Summary of the invention
Present invention purpose, is to utilize motherland's Chinese medical theory and resource, by adjusting the balance of human body, looks for new
Not only reduce the blood lipid level of patient but also reduce the new way of toxic and side effects.
It is an object of the invention to implement by following technical solution:
If a kind of Chinese medicine preparation treating turbid damp spleen stagnation type hyperlipemia of juice, it is made up of the Chinese medicine of following components by weight percent:
Fructus Hordei Germinatus 50~100 parts;Herb Gynostemmae Pentaphylli 50~100 parts;Rhizoma Dioscoreae 20~50. parts;Pericarpium Citri Reticulatae 10~20 parts;Fructus Crataegi 10~20
Part;Ganoderma 10~20 parts;Semen Lablab Album 10~20 parts;Fructus Jujubae 10~20 parts;Coriolous Dersicolor (Fr.) Quel 10~20 parts and Semen Phaseoli 10~20 parts.
The Chinese medicine preparation of above-mentioned treatment turbid damp spleen stagnation type hyperlipemia, is also made up of the Chinese medicine of following components by weight percent:
Fructus Setariae Germinatus 50~100 parts;Folium Nelumbinis 50~100 parts;Semen Cassiae 10~20 parts;Rhizoma Dioscoreae 20~50. parts;Semen Coicis 10~20
Part;Fructus Jujubae 10~20 parts;The Radix Angelicae Dahuricae 10~20 parts;Semen Phaseoli 10~20 parts;Poria 10~20 parts and Fructus Crataegi 10~20 parts.
The Chinese medicine preparation of above-mentioned treatment turbid damp spleen stagnation type hyperlipemia, is also made up of the Chinese medicine of following components by weight percent:
Fructus Oryzae Germinatus 50~100 parts;Stigma Maydis 50~100 parts;Rhizoma Dioscoreae 20~50. parts;Fructus Lycii 10~20 parts;Fructus Crataegi 10~20
Part;Semen Nelumbinis 10~20 parts;Semen Phaseoli 10~20 parts;Semen sojae atricolor 10~20 parts;Fructus Jujubae 10~20 parts and Fructus Ligustri Lucidi 10~20 parts.
The preparation method of above-mentioned a kind of Chinese medicine preparation treating turbid damp spleen stagnation type hyperlipemia, is characterized in that being divided into following step
Rapid:
The most above-mentioned each raw material is mixed by dosage, convention amount soak by water, filters, and filtrate is raw medicinal material mixing water extract,
Standby;
(2) raw medicinal material mixing water extract, is cooled to room temperature, and inoculation yeast bacterium is fermented
1. add strain be saccharomyces cerevisiae (Saccharomyces cerevisiae),
This primary yeast of karr (Sac.carlsbergensis Hansen) or
Schizosaccharomyces pombe (Schizosaccharomyces pombe) or
Cotton sick pin spore yeast (Nematospora gossypii);
The ratio that strain adds is
Raw medicinal material Aqueous extracts volume: strain weight=100:1~5;
2. fermentation temperature 20~32 DEG C, fermentation time 30~48h;
3. end point determination, when fermentation liquid pol reach≤1 ° of Bx time, arrive fermentation termination, it is thus achieved that raw medicinal material Aqueous extracts
Yeast fermentation broth;
(3) post processing
Hybrid state fermentation liquid evaporation and concentration is to after extractum shape, and 80~100 DEG C are dried to moisture and reach≤2%;Wear into grain
Footpath≤150 μm fine powder;Obtaining inactivation thalline and metabolite fine powder, detection protein content reaches >=40%, as preparation raw material,
Standby;
(4) capsule charge, it is thus achieved that finished product.
The application of above-mentioned a kind of Chinese medicine preparation treating turbid damp spleen stagnation type hyperlipemia, it is characterized in that preparation prevention and
Application in the preparation for the treatment of turbid damp spleen stagnation type hyperlipemia.
Hyperlipemia belongs to " expectorant is turbid " in Chinese Internal Medicine, " the expectorant stasis of blood " category, and the application is for the most common wet
Turbid spleen stagnation type hyperlipemia.
Its etiology and pathogenesis, loses in retrenching due to diet mostly, including drinking and eating irregularly (irregular, crapulence, gluttony), be addicted to drink and
Often it is satiated with food excessively, or surfeit delicious food savoury, thus impairing the spleen and stomach.The spleen has the function to transport and transform nutrients, main the lucid yang sending up, stomach receiving food and drink, main the turbid descending, spleen with
Stomach is connected with film, " spleen master be stomach promoting circulation of body fluid " (" Plain Questions faint opinion "), and the strong then body fluid of taste irrigates whole body, the Nellie vital organs of the human body,
Extremity bones of the body collectively outward, operation is not stopped.Once taste internal injury, transporting mistake department, lifting important department is not normal, and the wet then expectorant of the turbid spleen of stomach is raw, and expectorant
It is the change of body fluid, so-called " the spleen being the source of producing phlegm " (" card controls benefit "), it is meant that " expectorant " is that the pathology of some thick secretions produces
Thing, is also summarised as the resinous material of some muddinesses, and this kind of material and taste have pole substantial connection.As " Ling Shu Miraculous Pivot or Divine Axis passages through which vital energy circulates is other
Opinion " described: " food gas enters stomach, conveyance of turbid essence to the heart, transporting essential substances to vessel ", illustrate diet after taste effect, its greasy part of dense taste is returned foster
In heart arteries and veins, it both can be favourable with supporing yang activating QI, it is also possible to raw the moonization is turbid and has open-minded.Surfeit greasy and surfeit flavour person is fat and polyphyly expectorant
Wet body, then accumulation of phlegm fat gathers, and during fat is mixed-blood, causes a series of hyperlipemia disease.
According to the pathogenesis that spleen damp-phlegm is turbid, the rule for the treatment of is when based on invigorating the spleen for eliminating dampness, insufficiency of the spleen when spleen invigorating qi-restoratives, turbid damp then with food stagnation removing,
Dissipate, broken disappear it " resolving therapy ", utilize blood stasis dispelling, circulation of qi promoting, reduce phlegm, the slow method dissipated that fades such as diuretic, reach to get rid of evils and the mesh just do not hindered
's.Making damp thoroughly be reached, spleen fortune is able to healthy and vigorous.
In the raw material that the application uses:
Fructus Hordei Germinatus, Fructus Setariae Germinatus or Fructus Oryzae Germinatus, nature and flavor are sweet, flat or sweet, warm, return spleen, stomach warp.Circulation of qi promoting helps digestion, spleen benefiting and stimulating the appetite, relieving distension;Or
Help digestion and in, spleen benefiting and stimulating the appetite, do not disappear for food stagnation.
Herb Gynostemmae Pentaphylli energy activating human body normal cell, fat, strengthening the spleen and stomach, solution fatigue of losing weight;Enhance metabolism, fat-reducing, treatment
Constipation, promotes endocrine, delaying cell aging;Thus have and significantly reduce cholesterol (TCH), triglyceride (TG), low-density
Lipoprotein (LDL), high density lipoprotein increasing (HDL), protection blood vessel, stop lipid to deposit in blood vessel wall, and anti-tremulous pulse is hard
The effect changed.Herb Gynostemmae Pentaphylli can regulate the refuse fatty acid produced after oxygen decomposes in vivo, reaches the purpose of blood fat reducing.
Folium Nelumbinis nature and flavor are pungent, bitter, flat, return liver, spleen, stomach warp.Containing nuciferine (Roemerine), miltanthin
And multiple alkaloid and the vitamin C such as nuciferine (Nuciferine) (Pronuciferine);There is spleen invigorating yang invigorating, rise to dissipate and make
With, the Folium Nelumbinis that is considered as since ancient times among the people is weight reducing good medicine.Modern medicine study lotus flavone has antioxidation, defying age, clear
The medicinal health functions such as heat, blood fat reducing, cholesterol reducing and treatment cardiovascular and cerebrovascular disease.
Stigma Maydis nature and flavor are sweet, light, flat.Return bladder, liver, gallbladder meridian.Function of gallbladder promoting, diuresis, blood pressure lowering, can be used for treating fatty liver, height
Blood pressures etc., can substantially reduce the serum cholesterol content of hypercholesterolemia mice.
Rhizoma Dioscoreae, nature and flavor are sweet, flat.Return spleen, lung, kidney channel.Spleen reinforcing nourishing the stomach, for insufficiency of the spleen few food, deficiency-heat is quenched one's thirst.There is spleen reinforcing support
Stomach, invigorating the spleen and replenishing QI, effect of invigorating the lung and the kidney.Can prevent the sedimentation of fat on cardiovascular, keep blood vessel elasticity, stop tremulous pulse medicated porridge sample
Hardening occurs to early, and can reduce subcutaneous fat deposits;.
Semen Cassiae, nature and flavor are sweet, bitter, salty, are slightly cold.Return liver, large intestine channel.For liver heat removing and eyesight improving, loosening bowel to relieve constipation, lipid-lowering weight-reducing,
Treatment constipation and hyperlipidemia, hypertension.
Pericarpium Citri Reticulatae, nature and flavor are bitter, pungent, temperature.Attach to the lung and stomach meridians, spleen channel.Regulating qi-flowing for strengthening spleen, in tune, drying dampness to eliminate phlegm.Have warming stomach for dispelling cold,
Regulating qi-flowing for strengthening spleen, makes effect of stagnant fate row;For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm, abdominal distention uncomfortable in chest in turbid damp resistance,
Indigestion and loss of appetite loose stool.Phlegm-damp stops up the cough and asthma of lung.
Semen Coicis, nature and flavor are sweet, light, cool.Return spleen, stomach, lung meridian.Spleen invigorating eliminating dampness by diuresis, resolving depression of regulating the flow of vital energy, dampness removing, subside a swelling, lose weight, have
Enhance metabolism and reduce the effect that gastrointestinal is born, renal function can be strengthened;Eliminating impediment antidiarrheal, row is dense in heat clearing away;For arthralgia chiefly caused by damp pathogen contracture,
Diarrhea due to hypofunction of the spleen,
Fructus Lycii, nature and flavor are sweet, flat.Return liver, kidney channel.Nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, dizzy
Dizzy tinnitus, interior-heat quenches one's thirst, and blood deficiency and yellow complexion, blurred vision is failed to understand.Hemopoietic function there is is facilitation, improves lipid metabolism, moreover it is possible to be anti-ageing
Always, the effect such as mutation, antitumor, anti-fatty liver and blood sugar lowering.
Fructus Crataegi, sour, sweet, tepor.Return spleen, stomach, Liver Channel.Promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.Promote that gastrointestinal disturbances is long-pending for meat
Stagnant, gastral cavilty distension, trusted subordinate's twinge, treatment hyperlipidemia etc..And have anticancer, anti-cancer report.
Ganoderma, nature and flavor are sweet, flat, GUIXIN, lung, liver, kidney channel.Invigorating QI and tranquilization, relieving cough and asthma.For dizziness sleeplessness, cardiopalmus gas
Short, asthenia cough with asthma.Treatment neurasthenia, insomnia, hyperlipemia, myocardial ischemia, coronary heart disease, hypertension, fatty liver, alcoholic liver,
Its complication of diabetes mellitus prevention, effective diabetes and nephropathy preventing etc..
Semen Lablab Album, nature and flavor are sweet, tepor;Return spleen, stomach warp.Invigorating the spleen for eliminating dampness, and in relieve summer heat.For weakness of the spleen and stomach, inappetence,
Abdominal distention uncomfortable in chest.Air making-up and spleen enlivening, hold concurrently can removing dampness, the property of medicine is gentle, mends and the most stagnant, and is improved the report of the immunologic function of cell.
Fructus Jujubae, sweet, warm.Return spleen, stomach warp.Invigorating the spleen and replenishing QI, invigorating spleen and reinforcing stomach, benefiting qi and nourishing blood, strengthen body immunity, calm peace
God, nourishing blood to tranquillize the mind.
Semen Phaseoli is sweet, sour, flat.GUIXIN, small intestine meridian.Invigorating spleen to remove dampness, inducing diuresis to remove edema, removing toxic substances and promoting pus discharge.Can purify the blood, eliminate
Internal organs are tired, have fat-reducing effectiveness.
Coriolous Dersicolor (Fr.) Quel, nature and flavor are sweet, light, are slightly cold;Return liver;Spleen;Lung meridian.Relieving cough and asthma;Heat-clearing and toxic substances removing;Antitumor.For drying, and
It is improved body's immunity and presses down carcinous, antitumor action, suppresses the formation and development of atheromatous plaque effectively;
Preventing and treating blood glucose rising effect, have heat clearing away, removing toxic substances, antiinflammatory, anticancer, the effect such as protect the liver.
The Radix Angelicae Dahuricae, nature and flavor are pungent, temperature.Return stomach, large intestine, lung meridian.Wind dehumidifying, sensible pain relieving, heat radiation pain relieving weight reducing skin moistening can be dissipated.Dispel
Wind, dampness, antiinflammatory, antibacterial, hypotensive activity, and have activation sympathetic system hormone, the effect of suppression lipogenesis.
Poria, Poria slightly sweet flavor is put down, is entered the heart, lung, spleen channel.There is eliminating dampness and diuresis, invigorating the spleen and regulating the stomach, the merit of mind tranquilizing and the heart calming
Effect.Cardiopalmus, insomnia, insufficiency of the spleen leading to overabundance of dampness, damp and hot heap soil or fertilizer over and around the roots ties, have heart tonifying, protect the liver, calm, improve antineoplaston symptom, can reinforcement
Matter, enhancing human body immunity power.
Semen Nelumbinis, property is flat, sweet-puckery flavor, enters the heart, spleen, kidney channel;Clearing away heart-fire and be amusing, tonifying spleen and stopping diarrhea, kidney tonifying is puckery clearly, tranquilizing by nourishing the heart.Lotus
Sub-core has significant cardiotonic, can expand peripheral blood vessel, reduce blood pressure;Cancer-resisting, noncrystalline shape alkaloid contained by Semen Nelumbinis
N-9 also has hypotensive activity;Semen Nelumbinis have tonifying spleen and stopping diarrhea, improving eyesight, invigorating the spleen and replenishing QI, nourish vigour.
Semen sojae atricolor, sweet in the mouth, property is put down, high protein, low in calories, containing antioxidant anthocyanidin, can remove interior free yl, have solution
Table heat clearing away, the suppressing the hyperactive liver that nourishes blood, Bu Shen Zhuang the moon, qi-restoratives hair color, yin nourishing QI invigorating;Increase enterogastric peristalsis.Skin care slow down aging, softens
Blood vessel, blood viscosity can be reduced, suppression absorption of human body cholesterol, reduce blood cholesterol level.
Fructus Ligustri Lucidi, sweet in the mouth, micro-bitterness enter liver, kidney channel.Tonifying liver kidney yin, blood fat reducing and arteriosclerosis, blood sugar lowering, anti-liver damage
Wound, anticancer, mutation;The cardiovascular systeies such as heart tonifying, expansion coronary vasodilator, expansion peripheral blood vessel;Can auxiliary treatment coronary heart disease, height
Lipidemia, hypertension.
The application is to utilize relevant Chinese crude drug water decoction, and through culture propagation, final acquisition inactivates thalline and metabolite,
After dried, crushed, then make capsule for preventing and treat the preparation of turbid damp spleen stagnation type hyperlipemia.
Observation of curative effect situation
The capsule obtained by technical scheme is treatment group, and commercially available common drug zhibituo, as comparison, is carried out
Clinical investigation.
All clinical investigation case derives from certain provincial hospital, investigates 550 examples, wherein inpatient 227 example altogether, and outpatient service is sick
Example 323 example, is randomly divided into treatment group 420 example, matched group 130 example.
Sex, treatment group observes male 300 examples, female 120 example;Matched group observes male 83 examples, female 47 example.
Investigate the age distribution of case
Age (year) 18-30 40 50 60~70
Treatment group number of cases 12 40 148 155 65
Matched group number of cases 5 17 37 41 30
Investigate the course of disease distribution of case
The course of disease within 1 year more than 1 year more than 3 years more than 5 years
Treatment group 40 103 217 60
Matched group 12 80 30 8
Investigate case and debate disease typing by the traditional Chinese medical science
Investigate case and press tcm symptom analysis
Investigate the diagnostic criteria of case
1, the diagnostic criteria of hyperlipemia is formulated with reference to " the clinical guidance principle of new Chinese medicine treatment hyperlipemia ".
Under normal circumstances, in 2 weeks as 2 serum total cholesterol TC all >=6.0mmol/L;Or triglyceride TG >=
1.54mmol/L;Or high density lipoprotein (HDL C) male≤1.04mmol/L;Women≤1.17mmol/L person can make a definite diagnosis.
The differential diagnosis in tcm standard of investigation case:
Turbid damp spleen stagnation type
Primary symptom shape: dizziness;The bodily form is fat;) sensation of oppression over the chest with shortness of breath;Tongue fur is satiny;Stringy and rolling pulse.
Secondary symptom: tending to vomit of feeling sick;Indigestion and loss of appetite mouth glues;Cardiopalmus is weak;Limbs are heavy;Nose heave abdominal distention.
All observation cases possess more than two 2 persons of primary symptom shape or have one person of secondary symptom simultaneously, i.e. shape is made a definite diagnosis.
Investigate the blood fat grade scale of case
L blood fat weight classification
Investigate the inspection target of case
(1) survey is examined in safety
1. general health check-up project.
2. blood, urine, feces routine test.
3. hepatic and renal function, blood glucose, electrocardiogram etc..
(2) health giving quality examines survey
1. TCM syndrome and tongue, the change of arteries and veins.
Detection body weight 1 time the most weekly.
The indexs such as the most every 3 weeks cholesterol detection, triglyceride, high low density lipoprotein 1 time.
The most every 3 weeks detection Hemorheology indexs.
The most every 3 weeks detection apolipoprotein indexs.
The most every 3 weeks detection citrus orchards.
The most every 6 courses for the treatment of Monday, the hospital stays was no less than for 2~3 courses for the treatment of.
(3) the requirement to index test:
Clinical investigation case keeps life at ordinary times and dietary habit during investigating, and disables other fat-reducing medicaments.Every time
Blood extracting assay evening before that day should not high fat diet and drink spill, all indexs all in time starting the course for the treatment of, treatment examined in every 3 weeks of mid-term
Look into, look into the most again once when leaving hospital.
(4) curative effect determinate standard
1. clinical cure: every inspection of blood fat recovers normal.
The most effective: lipids detection reaches following any one person:
TC declines >=20%
TG declines >=40%
HDL C rising >=0.26mmol/L
TC HDL C/HDL C declines >=20%
The most effective: lipids detection reaches following any one person:
TC decline>=10% but<20%
TG decline>=20% but<40%
HDL C rising>=0.104mmol/L but<0.26mmol/dl
TC HDL C/HDC CF fall>=10% but<20%
The most invalid: the lipids detection person of being not improved.
(5) symptom curative effect determinate standard:
1. clinical cure: symptom integral improves 100%
The most effective: symptom integral improves >=70%
The most effective: symptom integral improves >=30%
The most invalid: symptom integral improves < 30%
(6) efficacy result
1. the capsule that technical scheme the obtains curative effect (with blood lipids index as standard) to hyperlipemia
Tcm symptom is improved the comparison of (disease curative effect) by the capsule that 2. technical scheme obtains
Untoward reaction
1. before and after clinical tests, detect routine blood test, routine urinalysis, kidney liver function, blood glucose, electrocardiogram etc. be showed no exception, say
The capsule of Mingzhi's treatment group is harmless to human body.
2., during clinical tests, have no obvious adverse reaction.
Model case one
Lee X, man, 67 years old, retired veteran cadre, suffer from hyperlipidemia 6 years, often have a dizzy spell, malaise, the tired weight of limbs, food
Few, slightly movable or stair climbing then sensation of oppression over the chest with shortness of breath, dim eyesight.Come to go to a doctor on July 26th, 2012, look into TC7.2mmol/L,
TG2.95mmol/L, HDL C≤0.85mmol/L, TC HDL C/HDL C3.89, blood pressure 160/100mm/Hg, cardiopulmonary
(1), tongue fur is satiny, and thready pulse moistens.
AD: turbid damp spleen stagnation type hyperlipemia, vascular hypertension.
Award the capsule of oral technical solution of the present invention, three times a day, each 6, after patient takes three weeks continuously, sensation
Easily, having a dizzy spell in the whole body, weak substantially alleviates, and continues to take the 6th week and checks, all transference cures, especially movable metathorax
The short transference cure of stifling, diet is obviously improved.Look into TC.4.26mmol/L, TG1.32mmol/L, HDL C1.66mmol/L,
TC HDL C/HDL C1.99mmol/L, tongue fur is white, thready and stringy pulse.
Patient's private prosecution: this capsule is excellent, I takes 1 first quarter moon, pushes up me and take the medicine of 5 years in the past.Taking convenience, curative effect
Good, have no adverse reaction.Should promote as early as possible.Continue hospitalization to leave hospital full three courses for the treatment of, check when leaving hospital, look into TC.3.26mmol/
L, TG1.11mmol/L, HDL C2.66mmol/L, TC HDL C/HDL C1.99mmol/L, doctor's advice, low fat, less salt is drunk
Food, suitably takes a walk, takes a good rest.Follow up a case by regular visits to after half a year, conscious be difficult front symptom, in check blood fat normal range.
Model case two
King XX, man, 58 years old, retired worker, cause outbreak angina pectoris in 2011, it is diagnosed as coronary heart disease: because indigestion and loss of appetite mouth glues
Symptom, Multiple Hospitalization is treated.It is main to be again admitted to hospital in March, 2012 with chest distress and palpitation symptoms, and has abdominal distention, indigestion and loss of appetite, patient's essence of having a medical check-up
God is depressed, and shallow complexion, deep-thready pulse, corpulent tongue is the most satiny, clinical assay: TC8.8mmol/L, TG1.48mmol/L, HDL
C1.1l mmol/L,
AD: turbid damp spleen stagnation type hyperlipemia, chronic coronary artery blood supply insufficiency.
Through taking the capsule of technical solution of the present invention, three times a day, each 6, after 6 weeks, check TC3.9mmol/L,
TG0.69mmol/L, the conscious whole body of patient is light, and energetically, chest distress and palpitation symptoms greatly takes a turn for the better extremity, can upper activity downstairs, feed voluntarily
It is obviously improved.
Continue hospitalization to leave hospital full three courses for the treatment of, check when leaving hospital, look into TC3.15mmol/L, TG1.24mmol/L,
HDL C2.56mmol/L, TC HDL C/HDL C1.26mmol/L, doctor's advice, low fat, low salt diet, suitably take a walk, note
Have a rest.Follow up a case by regular visits to after half a year, conscious be difficult front symptom, in check blood fat normal range.
Clinical tests conclusion
Capsule the most of the present invention has preferable curative effect to turbid damp spleen stagnation type hyperlipemia.Clinical cure rate is 32.90%, aobvious
Efficiency is 23.81%, and effective percentage is 32.14%, and total effective rate is 92.86%.
This product can reduce serum cholesterol, triglyceride, low density lipoprotein, LDL, simultaneously high density lipoprotein increasing, and
Atherogenic index can be reduced, there is certain study of anti-atherogenic effect.
2, this product has preferable curative effect to the syndrome of turbid damp spleen stagnation type hyperlipidemia patient.Viscous, the breast to dizziness, indigestion and loss of appetite mouth
Stifling is short, stringy and rolling pulse, cardiopalmus are weak, tongue fur is satiny, limbs are heavy, syndromes etc. such as being intended to Tuhe nose heave abdominal distention of feeling sick has and substantially changes
Kind effect.
3, in curative effect by not finding untoward reaction during examining, many patients react this medicine and can make stool over the course for the treatment of
Unobstructed.