CN105617272A - Pharmaceutical preparation for treating atherosclerosis and application thereof - Google Patents

Pharmaceutical preparation for treating atherosclerosis and application thereof Download PDF

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CN105617272A
CN105617272A CN201610090962.XA CN201610090962A CN105617272A CN 105617272 A CN105617272 A CN 105617272A CN 201610090962 A CN201610090962 A CN 201610090962A CN 105617272 A CN105617272 A CN 105617272A
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parts
radix
herba
pharmaceutical preparation
grams
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季新玲
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    • A—HUMAN NECESSITIES
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/88—Liliopsida (monocotyledons)
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    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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Abstract

The invention relates to a pharmaceutical preparation for treating atherosclerosis and application thereof. The pharmaceutical preparation comprises 5-10 parts of berberis poiretii schneid, 3-11 parts of circium japonicum, 2-9 parts of radix sophorae tonkinensis, 3-8 parts of olibanum, 5-12 parts of houttuynia cordata, 20-40 parts of fructus arctii, 0.5-3 parts of American ginseng, 8-12 parts of mentha haplocalyx, 6-11 parts of radix glycyrrhizae, 1-4 parts of asarum, 1-5 parts of lumbricus, 2-7 parts of Physalis alkekengi var. francheti, 3-8 parts of radix clematidis, 10-15 parts of eucommia bark, 11-15 parts of prunella vulgaris, 5-12 parts of Valeriana officinalis L., 10-18 parts of polygonum multiflorum, 5-11 parts of sedum sarmentosum, 6-14 parts of selaginella tamariscina and 6-12 parts of rhizoma curcumae. The pharmaceutical preparation has the advantages that the medicinal materials of the pharmaceutical preparation are scientifically selected and reasonably combined to achieve the synergic effect of improving blood circulation, and the pharmaceutical preparation emphasizes the traditional Chinese medicine theory and can achieve yin-yang balance and evidently lower the risks of atherosclerosis and myocardial infarction.

Description

One is used for treating atherosclerotic pharmaceutical preparation and application thereof
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of for treating atherosclerotic pharmaceutical preparation and application thereof.
Background technology
Epidemiological study shows, along with the change with dietary habit that improves constantly of living standards of the people, China or even the whole world sickness rate of cardiovascular disease, the mortality rate gesture in persistently rising, age of onset is gradually rejuvenation also. It was predicted that likely account for the 36% of total death number to the year two thousand twenty whole world cardiovascular disease death, occupy the first place of the various lethal cause of disease of the mankind.
Atherosclerosis be a kind of by multifactor facilitate change into main chronic, progressive disease with big, medium-sized artery chronic inflammatory disease, it is characterized in vascellum tunica interna incrassation, lipidosis, and atherosclerotic stenosis can be caused, systemic arterial blood vessel can be involved, especially most commonly seen with coronary artery and cervical region, entocranial artery. Richard etc. show through massive epidemiology investigation and experimentation, hyperlipidemia, smoking, diabetes, hypertension, sex difference etc. are all the risk factors relevant with atherosclerosis generation, and hyperlipemia is atherogenic immediate cause and primary risk factor, Hyperlipemia is one of the most dangerous (being susceptible to suffer from) factor in the acceleration multiple factor of atherosclerosis. Wherein serum cholesterol level is proportionate with atherosclerotic. Therefore, cholesterol absorption, high density lipoprotein increasing (HDL) are limited, it is suppressed that oxidative stress level and arterial wall inflammation have become the atherosclerotic important means of preventing and treating.
Atherosclerosis (Atherosclerosis, AS) it is the important pathologic basis of cardiovascular and cerebrovascular disease, also it is an important pivot of metabolic syndrome, the most often involve the important organs such as the heart, brain, kidney, and with the disease height correlation such as diabetes, hypertension, although AS has been increasingly subject to the attention of people, but still it is focus and the difficult point of medical circle research, actively carries out in a deep going way atherosclerotic study on prevention is had important practical significance. For now, this capsule has had substantial amounts of clinic and experimentation to confirm its definite effect in treatment acute cerebral hemorrhage, cerebral ischemia, cerebral trauma and sepsis etc., but is then lacking research for atherosclerotic therapeutical effect.
The Drug therapy of existing market is still with Western medicine for Main Means, but western medicine has serious drug dependence effect, although pharmaceutical preparation also has much, but can to play effective effect little the short time.
Summary of the invention:
For the defect of prior art, the present invention be directed to the present situation for the treatment of at present, it is provided that a kind of pharmaceutical preparation that just can reach therapeutic effect without depending on western medicine, and have no side effect, effective.
Specifically, the concrete scheme of the present invention is achieved in that
First, inventor provides a kind of for treating atherosclerotic pharmaceutical preparation according to drug matching experience, and the Chinese medicine ingredients contained in prescription is: Radix Berberidis, Radix Cirsii Japonici, Radix Sophorae Tonkinensis, Olibanum, Herba Houttuyniae, Fructus Arctii, Radix Panacis Quinquefolii, Herba Menthae, Radix Glycyrrhizae, Herba Asari, Pheretima, Calyx seu Fructus physalis, Radix Clematidis, the Cortex Eucommiae, Spica Prunellae, Rhizoma et radix valerianae, Radix Polygoni Multiflori, Herba Sedi, Herba Selaginellae, Rhizoma Curcumae.
Further, inventor provides a kind of for treating atherosclerotic pharmaceutical preparation according to drug matching experience, each raw material dosage of prescription all has good curative effect in the weight portion scope of the present invention, described formula and weight portion be: Radix Berberidis 5-10 part, Radix Cirsii Japonici 3-11 part, Radix Sophorae Tonkinensis 2-9 part, Olibanum 3-8 part, Herba Houttuyniae 5-12 part, Fructus Arctii 20-40 part, Radix Panacis Quinquefolii 0.5-3 part, Herba Menthae 8-12 part, Radix Glycyrrhizae 6-11 part, Herba Asari 1-4 part, Pheretima 1-5 part, Calyx seu Fructus physalis 2-7 part, Radix Clematidis 3-8 part, Cortex Eucommiae 10-15 part, Spica Prunellae 11-15 part, Rhizoma et radix valerianae 5-12 part, Radix Polygoni Multiflori 10-18 part, Herba Sedi 5-11 part, Herba Selaginellae 6-14 part, Rhizoma Curcumae 6-12 part.
Further, the formula of above-mentioned weight portion is carried out preferably, reach superior technique effect, it is preferred that formula is: Radix Berberidis 7.5 parts, Radix Cirsii Japonici 7 parts, Radix Sophorae Tonkinensis 6 parts, Olibanum 6 parts, Herba Houttuyniae 9 parts, Fructus Arctii 30 parts, Radix Panacis Quinquefolii 1 part, Herba Menthae 10 parts, 9 parts of Radix Glycyrrhizae, Herba Asari 1.5 parts, Pheretima 3 parts, Calyx seu Fructus physalis 4.5 parts, Radix Clematidis 5.5 parts, the Cortex Eucommiae 12.5 parts, Spica Prunellae 13 parts, Rhizoma et radix valerianae 8.5 parts, Radix Polygoni Multiflori 14 parts, Herba Sedi 8 parts, Herba Selaginellae 10 parts, Rhizoma Curcumae 9 parts.
Or: Radix Berberidis 8 parts, Radix Cirsii Japonici 7.5 parts, Radix Sophorae Tonkinensis 6.5 parts, Olibanum 6.5 parts, Herba Houttuyniae 8 parts, Fructus Arctii 28 parts, Radix Panacis Quinquefolii 1.5 parts, Herba Menthae 9 parts, 10 parts of Radix Glycyrrhizae, Herba Asari 1.5 parts, Pheretima 3 parts, Calyx seu Fructus physalis 4.5 parts, Radix Clematidis 6 parts, the Cortex Eucommiae 13 parts, Spica Prunellae 14 parts, Rhizoma et radix valerianae 9 parts, Radix Polygoni Multiflori 15 parts, Herba Sedi 9 parts, Herba Selaginellae 11 parts, Rhizoma Curcumae 10 parts.
In pharmaceutical preparation described above, the Chinese medicine used all uses its conventional medicinal part to be used as medicine, and the dosage of drug used is reasonable, all medicines share after for treating atherosclerotic good effect.
The function of each taste Chinese crude drug used in the pharmaceutical preparation of the treatment of the present invention is as follows:
Radix Berberidis: bitter in the mouth, cold in nature.
Gui Jing: liver; Stomach; Large intestine channel.
Function cures mainly: heat clearing and damp drying; Eliminating fire and detoxication. Main dysentery due to damp-heat profit; Diarrhoea; Jaundice; Eczema; Skin infection; Aphtha; Conjunctival congestion; Pharyngalgia.
Radix Cirsii Japonici: sweet in the mouth, cool in nature.
Function cures mainly: cooling blood for hemostasis, dissipating blood stasis for subsidence of swelling. Cure mainly: epistaxis, spitting of blood, spit blood, hematuria, dysfunctional uterine hemorrhage, postpartum hemorrhage, hepatitis, nephritis, mastitis, traumatic injury; Traumatic hemorrhage is controlled in external, carbuncle furuncle and phyma poison.
Radix Sophorae Tonkinensis: bitter, cold; Poisonous.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: heat-clearing and toxic substances removing, sore-throat relieving of subsiding a swelling.
Olibanum: acrid in the mouth, warm in nature.
Function cures mainly: promoting blood circulation and stopping pain. For all pains of trusted subordinate, muscle arteries and veins contracture, traumatic injury, sore, carbuncle and painful swelling; Externally used detumescence granulation promoting.
Herba Houttuyniae: acrid in the mouth, cold in nature.
Gui Jing: return lung meridian.
Function cures mainly: heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, inducing diuresis for treating stranguria syndrome. For lung abscess vomiting pus, expectorant dyspnea of heat type is coughed, hematodiarrhoea, pyretic stranguria, carbuncle sore tumefacting virus.
Fructus Arctii: acrid in the mouth, cold in nature.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat. For anemopyretic cold, cough with copious phlegm, measles, rubella, laryngopharynx swelling and pain, mumps erysipelas, carbuncle sore tumefacting virus.
Radix Panacis Quinquefolii: sweet in the mouth, micro-hardship is cool.
Gui Jing: GUIXIN, lung, kidney channel.
Function cures mainly: boosting qi and nourishing yin, clearing away heat and promoting production of body fluid. For deficiency of vital energy yin deficiency, interior-heat, cough with asthma expectorant blood, deficiency-heat is tired of tired, quenches one's thirst, dryness of the mouth and throat.
Herba Menthae: acrid in the mouth, cool, return lung, Liver Channel, dispelling wind-heat, refresh oneself, rash, for anemopyretic cold, pathogenic wind-warm is from the beginning of, headache, conjunctival congestion, sore throat, aphtha, rubella, measles, breast side of body feeling of distension and oppression.
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: enter spleen, stomach, the heart, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain.
Herba Asari: acrid in the mouth, warm in nature.
Gui Jing: GUIXIN, lung, kidney channel.
Function cures mainly: expelling wind and cold, sensible pain relieving, warming the lung to resolve fluid-retention. For anemofrigid cold, headache, toothache, nasal sinusitis of having a stuffy nose, rheumatic arthralgia, phlegm retention is breathed with cough.
Pheretima: salty in the mouth, cold in nature.
Gui Jing: return liver, spleen, bladder warp.
Function cures mainly: heat clearing away is calmed the frightened, and dredging collateral is relievingd asthma, diuresis. For unconsciousness due to high fever, infantile convulsion is twitched, arthralgia, numb limbs and tense tendons, hemiplegia, dyspnea and cough due to lung-heat, oliguria edema, hypertension.
Radix Clematidis: bitter in the mouth, warm in nature.
Function cures mainly: can wind-damp dispelling, diuresis, stimulate the menstrual flow, ease pain, control that wind and cold is damp and hot, migraine, jaundice edema, the hard larynx of fishbone, waist knee joint legs and feet cold type of pain. Fresh strain energy treating acute tonsillitis, pharyngolaryngitis;
The Cortex Eucommiae: sweet in the mouth, warm in nature.
Gui Jing: return liver, kidney channel.
Function cures mainly: invigorating the liver and kidney, and bone and muscle strengthening is antiabortive. For lumbago due to renal deficiency, muscles and bones is unable, blood leaking in gestation, frequent fetal movement; Hypertension.
Spica Prunellae: acrid in the mouth, cold in nature.
Gui Jing: return liver, gallbladder meridian.
Function cures mainly: relieve inflammation or internal heat, improving eyesight, eliminating stagnation, detumescence. For conjunctival congestion and swelling pain, order pearl nyctalgia, dizziness of having a headache, scrofula, goiter,
Acute mastitis swells and ache;
Rhizoma et radix valerianae: acrid in the mouth, sweet, warm in nature.
Function cures mainly: calm the nerves, and regulates the flow of vital energy, pain relieving. For neurasthenia, insomnia, hysteria, epilepsy, stomach abdominal distention and pain, lumbago and skelalgia, traumatic injury.
Calyx seu Fructus physalis return through: enter liver, spleen two warp.
Function cures mainly: heat clearing away, removing toxic substances, diuresis. Control hectic fever due to YIN-deficiency consumptive fever, cough, laryngopharynx swelling and pain, jaundice, edema, sky bubble eczema.
Radix Polygoni Multiflori: bitter in the mouth, warm in nature.
Gui Jing: return liver, the heart, kidney channel.
Function cures mainly: removing toxic substances, eliminating carbuncle, and loosening bowel to relieve constipation, for scrofula carbuncle sore, rubella pruritus, dryness of the intestine constipation; Hyperlipidemia.
Herba Sedi: sweet in the mouth, light, cool in nature.
Gui Jing: return liver, gallbladder, small intestine meridian.
Function cures mainly: dampness removing jaundice eliminating, heat-clearing and toxic substances removing. For jaundice due to damp-heat, dysuria, carbuncle skin infection.
Herba Selaginellae: acrid in the mouth, property is put down.
Gui Jing: return liver, heart channel.
Function cures mainly: promoting blood circulation to restore menstrual flow. For amenorrhea dysmenorrhea. Abdominal mass mass in the abdomen, injury from falling down. Herba Selaginellae charcoal removing stasis to stop bleeding. For spitting blood, metrorrhagia, have blood in stool, proctoptosis.
Rhizoma Curcumae: acrid in the mouth, warm in nature.
Gui Jing: return liver, spleen channel.
Function cures mainly: circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving. For abdominal mass mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain; Early cervical carcinoma.
Present invention also offers the purposes of a kind of pharmaceutical preparation, described pharmaceutical preparation application in the medicine of preparation prevention myocardial infarction.
Present invention also offers a kind of preparation method treating atherosclerotic pharmaceutical preparation, the step specific as follows that inventor provides:
1) taking Radix Berberidis, Radix Cirsii Japonici, Radix Sophorae Tonkinensis, Herba Houttuyniae, Herba Menthae, Radix Clematidis, Spica Prunellae, Rhizoma et radix valerianae, Herba Sedi and Herba Selaginellae to soak 1 hour, fast baked wheaten cake is opened, slow fire 1.5h; Pour out portion filtrate, then by step 3) in, decoct 3h at slow fire, filter, heating concentration, obtain concentrated solution, concentrated solution and medicinal residues standby;
2) take Olibanum, Fructus Arctii, Radix Panacis Quinquefolii, Radix Glycyrrhizae and Herba Asari and grind to form coarse powder, add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, stand 24 hours, standby;
3) take Pheretima, Calyx seu Fructus physalis, the Cortex Eucommiae, Radix Polygoni Multiflori and Rhizoma Curcumae to be ground into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collection extracting solution, stand 24 hours, standby;
4) taking the supernatant prepared in (2nd) and (3) step, decompression recycling ethanol, be concentrated into 70 DEG C, density is the extractum of 1.03-1.05, standby;
5) by 1) fine powder and 4 of step) extractum of step is mixed to get mixture, and add pharmaceutically acceptable adjuvant, make capsule.
Step 5 in above-mentioned preparation method) described in capsule be made up of the mixture that weight part ratio is 1: 0.05-02 and pharmaceutically acceptable adjuvant, it is preferred that for being made up of the mixture that weight part ratio is 1:0.1 and pharmaceutically acceptable adjuvant.
Compared with prior art, compatibility is more reasonable, focuses on theory of Chinese medical science, and negative and positive are balanced for the preparation of medicine of the present invention, and all medicines are mutually collaborative to be reached to improve blood circulation, has the risk significantly reducing atherosclerosis, myocardial infarction. In present invention therapeutic process in treatment, the medicine taking the present invention can be effective through 1 course for the treatment of, after taking 2-3 course for the treatment of continuously, has obvious therapeutic effect, the applicable industrialized great production simple, easy to operate of the technique of capsule provided by the invention.
Specific embodiment
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, and when without departing substantially from the spirit of the present invention or basic feature, it is possible to realize the present invention in other specific forms. Therefore, no matter from which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the invention rather than described above limits, it is intended that all changes in the implication of the equivalency dropping on claim and scope included in the present invention.
Embodiment 1: one is used for treating atherosclerotic capsule, containing following weight portion Chinese crude drug:
Radix Berberidis 5 grams, Radix Cirsii Japonici 3 grams, Radix Sophorae Tonkinensis 2 grams, Olibanum 3 grams, Herba Houttuyniae 5 grams, Fructus Arctii 20 grams, Radix Panacis Quinquefolii 0.5 gram, Herba Menthae 8 grams, 6 grams of Radix Glycyrrhizae, Herba Asari 1 gram, Pheretima 1 gram, Calyx seu Fructus physalis 2 grams, Radix Clematidis 3 grams, the Cortex Eucommiae 10 grams, Spica Prunellae 11 grams, Rhizoma et radix valerianae 5 grams, Radix Polygoni Multiflori 10 grams, Herba Sedi 5 grams, Herba Selaginellae 6 grams, Rhizoma Curcumae 6 grams.
Preparation method is:
1) taking Radix Berberidis, Radix Cirsii Japonici, Radix Sophorae Tonkinensis, Herba Houttuyniae, Herba Menthae, Radix Clematidis, Spica Prunellae, Rhizoma et radix valerianae, Herba Sedi and Herba Selaginellae to soak 1 hour, fast baked wheaten cake is opened, slow fire 1.5h; Pour out portion filtrate, then by step 3) in, decoct 3h at slow fire, filter, heating concentration, obtain concentrated solution, concentrated solution and medicinal residues standby;
2) take Olibanum, Fructus Arctii, Radix Panacis Quinquefolii, Radix Glycyrrhizae and Herba Asari and grind to form coarse powder, add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, stand 24 hours, standby;
3) take Pheretima, Calyx seu Fructus physalis, the Cortex Eucommiae, Radix Polygoni Multiflori and Rhizoma Curcumae to be ground into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collection extracting solution, stand 24 hours, standby;
4) taking the supernatant prepared in (2nd) and (3) step, decompression recycling ethanol, be concentrated into 70 DEG C, density is the extractum of 1.03-1.05, standby;
5) by the extractum mix homogeneously of step (1) and (4), add lactose in the mixture of the lactose of its weight 10% and the mixture of dextrin, lactose and dextrin and and the weight ratio of dextrin be 1:0.5; Stir heating to 75 DEG C, dry, add binding agent and cross 16 mesh sieves, granulate, dry and load capsule, obtaining capsule.
Embodiment 2: one is used for treating atherosclerotic capsule, containing following weight portion Chinese crude drug:
Radix Berberidis 10 grams, Radix Cirsii Japonici 11 grams, Radix Sophorae Tonkinensis 9 grams, Olibanum 8 grams, Herba Houttuyniae 12 grams, Fructus Arctii 40 grams, Radix Panacis Quinquefolii 3 grams, Herba Menthae 12 grams, 11 grams of Radix Glycyrrhizae, Herba Asari 4 grams, Pheretima 5 grams, Calyx seu Fructus physalis 7 grams, Radix Clematidis 8 grams, the Cortex Eucommiae 15 grams, Spica Prunellae 15 grams, Rhizoma et radix valerianae 12 grams, Radix Polygoni Multiflori 18 grams, Herba Sedi 11 grams, Herba Selaginellae 14 grams, Rhizoma Curcumae 12 grams.
Preparation method is with embodiment 1.
Embodiment 3: one is used for treating atherosclerotic capsule, containing following weight portion Chinese crude drug:
Radix Berberidis 7.5 grams, Radix Cirsii Japonici 7 grams, Radix Sophorae Tonkinensis 6 grams, Olibanum 6 grams, Herba Houttuyniae 9 grams, Fructus Arctii 30 grams, Radix Panacis Quinquefolii 1 gram, Herba Menthae 10 grams, 9 grams of Radix Glycyrrhizae, Herba Asari 1.5 grams, Pheretima 3 grams, Calyx seu Fructus physalis 4.5 grams, Radix Clematidis 5.5 grams, the Cortex Eucommiae 12.5 grams, Spica Prunellae 13 grams, Rhizoma et radix valerianae 8.5 grams, Radix Polygoni Multiflori 14 grams, Herba Sedi 8 grams, Herba Selaginellae 10 grams, Rhizoma Curcumae 9 grams.
Preparation method is with embodiment 1.
Embodiment 4: one is used for treating atherosclerotic capsule, containing following weight portion Chinese crude drug:
Radix Berberidis 8 grams, Radix Cirsii Japonici 7.5 grams, Radix Sophorae Tonkinensis 6.5 grams, Olibanum 6.5 grams, Herba Houttuyniae 8 grams, Fructus Arctii 28 grams, Radix Panacis Quinquefolii 1.5 grams, Herba Menthae 9 grams, 10 grams of Radix Glycyrrhizae, Herba Asari 1.5 grams, Pheretima 3 grams, Calyx seu Fructus physalis 4.5 grams, Radix Clematidis 6 grams, the Cortex Eucommiae 13 grams, Spica Prunellae 14 grams, Rhizoma et radix valerianae 9 grams, Radix Polygoni Multiflori 15 grams, Herba Sedi 9 grams, Herba Selaginellae 11 grams, Rhizoma Curcumae 10 grams.
Preparation method is with embodiment 1.
Embodiment 5, pharmacodynamics test
Simvastatin is mainly used to treat transient ischemic attack, hyperlipemia, atherosclerosis, cerebral blood supply insufficiency, myocardial infarction, hypercholesterolemia, hypertriglyceridemia, coronary heart disease, cerebral infarction, transience cerebral ischaemic shows effect, familial hypercholesterolemia, cerebral ischemia diseases, brain soldier, the present invention is used for testing as positive control.
5.1, animal model
Take 48 healthy new zealand white rabbits, body weight is 2.5-3.0kg, it is randomly divided into the basic, normal, high dosage group of capsule totally 5 groups of Normal group, model group, positive controls, embodiment 3, often group 8, all male, all animals marking pen traces Arabic numerals to distinguish individuality at left ear. model control group, positive controls, the capsule of embodiment 3 is low, in, the leading gavage height fat breast of high dose group animal 1 month, ear edge arterial blood extracting detection animal TG, after TC raises, pentobarbital sodium 30mg/kg auricular vein injecting anesthetic, reject cervical region by hair, sterilization, surgical exposure animal about left common carotid 2.5cm, blood vessel proximal part and distal end is closed with bulldog clamp successively folder, between two ends, artery-sparing length is about 2cm, draw 1% concentration sodium laurate 0.1ml with insulin injection syringe and inject blood vessel, distal end vascular clamp is unclamped after 5min, proximal part is unclamped again after cotton balls hemostasis by compression, sew up a wound, rearging cage is put back to after disinfecting. after the sterilization of postoperative intramuscular injection for three days on end 800,000 units of Penicillin, starting gastric infusion (administering mode dosage such as table 1), the administration time limit is 2 months, is administered every day 1 time, continues gavage height fat breast every day simultaneously.
Wherein high fat breast formula be: with formula be 3.5% cholesterol, 1.1% sodium cholate, 0.4% propylthiouracil, 6% white sugar, 12% Adeps Sus domestica, 77% normal feedstuff.
It is as follows that administration concrete condition respectively organized by table 1
Group Quantity Administering mode Administration kind Dosage (g/kg)
Normal group 8 Gavage Normal saline 2
Model group 8 Gavage Normal saline 2
Positive controls 8 Gavage Simvastatin 0.2
Capsule high dose group 8 Gavage The embodiment of the present invention 3 10
Dosage group in capsule 8 Gavage The embodiment of the present invention 3 5
Capsule low dose group 8 Gavage The embodiment of the present invention 3 2.5
5.2, result
It is administered ear edge arterial blood extracting 4ml after two months, centrifuging and taking serum, utilizes automatic clinical chemistry analyzer detection serum TG (blood fat), TC (cholesterol), HDL (high density fat), LDL (low density lipoprotein, LDL). Concrete condition is in Table 2.
Table 2 TG, TC, HDL, LDL measurement result after 2 months is as follows:
Note:
Compared with normal group,P < 0.05; Compared with normal group,P < 0.01;
Compared with model group,*P < 0.05; Compared with model group,**P < 0.01;
Compared with positive controls,��P < 0.05.
Effect from table 2, model group is compared with Normal group, there is the difference (p < 0.01) of significance, modeling of the present invention success is described, each group of Chinese medicine composition, positive controls I group, there is compared with model group significant difference, be respectively provided with significant difference (p < 0.05), there is good therapeutic effect, wherein, the content of Chinese medicine composition dosage TC and LDL high, middle, compared with positive controls, has significant difference.
Embodiment 6: the capsule man of the present invention protective effect to rat model of myocardial infarction cardiac muscle
6.1, animal model
Cleaning grade healthy rat 60, each 30 of male and female, body weight, between 230��280g, is divided into the basic, normal, high dosage group of sham operated rats, model control group, the embodiment of the present invention 4 capsule, often group 10, each 5 of male and female. 3% pentobarbital sodium 50mg/kg intraperitoneal injection of anesthesia, look at descending tracheal intubation straight, after adjustment animal respirator is consistent with respirator until rats breathing frequency and stable, reject art district (left breast the 3rd intercostal) by hair, sterilization, surgical exposure heart, at left auricle edge inserting needle, under pulmonary conus place, 1mm enters the arena, ligation ramus descendens anterior arteriae coronariae sinistrae, heart surface point lignocaine injection 1��2, preventing room from quivering generation, successively close breast, rearging cage is put back in incision sterilization. Except sham operated rats threading not ligation, other animal is all performed the operation according to the method described above, postoperative every animal intramuscular injection penicillin 100,000 units/sky, for three days on end. Animal starts administration, successive administration 2 weeks (concrete administrations such as table 3), every day 1 time for postoperative 2nd day.
It is as follows that administration concrete condition respectively organized by table 3
Group Quantity Administering mode Administration kind Dosage (g/kg)
Sham operated rats 10 Gavage Normal saline 2
Model control group 10 Gavage Normal saline 2
Positive controls 10 Gavage Simvastatin 0.003
Capsule high dose group 10 Gavage The embodiment of the present invention 3 0.5
Dosage group in capsule 10 Gavage The embodiment of the present invention 3 0.25
Capsule low dose group 10 Gavage The embodiment of the present invention 3 0.125
6.2, experimental result
6.2.1, survival of rats situation
Sham operated rats animal all survives, and the basic, normal, high dosage component of model control group, capsule is not survived 11,14,13,13 animals.
6.2.2, Serum bichemisbry inspection
After all Animal Anesthesia, abdomen cardinal vein takes blood, take serum after 3000rpm is centrifugal and carry out Serum bichemisbry inspection, result is in Table 7, result shows compared with sham operated rats, model control group AST, CKMB, LDH rising have significant difference (P < 0.05), it was shown that modeling success; Compare capsule group These parameters all have reduction with model group and have significant difference (P < 0.05), it was shown that myocardial infarction is all had therapeutic effect by both.
It is as follows that Serum bichemisbry inspection respectively organized by table 4
Group AST(��/L) CKMB(��/L) LDH(��/L)
Sham operated rats 649.3��88.8 744.3��86.3 1711.2��211.5
Model control group 1296.3��123.9 1400.1��133.9 2788.6��23.6
Positive controls 872.3��110.1** 996.3��124.8** 2113.5��241.0**
Capsule high dose group 802.1��121.3**�� 890.2��88.4**�� 2000.3��231.2**��
Dosage group in capsule 911.8��124.3** 1101.8��101.9** 2122.9��203.3**
Capsule low dose group 956.9��100.3** 1322.2��112.4** 2385.7��201.6**
Note:
Compared with normal group,P < 0.05; Compared with normal group,P < 0.01;
Compared with model group,*P < 0.05; Compared with model group,**P < 0.01;
Compared with positive controls,��P < 0.05.
Therapeutic effect from table 4, model group is compared with Normal group, there is the difference (p < 0.01) of significance, modeling of the present invention success is described, each group of Chinese medicine composition, positive controls I group, there is compared with model group significant difference, be respectively provided with significant difference (p < 0.05), there is good therapeutic effect, wherein, the content of Chinese medicine composition high dose TC and LDL, compared with positive controls, has significant difference. Illustrate that the myocardial infarction that atherosclerosis is caused by the capsule of the present invention has good therapeutic effect, it is possible to effectively alleviate Myocardial injury degree.
Embodiment 7: toxicity is verified
7.1, acute toxicity test
Test medicine preparation: the capsule manufactured by embodiment of the present invention 1-4, adds purified water by 1:2, makes solution, standby. Experimental animal: regular grade kunming mice, body weight 20g �� 5g, male and female half and half, female mice is all without pregnant.
The solution of mouse stomach Chinese medicine capsules preparation of the present invention, when given low reaches 735.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
Result of the test shows: the maximum dosage-feeding of the capsule manufactured by mouse stomach embodiment 1-4 is 735.5g crude drug/kg/d (LD50 > 735.5g crude drug/kg). The Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum; By weighing machine, the dosis tolerata of mouse stomach capsule is 4903.3 times of clinical patient. Point out this medicine acute toxicity extremely low, clinical drug safety.
7.2, long-term toxicity test for animals
Test medicine preparation: embodiment of the present invention 1-3 gained Chinese medicine capsules, adds purified water by 1:2, makes solution, standby. Experimental animal: regular grade SD rat, body weight 210g �� 14g, male and female half and half, female rats is all without pregnant.
7.3, method and result:
3 kinds of Chinese medicine capsules: be divided into high, medium and low three dosage groups, per weight dosage respectively the 180 of patient's dose, 60,20 times; Experimental mouse is randomly divided into 10 groups, and wherein the capsule solution of 9 groups of difference 3 kinds of three dosage of gavage, remains 1 group of gavage normal saline (40 times of patient's dose); All 10 groups of gavages 180 days all continuously, observe animal general toxic reaction and the order of severity, and place after death checks each position by rule of operation, and carries out hematology, the pathological examination of the main organs such as ALT, BUN and the heart, liver, spleen, lung, kidney, stomach; Through long-term feeding, all there is not toxic reaction in 10 groups of rats. Physically well develop. Macroscopic appearance and main organs no abnormality seen. Peripheral hemogram and Serum ALT, BUN compare with matched group without pathologic change. The all not significant changes such as the pathological replacement heart, liver, spleen, lung, kidney, stomach, it is therefore contemplated that through proved by pathology, animal is showed by 3 kinds of Chinese medicine capsules without chronic toxicity.
By two above toxicity test, it was demonstrated that the present invention is safe by the embodiment 1-3 Chinese medicine capsules made, and has no side effect, it is possible to taken by patient.
Embodiment 8, model case
Case 1: Lee, man, 56 years old, within 2013, check to my institute, patient for a long time uncomfortable in chest, nervous, weak, have a dizzy spell, be 5.78mmol/L through checking TC, TG is 3.17mmol/L, atherogenic index 4.98, the capsule taking the embodiment of the present invention 3 of patient is after 2 months, be 5.75mmol/L is 5.21 through rechecking TC, TG is 3.12mmol/L, atherogenic index 4.98 continues drug administration 4 months, and symptom is wholly absent, chemically examines blood fat normally, and Effect of follow-up visit by telephone does not recur for 1 year.
Case 2: Hu, female, 57 years old, 2012 suffer from hyperlipidemia, and the diet of patient's private prosecution notes always very much, but diet is irregular during lunar calendar Mid-autumn Festival, and diet contains the high oils and fats of content, cholesterol foods, the time of about 10 days afterwards, dizzy phenomenon occur, TC is 5.90mmol/L on inspection, TG is 3.13mmol/L, atherogenic index 5.23, the capsule taking the embodiment of the present invention 4 of patient, after 14 days, takes a turn for the better, dizzy phenomenon disappears substantially, oral administration medicine of the present invention is after 2 months, and transference cure, chemical examination blood fat is normal. Effect of follow-up visit by telephone does not recur for 1 year.

Claims (9)

1. one kind is used for treating atherosclerotic pharmaceutical preparation, it is characterised in that: described pharmaceutical preparation includes following Chinese crude drug: Radix Berberidis, Radix Cirsii Japonici, Radix Sophorae Tonkinensis, Olibanum, Herba Houttuyniae, Fructus Arctii, Radix Panacis Quinquefolii, Herba Menthae, Radix Glycyrrhizae, Herba Asari, Pheretima, Calyx seu Fructus physalis, Radix Clematidis, the Cortex Eucommiae, Spica Prunellae, Rhizoma et radix valerianae, Radix Polygoni Multiflori, Herba Sedi, Herba Selaginellae, Rhizoma Curcumae.
2. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation includes following weight portion Chinese crude drug: Radix Berberidis 5-10 part, Radix Cirsii Japonici 3-11 part, Radix Sophorae Tonkinensis 2-9 part, Olibanum 3-8 part, Herba Houttuyniae 5-12 part, Fructus Arctii 20-40 part, Radix Panacis Quinquefolii 0.5-3 part, Herba Menthae 8-12 part, Radix Glycyrrhizae 6-11 part, Herba Asari 1-4 part, Pheretima 1-5 part, Calyx seu Fructus physalis 2-7 part, Radix Clematidis 3-8 part, Cortex Eucommiae 10-15 part, Spica Prunellae 11-15 part, Rhizoma et radix valerianae 5-12 part, Radix Polygoni Multiflori 10-18 part, Herba Sedi 5-11 part, Herba Selaginellae 6-14 part, Rhizoma Curcumae 6-12 part.
3. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation includes following weight portion Chinese crude drug: Radix Berberidis 7.5 parts, Radix Cirsii Japonici 7 parts, Radix Sophorae Tonkinensis 6 parts, Olibanum 6 parts, Herba Houttuyniae 9 parts, Fructus Arctii 30 parts, Radix Panacis Quinquefolii 1 part, Herba Menthae 10 parts, 9 parts of Radix Glycyrrhizae, Herba Asari 1.5 parts, Pheretima 3 parts, Calyx seu Fructus physalis 4.5 parts, Radix Clematidis 5.5 parts, the Cortex Eucommiae 12.5 parts, Spica Prunellae 13 parts, Rhizoma et radix valerianae 8.5 parts, Radix Polygoni Multiflori 14 parts, Herba Sedi 8 parts, Herba Selaginellae 10 parts, Rhizoma Curcumae 9 parts.
4. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation includes following weight portion Chinese crude drug: Radix Berberidis 8 parts, Radix Cirsii Japonici 7.5 parts, Radix Sophorae Tonkinensis 6.5 parts, Olibanum 6.5 parts, Herba Houttuyniae 8 parts, Fructus Arctii 28 parts, Radix Panacis Quinquefolii 1.5 parts, Herba Menthae 9 parts, 10 parts of Radix Glycyrrhizae, Herba Asari 1.5 parts, Pheretima 3 parts, Calyx seu Fructus physalis 4.5 parts, Radix Clematidis 6 parts, the Cortex Eucommiae 13 parts, Spica Prunellae 14 parts, Rhizoma et radix valerianae 9 parts, Radix Polygoni Multiflori 15 parts, Herba Sedi 9 parts, Herba Selaginellae 11 parts, Rhizoma Curcumae 10 parts.
5. the preparation method of the pharmaceutical preparation prepared described in any one of claim 1-3, it is characterized in that, concrete step is: 1) takes Radix Berberidis, Radix Cirsii Japonici, Radix Sophorae Tonkinensis, Herba Houttuyniae, Herba Menthae, Radix Clematidis, Spica Prunellae, Rhizoma et radix valerianae, Herba Sedi and Herba Selaginellae and soaks 1 hour, fast baked wheaten cake is opened, slow fire 1.5h; Pour out portion filtrate, then by step 3) in, decoct 3h at slow fire, filter, heating concentration, obtain concentrated solution, concentrated solution and medicinal residues standby;
2) take Olibanum, Fructus Arctii, Radix Panacis Quinquefolii, Radix Glycyrrhizae and Herba Asari and grind to form coarse powder, add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, stand 24 hours, standby;
3) take Pheretima, Calyx seu Fructus physalis, the Cortex Eucommiae, Radix Polygoni Multiflori and Rhizoma Curcumae to be ground into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collection extracting solution, stand 24 hours, standby;
4) taking the supernatant prepared in (2nd) and (3) step, decompression recycling ethanol, be concentrated into 70 DEG C, density is the extractum of 1.03-1.05, standby;
5) by 1) fine powder and 4 of step) extractum of step is mixed to get mixture, and add pharmaceutically acceptable adjuvant, make capsule.
6. the preparation method of pharmaceutical preparation according to claim 5, it is characterised in that: step 5) described in capsule be made up of the mixture that weight part ratio is 1: 0.05-02 and pharmaceutically acceptable adjuvant.
7. the preparation method of pharmaceutical preparation according to claim 5, it is characterised in that: step 5) described in capsule be made up of the mixture that weight part ratio is 1: 0.1 and pharmaceutically acceptable adjuvant.
8. the pharmaceutical preparation according to claim 1-4, it is characterised in that: described pharmaceutical preparation application in the medicine of preparation prevention myocardial infarction.
9. the pharmaceutical preparation according to claim 1-4, it is characterised in that: described pharmaceutical preparation treats the application in antiatherogenic medicine in preparation.
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Application publication date: 20160601