CN109453249A - The pharmaceutical composition of protective agents hepatic injury and the preparation method of different dosage forms - Google Patents
The pharmaceutical composition of protective agents hepatic injury and the preparation method of different dosage forms Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- 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, decoction
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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
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention discloses a kind of pharmaceutical composition of protective agents hepatic injury and the preparation method of different dosage forms, which, for effective medicinal ingredient, is collectively constituted with Rosa roxburghii Tratt, Schisandra chinensis with acceptable auxiliary adding ingredient in drug；It is calculated in effective medicinal ingredient with the raw materials used dry weight of Rosa roxburghii Tratt and Schisandra chinensis, the mass ratio of the two is 1:0.1-10.By preparing powder or ethanol extract, effective component Rosa roxburghii Tratt is mixed in proportion with Schisandra chinensis, a variety of different dosage forms such as tablet, capsule, powder can be prepared.The pharmaceutical composition has significant preventive and therapeutic effect to drug induced hepatic injury especially alcoholic hepatic injury, while can also significantly fight the side effect that Schisandra chinensis increases liver index.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of protective agents hepatic injury and the preparation methods of different dosage forms, more specifically
Ground, enhancing hepatoprotective effect is used in combination by Rosa roxburghii Tratt and Schisandra chinensis in pharmaceutical composition of the invention, while significantly fighting the five tastes
Son increases the side effect of liver index.
Background technique
Drug induced hepatic injury (DILI) refer to by all kinds of chemicals, bio-pharmaceutical, Chinese herbal medicine and its preparation, health care product,
Dietary supplements and its metabolite etc. induce hepatocellular injury necrosis, liver enzyme exception and the disease for causing related clinical manifestations.
Clinical symptoms with jaundice, detest based on the symptoms of digestive tract such as oil, nausea, some patientss can have the allergic reactions such as fever, fash；It is biochemical
The change of index is based on transaminase and bilirubin level raising.Its mechanism of action is complicated, various, has no a kind of drug pair at present
All drug induced hepatic injuries have preventive and therapeutic effect.Wherein the most noticeable is alcoholic liver injury.
Alcoholic liver disease (alcoholic liver disease) refers to liver disease caused by long-term excessively intake ethyl alcohol
Disease, disease initial stage normally behave as alcoholic fatty liver, can then develop as alcoholic hepatitis, alcoholic fibrosis and alcohol
Property cirrhosis, may cause extensive necrosis of liver cells in severe alcoholism, induce liver failure.Alcoholic liver damage
Eventually leading to cirrhosis needs longer process, and clinician need to take positive prevention and treatment to arrange in the patients with alcoholic liver disease reversible stage
It applies, to reduce the generation of cirrhosis, development.
Alcoholic cirrhosis composition ratio in the cirrhosis cause of disease constantly rises.The northern area of China liver is hard within 2002 to 2010 years
Change patient's Pathogenesis and analysis of trend shows that alcoholic cirrhosis rises to 7.7% by 3%.It is sent out in North America, Europe etc.
Up to area, alcoholic liver disease is the primary cause of disease of cirrhosis.In world wides in 2010, alcoholic liver disease death toll is about
493 300 people, because alcohol causes disease number to be about 1 450000 people, alcoholic cirrhosis is accounted in cirrhosis Died Patients
47.9%.South Korea investigates 2000 to 2010 years during the decade shows to occur in alcoholic liver disease cirrhosis ratio by 6.3%
Rise to 78.1%.In the U.S., cirrhosis in 2002 is located at human mortality's reason the 12nd, and the death rate is from 1973 with incoming wave
It moves in same level, about 27794 people of annual death toll.Wherein be more than 43.6% the cirrhosis cause of death it is related to alcohol,
60.2% is accounted in more young cirrhotic population (35~45 years old).Only 2009, U.S.'s cirrhosis death toll was up to 31
522 people, wherein 48.2% is related with alcohol, while because the social economy of nearly 223.5 hundred million dollar/year caused by alcoholic liver disease is negative
Load.
The mechanism that alcohol leads to hepatic lesion mainly has the following aspects.Ethyl alcohol and metabolite toxic effect: it grinds in early days
Study carefully discovery, during oxidation of ethanol generates acetaldehyde, liver NADH/NAD ratio is increased, and NADH can promote the synthesis of fatty acid, suppression
Fatty acid oxidation processed leads to hepatic steatosis.The generation of oxygen radical increases simultaneously, and polyphenoils consumption increases induced oxidation
Stress generation, influence cellular respiration function and ATP and generate, cause necrosis of liver cells or apoptosis.NADH can be with active oxygen
(reactive oxygen species, ROS) effect causes tandem type inflammatory reaction, discharges more inflammatory factor damage livers
Cell.Recent studies have found that the relevant transcription factor of fat metabolism is adjusted in ethyl alcohol, the activation of these transcription factors can promote
The synthesis and inhibition lipolysis of fat.In addition, acetaldehyde can generate acetaldehyde protein adduct with body multiple protein covalent bond
(acetaldehyde-protein adduct, APA) and DNA adduct, influence protein function, and enzyme inactivation, DNA is caused to be repaired
The damage liver cells such as recoverin dysfunction, lipid peroxidation and mitochondria destruction.Acetaldehyde protein adduct is predominantly located at center
Around vein, the position hepatocellular damage is obvious in addition, further stimulates collage synthesis, leads to the hair of alcoholic fibrosis
It is raw.In addition, alcoholic liver injury is also with endotoxin, nutritional ingredient be abnormal etc., factors are closely related.
Currently, particularly effective control method is had no for alcoholic liver injury, although abstinence from alcohol is best prevention and treatment alcohol
The method of property hepatic injury, but since the increase of social pressures, popularity of wine and ratio are also increasing year by year: in recent years, China
Alcohol output and consumption be in raising trend.Have survey data to show: China's liquor production in 1984 is 711.3 ten thousand tons, is arrived
2001 annual outputs rise to 3 069.87 ten thousand tons, increase as many as 4 times within nearly 20 years.From the 1980s to the nineties, generally
Wine-head's ratio rises to 14.3% from 0.21% in crowd.China drug in some provinces epidemiological investigation is shown at the beginning of 21 century
The crowd of drinking rises to 26.98%~43.4%.
Rosa roxburghii Tratt (Rosa roxburghii Tratt) also known as send the spring to return, Wen Xianguo, rosa roxburghii, belong to rosaceae Rosa
Perennial fallen leaves bush, is mainly grown on the ground such as China Guizhou, Sichuan, Yunnan.
Rosa roxburghii Tratt edible value with higher and medical value, modern research shows that the dimension life rich in of Rosa roxburghii Tratt fresh fruit
The substances such as element, polyphenol, flavones, organic acid, polysaccharide, amino acid and microelement.The Flavonoid substances highest contained in Rosa roxburghii Tratt
Up to 0.8%, aglycon is respectively myricetin, Quercetin, mountain naphthalene element；Its triterpene compound is mainly Euscaphicoside, five rings three
Terpene ester glycosides, Euscaphic acid, tormentic acid, roxburic acid, Euscaphicoside, Rosamultin etc..The organic acid that Rosa roxburghii Tratt contains is main
For malic acid, lactic acid, tartaric acid, citric acid, oxalic acid and succinic acid；Also containing linoleic acid, linolenic acid, oleic acid, palmitinic acid and hard
Resin acid；It also contains superoxide dismutase (SOD) and 18 kinds of amino acid, and wherein SOD mainly exists in the form of Mn-SOD.
Modern pharmacological studies have shown that Rosa roxburghii Tratt, which has, adjusts the work such as body's immunity, anti-aging, anti-oxidant and liver protection
With.
Schisandra chinensis is the drying and ripening of magnoliaceae schisandra Schisandra chinensis (Turcz.) Baill.
Fruit is practised and claims " fructus schisandrae "；For conventional Chinese medicine, applicating history is long, first recorded in Shennong's Herbal；It is top grade Chinese medicine, taste
Acid, warm-natured, return lung, the heart, kidney channel；With astringency inducing, supplementing qi and promoting the production of body fluid, tonifying kidney and calming nerves and other effects；Chronic cough and dyspnea of deficiency type is cured mainly, nocturnal emission is sliding
Essence, frequent urination and enuresis, endless diarrhea, spontaneous sweating, injury thirst, palpitation and insomnia.Mainly contain Lignanoids compounds in Schisandra chinensis,
2%~8% is accounted for, also containing Multiple components such as volatile oil, polysaccharide, organic acid, fatty acid, protein.Schisandra chinensis is called
Kadsura longepedunculata, quality are slightly more secondary than fructus schisandrae.
Modern pharmacological studies have shown that Schisandra chinensis and its active principle have preferable anti-oxidant, antifatigue, removing toxic substances, liver protection,
Calmness, hypnosis, the cardiovascular effect of protection.
Although Rosa roxburghii Tratt has hepatoprotective effect, curative effect is weaker；Although the hepatoprotective effect of Schisandra chinensis is better than Rosa roxburghii Tratt, has and draw
Play the side effect that liver organization significantly increases.
Summary of the invention
A kind of hepatoprotective effect is strong and the drug of the side effect that does not cause liver organization to increase in order to obtain, after study, this
Invention provides a kind of pharmaceutical composition of protective agents hepatic injury and the preparation method of different dosage forms.
The specific technical solution of the pharmaceutical composition of protective agents hepatic injury is as follows:
A kind of pharmaceutical composition of protective agents hepatic injury, with Rosa roxburghii Tratt, Schisandra chinensis for effective medicinal ingredient, in drug
Acceptable auxiliary adding ingredient collectively constitutes；The dry weight raw materials used with Rosa roxburghii Tratt and Schisandra chinensis in effective medicinal ingredient
It is calculated, the mass ratio of the two is 1:0.1-10.
The effective component of Schisandra chinensis can be obtained using various ways, for example can be directly used as medicine using Chinese Magnolivine Fruit,
Or it extracts Schisandra chinensis using water, ethanol water or the ethyl alcohol that volume fraction of ethanol is 0-100% and obtains Schisandra chinensis and mention
Object is taken, Schisandra chinens P.E is used as medicine.
Schisandra chinensis in effective medicinal ingredient is Schisandra chinensis or kadsura longepedunculata.Schisandra chinensis typically refers to Chinese Magnoliavine
Son, for quality than kadsura longepedunculata with good, effective component is more.
The effective component of Rosa roxburghii Tratt can also be obtained using various ways, such as:
Mode one: the Rosa roxburghii Tratt in effective medicinal ingredient is the water utilized volume fraction of ethanol for 0-100%, ethanol water
The extract that solution or ethyl alcohol extract.
Mode two: the Rosa roxburghii Tratt in effective medicinal ingredient is the Rosa roxburghii Tratt powder that will be obtained after Rosa roxburghii Tratt drying and crushing.
Mode three: the Rosa roxburghii Tratt in effective medicinal ingredient is used as medicine at juice or Rosa roxburghi Juice is through dense with the squeezing of fresh Rosa roxburghii Tratt
Contracting is used as medicine after being dried.
The above-mentioned pharmaceutical composition of the present invention according to the needs of use can be by current usual manner, by described drug effect
Drug ingedient is corresponding to acceptable in drug to assist adding ingredient, such as disintegrating agent, excipient, lubricant, adhesive, filling
Agent etc. is prepared into the available oral type drug including the common formulations such as tablet, dripping pill, capsule, pellet jointly
Preparation.
The present invention provides the preparation methods of the different pharmaceutical dosage form of the pharmaceutical composition of protective agents hepatic injury, specifically
Content is as follows:
The preparation method of the medicament composition capsule agent of protective agents hepatic injury, it is the following steps are included: by fresh thorn
Pears dry, pulverize spare；By Schisandra chinensis ethanol water refluxing extraction, recycles extracting solution removing ethyl alcohol and obtain Schisandra chinensis alcohol extracting
Take object；Rosa roxburghii Tratt powder is added in schisandrol extract, is mixed, be dry, pulverize, capsule is made；The Rosa roxburghii Tratt powder and
The dry weight ratio of Schisandra chinensis is 1:0.1-10.
In above-mentioned preparation method, it is preferred that the Rosa roxburghii Tratt powder and the dry weight ratio of Schisandra chinensis are greater than 1；It is described
Ethanol water is the ethanol water that volume fraction of ethanol is 70%.
The preparation method of the medicinal composition tablets of protective agents hepatic injury, it is the following steps are included: by fresh Rosa roxburghii Tratt
It dry, pulverize spare；Kadsura longepedunculata is first decocted with water primary, discards decocting liquid, dregs of a decoction crushed after being dried, then it is water-soluble with ethyl alcohol
Liquid refluxing extraction recycles extracting solution and removes ethyl alcohol, and aqueous solution is stood or centrifugation, divides and kadsura longepedunculata is taken to precipitate, and Ribes burejense powder is added
It in end, mixes, is dry, crushing, tablet is made；The Rosa roxburghii Tratt powder and the mass ratio of Schisandra chinensis are 1:0.1-10.
In above-mentioned preparation method, it is preferred that the Rosa roxburghii Tratt powder and the dry weight ratio of Schisandra chinensis are less than or equal to
1；The ethanol water is the ethanol water that volume fraction of ethanol is 70%.
70% ethyl alcohol can more extract the effective component in Rosa roxburghii Tratt or Schisandra chinensis.
This project group is the study found that the curative effect that the hepatic injury of Rosa roxburghii Tratt protective agents is used alone is weaker, it is difficult in ideal agent
It achieves the desired results under amount.Schisandra chinensis has preferable preventive and therapeutic effect to drug induced hepatic injury, but in its performance preventive and therapeutic effect
Liver organization can be caused to significantly increase simultaneously, this phenomenon is to so as to cause new adverse reaction.By by Schisandra chinensis and Rosa roxburghii Tratt
It is used in combination and not only can express significant hepatoprotective effect, can also significantly fight the side effect that Schisandra chinensis increases liver index, tool
There is good application value.
Compared with prior art, the present invention at least has the advantages that the present invention provides a kind of pair of Drug livers
Damage especially alcoholic hepatic injury has the pharmaceutical composition of significant preventive and therapeutic effect, while the pharmaceutical composition can significantly fight five
The side effect of taste increase liver index.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
One, the preparation embodiment of the different dosage forms of pharmaceutical composition
Embodiment 1
Dry weight by 10:1 is crushed, is sieved with 100 mesh sieve, dispense, be prepared into powder than taking dry Schisandra chinensis, Rosa roxburghii Tratt.
Embodiment 2
Dry Rosa roxburghii Tratt, Schisandra chinensis are taken by the dry weight ratio of 1:10, is crushed, 8 times of 70% ethyl alcohol of amount, soaked overnight, heating is added
Refluxing extraction 3 times, merging filtrate, recovered alcohol is concentrated, dry, the excipient such as appropriate dextrin is added, tabletting is prepared into 0.5g's
Tablet.
Embodiment 3
Dry Rosa roxburghii Tratt, Schisandra chinensis is taken to feed intake in the ratio of 10:5, Rosa roxburghii Tratt ground ingredients fine powder is spare.Schisandra chinensis is measured with 6 times
70% alcohol reflux extracts 3 times, and recycling removes solvent and obtains schisandrol extract, and above-mentioned Rosa roxburghii Tratt fine powder is added, and mixes, dry,
It crushes, capsule is made.
Embodiment 4
Dry Rosa roxburghii Tratt, kadsura longepedunculata is taken to feed intake in the ratio of 1:1, Rosa roxburghii Tratt ground ingredients fine powder is spare.Kadsura longepedunculata is first used
8 times of amount water decoct 1 time, discard decocting liquid, the dregs of a decoction are dry, crushing, then are extracted 2 times with 10 times of 70% alcohol refluxs of amount, recycling
Ethyl alcohol is eliminated, aqueous solution centrifugation divides and kadsura longepedunculata is taken to precipitate, above-mentioned Rosa roxburghii Tratt fine powder is added, mixes, dry, pulverize, piece is made
Agent.
Two, influence research of the drug of embodiment to liver injury model
1 test material
1.1 test medications
Bicyclol: national drug standard H20040467,25mg/ piece, lot number 090307 are produced by Beijing XieHe medicine Factory.Face
It is spare with the preceding suspension for being made into required concentration with 0.5CMC.
1.2 experimental animal
Kunming mouse, SPF grades, production quality certification number is SCXK (river 2018-19), by Sichuan Provincial Academy of Traditional Chinese Medicine
Experimental Animal Center provides.
1.3 test apparatus
Electronic balance: Shimadzu EB-3200, Japan produce.
2 methods and result
The influence of 2.1 pairs of alcoholic liver injury mouse
Taking weight is 18-22g male mice, random to be grouped, respectively gastric infusion, 1 time a day, continuous 7 days.In administration the
4 days, in addition to Normal group, remaining each group was according to 50% ethyl alcohol 0.1ml/10g of the equal stomach-filling of mouse weight, and continuous 4 times.In last
After administration for 24 hours and after being deprived of food but not water 16h, hematometry Serum ALT, AST are taken, animal is put to death and takes that liver claims weight in wet base and to calculate its dirty
Device index.It the results are shown in Table 1.
Influence (x ± s) of each embodiment of table 1 to alcoholic liver injury mouse
Compared with model group:*P<0.05,**P<0.01,***P<0.001.
Compared with five tastes subgroup:△P<0.05,△△P<0.01,△△△P<0.001.
As seen from Table 1, after continuously giving alcohol 4 days, serum transaminase and liver index dramatically increase mouse, with
Control group compares with statistical difference.Schisandra chinensis, which is used alone, can significantly reduce alcoholic liver mice serum glutamic-pyruvic transaminase, but
Its liver index can be dramatically increased, compared with model group, difference has statistical significance.Rosa roxburghii Tratt is used alone, and has reduction to turn ammonia
The trend of enzymatic activity, but effect is weaker, also has no significant effect to liver index, the no difference of science of statistics compared with model group.Work as thorn
When pears and Schisandra chinensis share, the transaminase of alcoholic liver mouse can be significantly reduced, the liver for reducing alcoholic liver injury mouse refers to
Number has statistical significance with model group comparing difference, and compared with independent five tastes subgroup, difference has statistical significance.Remaining
Each embodiment also has similar effect.
2.2 pairs of carbon tetrachloride cause acute liver protective effect
Taking weight is 18-22g male mice, random to be grouped, respectively gastric infusion, and twice daily, continuous 5 times, last is given
1 hour after medicine, CCl is injected intraperitoneally410uL/kg, and after being deprived of food but not water 16 hours, take hematometry Serum ALT, AST activity.Knot
See Table 2 for details for fruit.
Table 2 causes the influence (x ± s) of acute liver to carbon tetrachloride
Compared with model group:*P<0.05,**P<0.01,***P<0.001.
As seen from Table 2, carbon tetrachloride can cause mice serum transaminase activity significantly raised, there is system compared with the control group
Meter learns difference.Each embodiment can significantly reduce carbon tetrachloride mice serum transaminase, there is statistical difference compared with model group.
The above-described embodiments merely illustrate the principles and effects of the present invention, and is not intended to limit the present invention.It is any ripe
The personage for knowing this technology all without departing from the spirit and scope of the present invention, carries out modifications and changes to above-described embodiment.Cause
This, institute is complete without departing from the spirit and technical ideas disclosed in the present invention by those of ordinary skill in the art such as
At all equivalent modifications or change, should be covered by the claims of the present invention.
Claims (10)
1. a kind of pharmaceutical composition of protective agents hepatic injury, it is characterised in that with Rosa roxburghii Tratt, Schisandra chinensis for effective medicinal ingredient,
It is collectively constituted with acceptable auxiliary adding ingredient in drug；With original used in Rosa roxburghii Tratt and Schisandra chinensis in effective medicinal ingredient
The dry weight of material is calculated, and the mass ratio of the two is 1:0.1-10.
2. the pharmaceutical composition of protective agents hepatic injury according to claim 1, it is characterised in that described effectively medicinal
Schisandra chinensis in ingredient is extracted using water, ethanol water or the ethyl alcohol that volume fraction of ethanol is 0-100%
Schisandra chinens P.E.
3. the pharmaceutical composition of protective agents hepatic injury according to claim 1, it is characterised in that described effectively medicinal
Schisandra chinensis in ingredient is Schisandra chinensis or kadsura longepedunculata.
4. the pharmaceutical composition of protective agents hepatic injury according to claim 1, it is characterised in that described effectively medicinal
Rosa roxburghii Tratt in ingredient is mentioned using what water, ethanol water or the ethyl alcohol that volume fraction of ethanol is 0-100% extracted
Take object.
5. the pharmaceutical composition of protective agents hepatic injury according to claim 1, it is characterised in that described effectively medicinal
Rosa roxburghii Tratt in ingredient is the Rosa roxburghii Tratt powder that will be obtained after Rosa roxburghii Tratt drying and crushing.
6. the pharmaceutical composition of protective agents hepatic injury according to claim 1, it is characterised in that described effectively medicinal
Rosa roxburghii Tratt in ingredient be with fresh Rosa roxburghii Tratt squeezing at juice be used as medicine or Rosa roxburghi Juice it is concentrated, be dried after be used as medicine.
7. the preparation method of the medicament composition capsule agent of protective agents hepatic injury, it is characterised in that the following steps are included: will
Fresh Rosa roxburghii Tratt dry, pulverize spare；By Schisandra chinensis ethanol water refluxing extraction, recycles extracting solution removing ethyl alcohol and obtain the five tastes
Sub- alcohol extracting thing；Rosa roxburghii Tratt powder is added in schisandrol extract, is mixed, be dry, pulverize, capsule is made；The Rosa roxburghii Tratt
Powder and the dry weight of Schisandra chinensis ratio are 1:0.1-10.
8. the preparation method of the medicament composition capsule agent of protective agents hepatic injury according to claim 7, feature
It is that the dry weight ratio of the Rosa roxburghii Tratt powder and Schisandra chinensis is greater than 1；The ethanol water is that volume fraction of ethanol is
70% ethanol water.
9. the preparation method of the medicinal composition tablets of protective agents hepatic injury, it is characterised in that the following steps are included: by new
Fresh Rosa roxburghii Tratt dry, pulverize spare；Kadsura longepedunculata is first decocted once with water, discards decocting liquid, dregs of a decoction crushed after being dried, then use second
Alcohol solution refluxing extraction recycles extracting solution and removes ethyl alcohol, and aqueous solution is stood or centrifugation, divides and kadsura longepedunculata is taken to precipitate, and is added
It in Rosa roxburghii Tratt powder, mixes, is dry, crushing, tablet is made；The Rosa roxburghii Tratt powder and the mass ratio of Schisandra chinensis are 1:0.1-10.
10. the preparation method of the medicinal composition tablets of protective agents hepatic injury according to claim 9, feature exist
It is less than or equal to 1 in the Rosa roxburghii Tratt powder and the dry weight ratio of Schisandra chinensis；The ethanol water is volume fraction of ethanol
For 70% ethanol water.
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