CN110151870B - A kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation and preparation method thereof - Google Patents
A kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation and preparation method thereof Download PDFInfo
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- CN110151870B CN110151870B CN201910638423.9A CN201910638423A CN110151870B CN 110151870 B CN110151870 B CN 110151870B CN 201910638423 A CN201910638423 A CN 201910638423A CN 110151870 B CN110151870 B CN 110151870B
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Abstract
The present invention relates to field of traditional Chinese medicine preparations, specifically, a kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation and preparation method thereof is disclosed, which is made of the medicinal material of following portions by weight: 8 ~ 12 parts of Bupleurum Chinese, 8 ~ 12 parts of Fructus Aurantii, 13 ~ 17 parts of Radix Paeoniae Alba, 3 ~ 7 parts of Radix Glycyrrhizae, 13 ~ 17 parts of Rhizoma Chuanxiong, 8 ~ 12 parts of dried orange peel, 28 ~ 32 parts of radix pseudostellariae, 8 ~ 12 parts of Radix Angelicae Sinensis, 8 ~ 12 parts of fructus lycii, 13 ~ 17 parts of fushen, 8 ~ 12 parts of Rhizoma Atractylodis Macrocephalae, 8 ~ 12 parts and 2 ~ 4 parts of black tea of lotus leaf.Preferably, the Chinese materia medica preparation is granule or capsule.Soothing liver and strengthening spleen tune rouge Chinese materia medica preparation component formula of the invention is simple, constituent species source is relatively easy to get, and by the effect of the soothing liver and strengthening spleen, tranquilize the mind and promote the intelligence of the Regulation serum lipids and other compositions of the ingredients such as black tea, achievees the purpose that improving this disease treats outer disease.Chinese drugs agentia of the invention is particularly suitable for phlegm wet obesity symptom caused by long-term stagnation of liver qi, spleen deficiency, insomnia, body metabolism regulatory function disorder.
Description
Technical field
The present invention relates to field of traditional Chinese medicine preparations, and in particular to a kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation and preparation method thereof.
Background technique
Today's society, obesity are to perplex a major reason of people's life.Obesity is a kind of sub-health state, leads to fertilizer
There are many fat reason, wherein there is inherent cause, also there is acquired disposition.The easily raw phlegm wet of spleen deficiency, leads to obesity, therefore should be good for
The treatment of spleen and removing dampness.Leading to fat reason, there are also sleep insufficiency, the study found that if lacking and sleeping, the whole pancreas islet of human body
Plain respond will decline 16%, and stomach fat cell has dropped 30% to the sensitivity of insulin, this horizontal usually only meeting
It appears in and suffers from obesity and diabetic.So extended sleep is insufficient, will also get fat, or even suffer from diabetes.This
The leader of item research is also represented by " to run well in vivo, fat cell is also required to sleep ".And have not enough sleep, also with irascibility
Prosperous, spleen deficiency, have no peace of mind, the factors such as anxiety it is related.Therefore, soothing liver and strengthening spleen, mental-tranquilization, promotion sleep quality etc. are conducive to
Solve problem of obesity caused by acquired disposition.
Chinese medicine similar at present, such as CN103386088B disclose a kind of Chinese medicine composition for treating insomnia,
By 5 ~ 25 parts of radix bupleuri, 10 ~ 30 parts of Radix Angelicae Sinensis, 10 ~ 40 parts of Radix Paeoniae Alba, 10 ~ 40 parts of fushen, 10 ~ 30 parts of Rhizoma Atractylodis Macrocephalae, 5 ~ 25 parts of Radix Curcumae, rhizoma cyperi 5
~ 20 parts, 10 ~ 40 parts of jujube kernel, 10 ~ 40 parts of lily, 5 ~ 20 parts of Radix Polygalae, 5 ~ 20 parts of Schisandra chinensis, 5 ~ 20 parts of campanulaceae, 5 ~ 25 parts of Fructus Aurantii,
5 ~ 20 parts of green peel, August be 5 ~ 25 parts fried, 10 ~ 40 parts of cortex albiziae, 10 ~ 40 parts of tuber fleeceflower stem, 10 ~ 30 parts of Rhizoma Chuanxiong, 5 ~ 20 parts of Morinda officinalis,
5 ~ 15 parts of 10 ~ 40 parts of Herba Epimedii, Radix Glycyrrhizae compatibilities are made, and there is the composition dispersing stagnated hepatoqi, strengthening spleen, tonifying kidney, promoting the circulation of qi to dissipate strongly fragrant, calming heart
Calm the nerves, treat the effect of insomnia.
But the Chinese medicinal capsule recipe ingredient is excessive, up to 21 kinds, and be principally dedicated to dispersing stagnated hepatoqi, strengthening spleen, tonifying kidney etc.
The therapeutic effect of aspect, for because of table disease caused by spleen deficiency --- obesity carries out regulating lipid and reducing weight, and because of stagnation of liver qi caused by
The symptoms such as facial colour spot, do not give but and consider, thus while recipe ingredient is a lot of but still have its deficiency.The existing Chinese medicine capsule
In, the amount ranges bound span of each component is very big, and whether effect determines, also waits pending further consideration.
Summary of the invention
In order to solve the above problem of the prior art, the present invention provides that a kind of component formula is relatively simple, Component Source is easier to
It obtains, Chinese materia medica preparation significant in efficacy, can significantly play the role of clearing liver qi-regulating, invigorating spleen and nourishing heart, tranquilizing the mind, promote sleep, have simultaneously
The effect for being reduced body fat, adjusting human body BMI index, U.S. face nti-freckle.The invention further relates in a kind of soothing liver and strengthening spleen tune rouge
The preparation method of medicine preparation helps to improve effective component absorption and availability, improves curative effect.
Technical solution
In order to achieve the above object, the main technical schemes that the present invention uses include:
A kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation, is made of the medicinal material of following portions by weight: 8 ~ 12 parts of Bupleurum Chinese, Fructus Aurantii 8 ~
12 parts, 13 ~ 17 parts of Radix Paeoniae Alba, 3 ~ 7 parts of Radix Glycyrrhizae, 13 ~ 17 parts of Rhizoma Chuanxiong, 8 ~ 12 parts of dried orange peel, 28 ~ 32 parts of radix pseudostellariae, 8 ~ 12 parts of Radix Angelicae Sinensis, Chinese holly
8 ~ 12 parts of Qi, 13 ~ 17 parts of fushen, 8 ~ 12 parts of Rhizoma Atractylodis Macrocephalae, 8 ~ 12 parts and 2 ~ 4 parts of black tea of lotus leaf.
As a better embodiment of the invention, it is preferable that the Chinese materia medica preparation is matched by the medicinal material of following portions by weight
It makes: 10 parts of Bupleurum Chinese, 10 parts of Fructus Aurantii, 15 parts of Radix Paeoniae Alba, 5 parts of Radix Glycyrrhizae, 15 parts of Rhizoma Chuanxiong, 10 parts of dried orange peel, 30 parts of radix pseudostellariae, Radix Angelicae Sinensis
10 parts, 10 parts of fructus lycii, 15 parts of fushen, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of lotus leaf and 3 parts of black tea.
Preferably, the Chinese materia medica preparation is granule or capsule.
The present invention also provides a kind of preparation methods of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation, include the following steps:
S1: standby medicinal material: in parts by weight, 8 ~ 12 parts of Bupleurum Chinese of weighing, 8 ~ 12 parts of Fructus Aurantii, 13 ~ 17 parts of Radix Paeoniae Alba, Radix Glycyrrhizae 3 ~
7 parts, it is 13 ~ 17 parts of Rhizoma Chuanxiong, 8 ~ 12 parts of dried orange peel, 28 ~ 32 parts of radix pseudostellariae, 8 ~ 12 parts of Radix Angelicae Sinensis, 8 ~ 12 parts of fructus lycii, 13 ~ 17 parts of fushen, white
8 ~ 12 parts of art, 8 ~ 12 parts of lotus leaf and 2 ~ 4 parts of black tea, are respectively washed clean, cutting, room temperature dries, and are put into wall-breaking machine and break together
Wall handles 5 ~ 15min；
S2: it extracts: impregnating Bupleurum Chinese with the vinegar of mass fraction 6-8%, soaking time is 10 ~ 20h, vinegar: Bupleurum Chinese mass ratio
10mL~15mL:1g；
Add distillation remaining medicinal material of water submerged, after impregnating 2 ~ 3h, decoct 1 ~ 1.5h for the first time, collects decocting liquid；Then to
Add distilled water in the dregs of a decoction after primary decoction, decoct 0.5 ~ 1h second, collects decocting liquid again；Repeat decoct and collect decocting liquid 2 ~
4 times, merge the decocting liquid of each collection；
Decocting liquid is cooled and is mixed afterwards with the vinegar for impregnating Bupleurum Chinese, the mixed liquor containing effective component is obtained；
S3: it produces medicinal powder: by mixed liquor micro-filtrate membrane filtration, filtrate being taken to depressurize under conditions of -0.09Mpa, 40 ~ 60 DEG C
Be concentrated into relative density be 1.30 ~ 1.40(60 DEG C) thick paste, take thick paste to be dried under reduced pressure in -0.09Mpa, 40 ~ 60 DEG C, be made medicine
Powder；
S4: preparation: crushing the medicinal powder obtained through step S3, and mechanical homogenization crosses 16 ~ 20 mesh sieves, dispenses 10 ~ 30g
The pack of specification, or be packed into capsule housing and capsule is made.
Preferably, in step S1, in parts by weight, 10 parts of Bupleurum Chinese, 10 parts of Fructus Aurantii, 15 parts of Radix Paeoniae Alba, Radix Glycyrrhizae 5 are weighed
Part, 15 parts of Rhizoma Chuanxiong, 10 parts of dried orange peel, 30 parts of radix pseudostellariae, 10 parts of Radix Angelicae Sinensis, 10 parts of fructus lycii, 15 parts of fushen, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of lotus leaf
With 3 parts of black tea.
Preferably, in step S2, it is 5 ~ 6:1 that the mass ratio of distilled water and medicinal material is added when decocting for the first time；Second of decoction
And later decoction, adding the mass ratio of distilled water and the dregs of a decoction is 3 ~ 4:1.
Preferably, in step S3, the aperture of microfiltration membranes is 1 ~ 5 μm.
In formula of Chinese materia medica preparation of the invention, the effect of each traditional Chinese medicinal components and feature is as follows:
Bupleurum Chinese: it is used for stagnation of QI due to depression of the liver, irregular menstruation, pain in chest and hypochondrium to be impregnated when being used for soothing liver-qi stagnation using vinegar, and second
It is that rising Yang acts on that alcohol, which impregnates,.The ingredient of radix bupleuri is mainly saikoside, sterol, volatile oil, fatty acid (oleic acid, linolenic acid, palm fibre
Palmitic acid acid, stearic acid etc.) and polysaccharide etc., it is oxidizable to light, thermally labile.
Fructus Aurantii: there is the effect of dispersing stagnated hepatoqi, row stagnant disperse accumulation.It is stagnant to control phlegm in the heart for returns spleen, stomach meridian.
Radix Paeoniae Alba: nourishing blood and liver, delay in analgesic, contagious yin, soft liver and spleen analgesic, have resist oxygen lack, high temperature resistant, nourishing, strong
Strong effect.
The effect of Radix Glycyrrhizae: for treating the diseases such as weakness of the spleen and the stomach, fatigue and weakness, invigorating the spleen and benefiting qi, strengthening the spleen and stomach, for reconciling,
Alleviate the toxicity, strong of other medicinal materials.
Rhizoma Chuanxiong: the gas medicine in blood has the functions such as promoting qi circulation and removing obstruction in the collateral, sensible, analgesic.
Dried orange peel: have the function of regulating qi-flowing for strengthening spleen, eliminating dampness and eliminating phlegm, stomach strengthening and digestion promoting.
Radix pseudostellariae: there is the effect of replenishing qi to invigorate the spleen, promoting production of body fluid and nourishing the lung.
Radix Angelicae Sinensis: return liver, the heart channel of Hang-Shaoyin, there is the effect of cosmetology, replenishing and activating blood, regulating menstruation and relieving pain, moistening intestines and relaxing bowels, for treating
The diseases such as blood deficiency chlorosis, dizziness palpitaition, irregular menstruation, amenorrhea and algomenorrhea；Liver protecting is used for blood often with the blood-activating drugs compatibility such as Rhizoma Chuanxiong
The disease of silt retardance.
Fructus lycii: containing polysaccharides, have promote immune, anti-aging, it is antitumor, remove free radical, be antifatigue, anti-spoke
Penetrate, liver protection, reproductive function protection and improve the effects of.It is usually used in nourishing liver and supports kidney, moistening lung.
Fushen: antitoxic heart-soothing and sedative controls shortness of breath of having a guilty conscience, and invigorating spleen to remove dampness is suitable for the diseases such as palpitation and severe palpitation, insomnia forgetfulness.
Rhizoma Atractylodis Macrocephalae: having strengthening the spleen and replenishing qi, eliminate dampness and have diuretic effect and other effects, control and worry beyond measure, internal lesion caused by overexertion heart spleen.
Lotus leaf: return heart, liver, the spleen channel, faint scent, which rises, to be dissipated；Have effects that summer heat relieving and dampness eliminating, invigorating the spleen rising Yang, dissipating stasis and stanching bleeding, to spleen
Empty qi collapse, stool diarrhea person can also be added in tonifying spleen stomach medicine with use.
Black tea: fatty liver, which drinks black tea, the effect for adjusting rouge, weight-reducing, invigorating the spleen, dispersing stagnated hepatoqi.
Beneficial effect
(1) soothing liver and strengthening spleen tune rouge Chinese materia medica preparation of the present invention is 13 kinds of medicinal materials, and compatibility is relatively simple, pharmacological property and drug effect are easy to control
System, will not generate toxic side effect because of complicated compatibility relationship.13 kinds of medicinal materials include Bupleurum Chinese, Fructus Aurantii, Radix Paeoniae Alba, Radix Glycyrrhizae,
Rhizoma Chuanxiong, dried orange peel, radix pseudostellariae, Radix Angelicae Sinensis, fructus lycii, fushen, Rhizoma Atractylodis Macrocephalae, lotus leaf and black tea, component the effect of including regulating qi-flowing for strengthening spleen are adjusted
Rouge is realized scientific compatibility, is taken into account except the effect of the effect of phlegm wet is lost weight component, promoting the circulation of qi nourishing blood function component and medicine is attenuated component
Soothing liver and strengthening spleen adjusts rouge, dispels the effect of vascular plaque and antitoxic heart-soothing and sedative, promotes sleep, the blood-nourishing nourishing curative effects such as beauty.
Wherein component includes Fructus Aurantii, dried orange peel, radix pseudostellariae, fushen, Rhizoma Atractylodis Macrocephalae the effect of regulating qi-flowing for strengthening spleen；Adjust rouge except phlegm wet weight-reducing
Effect component includes lotus leaf, black tea；Promoting the circulation of qi nourishing blood function component includes Bupleurum Chinese, Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Angelicae Sinensis, fructus lycii；It is attenuated with medicine
The effect of component include Radix Glycyrrhizae.
The present invention utilizes the Regulation serum lipids of the ingredients such as black tea, and the effect of the soothing liver and strengthening spleen, tranquilize the mind and promote the intelligence of other compositions reaches
Improve the purpose that this disease treats outer disease.Chinese drugs agentia of the invention is particularly suitable for long-term stagnation of liver qi, spleen deficiency, insomnia, body
Phlegm wet obesity symptom caused by Metabolism regulation dysfunction, and it is significant in efficacy, there is improvement after taking in short term.
(2) preparation method of the invention dissolves out effective component more thoroughly medicinal material broken wall treatment, when extraction pair
Bupleurum Chinese is extracted with low temperature vinegar, is prevented high warm purgative effect ingredient denaturation, is extracted compared to ethyl alcohol, can effectively avoid and cause user
The side effects such as excessive internal heat.
Specific embodiment
In order to preferably explain the present invention, in order to understanding with reference to specific embodiments retouched in detail to present invention work
It states.
Embodiment 1
Present embodiment discloses a kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation, the medicinal material comprising following weight: Bupleurum Chinese 10g,
Fructus Aurantii 10g, Radix Paeoniae Alba 15g, Radix Glycyrrhizae 5g, Rhizoma Chuanxiong 15g, dried orange peel 10g, radix pseudostellariae 30g, Radix Angelicae Sinensis 10g, fructus lycii 10g, fushen 15g, Rhizoma Atractylodis Macrocephalae
10g, lotus leaf 10g and black tea 3g, medicinal material gross weight 153g.
A kind of preparation method of soothing liver and strengthening spleen tune rouge Chinese herbal granules of the present embodiment, includes the following steps:
S1: standby medicinal material: weighing medicinal material according to above-mentioned parts by weight meter, is respectively washed clean, cutting, room temperature dries, and puts together
Enter broken wall treatment 10min in wall-breaking machine；
S2: it extracts: impregnating Bupleurum Chinese, soaking time 15h, vinegar 120mL with the vinegar of mass fraction 6.6%；
Add 800mL to distill remaining medicinal material of water submerged, after impregnating 2.5h, decocts 1.2h for the first time, collect decocting liquid；Then to
Add 500mL distilled water in the dregs of a decoction after decocting for the first time, decoct 0.8h second, collects decocting liquid again；It repeats to decoct and collect
Decocting liquid 3 times, merge the decocting liquid of each collection；
Decocting liquid is cooled and is mixed afterwards with the vinegar for impregnating Bupleurum Chinese, the mixed liquor containing effective component is obtained；
S3: it produces medicinal powder: by 3 μm of micro-filtrate membrane filtrations of mixed liquor, filtrate being taken to depressurize under conditions of -0.09Mpa, 55 DEG C
Be concentrated into relative density be 1.30(60 DEG C) thick paste, take thick paste to be dried under reduced pressure in -0.09Mpa, 55 DEG C, be made medicinal powder；
S4: preparation: crushing the medicinal powder obtained through step S3, and mechanical homogenization crosses 18 mesh sieves, packing 20g specification
Pack.
Instructions of taking: one after each meal takes 20 ~ 30g daily.Shelf-life 3 years, the cool place place of drying was stored.
Embodiment 2
A kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation disclosed in the present embodiment, the medicinal material comprising following weight: Bupleurum Chinese 12g,
It is Fructus Aurantii 12g, 17g parts of Radix Paeoniae Alba, Radix Glycyrrhizae 7g, Rhizoma Chuanxiong 17g, dried orange peel 12g, radix pseudostellariae 32g, Radix Angelicae Sinensis 12g, fructus lycii 12g, fushen 17g, white
Art 12g, lotus leaf 12g and black tea 4g, medicinal material gross weight 178g.
A kind of preparation method of soothing liver and strengthening spleen tune rouge Chinese herbal granules, includes the following steps:
S1: standby medicinal material: weighing medicinal material according to above-mentioned parts by weight meter, is respectively washed clean, cutting, room temperature dries, and puts together
Enter broken wall treatment 15min in wall-breaking machine；
S2: it extracts: impregnating Bupleurum Chinese, soaking time 20h, vinegar 180mL with the vinegar of mass fraction 8%；
Add 996mL to distill remaining medicinal material of water submerged, after impregnating 3h, decocts 1.5h for the first time, collect decocting liquid；Then to
Add 664mL distilled water in the dregs of a decoction after primary decoction, decoct 1h second, collects decocting liquid again；It repeats to decoct and collect decocting liquid 4
It is secondary, merge the decocting liquid of each collection；
Decocting liquid is cooled and is mixed afterwards with the vinegar for impregnating Bupleurum Chinese, the mixed liquor containing effective component is obtained；
S3: it produces medicinal powder: by 5 μm of micro-filtrate membrane filtrations of mixed liquor, filtrate being taken to depressurize under conditions of -0.09Mpa, 60 DEG C
Be concentrated into relative density be 1.35(60 DEG C) thick paste, take thick paste to be dried under reduced pressure in -0.09Mpa, 60 DEG C, be made medicinal powder；
S4: preparation: crushing the medicinal powder obtained through step S3, and mechanical homogenization crosses 20 mesh sieves, packing 10g specification
Pack.
Instructions of taking: one after each meal takes 20 ~ 30g daily.Shelf-life 3 years, the cool place place of drying was stored.
Embodiment 3
The medicinal material comprising following weight: a kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation disclosed in the present embodiment weighs Bupleurum Chinese
8g, Fructus Aurantii 8g, Radix Paeoniae Alba 13g, Radix Glycyrrhizae 3g, Rhizoma Chuanxiong 13g, dried orange peel 8g, radix pseudostellariae 28g, Radix Angelicae Sinensis 8g, fructus lycii 8g, fushen 13g, Rhizoma Atractylodis Macrocephalae
8g, lotus leaf 8g and black tea 2g, medicinal material gross weight 128g.
A kind of preparation method of soothing liver and strengthening spleen tune rouge Chinese herbal granules, includes the following steps:
S1: standby medicinal material: weighing medicinal material according to above-mentioned parts by weight meter, is respectively washed clean, cutting, room temperature dries, and puts together
Enter broken wall treatment 5min in wall-breaking machine；
S2: it extracts: impregnating Bupleurum Chinese, soaking time 10h, vinegar 80mL with the vinegar of mass fraction 6%；
Add 600mL to distill remaining medicinal material of water submerged, after impregnating 2h, decocts 1h for the first time, collect decocting liquid；Then to first
Add 360mL distilled water in the dregs of a decoction after secondary decoction, decoct 0.5h second, collects decocting liquid again；It repeats to decoct and collect decocting liquid 2
It is secondary, merge the decocting liquid of each collection；
Decocting liquid is cooled and is mixed afterwards with the vinegar for impregnating Bupleurum Chinese, the mixed liquor containing effective component is obtained；
S3: it produces medicinal powder: by 1 μm of micro-filtrate membrane filtration of mixed liquor, filtrate being taken to subtract under conditions of -0 .09Mpa, 40 DEG C
Pressure be concentrated into relative density be 1.40(60 DEG C) thick paste, take thick paste to be dried under reduced pressure in -0.09Mpa, 40 DEG C, be made medicinal powder；
S4: preparation: crushing the medicinal powder obtained through step S3, and mechanical homogenization crosses 16 mesh sieves, packing 30g specification
Pack.
Instructions of taking: one after each meal takes 20 ~ 30g daily.Shelf-life 3 years, the cool place place of drying was stored.
Embodiment 4
Chinese materia medica preparation disclosed in the present embodiment is the same as example 1, and is not repeated.
A kind of preparation method of soothing liver and strengthening spleen tune rouge Chinese herbal granules of the present embodiment, S1-S3 step and embodiment one
It is identical, it does not repeat.The difference is that finished product medicament, each glue is made in the present embodiment by the way of capsule in S4 step
The medicinal powder or particle of capsule filling 0.8g specification.
Instructions of taking: one after each meal, each taking 5, three times a day.Shelf-life 3 years, the cool place place of drying was stored.
Use example
The beneficial effect of drug of the present invention is further illustrated below by clinical test, these tests are using the present invention
The Chinese medicine composition mixture or granule that above-described embodiment prepares are tested:
1. clinical data
1.1 case sources
In March, 2018 ~ 2018 year are chosen to go to a doctor in the Internal Medicine-Cardiovascular Dept. outpatient service of affiliated hospital, Jiangxi University of Traditional Chinese Medicine November
140 patients, doctor trained in Western medicine diagnosis is diagnosed as dyslipidemia, and Chinese medical discrimination belongs to stagnation of liver-QI with deficiency of the spleen syndrome of qi stagnation.
1.2 diagnostic criteria
1.2.1 Western medicine diagnostic criteria
Meet in four below referring to " Blood Lipid Abnormality in Chinese Adults guideline of prevention and treatment (revised edition in 2016) " any one and
More than one, continuous 2 times prompt exception person, dyslipidemia can be diagnosed as:
Without high fat diet, without drinking before patient's blood drawing, and empty stomach 12-14 hour, examine a blood lipid full set, if 1. TG >
1.7mmmol/L or 2. TC>5.2mmmol/L or 3. HDL-C<1.0mmol/L or 4. LDL-C>3.4mmmol/L.
1.2.2 tcm diagnosis standard
With reference to " tcm internal medicine disease Standardization of diagnosis and curative effect " and " Diagnostics of Chinese Medicine (the new century second edition) ", " dyslipidemia
Combination of Chinese tradiational and Western medicine diagnosis and treatment Consensus of experts (2017) ", You Liangming cures mainly that traditional Chinese physician and the above rank doctor are comprehensive dialectical to belong to liver
Strongly fragrant spleen-deficiency qi-stagnation type；
Primary symptom: being irritable and getting angry easily, stomach duct and abdomen make swollen, dry, difference of receiving；
Minor symptom: bitter taste, is walked to alter pain at tinnitus；
Primary symptom meets 2-3, and minor symptom meets 1-2, and can diagnose as evidence referring to tongue vein.
1.3 case selection
1.3.1 case is included in standard
(1) meet the diagnostic criteria of doctor trained in Western medicine dyslipidemia；
(2) meet the diagnostic criteria of Chinese medicine dyslipidemia (stagnation of liver-QI with deficiency of the spleen syndrome of qi stagnation)；
(3) compliance is preferable, partner treatment and nurses and without special diet fads；
(4) drug influential on blood lipid metabolism is not taken within nearest 2 months；
(5) age is between -75 years old 25 years old；
(6) related informed consent form is signed, a group person is voluntarily entered.
1.3.2 case exclusion criteria
(1) diagnostic criteria person is not met；
(2) clinical research is disagreed, is unwilling to sign letter of consent person；
(3) age is less than 25 years old or greater than 75 years old person；
(4) gestation, breast feeding women；
(5) once to plurality of Chinese object allergy or known easily quick constitution person；
(6) with spirit or dysnoesia, not cooperation person；
(7) compliance is poor, cannot take medicine and further consultation person as required；
(8) there are bad life habits, such as chronic alcoholism, drug dependent；
(9) other clinical investigators have been received, but cannot determine whether to this research person of having an impact.
1.3.3 case rejects standard
(1) voluntarily bolter in therapeutic process；
(2) adverse reactions people is generated to Study of Traditional Chinese Medicine object, counts adverse reaction statistics；
(3) it does not take medicine as required, result is caused to have deviation person；
(4) occur aggravation in therapeutic process or suffer from other diseases, this researcher need to be terminated；
(5) person lost to follow-up.
2. research method
2.1 group technology
This 140 selected patient is grouped by random digits table, is equally divided into 2 groups, wherein treatment group 70
Example, control group 70.
2.2 test method
1. clinical test is carried out using double-blind study, signature treatment informed consent form before treating, and it is different to carry out blood lipid to patient
Normal health propaganda and education deepens cognition of the patient to dyslipidemia pathogenic factor and risk factors, while informing the life of patient's science
The help that mode living prevents and treats dyslipidemia, and reinforce patient by the idea of medication, improve curative compliance.
2. the soothing liver and strengthening spleen lipid-regulating grain that embodiment one is given by treatment group combines Simvastatin Tablets, (commercial specification: 20mg is criticized
Quasi- code: national drug standard J20130068, manufacturer: Hangzhou Mo Shadong pharmaceutical Co. Ltd) it is treated, wherein soothing the liver strong
Spleen lipid-regulating grain 2 times a day, Simvastatin Tablets 20mg/ days, and control group gives merely Simvastatin Tablets.
3. further consultation is primary every two weeks, 4 weeks are as a treatment course, continuous treatment 8 weeks, living habit of keeping fit during treatment,
Patient clinical symptom, sign and lab index are recorded after each course for the treatment of, according to experimental design fill in related table,
Record data.
2.3 observation of curative effect
2.3.1 tcm clinical practice symptom is observed
With reference to " tcm internal medicine disease Standardization of diagnosis and curative effect " and " Diagnostics of Chinese Medicine (the new century second edition) ", " dyslipidemia
Combination of Chinese tradiational and Western medicine diagnosis and treatment Consensus of experts (2017) ", formulate tcm symptom grade form.Such as table 1.
Inquire in first visit and that in detail patient sign changes after medication 8 weeks, and according to interrogation information, according to Chinese medicine syndrome integral
Table counts Chinese medicine syndrome integral situation of change.
2.3.2 blood lipids index is observed
In first visit, after medication 4 weeks, three consultation time nodal test blood lipids are a full set of after medication 8 weeks, Blood Lipid feelings are observed
Condition.
2.3.3 body mass index is observed
In first visit, medication 4 weeks after, medication 8 weeks after three consultation time nodes records Patient height's weight calculate weight
Index.
2.3.4 Carotid ultrasonography is observed
In first visit, medication latter two consultation time rows of nodes bilateral strength artery ultrasound inspection in 8 weeks, inspection personnel is by the court B
Super room fixed personnel is detected using same type, and patient removes pillow dorsal position, and head is biased to check opposite side, main detection patient
Bilateral strength ductus arteriosus wall inner membrance situation and whether there is or not patches to be formed, takes the average value in its two sides thickness IMT, after continuous measurement three times
It is averaged the fiducial value as IMT again.
IMT: refer to Carotid Intima-media Thickness.
2.3.5 safety indexes are observed
1. vital sign: the general vital sign such as blood pressure, breathing, pulse, heart rate (first visit takes medicine 4 weeks, takes medicine 8 weeks)；
2. general auxiliary examination (first visit, the medication 8 such as blood, routine urinalysis, electrocardiogram, liver function, renal function, myocardial enzymes
Week)；
3. adverse events (record in detail at any time).
2.4 efficacy determination
Following curative effect determinate standard is formulated according to " the new Chinese medicine guideline of clinical investigations " published referring to 2002.
2.4.1 Efficacy of Traditional Chinese Medicine determines
Following standard is formulated according to the variation of its Chinese medicine syndrome integral, as shown in table 2.
2.4.2 lipid therapy efficacy determination
It is effective: LDL-C decline >=20%, TC decline >=20%, HDL-C rising >=0.26mmol/L, TG decline >=40%, blood
Rouge repetition measurement meets one person of any of the above.
Effective: LDL-C declines 10%-20%, TC decline 10%-20%, HDL-C and rises 0.104-0.26mmol/L, TG decline
20%-40%, blood lipid repetition measurement meet one person of any of the above.
Invalid: LDL-C decline rises less than 0.104mmol/L, TG decline not less than 10%, TC decline less than 10%, HDL-C
Foot 20%, blood lipid repetition measurement meets all of above standard person.
Each index meaning:
LDL-C high-density lipoprotein cholesterol；
TC total cholesterol；
HDL-C high-density lipoprotein cholesterol；
TG triglycerides.
2.4.3 safe sex determination
1 grade: patient has no adverse reaction, test rating variation without exception.
2 grades: patient has mild adverse effects, but can be resistant to, without treatment of being discontinued.
3 grades: patient has more apparent adverse reaction, needs to carry out anti symptom treatment to adverse reaction, can continue after processing
Drug test treatment.
4 grades: patient's adverse reaction is obvious, can not be resistant to drug therapy, need termination test.
3. statistical method
To gender's number, the comparison among groups such as efficiently individual quantity, effective number, invalid number are examined using enumeration data card side
It tests；Treatment group is examined compared with the pretherapy and post-treatment measurement data of control group using paired sample mean t；Pretherapy and post-treatment two Sets of Measurement money
Material analysis is examined according to homogeneity of variance result using two independent sample mean t or t ' is examined, and the above inspection passes through
SPSS23.0 is carried out.Statistic retains after decimal point three after rounding up, the statistical testing results use two-sided test, P >
0.05 is two sample no significant differences；P < 0.05 is that two sample experimental result differences are statistically significant, P < 0.01
When be statistically significant for two sample experimental result differences.
4. result of study
4.1 genders and age
This 140 selected patient is grouped by random digits table, is equally divided into 2 groups, wherein treatment group 70,
Control group 70, treatment group falls off 6 in research process, and control group falls off 8, rejects 4 at random in remaining treatment group,
2 are rejected in control group at random, final treatment group's data 60, control group 60 for participating in statistics.Treatment group male 38, female
Property 22；Control group male 28, women 32.With the distribution situation for comparing two groups of genders after enumeration data Chi-square Test, P
Greater than 0.05, prompt is not statistically significant, and two groups are comparable.Treatment group's average age is 56.83 ± 13.02 years old, control
The average age of group is 55.10 ± 10.31 years old.Two groups of patient's average ages are analyzed with independent samples t test, P is big
In 0.05, no significant difference is prompted, two groups are comparable, and see Table 3 for details.
4.2 two groups of patients with lipid's therapeutic effect analyses
4.2.1 the pretherapy and post-treatment blood lipids index for the treatment of group
Treatment group pretherapy and post-treatment blood lipids index (TC, TG, LDL-C, HDL-C) is carried out in group relatively, examining through paired sample t
It is found after testing, P value is respectively less than 0.01, prompts difference to have statistical significance, blood lipid level obviously changes earlier above after treatment group's treatment
Kind, therapeutic effect is effective, and see Table 4 for details.
4.2.2 the pretherapy and post-treatment lipid therapy index self-contrast of control group
The pretherapy and post-treatment blood lipids index of control group (TC, TG, LDL-C, HDL-C) is carried out in group relatively, examining through paired sample t
It is found after testing, P value is respectively less than 0.01, prompts difference to have statistical significance, blood lipid level changes before relatively treating after control group treatment
Kind, therapeutic effect is effective, and see Table 5 for details.
4.2.3 blood lipids index compares after two groups of treatments
Blood lipids index (TC, TG, LDL-C, HDL-C) after two groups of treatments is subjected to comparison among groups, after independent samples t test
It was found that the P value of TC, TG, LDL-C and HDL-C are respectively less than 0.05, TC, TG, LDL-C, HDL-C are tested at two groups after illustrating treatment
Difference is statistically significant in person.Such as table 6.
4.2.4 rouge Comparison of therapeutic is adjusted after two groups of treatments
Total effective rate after two groups of patients are treated is compared, through enumeration data card side after comparison, it was found that, P <
0.05, difference has statistical significance.Such as table 7.
Chinese medicine syndrome integral compares after 4.3 two groups of treatments
By being found after rank sum test to tcm syndrome curative effect after treatment group and control group treatment, P=0.002, P <
0.01, difference is statistically significant, and treatment group's treatment total effective rate is apparently higher than control group, such as table 8.
4.4 two groups of patient's Carotid ultrasonography Comparative results
4.4.1 IMT value compares before two groups of treatments
By find after independent sample t tests school inspection to the IMT value before treatment group and control group treatment, P >
0.05, compare no difference of science of statistics before illustrating two groups of treatments.Such as table 9.
4.4.2 IMT value compares after two groups of treatments
By treatment group and control group treatment after IMT value compare, through independent sample t test school inspection after find, P
< 0.01, result has obvious statistical difference after two groups of treatments.See Table 10 for details.
4.4.3 two groups of pretherapy and post-treatment IMT value comparisons
Comparison in group is carried out by the IMT value pretherapy and post-treatment to treatment group and control group, after paired sample t test school inspection
It was found that two groups of equal P < 0.01, there is obvious statistical difference before and after treatment.Such as table 11.
4.5 two groups of safety comparisons
By two groups of pretherapy and post-treatment adverse reactions of patient of observation after a situation arises discovery, treatment group there is 1 patient taking
There is mild diarrhea performance during medicine, but remission disappears after a couple of days；And control group has 1 patient slight muscle occur
Pain present is voluntarily alleviated after a few days, has 2 patients the gastrointestinal discomforts such as nausea, abdominal distension occur, and symptom is slow after anti symptom treatment
Solution.Statistics shows treatment group's adverse reaction rate lower than control group, but through statistics Chi-square Test P > 0.05, and conclusion does not have system
Meter learns meaning.Such as table 12.
There are also a large amount of practical application examples and tracking data can provide for the court, but reason as space is limited, only provides above-mentioned control
Treat example.Such as because patent examination needs, we can provide whole data at any time as required.
Claims (7)
1. a kind of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation, which is characterized in that be formulated by the component of following portions by weight: Bupleurum Chinese
8 ~ 12 parts, 8 ~ 12 parts of Fructus Aurantii, 13 ~ 17 parts of Radix Paeoniae Alba, 3 ~ 7 parts of Radix Glycyrrhizae, 13 ~ 17 parts of Rhizoma Chuanxiong, 8 ~ 12 parts of dried orange peel, 28 ~ 32 parts of radix pseudostellariae,
8 ~ 12 parts of Radix Angelicae Sinensis, 8 ~ 12 parts of fructus lycii, 13 ~ 17 parts of fushen, 8 ~ 12 parts of Rhizoma Atractylodis Macrocephalae, 8 ~ 12 parts and 2 ~ 4 parts of black tea of lotus leaf.
2. soothing liver and strengthening spleen tune rouge Chinese materia medica preparation according to claim 1, which is characterized in that by the component of following portions by weight
Be formulated: 10 parts of Bupleurum Chinese, 10 parts of Fructus Aurantii, 15 parts of Radix Paeoniae Alba, 5 parts of Radix Glycyrrhizae, 15 parts of Rhizoma Chuanxiong, 10 parts of dried orange peel, 30 parts of radix pseudostellariae, when
Return 10 parts, 10 parts of fructus lycii, 15 parts of fushen, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of lotus leaf and 3 parts of black tea.
3. soothing liver and strengthening spleen tune rouge Chinese materia medica preparation according to claim 1, which is characterized in that the Chinese materia medica preparation is granule
Or capsule.
4. a kind of preparation method of soothing liver and strengthening spleen tune rouge Chinese materia medica preparation as described in claim 1, which is characterized in that including following
Step:
S1: standby raw material: in parts by weight, weigh 8 ~ 12 parts of Bupleurum Chinese, 8 ~ 12 parts of Fructus Aurantii, 13 ~ 17 parts of Radix Paeoniae Alba, 3 ~ 7 parts of Radix Glycyrrhizae,
13 ~ 17 parts of Rhizoma Chuanxiong, 8 ~ 12 parts of dried orange peel, 28 ~ 32 parts of radix pseudostellariae, 8 ~ 12 parts of Radix Angelicae Sinensis, 8 ~ 12 parts of fructus lycii, 13 ~ 17 parts of fushen, Rhizoma Atractylodis Macrocephalae 8 ~
12 parts, 8 ~ 12 parts of lotus leaf and 2 ~ 4 parts of black tea, are respectively washed clean, cutting, room temperature dries, by addition to Bupleurum Chinese it is above-mentioned other
Component is put into 5 ~ 15min of broken wall treatment in wall-breaking machine together；
S2: it extracts: being filtered after impregnating Bupleurum Chinese with the vinegar of mass fraction 6-8%, soaking time is 10 ~ 20h, vinegar: Bupleurum Chinese dosage
Than 10mL ~ 15mL:1g；
Add distillation remaining component of water submerged, after impregnating 2 ~ 3h, decoct 1 ~ 1.5h for the first time, collects decocting liquid；Then to for the first time
Add distilled water in the dregs of a decoction after decoction, decoct 0.5 ~ 1h second, collects decocting liquid again；It repeats to decoct and collect decocting liquid 2 ~ 4 times,
Merge the decocting liquid of each collection；
Decocting liquid is cooled and is mixed afterwards with the filtrate for the vinegar for impregnating Bupleurum Chinese, the mixed liquor containing effective component is obtained；
S3: it produces medicinal powder: by mixed liquor micro-filtrate membrane filtration, filtrate being taken to be concentrated under reduced pressure under conditions of -0.09Mpa, 40 ~ 60 DEG C
To the thick paste that relative density is 1.30 ~ 1.40 under the conditions of 60 DEG C, thick paste is taken to be dried under reduced pressure in -0.09Mpa, 40 ~ 60 DEG C, is made
Medicinal powder；
S4: preparation: crushing the medicinal powder obtained through step S3, and mechanical homogenization crosses 16 ~ 20 mesh sieves, dispenses 10 ~ 30g specification
Pack, or be packed into capsule housing in capsule is made.
5. the preparation method according to claim 4, which is characterized in that in step S1, in parts by weight, weigh Bupleurum Chinese
10 parts, 10 parts of Fructus Aurantii, 15 parts of Radix Paeoniae Alba, 5 parts of Radix Glycyrrhizae, 15 parts of Rhizoma Chuanxiong, 10 parts of dried orange peel, 30 parts of radix pseudostellariae, 10 parts of Radix Angelicae Sinensis, fructus lycii 10
Part, 15 parts of fushen, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of lotus leaf and 3 parts of black tea.
6. preparation method according to claim 5, which is characterized in that in step S2, for the first time decoct when add distilled water with
The mass ratio of medicinal material is 5 ~ 6:1；Second of decoction and later decoction, adding the mass ratio of distilled water and the dregs of a decoction is 3 ~ 4:1.
7. preparation method according to claim 5, which is characterized in that in step S3, the aperture of microfiltration membranes is 1 ~ 5 μm.
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| 疏肝健脾方药对非酒精性脂肪性肝病大鼠肝细胞PI3K p85α蛋白表达的影响;杨钦河等;《广东药学院学报》;20090215(第01期);62-67 * |
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