CN109692283A - Chinese medicine composition, the drug comprising Chinese medicine composition and preparation method and application - Google Patents
Chinese medicine composition, the drug comprising Chinese medicine composition and preparation method and application Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/62—Nymphaeaceae (Water-lily family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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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
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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, decoction
Abstract
The present invention provides a kind of Chinese medicine composition, the drug comprising Chinese medicine composition and preparation method and application, are related to technical field of traditional Chinese medicines, and Chinese medicine composition provided by the invention is made of rhizoma atractylodis 1-20 parts by weight, lotus leaf 5-40 parts by weight and red yeast rice 1-15 parts by weight.The Chinese medicine composition with invigorating the spleen to dry, dissolving stasisization it is turbid based on, the drug of composition enters the warp of liver,spleen,kidney three, embody the dyslipidemia interpretation of the cause, onset and process of an illness this, liver and spleen is the same as controlling.In addition, the medicine source of the bulk pharmaceutical chemicals of Chinese medicine composition provided by the invention is extensive, cheap, and has no toxic side effect, reasonable recipe, has many advantages, such as good effect, quick, economical and practical, uneasy to recur and to human zero damage.The preparation method of Chinese medicine composition provided by the invention, using composition of the present invention as raw material, and using the physical method decocted to effective component extraction and application in composition, preparation method is easy, quick.
Description
Technical field
The present invention relates to technical field of traditional Chinese medicines, more particularly, to a kind of Chinese medicine composition, include the drug of Chinese medicine composition
And preparation method and application.
Background technique
Hyperlipidemia is a kind of common disease frequently-occurring disease, and atherosclerotic Cardial or cerebral vascular diseases, such as coronary heart disease, the heart
The disease relationships such as flesh infarct, cerebral apoplexy are close, can lead to function of vascular endothelium damage, increase oxidative stress and inflammatory reaction, promote
Into foam wanshing, it also can induce endothelial cell apoptosis or necrosis, accelerate the pathogenesis of atherosclerosis.Artery is athero-
Hardenability disease is the most common cardiovascular disease that is detrimental to health, and is also the main original of western developed country human mortality
Cause.Long-term intervention and control are carried out to blood lipid in level appropriate, and stablizes patch, are controlled vascular inflammation factor expression, are
Effective prevention of arterial atherosis, to reduce the basis of the generation of cardiocerebrovasculaevents events.Therefore, the regulation of blood lipid is control artery
The important link of atherosis.
The contemporary medical science treatment of hyperlipidemia is mainly based on drug therapy, and with dietary adjustments, locomotive regulation, feelings will is adjusted
Supplemented by.Drug in terms of western medical treatment uses mainly based on Statins, fibrates, cholic acid chelating agent, wherein according to its effect
Principle, in terms of clinical application, mostly to interfere and inhibit based on the drug of Regulating Lipid Metabolism, and such drug, because its is quick,
The features such as convenient to take are in clinically having been widely recognized and apply.But in contrast, clinically used western medicine class drug
There is certain toxic side effect and risks, such as liver and kidney dysfunction, rhabdomyolysis, digestive system adverse reaction, nerveous system
System lesion, urinary system adverse reaction, diabetes risk improves, musclar toxicity reacts risk etc..And Chinese medicine in terms of, it is preceding on the market
The lipid-loweringing Chinese patent drug of mainstream is mostly to change based on turbidity and treating arthralgia, and dialectical aspect, differentiation of symptoms and signs for classification of syndrome is inconsistent, if any syndrome differentiation of zang-fu viscera and qi and blood
The difference of differentiation of body fluid, and lack the patent medicine prescription with invigorating the spleen for main dialectical thinking.
Equally, the contemporary medical science treatment of atherosclerosis is also mainly based on drug therapy.Wherein, western medicine side
Face: statins treat that Atherosclerosis is significant, and toxic side effect also can not be ignored in clinical use, if with
CYP drug cooperation, then will increase the toxic side effect of statins.In the adverse reaction side for the treatment of hyperlipidemia
Face, relatively conventional has: muscle damage, hepatorenal damage；Next common are: disease in the urological system and the nervous system disease etc..
And in terms of Chinese medicine, mainly there are 5 classes according to effect: it is activating microcirculation and removing stasis medicinal, qi and activate blood circulation, removing both phlegm and blood stasis at the same time, nourishing liver and kidney and clearing heat and detoxicating, but
One different doctors use different Syndrome Differentiation Systems, if any the difference of syndrome differentiation of zang-fu viscera and the differentiation of qi-blood-body fluid；Two are the absence of accordingly
Objective indicator dialectical thinking is quantified, and then from the clinical differentiation of symptoms and signs for classification of syndrome direction for carrying out directiveness, lack targetedly
Effective prescription.
Therefore, it is consistent to develop a kind of differentiation of symptoms and signs for classification of syndrome, lipid-lowering effect is obvious, can effectively treat atherosclerosis and nontoxic
The fat-reducing medicament of side effect is particularly important.
In view of this, the present invention is specifically proposed.
Summary of the invention
The first purpose of this invention is to provide a kind of Chinese medicine composition, at least to alleviate skill existing in the prior art
One of art problem.
Second object of the present invention is to provide a kind of drug comprising above-mentioned Chinese medicine composition have above-mentioned Chinese medicine group
Close whole beneficial effects of object.
Third object of the present invention is to provide the preparation method of above-mentioned Chinese medicine composition, and this method is with of the present invention
Chinese medicine composition is raw material, and has preparation method to effective component extraction and application in composition using the physical method decocted
Easy, the advantages that drug is quick.
Fourth object of the present invention is that providing above-mentioned Chinese medicine composition is preparing Jianpi Jiangzhi and/or treatment artery congee
Application in the drug of sample hardening.
The present invention provides a kind of Chinese medicine composition, the Chinese medicine composition is made of raw material from the following weight:
1-20 parts of rhizoma atractylodis, 5-40 parts of lotus leaf and 1-15 parts of red yeast rice.
Further, the Chinese medicine composition is made of raw material from the following weight:
5-15 parts of rhizoma atractylodis, 10-30 parts of lotus leaf and 2-12 parts of red yeast rice.
Further, the Chinese medicine composition is made of raw material from the following weight:
8-12 parts of rhizoma atractylodis, 15-25 parts of lotus leaf and 4-10 parts of red yeast rice.
The present invention also provides a kind of drugs, including above-mentioned Chinese medicine composition；
Preferably, the dosage form of the drug includes oral preparation or ejection preparation.
Further, the oral preparation includes tablet, capsule, granule, pill, syrup, oral solution, mouth
Take suspension or Orally taken emulsion.
Further, the ejection preparation includes injection or powder-injection.
Further, effective dosage of the drug is 400-800mg/kg/ days, preferably 500-700mg/kg/
It.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, the preparation method includes:
After taking the rhizoma atractylodis, lotus leaf and red yeast rice of formulation weight part to mix, thereto plus water is decocted, and obtains the Chinese medicine group
Close object.
In addition, drug or the above-mentioned preparation method of application are prepared the present invention also provides above-mentioned Chinese medicine composition
Chinese medicine composition preparing the application in Jianpi Jiangzhi drug.
In addition, drug or the above-mentioned preparation method of application are prepared the present invention also provides above-mentioned Chinese medicine composition
Chinese medicine composition preparing the application in drug for treating atherosclerosis.
Further, the treatment atherosclerosis is by any one of following (a)-(c) or multinomial realization:
(a) expression of MMPs is reduced；
(b) expression of NF- κ B is reduced；
(c) expression of CD68 is reduced.
Chinese medicine composition provided by the invention, including rhizoma atractylodis, lotus leaf and red yeast rice.The Chinese medicine composition with invigorating the spleen to dry, dispel
Based on the stasis of bloodization is turbid, the drug of composition enters the warp of liver,spleen,kidney three, embodies the dyslipidemia interpretation of the cause, onset and process of an illness originally, and liver and spleen is same to be controlled.Wherein spleen
For soil, in soil prosperous four seasons, all there are soil in the four seasons；Spleen long four is dirty, and four dirty all have spleen.Hundred body of four limbs reports gas in stomach, and stomach is with trough
Body fluid provides four limbs.When with money four limbs, stomach Qi is unable to diameter to four limbs, to obtain trough body fluid battalion Wei Zhiqi because in spleen, seek Yu Si
Limb, four limbs are acted on, Fang get Yong.If its lienopathla blockage of vessel, without gas with life, drum does not have to bones muscle.Therefore invigorating the spleen one
It then, is to be basic, the turbid interpretation of the cause, onset and process of an illness of blood is not transporting for spleen, and stagnating and gathering is disease, then the benefits of the resolving sputum of invigorating the spleen based uplink.Therefore it adjusts
Reason spleen is the core for treating the disease of the five internal organs, therefore the tune rouge rules for the treatment of based on going phlegm-blood stasis blood turbid are invigorating the spleen, invigorating the spleen row
Gas removes turbid, five viscera settling with eliminating dampness, and calming the liver gas protects kidney qi, reaches and improve blood lipid on the basis of invigorating the spleen, and the purpose of protect liver shield kidney.
In addition, the medicine source of the bulk pharmaceutical chemicals of Chinese medicine composition provided by the invention is extensive, cheap, and has no toxic side effect, reasonable recipe,
Has many advantages, such as good effect, quick, economical and practical, uneasy to recur and to human zero damage.
The preparation method of Chinese medicine composition provided by the invention, using composition of the present invention as raw material, and using pan-fried
The physical method boiled has many advantages, such as that preparation method is easy, drug is quick to effective component extraction and application in composition.
The present invention provides include rhizoma atractylodis, lotus leaf and red yeast rice Chinese medicine composition prepare Jianpi Jiangzhi and for treating it is dynamic
Application in the drug of pulse atherosclerosis.The present invention is subject to " to adjust the five internal organs i.e. so controlling spleen using the old the five internal organs correlation theory of Deng as core
Stomach controls taste i.e. so five viscera settling " it is center thought, based on " all have temper in the five internal organs, and also have QI of five ZANG-organs in taste ",
The core spleen of the disease for the treatment of the five internal organs is improved, turbid, five viscera settling is removed in invigorating the spleen promoting the circulation of qi with eliminating dampness, and calming the liver gas protects kidney qi, reaches
Atherosclerosis, and the purpose of protect liver shield kidney are treated on the basis of invigorating the spleen.
Detailed description of the invention
It, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical solution in the prior art
Embodiment or attached drawing needed to be used in the description of the prior art be briefly described, it should be apparent that, it is described below
Attached drawing is some embodiments of the present invention, for those of ordinary skill in the art, before not making the creative labor
It puts, is also possible to obtain other drawings based on these drawings.
Fig. 1 is MMP-9 ImmunohistochemistryResults Results comparison diagram between each group that the embodiment of the present invention 1 provides；
Fig. 2 is NF-kb ImmunohistochemistryResults Results comparison diagram between each group that the embodiment of the present invention 1 provides；
Fig. 3 is CD68 ImmunohistochemistryResults Results comparison diagram between each group that the embodiment of the present invention 1 provides.
Specific embodiment
Technical solution of the present invention is clearly and completely described below in conjunction with embodiment, it is clear that described reality
Applying example is a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, the common skill in this field
Art personnel every other embodiment obtained without making creative work belongs to the model that the present invention protects
It encloses.
Hyperlipidemia Chinese medicine is also referred to as " blood is turbid " and is generally belonged to dyslipidemia according to the clinical manifestation of different patients
In " phlegm is turbid ", " blood stasis " scope, wherein " phlegm-blood stasis " then through the occurrence and development of dyslipidemia until the progress of disease always, therefore
In the treatment of hyperlipidemia, using phlegm-blood stasis as point, it is often significant in efficacy to carry out diagnosis and treatment.The defeated cloth of spleen master, invigorating the spleen are to reinforce
The defeated cloth ability of essence of water and grain reaches mechanism of qi to adjust, can relieve irritability.The sheet of phlegm-blood stasis is just that stasis blocking is obstructed, and invigorating the spleen can reach
Strengthen the ability of ascending or descending movement of vital Qi, with liver and spleen correlation theory, the two complements each other, and irritability tune reaches, and the happy then liver and spleen of stomach Qi reconciles, and rises
Drop is orderly；It is on the contrary then can qi depression to blood stasis, aggravate stasis blocking.Therefore, where the card of liver and spleen is both interpretation of the cause, onset and process of an illness place, and treatment targets,
Therefore, according to the five internal organs correlation theory, The spleen and stomach provide the material basis of the acquired, posteriori mechanism of qi operation is determined, for the most important thing for the treatment of.
On the other hand, according to theory of traditional Chinese medical science, the main inducing of the turbid morbidity of blood is eating and drinking without temperance, preference for fat and sweet food savoury, feelings will
Imbalance, loving ease and hating work, worn with age etc..And the interpretation of the cause, onset and process of an illness of hyperlipidemia morbidity is then the visceral dysfunction of spleen, liver, kidney, from
Caused by the pathological products such as phlegm wet, hemostasis formed, because these pathological products such as phlegm wet, hemostasis glue turbid obstructed, deposited so that phlegm is turbid
In blood vessels, blood stasis then occurs, so that phlegm and blood stasis, deadlocked in sering, then leads to the generation of cardiovascular and cerebrovascular disease, this card is then
Belong to " card of asthenia in origin and asthenia in superficiality, simulataneous insufficiency and excessive ".
Based on this, the present invention provides a kind of Chinese medicine composition, the Chinese medicine composition by following parts by weight raw material system
At:
1-20 parts of rhizoma atractylodis, 5-40 parts of lotus leaf and 1-15 parts of red yeast rice.
Rhizoma atractylodis rhizomes is used as medicine, to transport spleen medicine, Wen Xinlie bitter in taste, returns spleen, stomach, Liver Channel.Have eliminating dampness, change it is turbid, relieve pain it
Effect.For abdominal distention, diarrhea, oedema, rheumatic arthralgia, tinea pedis Wei lame, anemofrigid cold, night blindness.
Lotus leaf, also known as lotus flower stem, lotus stem.It is the leaf of Nelumbonaceae Nelumbo perennial herb emergent aquactic plant lotus lotus.Its is bitterly micro-
Nature and flavor puckery, cool in nature are cold and cool, return heart, liver, the spleen channel.With summer heat relieving and dampness eliminating, the effect of invigorating the spleen rising Yang, dissipating stasis and stanching bleeding.Lotus leaf also contains
Alkaloid, glycosides displayed and organic acid abundant, can satisfy human nutrition demand.
Red yeast rice be the mycelium of Aspergillaceae fungi monascus Monascus purpureus Went. colonize on polished rice and
At red yeast rice.It is sweet in flavor, slightly warm in nature.Returns spleen, large intestine, Liver Channel.With reinforcing spleen to promote digestion, the effect of activating microcirculation and removing stasis medicinal.Cure mainly diet product
It is stagnant, abdominal fullness and distention, red white diarrhea, prolonged lochia, traumatic injury.
Chinese medicine composition provided by the invention by rhizoma atractylodis, lotus leaf and red yeast rice compatibility, with invigorating the spleen to dry, dissolving stasisization it is turbid based on,
The drug of composition enters the warp of liver,spleen,kidney three, embodies the dyslipidemia interpretation of the cause, onset and process of an illness originally, and liver and spleen is same to be controlled.Wherein that spleen is soil, Tu Wang
All there are soil in the four seasons, the four seasons；Spleen long four is dirty, and four dirty all have spleen.Hundred body of four limbs reports gas in stomach, and stomach provides four limbs with trough body fluid.
When with money four limbs, stomach Qi is unable to diameter to four limbs, to obtain trough body fluid battalion Wei Zhiqi, battalion reports in four limbs, four limbs because in spleen
It holds, Fang get Yong.If its lienopathla blockage of vessel, without gas with life, drum does not have to bones muscle.Therefore first invigorating the spleen, is for root
This, the turbid interpretation of the cause, onset and process of an illness of blood is not transporting for spleen, and stagnating and gathering is disease, then the benefits of the resolving sputum of invigorating the spleen based uplink.Therefore conditioning spleen is
It is to treat the core of the disease of the five internal organs, therefore the tune rouge rules for the treatment of based on going phlegm-blood stasis blood turbid are invigorating the spleen, invigorating the spleen promoting the circulation of qi is with eliminating dampness
Turbid, five viscera settling is removed, calming the liver gas protects kidney qi, reaches and improve blood lipid on the basis of invigorating the spleen, and the purpose of protect liver shield kidney.In addition, this hair
The medicine source of the bulk pharmaceutical chemicals of the Chinese medicine composition of bright offer is extensive, cheap, and has no toxic side effect, reasonable recipe, has curative effect
It is good, quick, economical and practical, uneasy to recur and the advantages that human zero damage.
Wherein, the content of rhizoma atractylodis for example can be, but be not limited to 1 part, 2 parts, 5 parts, 8 parts, 10 parts, 12 parts, 15 parts, 18 parts
Or 20 parts；The content of lotus leaf for example can be, but be not limited to 5 parts, 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts or 40 parts；
The content of red yeast rice for example can be, but be not limited to 1 part, 2 parts, 5 parts, 8 parts, 10 parts, 12 parts or 15 parts.
It is defined by the proportion to raw material components, so that Chinese medicine composition provided by the invention has good invigorating the spleen
The turbid effect of eliminating dampness, dissolving stasisization, can effectively improve blood lipid on the basis of invigorating the spleen, and protect liver protects kidney.
In some preferred embodiments, the Chinese medicine composition includes the component of following parts by weight:
5-15 parts of rhizoma atractylodis, 10-30 parts of lotus leaf and 2-12 parts of red yeast rice.
In some preferred embodiments, the Chinese medicine composition includes the component of following parts by weight:
8-12 parts of rhizoma atractylodis, 15-25 parts of lotus leaf and 4-10 parts of red yeast rice.
It is further limited by the proportion to raw material components, so that Chinese medicine composition provided by the invention has
The turbid effect of better invigorating the spleen to dry, dissolving stasisization, can effectively improve blood lipid on the basis of invigorating the spleen, and protect liver protects kidney.
The present invention also provides a kind of drugs, including Chinese medicine composition provided by the invention.
In some preferred embodiments, the dosage form of the drug includes oral preparation or ejection preparation.
When oral medication, said medicine can be made into and arbitrarily take orally acceptable dosage form, such as can be, but unlimited
In tablet, capsule, granule, pill, syrup, oral solution, oral suspensions or Orally taken emulsion.
Wherein, the carrier that tablet uses generally comprises lactose and cornstarch, and lubricant such as stearic acid in addition can also be added
Magnesium.The diluent that capsule uses generally comprises lactose and dried corn starch.Oral suspensions are then usually by active constituent
It is used in mixed way with suitable emulsifier and suspending agent.
Optionally, some sweeteners, aromatic or colorant can also be added in the above oral dosage form.
When being administered in the form of injection, said medicine can be made into the acceptable dosage form of any injection, such as can be with
For, but it is not limited to injection or powder-injection.
Wherein, workable carrier and solvent include water, Ringer's solution and isotonic sodium chlorrde solution.In addition, sterilizing
Fixed oil also is used as solvent or suspension media, such as monoglyceride or two glyceride.
In some preferred embodiments, effective dosage of the drug is 400-800mg/kg/ days, such as can
Think, but be not limited to 400mg/kg/ days, 450mg/kg/ days, 500mg/kg/ days, 550mg/kg/ days, 600mg/kg/ days,
650mg/kg/ days or 700mg/kg/ days；Preferably 500-700mg/kg/ days, more preferable 600mg/kg/ days.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, the preparation method includes:
After taking the rhizoma atractylodis, lotus leaf and red yeast rice of formulation weight part to mix, thereto plus water is decocted, and obtains the Chinese medicine group
Close object.
The preparation method of Chinese medicine composition provided by the invention, using composition of the present invention as raw material, and using pan-fried
The physical method boiled has many advantages, such as that preparation method is easy, drug is quick to effective component extraction and application in composition.
In addition, drug or the above-mentioned preparation method of application are prepared the present invention also provides above-mentioned Chinese medicine composition
Chinese medicine composition preparing the application in Jianpi Jiangzhi drug.
In addition, drug or the above-mentioned preparation method of application are prepared the present invention also provides above-mentioned Chinese medicine composition
Chinese medicine composition preparing the application in drug for treating atherosclerosis.
The present invention is subject to " to adjust the five internal organs i.e. so control taste, control taste i.e. so pacifying using the old the five internal organs correlation theory of Deng as core
The five internal organs " are center thought, based on " all have temper in the five internal organs, and also have QI of five ZANG-organs in taste ", to the disease for treating the five internal organs
Core spleen is improved, and turbid, five viscera settling is removed in invigorating the spleen promoting the circulation of qi with eliminating dampness, and calming the liver gas protects kidney qi, reaches and treat on the basis of invigorating the spleen
Atherosclerosis, and the purpose of protect liver shield kidney.
In some preferred embodiments, the treatment atherosclerosis is by any one of following (a)-(c)
Or multinomial realization:
(a) expression of MMPs is reduced；
(b) expression of NF- κ B is reduced；
(c) expression of CD68 is reduced.
For (a), the forming process of the atherosclerosis alternatively referred to as process that is reconstructed of cell in vitro matrix simultaneously.
Enzyme MMP-9 important as one kind of degradation extracellular matrix, plays in the process of atherosclerosis formation to Guan Chong
The effect wanted.MMP-9 belongs to one kind of gelatinase, mainly by degradation atherosclerotic plaque extracellular matrix to
Achieve the purpose that degrade IV Collagen Type VI and elastic fibers.Under normal circumstances, endothelial cell does not secrete MMP-9, and when artery is athero-
When hardening occurs, MMP-9 is synthesized and is secreted, this process becomes one of the key link of atherosclerosis occurrence and development.
And MMP-9 is mainly the plaque fibrous cap for passing through degradation atherosclerosis, the shoulder regions of especially fibrous cap are thinning, cause
The structure of patch changes, by the continuous continuous ablation increased with fibrous cap of lipid necrotic cores, so that plaque vulnerability increases
Add, the risk of thrombosis increases after plaque rupture.
Therefore, Chinese medicine composition of the present invention is by reducing the expression of MMP-9, so that it is athero- hard to reduce coronary artery
The risk for changing Vulnerable plaque, achievees the purpose that the treatment that can effectively realize atherosclerosis.
For (b), NF-kb (i.e. nuclea:factor) also known as nuclear factor are controlled in atherosclerosis
The transcription of many genes to play an important role takes part in the initiating link of atherosclerosis.Monocyte enters damaging part
It is divided into macrophage, Main Factors therein are the macrophage colony stimulating factors regulated and controled by NF- κ B, and it is athero- to aggravate artery
The formation of hardened foam cell.Meanwhile NF- κ B takes part in multi-signal transduction pathway in inflammatory process, and it is athero- to promote artery
The formation of hardening eventually leads to smooth muscle cell abnormality proliferation, forms atherosclerotic plaque.
Therefore, Chinese medicine composition of the present invention is by reducing the expression of NF- κ B, so that it is athero- hard to reduce coronary artery
Change plaque area, increases plaque stability, the risk of low coronary atherosclerosis Vulnerable plaque, reaching can be effectively real
The purpose of the treatment of existing atherosclerosis.
It is distributed across the transmembrane glycoprotein of cell surface for (c), CD68, is that classical having represents the positive huge of meaning
Phagocyte specific surfaces marker.The positive macrophage number of CD68 early stage and progressive stage atherosclerotic lesion it
Between have significant difference, and be positively correlated with the degree of the lesion type of coronary atherosclerosis, luminal stenosis.I.e. with dynamic
The positive expression of the exacerbation of pulse atherosclerosis lesion, the exacerbation CD68 of luminal stenosis degree is consequently increased.Also, with CD68
Expression increase, the unstability of patch also increases at any time, since vulnerable plaque easily leads to thrombus rupture, while the positive of CD68
Expression, which increases, can increase thrombus risk of rupture.
Therefore, Chinese medicine composition of the present invention is by reducing the expression of CD68, to reduce plaque area, increases spot
Block stability, the risk of low coronary atherosclerosis Vulnerable plaque, atherosclerosis can effectively be realized by reaching
The purpose for the treatment of.
Combined with specific embodiments below and comparative example, the invention will be further described.
Embodiment 1
A kind of Chinese medicine composition is present embodiments provided, the Chinese medicine composition is made of raw material from the following weight:
1 part of rhizoma atractylodis, 40 parts of lotus leaf and 1 part of red yeast rice.
Embodiment 2
A kind of Chinese medicine composition is present embodiments provided, the Chinese medicine composition is made of raw material from the following weight:
20 parts of rhizoma atractylodis, 5 parts of lotus leaf and 15 parts of red yeast rice.
Embodiment 3
A kind of Chinese medicine composition is present embodiments provided, the Chinese medicine composition is made of raw material from the following weight:
8 parts of rhizoma atractylodis, 25 parts of lotus leaf and 5 parts of red yeast rice.
Embodiment 4
A kind of Chinese medicine composition is present embodiments provided, the Chinese medicine composition is made of raw material from the following weight:
15 parts of rhizoma atractylodis, 10 parts of lotus leaf and 12 parts of red yeast rice.
Embodiment 5
A kind of Chinese medicine composition is present embodiments provided, the Chinese medicine composition is made of raw material from the following weight:
10 parts of rhizoma atractylodis, 20 parts of lotus leaf and 6 parts of red yeast rice.
Comparative example 1
This comparative example provides a kind of Chinese medicine composition, and the Chinese medicine composition is made of raw material from the following weight:
20 parts and 6 parts of red yeast rice of lotus leaf.
Comparative example 2
This comparative example provides a kind of Chinese medicine composition, and the Chinese medicine composition is made of raw material from the following weight:
10 parts and 6 parts of red yeast rice of rhizoma atractylodis.
Comparative example 3
This comparative example provides a kind of Chinese medicine composition, and the Chinese medicine composition is made of raw material from the following weight:
10 parts and 20 parts of lotus leaf of rhizoma atractylodis.
Comparative example 4
This comparative example provides a kind of Chinese medicine composition, and the Chinese medicine composition is made of raw material from the following weight:
25 parts of rhizoma atractylodis, 3 parts of lotus leaf and 18 parts of red yeast rice.
Comparative example 5
This comparative example provides a kind of Chinese medicine composition, and the Chinese medicine composition is made of raw material from the following weight:
0.8 part of rhizoma atractylodis, 42 parts of lotus leaf and 0.8 part of red yeast rice.
The Chinese medicine composition for taking the embodiment 1-5 and comparative example 1-5 of formula ratio to provide respectively is thought after mixing each raw material
Wherein plus water is decocted, and Chinese medicine composition is prepared.
Experimental example 1
1, case source
Experimental example of the present invention be included in July, 2013 to No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ outpatient service in 2 months in 2015 and
The patient for being diagnosed as hyperlipidemia is accepted in ward (including great virtue Lu Zongyuan, two sand island branches, branch, fragrant village, branch, university city) for medical treatment,
TCM Syndrome Type, which is respectively that phlegm is turbid, checks card, syndrome of yang deficiency of spleen and kidney, syndrome of yin deficiency of liver and kidney, syndrome of hyperactivity of yang due to yin deficiency.
2, tcm diagnosis standard
With reference to " new Chinese medicine guideline of clinical investigations (2002) ", tcm diagnosis standard is as follows:
Phlegm is turbid to check card: primary symptom is as follows: patient symptoms include body is fat, uncomfortable in chest, evil of vomitting sputum, heaviness of the head as if it were tightly bandaged, limb fiber crops are heavy,
Enter a group person and needs to have one of primary symptom；Minor symptom is as follows: palpitaition, mouth are light, deficiency of food, insomnia, tongue nature is fat, tongue fur is satiny, wiry and rolling pulse, enter group
Person need to have above-mentioned symptom >=2.
Syndrome of yang deficiency of spleen and kidney: primary symptom is as follows: patient symptoms include aversion to cold and cold limbs, fatigue and weakness, dizziness, loose stool enter a group person and need to have
One of standby primary symptom；Minor symptom is as follows: deficiency of food stomach duct and abdomen makees that swollen, face limb edema, pale tongue matter is tender, whitish tongue deep thready pulse, enters on group person need to have
State symptom >=2.
Syndrome of yin deficiency of liver and kidney: primary symptom is as follows: patient symptoms include dizziness, the soreness of waist, knee be soft, tinnitus, dysphoria in chestpalms-soles, enters a group person and needs to have
One of standby primary symptom；Minor symptom is as follows: dry, insomnia, amnesia, red tongue body, less fur thready rapid pulse, above-mentioned symptom >=2 need to be had by entering group person
?.
Syndrome of hyperactivity of yang due to yin deficiency: primary symptom is as follows: patient symptoms include dizziness, flushing bitter taste, headache, being irritable and getting angry easily enter a group person and need to have
One of standby primary symptom；Minor symptom is as follows: palpitaition, insomnia, constipation, red, red tongue body of urinating or purple dim veins string or string carefully count, and entering a group person needs to have
There are above-mentioned symptom >=2.
Syndrome of qi stagnation and blood stasis: primary symptom is as follows: patient symptoms include Breast bilges frowsty walk to alter pain, pareordia shouting pain, enter a group person and need to have
One of standby primary symptom；Minor symptom is as follows: vexed uneasy, the tip of the tongue side has petechia or ecchymosis, deeptensepulse puckery, enter group person need to have above-mentioned symptom >=
2
Tongue picture: tongue nature is light, tongue nature is purple, tongue is fat, indentations at the margin of the tongue, other exceptions (description).
Pulse condition: weak, puckery, sliding, string, other exceptions (description).
3, it the selection of subject and exits
3.1, it is included in standard
It is included in canonical reference " China Cholesterol Education Program dyslipidemia prevents and treats expert advice within 2014 ".
(1) meet hyperlipidemia diagnostic criteria.
(2) laboratory checks: TC >=5.72mmol/L；Or LDL-C >=3.37mmol/L；Diabetic LDL-C >=
2.6mmol/L；Hypertensive patient merges a risk factor LDL-C >=2.6mmol/L；Or atherosclerotic cardiovascular disease
Patient LDL-C >=1.8mmol/L；Or diabetic's complicated hypertension or other risk factor person LDL-C >=
1.8mmol/L.Wherein hypertensive patient includes systolic pressure >=140mmHg and≤180mmHg；Or diastolic pressure >=90mmHg and≤
110mmHg.Diabetic includes the patient of fasting blood-glucose >=6mmol/L and≤15mmol/L.Risk factor include it is dangerous because
Element includes: age male >=45 years old, female >=55 year old；Smoking；HDL-C < 1.04mmol/L；Early hair ischemic cardiovascular disease family history；
Constitutional index >=28kg/m2.
3. Chinese medical discrimination belongs to one of standard syndrome.
4. the age 18~75 years old.
5. understanding and signing informed consent form.
3.2, exclusion criteria
If any one following answer is "Yes", this subject cannot participate in this clinical test:
1. age < 18 years old or 75 years old person of age >；
2. familial hyperlipidemia；
3. endogenous creatinine clearance rate is less than 60ml/min；
4. dysfunction of liver, paddy third, glutamic-oxalacetic transaminease or bilirubin are greater than 2 times of persons of normal upper limit；
5. being drawn by certain drug (such as diuretics, beta-blocker, glucocorticoid, estrogen) or other diseases
The Secondary Hyperlipidemia of hair；
6. with heart failure, heart function >=NYHA III level person；It is associated with severe arrhythmia (such as room of taking place frequently morning, room
Speed, atrial fibrillation etc.；
7. once suffering from acute myocardial infarction AMI, cerebrovascular accident or PCI being postoperative etc. need to take fat-reducing medicament for a long time；
8. uncontrolled 3 grades of hypertension (SiDBP >=110mmHg or systolic pressure >=180mmHg)；
9. fasting blood-glucose >=15mmol/L；
10. heparin, thyroxine and other influences blood lipid metabolism drug is used or nearly 2 weeks were once arranged using other lipid-loweringings
It applies；
There is the internal medicine illness such as the serious or unstable heart, liver, kidney, endocrine, blood；
It is mentally ill, or has alcohol or pharmacological dependence；
With malignant tumour or there is related history；
To statins allergy, or there is Statins serious adverse reaction history.
Serious enterogastric diseases, current gastrointestinal symptom is obvious, needs curer；
Gestation, breast feeding women plan to be pregnant during test, or make its spouse pregnancy person；
Severe depletion of oxygen pulmonary disease person, such as asthma, chronic bronchitis, COPD person；
Person is not able to cooperate；
It is expected that compliance is poor, the patient that cannot be checked on time；
Other clinical tests were participated in nearest 3 months；
Research group discusses the other situations for determining and existing and being not suitable for participating in the test.
3.3, subject exits and (falls off) condition and step of test:
(1) researcher determines to exit: acute coronary syndrome, severe arrhythmia, the heart 1. occurring in patient's drug administration process
The serious adverse events person such as functional failure, sudden death；2. serious liver kidney, systemic complications shape occur in drug administration process, need to close
And other treatment person or occur gestation person；3. subject violates clinical trial protocol and takes other drugs or food and cannot be by doctor
Advise the person of taking drugs.
(2) subject voluntarily exits: subject has the right to drop by the wayside test, is not subjected to reprisal.Or patient is not
Receive medication and detection again and lost to follow-up.
(3) no matter which kind of reason answers comprehensive, objective fill in exit reason, in this way because of bad thing the case for exiting test
Part exits, and need to record corresponding treatment measures, effect and follow-up and records to stable disease or event and properly settle.
4, treatment method
Random packet method uses simple randomization method, and SAS " PLAN " program is realized, passes through the center Guangdong Provincial TCM Hospital DME
" central randomization distributes interactive voice operating system " is grouped at random, and the qualified hyperlipidemia patient of screening is randomly divided into
Test group (Chinese medicine composition group) and control group (Simvastatin group), experimental group is given on the basis of having neither part nor lot in other Lipid modulatings
The Chinese medicine of 1 month Chinese medicine composition is treated, and effective dose is 600mg/kg/ days, and control group takes simvastatin dispersible tablets, often
Secondary 20mg takes before sleeping one time a day, and totally 30 days.
5, parameters for observation on effect
5.1, tcm syndrome curative effect index
For meeting the common sympton amount of progress of the hyperlipidemia patient patient for meeting the standard of being included in of above-mentioned TCM Syndrome Type
Change is scored, and same term is used when interrogation, is carried out before treatment, after treatment.Tcm syndrome is scored, and " Chinese medicine is new for table reference
Medicine guideline of clinical investigations (tentative) " (2002, Zheng Xiao cornel) and " tcm clinical practice diagnosis and treatment term syndrome part " (GB/
T16751.2 1 is 1997).
5.2, tcm syndrome criterion of therapeutical effect
The guideline of clinical investigations of diagnosis and treatment hyperlipemia in foundation " new Chinese medicine guideline of clinical investigations (tentative) ",
Tcm syndrome evaluation criteria is as follows:
1. invalid: syndrome integral reduces < 30%, and clinical symptoms are not significantly changed with sign, or even aggravates；
2. effectively: syndrome integral reduces >=30%, and clinical symptoms are improved with sign；
3. effective: syndrome integral reduces >=70%, and clinical symptoms and sign improve obvious.
4. recovery from illness: syndrome integral reduces >=95%, and Clinical symptom and sign disappears or disappeared substantially.
6, result of study
Clinical observation plan is included in 200, wherein embodiment 1-5, comparative example 1-5 and control group each 20, is actually included in
Patient 200, wherein each 20 of embodiment 1-5 and comparative example 1-5, fall off 4 by control group 16.Actually accomplish case observation
It is 216 total.As a result as shown in the table:
| Group | It cures | It is effective | Effectively | In vain | Total effective rate (%) |
| Embodiment 1 | 3 | 13 | 2 | 2 | 90 |
| Embodiment 2 | 3 | 12 | 4 | 1 | 95 |
| Embodiment 3 | 2 | 13 | 3 | 2 | 90 |
| Embodiment 4 | 2 | 17 | 1 | 1 | 95 |
| Embodiment 5 | 1 | 11 | 5 | 3 | 85 |
| Comparative example 1 | 0 | 0 | 5 | 15 | 25 |
| Comparative example 2 | 0 | 1 | 3 | 16 | 20 |
| Comparative example 3 | 0 | 0 | 5 | 15 | 25 |
| Comparative example 4 | 0 | 0 | 10 | 10 | 50 |
| Comparative example 5 | 0 | 0 | 8 | 12 | 40 |
| Control group | 3 | 12 | 3 | 2 | 90 |
As can be seen that the Chinese medicine composition that 1-5 of the embodiment of the present invention is provided, divides it by each specific group in from the above
Between coordinated so that Chinese medicine composition provided by the invention have the function of good invigorating the spleen and conditioning blood lipid.And it compares
The Chinese medicine composition that example 1-5 is provided, level of the curative effect far away from the embodiment of the present invention.
Wherein, the Chinese medicine composition that embodiment 1-5 is provided, raw material components are identical, and only proportion is different.But embodiment
5 Chinese medicine compositions provided are superior to the level of embodiment 1-4 in terms of invigorating the spleen and conditioning blood lipid, what embodiment 3 and 4 provided
Chinese medicine composition is superior to the horizontal Chinese medicine composition of Examples 1 and 2 in terms of invigorating the spleen and conditioning blood lipid.Illustrate by each
The proportion of component is further adjusted and is optimized, so that Chinese medicine composition provided by the invention has better invigorating the spleen dry
Effect wet, dissolving stasisization is turbid, can effectively improve blood lipid on the basis of invigorating the spleen, and protect liver protects kidney.
The Chinese medicine composition that embodiment 5 and comparative example 1-3 are provided, the proportion of same composition is identical, but comparative example 1 lacks
Rhizoma atractylodis, comparative example 2 lack lotus leaf, comparative example 3 lacks red yeast rice.The Chinese medicine composition that embodiment 5 provides is in invigorating the spleen and conditioning blood lipid
Aspect be superior to the level of comparative example 1-3.Illustrate to pass through the collaboration of each component in the identical situation of proportion of same composition
Cooperation, so that Chinese medicine composition provided by the invention has the effect of that better invigorating the spleen to dry, dissolving stasisization are turbid, it can be effectively strong
Blood lipid is improved on the basis of spleen, protect liver protects kidney.
The Chinese medicine composition that embodiment 1-5 and comparative example 4 and 5 provide, component is identical, and only proportion is different.But embodiment
The Chinese medicine composition that 1-5 is provided is superior to the Chinese medicine composition of the offer of comparative example 4 and 5 in terms of invigorating the spleen and conditioning blood lipid.It says
The bright proportion by each component is further adjusted and is optimized, so that Chinese medicine composition provided by the invention has more preferably
Invigorating the spleen to dry, the turbid effect of dissolving stasisization, blood lipid can be effectively improved on the basis of invigorating the spleen, protect liver protects kidney.
Experimental example 2
For save the cost, Chinese medicine composition that this experimental example selection embodiment 5 that effect is best in experimental example provides into
Row test.
In animal experiments, 48 ApoE knock out mice (hyperlipidemic mice) are randomly divided into model group by inventor,
High dose group, middle dose group, low dose group, Western medicine group and blank control group, every group 8, half male and half female；It is changed according to body surface area
Algorithm matches the stomach-filling drug for taking various concentration, and the high, medium and low dosage group of Chinese medicine composition provided by the invention presses 6.08g/ respectively
Kg, 3.04g/kg, 1.52g/kg (4 times, 2 times, 1 times that are equivalent to 60kg adult daily dosage) stomach-filling invigorating the spleen tune rouge recipe liquid, often
Day is primary；Simvastatin group Simvastatin medical fluid stomach-filling 5mg/kg, once a day, other groups give equal dosage purified water stomach-filling.
After continuous gavage 6 weeks, row lipid determination and the observation of arch of aorta pathology, all data analyses are divided with SPSS17.0 software
Analysis is compared, and measurement data uses mean ± standard deviationMedian (M), maximum value (Max), minimum value (Min), four points
Column pitch (P75-P25) indicates, and carry out test of normality is distributed to it.As a result, it has been found that comparison blank control group, the high agent of Chinese medicine
The mean value of TC, TG, hsCRP, FFA, AST of amount group, which all exist, to be improved, as shown in the table:
The result of above-mentioned high dose group and blank control group has Variant statistical meaning (P < 0.003).Chinese medicine high dose
Group compares Chinese medicine middle dose group, Chinese medicine low dose group, Simvastatin group respectively, as a result prompts indifference statistical significance (P >
0.003)。
Experimental example 3 treats atherosclerosis
One, zoopery
In animal experiments, 48 ApoE knock out mice (hyperlipidemic mice) are randomly divided into model group by the present embodiment
(A), high dose group (B), middle dose group (C), low dose group (D), Western medicine group (E) and blank control group (F), every group 8, male and female
It is fifty-fifty；Match the stomach-filling drug for taking various concentration according to body surface area scaling method, Chinese medicine composition of the present invention is high, medium and low
Dosage group is respectively by 6.08g/kg, 3.04g/kg, 1.52g/kg (4 times, 2 times, 1 times that are equivalent to 60kg adult daily dosage) stomach-filling
Invigorating the spleen tune rouge recipe liquid, once a day；Simvastatin group Simvastatin medical fluid stomach-filling 5mg/kg, once a day, other groups are given
Equal dosage purified water stomach-filling.After continuous gavage 6 weeks, row lipid determination and the observation of arch of aorta pathology, all data analyses are used
SPSS17.0 software carries out analysis comparison, and measurement data uses mean ± standard deviationMedian (M), maximum value
(Max), minimum value (Min), quartile spacing (P75-P25) indicate, and are distributed carry out test of normality to it.
In lab index analysis, Chinese medicine composition middle dose group of the present invention, which compares other each groups, obviously to be had
MMP-9 expression is reduced, the effect of the risk of Vulnerable plaque is reduced.The comparison of MMP-9 ImmunohistochemistryResults Results is such as Fig. 1 institute between each group
Show.NF- κ B compares remaining each group, positive expression is bright in the case where the adjusting of Chinese medicine composition middle dose group of the present invention is intervened
Aobvious to reduce, plaque area is opposite in the case where preventative-therapeutic high lipid food induces and drug is intervened simultaneously to be reduced, and
Stability increases (P < 0.01).The comparison of NF- κ B ImmunohistochemistryResults Results is as shown in Figure 2 between each group.In the arch of aorta in this research
In terms of the positive expression of the CD68 in portion, Chinese medicine composition middle dose group of the present invention compares remaining each group, and positive expression is bright
Aobvious to reduce, plaque area is opposite in the case where preventative-therapeutic high lipid food induces and drug is intervened simultaneously to be reduced, and
Stability increases (P < 0.01), and best in curative effect.And by comparing two-by-two, high, medium and low dosage Chinese medicine of the present invention
The positive expression rate of the CD68 of composition group is below simvastatin dispersible tablets group (P < 0.01), and middle dose group effect is best.
The comparison of CD68 ImmunohistochemistryResults Results is as shown in Figure 3 between each group.
Each group result is as shown in the table:
MMP-9 positive expression rate compares between each group
NF-kb positive expression rate compares between each group
CD68 positive expression rate compares between each group
Two, clinical test
It is random to be grouped in the random of the invention traditional Chinese medicine composition for treating atherosclerosis, control clinical research
Method uses simple randomization method, and SAS " PLAN " program is realized, passes through " the central randomization distribution interaction of the center Guangdong Provincial TCM Hospital DME
Formula voice operating system " is grouped at random, and the qualified atherosclerotic of screening is randomly divided into test group (invention institute
The Chinese medicine composition group stated) and each 40 of control group (Simvastatin group), experimental group controls having neither part nor lot in other atherosclerosis
The Chinese medicine treatment of Chinese medicine composition described in invention in 1 month is given on the basis for the treatment of, effective dose is 1520mg/kg/ days, control
Group takes simvastatin dispersible tablets, and each 20mg takes before sleeping one time a day, and totally 30 days.
As a result prompt combines the layering statistical result of LDL-C, and the raised patient's totality tcm syndrome of test group severe LDL is commented
Point it is better than control group (P < 0.05), prompts the TCM syndrome evaluation of Chinese medicine composition of the present invention layering severe after treatment
Better than Simvastatin control group, and light moderate patient's indifference opposite sex statistical significance (P > 0.05), prompt therapeutic equivalence.Pacifying
In terms of full property metrics evaluation, there is the raised risk of AST compared to Chinese medicine composition group of the present invention in Simvastatin group.It is scorching
Two groups of curative effect comparision indifference statistical significances (P > 0.05) of inflammation factor SOD, MCP-1, IL-6 prompt test group to comparison
According to group, therapeutic equivalence.It is right in terms of the curative effect of light moderate sufferer by the difference analysis of ranked data in terms of therapeutic evaluation
It is more obvious according to organizing, have otherness statistical significance (P < 0.05), and severe patient then no significant difference statistical significance (P
> 0.05), prompt therapeutic equivalence.Each group result is as shown in the table:
Syndrome score compares before two groups of Case treatments
Syndrome score compares (severe) after two groups of Case treatments
Syndrome score compares (light moderate) after two groups of Case treatments
TCM syndrome evaluation deduction rate is qualitative
*Fisher′s Exact Test
Pretherapy and post-treatment test group patient safety index level (severe LDL-C grouping)
Pretherapy and post-treatment control group patient safety index level (severe LDL-C grouping)
Pretherapy and post-treatment test group patient safety index level (light moderate LDL-C grouping)
Pretherapy and post-treatment control group patient safety index level (light moderate LDL-C grouping)
Pretherapy and post-treatment two groups of SOD, MCP-1, IL-6 expressions of test group (severe LDL-C grouping)
Pretherapy and post-treatment two groups of SOD, MCP-1, IL-6 expressions of test group (light moderate LDL-C grouping)
Pretherapy and post-treatment two groups of SOD, MCP-1, IL-6 expressions of control group (severe LDL-C grouping)
Pretherapy and post-treatment two groups of SOD, MCP-1, IL-6 expressions of control group (light moderate LDL-C grouping)
Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Pipe present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: its according to
So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into
Row equivalent replacement；And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (10)
1. a kind of Chinese medicine composition, which is characterized in that the Chinese medicine composition is made of raw material from the following weight:
1-20 parts of rhizoma atractylodis, 5-40 parts of lotus leaf and 1-15 parts of red yeast rice.
2. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition by following parts by weight original
Material is made:
5-15 parts of rhizoma atractylodis, 10-30 parts of lotus leaf and 2-12 parts of red yeast rice；
Preferably, the Chinese medicine composition is made of raw material from the following weight:
8-12 parts of rhizoma atractylodis, 15-25 parts of lotus leaf and 4-10 parts of red yeast rice.
3. a kind of drug, which is characterized in that including Chinese medicine composition of any of claims 1 or 2；
Preferably, the dosage form of the drug includes oral preparation or ejection preparation.
4. drug according to claim 3, which is characterized in that the oral preparation include tablet, capsule, granule,
Pill, syrup, oral solution, oral suspensions or Orally taken emulsion.
5. drug according to claim 3, which is characterized in that the ejection preparation includes injection or powder-injection.
6. drug according to claim 3, which is characterized in that effective dosage of the drug is 400-800mg/
Kg/ days, preferably 500-700mg/kg/ days.
7. the preparation method of Chinese medicine composition according to claim 1 or 2, which is characterized in that the preparation method includes:
After taking the rhizoma atractylodis, lotus leaf and red yeast rice of formulation weight part to mix, thereto plus water is decocted, and obtains the Chinese traditional medicine composition
Object.
8. Chinese medicine composition as claimed in claim 1 or 2 or the described in any item drugs of claim 3-6, or apply right
It is required that the Chinese medicine composition that preparation method described in 7 is prepared is preparing the application in Jianpi Jiangzhi drug.
9. Chinese medicine composition as claimed in claim 1 or 2 or the described in any item drugs of claim 3-6, or apply right
It is required that the Chinese medicine composition that preparation method described in 7 is prepared is preparing answering in the drug for treating atherosclerosis
With.
10. application according to claim 9, which is characterized in that the treatment atherosclerosis is by following (a)-
Or multinomial realization any one of (c):
(a) expression of MMPs is reduced；
(b) expression of NF- κ B is reduced；
(c) expression of CD68 is reduced.
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| CN104189776A (en) * | 2014-09-19 | 2014-12-10 | 宋鲁成 | Medicinal preparation for treating atherosclerosis and preparation method thereof |
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| CN111863199A (en) * | 2020-07-30 | 2020-10-30 | 上海群有信息技术有限公司 | Decision system for assisting western medicine in applying Chinese patent medicine based on syndrome differentiation |
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Application publication date: 20190430 |