CN1686273A - Theory and medicine for treating high blood fat, fatty liver, liver fibrosis and preparation method - Google Patents
Theory and medicine for treating high blood fat, fatty liver, liver fibrosis and preparation method Download PDFInfo
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Abstract
A novel theory for treating hyperlipemia, fatty liver and hepatofibrosis is that the intestine, blood vessel and liver must be cleaned by the Chinese medicine which is prepared from 14 Chinese-medicinal materials including haw, notoginseng, tangerine peel, capejasemine fruit, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of new theory and Chinese medicine medicine, specifically relate to treat the new theory of hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury and medicine and preparation method thereof.
Background technology
1, cardiovascular and cerebrovascular disease-human health first killer
A large amount of scientific researches clearly show, the mortality rate of cardiovascular and cerebrovascular disease (coronary heart disease, hypertension, apoplexy etc.) is higher than the cancer mortality number far away in China and some developed countries tool first place that jumped.Its arch-criminal is an arteriosclerosis.And the arteriosclerotic is caused by hyperlipemia more than 80%.In China, the cardiovascular and cerebrovascular disease sickness rate is up to 8% of total population, mortality rate just had a people because of cardiovascular and cerebrovascular disease death in average per 20 seconds up to 50% of general mortality rate, and the hyperlipemia sickness rate is more than 7%, there is the scholar to report, did among the crowd of lipid examination in 15-69 year, the hyperlipidemia person accounts for 40%, in the Patients with Fatty Liver, triglyceride rising person accounts for 60-80%, and hyperlipidemia can also increase the weight of many relevant diseases such as hypertension, fatty liver, diabetes, gout, the nephrotic syndrome simultaneously.
2, hepatic injury-modern healthy killer that must face
Liver is the body of gland and the parenchymal viscera of human body maximum, is the ground of the store blood of human body maximum, and systemic blood all will pass through liver circulation, processing, filtration all the time.Theory of Chinese medical science thinks that liver is first of the five internal organs, " main dredging rushed down ", " main store blood ".Modern medicine study shows that liver has synthesis secretion, detoxifcation, material to transform, regulate effects such as body's immunity.
Modern society's rapid development of economy, environmental pollution, way of act change etc. cause the morbidity of hepatic injury to greatly increase.Become the big health problem that the modern must face.
3, the fearful killer of fatty liver-attack to modern's " silently "
Fatty liver is meant that mainly the hepatocyte fat content that is caused by a variety of causes surpasses due to the arm's length standard.It is generally acknowledged that fat content promptly fatty liver might take place above 5% o'clock of liver weight in the liver.In recent years, along with China living standards of the people improve, bigger variation has taken place in dietary structure, but the prevention and health care measure relatively lags behind, and the pathogenesis of fatty liver rate that is called as the modern times " affluenza " rises year by year, and age of onset is more and more littler.
According to statistics, the sickness rate of China's fatty liver has accounted for 10% of average population, and is higher at some big city sickness rate, as Shanghai: 13%, Beijing: 12%, Guangzhou: 20%, and Shenzhen, minimus city has leapt to the first, its sickness rate is near 22%.Also have an incredible situation to be, participated in 1998 among Guangdong Province's conscription 12.4 ten thousand youth enlisted in the arms, eligible only is 3.4 ten thousand (qualification rate is 27%), and in the middle of 90,000 defective people, is hindered epigenesist in the army gate because liver function reaches fatty liver unusually up to 25.6%.In 20～30 years old the youngster in Guangzhou, the pathogenesis of fatty liver rate illustrates that unexpectedly up to 20%～30% fatty liver is quite serious to the degree that teenager draws out, and has also caused strong repercussion and shock socially according to another report! In addition, in many other diseases patients, as more than 80% of hyperlipemic patients, 50% of fat and diabetic, chronic alcoholic 57.7% all with in various degree fatty liver.About 25% generation hepatic fibrosis in the Patients with Fatty Liver, 1.5%～8.0% develop into liver cirrhosis.Press sickness rate and calculate, China has more than Patients with Fatty Liver 12,000 ten thousand people approximately at present.
Form the reason of fatty liver: a: the b of nutritional disorder: drink for a long time or indulge in excessive drinking c: endocrine regulation and Developmental and Metabolic Disorder d: chemical substance and some drugs e: anoxia and infective agent f: Bad Eating Habit and life style.
How asymptomatic slight fatty liver is, this also is the disapprobatory reason of most Patients with Fatty Liver, by the time in, during severe, then can feel weak, dyspepsia, anorexia, bitter taste, xerostomia, dizziness, abdominal distention, hepatic region feeling of distension and oppression or pain or heavy physical labour or the postemphasis of drinking, the symptom of typical fatty liver is similar to hepatitis.
Long-term fatty liver can not obtain proper treatment, can cause the generation of hypertension, diabetes and cardiovascular and cerebrovascular disease etc., has groups of people will develop into hepatic fibrosis, liver cirrhosis among the severe fatty liver crowd, threat to life.Hepatic fibrosis and liver cirrhosis are the irreversible pathological changes of liver, seriously jeopardize human health, and fatty liver can be cured fully.
4, intestinal, blood vessel, liver and blood fat
(1): cholesterol 80% is to be produced by small intestinal, liver, skin, the 20%th, bring into by food.
The cholesterol that liver produces is transported to each tissue of human body by low density lipoprotein, LDL (LDL) and uses for normal, and unnecessary cholesterol is taken back liver by high density lipoprotein and got rid of.When high density lipoprotein (HDL) and low density lipoprotein, LDL (LDL) when the two is in poised state, just do not have unnecessary lipoprotein and in blood vessel, do not gather, in the blood vessel wall deposition, can not cause hyperlipemia, can not cause cardiovascular and cerebrovascular disease,
(2): intestinal is absorption and the secretory that body weight for humans is wanted, if prolonged constipation, then cholesterol increases in the generation of small intestinal, and the absorption to cholesterol in the food simultaneously increases, and causes that blood cholesterol increases, and is deposited on blood vessel wall, causes cardiovascular and cerebrovascular disease; The transportation of cholesterol between liver and tissue must pass through blood vessel, if high density lipoprotein (HDL) inadequately or low density lipoprotein, LDL too high (LDL) then the blood vessel inner cholesterol is too high, in the course of time, be deposited on blood vessel wall, form artery plaque, cause arteriosclerosis, cardiovascular and cerebrovascular disease takes place; Drink for a long time, hepatic injury such as fatty liver, hepatitis cause liver function low, then liver weakens the elimination ability of cholesterol, causes blood fat to raise.Clean liver, liver youth, function are improved, high density lipoprotein (HDL) generates to be increased, low-density lipoprotein (LDL) generates and reduces, liver is got rid of cholesterol to be increased, and liver fat reduces, and then steady, the hardened blood vessel elasticity of blood pressure improves, toughness increases, and suffers stroke, the danger coefficient of disease such as myocardial infarction descends.Blood fat reducing, treatment fatty liver, hepatic injury, prevention cardiovascular and cerebrovascular disease must be set about from bowel relieving, the pipe that purifies the blood, liver heat removing hepatoprotective comprehensively.
5, integrally-regulated theoretical " three is clear " theory of annotating of the traditional Chinese medical science
Hyperlipemia, fatty liver, hepatic injury, cardiovascular and cerebrovascular disease etc. are " modern disease ", all pollute with modern environment, competitive pressure increases, way of act changes, and it is closely related that it is very few to move etc.Be the multi-pathogenesis disease, single etiological treatment often effect is not good enough, traditional Chinese medical science global theory, and the many target spots of Chinese medicine, stage construction, three-dimensional multidirectional treatment show special advantages especially.The traditional Chinese medical science thinks that hyperlipemia, fatty liver, hepatic injury, cardiovascular and cerebrovascular disease are by eating and drinking without temperance, dysfunction of the spleen in transportation; Feelings will internal injury, liver are lost bar and reach; Inappropriate, the phlegm stagnation in collateral of work and rest; Weakness due to chronic disease, qi-blood disharmony etc. due to.If surfeit delicious food savoury, insobriety, irregular diet; Or be in a very depressed state excessive thinking; Or excessive few labor, will impairing the spleen and stomach, cause dysfunction of the spleen in transportation, water-damp not being transformed, and it is turbid to give birth to expectorant.The turbid intestinal that stays in of expectorant, intestinal functional activity of QI being not smooth then, FU QI being obstructed will cause constipation; The expectorant turbidity current is annotated in meridians (blood vessel), blockage of meridian-QI blood stasis then, and the expectorant stasis of blood is handed over knot, will cause hyperlipemia and cardiovascular and cerebrovascular disease; Expectorant is turbid to accumulate in liver, and then irritability is not dredged, and liver blood is not smooth, will cause fatty liver, hepatic injury.Obstinate disease in addition, physical weakness, qi-blood disharmony, qi depression to blood stasis will increase the weight of the above-mentioned state of an illness.We are at above-mentioned etiology and pathogenesis, with invigorating the spleen and relieving depression of liver-QI, removing dampness eliminate the phlegm, circulation of qi promoting purging FU-organs, blood circulation promoting and blood stasis dispelling be the principles of formulating prescriptions, can make the strong fortune of temper behind the clothes, the multiple bar of liver reaches, water is wet to change, expectorant is turbid with clearly, and the smooth internal organs of gas is logical, and the blood clots absorbing goes, thereby reach bowel relieving, the pipe that purifies the blood, the purpose of cleaning liver, make the source clear, pipeline is clear, and terminal point is clear.
Summary of the invention
Purpose of the present invention is exactly in order to address the above problem, bowel relieving has been proposed, the pipe that purifies the blood, the three cleaning opinions of cleaning liver, provide a kind of medicine for the treatment of hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury according to this theory and traditional Chinese medicine theory simultaneously, this medicine can reach the effect of treatment hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury.
The present invention also aims to provide the preparation method of the various preparations of described medicine.
The parts by weight of the medicine of treatment hypertriglyceridemia of the present invention, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury are composed as follows: Fructus Crataegi 10～35, Rhizoma Curcumae Longae 6～20, Radix Notoginseng 5～12, Cortex Magnoliae Officinalis 3～20, Radix et Rhizoma Rhei (stir-fried with wine) 5～16 Pericarpium Citri tangerinaes 8～20 Fructus Citri Sarcodactylis 5～19 Herba Taraxacis 10～25 Fructus Gardeniaes 5～30 Semen Ziziphi Spinosaes 10～30 Herba Artemisiae Scopariaes 5～20, Radix Bupleuri 5～15, Rhizoma Alismatis 5～15 Rhizoma Atractylodis (parched) 5～18
Best composed as follows: Fructus Crataegi 20～25, Rhizoma Curcumae Longae 11～14, Radix Notoginseng 6～9, Cortex Magnoliae Officinalis 6～10, Radix et Rhizoma Rhei (stir-fried with wine) 5～9 Pericarpium Citri tangerinaes 8～12 Fructus Citri Sarcodactylis 8～11 Herba Taraxacis 18～22 Fructus Gardeniaes 18～21 Semen Ziziphi Spinosaes 16～20 Herba Artemisiae Scopariaes 9～11, Radix Bupleuri 8～12, Rhizoma Alismatis 7～10 Rhizoma Atractylodis (parched) 10～13
For consumption per capita, the unit of above-mentioned composition is gram.
The Main Ingredients and Appearance of medicine each component of the present invention comprises:
Fructus Crataegi: contain organic acids composition, as Crataegolic acid (crategolic acid), tartaric acid (tartaric acid); Flavonoid has: Quercetin (quercetin), hyperin (hyperin) etc.
Rhizoma Curcumae Longae: contain volatile oil, as turmerone (turmerone) etc.; Also contain curcumin yellow compositions such as (curcumin).
Radix Notoginseng: contain the total saponins constituents, be mainly ginsenoside (panaxosides) Rb1, Rg1, Rg2, Rb2, Rd etc., other contains arasaponin class, amino acids, flavones ingredient.
Cortex Magnoliae Officinalis: contain volatile oil, magnolol (magnolo) l, honokiol (honokiol) etc.
Radix Et Rhizoma Rhei: contain anthraquinone component, as chrysophanol (chrysophanol), emodin (emodin), physcione (parietin), aloe-emodin (aloe-emodin), chrysophanic acid (rhein) and glycosides composition thereof, also contain Senna fruit glycoside (sennoside) class, tannin class, polysaccharide composition.
Pericarpium Citri tangerinae: contain compositions such as volatile oil, flavonoid.
Fructus Citri Sarcodactylis: contain lactone, flavones ingredient.
Herba Taraxaci: contain taraxasterol (taraxasterol), choline (choline), inulin (inulin), pectin compositions such as (pectin).
Fructus Gardeniae: contain iridoid glycosides, organic acid, pigment and ursolic acid compositions such as (ursolic acid).
Semen Ziziphi Spinosae: contain compositions such as triterpenes, flavonoid and ferulic acid (ferulic acid), plant sterol (phytosterol), vitamin (vitamin) C.
Herba Artemisiae Scopariae: contain Coumarins, flavonoid, organic acid, volatile oil composition.
Radix Bupleuri: contain volatile oil, saponins, organic acid, alcohols and flavones ingredient.
Rhizoma Alismatis: contain aminoacid, fatty acid, saccharide, tetracyclic triterpenes such as alisol (alisol) etc.
Rhizoma Atractylodis: mainly contain the volatile oil composition, become to grade as atractylol (atractylol), atractylone (atractyione), eucalyptol (eudesmol).
The inventor through investigative test, finds out the medicine of specific composition, specific consumption, its clinical efficacy highly significant at the etiology and pathogenesis of hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury.The Fang Zhongyong hawthorn digesting is good for the stomach, the liver benefiting is nourished heart in Pericarpium Citri tangerinae circulation of qi promoting spleen invigorating, Fructus Citri Sarcodactylis promoting the circulation of QI to relieve pain, Semen Ziziphi Spinosae, the Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI with spleen invigorating regulate the flow of vital energy, dispersing the stagnated live-QI to relieve the stagnation of QI; With Herba Artemisiae Scopariae clearing away heat-damp and promoting diuresis, Rhizoma Alismatis promoting diuresis to eliminate damp pathogen, Rhizoma Atractylodis (parched) is drying damp and strengthening spleen, Fructus Gardeniae clearing away heat-damp and promoting diuresis, Herba Taraxaci heat-clearing and toxic substances removing dampness removing, Pericarpium Citri tangerinae drying dampness to eliminate phlegm, Fructus Citri Sarcodactylis stomach function regulating reduce phlegm with clearing away heat and promoting diuresis, drying dampness to eliminate phlegm; Cortex Magnoliae Officinalis activating qi for lowering adverse qi, Radix et Rhizoma Rhei (stir-fried with wine) stasis removing are with the circulation of qi promoting purging FU-organs; Rhizoma Curcumae Longae removing blood stasis promote qi circulation opening warp, Radix Notoginseng dissipating blood stasis for subsidence of swelling, Fructus Crataegi and Radix et Rhizoma Rhei (stir-fried with wine) blood circulation promoting and blood stasis dispelling are with blood circulation promoting and blood stasis dispelling.Full side share and plays altogether that invigorating the spleen and relieving depression of liver-QI, removing dampness eliminate the phlegm, the effect of circulation of qi promoting purging FU-organs, blood circulation promoting and blood stasis dispelling.
Medicine of the present invention can be pulverized solid preparations such as making powder, pill, tablet, capsule, or water decocts or with making various oral formulations after the alcohol extraction.
The concrete preparation method of the oral liquid of medicine of the present invention is: the water or the ethanol that add 5～13 times of suitable medicine gross weights in the medicine extract; 1～3 hour time of extracting, extract 1～3 time; Medicinal liquid after the extraction carries out vacuum concentration after filtering, places, and precipitation is got liquid and is prepared into liquid preparations such as mixture, oral liquid;
The concrete preparation method of the solid preparation of medicine of the present invention is: the water or the ethanol that add 5～13 times of amounts of suitable medicine gross weight in the medicine extract; 1～3 hour time of extracting, extract 1～3 time; Medicinal liquid after the extraction carries out vacuum concentration after filtering, and the relative density of 60 ℃ of following concentrated solutions is 1.01～1.30, and spray drying obtains dry extract, dry granulation, and mix homogeneously is prepared into solid preparations such as granule, tablet, capsule.
The present invention compared with prior art has following advantage:
(1) this prescription therapeutic hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury effect are remarkable, have no side effect.According to acute toxicity test, this poison of drug is very little, can not ask LD
50This medicine clinical practice safety non-toxic.Long term toxicity test finds no toxic action.Clinical observation is taken back free movement of the bowels, lose weight (based on abdominal part), subjective symptoms improvement obviously, taking after 30 days patient's blood fat of 72% continuously reduces to normally, Patients with Fatty Liver take continuously after 90 days 79% alleviate fully,, after long-term alcohol user takes the liver protection effect that obviously relieves the effect of alcohol is arranged, take for a long time and prevent the cardiovascular and cerebrovascular disease effect obvious.
(2) its prescription of oral formulations of the present invention is precise and appropriate, and by conventional Chinese medicine is formed, the medicine source is clear, and wide material sources are cheap and easy to get;
(3) preparation is simple, adopted advanced technologies such as spray drying, dry granulation, taking convenience, and dosage is accurate, and is economical and practical.
The specific embodiment
Embodiment 1, production pill medicine
Form (unit gram): Fructus Crataegi 20, Rhizoma Curcumae Longae 10, Radix Notoginseng 8, Cortex Magnoliae Officinalis 7, Radix et Rhizoma Rhei (stir-fried with wine) 9, Pericarpium Citri tangerinae 11, Fructus Citri Sarcodactylis 8, Herba Taraxaci 15, Fructus Gardeniae 18, Semen Ziziphi Spinosae 18, Herba Artemisiae Scopariae 10, Radix Bupleuri 11, Rhizoma Alismatis 8, Rhizoma Atractylodis (parched) 10
Earlier will above-mentioned 14 flavor Chinese medicines, assort by the recipe quantity weighing, drying (below 80 ℃), be ground into powder, sieve (more than 80 mesh sieves), mixing, every 100g powder add refined honey 90～110g and make honeyed pill, promptly.This method preparation technology is easy, and effect relaxes lasting, takes, easy to carry.
Embodiment 2, production mixture
Form (unit gram): Fructus Crataegi 24, Rhizoma Curcumae Longae 12, Radix Notoginseng 9, Cortex Magnoliae Officinalis 8, Radix et Rhizoma Rhei (stir-fried with wine) 9, Pericarpium Citri tangerinae 10, Fructus Citri Sarcodactylis 10, Herba Taraxaci 18, Fructus Gardeniae 20, Semen Ziziphi Spinosae 20, Herba Artemisiae Scopariae 10, Radix Bupleuri 9, Rhizoma Alismatis 10, Rhizoma Atractylodis (parched) 12
With above-mentioned 14 flavor Chinese medicines, assort earlier, put into extraction pot, add 5～13 water gagings and extract, extract 1～3 time by the recipe quantity weighing, each 1～3 hour, filter, merging filtrate, extracting solution to the clear paste shape, adds correctives through vacuum concentration, antiseptic is an amount of, leave standstill, filter, stir evenly, packing, promptly.This method preparation technology is easy, and oral post-absorption is fast, the bioavailability height.
Embodiment 3, production capsule
Form (unit gram): Fructus Crataegi 25, Rhizoma Curcumae Longae 12, Radix Notoginseng 9, Cortex Magnoliae Officinalis 7, Radix et Rhizoma Rhei (stir-fried with wine) 8, Pericarpium Citri tangerinae 10, Fructus Citri Sarcodactylis 10, Herba Taraxaci 20, Fructus Gardeniae 20, Semen Ziziphi Spinosae 18, Herba Artemisiae Scopariae 11, Radix Bupleuri 9, Rhizoma Alismatis 10, Rhizoma Atractylodis (parched) 12
Elder generation assorts above-mentioned 14 flavor Chinese medicines by the recipe quantity weighing, put into extraction pot, adds 5～13 times of amounts of dose, 5～80% ethanol extractions once, filters, and the filtrate vacuum concentration reclaims ethanol, and it is standby to get alcohol extract liquid.Medicinal residues add 5～10 times of water gagings and extracted 1～2 hour, filter, and filtrate merges with the alcohol extraction concentrated solution through vacuum concentration, mixing, and the concentrated solution spray drying gets dry extract, and the dry extract mixing is made granule through dry method, incapsulates, promptly.
This method preparation technology advanced person has adopted spray drying and dry granulation technology, and technology is rationally feasible, the medicine stability height, and it is fast to take post-absorption, the bioavailability height.
Embodiment 4, production granule
Form (unit gram): Fructus Crataegi 22, Rhizoma Curcumae Longae 9, Radix Notoginseng 6, Cortex Magnoliae Officinalis 8, Radix et Rhizoma Rhei (stir-fried with wine) 7, Pericarpium Citri tangerinae 9, Fructus Citri Sarcodactylis 8, Herba Taraxaci 20, Fructus Gardeniae 21, Semen Ziziphi Spinosae 12, Herba Artemisiae Scopariae 9, Radix Bupleuri 9, Rhizoma Alismatis 10, Rhizoma Atractylodis (parched) 12
With above-mentioned 14 flavor Chinese medicines, assort earlier, put into extraction pot, add 5～13 times of water gagings of dose and extract extracting solution by the recipe quantity weighing.
Through vacuum concentration, obtain concentrated solution, the concentrated solution spray drying gets dry extract, the dry extract mixing, granulation, packing, promptly.
Embodiment 5, production tablet
Form (unit gram): Fructus Crataegi 22, Rhizoma Curcumae Longae 12, Radix Notoginseng 8, Cortex Magnoliae Officinalis 8, Radix et Rhizoma Rhei (stir-fried with wine) 5, Pericarpium Citri tangerinae 9, Fructus Citri Sarcodactylis 10, Herba Taraxaci 19, Fructus Gardeniae 19, Semen Ziziphi Spinosae 18, Herba Artemisiae Scopariae 8, Radix Bupleuri 9, Rhizoma Alismatis 7, Rhizoma Atractylodis (parched) 11
With above-mentioned 14 flavor Chinese medicines, assort earlier, put into extraction pot, add 5～13 times of amounts of dose, 30～80% ethanol and carry by the recipe quantity weighing.
Get, extracting solution obtains concentrated solution through vacuum concentration, and the concentrated solution spray drying gets dry extract, the dry extract mixing, and granulation, tabletting are promptly.
Zoopery and clinical research
Pharmacodynamic study
1. test objective
Cure mainly the function of hyperlipemia and fatty liver according to this medicine, select hyperlipemia and fatty liver model and intact animal for use, the effect for reducing fat of this medicine of thoroughly evaluating and the effect of treatment fatty liver are to determine drug action, efficacy strength and the characteristics of this medicine, for clinical research provides foundation.
2. this medicine is to the influence of normal rat fat
2.1 experiment material
(1) medicine: this medicine, every content is equivalent to crude drug in whole 3g, is provided lot number by Guangzhou Lanyun Medicine Research Co., Ltd.: 990812; DONGBAO GANTAI is produced lot number: 981123 by Tonghua Dongbao Pharmaceutical Co., Ltd.
(2) animal: the SD rat, male and female half and half, body weight (200 ± 20) g is provided by Guangdong Province's Experimental Animal Center.
(3) main agents: cholesterol (chemical pure), by the import packing of Guangzhou Medical Depot chemical reagents corporation, lot number: 990413; Adeps Sus domestica, commercially available; CH, TG, HDL, LDL test kit are produced by Beijing Chemical Plant's clinical reagent subsidiary factory, and lot number is respectively 990319,990408, and 990522,990612.
(4) key instrument: Italian BT-2000 biochemistry analyzer.
2.2 experimental technique
Get 50 of rats, be divided into 5 groups at random, 10 every group.Be respectively dosage group, sweet easypro low dose group in matched group, DONGBAO GANTAI group, sweet easypro high dose group, sweet the relaxing.Capacity such as each treated animal every day are irritated stomach (ig) 10ml/kg, matched group ig normal saline wherein, DONGBAO GANTAI group ig DONGBAO GANTAI suspension (1g/kg), the sweet high, medium and low dosage group ig suspension that relaxes (distilled water preparation, dosage is respectively 2.25g/kg, 1.35g/kg, 0.45g/kg, 5 times, 3 times, 1 times of the clinical dosage that is equivalent to be grown up).Each treated animal is by above-mentioned dosage ig administration, every day 1 time, continuous 10 days.Behind administration in the 10th day or the normal saline 1 hour, every Mus was cut tail and gets blood 1.5ml, leaves standstill 30min, got serum after centrifugal to survey cholesterol in serum (CH) and triglyceride (TG) with biochemistry analyzer.Experimental result sees Table 1:
This medicine of table 1 to the influence of normal rat fat (x ± s, n=10)
Group TH (mmol/L) TG (mmol/L)
Matched group 1.68 ± 0.22 1.25 ± 0.48
DONGBAO GANTAI group 1.66 ± 0.32 0.89 ± 0.33*
Sweet easypro high dose group 1.34 ± 0.50* 0.54 ± 0.44**
Dosage group 1.57 ± 0.43 0.68 ± 0.35** in sweet the relaxing
Sweet easypro low dose group 1.69 ± 0.28 0.87 ± 0.31*
Annotate: compare * P＜0.01, * * P＜0.05 with matched group.
Conclusion: the high, medium and low dosage group of this medicine all can obviously reduce the triglyceride levels in the normal rat serum, and wherein high, middle dosage group is more obvious; Except that this medicine high dose group can obviously reduce cholesterol levels in the normal rat serum, other each group did not all have obvious influence to cholesterol.
3. this medicine is to the influence of hyperlipemia model rat fat
3.1 experiment material
With 2.1.
3.2 experimental technique
Get 60 of rats, be divided into 6 groups at random, 10 every group.Be respectively dosage group, sweet easypro low dose group in matched group, model group, DONGBAO GANTAI group, sweet easypro high dose group, sweet the relaxing.Experimental session, except that normal group gave normal feedstuff, all the other each groups were all fed high lipid food (compound method: 2% cholesterol, 7.5% Adeps Sus domestica, 0.2% propylthiouracil, 0.3% sodium cholate, 90% normal feedstuff).Capacity such as each treated animal every day are irritated stomach (ig) 10ml/kg, wherein matched group and model group ig normal saline, DONGBAO GANTAI group ig DONGBAO GANTAI suspension (1g/kg), the sweet high, medium and low dosage group ig suspension (dosage is the same) that relaxes.Each treated animal is by above-mentioned dosage ig administration, every day 1 time, continuous 30 days.Fasting 12 hours (can't help water) behind administration in the 30th day or the normal saline, every Mus is cut tail and gets blood, by preceding method separation of serum, surveys TC, TG and high density lipoprotein (HDL), low density lipoprotein, LDL (LDL).Measurement result sees Table 2.
This medicine of table 2 to the influence of hyperlipemia model rat fat (x ± s, n=10)
Group TC (mmol/L) TG (mmol/L) HDL (mmol/L) LDL (mmol/L)
Matched group 1.63 ± 0.25
*1.25 ± 0.42
*0.78 ± 0.23 0.36 ± 0.13
*
Model group 2.89 ± 0.34 2.38 ± 0.24 0.86 ± 0.3 10.87 ± 0.21
DONGBAO GANTAI group 2.70 ± 0.46 1.21 ± 0.39
*1.02 ± 0.31
*0.58 ± 0.20
*
Sweet easypro high dose group 2.54 ± 0.43
*0.91 ± 0.35
*1.26 ± 0.30
*0.42 ± 0.22
*
Dosage group 2.77 ± 0.47 1.18 ± 0.37 in sweet the relaxing
*1.12 ± 0.36
*0.49 ± 0.19
*
Sweet easypro low dose group 2.80 ± 0.45 127 ± 0.38
*0.98 ± 0.21 0.59 ± 0.18
*
Annotate: compare with model group
*P＜0.01,
*P＜0.05.
Conclusion: the high, medium and low dosage group of this medicine all can obviously reduce triglyceride and the low-density lipoprotein white level in the hyperlipemia model rat blood serum, wherein the effect of very obvious, high, the middle dosage group reduction of the effect of triglyceride reducing low density lipoprotein, LDL is more obvious; High, middle dosage group can also improve hdl level; Except that high dose group can obviously reduce cholesterol levels in the hyperlipemia model rat blood serum, other each group did not all have obvious influence to cholesterol.
4. this medicine is to the influence of fatty liver rat model liver fat
4.1 experiment material
With 2.1.
4.2 experimental technique
Animal grouping and ig are with 3.2.Experimental session, except that normal group gave normal feedstuff, all the other each group was all fed high lipid food (compound method: cholesterol 10g, Adeps Sus domestica 20g, methylthiouracil 1g, sodium cholate 2g, add Tween 80-20ml, propylene glycol 30ml, distilled water adds to 100ml).Each treated animal is by above-mentioned dosage ig administration, every day 1 time, continuous 10 days.Fasting 12 hours (can't help water) behind administration in the 10th day or the normal saline, broken end is also cut open the belly and is won liver, accurately weigh up 0.1g at the lobus sinister fixed position, with extractant (ethanol, the isopyknic mixed liquor of acetone) 2.5ml, be ground into tissue homogenate, measure liver fat content, be converted into TC, the TG content of every g hepatic tissue again.Measurement result sees Table 3.
This medicine of table 3 to the influence of fatty liver rat model liver fat (x ± s, n=10)
Group TC (mmol/g) TG (mmol/kg)
Matched group 1.23 ± 0.22
*0.95 ± 0.18
*
Model group 2.67 ± 0.29 1.58 ± 0.20
DONGBAO GANTAI group 1.52 ± 034
*1.48 ± 0.21
Sweet easypro high dose group 1.18 ± 0.31
*1.01 ± 0.18
*
Dosage group 1.34 ± 0.28 in sweet the relaxing
*1.17 ± 0.24
*
Sweet easypro low dose group 1.48 ± 0.26
*1.46 ± 0.27
Annotate: compare with model group
*P＜0.01,
*P＜0.05.
Conclusion: the sweet high, medium and low dosage group of relaxing all can reduce the cholesterol levels in the fatty liver rat model liver very significantly, and high, middle dosage group can also reduce the triglyceride levels in the fatty liver rat model liver.
Toxicologic study
Acute toxicity test
1. test objective
Observe the acute toxicity test and the maximum tolerated dose of this medicine.
2. be subjected to the reagent thing
This medicine, every contains crude drug 3g, is provided lot number by Guangzhou Lanyun Medicine Research Co., Ltd.: 990812.Concentrate before the test and be mixed with the Cmax (100%) that can irritate stomach (ig), cold preservation is standby.
3. animal origin
30 of Kunming kind closed colony mices, male and female half and half, body weight 18-22g is provided by medical faunae center, Guangdong Province.
4. experimental technique
4.1 acute toxicity test
Get 10 of mices, fasting (can't help water) 12 hours before the experiment, this medicine that every Mus press Cmax with maximum gastric capacity (0.4ml/10g body weight) ig after,, observed continuously 7 days with normal diet to animal.
4.2 maximum tolerance determination
Get 20 of mices, fasting (can't help water) 12 hours before the experiment, every Mus press this drug solution of Cmax and irritates with maximum gastric capacity (0.4ml/10g body weight), in 1 day continuously behind the ig 3 times, total dosage 7.2g/20g body weight.Give animal with normal diet, observed continuously 7 days.
5. experimental result
5.1 acute toxicity test
Laboratory animal was observed 7 days, did not see animal dead.And because of being subjected to drug level and volume restrictions, can not find to cause the dosage of dead mouse, so can't measure the LD of this drug solution ig
50
5.2 maximum tolerance determination
Laboratory animal was observed 7 days, did not see animal dead, and rarely seen just to behind the animal ig, animal activity reduces, recovered normal in general about 1 hour, after weighing in the 7th day, put to death mice, core, liver, spleen, lung, stomach, intestinal, brain, macroscopic pathological abnormalities is not seen in perusal.
Be calculated as follows the maximum tolerated dose of mice:
6. conclusion
According to acute toxicity test, this poison of drug is very little, can not ask LD
50Its, maximum tolerated dose was the 7.2g/20g body weight every day, was more than 800 times of clinical consumption.Therefore, this medicine clinical safety is nontoxic.
Long term toxicity test
1. experiment purpose
The safety of this medicine of objective evaluation.
2. be subjected to the reagent thing
This medicine, every contains crude drug 3g, is provided lot number by Guangzhou Lanyun Medicine Research Co., Ltd.: 990812.Concentrate before the test and be mixed with the Cmax (100%) that can irritate stomach (ig), cold preservation is standby.
3. laboratory animal
The SD rat, body weight (200 ± 20) g is provided by medical faunae center, Guangdong Province.
4. test method
Get 80 of rats, arrange in pairs or groups at random by sex and body weight and to be divided into 4 groups, every group 20, respectively as high, medium and low dosage group of this medicine and blank group, 3 dosage groups are respectively: 22.5g crude drug/kg, 11.25g crude drug/kg, 2.25g crude drug/kg (be equivalent to be grown up clinical dosage 50 times, 25 times, 5 times), matched group ig distilled water, administration and distilled water volume are 1ml/100g, every morning ig administration 1 time, successive administration and distilled water 3 months, claim the weight of animals weekly 1 time before the administration and during the administration, adjust dosage with the average weight of animal weekly.
Duration of test is observed rat general state, sign, food ration, drinking-water and feces character every day.It is heavy to write down each Mus that takes by weighing weekly, understands the influence of this medicine to the weight of animals.Last administration 24 hours, every group is extracted rat each 14 (male and female half and half), from left external iliac vein blood-letting and collect blood and check animal as first.The rat of every group of remainder stops administration, and animal is checked as second batch in the conventional 2 all backs of raising.Blood to two batches of animals carries out following index determining: hematochrome (Hb), red blood cell count(RBC) (RBC), reticulocyte (Rct), platelet (PLT), numeration of leukocyte (WBC), leukocyte differential count (WDC), blood glucose (GLu), creatinine (CRE), blood urea nitrogen (BUN), T-CHOL (TC), total protein (TP), albumin (ALR), total bilirubin (T-BIL),, glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), have harmless to observe this medicine to the hemogram and the hepatic and renal function of laboratory animal.After getting blood, each treated animal is put to death, get brain, the heart, liver, spleen, lung, kidney immediately and weigh, internal organs such as brain, the heart, liver, spleen, lung, kidney, adrenal gland, testis, epididymis, ovary, uterus carry out perusal, and make tissue slice, mirror checks that down pathology change.
5. experimental result
5.1 this medicine is to the influence of rat ordinary circumstance and body weight
In 3 months of successive administration, each administration group and matched group relatively at aspect there was no significant differences such as activity, food ration, stool, fur and body weight gains, show no obvious abnormalities situation.The body weight gain situation sees Table 4.
The influence that this medicine successive administration of table 4 increased rat body weight in 3 months (n=20, x ± s, g)
1W 3W 5W 7W 9W 11W 13W before the group administration
Matched group 102.32 ± 4.67 115.89 ± 8.00 165.43 ± 10.88 197.48 ± 17.87 260.86 ± 25.31 304.41 ± 32.42 361.21 ± 34.82 382.43 ± 35.38
High dose group 101.76 ± 6.03 116.21 ± 7.24 165.82 ± 10.11 201.43 ± 14.65 264.75 ± 25.86 309.57 ± 34.43 368.76 ± 36.17 391.74 ± 36.25
Middle dosage group 103.01 ± 4.66 118.43 ± 7.54 164.32 ± 10.02 199.65 ± 14.56 260.76 ± 22.18 308.65 ± 32.67 363.68 ± 33.45 386.23 ± 35.28
Low dose group 102.78 ± 5.23 117.32 ± 832 166.76 ± 12.14 200.98 ± 16.44 266.33 ± 26.53 311.34 ± 36.76 372.03 ± 37.12 393.57 ± 37.55
Annotate: it is wide to be limited to table, the weight of animals in unlisted 2,4,6,8,10,12 weeks; Each organize the administration group respectively with matched group relatively, p is all＞0.05.
5.2 this medicine is to the influence of rat hemogram
In 2 weeks after successive administration 3 months and the drug withdrawal, each administration group and control rats hemogram be there was no significant difference relatively, and all in normal range.The results are shown in Table 5,6.
The influence to the rat hemogram in 3 months of this medicine successive administration of table 5 (n=14, x ± s)
| Group | ??Hb ?(g/L) | ???RBC ???(×10 12/L) | ??Rct ??(％) | ?PLT ?(×10 9/L) | ?WBC ?(×10 9/L) | ?????????????????????????????????WDC(％) | |||
| ??N | ??L | ??E | ??M | ||||||
| Dosage group low dose group in the matched group high dose group | ?136.65±6.70 ?137.35±6.46 ?138.43±6.32 ?135.34±7.18 | ???7.26±0.76 ???8.08±1.19 ???7.63±0.81 ???7.27±0.86 | ??2.69±1.67 ??2.76±1.86 ??2.58±1.77 ??2.45±1.26 | ?595.47±73.22 ?610.00±83.35 ?599.67±73.32 ?590.46±71.38 | ??11.34±2.86 ??12.36±3.03 ??12.47±2.78 ??11.90±3.43 | ??24.57±3.36 ??25.62±3.91 ??25.2±3.65 ??25.12±3.47 | ??78.21±8.68 ??76.35±8.99 ??77.46±8.21 ??78.43±8.51 | ??0.92±0.31 ??0.99±0.36 ??1.02±0.38 ??0.89±0.29 | ??0.89±0.37 ??0.89±0.41 ??0.98±0.46 ??0.78±0.31 |
Annotate: each administration group rat hemogram value compares with matched group respectively, and p all＞0.05.
This medicine successive administration of table 6 after 3 months 2 weeks of drug withdrawal to the influence of rat hemogram (n=6, x ± s)
| Group | ??Hb ??(g/L) | ?RBC ?(×10 12/L) | Rct (％) | ??PLT ??(×10 9/L) | ??WBC ??(×10 9/L) | ?????????????????????????????????????????WDC(％) | |||
| ??N | ??L | ??E | ?M | ||||||
| Dosage group low dose group in the matched group high dose group | ??132.45±6.28 ??137.65±7.54 ??132.54±6.65 ??131.32±7.43 | ??6.77±0.87 ??7.88±1.28 ??7.27±0.98 ??6.29±1.21 | ?2.01±1.76 ?2.43±2.12 ?2.21±1.54 ?2.08±1.36 | ??587.65±70.98 ??598.76±83.23 ??578.88±78.54 ??583.43±71.48 | ??10.14±2.34 ??11.98±2.69 ??11.08±2.43 ??10.01±2.87 | ??21.96±3.46 ??24.76±3.04 ??23.98±2.95 ??23.67±3.43 | ??75.77±7.87 ??78.67±8.32 ??76.32±7.65 ??74.89±6.87 | ??0.87±0.87 ??1.21±0.97 ??0.96±0.89 ??0.87±0.89 | ?0.76±0.65 ?0.78±0.85 ?0.76±0.81 ?0.70±0.56 |
Annotate: each administration group rat hemogram value compares with matched group respectively, and p all＞0.05.
5.3 this medicine is to the influence of rat blood biochemical indicator
In 2 weeks after successive administration 3 months and the drug withdrawal, each administration group and control rats blood parameters be there was no significant difference relatively, and all in normal range.The results are shown in Table 7,8.
The influence to the rat blood biochemical indicator in 3 months of this medicine successive administration of table 7 (n=14, x ± s)
GLu??????????CRE?????????????BUN?????????TC??????????TP??????????????????????????ALR???????????T-BIL???????????ALT????????????AST
Group (mmol/L) is (mmol/L) (mmol/L) (g/L) (g/L) (mmol/L) (IU/L) (IU/L) (mmol/L)
Matched group 6.56 ± 0.64 64.71 ± 7.46 6.98 ± 0.43 2.04 ± 0.92 69.61 ± 5.07 3328 ± 3-5 13.58 ± 4.15 64.49 ± 13.05 146.13 ± 26.16
High dose group 6.78 ± 0.62 65.68 ± 7.32 7.82 ± 0.78 1.69 ± 0.75 72.47 ± 5.81 31.71 ± 3.23 13.85 ± 4.23 62.79 ± 12.23 153.57 ± 28.28
Middle dosage group 6.91 ± 0.54 65.35 ± 6.42 7.43 ± 0.67 1.86 ± 0.69 73.31 ± 5.44 34.19 ± 3.82 15.05 ± 4.17 65.48 ± 13.29 150.83 ± 27.74
Low dose group 7.12 ± 0.73 67.21 ± 7.58 7.44 ± 0.57 1.98 ± 0.63 75.37 ± 5.56 36.55 ± 4.31 15.52 ± 4.36 68.17 ± 14.27 157.22 ± 29.03
Annotate: each administration group rat blood biochemical indicator value compares with matched group respectively, and p all＞0.05.
This medicine successive administration of table 8 after 3 months 2 weeks of drug withdrawal to the influence of rat blood biochemical indicator (n=6, x ± s)
GLu?????????CRE????????????BUN???????????TC???????????TP????????????ALR???????????T-BIL??????????ALT????????????AST
Group (mmol/L) is (mmol/L) (mmol/l) (g/L) (g/L) (mmol/L) (IU/L) (IU/L) (mmol/L)
Matched group 6.74 ± 0.62 62.43 ± 6.58 6.54 ± 0.62 1.77 ± 0.66 68.37 ± 4.73 30.75 ± 3.35 11.83 ± 4.38 62.86 ± 11.72 149.38 ± 27.31
High dose group 7.32 ± 0.71 65.17 ± 6.24 7.13 ± 0.47 1.84 ± 0.38 71.36 ± 5.37 31.43 ± 3.26 13.07 ± 4.21 62.29 ± 11.54 150.26 ± 28.27
Middle dosage group 7.47 ± 0.82 64.27 ± 6.34 7.36 ± 0.52 1.39 ± 0.44 70.33 ± 5.11 35.21 ± 3.36 13.66 ± 4.32 65.81 ± 13.15 149.76 ± 27.52
Low dose group 7.16 ± 0.61 67.23 ± 6.87 7.38 ± 0.63 1.63 ± 0.48 72.28 ± 5.78 34.27 ± 4.12 15.14 ± 4.25 64.58 ± 14.31 153.33 ± 28.26
Annotate: each administration group rat blood biochemical indicator value compares with matched group respectively, and p all＞0.05.
5.4 this medicine is to the influence of rat important organ weight
In 2 weeks after successive administration 3 months and the drug withdrawal, each administration group and control rats main organs weight ratio are than there was no significant difference.The results are shown in Table 9,10.
The influence to rat main organs weight in 3 months of this medicine successive administration of table 9 (n=14, x ± s)
Group brain conscience spleen lung kidney
Matched group 1.83 ± 0.12 1.40 ± 0.27 14.87 ± 3.25 1.70 ± 0.55 2.86 ± 0.61 1.50 ± 0.29
High dose group 1.81 ± 0.09 1.42 ± 033 14.37 ± 3.28 1.69 ± 0.32 2.97 ± 0.65 1.51 ± 0.34
Middle dosage group 1.90 ± 0.09 1.28 ± 0.23 14.23 ± 2.58 1.66 ± 0.51 2.81 ± 0.70 1.49 ± 0.27
Low dose group 1.82 ± 0.08 1.39 ± 0.18 15.26 ± 3.14 1.72 ± 0.62 2.77 ± 0.63 1.47 ± 0.24
Annotate: each administration group rat body weight value compares with matched group respectively, and p all＞0.05.
This medicine successive administration of table 10 after 3 months 2 weeks of drug withdrawal to the influence of rat main organs weight (n=6, x ± s)
Group brain conscience spleen lung kidney
Matched group 1.90 ± 0.10 1.49 ± 0.48 15.33 ± 3.43 1.78 ± 0.45 2.96 ± 0.72 1.50 ± 0.44
High dose group 1.87 ± 0.11 1.50 ± 0.57 15.17 ± 3.32 1.82 ± 0.42 2.85 ± 0.67 1.48 ± 0.41
Middle dosage group 1.88 ± 0.13 1.48 ± 0.52 14.26 ± 3.24 1.80 ± 0.51 2.88 ± 0.70 1.47 ± 0.40
Low dose group 1.91 ± 0.14 1.55 ± 0.64 16.18 ± 3.36 1.84 ± 0.53 2.72 ± 0.58 1.57 ± 0.51
Annotate: each administration group rat body weight value compares with matched group respectively, and p all＞0.05.
5.5 this medicine is to the influence of rat important organ histopathology form
2 weeks after successive administration 3 months and the drug withdrawal, two batches of rats of getting are extremely dissected, each administration group important organ brain of perusal, the heart, liver, spleen, lung, kidney, adrenal gland, testis, epididymis, ovary, uterus etc. are no abnormal, then each group rat important organ is drawn materials in same area, fix with 10% formalin.The above-mentioned organ-tissue of each administration group and control rats is made tissue slice and carried out pathological examination, find that various organ structures are normal, cell dyeing is even, does not have obviously to change.
6 experiment conclusion
The result shows through the rat long term toxicity test, with this medicine 22.5,11.25,2.25g three kinds of dosage of crude drug/kg (are respectively 50 times of adult's consumption, 25 times and 5 times), every day 1 time, continuous 3 months to 2 weeks after rat ig administration and the drug withdrawal, compare with the blank group of ig distilled water, each dosed administration is to the general state (mode of appearance of rat, movable, food ration, stool shape etc.), growth promoter (body weight gain), hemopoietic function (hematological examination), liver function (blood parameters), renal function (blood parameters), vitals weight and pathological examination all find no the overt toxicity effect.So it is very low to think that under prescribed dose take this drug toxicity the longer course of treatment, takes safety.Clinic trial can be provided, further examine or check it again and have or not toxicity.
Clinical research
This medicine is the pure Chinese medicinal preparation of treatment fatty liver, hyperlipemia and the obesity of Guangzhou Lanyun Medicine Research Co., Ltd.'s development, effect with depressed liver-energy dispersing and QI regulating, clearing away heat-damp and promoting diuresis, blood circulation promoting and blood stasis dispelling, spleen invigorating removing food stagnancy, drying dampness to eliminate phlegm proves that through pharmacodynamic study its serum and liver inner lipid to experimental hyperlipidemia and fatty liver animal pattern has tangible reduction effect.In order further to observe the clinical efficacy of this medicine, the clinical observation that patient that we merge hyperlipemia to fatty liver has carried out is now reported as follows.
1 physical data
All observe case and be in hospital and the outpatient, totally 120 examples are divided into treatment group and matched group at random, and wherein 80 examples are organized in treatment, male's 54 examples, women's 26 examples; Age 28-65 year, average 45.4 years old; Course of disease 0.5-5, average 3.5 years; Matched group 40 examples, male's 29 examples, women's 11 examples; Age 27-64 year, average 44.9 years old; Course of disease 0.5-5, average 3.6 years.Through the homogeneity check, P＞0.1 has comparability.
2 cases are selected
2.1 diagnostic criteria
1. soft-fat type, dull pain in liver or distending pain discomfort.
2. with reference to " clinical research guideline ": serum cholesterol (TC) 〉=5.8mmol/L, triglyceride (TG) 〉=1.6mmol/L, high density lipoprotein (HDL)≤0.8mmol/L.
3. liver function test glutamate pyruvate transaminase (ALT) 〉=50U/L.
4. B-type ultrasonography is the fatty liver feature.
2.2 the standard of including in
In the above-mentioned diagnostic criteria 2., 4. item exists simultaneously, and/or with 1., 3. patient.
2.3 exclusion standard
The person that can be suspected to have the malignant disease, with the glycosuria patient, with severe cardiac, liver, renal dysfunction person, can not cooperation person with psychosis, alzheimer disease etc.
3 Therapeutic Method
Oral this medicine of treatment group is provided lot number by Guangzhou Lanyun Medicine Research Co., Ltd.: 990812, every day 3 times, each 2, treated for 12 weeks continuously; Matched group is taken DONGBAO GANTAI PIAN, is produced lot number by Tonghua Dongbao Pharmaceutical Co., Ltd: 981123, every day 3 times, each 3, treated for 12 weeks continuously.
4 observation index
1. clinical symptoms: hypochondriac pain, the side of body expand, abdominal distention, dizziness, weak, bitter taste etc.
2. blood fat and liver function are measured: TC, TG, HDL, LDL, ALT.
3. ultrasound diagnosis: operated by the special messenger morning on an empty stomach. and routine is detected liver.
4. the Body Mass Index bluntness is measured: the Body Mass Index bluntness is measured the WHO's standard that all adopts.That is: square (kg/m of obesity index=body weight/height
2), bluntness: (actual measurement body weight-weight for standard height)/weight for standard height * 100%.
5. security inspection.
5 criterions of therapeutical effect
1. clinical symptoms, sign take a turn for the better or disappear.
2. descend 〉=20% with reference to " clinical research guideline ": TC, or TG decline 〉=40%, or HDL rises 〉=20%.
3. descend 10%～20% with reference to " clinical research guideline ": TC, TG descends 20%～40%, or HDL rises 10%～20%.
4. ultrasound diagnosis recovers normally the fatty liver characteristic disappear substantially.
5. ALT recovers arm's length standard.
6 curative effect determinate standards
Clinical recovery: meet criterion of therapeutical effect 1., 2., 4., 5. item person.
Effectively: meet criterion of therapeutical effect 1., 3., 5. item person.
Invalid: as not meet criterion of therapeutical effect person.
7 statistical method:
Ranked data are checked with Ridit, relatively with paired t check, relatively check the enumeration data X 2 test between group with two sample t before and after the measurement data treatment.
8 therapeutic outcomes
8.1 this medication effect.See Table 11.
The comparison of table 11 therapeutic effect (n, %)
Group case load clinical recovery enabledisable total effective rate
Treatment organizes 80 56 (70) 21 (26.25) 3 (3.75) 77 (96.25)
Matched group 40 24 (60) 10 (25) 6 (15) 34 (85)
Data are analyzed through Ridit in the table 11, and treatment group curative effect is better than matched group (P＜0.05).
8.2 this medicine improves the clinical symptoms situation.See Table 12.
Table 12 improve the clinical symptoms situation (n, %)
The invalid total effective rate of symptom case load disappearance improvement
The side of body expands 65 52 (80) 11 (16.92) 2 (3.08) 63 (96.92)
Hypochondriac pain 53 44 (83.02) 8 (15.09) 1 (1.89) 52 (98.11)
Abdominal distention 52 46 (88.46) 5 (9.62) 1 (1.92) 51 (98.08)
Dizzy 60 41 (68.33) 12 (20) 7 (11.67) 53 (88.33)
Weak 63 38 (60.32) 15 (23.81) 10 (15.87) 53 (74.13)
Bitter taste 40 24 (60) 12 (25) 4 (15) 34 (85)
8.3 this medicine is to the influence of blood fat.See Table 13.
Blood Lipid comparison before and after table 13 treatment (x ± s, mmol/L)
Group case load TC TG HDL LDL
Treatment group treatment preceding 80 6.56 ± 0.74 2.03 ± 1.08 1.79 ± 0.72 3.78 ± 0.79
Treatment back 80 5.62 ± 1.23** Δ, 1.36 ± 0.86** Δ, 1.98 ± 0.68*, 3.02 ± 0.88*
Treatment of control group preceding 40 6.63 ± 0.64 2.06 ± 1.11 1.78 ± 0.53 3.67 ± 0.83
Treatment back 40 5.97 ± 1.15* 1.63 ± 0.73 1.88 ± 0.91 3.31 ± 0.67
Annotate: relatively preceding with treatment, * * P＜0.01, * P＜0.05; Compare Δ P＜0.05 with matched group.
8.4 this medicine is to the influence of liver function.See Table 14.
ALT changes normal rate relatively before and after table 14 treatment
The common practice number of becoming a full member after the undesired routine number treatment before the treatment of group case load changes normal rate (%)
Treatment organizes 80 70 59 84.29
Matched group 40 32 25 78.13
Data are analyzed through Ridit in the table 14, and treatment group and control group A LT change relatively no significant difference (P＞0.05) of normal rate.
8.5 this medicine is to ultrasound diagnosis result's influence.See Table 15.
The ultrasound diagnosis result changes normal rate relatively before and after table 15 treatment
The common practice number of becoming a full member after the undesired routine number treatment before the treatment of group case load changes normal rate (%)
Treatment organizes 80 80 49 61.25
Matched group 40 40 10 25.00
Data are analyzed through Ridit in the table 15, and treatment group and matched group ultrasound diagnosis result change normal rate relatively notable difference (P＞0.05), and the treatment group is better than matched group.
8.6 this medicine is to the influence of body weight.See Table 16.
Body weight change comparison before and after table 16 treatment (x ± s)
Group case load body weight (kg) bluntness (%) obesity index
Treatment group treatment preceding 80 87.76 ± 8.79 48.43 ± 8.65 30.13 ± 2.09
Treatment back 80 81.54 ± 8.42* Δ, 41.32 ± 8.56* Δ, 29.06 ± 1.81* Δ
Treatment of control group preceding 40 88.23 ± 8.45 47.55 ± 7.83 31.01 ± 2.14
Treatment back 40 86.76 ± 8.62 45.86 ± 8.14 30.86 ± 1.78
Annotate: relatively preceding with treatment, * P＜0.05; Compare Δ P＜0.05 with matched group.
8.7 adverse reactions of patients is observed
Two groups of patient's blood, urine, just conventional, kidney function test is not all found significant change after the treatment, do not find apparent side effect, stool was soft partially when only the part patient began medication, day row 2～3 times, but promptly recover normal after 1 week; Slight hunger sensation after taking medicine, part patient is arranged.What deserves to be mentioned is, find in the treatment that this medicine improves significantly to sense of discomfort after drinking, companion's irregular person's effect of drinking for a long time, do not have enough sleep, live is better.
9 discuss
According to theory of Chinese medical science, the formation of hyperlipemia, fatty liver is many because of the preference for fat and sweet food savoury, more double lacking exercise, so that dysfunction of the spleen in transportation, and normal transmitting and distributing the fluids, the wet cohesion of water then is phlegm-damp.Expectorant is turbid stagnates that then QI and blood is current not smooth in blood vessels, can not moisten and support in whole body, then causes dizzy, weak; Expectorant is turbid to be stopped amassing in liver and then forms fatty liver, causes the liver failing to maintain the normal flow of QI, occurs that the side of body expands, hypochondriac pain and abdominal distention; The turbid stagnation of expectorant with the passing of time, then heat-transformation then has bitter taste etc.So it is rule of treatment that treatment is gone up with depressed liver-energy dispersing and QI regulating, clearing away heat-damp and promoting diuresis, blood circulation promoting and blood stasis dispelling, spleen invigorating removing food stagnancy, drying dampness to eliminate phlegm.
10 conclusions
This medicine has excellent curative to fatty liver, hyperlipemia and obesity.No obvious adverse reaction, and sense of discomfort after drinking improved significantly, that the companion drinks for a long time, does not have enough sleep, lives is irregular, constipation person's effect is better.
Claims (5)
1, new theory, it is characterized in that according to modern scientific theory and Traditional Chinese medical theory the traditional Chinese medical science prescription that proposes diseases such as treatment hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury should be a theoretical basis with bowel relieving, the pipe that purifies the blood, cleaning liver.Bowel relieving, the pipe that purifies the blood, cleaning liver, the source is clear, and pipeline is clear, and terminal point is clear, works on the three areas simultaneously, and three steps are a chain of, and circulation is short mutually.
2, a kind of medicine for the treatment of hypertriglyceridemia, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury, three cleaning opinion scientific composition according to founding is characterized in that its medicine is composed as follows: Fructus Crataegi, Rhizoma Curcumae Longae, Radix Notoginseng, Cortex Magnoliae Officinalis, Radix et Rhizoma Rhei (stir-fried with wine), Pericarpium Citri tangerinae, Fructus Citri Sarcodactylis, Herba Taraxaci, Fructus Gardeniae, Semen Ziziphi Spinosae, Herba Artemisiae Scopariae, Radix Bupleuri, Rhizoma Alismatis, Rhizoma Atractylodis (parched).
3, the medicine of treatment hypertriglyceridemia according to claim 2, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury is characterized in that each drug weight umber is composed as follows: Fructus Crataegi 10～35, Rhizoma Curcumae Longae 6～20, Radix Notoginseng 5～12, Cortex Magnoliae Officinalis 3～20, Radix et Rhizoma Rhei (stir-fried with wine) 5～16 Pericarpium Citri tangerinaes 8～20 Fructus Citri Sarcodactylis 5～19 Herba Taraxacis 10～25 Fructus Gardeniaes 5～30 Semen Ziziphi Spinosaes 10～30 Herba Artemisiae Scopariaes 5～20, Radix Bupleuri 5～15, Rhizoma Alismatis 5～15 Rhizoma Atractylodis (parched) 5～18.
4, the preparation method of the medicine oral liquid of the described treatment hypertriglyceridemia of claim 2, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury is characterized in that the water or the ethanol that add 5～13 times of suitable medicine gross weights in medicine extract; 1～3 hour time of extracting, extract 1～3 time; Medicinal liquid after the extraction carries out vacuum concentration after filtering, places, and precipitation is got liquid.
5, the preparation method of the medical solid preparation of the described treatment hypertriglyceridemia of claim 2, hypercholesterolemia, fatty liver, hepatic fibrosis, chemical liver injury is characterized in that the water or the ethanol that add 5～13 times of amounts of suitable medicine gross weight in medicine extract; 1～3 hour time of extracting, extract 1～3 time; Medicinal liquid after the extraction carries out vacuum concentration after filtering, and the relative density of 80 ℃ of following concentrated solutions is 1.01～1.30, and spray drying obtains dry extract, dry granulation, mix homogeneously.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101028392B (en) * | 2007-04-16 | 2010-05-19 | 北京艺信堂医药研究所 | Chinese medicine for treating hyperlipemia |
| CN105231198A (en) * | 2015-09-16 | 2016-01-13 | 安徽阜南常晖食品有限公司 | Hangover relieving and liver protecting sweet orange drink |
| CN105853626A (en) * | 2016-05-24 | 2016-08-17 | 内蒙古中安类风湿骨关节病专科医院有限责任公司 | Traditional Chinese medicine composition for treating fatty liver and hyperlipidemia |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1232279C (en) * | 2003-03-31 | 2005-12-21 | 江西汇仁药业有限公司 | Antilipemic Chinese medicine |
| CN1265836C (en) * | 2004-06-30 | 2006-07-26 | 曹琼 | Blood fat lowering Chinese traditional medicine |
-
2005
- 2005-04-18 CN CNB2005100341454A patent/CN1319588C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101028392B (en) * | 2007-04-16 | 2010-05-19 | 北京艺信堂医药研究所 | Chinese medicine for treating hyperlipemia |
| CN105231198A (en) * | 2015-09-16 | 2016-01-13 | 安徽阜南常晖食品有限公司 | Hangover relieving and liver protecting sweet orange drink |
| CN105853626A (en) * | 2016-05-24 | 2016-08-17 | 内蒙古中安类风湿骨关节病专科医院有限责任公司 | Traditional Chinese medicine composition for treating fatty liver and hyperlipidemia |
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| Publication number | Publication date |
|---|---|
| CN1319588C (en) | 2007-06-06 |
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