CN1325089C - Chinese patent medicine on health food composition and its use - Google Patents
Chinese patent medicine on health food composition and its use Download PDFInfo
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- CN1325089C CN1325089C CNB2005100491038A CN200510049103A CN1325089C CN 1325089 C CN1325089 C CN 1325089C CN B2005100491038 A CNB2005100491038 A CN B2005100491038A CN 200510049103 A CN200510049103 A CN 200510049103A CN 1325089 C CN1325089 C CN 1325089C
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Abstract
The present invention relates to a Chinese patent medicine or the composition of health foods, which relates to a Chinese patent medicine or the composition of health foods for preventing and treating hyperlipoidemia, hypertension and fatty liver, and the application thereof. The present invention is characterized in that the Chinese patent medicine or the composition of health foods contains the following raw medicinal materials in weight proportion: 5 to 60% of red infested rice, 0.3% to 50% of soybean isoflavone, 10 to 75% of water plantain and one or both of hawthorn fruit and semen cassiae. The composition of the present invention has the characteristics of no toxic or side effect, favorable effect of fat regulation and obvious reduction of cholesterol, triglyceride and low-density lipoprotein in blood, has obvious effects on preventing and treating hypertension and fatty liver and is applied to the preparation of medicine or health foods for preventing and treating hyperlipoidemia, hypertension and fatty liver.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine or health-care food composition and application thereof that prevents and treats hyperlipemia, hypertension, fatty liver.
Background technology
According to the data show that World Health Organization (WHO) announces, cardiovascular and cerebrovascular disease has become first killer of harm humans health.Raising with low density lipoprotein, LDL and very low density lipoprotein (VLDL) is that the hyperlipemia of feature is to cause atherosclerosis, and then brings out one of main hazard factor of coronary heart disease, simultaneously, might concurrent myocardial ischemia, a series of cardiovascular disease such as angina pectoris.At present, the medicine that is used to prevent and treat hyperlipemia in the world is various in style, and wherein HMG-CoA reductase inhibitor (Statins) is the most effective lipid regulating agent, and treatment severe hyperlipemia has tangible curative effect.But the side effect of chemicals makes medium or slight hyperlipidemia patient be difficult to take for a long time.
Show that according to another the China's Statistical data among 35 to 74 years old crowd of China, hypertensive sickness rate is up to about 27 percent, patient's number is near 100,013,000, and is annual newly-increased more than 3,000,000.Surplus the existing patients with cerebral apoplexy 500 ten thousand, annual neopathy 1,500,000 people, dead 200,000 people.Hypertension can cause the damage of organs such as the heart, brain, kidney, serious threat human beings'health and life.
Fatty liver is that its sickness rate was up to 10～20% due to fat was accumulated in liver in a large number.The transaminase person of increasing about 35% is a fatty liver in adult's health check-up, and part patient can develop into liver cirrhosis.Fatty liver often is associated with blood fat and increases, and the foreign study personnel find that also the Arterial Hypertention patient is than irrelevant fatty livers of other main hazard factor such as the easier appearance of normal person and rising of liver enzyme or hepatitis steatosis.On the other hand, fatty liver takes place and often prompts for pernicious obesity in overweight and overweight people, and the latter and impaired glucose tolerance, hyperlipemia and hypertension are referred to as " dead quartet ", the very easily concurrent mortality cardiovascular and cerebrovascular disease of this class patient.Therefore, Prevention and Management of Fatty Liver is of crucial importance to the progress that stops chronic hepatopathy and the generation that reduces cardiovascular and cerebrovascular disease.
Summary of the invention
The objective of the invention is to overcome problems of the prior art, with medicine food dual-purpose plant is raw material, provides a kind of to preventing and treating Chinese patent medicine or health-care food composition and the application in such medicine of preparation or health food thereof that hyperlipemia, hypertension, fatty liver have positive effect.
Monas cuspurpureus Went is exactly the good merchantable brand of medicine food dual-purpose since ancient times, and having helps digestion invigorates blood circulation, the effect of the dry stomach of spleen invigorating.Monas cuspurpureus Went contains the HMG-CoA reductase inhibitor, has the mechanism of action of statins.Because be natural product, so aspect safety, be much better than synthetic statins.Chinese scholars found also that Monas cuspurpureus Went had the effect of blood fat reducing, blood pressure lowering, blood sugar lowering simultaneously in recent years.
Soybean isoflavone is a natural plants estrogen, it safely, have no side effect.Studies show that soybean isoflavone can reduce the susceptibility of body to the serum LDL oxidation, also can improve the non-oxidizability of serum LDL, the formation of prevention of arterial blood vessel wall atheromatous plaque, anti-hemostatic tube medicated porridge sample sclerosis increases arterial vascular compliance, blood vessel dilating simultaneously.The Japan scientific research personnel finds that also soybean isoflavone also has the effect of blood pressure lowering, anti-apoplexy.
Rhizoma Alismatis is a conventional Chinese medicine.Clinical observation shows that Rhizoma Alismatis extract in the TC, can also reduce the content of triglyceride in the blood (TC) in reducing blood.Single Rhizoma Alismatis preparation all has certain curative effect to IIa, IIb, IV, V-type hyperlipoproteinemia, and is especially best to the curative effect of high TC mass formed by blood stasis.Rhizoma Alismatis can reduce LDL content in the blood, improves the ratio of HDL level and HDL-Ch and TC.To the experimental atherosclerosis rabbit, Rhizoma Alismatis extract can obviously suppress the generation of aortic tunica intima speckle.Rhizoma Alismatis also has slight hypotensive activity, and Rhizoma Alismatis extractum and alisol are exempted from the aortic article contraction to exsomatizing have relexation, can suppress the inflow of calcium ion voltage dependent channel.Rhizoma Alismatis can also be improved the liver fat metabolism, has lipotropy.For the Animal fat liver pathological changes due to hypercholesterolemia, high fat, the low albumen feedstuff, Rhizoma Alismatis water extract or benzene are carried thing can make all that fat content reduces in the liver, and the hepatic injury that CCL4 is caused has protective effect.
Fructus Crataegi has the effect of blood circulation promoting and blood stasis dispelling, is traditional facilitating digestion, the medicine of the greasy meat stagnation that disappears.The blood fat reducing of modern pharmacological research proof Fructus Crataegi energy, blood pressure lowering, atherosclerosis; Increase the coronary vasodilator blood flow, improve the coronary disease circulation, and it is compensatory that the coronary artery sexual exhaustion is able to, reach cardiotonic, and improve the sensitivity of cardiac muscle, increase heart output the cardiotonic glycoside effect, weaken myocardium irritability and conductivity, has anti-ventricular fibrillation, effects such as atrial fibrillation and paroxysmal arrhythmia, and the heartthrob effect that all sets up.
Semen Cassiae is the seed that leguminous plant is stewed leaf Semen Cassiae or Semen Cassiae, includes anthracene ester and anthraquinone glycoside, obtusin and vitamin A etc., and pharmacological testing proves: Semen Cassiae has bringing high blood pressure down and reduces the effect of serum cholesterol; Anti-various pathogens and the effect of soft stool cathartic are arranged.The traditional Chinese medical science is thought, its cold nature, and sweet in the mouth, hardship, the function liver heat removing and eyesight improving, the diuretic relieving constipation is applicable to the puckery pain of conjunctival congestion due to liver-heat or the wind-heat of liver channel, the many tears of photophobia etc.; In addition to the treatment hypertension, hepatitis, cirrhotic ascites and habitual constipation etc. are also effective.
Described a kind of Chinese patent medicine or health-care food composition is characterized in that containing following raw materials by weight proportions and make: Monas cuspurpureus Went 5-60%, soybean isoflavone 0.3%-50%, Rhizoma Alismatis 10-75%.
Described Chinese patent medicine or health-care food composition is characterized in that containing: Monas cuspurpureus Went 5-35%, soybean isoflavone 1%-30%, Rhizoma Alismatis 20-70%.
Described Chinese patent medicine or health-care food composition is characterized in that containing: Monas cuspurpureus Went 10-25%, soybean isoflavone 2%-10%, Rhizoma Alismatis 30-60%.
Described Chinese patent medicine or health-care food composition is characterized in that containing in the crude drug Fructus Crataegi 10-60%, preferred 20-40%, more preferably 20-30%, most preferably 25%.
Described Chinese patent medicine or health-care food composition is characterized in that containing in the crude drug Semen Cassiae 5-60%, preferred 10-40%, more preferably 10-20%, most preferably 15%.
Described Chinese patent medicine or health-care food composition is characterized in that containing: Monas cuspurpureus Went 12%, soybean isoflavone 4%, Rhizoma Alismatis 38%, Fructus Crataegi 28%, Semen Cassiae 18%.
Described Chinese patent medicine or health-care food composition is characterized in that dosage form is a solid preparation, is specially tablet or capsule or granule or electuary.
The purposes of described Chinese patent medicine or health-care food composition is characterized in that preventing and treating the medicine of hyperlipemia, hypertension, fatty liver or the application in the health food in preparation.
The proportioning that relates in the present patent application file is weight percentage or weight proportion.
According to said ratio, utilize conventional production process to carry out the extraction of effective ingredient, add conventional adjuvant and fully make finished product after the mixing by different dosage form, can be tablet or capsule or granule or electuary.Because of the adjuvant that adds and consumption, concrete production technology all belong to existing known technology, do not repeat them here.
The recommended amounts of the present composition: tablet, capsule preparations are 2.0g/ people/sky, and granule, electuary are 4.0g/ people/sky, and be oral at twice, swallow or take after mixing it with water according to the different waters of dosage form.
The present composition has no side effect, regulating lipid is good, can significantly reduce cholesterol in the blood, triglyceride, low density lipoprotein, LDL, positive effect also be arranged, can apply to prepare medicine or the health food of preventing and treating hyperlipemia, hypertension, fatty liver preventing and treating hypertension, fatty liver.
The specific embodiment
By the following examples the present invention is elaborated, and further specify beneficial effect of the present invention with animal and clinical trial example.Following prescription is the weight in grams number of crude drug.
The tablet of embodiment 1:0.5g/ sheet
| Composition | 1000 consumptions (1) | 1000 consumptions (2) | 1000 consumptions (3) |
| Monas cuspurpureus Went soybean isoflavone Rhizoma Alismatis hawthorn and cassia seeds | 250g 40g 1000g 1000g 500g | 250g 40g 1000g 1000g - | 250g 40g 1000g - - |
The capsule of embodiment 2:0.5g/ grain
| Composition | 1000 consumptions (1) | 1000 consumptions (2) | 1000 consumptions (3) |
| Monas cuspurpureus Went soybean isoflavone Rhizoma Alismatis hawthorn and cassia seeds | 250g 40g 1000g 1000g 500g | 250g 40g 1000g 1000g - | 250g 40g 1000g - - |
The granule of embodiment 32g/ bag
| Composition | 1000 bag consumptions (1) | 1000 bag consumptions (2) | 1000 bag consumptions (3) |
| Monas cuspurpureus Went soybean isoflavone Rhizoma Alismatis hawthorn and cassia seeds | 500g 80g 2000g 2000g 1000g | 500g 80g 2000g 2000g - | 500g 80g 2000g - - |
The electuary of embodiment 4 electuary 2g/ bag
| Composition | 1000 bag consumptions (1) | 1000 bag consumptions (2) | 1000 bag consumptions (3) |
| Monas cuspurpureus Went soybean isoflavone Rhizoma Alismatis hawthorn and cassia seeds | 500g 80g 2000g 2000g 1000g | 500g 80g 2000g 2000g - | 50g 80g 2000g - - |
One, safety toxicology test
1 materials and methods
1.1 tried thing: plant the capsule that prescription production obtains by the embodiment of the invention 2 (1), below all be called for short and tried thing, prosperous rich Pharma Inc. provides by Hangzhou.
1.2 experimental animal: ICR mice, cleaning level; The SD rat, the cleaning level.The medical experiment animal quality certification numbers 2001001 is provided by Zhejiang Province's Experimental Animal Center.
2 acute toxicity tests
SD rat body weight 180-220g, each 20 of male and female; ICR mice body weight 18-22g, each 20 of male and female.By horn method SD rat, ICR mice are divided into 1.00g/kg, 2.15g/kg, 4.64g/kg, four dosage groups of 10.00g/kg body weight at random, each 5 of every group of male and female.Each treated animal is after stopping eating 16 hours, and disposable per os is tried thing, observes general situation, poisoning symptom and the death condition of rat and mice, is tried the half lethal dose LD of thing to rat and mice to determine this
50, observe 2 weeks of time limit, the results are shown in Table 1.
Table 1 is tried the acute toxicity of thing to rat and mice
| Dosage (g/kg) | Female | Male | Reaction of animals | LD 50(g/kg body weight) | |||
| Number of animals | Death toll | Number of animals | Death toll | ||||
| The SD rat | 1.00 2.15 4.64 10.0 | 5 5 5 5 | 0 0 0 0 | 5 5 5 5 | 0 0 0 0 | Normal | ＞10 |
| The ICR mice | 1.00 2.15 4.64 10.0 | 5 5 5 5 | 0 0 0 0 | 5 5 5 5 | 0 0 0 0 | Normal | ＞10 |
3 genetic toxicity tests
3.1 Salmonella reversion test: select the histidine auxotroph Salmonella typhimurium for use, totally four strains, i.e. TA
97A, TA
98, TA
100, TA
102, establish five dosage groups of 5000,1000,200,40,8 μ g/ wares, each dosage is established three parallel wares, and repeated trials is once.Positive controls: 9-aminoacridine, 2,7 diamin of luorene, sodium azide, 2-acetamidofluorene, ametycin, 1,8-dihydroxyanthraquinone; Negative control group: distilled water.Observe that returning of each bacterial strain becomes clump count on the counting culture medium, result of the test sees Table 2, table 3.
Table 2 is tried the dull and stereotyped infiltration test result of thing Ames
| Dosage (μ g/ ware) | Return to become clump count (X ± SD) | ||||||||
| TA97a | TA98 | TA100 | TA102 | ||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
| Tried thing | 0 8 40 200 1000 5000 | 156.3±11.59 146.7±23.18 160.0±12.00 156.7±11.93 152.3±4.04 162.3±11.93 | 174.7±5.77 172.3±11.93 168.3±8.39 165.0±7.55 162.3±8.50 172.7±10.07 | 30.7±2.31 30.3±2.08 31.3±2.52 29.7±2.89 30.7±3.21 30.7±2.52 | 37.7±3.51 39.0±2.65 39.7±4.04 37.3±3.21 41.0±2.65 40.0±2.65 | 166.7±14.01 157.7±8.39 161.3±6.03 160.3±11.59 167.0±12.53 157.3±7.23 | 179.0±12.53 184.3±7.23 190.3±13.58 187.3±6.43 186.3±11.50 186.7±13.61 | 259.7±11.59 262.0±18.33 263.7±18.01 161.7±12.34 256.0±11.14 255.0±10.44 | 295.7±6.51 287.3±14.74 293.7±17.56 290.3±12.10 315.0±6.56 296.7±10.07 |
| 9AA | 25 | ＞1000 | |||||||
| 2.7AF | 20 | 330 | |||||||
| NaN3 | 1.5 | ＞1000 | |||||||
| 2AAF | 10 | ＞1000 ＞1000 ＞1000 | |||||||
| MMC | 0.5 | ＞1000 | |||||||
| 1.8HAQ | 25 | ＞1000 | |||||||
Table 3 is tried the dull and stereotyped infiltration test of thing Ames repeated trials result as a result
| Tried thing | Dosage (μ g/ ware) | Return to become clump count (X ± SD) | |||||||
| TA97a | TA98 | TA100 | TA102 | ||||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
| Tried thing | 0 8 40 200 1000 5000 | 152.0±6.00 154.0±7.94 155.7±11.85 151.0±16.64 160.3±8.62 162.7±10.07 | 177.0±10.44 166.7±10.26 162.3±11.93 174.7±9.45 166.0±8.89 176.0±8.72 | 31.0±2.65 30.0±2.00 31.0±1.73 31.7±2.08 34.0±2.65 30.0±1.00 | 39.0±2.65 39.3±4.16 41.3±1.53 38.7±3.06 37.7±3.06 38.0±2.00 | 170.7±14.74 161.3±12.22 158.3±13.87 153.7±10.21 157.3±6.03 165.7±20.98 | 175.3±12.34 164.3±14.57 157.0±5.57 160.3±12.01 170.0±9.85 175.3±15.14 | 248.7±13.01 259.0±10.44 272.7±8.33 257.7±14.50 258.7±13.32 260.3±15.50 | 296.0±7.00 293.0±7.81 306.0±5.29 295.7±6.51 295.0±15.39 297.7±9.45 |
| 9AA | 25 | ＞1000 | |||||||
| 2.7AF | 20 | 321 | |||||||
| NaN3 | 1.5 | ＞1000 | |||||||
| 2AAF | 10 | ＞1000 ＞1000 ＞1000 | |||||||
| MMC | 0.5 | ＞1000 | |||||||
| 1.8HAQ | 25 | ＞1000 | |||||||
9AA 9-aminoacridine 2.7AF 2.7-N-2-Fluorenylamine NaN3 sodium azide
2AAF 2-acetamidofluorene MMC ametycin 1.8HAQ 1.8-dihydroxyanthraquinone
3.2 mouse marrow cell micro nuclear test: ICR mice body weight 25-28g.Mice divides 2.5,5.0 at random, three dosage groups of 10.0g/kg body weight, a negative control group (1% carboxymethyl cellulose) and a positive controls (cyclophosphamide 40mg/kg body weight), 10 every group, each 5 of male and female.Tried thing and be mixed with corresponding dosage with 1% carboxymethyl cellulose.Mice is 24 hours continuous irrigation stomaches 2 times at interval, in irritating for the second time the stomach execution that dislocates after 6 hours.Get bone marrow of sternum and make the bone marrow sheet, methanol is fixed, Giemsa dyeing.1000 polychromatic erythrocytes of every animal counting calculate the micronucleus permillage when observing microscopy, the results are shown in Table 4.
Table 4 is tried the influence of thing to the micronuclei in mice rate
| Sex | Group | Dosage (g/kg) | The Mus number | The polychromatic erythrocyte number | The micronucleus cell number | Micronuclear rates (‰) |
| Female | Negative control | 0.0 | 5 | 5000 | 9 | 1.8 |
| Tried thing | 2.5 | 5 | 5000 | 7 | 1.4 | |
| 5.0 | 5 | 5000 | 9 | 1.8 | ||
| 10.0 | 5 | 5000 | 8 | 1.6 | ||
| Cyclophosphamide | 0.04 | 5 | 5000 | 74 | 14.8* | |
| Male | Negative control | 0.0 | 5 | 5000 | 7 | 1.4 |
| Tried thing | 2.5 | 5 | 5000 | 10 | 2.0 | |
| 5.0 | 5 | 5000 | 8 | 1.6 | ||
| 10.0 | 5 | 5000 | 9 | 1.8 | ||
| Cyclophosphamide | 0.04 | 5 | 5000 | 76 | 15.2* |
Annotate * P＜0.01 (with the negative control group ratio)
3.3 mouse sperm deformity test: 50 of ICR male mices, body weight 21-25g.2.5,5.0, three dosage groups of 10.0g/kg body weight if, a negative control group (1% carboxymethyl cellulose) and a positive controls (ametycin 2.0mg/kg body weight), 10 every group.Sample gives to irritate the stomach mode, and continuous 5 days, once a day, matched group is same treatment also.Dislocation is put to death after the 35th day after irritating stomach first, and every group is selected 5 mices to get the both sides epididymis respectively at random, makes suction strainer liquid direct smear, natural drying, and methanol is fixed, and dyes with 1% Yihong.Observe sperm morphology and counting under high power lens, every mice is counted 1000 of complete sperms, calculates sperm deformity incidence rate (%), the results are shown in Table 5.
Table 5 is tried the influence of thing to the mouse sperm deformity incidence rate
| Group | Dosage (g/kg) | The Mus number | Observe sperm count | The teratospermia number | Subtotal | Micronuclear rates (‰) | ||||||
| Indefiniteness | Wugou | Folding | Fat head | Fructus Musae | Double end | Two tails | ||||||
| Tried thing | 0.0 | 5 | 5000 | 67 | 4 | 1 | 72 | 1.44 | ||||
| 2.5 | 5 | 5000 | 71 | 6 | 1 | 78 | 1.56 | |||||
| 5.0 | 5 | 5000 | 75 | 3 | 2 | 80 | 1.60 | |||||
| 10.0 | 5 | 5000 | 68 | 3 | 1 | 72 | 1.44 | |||||
| MMC | 0.002 | 5 | 5000 | 246 | 24 | 20 | 20 | 18 | 328 | 6.56* | ||
Annotate: MMC ametycin * P＜0.01 (with the negative control group ratio)
30 days feeding trials of 4 rats
The SD rat is divided into 4 groups at random, 20 every group, male and female half and half.Matched group is established in test, is tried thing 1.25,2.5,3.3g/kg body weight group.Being tried thing gives to mix feedstuff mode mode.Ad lib, drinking-water write down body weight and food-intake weekly and calculate food utilization.Experiment end of term overnight fasting, next day sacrificed by decapitation, taking internal organ is weighed and is compared group and the liver of high dose group, nephropathy are managed cut sections for microscopic examination, gets blood and carries out hemogram, blood biochemical analysis.Experimental result sees Table 6, table 7, table 8, table 9, table 10.
Table 6 is tried the influence of thing to rat body weight
| Sex | Dosage (g/kg) | The Mus number | Starting weight (g) | First week (g) | Second week (g) | The 3rd week (g) | Around (g) |
| Female | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 77.6±4.8 77.7±4.4 77.7±5.3 76.7±5.7 | 123.4±8.7 120.9±6.6 123.7±7.6 121.1±6.4 | 159.9±10.0 159.3±9.4 154.3±7.2 155.4±7.3 | 178.1±10.5 181.7±9.8 180.1±9.4 179.9±9.2 | 205.6±10.4 211.9±11.6 207.6±12.5 206.1±9.8 |
| Male | 1.0 1.25 2.5 3.3 | 10 10 10 10 | 80.6±6.1 80.8±5.4 80.6±4.0 80.8±5.0 | 140.9±10.6 138.6±8.8 137.0±5.0 135.9±7.4 | 196.5±14.1 190.1±10.3 190.5±13.6 184.6±15.9 | 240.3±16.8 235.5±17.2 241.6±15.0 232.6±24.9 | 275.9±22.6 260.3±17.6 274.8±15.5 268.3±24.1 |
Table 7 is tried the influence of thing to weightening finish, food-intake and the food utilization of rat
| Sex | Dosage (g/kg) | The Mus number | Weightening finish (g) | Food-intake (g) | Food utilization (g) |
| Female | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 128.0±9.3 134.2±12.1 129.9±10.3 129.4±13.1 | 534.0±23.2 535.5±18.6 536.7±24.4 539.6±17.5 | 23.97±1.37 25.04±1.78 24.19±1.32 23.98±2.27 |
| Male | 1.0 1.25 2.5 3.3 | 10 10 10 10 | 195.3±21.2 179.5±18.7 194.2±15.4 187.5±25.0 | 686.3±32.5 666.7±23.6 685.3±21.8 669.3±26.5 | 28.40±2.10 26.88±2.13 28.30±1.36 27.93±2.82 |
Table 8 is tried the influence of thing to the rat hemogram
| Sex | Dosage (g/kg) | The Mus number | Erythrocyte (* 1012/L) | Hemoglobin (g/L) | Leukocyte (* 109/L) | Leukocyte differential count (%) | ||
| Lymph | Neutral | Other | ||||||
| Female | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 8.55±0.33 7.93±0.33 8.15±0.64 7.89±0.38 | 156.17.4 155.4±4.4 156.9±4.9 157.9±6.7 | 14.15±2.93 11.01±2.04 11.30±3.71 13.86±3.50 | 79.2 79.2 80.0 84.0 | 19.4 20.1 19.0 14.0 | 1.4 0.7 1.0 2.0 |
| Male | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 8.13±0.34 8.99±1.11 8.80±1.68 8.32±1.46 | 155.9±7.7 172.9±16.8 172.8±24.7 163.8±19.0 | 13.48±3.51 12.30±2.94 13.85±3.35 13.46±1.82 | 79.5 74.3 78.5 81.1 | 19.4 24.3 19.4 15.5 | 1.1 1.4 2.1 3.4 |
Table 9 is tried the influence of thing to blood biochemistry of rats
| Sex | Dosage (g/kg) | The Mus number | ALT (IU/L) | TP (g/L) | ALB (g/L) | TG (mmol/L) | Chol (mmol/L) | Glu (mmol/L) | Urea (mmol/L) | CR (umol/L) |
| Female | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 60.3±7.0 69±11.1 61.9±9.3 56.1±7.4 | 68.0±3.5 69.4±4.7 70.9±6.1 65.4±3.7 | 36.3±1.8 38.5±2.2 39.2±3.6 35.8±1.6 | 0.46±0.36 0.37±0.20 0.28±0.11 0.31±0.21 | 1.84±0.27 1.90±0.19 1.70±0.31 1.76±0.29 | 4.22±0.57 3.90±0.57 4.06±0.65 3.73±0.45 | 5.63±0.96 6.41±1.09 6.04±0.73 6.09±1.22 | 48.6±3.0 52.6±3.3 50.7±6.3 45.8±7.0 |
| Male | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 88.3±10.3 81.0±14.6 81.3±9.9 89.2±11.2 | 62.7±3.1 63.7±1.5 62.8±2.5 67.0±3.0 | 34.9±1.2 34.4±1.1 34.0±1.4 36.1±1.6 | 0.50±0.11 0.41±0.14 0.37±0.16 0.52±0.21 | 1.78±0.38 1.57±0.38 1.57±0.15 1.71±0.36 | 4.13±0.25 3.28±0.78 3.62±0.69 3.79±0.67 | 6.23±1.04 6.47±1.30 6.48±0.77 6.42±0.87 | 46.3±5.1 50.4±7.6 48.1±3.5 48.7±4.2 |
Table 10 is tried the influence of thing to the dirty body ratio of rat
| Sex | Dosage (g/kg) | The Mus number | The liver body is than (%) | The kidney body is than (%) | The spleen body is than (%) | The testis body is than (%) |
| Female | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 3.43±0.15 3.22±0.16 3.23±0.17 3.31±0.36 | 0.90±0.08 0.92±0.06 0.93±0.05 0.95±0.08 | 0.26±0.02 0.25±0.05 0.24±0.02 0.26±0.07 | |
| Male | 0.0 1.25 2.5 3.3 | 10 10 10 10 | 3.37±0.22 3.41±0.15 3.30±0.18 3.37±0.18 | 0.97±0.04 0.97±0.07 1.00±0.05 0.98±0.04 | 0.23±0.04 0.25±0.02 0.22±0.03 0.23±0.03 | 0.94±0.07 0.94±0.12 0.98±0.07 0.96±0.08 |
5 conclusions
According to this result of the test, compositions of the present invention is to the large and small Mus per os of male and female LD
50All greater than the 10.00g/kg body weight, true border is nontoxic.Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity result of the test are all negative.30 days feeding trial results of rat do not see that poisoning symptom appears in laboratory animal, and gross anatomy is the no abnormality seen pathological change also, the influence of all harmless property of routine blood test and biochemical indicator.
Two, clinical trial
In order to verify the drug effect of the present composition, entrust Zhejiang Center For Disease Control and Prevention and Zhejiang Province to stand and finish human feeding trial jointly with moral hospital.
1 materials and methods
1.1 sample: plant the tablet that prescription production obtains by the embodiment of the invention 1 (1), below all be called for short and tried thing; Placebo (starch), prosperous rich Pharma Inc. provides by Hangzhou, and the two is in full accord on packing, outward appearance, color and luster and mouthfeel, and recommended intake is 2.0g/ day.
1.2 the experimenter selects: the age requires to keep usual diet at the hyperlipemia in 18-65 year, and blood sampling is 2 times in half a year, and its serum total cholesterol (TC) 〉=5.2mmol/L or serum levels of triglyceride (TG) 〉=1.65mmol/L person all can include test in.
1.3 test method: adopt the double blind random grouping, between group and self two kinds of control design.According to above-mentioned Standard Selection 100 routine hyperlipemias, patient's 25 examples of complicated hypertension wherein merge patient's 18 examples of fatty liver.By age, sex, blood lipid level etc. are divided into two groups of test-meal group and matched groups, wherein test-meal group 50 examples, matched group 50 examples at random.The test-meal group is taken and is tried thing, and every day 2 times, each 2, matched group is taken placebo, and instructions of taking was taken 30 days continuously with the test-meal group.
1.4 observation index: each tests once every index when test-meal begins and finish.
Safety indexes: blood, urine, stool routine examination inspection comprise blood rbc counting (RBC), hemoglobin (Hb), numeration of leukocyte (WBC); Biochemical indicator comprises glutamic oxaloacetic transaminase, GOT (AST), glutamate pyruvate transaminase (ALT), total serum protein (TP), albumin (ALB), blood glucose (GLU), blood urea nitrogen (BUN), creatinine (Cr); Electrocardiogram; Abdominal B type ultrasonography; The fluoroscopy of chest of X line.
Effect index: get blood on an empty stomach, measure serum total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) level and reduce percentage rate, HDL-C (HDL-C) level and ascensional range.
1.5 criterion of therapeutical effect
Effectively: TC reduces＞10%; TG reduces＞15%; HDL-C rising＞0.104mmol/L.
Invalid: as not reach effective standard.
2 result of the tests
2.1 clinical observation: take and tried thing one month, test-meal group clinical observation total effective rate is 74%, with matched group (28%) significance meaning (X is arranged relatively
2=21.168, P=0.000).Clinical observation result sees Table 11.
Table 11 clinical observation effect relatively
| Group | Example number (n) | Effectively | Invalid | Total effective rate % | The check of significance meaning |
| Matched group test-meal group | 50 50 | 14 37 | 36 13 | 28.00 74.00 | X 2＝21.168 P＝0.000 |
2.2 T-CHOL: the T-CHOL variation sees Table 12 before and after the test-meal.Table 12 shows, because initial data heterogeneity of variance (P＜0.05), so adopt t ' check between organizing during relatively significance test.Compare before cholesterol and the test-meal after the test-meal of test-meal group, difference has significance meaning (t=3.820, P＜0.01), with the matched group comparing difference significance meaning (t=2.433, P＜0.05) is arranged also; Its average decline percentage rate is 10.17%, with matched group (0.42%) relatively, difference also have the significance meaning (t '=3.114, P＜0.01).
Cholesterol variation before and after the table 12 liang group test-meal (mmol/L, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal | Fall | The decline percentage rate | t | P |
| Matched group test-meal group | 50 50 | 5.63±1.17 5.89±1.35 | 5.56±1.18 5.08±0.71 *# | 0.07±0.71 0.81±1.50 ## | 0.42±11.74 10.17± 18.78 ## | 0.683 3.820 | 0.498 0.000 |
| t’ P | 1.055u 0.294 | 2.433 a 0.017 | 3.158 0.002 | 3.114 0.003 |
Annotate: *: with comparison P＜0.01 before the test-meal; #: compare P＜0.05 with matched group; ##: compare P＜0.01 with matched group; A: variance is neat.
2.3 triglyceride: the triglyceride variation sees Table 13 before and after the test-meal.Table 13 shows, because initial data heterogeneity of variance (P＜0.05), so adopt t ' check between organizing during relatively significance test.After the test-meal of test-meal group before triglyceride and the test-meal relatively, difference has significance meaning (t=7.546, P＜0.01), with the matched group comparing difference also have the significance meaning (t '=4.950, P＜0.05); Its average decline percentage rate is 25.05%, with matched group relatively, difference also have the significance meaning (t '=6.897, P＜0.01).
Triglyceride variation before and after the table 13 liang group test-meal (mmol/L, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal | Fall | The decline percentage rate | t | P |
| Matched group test-meal group | 50 50 | 2.63±0.59 2.86±0.86 | 2.54 0.42 2.07 0.52 *# | ±0.09±0.55 ±0.79±0.74 # | 1.32±16.36 25.05±18.00 # | 1.189 7.546 | 0.240 0.000 |
| t’ P | 1.570 a 0.120 | 4.950 a 0.000 | 5.337 0.000 | 6.897 0.000 |
Annotate: *: with comparison P＜0.01 before the test-meal; #: compare P＜0.01 with matched group; A: variance is neat.
2.4 HDL-C: the HDL-C variation sees Table 14 before and after the test-meal.Table 14 shows, because initial data heterogeneity of variance (P＜0.05), so adopt t ' check between organizing during relatively significance test.HDL-C is respectively at comparing difference there are no significant meaning (P＞0.05) between group before and after the test-meal, and test-meal group and matched group are respectively at comparison before and after the test-meal, and difference does not have significance meaning (P＞0.05) yet.
HDL-C variation before and after the table 14 liang group test-meal (mmol/L, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal | Fall | t | P |
| Matched group test-meal group | 50 50 | 1.55±0.25 1.53±0.44 | 1.50±0.20 1.52±0.41 | 0.053±0.21 0.007±0.27 | 1.738 0.185 | 0.088 0.854 |
| t’ P | 0.292 0.771 | 0.388 0.699 | 0.944a 0.348 |
Annotate: a: variance is neat.
2.5 low-density lipoprotein cholesterol: the variation of low-density lipoprotein cholesterol sees Table 15 before and after the test-meal.Table 15 shows, compares before low-density lipoprotein cholesterol and the test-meal after the test-meal of test-meal group, and difference has highly significant (P＜0.01), with the matched group comparing difference significance (P＜0.05) is arranged also.
The variation of low-density lipoprotein cholesterol before and after the table 15 liang group test-meal (mmol/L, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal | Fall |
| Matched group test-meal group | 50 50 | 3.18±0.58 3.24±0.65 | 3.11±0.74 2.83±0.50 *# | 0.08±0.40 0.41±0.52 ## |
Annotate: *: with comparison P＜0.01 before the test-meal; #: compare P＜0.05 with matched group; ##: compare P＜0.01 with matched group.
2.6 security inspection: during being tried, experimenter's stool routine examination and routine urianlysis there is no abnormal change.All in normal range, see Table 16 before and after two groups of hemogram and the test-meal of the every inspection index of hepatic and renal function.
The variation of hemogram and hepatic and renal function before and after table 16 test-meal (x ± SD)
| Project | Matched group (n=50) | Test-meal group (n=50) | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| Erythrocyte (* 10 12/ L) leukocyte (* 10 9/ L) hemoglobin (g/L) total serum protein (g/L) albumin (g/L) glutamic-pyruvic transaminase (glutamic-oxalacetic transaminease of μ/L) (blood sugar (mmol/L) urea nitrogen (mmol/L) creatinine (μ mol/L) of μ/L) | 4.61±0.37 5.01±0.65 142.14±14.15 79.92±3.16 47.29±2.57 28.14±11.92 26.34±6.70 4.33±0.36 3.71±0.70 67.98±13.93 | 4.57±0.32 5.10±0.55 141.94±13.27 79.59±2.31 46.17±1.83 25.92±8.16 24.06±7.70 4.48±0.30 3.55±0.53 66.72±9.15 | 4.61±0.46 5.68±1.25 142.62±16.62 79.34±3.05 47.16±2.32 29.88±13.67 26.90±8.46 4.28±0.40 3.78±0.89 67.70±13.06 | 4.62±0.42 5.24±0.83 142.84±16.26 79.37±2.30 46.13±1.12 26.84±9.46 22.88±7.28 4.42±0.26 3.74±0.73 66.60±7.73 |
3 conclusion (of pressure testing)s
According to this result of the test, the present invention's compositions can reduce serum total cholesterol and triglyceride level, test-meal group self reaches relatively that comparing difference all has significance meaning (P＜0.05) between two groups, wherein T-CHOL on average descends 10.17%, triglyceride on average descends 25.05%, and HDL-C level and matched group relatively do not have obvious decline.Total effective rate is 74%, compares with matched group (28%), and difference has significance meaning (P＜0.01).Also find in the test, 25 routine patients of complicated hypertension, after taking medicine, 21 routine patient's blood pressures obviously reduce; The 18 routine patients that merge fatty liver, by taking the photograph the sheet contrast, medication 11 routine patients' fibrosis after two months obviously alleviates.
In sum, the present composition has no side effect, and has significant accent blood fat, also has positive effect to preventing and treating hypertension, fatty liver, can make medicine or health food that hyperlipemia, hypertension, Patients with Fatty Liver can be taken for a long time.
Claims (9)
1. Chinese patent medicine or health-care food composition is characterized in that: contain the Monas cuspurpureus Went 5-60% of following weight proportioning in the crude drug of preparation said composition, soybean isoflavone 0.3-50%, Rhizoma Alismatis 10-75%.
2. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that: the crude drug of preparation said composition contains Monas cuspurpureus Went 5-35%, soybean isoflavone 1-30%, Rhizoma Alismatis 20-70%.
3. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that: the crude drug of preparation said composition contains Monas cuspurpureus Went 10-25%, soybean isoflavone 2-10%, Rhizoma Alismatis 30-60%.
4. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that also containing in the crude drug Fructus Crataegi 10-60%.
5. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that also containing in the crude drug Semen Cassiae 5-60%.
6. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that crude drug by Monas cuspurpureus Went 12%, soybean isoflavone 4%, and Rhizoma Alismatis 38%, Fructus Crataegi 28%, Semen Cassiae 18% is formed.
7. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that dosage form is a solid preparation.
8. Chinese patent medicine according to claim 1 or health-care food composition is characterized in that dosage form is tablet or capsule or granule or electuary.
9. prevent and treat the medicine of hyperlipemia, hypertension, fatty liver or the application in the health food according to claim 1 or 7 or 8 described compositionss in preparation.
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| ITPI20110038A1 (en) * | 2011-04-08 | 2012-10-09 | Funcional Food Res S R L | FUNCTIONAL FOOD COMPOSITION BASED ON FLOUR. |
| CN102940209B (en) * | 2011-08-15 | 2013-12-18 | 曾广宁 | Health food for preventing and removing extra fat in liver and preparation method thereof |
| CN108186920B (en) * | 2018-02-02 | 2021-05-25 | 金华寿仙谷药业有限公司 | Pharmaceutical composition with auxiliary blood fat reducing effect and preparation method thereof |
| CN110170027B (en) * | 2019-04-23 | 2021-06-29 | 广东健信制药股份有限公司 | Hawthorn and monascus powder pills and preparation method thereof |
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| CN1394614A (en) * | 2001-07-05 | 2003-02-05 | 深圳太太药业股份有限公司 | Health-care product capable of regulating blood-lipid and its preparation method |
| CN1522731A (en) * | 2003-09-06 | 2004-08-25 | 郭凌云 | Blood fat regulating drug or health food |
| CN1537632A (en) * | 2003-04-14 | 2004-10-20 | 李朝晖 | Health-care food for preventing and treating hyperlipoidemia |
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| CN1537632A (en) * | 2003-04-14 | 2004-10-20 | 李朝晖 | Health-care food for preventing and treating hyperlipoidemia |
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