CN103623189B - A kind of Chinese traditional compound medicine and preparation method thereof of recession and reversal of atherosclerosis patch - Google Patents
A kind of Chinese traditional compound medicine and preparation method thereof of recession and reversal of atherosclerosis patch Download PDFInfo
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- CN103623189B CN103623189B CN201210310604.7A CN201210310604A CN103623189B CN 103623189 B CN103623189 B CN 103623189B CN 201210310604 A CN201210310604 A CN 201210310604A CN 103623189 B CN103623189 B CN 103623189B
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Landscapes
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to the Chinese traditional compound medicines of a kind of recession and reversal of atherosclerosis patch, it is characterized by: the Chinese traditional compound medicine is made of this main Chinese medicine of three tastes of Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng and certain auxiliary medicinal material, the ratio between weight percent between Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 1:1-3:1-4, and it is 50-100% that three, which accounts for total formulation weight percentage,.When use, the present invention is on the basis of effectively steadily inhibiting atherosclerotic lesion progress, realize induction plaque regression, to realize the Forward of wholistic therapy time window, fundamentally reduce the occurrence probability of all kinds of cardiocerebrovasculaevents events caused by atherosclerotic lesion, furthermore the compatibility of this compound reduces the burden such as liver kidney, reducing traditional statins intensive treatment leads to the risk of liver renal toxicity by optimization improvement.
Description
Technical field
The present invention relates to the technical field of medicine, specifically a kind of recession is answered with reversal of atherosclerosis patch
Square Chinese materia medica preparation and preparation method thereof.
Background technique
With the raising of human living standard, the quickening of Working Life rhythm and the aggravation of social senilization, with artery
Atherosis (atherosclerosis, AS) is the cardiovascular and cerebrovascular disease of pathologic basis, due to higher disease incidence, lethality
And disability rate, it has also become the main disease of human health is seriously endangered, the disease incidence in China shows an increasing trend year by year, and to
Rejuvenation development dies of the number of vascular conditions up to more than 300 ten thousand people every year, has accounted for the annual total dead people in China in China
Several 35%-40%, for treating the expenses of AS vascular diseases at hundred billion yuan or more, countries in the world are by AS and its complication
Study the most important thing studied as cardiovascular and cerebrovascular disease.Although current synthesis drug and interventional therapy effectively reduce such
The acute phase mortality of patient, but it is still relatively limited to the improvement of the long-term prognosis of patient, more lack active and effective early prevention and treatment and arranges
It applies, even most effective statin and aspirin drug therapy can only also reduce the generation of 30% cardiocerebrovasculaevents events, how
Remaining 70% residual risk is further decreased, pressing issues urgently to be resolved at present, and the hot spot of current medical research are become.
Numerous studies confirm: cardiovascular and cerebrovascular disease and endovascular atherosclerotic plaque are directly closely related, simultaneously
Patch formation is a long-term chronic pathology process, and its progress will constantly accelerate patch once being formed, so as to cause each
Kind cardiovascular and cerebrovascular disease, such as: apoplexy, heart infarction and lower limb ischemia or internal organs embolism etc..Although serum regulating drugs such as statins
Extensive use clinically, but it is unobvious to the recession of the established patch of industry, and generally requires large dosage of long-term clothes
With again the problems such as this brings corresponding liver kidney and musclar toxicity is a clinical critical issue in the urgent need to address.
Summary of the invention
The purpose of the present invention is to provide the herbal mixture systems of a kind of improved recession and reversal of atherosclerosis patch
Agent and preparation method thereof, it, which can overcome, in the prior art improves the long-term prognosis of patient still relatively limited, more lacks active and effective
Early-stage preventive measures, even most effective statin and aspirin drug therapy can only also reduce by 30% cardiovascular and cerebrovascular thing
The some shortcomings of the generation of part.
To achieve the goals above, the technical scheme is that a kind of recession and reversal of atherosclerosis patch
Chinese traditional compound medicine, it is characterised in that: the Chinese traditional compound medicine is made of this three tastes Chinese medicine of Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng, and three
Seven, the ratio between weight percent of Longstamen Onion Bulb and Snakegourd Fruit is 1:1-3:1-4.
A kind of Chinese traditional compound medicine of recession and reversal of atherosclerosis patch, it is characterised in that: in the compound
Medicine preparation is made of weight percent of 50-100% major ingredient and 0-50% auxiliary material, and the major ingredient includes by Snakegourd Fruit, Chinese onion
White and this three tastes Chinese medicine of Radix Notoginseng is constituted, and the ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 1:1-3:1-4.
A kind of preparation method of recession and the Chinese traditional compound medicine of reversal of atherosclerosis patch, it is characterised in that: institute
The preparation method stated be water decoction-alcohol sedimentation the preparation method, the specific steps are as follows: a, by Snakegourd Fruit, Longstamen Onion Bulb and crude Panax notoginsensr according to 1:1-3:
1-4 proportion is mixed, and the water decoction for accounting for 10-20 times of medicinal material total weight is added, and decocting time is 2-6 hours；B, after decoction
The decoction liquor of acquisition passes through 40 mesh vibrating screen devices, is separated by solid-liquid separation, by isolated aqueous extract in thin-film concentrator
On (pressure be -740mmHg) is concentrated under reduced pressure, be then transferred in Stainless steel pressure cooking-vessel and carry out normal pressure concentration, after concentration
Medicinal extract is that every 1ml is equivalent to Chinese medicine 6-10g；C, 95% amount of alcohol is added in above-mentioned medicinal extract, is allowed to alcohol content and reaches 60%, stir
48 hours acquisitions precipitation solutions are stood after even, are placed in alcohol recycle pot recycling ethyl alcohol after precipitation solution is filtered again to no alcohol taste simultaneously
Obtain medicinal extract again, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-12g；D, it adds and accounts for medicinal extract weight
Percentage modulates softwood for 6% crospovidone and 70% ethyl alcohol, then makes in 16 mesh stainless steel mesh oscillating granulators
Wet grain；E, wet grain is uniformly spread out and is distributed in baking pan, be re-fed into forced air drying in heated-air circulation oven, oven temperature is controlled 75
DEG C, make cooling in particle water content to prescribed limit (lower than 6%), finally with the artificial whole grain of 16 mesh screens to get herbal mixture system
Agent.
The invention further relates to a kind of capsules, and the compound preparation of described stabilization and recession atherosclerotic plaque is packed into
To get stable and recession atherosclerosis compound capsule in capsule.
The invention further relates to a kind of lozenges, by the Chinese traditional compound medicine of described recession and reversal of atherosclerosis patch
Particle medicinal powder be added account for total weight percent 1% magnesium stearate mix 30 minutes, it is re-compacted in flakes, can be obtained recession and
The herbal mixture buccal tablet of reversal of atherosclerosis patch.
The invention further relates to a kind of coating tablets, by the herbal mixture system of described recession and reversal of atherosclerosis patch
The magnesium stearate that the particle medicinal powder addition of agent accounts for total weight percent 1% mixes 30 minutes, is pressed into label, and then outer package is sugared
The herbal mixture coating tablet of recession and reversal of atherosclerosis patch can be obtained in clothing or macromolecule membrane.
The invention further relates to a kind of ultrafine preparations, will be in the compound of described recession and reversal of atherosclerosis patch
The particle of medicine preparation is pulverized rod mill processing again, obtains the ultrafine preparation that partial size is 10-40um, and packing is spare,
It can be used as the inner stuffing of capsule preparation, lozenge preparation and coating tablet preparation.
In use, the present invention on the basis of effectively steadily inhibiting atherosclerotic lesion progress, realizes induction spot
Block subsides, to realize the Forward of wholistic therapy time window, fundamentally reduces all kinds of caused by atherosclerotic lesion
The occurrence probability of cardiocerebrovasculaevents events, furthermore the compatibility of this compound reduces the burden such as liver kidney, reduces biography by optimization improvement
System statins intensive treatment leads to the risk of liver renal toxicity.
Detailed description of the invention
Fig. 1 is inhibiting effect icon of the compound preparation of the present invention to experimental rabbit Carotid Atherosclerosis patch.
Specific embodiment:
The invention will be further described with reference to the accompanying drawings and examples.
The Chinese traditional compound medicine of a kind of recession and reversal of atherosclerosis patch of the present invention, with the prior art
Difference be: the Chinese traditional compound medicine is made of this three tastes Chinese medicine of Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng, Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit
The ratio between weight percent be 1:1-3:1-4.
A kind of Chinese traditional compound medicine of recession and reversal of atherosclerosis patch, difference with the prior art are:
The Chinese traditional compound medicine is made of weight percent of 50-100% major ingredient and 0-50% auxiliary material, the major ingredient packet
It is constituted containing this three tastes Chinese medicine by Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng, the ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 1:1-3:1-
4.By 1-60 parts of fritillaria, 1-40 parts and coptis 1-12 parts of the tuber of pinellia mix the auxiliary material；The auxiliary material is by dried immature fruit of citron orange 1-60
Part, 1-60 parts and Poria cocos 1-60 parts of campanulaceae mix；The auxiliary material is by 1-60 parts of dried orange peel, 1-60 parts of mountain Cape jasmine and Radix Angelicae Sinensis 1-40
Divide and mixes；By 1-35 parts of fructus amomi, 1-35 parts and Radix Glycyrrhizae 1-40 parts of radix aucklandiae mix the auxiliary material.
In the Chinese traditional compound medicine formula, major ingredient accounts for 65-70%, weight hundred shared by auxiliary material
Point than being 30-35%, the ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 3:2:1 in major ingredient, the auxiliary material by fritillaria,
The tuber of pinellia and the coptis this three tastes Chinese medicine are made, wherein the ratio between weight percent of fritillaria, the tuber of pinellia and the coptis is 1:1:1.The compound
In formula of Chinese materia medica preparation, major ingredient accounts for 65-70%, and auxiliary material accounts for 30-35%, master
The ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 3:2:1 in material, and the auxiliary material is by this three taste of the dried immature fruit of citron orange, campanulaceae and Poria cocos
Chinese medicine is made, wherein the ratio between weight percent of the dried immature fruit of citron orange, campanulaceae and Poria cocos is 2:1:1.In the Chinese traditional compound medicine formula,
Major ingredient accounts for 65-70%, and auxiliary material accounts for 30-35%, Radix Notoginseng in major ingredient, Longstamen Onion Bulb and
The ratio between weight percent of Snakegourd Fruit is 3:2:1, and the auxiliary material is made of this three tastes Chinese medicine of dried orange peel, mountain Cape jasmine and Radix Angelicae Sinensis, wherein old
The ratio between weight percent of skin, mountain Cape jasmine and Radix Angelicae Sinensis is 1:2:1.In the Chinese traditional compound medicine formula, weight hundred shared by major ingredient
Point than being 65-70%, auxiliary material accounts for 30-35%, Radix Notoginseng in major ingredient, Longstamen Onion Bulb and Snakegourd Fruit weight percent
The ratio between be 3:2:1, the auxiliary material is made of this three tastes Chinese medicine of fructus amomi, radix aucklandiae and Radix Glycyrrhizae, wherein fructus amomi, radix aucklandiae and Radix Glycyrrhizae
The ratio between weight percent is 1:1:1.
A kind of preparation method of recession and the Chinese traditional compound medicine of reversal of atherosclerosis patch, it is characterised in that: institute
The preparation method stated is water decoction-alcohol sedimentation the preparation method, the specific steps are as follows: a, the Chinese traditional compound medicine are by weight percent
50-100% major ingredient and 0-50% auxiliary material are made, and the major ingredient includes by this three tastes Chinese medicine structure of Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng
At the water that addition accounts for 10-20 times of medicinal material total weight in above-mentioned mixture decocts, and decocting time is 2-6 hours；B, it is obtained after decoction
The decoction liquor obtained passes through 40 mesh vibrating screen devices, is separated by solid-liquid separation, by isolated aqueous extract on thin-film concentrator
It is concentrated under reduced pressure, is then transferred in Stainless steel pressure cooking-vessel and carries out normal pressure concentration, the medicinal extract after concentration is during every 1ml is equivalent to
Medicinal material 6-10g；C, 95% amount of alcohol is added in above-mentioned medicinal extract, is allowed to alcohol content and reaches 60%, 48 hours are stood after stirring evenly and is obtained
Precipitation solution is placed in alcohol recycle pot again after filtering precipitation solution and recycles ethyl alcohol and obtain medicinal extract, above-mentioned leaching to no alcohol taste and again
Cream, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-12g；D, the poly- dimension of crosslinking for accounting for that medicinal extract weight percent is 6% is added
Ketone and 70% ethyl alcohol modulate softwood, then make wet grain in 16 mesh stainless steel mesh oscillating granulators；E, wet grain is uniformly spread out into cloth
In baking pan, it is re-fed into forced air drying in heated-air circulation oven, oven temperature is controlled at 75 DEG C, makes particle water content to regulation model
Interior cooling is enclosed, finally with the artificial whole grain of 16 mesh screens to get Chinese traditional compound medicine particle.
In a step, in the major ingredient, the ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 1:1-3:1-4；It is described
Auxiliary material in use the proportions of four kinds of heterogeneities, be respectively 1-60 part of fritillaria, 1-40 parts of the tuber of pinellia and 1-12 parts of the coptis mix and
At；1-60 parts of the dried immature fruit of citron orange, 1-60 parts of campanulaceae and 1-60 parts of Poria cocos mix；1-60 parts of dried orange peel, 1-60 parts of mountain Cape jasmine and Radix Angelicae Sinensis 1-40
Divide and mixes；1-35 parts of fructus amomi, 1-35 parts of radix aucklandiae and 1-40 parts of Radix Glycyrrhizae mix.In b step, the pressure model of reduced pressure
Enclose the negative 750mmHg of the 650mmHg-that is negative；In Step d, particle water content is cooled down after being lower than 6%.
It is added in the Chinese traditional compound medicine particle obtained in step e and accounts for Chinese traditional compound medicine weight percentage 1%
Magnesium stearate mixes 30 minutes, the particle after total mix, selects 0# gelatin hollow capsule, carries out capsule filling and obtains capsule, grain weight
0.35g/.
It is added in the Chinese traditional compound medicine particle obtained in step e and accounts for compound preparation particle medicinal powder weight percent 1%
Magnesium stearate mixes 30 minutes, re-compacted in blocks, and buccal tablet, slice weight 0.35g/ piece can be obtained.
It is added in the Chinese traditional compound medicine particle obtained in step e and accounts for compound preparation particle medicinal powder weight percent 1%
Magnesium stearate mixes 30 minutes, and at label, then outer package sugar-coat or macromolecule membrane, can be obtained coating tablet, slice weight
0.35g/ piece.
The Chinese traditional compound medicine particle obtained in step e is pulverized rod mill processing again, and acquisition partial size is 10-
The ultrafine preparation of 40um, packing is spare, can be used as the inner stuffing of capsule preparation, lozenge preparation and coating tablet preparation.
Although motherland's medicine successive dynasties document does not have the record of atherosclerosis, the phlegm of asthenia in origin and asthenia in superficiality is attributable in Chinese medicine
Turbid, blood stasis scope.The internal cause that phlegm generates is visceral dysfunction, and overfeeding sorghum savoury is its external cause, is said from hereditary angle
Tcm constitution situation such as " the fertile more phlegm of people " is also key factor.The pathogenic factors such as hyperlipidemia and hyperglycemia can be referred to as " in blood
Phlegm it is turbid ", Chinese medicine is attributed to phlegm card, and Shen Jinao " miscellaneous diseases source stream rhinoceros candle " says: " phlegm is object, flowing accident, therefore it is
Evil is pushed up up to top, down toward spring, is dropped with gas lift, and the whole body is inside and outside all to be arrived, and the vital organs of the human body all have." have the characteristics that easily to gather it is easy.
Foam cells gathers as the turbid retardance of phlegm, the solidifying not scattered specific body of phlegm under Earlier atherosclerotic lesion fatty streaks, inner membrance
It is existing, with the pathological characters easy to form for being also easy dissipation.Blood stasis, which refers to, hypostasis in body, mainly blood circulating out of vessels is accumulated
In vivo or blood fortune is unsmooth, blocks in the blood in passages through which vital energy circulates and internal organs.Chinese medicine is by plaque rupture, platelet activation and high blood coagulation
State, thrombosis are considered as syndrome of blood stasis scope.Phlegm is turbid, blood stasis is both the main pathological product of atherosclerosis and pathogenic
Factor, the two reciprocal causation can mutually convert, and phlegm can cause the stasis of blood, and the stasis of blood can give birth to phlegm, the overall process occurred through AS pathology, and phlegm-blood stasis is mutual
Knot is the Etiological interpretation of the cause, onset and process of an illness of atherosclerosis.Phlegm is derived from saliva, stasis of blood sheet in blood, but different stream and it is homologous, in certain specified conditions
Under can mutually convert.They are physiologically belonging to " homogeny of clear fluid and blood " in brief, are pathologically " phlegm-blood stasis is with disease ".Such as " Ling Shu Miraculous Pivot or Divine Axis carbuncle
Subcutaneous ulcer " cloud: " body fluid and tune, variation and it is red be blood ".There is " obstruction of the heart qi pain person also has the dead blood of chronic phlegm " in " Plain Questions numbness opinion "；" blood trouble
By water internal heat blood opinion " cloud: " hemostasis was both long, can also turn to phlegm water ".And for the theoretical origin of thoracic obstruction removing both phlegm and blood stasis at the same time
Long.If " the big opinion of Plain Questions YIN YANG classification of natural phenomena " proposes " blood reality person preferably determines it ", " the Ling Shu Miraculous Pivot or Divine Axis five tastes " also have building for " pained preferably to eat Chinese onion "
View；The two is the thinking blank that chest impediment and cardialgia is treated from phlegm, the stasis of blood.
The corresponding therapy rules for the treatment of theoretically are given to the phlegm and blood stasis disease such as atherosclerosis to this Chinese medicine, such as
" Treatise on Febrile and Miscellaneous Disease " summarizes the pervious theory of medicine of Qin Han, has founded the analysing and differentiating of febrile disease in accordance with the theory of the six pair of channels and therapeutic rules, has been put forward for the first time " phlegm and blood "
Relationship.It is cured mainly in " chest impediment and cardialgia lose heart abnormal pulse card control " piece and is equipped with the fluent qi and blood of white wine in all phlegm sides, be to imply phlegm
The stasis of blood is the same as the thinking controlled.The Tang Dynasty Prescriptions Worth Thousand Gold for Emergencies to soldier hair chest impediment and cardialgia control with rheum officinale, Ramulus euonymi activating microcirculation and removing stasis medicinal, Podophyllum emodi var chinense is dispelled
Phlegm dissipating bind, blood-breaking, campanulaceae resolving sputum；Song Dynasty " General Records of Holy Universal Relief thoracic obstruction door " controls thoracic obstruction, and the scattered Fang Zhongyong dried immature fruit of citron orange eliminating phlegm knot of four temperature dissipates ruffian
Product, with fluffy cowherb promoting circulation of blood stagnation resolvation.Jin Dynasty " red small stream heart mirror " " phlegm water drink stops knot and do not dissipate name thoracic obstruction side " takes Snakegourd Fruit, rhizoma atractylodis, Fructus Aurantiiization
Phlegm removes ruffian knot, Chinese herbaceous peony promoting blood circulation.Cao Renbai then clearly proposes that " chest pain radiating to the back is a chest in " after will hall case numbness valve "
Numbness ..., only phlegm is not turbid for this pain, and has hemostasis, hands between hindering diaphragm.Side full Snakegourd Fruit, Longstamen Onion Bulb, peach kernel, safflower ", not only recognizes chest
Numbness is closely related with phlegm-blood stasis, and the method for using removing both phlegm and blood stasis at the same time.
The present invention is based on the famous prescription Gualou Xiebai Tang in Han dynasty name doctor Zhang Zhongjing " Synopsis Golden Chamber ", according to " phlegm-blood stasis
With controlling " newest antiatherosclerosis new theory, improved and obtained in combination with long-term clinical practice.Snakegourd Fruit Longstamen Onion Bulb is white
Caudle activates yang and remove abstruction, and under slit phlegm, Radix Notoginseng and battalion's hemostasis, the row stasis of blood of promoting blood circulation, the two closes and adds taste, while removing white wine, function qi-regulating
Wide chest washs phlegm dissipating bind, activating microcirculation and removing stasis medicinal, removing both phlegm and blood stasis at the same time.Snakegourd Fruit nature and flavor sweetness and bitterness trembles with fear, enters lung, stomach, large intestine channel, cures mainly moistening lung, resolving sputum,
Dissipating bind, ease constipation.Control phlegm-heat cough, thoracic obstruction, accumulation of pathogens in chest, consumptive lung disease hemoptysis quenches one's thirst, jaundice, constipation, carbuncle swells from the beginning of；Longstamen Onion Bulb nature and flavor are pungent,
Hardship, temperature are cured mainly and are activated yang and removed abstruction with lung, stomach, large intestine channel is entered, promoting the circulation of qi promoting.For thoracic obstruction pain, phlegm retention cough and asthma lets out weight after dysentery；
Radix Notoginseng nature and flavor are sweet, slight bitter, warm-natured, return liver, stomach, the heart, lung, large intestine channel, cure mainly and fall flutter the stasis of blood swollen, thoracic obstruction colic pain, abdominal mass, blood stasis warp
It closes, dysmenorrhea, postpartum stasis of blood yin abdominal pain, sore, carbuncle and painful swelling.According to the principles of formulating prescriptions of " monarch ", monarch drug in a prescription is that Snakegourd Fruit is real, the wide chest of qi-regulating,
Phlegm dissipating bind is washed, the key medicine of thoracic obstruction pectoralgia is controlled, ministerial drug is Longstamen Onion Bulb, and the logical sliding benefit of temperature is activated yang and removed abstruction, promoting qi circulation and relieving pain, two medicines match, to control
The key medicine of thoracic obstruction, then help with pseudo-ginseng blood-circulation-invigovating stagnation resolvation, enhance the function that Longstamen Onion Bulb promoting the circulation of qi activates yang.Three taste medicines are mutually auxiliary to use, with the wide chest of qi-regulating,
Wash phlegm dissipating bind, activating microcirculation and removing stasis medicinal, removing both phlegm and blood stasis at the same time.
Zoopery proves that drug of the invention, toxicity is smaller, even if largely taking, also has no toxic side effect.Stablize and disappears
Atherosclerotic plaque compound preparation acute toxicity testing is moved back the results show that holding by drug maximum concentration of ordinary dissolution, maximum administration
Amount, SPF rank kunming mice stomach-filling gives 285g(crude drug) the compound preparation medicinal extract (without auxiliary material) of/kg.d weight is only being administered
Occurs apathetic, few phenomena such as moving, feeding less in 2 hours afterwards, administration restores successively after 2 hours, and test mice is in experiment
None is dead in phase, and median lethal dose LD50 is not measured, therefore only does maximum dosage-feeding (MTD) experiment.The result shows that mouse is given
MTD > 285g(of compound preparation converts into crude drug and calculates)/kg.d is the 21.4 of referrer's clinical dosage (weight is calculated by 60kg)
Times, illustrate that the medicine is nontoxic, clinical application safety.
Experimental animal grouping and its dosage: 8 week old SPE kunming mices totally 26, weight: 19.0~22.0g, male and female are each
Half, provided by Shanghai western Poole-Bi Kai experimental animal Co., Ltd, experimental animal production licence number: the Shanghai SCXK() 2008-
0016, raising: quality certification number: Naval Medical Research Institute, The 2nd Army Medical College animal house cures dynamic word the 0075045th.
Experimental method:
1) with the medicinal extract of embodiment 1, suspension is made, calculates maximum acceptable concentration 9.5g/ml.
2) animal fasting (12-16 hours), can't help water, according to weight gastric infusion, every mouse with 30ml/kg weight,
Disposable gastric infusion observes the poisoning and death condition of animal in 14 days after being administered.
3) observation index: toxic reaction and death condition after observation animal administration.Toxic reaction primary part observation symptom, journey
Degree, toxic reaction initial time, duration and recovery time etc..
4) maximum acceptable concentration and maximum allowable volume do not measure LD50 yet, can only demand maximum tolerated dose (MTD) value.Side
Method: the primary maximum allowable volume drug by maximum concentration gives 20 animals, is observed continuously 14 days, has no any animal dead,
Then MTD > XXg/kg.If only sporadic deaths,
As a result: 1) preliminary experiment: selection Kun Ming mice 6, half male and half female, 20 ± 2g of weight.Fasting, can't help water 12~
16 hours.The each stomach-filling of every mouse gives the spot that concentration is the 9.5g/ml containing crude drug and knows capsule medicinal extract 30ml/kg(weight), it fills
It stomach 1 time, then routinely raises.Situations such as observing mouse appearance, behavioral activity, breathing, secretion, defecation, death simultaneously claims body
Reconnection is 7 days continuous.Because being influenced by drug concentration and volume, single administration does not measure half cause with maximum concentration, maximum capacity
Dead amount (LD50), therefore only do maximum dosage-feeding experiment；2) maximum dosage-feeding is tested: selecting Kun Ming mice 20, male and female are each
Half, 20 ± 2g of weight.Fasting can't help water 12~16 hours.It is the 9.5g/ml's containing crude drug that concentration is given in each stomach-filling of every mouse
Spot knows capsule medicinal extract 30ml/kg(weight), stomach-filling 1 time, 2 hours after administration, there is in various degree apathetic, lacks in mouse
Dynamic, phenomena such as not feeding or feeding less, but after 2 hours restore successively, mouse shows no obvious abnormalities reaction, movable
Freely, diet, excrement and other situations are without exception, the personal light of hair color.7 days and 14 days animal subject weight have after administration
It obviously increases and (is shown in Table 1), visually observe no abnormality seen through dissect after mouse is put to death within the 14th day.The result shows that mouse is to compound preparation
MTD > 285g/kg.
Table 1 is stable and recession atherosclerotic plaque compound preparation is to acute toxicity test in mice changes of weight
Research of the stable and recession atherosclerotic plaque compound preparation to new zealand rabbit carotid artery atherosclerosis plaques
As the result is shown: stable and recession atherosclerotic plaque compound preparation, which has, adjusts blood lipid and inhibition atherosclerotic plaque
The effect of block progress, while there is significant regressive effect to the established carotid artery atherosclerosis plaques of industry.
Experimental animal grouping and its dosage:
Purebred new zealand white rabbit 48, half male and half female, weight 2.50kg ± 0.5kg are tested dynamic by The 2nd Army Medical College
Object center provides.Animal productiong licensing number: the Shanghai SCXK() 2007-0003；Animal uses credit number: the Shanghai SYXK() 2007-
0003。
Experimental method:
1) suspension, dosage 3.4mg/ are made into physiological saline with capsule 's content made from embodiment 6
(kg.d), experimental animal single cage routine feeding, free water, activity are unrestricted.All animals undergo 1 week common drink first
After eating the laundering period, 48 are carried out modeling after rabbit high fat diet 5 weeks, it is postoperative to continue (high lipid food formula: 5% glycerol three high in fat
Ester, 1% cholesterol, 94% rabbit basal feed) diet, then it is randomly divided into control group, compound preparation capsule intervention group and atropic
Cut down statin group 10mg/(kg.d), it is made into suspension same volume gastric infusion with physiological saline, control group gives isometric physiology
Salt water stomach-filling.Carotid atherosclerosis is induced using the method for inner membrance collagenase digesting damage.It is dynamic to give within 4 weeks after surgery neck
Arteries and veins ultrasonic evaluation patch situation finally repeated ultrasonic evaluation at experimental endpoints 24 weeks, then puts to death animal, leave and take blood sample, go forward side by side
The pathological analysis of promoting circulation of blood pipe.
2 compound preparation capsule of table to the adjustment effect of experimental rabbit blood lipid ()
* compared with the control group, #p < 0.05 is compared with Atorvastatin intervention group for p < 0.05
Table 2 the result shows that: 24 weekends, compound preparation intervention can significantly reduce the cholesterol of experimental animal serum, glycerol three
The level of ester and low density lipoprotein cholesterol, effect is similar with control drug Atorvastatin, while compound preparation can also
The hdl level of experimental animal serum is improved, effect will be significantly stronger than positive control medicine.
2) inhibit rabbit carotid atherosclerosis progress
The ultrasonic examination of arteria carotis body surface is carried out to experimental rabbit using toy ultrasonic image system Vevo 770, it is long along blood vessel
Axis measures lumen and measures backwall arterial intima-media thickness (IMT), left common carotid artery internal diameter (LCCAD).It is left and taken after putting to death animal
Arteria carotis sample carries out specimens paraffin embedding slices analysis, and concrete outcome is shown in Table 2 and Fig. 1.
3 compound preparation of table to the inhibiting effect of experimental rabbit Carotid Atherosclerosis patch ()
* p < 0.05 is compared with the control group
Table 3 and Fig. 1's the result shows that: give compound preparation intervention can significantly inhibit high fat diet new zealand rabbit inner membrance damage
The progress of carotid artery atherosclerosis plaques lesion caused by hurting, while increasing lumen diameter, the effect is compared with control drug statin
It is stronger, although statistical difference is not significant (p > 0.05).
3) stable and recession rabbit carotid atherosclerosis
Carotid ultrasound dynamic evaluation prompt: for spontaneous regression group although being changed to regular diet, plaque area still has increase,
And internal diameter of carotid reduces (#p < 0.05 is compared with 4 weeks), and compound preparation intervention then can effectively stable and recession rabbit arteria carotis congee
Sample plaque lesion, plaque area are reduced significantly (#p < 0.05 is compared with 4 weeks), and strengthening statin intervention has similar effect, but spot
Block regressive effect is markedly less than compound preparation intervention group.
4 compound preparation of table to the regressive effect of experimental rabbit Carotid Atherosclerosis patch ()
* #p < 005 clinical application compared with 4 weeks proves compared with the control group for p < 0.05, stabilization of the invention and recession artery
The Chinese traditional compound medicine of atherosclerotic plaque has very significant curative effect for patients with coronary heart disease, and general dosage is daily 5-
20mg/kg weight can specifically be determined according to concrete conditions such as the age state of an illness of patient by doctor.
Embodiment 1
Stable and recession atherosclerosis compound preparation particle medicinal powder manufacturing process, by Snakegourd Fruit, Longstamen Onion Bulb, three taste of Radix Notoginseng
After crude drug is according to the weight ratio mixing of 3:2:1,10 times of water is added to decoct, extraction time is 5 hours, through 40 mesh vibrating screen devices,
It is separated by solid-liquid separation, isolated aqueous extract is concentrated under reduced pressure on thin-film concentrator, is then transferred to stainless steel
Normal pressure concentration is carried out in pressure cooker, the liquid extract amount after concentration, which should be controlled, is equivalent to Chinese medicine 6-10g in every 1ml, and 95% second is added
Alcohol amount, alcohol content 60% stand 48 hours after stirring evenly, and after precipitation solution is filtered, set and recycle ethyl alcohol in alcohol recycle pot to no alcohol
Taste, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-12g, adds -70% ethyl alcohol tune of 6% crospovidone
Softwood processed then makes wet grain in 16 mesh stainless steel mesh oscillating granulators.Wet granular is uniformly spread out and is distributed in baking pan, is re-fed into
Forced air drying in heated-air circulation oven, oven temperature are controlled at 75 DEG C, keep particle water content cooling to < 6%, finally with 16 meshes
The carefully and neatly done grain of netizen to get.
Embodiment 2
3 parts of Snakegourd Fruit, 2 parts of Longstamen Onion Bulb, 1 part of Radix Notoginseng, 1 part of fritillaria, 1 part of the tuber of pinellia after 1 part of coptis mixing, will be added 10 times of decoctings
It boils, extraction time is 5 hours, through 40 mesh vibrating screen devices, is separated by solid-liquid separation, and isolated aqueous extract is dense in film
It is concentrated under reduced pressure on contracting machine, is then transferred in Stainless steel pressure cooking-vessel and carries out normal pressure concentration, the liquid extract amount after concentration should be controlled
System is equivalent to Chinese medicine 6-10g in every 1ml, and 95% amount of alcohol is added, and alcohol content 60% stands 48 hours after stirring evenly, by precipitation solution
After filtering, recycling ethyl alcohol is set in alcohol recycle pot to no alcohol taste, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine
8-12g adds -70% ethyl alcohol of 6% crospovidone modulation softwood, then makes in 16 mesh stainless steel mesh oscillating granulators wet
Grain.Wet granular is uniformly spread out and is distributed in baking pan, forced air drying in heated-air circulation oven is re-fed into, oven temperature is controlled at 75 DEG C,
Keep particle water content cooling to < 6%, finally with the artificial whole grain of 16 mesh screens to get.
Embodiment 3
By 3 parts of Snakegourd Fruit, 2 parts of Longstamen Onion Bulb, 1 part of Radix Notoginseng, 2 parts of the dried immature fruit of citron orange, 1 part of campanulaceae, after 1 part of Poria cocos mixing, 10 times of water is added to decoct,
Extraction time is 5 hours, through 40 mesh vibrating screen devices, is separated by solid-liquid separation, and isolated aqueous extract is concentrated in film
It is concentrated under reduced pressure on machine, is then transferred in Stainless steel pressure cooking-vessel and carries out normal pressure concentration, the liquid extract amount after concentration should control
It is equivalent to Chinese medicine 6-10g in every 1ml, 95% amount of alcohol is added, alcohol content 60% stands 48 hours after stirring evenly, by precipitation solution mistake
After filter, recycling ethyl alcohol is set in alcohol recycle pot to no alcohol taste, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-
12g adds -70% ethyl alcohol of 6% crospovidone modulation softwood, then makes in 16 mesh stainless steel mesh oscillating granulators wet
Grain.Wet granular is uniformly spread out and is distributed in baking pan, forced air drying in heated-air circulation oven is re-fed into, oven temperature is controlled at 75 DEG C,
Make particle water content to cooling after < 5%, finally with the artificial whole grain of 16 mesh screens to get.
Embodiment 4
By 3 parts of Snakegourd Fruit, 2 parts of Longstamen Onion Bulb, 1 part of Radix Notoginseng, 1 part of dried orange peel, 2 parts of mountain Cape jasmine, after Radix Angelicae Sinensis 1 divides mixing, 10 times of water is added to decoct,
Extraction time is 5 hours, through 40 mesh vibrating screen devices, is separated by solid-liquid separation, and isolated aqueous extract is concentrated in film
It is concentrated under reduced pressure on machine, is then transferred in Stainless steel pressure cooking-vessel and carries out normal pressure concentration, the liquid extract amount after concentration should control
It is equivalent to Chinese medicine 6-10g in every 1ml, 95% amount of alcohol is added, alcohol content 60% stands 48 hours after stirring evenly, by precipitation solution mistake
After filter, recycling ethyl alcohol is set in alcohol recycle pot to no alcohol taste, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-
12g adds -70% ethyl alcohol of 6% crospovidone modulation softwood, then makes in 16 mesh stainless steel mesh oscillating granulators wet
Grain.Wet granular is uniformly spread out and is distributed in baking pan, forced air drying in heated-air circulation oven is re-fed into, oven temperature is controlled at 75 DEG C,
Make particle water content to cooling after < 6%, finally with the artificial whole grain of 16 mesh screens to get.
Embodiment 5
By 3 parts of Snakegourd Fruit, 2 parts of Longstamen Onion Bulb, 1 part of Radix Notoginseng, 1 part of fructus amomi, 1 part of radix aucklandiae, after 1 part of Radix Glycyrrhizae mixing, 10 times of water is added to decoct,
Extraction time is 5 hours, through 40 mesh vibrating screen devices, is separated by solid-liquid separation, and isolated aqueous extract is concentrated in film
It is concentrated under reduced pressure on machine, is then transferred in Stainless steel pressure cooking-vessel and carries out normal pressure concentration, the liquid extract amount after concentration should control
It is equivalent to Chinese medicine 6-10g in every 1ml, 95% amount of alcohol is added, alcohol content 60% stands 48 hours after stirring evenly, by precipitation solution mistake
After filter, recycling ethyl alcohol is set in alcohol recycle pot to no alcohol taste, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-
12g adds -70% ethyl alcohol of 6% crospovidone modulation softwood, then makes in 16 mesh stainless steel mesh oscillating granulators wet
Grain.Wet granular is uniformly spread out and is distributed in baking pan, forced air drying in heated-air circulation oven is re-fed into, oven temperature is controlled at 75 DEG C,
Make particle water content to cooling after < 6%, finally with the artificial whole grain of 16 mesh screens to get.
It gives Chinese traditional compound medicine obtained above to following case to take, specific effect is as follows:
Typical case 1: male, 53 years old, business manager, patient had history of coronary heart disease 10 years, and feeling of oppression and pain in the chest is anti-with dizziness
In the multiple January of exacerbations in 3 years, row, which checks, after being admitted to hospital finds: blood lipid level significantly increases, moderate fatty liver；Angiography prompt: coronary artery three
Branch vessel lesion, left anterior descending branch moderate stenosis；Carotid ultrasound prompts: the visible area in right carotid artery bifurcation is about
3.52±0.04mm2Soft patch, give the compound preparation intervention of the stabilization and recession atherosclerosis of embodiment 6, every time 3
Grain, 3 times a day, patient's feeling of oppression and pain in the chest and dizziness are alleviated obvious after 2 months, and it is aobvious that carotid ultrasound visible plaques are checked after half a year
It writes and reduces.
Typical case 2: female, 41 years old, company clerk, patient's routine work pressure was big, lived irregular, and two years ago finds blood
Rouge increases, and gives the oral blood lipid of the fat-reducing medicaments such as statin and returns to normal, is often accompanied by dizziness uncomfortable in chest, aggravates 2 months, come
Our hospital's ECG examination prompts myocardial ischemia, and carotid ultrasound prompt bilateral carotid arteries inner membrance significantly thickens, IMT 2.75mm,
The compound preparation intervention of stabilization and recession atherosclerosis that embodiment 4 is content is given, 2 tablets each time, 3 times a day, January
Patient's dizziness uncomfortable in chest is alleviated obvious afterwards, and electrocardiogram prompt ST is forced down to be obviously improved than before, and it is super that arteria carotis is checked after half a year
The visible carotid artery intima IMT of sound is reduced to 1.75mm.
Typical case 3: female, 65 years old, housewife, patient had history of coronary heart disease 15 years, took the Western medicine pectoralgia head such as statin
The symptoms control such as dizzy is bad, with weakness of the lower extremities, in the recent period because Changes in weather, pectoralgia dizziness aggravate, carrys out our hospital's outpatient clinic,
Electrocardiogram prompts ST sections to force down obviously, and arteria carotis and the visible several patches of artery of lower extremity ultrasound, hemadostewnosis is obvious, and row coronary artery is made
Shadow and double lower limb angiography are clear: left anterior descending branch interrupts narrow 80%, right to be preced with narrow 40%, double lower limb thrombosis, it is seen that more
Locate filling defect, it is eccentric Vulnerable plaque that intravascular ultrasound, which prompts left anterior descending branch stenosis patch, and lactones core is larger, gives
Embodiment 2 is the compound preparation intervention of the stabilization and recession atherosclerosis of content, 4 tablets each time, 3 times a day, 2 months future troubles
Person's pectoralgia remission is obvious, and lower extremity motor function restores substantially, and intravascular ultrasound prompt: left anterior descending branch before is checked after half a year
Stenosis Vulnerable plaque has tended towards stability, and rouge core reduces obviously, and plaque area is reduced significantly, and it is 50% that stenosis, which improves,.
Typical case 4: male, 51 years old, leading cadre, patient had hypertension history 20 years, and history of coronary heart disease 10 years, smoking
400 years branch, frequent social activities are more, and daily 3 liang of white wine, the dizzy symptom out of strength of pectoralgia companion uncomfortable in chest occurs in nearly half a month, carry out the hospital emergency
Medical, electrocardiogram prompts Hypertensive disease, and ST sections greatly drive up, the visible severe fatty liver of abdomen MRI, and coronary angiography prompts three blood
Pipe lesion, is attached most importance to left anterior descending branch, opening narrow 70%, right hat many places filling defect, and neck ultrasound prompts bilateral carotid arteries
Multiple patch gives the compound preparation intervention of stabilization and recession atherosclerosis that embodiment 1 is content, 4 tablets each time, often
It 3 times, while cooperation such as is discontinued the habit of smoking and drinking at the life styles adjustment, patient's pectoralgia is uncomfortable in chest obvious with dizzy remission out of strength after January,
It checks coronary angiography prompt left anterior descending branch opening stenotic lesion after half a year to be obviously reduced, it is 40% that stenosis, which improves, arteria carotis
Ultrasound prompt bilateral carotid arteries patch number significantly reduces, and area reduces.
Above 4 patients take stable and recession atherosclerosis compound preparation, follow-up half a year, no allergy, fash
Wait adverse reactions, check blood urine routine and hepatic and renal function also no abnormality seen.
Embodiment 6
24 are selected with anginal patients with coronary heart disease, test group is decocted using compound preparation, and control group is using positive
Control drug Atorvastatin is treated, the effect of observation comparison two schemes.As a result: compound preparation can be obviously improved patient
Clinical symptoms, show as reduce patient blood lipid level, improve Hemorheology index, effect be better than positive control medicine,
Furthermore compound preparation can also significantly increase high density lipoprotein level of serum and carotid plaques can be promoted significantly to subside, the medicine pair
Liver kidney does not have any toxic side effect, is a kind of ideal antiatherosclerosis compound medicine.
General information and case selection
(1) age -55 years old 50 years old, male or female；(2) Shanghai Long March Hospital's in June, 2011 to outpatient service in April, 2012 and
In hospital with anginal patients with coronary heart disease, angina pectoris integral mean is 12.32 ± 3.06 points before treating, state of an illness moderate 54
Example, compared with severe 40, severe 6；(3) exist simultaneously patients with coronary heart disease 100 of carotid plaques, one in maximum arteria carotis in
Film thickness (IMT) >=1.3mm is defined as carotid plaques；(4) exclusion criteria: myocardial infarction, the hypertension for not obtaining control (are shunk
Pressure >=140mmHg, diastolic pressure >=90mmHg), the diabetes (fasting blood-glucose > 7.0mmol/L) that do not obtain control, Severe Left Ventricular
Incomplete (LVEF < 40), serious liver and kidney disease, it is 1 month nearly in cerebral apoplexy history, previously once took ACEI class drug and other may
The serious disease patient that experiment is impacted；(5) selected case average age 59.6 years old, male 56, women 44.Patient
Informed consent simultaneously signs informed consent form.
Test method
24 patient's randomized double-blinds are grouped, test group with control group each 12, select Atorvastatin (Lipitor, brightness
Auspicious company) it is positive control drug, do not set placebo.Oral administration, Atorvastatin 10mg/d, the leaching of Example 1
Cream be made compound preparation decoction decoction, specific dosage be 1 note/time, 3 times/day, the course for the treatment of is set to 40 weeks.
Observation index and method:
(1) clinical symptoms improve situation: angina pectoris attacks number, pain degree, duration, induced factor, nitric acid are sweet
Oily dose and stop lapse rate etc.；(2) electrocardiogram: 12 lead electrocardiogram；(3) blood lipid (total cholesterol TC, triacylglycerol TG, high density
Lipoprotein cholesterol HDL-C and low density lipoprotein cholesterol LDL-C)；Blood examination (platelet aggregation rate test)；
(4) carotid ultrasonography: longitudinal and transverse direction scanning is made using the white arteria carotis initial part of High-resolution ultrasound diagnostic system and is successively shown
Show arteria carotis communis, furcation and bifurcated distal end about 2cm within the scope of neck in and external carotid artery, measure carotid wall maximum IMT.Institute
Having ultrasonic index measurement person is same people, and is unaware that this Experimental detail；(5) safety observation index: blood routine (leucocyte
Sum and classification, Erythrocytes and hemoglobin, platelet count) routine urinalysis (Urine proteins), electrolyte (blood potassium, blood sodium, blood
Chlorine), liver function (bilirubin direct, indirect bilirubin, Archon ratio), renal function (serum creatinine, plasma wrea)；(6) adverse reaction: packet
Include gastrointestinal reaction, hemorrhagic lesions, arrhythmia cordis, liver and kidney dysfunction, electrolyte disturbance etc..
Curative effect judging standard:
It is formulated according to " guideline of clinical investigations of new Chinese medicine treatment coronary disease and angina pectoris ".1) curative effect of disease judgement mark
Quasi-: a. is effective: the cardinal symptoms such as angina pectoris disappear or reach effective standard (angina pectoris integrates deduction rate >=70%), and electrocardiogram is extensive
It answers to normal ECG or reaches substantially normal (i.e. normal range (NR) electrocardiogram)；B. effectively: the cardinal symptoms such as angina pectoris mitigate or
Reach effective standard (angina pectoris integrates deduction rate >=30%), electrocardiogram improvement reaches effective standard；C. invalid: angina pectoris etc. is main
Want symptom without improvement (angina pectoris integrates deduction rate < 30%), electrocardiogram is substantially identical as before treatment；D. aggravate: angina pectoris etc. is main
Exacerbation of symptoms (angina pectoris integrates deduction rate < 0) is wanted, electrocardiogram aggravates before relatively testing.2) cardinal symptom curative effect determinate standard: a. is aobvious
Effect: symptom disappear or mostly disappear (angina pectoris integrates deduction rate >=70%)；B. effectively: panic attacks number, degree and continue
Time has substantially reduced (angina pectoris integrates deduction rate >=30%)；C. invalid: symptom is substantially identical as before treatment, and (angina pectoris integrates
Deduction rate < 30%)；D. aggravate: panic attacks number, degree and duration are aggravated (angina pectoris integrates deduction rate < 0)；
4) ECG curative effect criterion: a. is effective: electrocardiogram restores to " substantially normal " or reaches " normal ECG "；B. effectively:
ST sections of reductions with rise 0.05mV or more after treatment, but do not reach normal level, shoal and (reach in main lead negative T wave
25% or more person)；Or T wave becomes upright from flat, chamber or intraventricular block improver；C. invalid: electrocardiogram substantially with
It is identical before treatment；D. aggravate: ST sections of reduction 0.05mV or more, main lead negative T wave deepen (up to 25% or more person) after treatment,
Or the upright T wave smooth or flat T wave that flattens becomes and is inverted.And there is ectopic cardiac rhythm, atrioventricular block or intraventricular block.
Carotid plaques progress: being subject to high frequency carotid ultrasonography result, is compared with baseline level.
As a result:
1. main clinic symptoms and electrocardiogram improve curative effect and compare after two groups of treatments:
Compound preparation decoction group effective percentage significantly improves (P < 0.01) up to 88%, 78% compared with Atorvastatin group.Two groups
Electrocardiogram improves curative effect and compares after treatment: two groups without significant difference (P > 0.05).
2. two groups of reducing blood lipid and improvement Hemorheology Indexes Comparison:
Compound preparation decoction group, Atorvastatin group can be substantially reduced the blood lipid level (P < 0.01) of patients with coronary heart disease,
Wherein compound preparation decoction can also significantly increase high density lipoprotein level of serum, and index difference compared with Atorvastatin is aobvious
It writes (P < 0.05), the results are shown in Table 5, while the effect of compound preparation decoction group improvement Hemorheology index will be substantially better than atropic
Statin (P < 0.01) is cut down, the results are shown in Table 6.
5 two groups of pretherapy and post-treatment Blood Lipids of table compare (X ± S, mmol/L)
* P < 0.01 compared with before treatment；# is compared with Atorvastatin group, P < 0.05.
(X ± S) is compared in 6 two groups of table pretherapy and post-treatment Hemorheology variations
* P < 0.05 compared with pre-treatment, P < 0.05 compared with Atorvastatin group #
3. two groups of influences to carotid plaques:
Spot dawn decoction treats 6 months rear neck artery patches and significantly subsides (P < 0.05), and Atorvastatin intervention is only capable of prolonging
Slow plaque progression, not significant (P>0.05) the two groups of IMT average change value significant differences (P<0.01) of IMT variation.
The comparison (mm) of 7 two groups for the treatment of rear neck artery IMT of table and its changing value
* P<0.05 compared with pre-treatment, & P>0.05 compared with pre-treatment, P<0.01 compared with Atorvastatin group #
4. safety evaluatio: sharing 3 adverse events in this clinical test, compound preparation decoction group 1, atropic is cut down
Statin group 2.Compound preparation decoction group 1 is epigastric discomfort, and mild degree continues medication symptom eliminates, and statin group 2 are creatase
It is slight to increase, restore normal after continuing medication, two groups of comparing differences are without conspicuousness (P > 0.05).Two groups because of drug side-effect
And stop treatment.Two groups of pretherapy and post-treatment hearts rate, blood, routine urinalysis, hepatic and renal function, blood glucose and electrolyte etc. have no significant change.Institute
Vital signs, weight are steady after having observation case to treat, variation without exception.Two groups are abnormal after medication without normal before medication,
Or exception and there is the case where clinical meaning before and after treatment.
Claims (2)
1. a kind of Chinese traditional compound medicine of recession and reversal of atherosclerosis patch, it is characterised in that: the herbal mixture system
In agent prescription, major ingredient accounts for 65-70%, and auxiliary material accounts for 30-35%, the master
By Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit, this three tastes Chinese medicine is made material, wherein the ratio between weight percent of Radix Notoginseng, Longstamen Onion Bulb and Snakegourd Fruit is 3:2:
1, the auxiliary material is made of this three tastes Chinese medicine of the dried immature fruit of citron orange, campanulaceae and Poria cocos, wherein the weight percent of the dried immature fruit of citron orange, campanulaceae and Poria cocos
The ratio between be 2:1:1.
2. a kind of preparation method of the Chinese traditional compound medicine of recession and reversal of atherosclerosis patch, it is characterised in that: described
Preparation method be water decoction-alcohol sedimentation the preparation method, the specific steps are as follows: a, the Chinese traditional compound medicine by weight percent be 65-
70% major ingredient and the auxiliary material of 30-35% are made, and the major ingredient is made of this three tastes Chinese medicine of Snakegourd Fruit, Longstamen Onion Bulb and Radix Notoginseng, above-mentioned
The water decoction for accounting for 10-20 times of medicinal material total weight is added in mixture, decocting time is 2-6 hours, in the major ingredient, three in major ingredient
Seven, the ratio between weight percent of Longstamen Onion Bulb and Snakegourd Fruit is 3:2:1, and the auxiliary material is by this three tastes Chinese medicine system of the dried immature fruit of citron orange, campanulaceae and Poria cocos
At, wherein the ratio between weight percent of the dried immature fruit of citron orange, campanulaceae and Poria cocos is 2:1:1；B, the decoction liquor obtained after decoction is shaken by 40 mesh
Dynamic screen device, is separated by solid-liquid separation, isolated aqueous extract is concentrated under reduced pressure on thin-film concentrator, is then shifted
Normal pressure concentration is carried out in Stainless steel pressure cooking-vessel, the medicinal extract after concentration is that every 1ml is equivalent to Chinese medicine 6-10g, reduced pressure
Pressure limit is negative 650 mmHg-negative 750mmHg；C, 95% ethyl alcohol is added in above-mentioned medicinal extract, is allowed to alcohol content and reaches 60%,
48 hours acquisition precipitation solutions are stood after stirring evenly, be placed in again after precipitation solution is filtered in alcohol recycle pot recycle ethyl alcohol to no alcohol taste simultaneously
Obtain medicinal extract again, above-mentioned medicinal extract, which continues to be concentrated into every 1ml medicinal extract, is equivalent to Chinese medicine 8-12g；D, it adds and accounts for medicinal extract weight
Percentage modulates softwood for 6% crospovidone and 70% ethyl alcohol, then makes in 16 mesh stainless steel mesh oscillating granulators
Wet grain, particle water content are cooled down after being lower than 6%；E, wet grain is uniformly spread out and is distributed in baking pan, is re-fed into heated-air circulation oven
Forced air drying, oven temperature are controlled at 75 DEG C, make cooling in particle water content to prescribed limit, finally manually whole with 16 mesh screens
Grain is added in Chinese traditional compound medicine particle and accounts for Chinese traditional compound medicine weight percentage 1% to get Chinese traditional compound medicine particle
Magnesium stearate mix 30 minutes, the particle after total mix, select 0# gelatin hollow capsule, carry out capsule filling obtain capsule, grain
Weight 0.35g/.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199733A (en) * | 2007-12-05 | 2008-06-18 | 邓淑元 | Arthralgia gas pill capsule |
| CN101554443A (en) * | 2008-04-09 | 2009-10-14 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating angina |
| CN102058757A (en) * | 2010-11-25 | 2011-05-18 | 代龙 | Traditional Chinese medicinal composition for treating cardiovascular diseases and preparation method thereof |
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|---|---|---|---|---|
| CN101199733A (en) * | 2007-12-05 | 2008-06-18 | 邓淑元 | Arthralgia gas pill capsule |
| CN101554443A (en) * | 2008-04-09 | 2009-10-14 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating angina |
| CN102058757A (en) * | 2010-11-25 | 2011-05-18 | 代龙 | Traditional Chinese medicinal composition for treating cardiovascular diseases and preparation method thereof |
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| Title |
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| HPLC法测定心通滴丸中丹酚酸B的含量;王徽 等;《辽宁中医杂志》;20111231;第38卷(第9期);1868-1869 |
| 从痰论治冠心病;李敬孝 等;《长春中医药大学学报》;20091031;第25卷(第5期);685-686 |
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