CN102580024B - Composition for treating cardiovascular diseases - Google Patents
Composition for treating cardiovascular diseases Download PDFInfo
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- CN102580024B CN102580024B CN 201210041126 CN201210041126A CN102580024B CN 102580024 B CN102580024 B CN 102580024B CN 201210041126 CN201210041126 CN 201210041126 CN 201210041126 A CN201210041126 A CN 201210041126A CN 102580024 B CN102580024 B CN 102580024B
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Abstract
The invention relates to a composition for treating cardiovascular diseases. The composition is prepared from the following components in parts by weight: 1-20 parts of garlic, 1-15 parts of ginger, 1-10 parts of green onion, 30-70 parts of pseudo-ginseng root, 10-40 parts of tuber fleeceflower root, 10-40 parts of red-rooted salvia root, 10-40 parts of kudzuvine root, 4-20 parts of safflower and 4-20 parts of szechuan lovage rhizome. The composition provided by the invention has remarkable treatment effects on hyperlipemia, hyperglycemia and hypertension.
Description
Technical field
The present invention relates to field of health care products, be specifically related to a kind of compositions for the treatment of cardiovascular disease.
Background technology
Bulbus Allii (Allium sativun L) Main Ingredients and Appearance contains volatile oil 0.2%, and oil includes sulfide compound, citral, linalool, α, β phellandrene, propionic aldehyde, valeral, the alliin that allicin (being commonly called as allicin (Allica)), multiple pi-allyl, propyl group and methyl are formed; Other composition contains protein 4.4g, fatty 0.2mg, carbohydrate 23g, crude fibre 0.7g, calcium 5mg, phosphorus 44mg, ferrum 0.4mg, thiamine 0.24mg, riboflavin 0.03mg, nicotinic acid 0.9mg, ascorbic acid 3mg.Its pharmacological action: aspect cardiovascular, the record of " Chinese medicine voluminous dictionary " first volume 110-111 page or leaf, the new gallon of Bulbus Allii preparation, toxicity is very little, can slow down heart rate, increases heart contractility, the expansion end is blood vessel slightly, increases diuresis, can reduce the blood pressure that experimental atherosclerosis is exempted from.Clinical treatment hypertension and atherosclerosis are effective." single medicinal material cure the disease complete works " 55 pages, 57 pages of records, Bulbus Allii quintessence oil treatment hyperlipidemia, use the Bulbus Allii quintessence oil soft gelatin capsule, oral 9 of every day (containing Bulbus Allii quintessence oil 0.2ml), divide three taking medicine after meales, 78 examples are after one month, various hyperlipemias all have obvious decline, prove that Bulbus Allii quintessence oil all has significant decline effect to cholesterol, triglyceride and lipoprotein.Other 110 cases, oral Bulbus Allii powder tablet, specification is for containing garlicin 1.3%, every day 800ml, 4 months courses for the treatment of, the blue or green cholesterol of blood on average reduces by 12%, the blue or green triglyceride of blood reduces by 17%.The proof garlic preparation all has remarkable decline effect to cholesterol, triglyceride and lipoprotein.
Chinese patent application 95111204.X (hereinafter to be referred as 95 years patents) discloses a kind of health-care garlic-liquor, this health care liquid be by mashed garlic and edible ethanol according to weight ratio 45-60: 40-55 makes, can also contain pollen, juice of Fructus Hippophae in this health care liquid, the health-care effect of this health-care garlic-liquor is confined to that hypertension, atherosclerosis, germ digestive tract disease are had comparatively significantly curative effect, and centering, old people have the effect of health care.
On the basis of above-mentioned patent, the inventor has made Chinese patent application 98112190.X (hereinafter to be referred as 98 years patents) again, this patent disclosure a kind of Chinese herbal medicine allicin health-care liquid, it is the Rhizoma Zingiberis Recens with cleaning, Herba Alii fistulosi, Bulbus Allii powder is broken into mud, after soaking 16-32 days with the edible ethanol sealing respectively, filter, remove slag Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid, Bulbus Allii liquid is then with Radix Polygoni Multiflori, Radix Glycyrrhizae, Fructus Jujubae, husky short, bristly hair or beard flavone, pollen liquid, haw liquid, phyllostachys nigra (lodd.ex lindl.) munro var.henonis (miff.) spapf et rendle liquid, liquid salvia, juice of Fructus Hippophae, Herba Taraxaci liquid, Kudzu vane root liquid, Rhizoma Chuanxiong liquid, Flos Carthami liquid, Poria, Radix Angelicae Sinensis, ice slush tea, Semen Cassiae, Herba bromi japonici, Fructus Crataegi flavone etc. have been formed the I oral liquid.
After the I oral liquid listing of the product of 95 years patents and 98 years patents, numerous consumers that the cardiovascular and cerebrovascular disease history is arranged, feedack is: take health-care garlic-liquor, I Chinese herbal medicine allicin health-care liquid, both character is similar, it is also similar to take effect, after taking one or two months, feel " eat; sleep; the mental status is much better ", hyperlipidemia reduces comparatively obvious, blood pressure, blood glucose reduces not too remarkable, this health product prescription is further improved, though especially I Chinese medicine allicin health-care liquid contains numerous blood fat reducing, the medicine of blood pressure lowering, but combination back effect is not remarkable, may be that effect is cancelled out each other between each medicine, causes final result undesirable.
Do not see nine kinds of reports that composition share such as Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi, Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami, Rhizoma Chuanxiong as yet.
Summary of the invention
A kind of compositions for the treatment of cardiovascular disease that the object of the present invention is to provide,
Another object of the present invention provides the preparation method of above-mentioned composition.
The compositions for the treatment of cardiovascular disease provided by the invention is made by the composition of following weight portion: Bulbus Allii 1-20 part, Rhizoma Zingiberis Recens 1-15 part, Herba Alii fistulosi 1-10 part, Radix Notoginseng 30-70 part, Radix Polygoni Multiflori 10-40 part, Radix Salviae Miltiorrhizae 10-40 part, Radix Puerariae 10-40 part, Flos Carthami 4-20 part and Rhizoma Chuanxiong 4-20 part.
Preferably, compositions provided by the invention is made by the composition of following weight portion: Bulbus Allii 5-15 part, Rhizoma Zingiberis Recens 4-12 part, Herba Alii fistulosi 2-8 part, Radix Notoginseng 40-60 part, Radix Polygoni Multiflori 20-30 part, Radix Salviae Miltiorrhizae 20-30 part, Radix Puerariae 20-30 part, Flos Carthami 8-12 part and Rhizoma Chuanxiong 8-12 part.
Further preferred, compositions provided by the invention is made by the composition of following weight portion: 10 parts of 10 parts of Bulbus Alliis, 8 parts of Rhizoma Zingiberis Recens, 5 parts of Herba Alii fistulosis, 50 parts of Radix Notoginseng, 25 parts of Radix Polygoni Multiflori, 25 parts of Radix Salviae Miltiorrhizaes, 25 parts of Radix Puerariaes, 10 parts on Flos Carthami and Rhizoma Chuanxiongs.
The present invention also provides the preparation method of above-mentioned composition, may further comprise the steps:
1) soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi: respectively Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi being pulverized is mud, then according to the 2-5 of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi weight portion doubly, 2-5 doubly and 1-4 doubly add edible ethanol, lixiviate 18-50 days is soaked in sealing, be preferably 18-45 days, more preferably after 20-36 days, filter, remove slag, obtain the soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi;
2) extraction of Six-element Chinese medicine: Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami and Rhizoma Chuanxiong are with above-mentioned Chinese medicine gross weight 2-6 edible ethanol doubly, sealing was soaked 18-50 days, be preferably 18-45 days, more preferably 20-36 days, take out and filter, medicinal liquid is the soak of Six-element Chinese medicine, and the medicinal residues that leach are standby;
Above-mentioned medicinal residues decoct with water 1-3 time, and the 2-6 that at every turn adds medicinal residues weight doubly measures and decocts with water, and treat to stop when decoction liquor approaches glue, and merging filtrate filters, and removes slag, and gained filtrate is the decoction liquor of Six-element Chinese medicine;
3) soak of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid and Six-element Chinese medicine, decoction liquor mix homogeneously, namely.
Preferably, described edible ethanol is the grain preparation, and as Sorghum vulgare Pers., Oryza glutinosa etc., concentration is 1%-50%.
Preferably, in the described step 1): the weight ratio of Bulbus Allii and edible ethanol is 1: 2.5; The weight ratio of Rhizoma Zingiberis Recens and edible ethanol is 1: 2.5; The weight ratio of Herba Alii fistulosi and edible ethanol is 1: 2.
Preferably, described step 2): the weight ratio of Six-element Chinese medicine and edible ethanol is 1: 4; The weight ratio of medicinal residues and water is 1: 4.
The present invention also provides above-mentioned composition in the health product of preparation treatment cardiovascular disease and the application in the medicine, and described cardiovascular disease is hyperlipidemia, hyperglycemia, hypertension.
Compositions provided by the invention, intending consumption is 0.01-5ml/ days.
In the compositions provided by the invention by Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi, Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami, compositions such as Rhizoma Chuanxiong, main part of this nine flavors Chinese medicine, pharmacology, clinical practice, on " Chinese medicine voluminous dictionary ", following two (the new medical college in Jiangsu is compiled, Science and Technology of Shanghai publishing house publishes, in May, 1986 front page), " Chinese medicine complete works " (Cui Shude chief editor, Heilungkiang science and technology publishing house publishes, in June, 1989 front page), (people such as He Zhenquan compiles " single medicinal material cure the disease complete works ", Chinese Medicine science and technology publishing house publishes, June nineteen ninety-five, front page reprinted in 1998) all on the books respectively:
Rhizoma Zingiberis Recens (Zingiber officinale Rosc) comprises Rhizoma Curcumae Longae and Cortex Zingiberis, and main part contains volatile oil 4.5-6%, contain turmerone 58%, zingerene 25%, phellandrene 1%, cineole %, sabinene 0.6%, Borneolum Syntheticum 0.5%, curcumin 0.3% in the oil.1736 pages of records of pharmacology aspect " Chinese medicine voluminous dictionary " volume two, the curcumol extracting solution has hypotensive effect.1316 pages of records of " Chinese medicine voluminous dictionary " first volume Radix Curcumae also contains turmerone, curcumin, suffers from the rabbit of the disorders of blood of high cholesterol, the ether extract of oral Radix Curcumae, make the content of blood cholesterol drop to the also corresponding decline of 36%, c/p ratio by 266% in three weeks, aorta weight also obviously alleviates, weight increase, yet 1736 pages of records of " Chinese medicine voluminous dictionary " volume two, main trusted subordinate ties long-pending, chronic infectious disease is disobedient, the therapeutic method to keep the adverse QI flowing downwards, removing blood stasis is except wind heat, subduing inflammation, the power of Rhizoma Zingiberis Recens is strong in Radix Curcumae.
Herba Alii fistulosi (Allium fistulosum) bulb contains volatile oil, and main component is allicin (Allicin) in the oil, and other contains allyl sulfide, dimension B
1, the dimension B
2, dimension A, nicotinic acid, fatty oil and phlegmatic temperament.Palmic acid, stearic acid, arachidic acid, oleic acid, linoleic acid in the fatty oil.Contain polysaccharide, cellulose, pectin in the mucus juice.Pharmacological action and Bulbus Allii are basic identical.
Radix Notoginseng (Radix Notoginseng) has another name called Typhonium flagelliforme (Lodd.) Blume (Panax pseudoginseny wall), and Latin is called " can control all kinds of diseases and ailments ", and its main part contains arasaponin A (C
30H
52O
10), arasaponin B (C
23H
38O
10) and flavonoid glycoside.55 pages of " Chinese medicine voluminous dictionary " first volumes, " Chinese medicine complete works " 456 pages of all records: Radix Notoginseng is aspect blood circulation, coronary blood flow increasing is arranged, reduce myocardial oxygen consumption, the alcohol lixiviating solution has hypotensive activity again, cardiotonic, the blood vessel dilating effect reduces capillary permeability, increases the blood capillary drag.Also have hemostasis, blood stasis dispelling, detumescence, pain relieving, antibacterial action.The 56th page of record of " Chinese medicine voluminous dictionary " first volume, clinical report, the treatment angina pectoris, each oral Radix Notoginseng powder 0.45g, day clothes three times, serious symptom doubles.The coronary disease patient that 16 examples are chief complaint with angina pectoris, except a routine angina pectoris merged myocardial infarction person's medication invalid drug withdrawal of a couple of days, all the other 15 routine pain palliation efficacies were all satisfied through treatment.The 4 routine former need person that takes the nitrol tablet is for a long time arranged, can withdraw behind the clothes Radix Notoginseng; 5 routine complicated hypertension patients, the back blood pressure of taking medicine slowly descends; Heart rate changeed slow after 3 examples were taken medicine; 4 routine electrocardiograms slightly take a turn for the better.Experiment showed, that Radix Notoginseng is significantly increased the effect of coronary artery blood flow, myocardial oxygen consumption minimizing, the descending artery pressure is arranged again and slightly subtract heart rate function, the heart working amount is lowered.Above-mentioned effect all helps to alleviate the heart burden, relaxes the contradiction of myocardium requirementing keto quantity and oxygen supply deficiency, thereby is treatment coronary heart disease, anginal favorable factor.According to the minority case observation, take Radix Notoginseng powder 1.8g every day again, divide three secondary eclipses preceding clothes, continuous one month, blood fat reducing and cholesterol are had certain effect.
The main part of Radix Polygoni Multiflori (Polygonum multiflorum Thunb.) contains anthraquinone class such as chrysophanol, chrysophanic acid, physcione, chrysophanic acid anthrone, processs to contain no chrysophanic acid later; Other contains lecithin, starch, fat.Pharmacology aspect: in " Chinese medicine complete works " 552,553 pages of records, cholesterol reducing, arteriosclerosis effect are arranged; " Chinese medicine voluminous dictionary " first volume, 1136 pages record blood fat reducing, hypoglycemic activity.
Radix Salviae Miltiorrhizae (Radix Salviae miltiorrhizae) contains main the branch: TANSHINONES A (C
18H
12O
3), TANSHINONES B (C
19H
18O
3), TANSHINONES C (C
19H
20O
3), cryptotanshinone (C
19H
20O
3), iso tanshinone, tanshinol, vitamin E.Pharmacological action, " Chinese medicine complete works " 407 pages of records, blood circulation promoting and blood stasis dispelling, blood vessel dilating, blood pressure lowering, antibacterial action.The clinical angina pectoris that is used for the treatment of due to the heart arteries and veins retardance, the effect of getting its mediation stasis of blood plug, blood vessel dilating; 481 pages of records of " Chinese medicine voluminous dictionary " first volume, treatment coronary heart disease, extract is made tablet, for oral administration, each 2,3 times on the one, with two thoughtful one month be a course for the treatment of, observe 323 examples, take medicine and do not wait in 1-3 month, the angina pectoris total effective rate is 82.3% as a result, wherein obvious effective rate is 20.3%, curative effect with in, slight better, the be height of 2 months person's curative effects of taking medicine than 1 month, the electrocardiogram total effective rate is 53.2%, and obvious effective rate accounts for 14.8%.
The main part of Radix Puerariae (Radix Puerariae) contains puerarin, puerarin xyloside, Radix Puerariae flavone, daidzein, flavone, daidzin, cupreol, arachidic acid, volume starch.Pharmacology, 2308 pages of records of " Chinese medicine voluminous dictionary " volume two, the intravenous injection of kudzuvine root wine extractum all can make the coronary vasodilator blood flow increase, and vascular resistance reduces, and taking the Radix Puerariae water decoction has obvious hypotensive effect and hypoglycemic activity.2309 pages of " Chinese medicine voluminous dictionary " volume two record clinical report, treatment hypertension neck pain, oral decoct, 10-15g/ day, divide the secondary clothes, serve on 2-8 week, observe 52 examples, neck pain 17 examples that disappear obviously alleviate 30 examples; The treatment angina pectoris with kudzuvine root wine extractum sheet 6-12 every day sheet, divides clothes 2-3 time, always treats 4-22 week, treat 71 examples, angina pectoris symptom produce effects 29 examples are improved 20 examples, substantially invalid 22 examples, electrocardiogram effective percentage are 4.13%, and serum ornitrol and beta lipoprotein do not have significant change at period in a medicine.
The main part of Flos Carthami (Flos Carthami) contains carthamin (C
21H
22O
11) have another name called glycerolipids such as red pigment, Carthamus yellow, safflower oil, Palmic acid, arachidic acid, oleic acid, linolenic acid, linoleic acid.434 pages of pharmacology aspects " Chinese medicine complete works ", 993 pages of " Chinese medicine voluminous dictionary " first volumes, all record effect, the hypotensive activity of expansion heart coronary artery, and can keep the long period, total cholesterol in the serum of reduction, total fat, trinitroglycerin and non-esterified fatty acid level are arranged.Clinical practice, " Chinese medicine complete works " 435 pages of records, the treatment angina pectoris, forefathers join Rhizoma Chuanxiong, Radix Angelicae Sinensis with Flos Carthami, can control " breast abdomen vim and vigour stagnate bitterly ", modern practice Flos Carthami 15g joins Rhizoma Chuanxiong 15g, fries in shallow oil water (or using tablet), as the basic skills of controlling the qi stagnation and blood stasis type angina pectoris, with the card compatibility, truly have certain curative effect again, may be relevant with the effect of Rhizoma Chuanxiong, Flos Carthami expansion heart coronary artery.
The main part of Rhizoma Chuanxiong (Rhizoma Chuanxiong) contains ligustrazine, ferulic acid (C
10H
10O
4), volatile oil, alkaloid, phenol sexual element, interior lipid etc.Pharmacology, " Chinese medicine complete works " 415 pages of records, water logging agent, aqueous extract solution have tangible hypotensive effect, and ethanol extraction can make coronary artery blood flow and lower extremity blood flow amount increase, due to vasodilation when coronary artery and femoral artery injection drug.Clinical report " single medicinal material cure the disease complete works ", 64 pages of records, ligustrazine injection [Shenyang No. 1 Pharmaceutical Factory production, lot number the Liao Dynasty defends medicine (82) 133-3 number] 160ml is dissolved in 5% or 10 glucose injection 500ml, with the speed intravenous drip of 20 of per minutes, once a day, administration time 1-3 week, in 12 examples, the patient that 10 routine ST section levels move down, 9 examples return to isoelectric level money substantially; 2 routine T ripples are inverted the patient, and wherein 1 example recovers normal, 1 routine no change.The logical not outbreak substantially of 10 routine heart strands, the logical attack degree of 2 routine heart strands obviously alleviates, and number of times reduces.
The compositions for the treatment of cardiovascular disease provided by the invention has the following advantages:
1, the present invention is the improvement on the basis of Chinese herbal medicine allicin health-care liquid 98112190.X patent (being called for short 98 years patents) technical scheme, made by Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi, Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami, Rhizoma Chuanxiong etc. nine flavor compositions, realized the raising antihypertensive, fall hyperlipidemia, reducing hyperglycaemia, the anginal purpose of prevention coronary disease patient acute attack.
2, the test of pesticide effectiveness confirms, compositions provided by the invention effect aspect treatment hyperlipidemia, hyperglycemia, hypertension is remarkable, is better than prior art.
3, technical scheme of the present invention remains the preparation method of succession Chinese medicine preparation: the one, and with edible ethanol lixiviate Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi and Six-element raw material of Chinese medicine, the medicated wine after having obtained to soak; The 2nd, the Chinese medicine slag of wine extracted adds decocting system, obtains the fried liquid liquid medicine of Chinese medicine.The compositions that is deployed into required treatment cardiovascular disease with the medicated wine that soaks and decocting for Chinese herbal medicine liquid then.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Embodiment 1-5: the compositions for the treatment of cardiovascular disease
1, forms: see Table 1
Table 1: the composition of embodiment 1-5
2, the preparation method of embodiment 1:
1) preparation of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid: respectively with Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi, peeling, take by weighing Bulbus Allii 5kg, Rhizoma Zingiberis Recens 12kg, Herba Alii fistulosi 5kg, clean respectively, mashed garlic, Rhizoma Zingiberis Recens mud, Herba Alii fistulosi mud are smash in pulverizing, respectively add 25kg, 60kg, 20kg edible ethanol (concentration 30%) then, and the sealing lixiviate is after 20 days, take out and filter, removing slag obtains Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid.
2) soak of Six-element Chinese medicine: the proportioning according to embodiment in the table 11 takes by weighing Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami, Rhizoma Chuanxiong, add up to 174kg, the edible ethanol (concentration is 30%) that adds 350kg, sealing was soaked 37 days then, take out and filter, the soak of Six-element Chinese medicine, the medicinal residues that leach are standby;
3) get the decocting that the medicinal residues that obtain after the Six-element Chinese medicine soak with ethanol add 3 times of amounts of its weight and boil, treat that medicinal liquid approaches when gluey, stop to decoct, take out and filter, remove slag, namely get the decoction liquor of Six-element Chinese medicine;
4): get the soak of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid, Six-element Chinese medicine, the decoction liquor mix homogeneously of Six-element Chinese medicine, namely.
3, the preparation method of embodiment 2:
1) preparation of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid: respectively with Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi, peeling, take by weighing Bulbus Allii 10kg, Rhizoma Zingiberis Recens 8kg, Herba Alii fistulosi 5kg, clean respectively, mashed garlic, Rhizoma Zingiberis Recens mud, Herba Alii fistulosi mud are smash in pulverizing, respectively add 25kg, 20kg, 20kg edible ethanol (concentration is 20%) then, and the sealing lixiviate is after 30 days, take out and filter, removing slag obtains Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid;
2) soak of Six-element Chinese medicine: the proportioning according to embodiment in the table 22 takes by weighing Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami, Rhizoma Chuanxiong, add up to 145kg, the edible ethanol (concentration is 35%) that adds 300kg, sealed then, soak 32 days, take out and filter, the soak of Six-element Chinese medicine, the medicinal residues that leach are standby;
3) get the decocting that the medicinal residues that obtain after the Six-element Chinese medicine soak with ethanol add 4 times of amounts of its weight and boil, treat that medicinal liquid approaches when gluey, stop to decoct, take out and filter, remove slag, namely get the decoction liquor of Six-element Chinese medicine;
4): get the soak of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid, Six-element Chinese medicine, the decoction liquor mix homogeneously of Six-element Chinese medicine, namely.
4, the preparation method of embodiment 3:
Mutually identical with embodiment 1, difference is:
Step 1): the ratio of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi and edible ethanol is 1: 3,1: 2,1: 2, sealing lixiviate 36 days, and concentration of alcohol is 35%;
Step 2) weight ratio of Chinese medicine and edible ethanol is 1: 4,, concentration of alcohol is 40%, sealing, immersion 45 days;
The weight ratio of step 3) medicinal residues and water is 1: 4.5.
5, embodiment 4,5 preparation method:
Identical with embodiment 1 and 2, the difference part is:
Step 1): the ratio of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi and edible ethanol is 1: 2.5,1: 2.5,1: 2, sealing lixiviate 36 days, and concentration of alcohol is 25%;
Step 2) weight ratio of Six-element Chinese medicine and edible ethanol is 1: 4, and concentration of alcohol is 40%, sealing, immersion 40 days;
The weight ratio of step 3) medicinal residues and water is 1: 4.
As not specifying the product that the pharmaceutical composition that following experimental example is mentioned is prepared from for composition and method according to embodiment 2.
Experimental example 1: toxicity test
One, acute toxicity testing
1, experimental animal: one-level SD rat and NIH mice, available from Sichuan Industrial Institute of Antibiotics's Experimental Animal Center.
2, test method: large and small Mus acute toxicity test is all according to horn method (HornShi method), if four dosage groups of compositions, be respectively: 2150,4640,10000 and 21500mg/kgbw (described medicine is embodiment 2), every group of 10 animals (female, hero half and half), all irritate stomach according to the disposable per os of 2% volume, observe its poisoning symptom, sign and death condition after irritating stomach, observed for two weeks continuously, judge its acute toxicity according to the dead animal number.
3, result of the test: see Table 1
Table 1: The acute toxicity tests
Overview: irritate after stomach tried thing number minute, 4640mg/kgbw group minority rat and 10000mg/kgbw, 21500mg/kgbw organize most rats and mice hind leg to occur weak, creep and lurch, and lie on one's side.Animal the earliest the death time tried behind the thing 84 minutes for giving, symptom appears, in about 10 hours, recover normal, the part animal is poisoned to death.
Table 1 result shows: each is organized dead and the symptom time occurs.
Therefore, look into GB15193.3-2003 according to each group dead animal number, the medicine that embodiment 1 provides is to the LD of female, male SD rat and NIH mice
50All greater than 10000mg/kgbw.
4, according to the acute toxicity classification of GB15193.3, embodiment 1 belongs to nontoxic level.
Two, genetic toxicity test
1, Salmonella reversion test
1.1 test method: adopt through identifying that satisfactory Salmonella typhimurium histidine defect TA97, TA98, TA100, TA102 four strain test strains add with the dressing plate that does not add rats'liver S9 and mix the method test.
Compositions 0.8,4,4 dosage groups of 20 and 100 μ l/ wares are established in test, and negative control group and positive controls are established in each test simultaneously, and negative control group is distilled water, and positive controls is respectively TNFone, NaN
3, MMC and 2-AF.Each test dose is done three parallel wares, twice of repeated trials.
1.2 result of the test: see Table 2
Table 2:Ames result of the test
Annotate: numerical value is 3 plate averages in the table.
Table 2 result shows: except the TA102 bacterial strain that adds S9, average the returning of positive control ware becomes the bacterium colony number average greater than the twice of negative control; And average the returning of embodiment 2 each dosage group becomes the bacterium colony number average in the twice of negative control.
1.3 conclusion: embodiment 2 is negative in Salmonella reversion test.
2, mouse Bone marrow cells micronucleus experiment
2.1 laboratory animal: one-level NIH mice, available from Sichuan antibiotics industry institute Experimental Animal Center.
2.2 test grouping: mice is divided into five groups at random, be specially: (administration medicine is embodiment 2 to four dosage groups of compositions, dosage be respectively 625,1250,2500 and 5000mg/kg bw), negative control group (distilled water) and positive controls (cyclophosphamide of 40mg/kgbw dosage), every group 10, female, hero half and half.Respectively at 0h and twice per os gastric infusion of 24h, 30h puts to death mice, gets the bone marrow of sternum smear, the Giemsa dyeing of fixing back, and polychromatophilia color erythrocyte (PCE) is had a liking in 1000 of every Mus observations under the mirror, and the cell number of record paper micronucleus is calculated micronuclear rates.
2.3 statistical method: the difference that compares micronuclear rates between each experimental group and matched group with the t check.
2.4 result: see Table 3
Table 3: mouse marrow cell micro nuclear test result
Compare with negative control group,
*P＜0.01
Table 3 result shows: the average micronucleus of positive controls is significantly higher than negative control group (P＜0.01), and micronuclear rates and the negative control group of embodiment 2 each group relatively do not have significant difference.
2.5 the product of conclusion: embodiment 2 is negative result in mouse marrow cell micro nuclear test.
3, mouse sperm deformity test
3.1 experimental animal: male NIH mice, available from Sichuan Industrial Institute of Antibiotics's Experimental Animal Center.
3.2 test grouping: mice is divided into five groups at random, be respectively: compositions 1250,2500 and three dosage groups of 5000mg/kgbw (administration medicine for embodiment 2 product) and negative control group (distilled water) and positive controls (cyclophosphamide of 40mg/kgbw dosage), every group 5, irritate stomach every day and tried thing, continuous 5 days.
Put to death animal in 35 days after irritating stomach first, get the bilateral epididymis and make the sperm smear, Yihong dyeing of fixing back is observed sperm morphology under the mirror, and every animal is observed 1000 complete sperms, records all kinds of teratospermia numbers, calculates rate of teratosperm.
3.3 result of the test: see Table 4
Table 4: mouse sperm deformity test
| Group | Dosage (mg/kg) | Observe sperm count (individual) | Teratospermia sum (individual) | Abnormal rate (%) |
| Negative control group | 0 | 1000*5 | 155 | 3.10±0.76 |
| Compositions | 1250 | 1000*5 | 172 | 3.44±0.52 |
| 2500 | 1000*5 | 128 | 2.56±1.21 | |
| 5000 | 1000*5 | 130 | 2.60±0.99 | |
| Cyclophosphamide | 40 | 1000*5 | 412 | 8.24±0.95 * |
Compare with negative control group,
*P＜0.01
Table 4 result shows: the average rate of teratosperm of positive controls is significantly higher than negative control group (P＜0.01), and compositions of the present invention is respectively organized rate of teratosperm and negative control group compares no significant difference.
3.4 conclusion: embodiment 2 is negative result in the mouse sperm deformity test.
Three, tertogenicity test
1, experimental animal: one-level SD rat, available from Sichuan Industrial Institute of Antibiotics's Experimental Animal Center.
2, test method
Test grouping: rat is divided into four groups at random, is respectively compositions 156,625 and three dosage groups of 2500mg/kgbw (adopting the product of embodiment 2), and negative control group (distilled water).
The one-level of healthy mature is the SD rat of copulation not, 1: 2 mate by female, hero night, determine whether copulation with vaginal smear morning next day, see that to look into sperm same day was as " becoming pregnant " 0 day, the pregnant Mus of finding is divided into 4 groups at random, 15 every group, all in 7-16 days gastric infusions, respectively weighed once on 0th, 7,12,16 and 20, and irritate the stomach volume according to the body weight change adjustment.
Pregnant Mus is put to death in the back of weighing on 20th, weighs in the extraction uterus of cutting open the belly, check and record every nest the implantation number, absorb tire number, stillborn fetus number, the tire number of living, the young body weight of the tire of living and height.Outward appearance, skeleton and the internal organs deformity of routine examination and record tire alive.
3, result of the test: see Table 5.1-5.3
Table 5.1: pregnant Mus body weight gain situation
Table 5.2: to the influence of rat motherhood situation and fetal development
Compare with negative control group,
*P＜0.05
Table 5.3: to the teratogenesis activity of rat embryo
Compare with negative control group,
*P＜0.01
Table 5.1-5.3 result show: 156mg/kg group and 625mg/kg group tire average weight alive are higher than matched group; Fontanel is significantly less than matched group, but all do not have the pathology meaning.High dose group (2500mg/kg) group tire Mus breastbone miss rate is higher than normal control group (P＜0.01), though the breastbone disappearance can not be fully owing to teratogenesis, but it is obviously higher to organize the breastbone miss rate, under heavy dose of situation, rat there is certain teratogenesis probability so can not get rid of compositions, for safety, its minimum teratogenesis dosage is decided to be 2500mg/kg (maximum not teratogenesis dosage is 625mg/kg), teratogenic index is (10000/2500)=4, according to the evaluation criterion of GB15193.14, this product does not have teratogenesis.
4, the maximum of conclusion: embodiment 2 in the rat tertogenicity test not teratogenesis dosage is 625mg/kg, and teratogenic index is 4, and according to the evaluation criterion of GB15193.14, this product does not have teratogenesis.
Four, 30 days feeding trials of rat
1, experimental animal: the SD rat, available from Sichuan Industrial Institute of Antibiotics's Experimental Animal Center.
2, test grouping: the SD rat is divided into four groups at random, is specially: compositions 400,1600 and three dosage groups of 6400mg/kgbw (adopting the product of embodiment 2) and negative control group (giving distilled water), 24 every group, female, hero half and half.All press 2% filling stomach of the volume of stomach, once a day, continuous 30 days.
Weigh once weekly, and irritate the stomach amount according to the body weight change adjustment, the food intake dose of weighing is simultaneously calculated average weight gain and the food utilization of respectively organizing the male and female Mus.
After the off-test on the 30th, carry out hematology and blood biochemical inspection, histopathological examination and organ coefficient mensuration according to the GB15193.13-94 regulation.
3, result of the test: see Table 6.1-6.4
Table 6.1: body weight change and food utilization
Table 6.2: hematology's conventional sense result
Compare with negative control group,
*P＜0.01
Table 6.3: blood parameters testing result
Compare with negative control group,
*P＜0.01
Table 6.4: internal organs testing result
Table 6.1-6.4 result show: compare with matched group, 400 and the platelet (BPC) of 1600mg/kg group male rat increase to some extent, reticulocyte (Ret) reduces to some extent; The creatinine (Cr) of male Mus reduces to some extent, but the change of these indexs does not have dose-response relationship or do not have clinical meaning.The serum urea nitrogen (BUN) of 6400mg/kg group male rat raises to some extent, and can not get rid of fully is pathological change.Other serum biochemistry index no abnormality seens of each dosage group.Pathology histological examination result, internal organs and negative control group comparisons such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, thyroid, gastrointestinal, testis and the ovary of the female tom of each dosage group, all do not find toxic pathology Histological change, because it is the effect that is tried thing that serum urea nitrogen (BUN) rising of 6400mg/kg group male mouse can not be got rid of fully, so consider from security standpoint, the maximum no-effect dose of embodiment 2 is decided to be 1600mg/kgbw.
4, the maximum no-effect dose of the product of conclusion: embodiment 2 in rat nursing experiment in 30 days is greater than 1600mg/kgbw (being human body recommended intake 5ml/ people/day, namely more than 10 of 150mg/kgbw times).
Simultaneously, other embodiment provided by the invention and proportioning are carried out identical test, the result is similar to embodiment 2.
Five, conclusion and evaluation:
1, compositions provided by the invention is to the acute oral LD of SD rat and NIH mice
50All greater than 10000mg/kgbw, according to the acute toxicity classification, compositions of the present invention belongs to nontoxic level;
2, three genetic toxicity tests (Salmonella reversion test, bone marrow cell micronucleus test, mouse sperm deformity test) are negative findings;
3, rat tertogenicity test: minimum teratogenesis dosage is 2500mg/kgbw, and teratogenic index is 4, the no teratogenesis in surface;
4, fed experiment in 30 days: maximum no-effect dose is greater than 1600mg/kgbw (being more than 10 times of human body recommended intake).
Experimental example 2: the test of pesticide effectiveness
1, case is collected: between year August in October, 2008-2011 to 360 routine hyperpietics (male 170 examples, woman's 190 examples, 55 years old mean age, course of disease 0.5-20), 225 routine diabetes (male 115 examples, women 110 examples, case selects all to meet definite type 2 diabetes mellitus diagnostic criteria in 1999,49 years old mean age, course of disease 0.5-18) and 315 routine hyperlipemic patients (male 154 examples, women 161 examples, 54 years old mean age, course of disease 0.5-19).
2, administrated method:
Hypertension, diabetes, hyperlipidemia respectively are divided into 9 groups, be respectively: placebo group, 98 years patent groups (giving I medicine 3ml/ people), experiment 1 high dose group (embodiment 3 medicines, 1.5ml/ the people), middle dosage group (embodiment 3 medicines, 2ml/ people), low dose group (embodiment 3 medicines, 3ml/ people), 1 group of (embodiment 1 medicine of experiment, 2ml/ people), 2 groups of (embodiment 2 medicines of experiment, 2ml/ people), 4 groups of (embodiment 4 medicines of experiment, 2ml/ people), 5 groups (embodiment 5 medicines, 2ml/ people) of experiment.
3, efficacy assessment standard:
1) hypertension efficacy assessment standard:
Judge efficacy of antihypertensive treatment according to Ministry of Public Health hypertension evaluation criteria in 1998, that is:
Produce effects: diastolic pressure is more than or equal to 10mmHg (1.3kPa) and reach normal range, or more than the decline 20mmHg (2.7kPa);
Effectively: do not reach 10mmHg (1.3kPa) though diastolic pressure descends, reached normal range, or decline 10-19mmHg (1.3-2.5kPa);
Invalid: as not reach above-mentioned level.
2) hyperglycemia efficacy assessment standard: with reference to hypoglycemic medicine curative effect judging standard in Ministry of Health of the People's Republic of China's " Clinical Researches of New Drugs guideline ", that is:
Produce effects: fasting glucose is down to 6.5mmol/L, or reduces by 30%, 2 hours after the meal near 9.25mmol/L of blood glucose or reduce by 30%, clinical symptom disappearance or obviously alleviate;
Effectively: fasting glucose is down to 7.0mmol/L, or reduces 10-29%, 2 hours after the meal near 9.90mmol/L of blood glucose or reduce 10-29%, and clinical symptoms is obviously improved;
Invalid: fasting glucose and 2 hours after the meal blood glucose have no significant change, and clinical symptoms is improved not obvious or do not had improvement.
3) hyperlipidemia efficacy assessment standard: the curative effect determinate standard of the hyperlipemia of formulating according to Ministry of Public Health 1997, that is:
Produce effects: lipids detection reaches following each person:
1. TC descends more than or equal to 20%;
2. TG descends more than or equal to 40%;
3. HDLC-C rises more than or equal to 0.26mmol/L (10mg/dl);
4. TC-HDL-C/HDL-C descends more than or equal to 20%.
Effectively: lipids detection reaches following each person:
1. TC descends more than or equal to 10% but less than 20%;
2. TG descends more than or equal to 20% but less than 40%;
3. HDLC-C rises more than or equal to 0.104mmol/L (4mg/dl), but HDLC-C rises less than 0.26mmol/L;
4. TC-HDL-C/HDL-C descends more than or equal to 10% but less than 20%.
Invalid: lipids detection does not reach above standard person.
3, therapeutic effect:
1) to hypertensive therapeutic effect: see Table 1
Table 1: to hypertensive therapeutic effect
Table 1 result shows: no matter from obvious effective rate, effective percentage or total effective rate: compare with placebo group, experiment 1-5 of the present invention is remarkable to hypertensive therapeutic effect, and is better than 98 years patent groups.
2) to the therapeutic effect of hyperglycemia: see Table 2:
Table 2: hyperglycemia treatment situation
Table 2 result shows: the total effective rate of 98 years patent groups is 5.7%, and the total effective rate of each group of experiment 1-5 has all reached 100%, and obvious effective rate is also all above 88%, and each group of experiment 1-5 all is better than placebo group and 98 years patent groups.
3) to the therapeutic effect of hyperlipidemia: see Table 3
Table 3: hyperlipidemia treatment situation
Table 3 result shows: lipid-lowering effect, experiment 1-5 of the present invention and 98 years patent groups are remarkable to the therapeutic effect of hyperlipidemia, all are better than placebo group.
4, test brief summary: but compositions obvious treatment hypertension provided by the invention, hyperlipidemia, hyperglycemia, and effect is better than prior art.
Though, above used general explanation, the specific embodiment and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvements it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (12)
1. compositions for the treatment of cardiovascular disease, it is characterized in that, said composition is made by the composition of following weight portion: Bulbus Allii 1-20 part, Rhizoma Zingiberis Recens 1-15 part, Herba Alii fistulosi 1-10 part, Radix Notoginseng 30-70 part, Radix Polygoni Multiflori 10-40 part, Radix Salviae Miltiorrhizae 10-40 part, Radix Puerariae 10-40 part, Flos Carthami 4-20 part and Rhizoma Chuanxiong 4-20 part, and it is prepared by following method:
1) soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi: respectively Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi being pulverized is mud, then respectively according to the 2-5 of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi weight portion doubly, 2-5 doubly and 1-4 doubly add edible ethanol, sealing was soaked lixiviate after 18-50 days, filtered, remove slag, obtain the soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi;
2) extraction of Six-element Chinese medicine: Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami and Rhizoma Chuanxiong stir with above-mentioned Chinese medicine gross weight 2-6 edible ethanol doubly, sealing, soaked 18-50 days, take out and filter, medicinal liquid is the soak of Six-element Chinese medicine, and the medicinal residues that leach are standby;
Above-mentioned medicinal residues water decocts 1-3 time, adds the water that the 2-6 as medicinal residues weight doubly measures at every turn, and each the decoction to when approaching glue stops, merging filtrate, and filtration is removed slag, and gained filtrate is the decoction liquor of Six-element Chinese medicine;
3) soak of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid and Six-element Chinese medicine, decoction liquor mix homogeneously, namely.
2. pharmaceutical composition according to claim 1, it is characterized in that said composition is made by the composition of following weight portion: Bulbus Allii 5-15 part, Rhizoma Zingiberis Recens 4-12 part, Herba Alii fistulosi 2-8 part, Radix Notoginseng 40-60 part, Radix Polygoni Multiflori 20-30 part, Radix Salviae Miltiorrhizae 20-30 part, Radix Puerariae 20-30 part, Flos Carthami 8-12 part and Rhizoma Chuanxiong 8-12 part.
3. compositions according to claim 1 is characterized in that, said composition is made by the composition of following weight portion: 10 parts of 10 parts of Bulbus Alliis, 8 parts of Rhizoma Zingiberis Recens, 5 parts of Herba Alii fistulosis, 50 parts of Radix Notoginseng, 25 parts of Radix Polygoni Multiflori, 25 parts of Radix Salviae Miltiorrhizaes, 25 parts of Radix Puerariaes, 10 parts on Flos Carthami and Rhizoma Chuanxiongs.
4. one kind prepares each described method for compositions of claim 1-3, it is characterized in that this method may further comprise the steps:
1) soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi: respectively Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi being pulverized is mud, then respectively according to the 2-5 of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi weight portion doubly, 2-5 doubly and 1-4 doubly add edible ethanol, sealing was soaked lixiviate after 18-50 days, filtered, remove slag, obtain the soak of Bulbus Allii, Rhizoma Zingiberis Recens, Herba Alii fistulosi;
2) extraction of Six-element Chinese medicine: Radix Notoginseng, Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Carthami and Rhizoma Chuanxiong stir with above-mentioned Chinese medicine gross weight 2-6 edible ethanol doubly, sealing, soaked 18-50 days, take out and filter, medicinal liquid is the soak of Six-element Chinese medicine, and the medicinal residues that leach are standby;
Above-mentioned medicinal residues water decocts 1-3 time, adds the water that the 2-6 as medicinal residues weight doubly measures at every turn, and each the decoction to when approaching glue stops, merging filtrate, and filtration is removed slag, and gained filtrate is the decoction liquor of Six-element Chinese medicine;
3) soak of Bulbus Allii liquid, Rhizoma Zingiberis Recens liquid, Herba Alii fistulosi liquid and Six-element Chinese medicine, decoction liquor mix homogeneously, namely.
5. method according to claim 4 is characterized in that, in the described step 1): the weight ratio of Bulbus Allii and edible ethanol is 1:2.5; The weight ratio of Rhizoma Zingiberis Recens and edible ethanol is 1:2.5; The weight ratio of Herba Alii fistulosi and edible ethanol is 1:2.
6. method according to claim 4 is characterized in that, the time in the described step 1) is 18-45 days.
7. method according to claim 6 is characterized in that, the time in the described step 1) is 20-36 days.
8. method according to claim 4 is characterized in that, described step 2) in: the weight ratio of Six-element Chinese medicine and edible ethanol is 1:4; The weight ratio of medicinal residues and water is 1:4.
9. method according to claim 4 is characterized in that, described step 2) in time be 18-45 days.
10. method according to claim 9 is characterized in that, described step 2) in time be 20-36 days.
11. each described compositions of claim 1-3 is in the health product of preparation treatment cardiovascular disease and the application in the medicine.
12. application according to claim 11 is characterized in that, described cardiovascular disease is hypertension, hyperlipidemia and hyperglycemia.
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