorted seminiferous tubules is out of shape, spermatogonium such as to reduce in a large number at the damage, and test group gives silent board indigo plant difficult to understand and supports sheet and significantly can reduce contorted seminiferous tubules structural deterioration that DEHP causes rat testis and spermatogonium quantity reduces.
Embodiment 4: Pharmaceutical composition is to the protective effect of the injury of testis that butyl benzyl phthalate (butylbenzylphthalate, BBzP) causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 4.
Testis tissue: serum testosterone (T) level:
Rat tail point gets blood, adds anticoagulant heparin, 4
oc, 3000 revs/min get supernatant after centrifugal 15 minutes, supernatant utilizes radioimmunoassay kits to measure serum testosterone (T) concentration.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 5.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Discussion of results:
BBzP significantly can reduce level of serum testosterone, test group gives silent board indigo plant difficult to understand and supports sheet, level of serum testosterone significantly improves compared with model group, does not have significant difference with negative control group simultaneously, shows that silent board indigo plant difficult to understand supports the reduction that sheet can significantly improve the level of serum testosterone that BBzP causes.
Embodiment 5: Pharmaceutical composition is to the protective effect of the cerebral tissue damage that butyl benzyl phthalate (butylbenzylphthalate, BBzP) causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 6.
Rat tail point gets blood, adds anticoagulant heparin, 4
oc, 3000 revs/min get supernatant after centrifugal 15 minutes, utilize radioimmunoassay kits to measure serum follicule-stimulating hormone (FSH) (FSH), lutropin (LH) level.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 7.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Discussion of results:
BBzP can significantly improve serum follicule-stimulating hormone (FSH) level; the remarkable reduction compared with model group of test group serum follicule-stimulating hormone (FSH) level; there is no significant difference simultaneously compared with negative control group, show that silent board indigo plant difficult to understand is supported the damage of sheet to the cerebral tissue caused because of BBzP and had certain protective effect.
BBzP can significantly reduce serum the level of luteinizing hormone; test group serum the level of luteinizing hormone significantly improves compared with model group; there is no significant difference simultaneously compared with negative control group, show that silent board indigo plant difficult to understand is supported the damage of sheet to the cerebral tissue caused because of BBzP and had certain protective effect.
Embodiment 6: to the reverse effect of DEHP content accumulation in rat different tissues
Experimental program:
Administering mode: gastric infusion
Animal: SD male rat, 200-220g, SPF level
Experiment grouping (often organizing 6):
Negative control group: edible oil, 10mL/ (kgday), 5 weeks
Model group: DEHP, 500mg/kg/day, 5 weeks
Test group: DEHP gives 500mg/kg/day, silent board indigo plant difficult to understand is supported sheet and is given 500mg/kg/day, 5 weeks
Got rat brain, testis, liver, kidney, correct amount respectively at after last administration 2 hours, 4 hours, 6 hours, add the dichloromethane of 2 times of w/vs after smashing process respectively to pieces and fully smash even.By ultrasonic for homogenate 30min, jolting 4h, homogenate collecting by filtration filtrate, the dichloromethane same method simultaneously continuing to add same volume in tissue residue thing extracts again, in triplicate, and combined dichloromethane filtrate, add anhydrous sodium sulfate to anhydrate, filter and obtain extracting solution.Extracting solution is separated through alumina column chromatography, collected the extracting solution after post, utilize GC/MS method to measure wherein DEHP content.
Measurement result: see table 8.DEHP content in tissue, unit: μ g/g.
*: compare with negative control group,
p<0.05.△: organize with same and compare with time experimental tests group,
p<0.05.
Result shows, and after giving rat DEHP, DEHP all has and accumulates in various degree in each internal organs, and test group gives silent board indigo plant difficult to understand and supports sheet, DEHP content in each internal organs content and model group with remarkable reduction compared with time test point.Simultaneously, when 6 little time point, each internal organs of model group DEHP content has the significance difference opposite sex compared with negative control group, and the content of test group DEHP in the internal organs such as brain, kidney, liver does not have the significance difference opposite sex compared with negative control, prompting silent board indigo plant difficult to understand is supported sheet and can be significantly improved each internal organs of body to the metabolism of DEHP and excretion.
Embodiment 7, Pharmaceutical composition to rat testicle because DEHP causes protective effect and the dose-effect relationship thereof of damage
Animal: SD rat, male, 200-220g
Rat grouping and experimental program carry out according to table 9.
Serum testosterone measures:
Rat tail point gets blood, to add after anticoagulant heparin 1000 turn 4
oc gets supernatant in centrifugal 20 minutes, utilizes radioimmunoassay kits to measure Serum testosterone concentrations.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 10.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Discussion of results:
DEHP can significantly reduce testis tissue testosterone levels; low dose group, middle dosage group, high dose group level of serum testosterone are significantly increased compared with negative control group; and presenting good dose-effect relationship, the above results confirms that silent board indigo plant difficult to understand is supported sheet and had significant protective effect to causing injury of testis because of DEHP.Meanwhile, high dose group level of serum testosterone there was no significant difference compared with negative control group, confirms that the silent board indigo plant of high dose Austria is supported sheet and can be had good therapeutical effect to the rat testis that DEHP causes.
Embodiment 8: Pharmaceutical composition to rat liver because DBP causes protective effect and the dose-effect relationship thereof of damage
Testing index: superoxide dismutase (SOD), malonaldehyde (MDA) in hepatic tissue
Laboratory animal: SD rat, 200-220g, male.Rat grouping and experimental program carry out according to table 11.
Tissue samples:
Get rat liver tissue, after correct amount, add 4 of 9 times of mass volume ratios
othe normal saline of C pre-cooling, fully smashs mixing to pieces with glass homogenizer, makes homogenate, and 4
oc, 10000 revs/min centrifugal 30 minutes, ice bath gets supernatant after leaving standstill, and by MDA level in improvement thiobarbituricacidα-(TBA) microdetermination liver, measures SOD level with xanthine oxidase.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 12.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Result shows:
DBP significantly can reduce hepatic tissue SOD vigor; in low dose group, middle dosage group, high dose group three dosage groups, hepatic tissue SOD vigor is significantly increased compared with model group; and presenting good dose-effect relationship, the above results confirms that silent board indigo plant difficult to understand is supported sheet and had significant protective effect to causing hepar damnification because of DBP.Meanwhile, high dose group hepatic tissue SOD vigor there was no significant difference compared with negative control group, confirms that the silent board indigo plant of high dose Austria is supported sheet and can be had good therapeutical effect to the damage of the rat liver tissue that DBP causes.
DBP can significantly improve hepatic tissue MDA level; low dose group, middle dosage group, the remarkable reduction compared with model group of high dose group hepatic tissue MDA level; and presenting good dose-effect relationship, the above results confirms that silent board indigo plant difficult to understand is supported sheet and had significant protective effect to causing hepar damnification because of DBP.Meanwhile, high dose group hepatic tissue MDA level there was no significant difference compared with negative control group, confirms that the silent board indigo plant of high dose Austria is supported sheet and can be had good therapeutical effect to the damage of the rat testis that DBP causes.
Embodiment 9: Pharmaceutical composition to rat kidney because dibutyl phthalate (Di-n-butylphthalate, DBP) causes protective effect and the dose-effect relationship thereof of damage
Testing index: serum creatinine (Cr), blood urea nitrogen (BUN).
Laboratory animal: SD rat, 200-220g, male.Rat grouping and experimental program carry out according to table 13.
Tissue samples:
Rat tail point gets blood, to add after anticoagulant heparin 1000 turn 4
oc gets supernatant in centrifugal 20 minutes, utilizes automatic clinical chemistry analyzer to measure serum creatinine (Cr) and blood urea nitrogen (BUN) level.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 14.
Experimental data represents with average ± standard deviation, with homogeneity test of variance, one factor analysis of variance.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Result shows:
DBP can significantly improve renal tissue creatinine level; in low dose group, middle dosage group, high dose group three dosage groups, serum creatinine level all significantly reduces compared with model group; and presenting certain dose-effect relationship, the above results confirms that Pharmaceutical composition has significant protective effect to causing kidney injury because of DBP.Meanwhile, middle dosage group, high dose group serum creatinine level there was no significant difference compared with negative control group, confirm that the damage of the rat kidney tissue that Pharmaceutical composition can cause DBP has good therapeutical effect.
DBP can significantly improve renal tissue urea nitrogen levels; in low dose group, middle dosage group, high dose group three dosage groups, serum urea nitrogen level all significantly reduces compared with model group; and presenting certain dose-effect relationship, the above results confirms that Pharmaceutical composition has significant protective effect to causing kidney injury because of DBP.Meanwhile, middle dosage group, high dose group serum urea nitrogen level there was no significant difference compared with negative control group, confirm that the damage of the rat kidney tissue that Pharmaceutical composition can cause DBP has good therapeutical effect.
Embodiment 10: Pharmaceutical composition is to the therapeutical effect of the cerebral tissue damage that DEHP causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 15.
Testing index: serum follicule-stimulating hormone (FSH) (FSH), lutropin (LH) level.
Above-mentioned three groups were all carried out hormonal readiness determination experiment at the 12 week:
Rat tail point gets blood, adds anticoagulant heparin, 4
oc, 3000 revs/min get supernatant after centrifugal 15 minutes, utilize radioimmunoassay kits to measure FSH and LH concentration.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 16.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Discussion of results:
Give rat DEHP rear drug withdrawal in six weeks six weeks continuously, model group serum follicule-stimulating hormone (FSH) level still significantly improves compared with negative control group, prompting DEHP has obvious damaging action to brain, inactive DEHP gives board difficult to understand silent indigo plant and supports sheet after six weeks, test group serum follicule-stimulating hormone (FSH) level reduce and with negative control there was no significant difference.Above results demonstrate that silent board indigo plant difficult to understand is supported sheet and had significant therapeutic effect to the cerebral lesion tool caused because of DEHP.
Give rat DEHP rear drug withdrawal in six weeks six weeks continuously, model group serum the level of luteinizing hormone still significantly reduces compared with negative control group, prompting DEHP has obvious damaging action to brain, inactive DEHP gives board difficult to understand silent indigo plant and supports sheet after six weeks, test group serum the level of luteinizing hormone reduce and with negative control there was no significant difference.Above results demonstrate that silent board indigo plant difficult to understand is supported sheet and had significant therapeutic effect to the cerebral lesion tool caused because of DEHP.
Embodiment 11: silent board indigo plant difficult to understand supports sheet to the therapeutical effect of the injury of testis that DBP causes
Rat: SD male rat, 200-220g.Rat grouping and experimental program carry out according to table 17.
Testing index: serum testosterone (T) level:
Above-mentioned three groups were all carried out hormonal readiness determination experiment at the 12 week:
Rat tail point gets blood, adds anticoagulant heparin, 4
oc, 3000 revs/min get supernatant after centrifugal 15 minutes, supernatant utilizes radioimmunoassay kits to measure serum testosterone (T) concentration.Experimental data represents with average ± standard deviation, and with homogeneity test of variance, one factor analysis of variance, result is see table 18.
*: compare with negative control group,
p<0.05.△: compare with test group,
p<0.05.
Discussion of results:
Give rat DBP rear drug withdrawal in six weeks six weeks continuously, model group level of serum testosterone still significantly reduces compared with negative control group, prompting DBP has obvious damaging action to testis tissue, inactive DBP gives board difficult to understand silent indigo plant and supports sheet after six weeks, test group level of serum testosterone improve and with negative control group there was no significant difference.The above results describes the foster sheet of silent board indigo plant difficult to understand and has significant therapeutic effect to the injury of testis tool caused because of DBP.
Claims (1)
1. a compositions causes the purposes in the medicine of histologic lesion at preparation control plasticiser, described compositions is that silent board indigo plant difficult to understand supports sheet, primary raw material: citrulline, dlornithine hydrochloride, Radix Ginseng extract, Folium Ginkgo extract, Fructus Jujubae powder, hydroxypropyl cellulose, micropowder silica gel, Glyceryl Behenate, magnesium stearate, titanium dioxide, Pulvis Talci, Brilliant blue aluminum lake, Macrogol 4000, the every 100g of main component contains: citrulline 43.07g, dlornithine hydrochloride 20.27g, it is characterized in that, described plasticiser is phthalic acid two (2-ethylhexyl) ester, diisononyl phthalate, dibutyl phthalate, BBP(Butyl Benzyl Phthalate, diisooctyl phthalate, dinoctyl phthalate, diisooctyl phthalate, diethyl phthalate, one in diisobutyl phthalate or the just own ester of phthalic acid two, described tissue refers to the one in animal kidney or testis organ-tissue.
Priority Applications (1)
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| CN1451426A (en) * | 2003-05-18 | 2003-10-29 | 漆又毛 | Medicinal composition and use thereof |
| EP1210096B1 (en) * | 2000-07-14 | 2004-08-11 | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | Health food useful for preventing liver dysfunctions containing an alkanoyl l-carnitine and silybum marianum extract and its use |
| CN1583036A (en) * | 2004-06-03 | 2005-02-23 | 昆明香格喜玛生物技术有限责任公司 | Composite panaxadiol and saponin with physiologic activity and its use and preparation |
| CN101721598A (en) * | 2008-10-22 | 2010-06-09 | 维康力(国际)有限公司 | Traditional Chinese medicine composition for treating liver diseases and preparation method and use thereof |
| CN102058694A (en) * | 2010-12-24 | 2011-05-18 | 漆又毛 | Application of pharmaceutical composition consisting of amino acids and extracts |
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| EP1210096B1 (en) * | 2000-07-14 | 2004-08-11 | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | Health food useful for preventing liver dysfunctions containing an alkanoyl l-carnitine and silybum marianum extract and its use |
| CN1451426A (en) * | 2003-05-18 | 2003-10-29 | 漆又毛 | Medicinal composition and use thereof |
| CN1583036A (en) * | 2004-06-03 | 2005-02-23 | 昆明香格喜玛生物技术有限责任公司 | Composite panaxadiol and saponin with physiologic activity and its use and preparation |
| CN101721598A (en) * | 2008-10-22 | 2010-06-09 | 维康力(国际)有限公司 | Traditional Chinese medicine composition for treating liver diseases and preparation method and use thereof |
| CN102058694A (en) * | 2010-12-24 | 2011-05-18 | 漆又毛 | Application of pharmaceutical composition consisting of amino acids and extracts |
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