CN109432082A - A kind of pharmaceutical composition preventing and treating chemical damage - Google Patents
A kind of pharmaceutical composition preventing and treating chemical damage Download PDFInfo
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- CN109432082A CN109432082A CN201811504184.XA CN201811504184A CN109432082A CN 109432082 A CN109432082 A CN 109432082A CN 201811504184 A CN201811504184 A CN 201811504184A CN 109432082 A CN109432082 A CN 109432082A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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Abstract
The present invention relates to a kind of pharmaceutical compositions for preventing and treating chemical damage, the pharmaceutical composition is made of effective component and medically acceptable auxiliary material, it is characterized in that, the effective component is made of the chemical component of following weight percent: Tricin 70%-80%, galuteolin 20%-30%；Wherein, shown in the chemical structure of the Tricin such as following formula (I), shown in the chemical structure of the galuteolin such as following formula (II).Pharmaceutical composition of the present invention can be substantially reduced the transaminase of chemical liver injury rat, increase the content of superoxide dismutase and glutathione in rat blood serum, inhibit the reduction of inflammatory factor in liver, prevent and treat the significant effect of chemical damage.
Description
Technical field
The present invention relates to the field of Chinese medicines, and in particular to the drug containing flavonoid glycoside compound.
Background technique
Chemical damage is the hepatic injury as caused by chemically Hepatoxic substance.These chemical substances include alcohol,
Chemical toxic substances and some drugs in environment.As important removing toxic substances organ --- the liver of human body, there is arteria hepatica and liver
Vein double blood supply.
Chemical substance can enter liver by gastrointestinal tract portal vein or body circulation and be converted, therefore liver easyization
Learn the toxicant damage in object.There are some pairs of virose substances of liver in the Nature and human industry's production process,
Referred to as " hepatotropic poison ", these poisonous substances are universal susceptible in crowd, and incubation period is short, the process of lesion and the direct phase of the dosage of infection
It closes, necrosis of liver cells, fat deformation, cirrhosis and the liver cancer that liver can be caused different degrees of.
The drug for the treatment of chemical damage is mainly Western medicine at present, such as: 1) 10% glucose of intravenous drip, vitamin C
Deng 1 gram of 12 unit of regular insulin, potassium chloride can be added in every 10% glucose 1000ml；2) take dexamethasone 20~
40mg/ days, curative effect and reaction are observed after medication, adjusts dosage in time, to pay special attention to protect gastric mucosa, prevent upper digestive tract from going out
Blood；3) lactulose, neomycin, flagyl (metronidazole) or ampicillin etc. are taken orally, to inhibit intestinal bacterium to grow, is made thin
Bacterium decomposition of protein is reduced, to reduce the generation of ammonia；4) fresh plasma or human albumin are given, to correct Hypoproteinemia；
5) intravenous drip branched-chain amino acid, to reverse blood plasma branch/ArAA ratio；6) levodopa is applied, removes, replace liver
The false neurotransmitter of comatose patient intracerebral, promotes patient awoke.
Compared to Western medicine, the Chinese medicine advantage small with toxic side effect.Publication No. CN 101502627A application for a patent for invention
Disclose it is a kind of prevent and treat alcoholic liver disease traditional Chinese medicine health care product preparation, said preparation by flower of kudzuvine, hoveniae semoveniae semen, pueraria lobata, fructus amomi, dark plum,
Jujube and Radix Glycyrrhizae are made, and can effectively preventing ethyl alcohol from causing, liver GSH exhausts and MDA is increased, and mitigate hepatic cell fattydegeneration.But
It is that above-mentioned Chinese medicine health-care preparation flavour of a drug are more, complex chemical composition is difficult to control product quality.
Hit Cherub is composite family Dendranthema west szechwan pyrethrum Pyrethrum tatsienense (Bur.et Franch.)
The drying inflorescence of Ling, main product are Tibetan's common medicines in China Qinghai, Sichuan, Yunnan and Tibet and other places, have promoting blood circulation to remove blood stasis,
The effect of dispelling wind and eliminating dampness, anti-inflammatory analgetic, is clinically usually used in treating headache, head wound, injury from falling down, damp and hot, sore, wound stream Huang
Water, impetigo, hepatitis etc..Scholar Xia Yuying etc. isolates Tricin, luteolin -7-O- β-D-Glucose glycosides etc. from Hit Cherub
18 flavone compounds, and predict that 18 flavone compounds have using point-target spot-disease network analysis is studied
(its beauty of Xia Yuying, Zhu Chen Gall, Lin Chaozhan, He Yingying, Kang Sa Soinam, Bei Ze benevolence are based on the pharmacological activity of liver protection up to a watt
UPLC-Triple TOF MS/MS and network pharmacology technology analysis Hit Cherub total flavone part liver-protecting activity ingredient and its potential
Target spot studies [J] Chinese medicine, in the July, 2018 the 7th phase of volume 41: 1610-1615).But it will be from above-mentioned numerous flavonoids
Filtering out several compounds with synergy in compound to be used as medicine is still the technical problem for needing to solve.
Summary of the invention
Technical problem to be solved by the invention is to provide a kind of pharmaceutical composition for preventing and treating chemical damage, the drugs
The significant effect of composition for preventing and controlling chemical damage.
Technical proposal that the invention solves the above-mentioned problems is as follows:
A kind of pharmaceutical composition preventing and treating chemical damage, the pharmaceutical composition is by effective component and medically acceptable
Auxiliary material composition, which is characterized in that the effective component is made of the chemical component of following weight percent: Tricin
70%-80%, galuteolin 20%-30%；Wherein, shown in the chemical structure of the Tricin such as following formula (I), the reseda
Shown in the chemical structure of glycosides such as following formula (II):
Aforementioned pharmaceutical compositions, wherein the best weight ratio of the chemical component is Tricin 75%, galuteolin
25%.
The dosage form of aforementioned pharmaceutical compositions can be tablet, granule, capsule, pill or dripping pill.
Pharmaceutical composition of the present invention has anti-inflammatory and inhibits the double target activity of oxidative stress, on the one hand significantly inhibits TNF-
The anti-inflammatory effect of the overexpression of the inflammatory factors such as α, IL-1 β；On the other hand also have and adjust vivo oxidation stress level, pass through tune
IIth phase detoxication enzyme of control and antioxidase gene expression adjust liver metabolism, removing toxic substances and promote liver cell regeneration, keeps liver function
It can stablize and prevent the occurrence and development of liver diseases.Especially, the effective component clover of pharmaceutical composition of the present invention is formed
Element has synergistic function with galuteolin, prevents and treats the significant effect of chemical damage.
Prove that technology possessed by Chinese medicine composition Tricin and galuteolin of the present invention is imitated below by experiment
Fruit.
Pharmacodynamics and its Mechanism Study of the pharmaceutical composition to rat oxidative stress hepatic injury
SPF grades male SD rat (200~220g) totally 60, it is randomly divided into 6 groups: 1. normal group；2. model control group；③
Positive drug control group: bifendate group (50mg/kg)；4. drug A group；5. drug B group；6. drug C group；7. control group 1；⑧
Control group 2.Wherein drug A group is the capsule of following embodiments 1, and drug B group is the tablet of following embodiments 2, and drug C group is
The soft capsule of following embodiments 3；The drug of control group 1 is prepared as follows: taking Tricin 75g by the method system for implementing 1
For at capsule；The drug of control group 2 is prepared as follows: galuteolin 25g being taken to be prepared into capsule by the method for implementing 1
Agent.
In in stainless steel metal cage, 5, every cage, room temperature is adjusted in (26 ± 2) DEG C, humid control each group rat sub-cage rearing
40%~70%, free diet and water is taken the photograph.(normal group is big by 1ml/100g gastric infusion 3d for each group rat from testing the first day
Mouse gavages the distilled water of same volume).Beginning modeling from 4th day, 20%CCl is injected intraperitoneally in each group rat except for the normal group4Greatly
Soybean oil solution 0.1ml/100g (0.2ml/100g for the first time), 2 times/week, continuous 6 weeks.Each group rat presses above-mentioned reality during modeling
Proved recipe method gastric infusion, continuous 6 weeks, after last dose (is deprived of food but not water 12h) for 24 hours, abdominal aortic blood dissected rat, point
Separate out thymus gland, spleen, liver.Wherein, the dosage of drug A group, drug B group, drug C group, control group 1 and control group 2 is pressed
The each kg rat of the poidometer of corresponding chemical ingredient (weight) is 40mg.Obtained experimental data SPSS17.0 software statistics
Processing is indicated with x ± s.
(1) to the influence of Rats Organs and Tissues coefficient
Rats Organs and Tissues coefficient be react each group rat body weight and liver, spleen, chest gland weight relationship index.The size of organ coefficient
Lesion and lesion degree whether can occur with indirect reaction lung tissue.The liver coefficient of model group rats is apparently higher than normally
Group, thymus gland coefficient are significantly lower than Normal group, show that model group liver increases, atrophy of thymus gland.Compared with model group, A Xiasai
Your the high, medium and low dosage group of prefecture general flavone, which has, inhibits liver increase and atrophy of thymus gland effect, and significant difference, and biphenyl is double
Ester group has no this effect.Mu lucerne element has no significant effect Spleen coefficient, the results are shown in Table 1.
1 Chinese medicine composition of table to each group Rats Organs and Tissues coefficient influence (N=8)
Note: compared with normal group,##P < 0.01,#P<0.05；Compared with model group**P < 0.01,*P<0.05；With control group 1
It compares⊿⊿P < 0.01,⊿P<0.05；Compared with control group 2★★P < 0.01,★P<0.05。
(2) to the influence of AST, ALT, MDA, SOD and GSH content in serum
AST and ALT is evaluation hepatic injury " Jin Zhibiao ", and when hepatic injury, AST and ALT content increases extremely in liver, is surveyed
The content of AST and ALT are determined, to react the degree of hepatic injury.This experiment is by the content of AST and ALT in measurement serum come preliminary
React the degree of hepatic injury.The experimental results showed that model group rats serum AST, ALT content be obviously higher than Normal group,
Illustrate that hepatic injury has been formed, model copy success.Drug A, B, C group can significantly reduce AST, ALT content caused by modeling
It is abnormal to increase, and certain dose-dependent relationship (P < 0.05) is presented in drug A, B, C group drug effect, illustrates the Chinese medicine composition energy
Mitigate the hepatic injury degree of rat model.
MDA is the index of body lipid peroxidation, SOD and GSH index has reacted antioxidant ability of organism, is detection body
Most common index that oxidative and anti-oxidative is unbalance.The experimental results showed that compared with normal rats, MDA content in model group serum
It is significantly higher than normal group control group；SOD and GSH content is substantially less than Normal group, shows oxidation resistance after rat modeling
Weaken, level of lipid peroxidation enhancing, each administration group can significantly improve the oxidation resistance and inhibition lipid of rat after modeling
Peroxidating.Concrete outcome is shown in Table 2,3.
2 Chinese medicine composition of table to each group rat blood serum AST, ALT content influence (N=10)
Note: compared with normal group,##P < 0.01,#P<0.05；Compared with model group**P < 0.01,*P<0.05；With control group 1
It compares⊿⊿P < 0.01,⊿P<0.05；Compared with control group 2★★P < 0.01,★P<0.05。
3 Chinese medicine composition of table to each group rat blood serum MDA, SOD and GSH content influence (N=10)
Note: compared with normal group,##P < 0.01,#P<0.05；Compared with model group**P < 0.01,*P<0.05；With control group 1
It compares⊿⊿P < 0.01,⊿P<0.05；Compared with control group 2★★P < 0.01,★P<0.05。
(3) to the content of inflammatory factor TNF-α and IL-1 β in liver homogenate
Chronic hepatitis is a slow and complicated process, and inflammatory factor TNF-α and IL-1 β are common for judging inflammation
Index, and research shows that the two inflammatory factors play a significant role in chronic hepatitis.This experiment passes through measurement liver group
It knits middle inflammatory factor TNF-α and IL-1 β content judges whether there is inflammation.The result shows that compared with normal group, model group liver group
The content for knitting middle TNF-α and IL-1 β more normally organizes significant raising (P < 0.01), and TNF-α degree is more significant.And pass through Chinese medicine group
After closing object treatment, TNF-α and the content of IL-1 β are remarkably decreased (P < 0.05) compared with model group in each administration group hepatic tissue, more approach
It in normal group, thus can deduce, the initial stage which may form from chronic hepatitis intervenes preferably, and concrete outcome is shown in
Table 4.
TNF-α and IL-1 β content in 4 each group liver tissues of rats of table (N=10)
Note: compared with normal group,##P < 0.01,#P<0.05；Compared with model group**P < 0.01,*P<0.05；With control group 1
It compares⊿⊿P < 0.01,⊿P<0.05；Compared with control group 2★★P < 0.01,★P<0.05。
(4) HE is dyed
Rat liver pathological section microscopic observation, the liver rope marshalling of normal rats, hepatic tissue structural integrity are accidental
Portal area inflammatory infiltration；Model group rats liver rope irregular arrangement, liver cell arrangement is loose, and nearby cell dissolution is bad for central vein
Extremely, nearby there is part inflammatory infiltration, large stretch of necrosis of liver cells in portal area, wherein being the most significantly liver cell fatty degeneration, table
Now to occur in cell cytoplasm differing in size, round, tensioned vacuole, nucleus is pushed to side.Drug A, B, C group and
The bifendate group substantially reduced Liver Damage in Rats degree of energy, illustrates Chinese medicine composition to CCl4Caused rat chronic hepatic injury has
Certain protective effect, wherein the protective effect of drug A group is than more significant.Meanwhile aforementioned four experiment the results show that the present invention
The pharmaceutical composition of the prevention and treatment chemical damage has synergistic function.Representative pathology figure and hepatic tissue pathology degree
Standards of grading are shown in Fig. 1 (A-H).
" chronic hepatitis course inflammatory activity degree and the degree of fibrosis scoring scheme " proposed according to Wang Tai age is to sample hepatic tissue
Course inflammatory activity degree pathology is judged, the results are shown in Table 5.Principle of scoring is as follows:
Formula of score: P+L+2 (PN+BN)
5 each group Liver Damage in Rats of table score score value
(5) related target protein blot experiment result in Nrf2-ARE signal path in hepatic tissue
The total protein expression of Nrf2 in liver tissues of rats: compared with normal group, Nrf2 in model group rats hepatic tissue
The expression of albumen significantly increases (P < 0.05)；Compared with model group, the expression of the Nrf2 albumen in liver tissues of rats is administered
Level also significantly increases (P < 0.05), sees Fig. 3 A.The total protein expression of Keap1: compared with normal group, model group hepatic tissue
Middle Keap1 is without significant difference；Compared with model group, in administration group liver tissues of rats the expression of Keap1 albumen significantly rise (P <
0.05).The total protein expression of Bach1: compared with normal group, the expression of Bach1 albumen is aobvious in model group hepatic tissue
Work increases, (P < 0.05)；Compared with model group, in administration group liver tissues of rats the expression of Bach1 albumen significantly increase (P <
0.05), see Fig. 2A.
The expression of HO-1, NQO1, GCLC in liver tissues of rats: compared with normal group, HO-1 in model group hepatic tissue,
The expression of NQO1, GCLC albumen obviously increases, and difference is statistically significant (P < 0.01 or P < 0.05)；With model group ratio
Compared with, the expression of HO-1, NQO1, GCLC albumen increased significantly in medicine group hepatic tissue, difference it is statistically significant (P <
0.05), see Fig. 2 B.
(6) Nrf2 nuclear factor protein expression result in endochylema and karyon
Compared with normal group, Nrf2 expresses conspicuousness increase in karyon after rat modeling, and the expression of Keap1 albumen is significant
Property reduce；And Nrf2 protein expression significantly reduces in endochylema, the no significant difference of the expression of Keap1 albumen.With model group
It compares, PTTF can dramatically increase the expression of Nrf2 albumen in karyon, significantly reduce the expression of Keap1 albumen；And it is shown in endochylema
The expression for reducing Nrf2 albumen is write, the no significant difference of the expression of Keap1 albumen is shown in Fig. 3.
(7) RT-PCR is tested
The expression of Nrf2, Keap1, Bach1, HO-1, NQO1, GCLC mRNA in liver tissues of rats: compared with normal group,
Nrf2 in model group hepatic tissue, Bach1, HO-1, NQO1, GCLC mRNA expression obviously increase, difference has statistics
Meaning (P < 0.01), and Keap1 mRNA expresses no significant difference；Compared with model group, Nrf2 in medicine group hepatic tissue,
Keap1, Bach1, HO-1, NQO1, GCLC mRNA expression increased significantly, difference is statistically significant (P < 0.01),
See Fig. 4.
Detailed description of the invention
Fig. 1 is that each group liver tissues of rats HE dyes displaing micro picture (× 100).
Fig. 2 is Chinese medicine composition to related target protein blot experiment result in Nrf2-ARE signal path in hepatic tissue.
Fig. 3 is Chinese medicine composition on the Nrf2 nuclear factor effect picture that protein expression influences in endochylema and karyon.
Fig. 4 is table of the Chinese medicine composition to Nrf2, Keap1, Bach1, HO-1, NQO1, GCLC mRNA in liver tissues of rats
Up to the effect picture of influence.
Specific embodiment
Example 1
1, the prescription of effective component: Tricin 75g, galuteolin 25g.
2, preparation method:
Tricin and galuteolin are taken, excipients HPMC is distinguished according to equivalent gradually-increased and superfine silica gel powder presses 1:7.5:2.5
Ratio be uniformly mixed, cross No. 6 sieves particle is made, at a temperature of 60 DEG C dry 3 hours.Take 1#Empty capsulae enterosolubilis, is filled respectively
The above dry particle, every 1 capsule 0.2g apply one layer of mucialga of arabic gummy at Nang Kou, and sleeve capsule wipes glue with dry gauze
After capsule, loaded in closed brown bottle to get.The dosage of said preparation is twice daily, 2 tablets each time, to take orally.
Example 2
1, the prescription of effective component: Tricin 80g, galuteolin 20g.
2, preparation method:
Tricin and galuteolin are taken, it is equal that starch 60g, dextrin 20g, sucrose 15g and the mixing of suitable 65% ethyl alcohol is added
After even, granulation is dried to obtain particle, and superfine silica gel powder 1.0g is added after whole grain of being sieved and is uniformly mixed, is pressed into conventional tablet.It should
The dosage of preparation is twice daily that 2 tablets once, is taken orally.
Example 3
1, the prescription of effective component: Tricin 70g, galuteolin 30g.
2, preparation method:
Tricin and galuteolin are taken, soybean oil 40g mixing is added, 10.0g beeswax and 0.6g Tween-80 is added, then use
Rotary Zhanang machine is pressed into 300 soft capsules (0.2g/).The dosage of said preparation is twice daily, 4 tablets each time, to take orally.
Example 4
1, the prescription of effective component: Tricin 80g, galuteolin 20g.
2, preparation method:
It takes Tricin and galuteolin, PVP 50g, CMC-Na 40g, L-HPC 15g, CMS-Na 10g and appropriate is added
65% ethyl alcohol prepare softwood, cross sieve, 60 DEG C are dried to obtain particle, after whole grain of being sieved, are packaged into using packaging facilities
Granule, every bag of 5g.The dosage of said preparation is 1 bag every time twice daily, warm boiled water.
Example 5
1, the prescription of effective component: Tricin 75g, galuteolin 25g.
2, preparation method:
Take Tricin and galuteolin, be added honey 50g, rice paste 40g, batter 40g and appropriate 65% ethyl alcohol prepare it is soft
Material is then pressed into 0.1g/ pills.The dosage of said preparation is that twice daily, 6 ball, takes orally every time.
Example 6
1, the prescription of effective component: Tricin 70g, galuteolin 30g.
2, preparation method:
Tricin and galuteolin are taken, gelatin 150g, polyethylene glycol 3g is added, 0.05g/ dripping pills are made.Said preparation
Dosage be that twice daily, 20 ball every time takes orally.
Example 7
1, the prescription of effective component: Tricin 80g, galuteolin 20g.
2, preparation method:
Tricin and galuteolin are taken, gelatin 40g, Arabic gum 45g, sodium carboxymethylcellulose 8g is added, is made
0.06g/ micro-capsules.The dosage of said preparation is twice daily, 20 tablets each time, to take orally.
Claims (3)
1. a kind of pharmaceutical composition for preventing and treating chemical damage, the pharmaceutical composition is by effective component and medically acceptable
Auxiliary material composition, which is characterized in that the effective component is made of the chemical component of following weight percent: Tricin 70%-
80%, galuteolin 20%-30%；Wherein, shown in the chemical structure of the Tricin such as following formula (I), the galuteolin
Shown in chemical structure such as following formula (II):
2. a kind of pharmaceutical composition for preventing and treating chemical damage according to claim 1, which is characterized in that described has
Effect ingredient is made of the chemical component of following weight percent: Tricin 75%, galuteolin 25%.
3. a kind of pharmaceutical composition for preventing and treating chemical damage according to claim 1 or 2, which is characterized in that described
The dosage form of pharmaceutical composition is tablet, granule, capsule, pill or dripping pill.
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| CN107397740A (en) * | 2017-07-17 | 2017-11-28 | 华南理工大学 | A kind of antitumor polyphenol compositions of Synergistic and application |
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| CN107397740A (en) * | 2017-07-17 | 2017-11-28 | 华南理工大学 | A kind of antitumor polyphenol compositions of Synergistic and application |
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| Title |
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| 夏玉英等: "基于UPLC-Triple TOF MS/MS和网络药理学技术分析打箭菊总黄酮部位保肝活性成分及其潜在靶点研究", 《中药材》 * |
| 贺兰芝: "木犀草素对对乙酰氨基酚诱导的L02肝细胞损伤的保护作用", 《中国中药杂志》 * |
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