Medicine with blood lipid regulation function
Technical field
The invention belongs to the drug world that to regulate the human body blood fat function.
Background technology
Blood fat generally comprises triglyceride, cholesterol, phospholipid and fatty acid etc., and lipid and certain protein constitute water miscible lipoprotein and exists in blood plasma.Modern medicine thinks that the morbidity of diseases such as hyperlipidemia and coronary heart disease, atherosclerosis has substantial connection, prevent and treat above-mentioned disease and must prevent and treat hyperlipidemia, and blood fat reducing manages to reduce triglyceride in the blood, content of cholesterol exactly; Motherland's medical science think hyperlipidemia by expectorant turbidly do not change, reason such as congestion retardance causes available activating blood circulation to dissipate blood stasis, the control of expelling phlegm and resolving turbidity method.
At present existing medicine or health food that much can the blood lipid regulation function, the certain therapeutic effect of they each tools have solved the needs of people to the treatment hyperlipidaemic conditions to a certain extent.But the curative effect of various medicines or food differs widely, and cost of manufacture also falls far short, the toxic side effect that also has.Now existing technology of utilizing Folium Ginkgo and Herb Gynostemmae Pentaphylli to make treatment hyperlipidaemic conditions medicine occur, they are once the attention that people occur having caused, but the general prescription that only crude drug is used for of these technology, and crude drug makes that its quality discrepancy is bigger owing to be subjected to the influence of weather, the place of production, the season of gathering, time, method etc.Therefore curative effect difference great achievement the distinct issues of this series products.
Folium Ginkgo is the dried leaves of Ginkgoaceae plant Ginkgo biloba Ginkgo biloba L., is to defend method prison to send out the Chinese medicine that [2002] No. 51 files specify can be used for health food.Folium Ginkgo is sweet, bitter, puckery, flat, GUIXIN, lung meridian." Chinese pharmacopoeia one one of version in 2000 is carried and " is astringed the lung, relieving asthma, blood circulation promoting and blood stasis dispelling, pain relieving.Be used for ... hyperlipidemia.”
Folium Ginkgo extract (EGB) is the extract of dried leaves through being processed into of Ginkgoaceae plant Ginkgo biloba Ginkgo biloba L., and mainly contains 24% flavonoid glycoside and 6% terpene lactone.
Folium Ginkgo is used as medicine and starts from the Ming Dynasty, is used for the treatment of cough and asthma due to lung deficiency and cardiac disorder according to record.Recent two decades is furtherd investigate the effective ingredient and the activity of Folium Ginkgo both at home and abroad, and basis and clinical research confirm that all Folium Ginkgo has hypolipidemic activity preferably.The main component of Folium Ginkgo and Folium Ginkgo extract is flavonoid and lactone compound.Efficacy test shows that Folium Ginkgo total flavones can obviously reduce the content of apolipoprotein B and low density lipoprotein, LDL, also reduces the content of apolipoprotein A-1, and high density lipoprotein is not had obvious influence.(Folium Ginkgo total flavones to the influence of ApoA, B, " Changchun Traditional Chinese Medical College's journal " 1995.9.P50); Ginkgo leaf tea has certain effect to the generation tool of prevention hyperlipemia, under the dosage that is equivalent to ginkgo leaf tea 0.1,0.5,3.0g/kg.bw, irritate stomach and gave rat 14 days, can significantly reduce serum TC, LDL-C level (P<0.01), TG, HDL-C also there are certain regulating action (research of ginkgo leaf tea prevention hyperlipemia effect, " Henan preventive medicine magazine " 1999.6.P340; Large and small Mus blood fat to the high lipid food diet studies show that, Folium Ginkgo has good resistance inhibitor action to the rising of the inductive serum TC of high lipid food, TG, can obviously improve blood fat and the lipoprotein metabolism situation of the large and small Mus of hyperlipemia, especially obvious to reduce TC, TG, (ginkgo leaf tea is to the influence of hypercholesterolemia diet mice blood fat, " contemporary Chinese medical journal " 2001.4.P51; Ginkgo biloba succi is to the influence of rat fat level, " Journal of Nutrition " 1999.3 P347; Folium Ginkgo tea blood lipid regulation and Experimental Study on Antioxidation, " practical preventive medicine " 2000.2.P135; Folium Ginkgo is regulated the research of rat fat function, " preventive medicine documentation ﹠ info " 1999.3. envelope 2); The antiplatelet aggregative activity of Folium Ginkgo and aspirin is (experimentation of regulating the Chinese medicine antiplatelet aggregation and erythrocyte rheology being influenced, " Chinese medicine research " 1999.5.P47) quite; Folium Ginkgo extract GBE can reduce serum cholesterol, it is synthetic to suppress lipid, induce lipid metabolism, obviously delay to raise hypercholesterolemia rabbit aorta atherosclerotic plaque and form (p<0.01), and external oxidative modification effect that can anti-low density lipoprotein, LDL (Folium Ginkgo extract is to raising the effect of the atherosis and external oxidation of low density lipoprotein, LDL of hypercholesterolemia rabbit arterial, " cardiopulmonary angiopathy magazine " 2001.1.P46); The serum cholesterol-lowering agents reason experiment of Folium Ginkgo extract, " chemical-pharmaceutical industries information " 1997.4.P12); GBE can make that zinc content obviously reduces in the hyperlipemia rat blood plasma, copper, content of magnesium raise, this may be its principal element that influences cholesterol metabolism (Folium Ginkgo extract is to the experimentation of hyperlipemia rat blood plasma zinc-copper magnesium influence, " trace element and health research " 2000.3.P6).
Clinical research shows, Folium Ginkgo has good effect for reducing fat, take gingko leaf preparation after 4 weeks, can obviously reduce the cholesterol and the triglyceride (p<0.01) of hyperlipidemia patient, improve the HDL-ch level, and can obviously improve hemorheology, reduce LPO and improve the SOD vigor, (Folium Ginkgo is to the clinical research of blood fat, " the Jiangsu traditional Chinese medical science " 1997.4.P44 for no lesions of liver and kidney and other untoward reaction; The clinical research of Folium Ginkgo electuary treatment hyperlipidemia, " Nanjing University of Traditional Chinese Medicine's journal " 1996.2.P13; Gingko leaf preparation is to the influence of coronary heart disease, hyperlipoidemia, blood viscosity and oxygen-derived free radicals, " new drug and clinical " 1995.3.P151); Gingko leaf preparation also has stronger anti-oxidative damage and lipid-peroxidation effect (discussion of Folium Ginkgo antioxidation and anti peroxidation of lipid damage effect, " practical geriatrics " 1997.6.P256).
Herb Gynostemmae Pentaphylli is the dry herb of cucurbitaceous plant Herb Gynostemmae Pentaphylli Gynostemma pentaphyllum (Thunb.) Makino, is to defend method prison to send out the Chinese medicine that [2002] No. 51 files specify can be used for health food.Herb Gynostemmae Pentaphylli property hardship, little sweet, cold." Guangxi Chinese crude drug standard " second carried " heat-clearing and toxic substances removing, eliminating phlegm and stopping cough, supplementing QI and nourishing YIN, slow down aging.Be used for ... hyperlipidemia ... ".The main functional component of this product is the Radix Ginseng saponins compound.Herb Gynostemmae Pentaphylli (GP) has the effect that the ginsenoside improves blood fat disease, efficacy test to animals such as experimental hyperlipidemia mice, rat, Carnis Coturnicis japonicae, rabbit shows that (see following document: the thick Saponin of Herb Gynostemmae Pentaphylli is to the influence of lipid metabolism, " foreign medical science Chinese medicine fascicle " 1983.4.P219; Herb Gynostemmae Pentaphylli total glycosides is to the influence of various lipoproteins, " Chinese herbal medicine " 1989.4.P172; The many glycosides of Herb Gynostemmae Pentaphylli are to the influence of rabbit lipid metabolism, " Pharmacology and Clinics of Chinese Materia Medica " 1995.3.P35; Herb Gynostemmae Pentaphylli total glycosides is to the influence of mice blood fat and hemorheological property, " Hunan medical science " 1991.6.P358; The influence that Herb Gynostemmae Pentaphylli total glycosides forms high fat animal serum lipoprotein, liver and atherosclerosis, " CHINA JOURNAL OF CHINESE MATERIA MEDICA " 1996.9.P562) Herb Gynostemmae Pentaphylli total glycosides not only suppresses triglyceride (TG) rising, significantly cholesterol reducing (TC), low density lipoprotein, LDL (LDL), very low density lipoprotein (VLDL) (VLDL), phospholipid (PL), lipid peroxide (LPO), and the ratio of raising high density lipoprotein (HDL) and HDL/LDL, imbalance improves significantly and regulating action to lipid metabolism; GP the liver diffusivity fat of high fat animal is become and atherosclerotic lesion be formed with protective effect, can also improve hemorheological property, blood viscosity lowering suppresses and removes lipofuscin, keeps collagen content, slow down aging.
Clinical trial shows, Herb Gynostemmae Pentaphylli treatment hyperlipidemia determined curative effect.Zhou Hong grinds etc. with Herb Gynostemmae Pentaphylli treatment hyperlipidemia 105 examples, 2 months courses of treatment, the result obviously reduces serum total cholesterol, triglyceride and fibronectin, high density lipoprotein increasing, do not find apparent side effect (curative effect of Herb Gynostemmae Pentaphylli treatment hyperlipidemia, " Hunan medical science " 1991.3.P259); Liu Xin etc. observe 80 routine high fat and the oral Herb Gynostemmae Pentaphylli capsule of high blood viscosity, the result takes the 7th day blood fat and begins to descend, effective percentage 96.3% after 15 days, (the Herb Gynostemmae Pentaphylli capsule is to blood fat and hemorheology influence, " clinical assembling " 1991.11.P499 obviously to improve hemorheological indexes; Yu Yanqin, Yu Guoyou, Kang Jinian, Chen Yuming etc. are used for Herb Gynostemmae Pentaphylli sheet, oral liquid, electuary clinical respectively, the result proves that Herb Gynostemmae Pentaphylli preparation effect for reducing fat is remarkable, can reduce patient's TC, TG, LDL, APOB and LP, consistent (observation of Herb Gynostemmae Pentaphylli total glycosides effect for reducing blood fat, " Shanxi Medical College's journal " 1993.2.P144 with efficacy study; The 158 routine clinical observations of Herb Gynostemmae Pentaphylli treatment hyperlipidemia, " Zhejiang Journal of Traditional Chinese Medicine " 1994.5 P204; Gynostemma pentaphylla granule treatment deficient syndrome reaches the influence to blood lipid metabolism, " Chinese herbal medicine " 2000.10.P770; Herb Gynostemmae Pentaphylli total glycosides treatment constitutional hyperlipidemia 24 examples, " Zhejiang medical science " 1994.6.P357).
Summary of the invention
The technical problem to be solved in the present invention is by the extract of using Folium Ginkgo the active ingredient of the Folium Ginkgo in the medicine quantitatively to be controlled, and effectively reduces the difference of bringing to curative effect because of the character instability of medical material own.
The present invention solves the problems of the technologies described above with following technical scheme:
The prescription of medicine of the present invention is: (weight portion)
Folium Ginkgo 10-50 part Herb Gynostemmae Pentaphylli 5-40 part Folium Ginkgo extract 1-30 part.
The method of making above prescription drug is:
1, get bright leaf of Semen Ginkgo and the remove impurity respectively of the dried herb of Herb Gynostemmae Pentaphylli, clean, dry, pulverize, get mix with above-mentioned two kinds of coarse powder again after the Semen Ginkgo cured leaf extracts, filters, concentrates with alcohol heating reflux, oven dry, packing, pack medicinal tea.
2, get the bright leaf of Semen Ginkgo, the dried herb of Herb Gynostemmae Pentaphylli remove impurity clean dry crushing screening respectively, get Semen Ginkgo cured leaf alcohol reflux, with last two powder mixings oven dry crushing screening, the dress capsule gets capsule preparations after the filtering and concentrating.
3, get the bright leaf of Semen Ginkgo, the dried herb of Herb Gynostemmae Pentaphylli remove impurity clean dry crushing screening respectively, get the Semen Ginkgo cured leaf and extract filtering and concentrating, mixes the back adding starch remix dry granulate tabletting of granulating with last two powder and get tablet with alcohol heating reflux.
Use method of the present invention to make medicine, can quantitatively control, the preparation function is more tended towards stability, significantly reduced, improved curative effect because of using different medical materials to cause curative effect difference to the active ingredient of Folium Ginkgo with blood lipid regulation function.It below is the clinical efficacy investigation of this drug products.
Hyperlipemia is that to increase with blood plasma lipide concentration be the disease of main clinical manifestation.In blood circulation, blood fat is general to be combined into lipoprotein with the blood apolipoprotein and to participate in turning round and metabolism, so hyperlipemia often is reflected in hyperlipoproteinemia.Be found in multiple disease.Primary disease belongs to the turbid category that waits of expectorant of the traditional Chinese medical science.
One, case is selected and quantitative criteria
The clinical research guideline of new Chinese medicine treatment hyperlipemia is carried out according to " new Chinese medicine clinical research guideline " (Zheng Xiao cornel chief editor, Chinese Medicine science and technology publishing house, the 1st edition the 85th~89 page of May in 2002).Stipulate diagnostic criteria, symptom scalar quantization, the classification of the syndrome state of an illness, included the case standard in, got rid of case standard etc.
Two, efficacy determination
(1) therapeutic effect of syndrome criterion
(1) clinic control clinical symptoms, sign disappear or basic the disappearance, and the syndrome integration reduces 〉=95%.
(2) produce effects clinical symptoms, sign are obviously improved, and the syndrome integration reduces 〉=70%.
(3) effectively clinical symptoms, sign all take a favorable turn, and the syndrome integration reduces 〉=30%.
(4) invalid clinical symptoms, sign do not have obvious improvement, even increase the weight of, the syndrome integration reduces less than 30%.
Three, medication
Get the product of embodiment 1, boiled water brews to be drunk.Each 1 bag of 2 gram, serve on 20 days at every day 3 times.
Product curative effect survey result table
Example product curative effect
The invalid % of the number clinic control % effective % of produce effects %
176 91 51.7 60 34.1 22 12.5 3 1.7
The specific embodiment
Folium Ginkgo, Herb Gynostemmae Pentaphylli all have the function that can regulate the human body blood fat, have no side effect, and both share the effect of playing blood lipid regulation altogether, complement each other, and effectively control medicinal component with the extract of Folium Ginkgo in addition, make prescription reach scientific and reasonable, improve curative effect.Needs according to the different patients and the state of an illness, this prescription and appropriate excipients can be made multiple dosage form with conventional pharmaceutical methods, as medicinal tea, capsule, tablet, oral liquid, electuary etc., also can further comprise additives such as correctives, sweeting agent and antiseptic, but the preferred dosage form of this medicine is a medicinal tea.
Embodiment 1:
Prescription: Folium Ginkgo 67g Herb Gynostemmae Pentaphylli 30g Folium Ginkgo extract 3g
Method for making:
1, get the bright leaf of Semen Ginkgo, choose except that impurity such as rotted leaves, wash repeatedly to cleaning with drinking water in rinse bath, put in the drying baker and toasted 1~2 day down at 55 ℃, below 10%, it is standby to be crushed to 1~2mm with pulverizer to moisture.
2, get the dried herb of Herb Gynostemmae Pentaphylli, choose impurity such as cut weeds, be cut into 5~10cm section, wash repeatedly to cleaning with drinking water in rinse bath, put in the drying baker 55 ℃ of bakings 1~2 day down, below 10%, it is standby to be crushed to 1~2mm with pulverizer to moisture.
3, get the Semen Ginkgo cured leaf, pulverize, with 60% ethanol heating (80 ℃ of temperature) reflux, extract,, for the first time add 12 times of amounts, reflux, extract, 2 hours adds 10 times of amounts for the second time, reflux, extract, 1 hour, merge extractive liquid, filters, (100 ℃ of temperature, pressure≤85KPa) are the extractum of 1.30~1.35 (50 ℃) to relative density, with above-mentioned Folium Ginkgo coarse powder, Herb Gynostemmae Pentaphylli coarse powder mix homogeneously to reclaim ethanol and concentrating under reduced pressure, 80 ℃ of oven dry down, by the packing of every bag 2 gram, packing promptly gets medicinal tea.
Embodiment 2:
Prescription: Folium Ginkgo 70g Herb Gynostemmae Pentaphylli 25g Folium Ginkgo extract 5g
Method for making:
1, the processing mode of bright leaf of Semen Ginkgo and Herb Gynostemmae Pentaphylli is with embodiment 1.
2, get the Semen Ginkgo cured leaf, pulverize, with 75% ethanol heating (80 ℃ of temperature) reflux, extract,, for the first time add 10 times of amounts, reflux, extract, 2 hours adds 8 times of amounts for the second time, reflux, extract, 1 hour, merge extractive liquid, filters, (100 ℃ of temperature, pressure≤85KPa) are the extractum of 1.30~1.35 (50 ℃) to relative density, with above-mentioned Folium Ginkgo coarse powder, Herb Gynostemmae Pentaphylli coarse powder mix homogeneously to reclaim ethanol and concentrating under reduced pressure, 80 ℃ of oven dry down, packing by every bag 2 gram packing, promptly gets medicinal tea.
Embodiment 3:
Prescription: Folium Ginkgo 30g Herb Gynostemmae Pentaphylli 20g Folium Ginkgo extract 50g
Method for making:
1, bright leaf of Semen Ginkgo and the processing method of the absolutely dry grass of Herb Gynostemmae Pentaphylli before pulverizing are with embodiment 1, and it is standby that the powder after the pulverizing is crossed 80 mesh sieves.
2, get the Semen Ginkgo cured leaf, pulverize, with 70% ethanol heating (80 ℃ of temperature) reflux, extract,, for the first time add 14 times of amounts, reflux, extract, 2 hours adds 12 times of amounts for the second time, reflux, extract, 1 hour, merge extractive liquid, filters, and reclaims ethanol and concentrating under reduced pressure (100 ℃ of temperature, pressure≤85KPa) is the extractum of 1.30~1.35 (50 ℃) to relative density, with above-mentioned ginkgo leaf powder, Herb Gynostemmae Pentaphylli powder mix homogeneously,, put cold 80 ℃ of oven dry down, pulverize (crossing 80 mesh sieves), the dress capsule is adorned 0.40 gram, is got capsule for every.
Embodiment 4:
Prescription: Folium Ginkgo 20g Herb Gynostemmae Pentaphylli 25g Folium Ginkgo extract 45g
Method for making:
1, bright leaf of Semen Ginkgo and Herb Gynostemmae Pentaphylli herb processing method are with embodiment 3.
2, get the Semen Ginkgo cured leaf, pulverize,, add 12 times of amounts for the first time with 60% ethanol heating (80 ℃ of temperature) reflux, extract,, reflux, extract, 2 hours adds 10 times of amounts, reflux, extract, 1 hour, merge extractive liquid, for the second time, filter, reclaim ethanol and concentrating under reduced pressure (100 ℃ of temperature, pressure≤85KPa) is the extractum of 1.30~1.35 (50 ℃) to relative density, with above-mentioned ginkgo leaf powder, Herb Gynostemmae Pentaphylli powder mix homogeneously, add starch 20 grams, mix, granulate drying, granulate, tabletting, every heavy 0.3 gram gets tablet.