CN106039001A - Probiotic fermentation Chinese herbal compound composition for treating breast cancer and preparation method and application thereof - Google Patents
Probiotic fermentation Chinese herbal compound composition for treating breast cancer and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a probiotic fermentation Chinese herbal compound composition for treating breast cancer and a preparation method thereof. Chinese herbal compound medicinal materials are extracted, then nutrients and inorganic salt in different proportions are added, high-temperature sterilization is performed, compound probiotic is inoculated for fermentation, then stabilizing treatment is performed, and the probiotic fermentation Chinese herbal compound composition is obtained. Experiments show that the content of general flavone in the Chinese herbal compound composition can be increased, and the disease treatment effect of the Chinese herbal compound composition can be enhanced. The probiotic fermentation Chinese herbal compound composition is capable of relieving digestive disorder, body fatigue and other symptoms caused by radiotherapy and chemotherapy of a patient, moderate in taste, capable of being easily taken by the patient, fast to absorb, good in treatment effect, capable of effectively inhibiting growth of breast tumors, improving the physical condition and life quality of the patient and improving the immunity of the patient, and beneficial to improving the condition of the patient and prolonging the lifetime of the patient, and clinical tests show that the cure rate is about 85%; besides, the probiotic fermentation Chinese herbal compound composition is safe, effective and free of toxic or side effects.
Description
Technical field
The present invention relates to the fermentation composition that a kind of Chinese medicine extract prepares, and this fermentation group through intestinal probiotics fermention
Compound is used for the application treating in the medicine of breast carcinoma in preparation, belongs to technical field of biological fermentation.
Background technology
Breast carcinoma is the harm topmost malignant tumor of women's health.Within 2015, up-to-date number is announced according to National Cancer Center
According to display, China's registration area female mammary gland cancer morbidity is 37.86/10 ten thousand, the most just with 3% speed increase, China becomes
For one of fastest-rising country of breast cancer incidence.Studying on Risk Factors of Breast Cancer in Chinese Women only has part and high-income countries
Unanimously.The part identical with west includes: reproduction and Hormone Factors such as menstruation year limit for length (menophania is relatively early or menopause is postponed), from
Not giving birth to, Age of first delivery is postponed, and breast feeding is limited.In Chinese population, these factors have been slowly increased the wind suffered from breast cancer
Danger.Fertility rate declines also can remote-effects mammary cancer risk (such as shortening the breast feeding time).
Operation is one of method curing breast carcinoma, and it is first-selected treatment side that breast carcinoma in early days carries out ocal resection
Formula, postoperative being typically necessary is aided with chemicotherapy, and chemicotherapy, while killing cancerous cell, also can kill the normal thin of body part
Born of the same parents, including the immunocyte of human body, and affect the digestive system of patient, thus can cause the immunity degradation of patient, digestion
A series of untoward reaction such as obstacle, easily causes disease relapse.Chinese medicine has the advantage of uniqueness in terms for the treatment of tumor, natural
Class medicine has the features such as toxic and side effects is little, action target spot is various, better tolerance, more and more by weight in terms for the treatment of tumor
Depending on.But traditional decoction taste is more bitter, patient is typically difficult to swallow, and antineoplastic agent hinders stomach more, and the health destroying patient is put down
Weighing apparatus, impact is digested and assimilated, and affects the body constitution of patient further, reduces therapeutic effect.
Summary of the invention
For overcoming the deficiencies in the prior art, the invention provides one and be prone to take, absorb fast and good effect and bad
React low anti-breast cancer Chinese medicine preparation.
It is an object of the present invention to provide a kind of probiotics fermention Traditional Chinese medicine compound composition treating breast carcinoma, this combination
Thing is prepared after composite probiotics ferment by traditional Chinese medicine compound extract.The technical scheme used is: Chinese medicine compound medical material is extracted
The nutrient of rear addition different ratio and inorganic salt etc., high temperature sterilize, accesses compound intestinal probiotics fermention rear stabilization and processes
Obtain the probiotics fermention Traditional Chinese medicine compound composition of the present invention.
Described Chinese medicine compound is made up of the Chinese medicine ingredients of following weight portion: Bulbus Fritillariae Thunbergii 12～40 parts, Rhizoma Bolbostematis 12～40
Part, Pseudobulbus Cremastrae Seu Pleiones 12～36 parts, Spica Prunellae 20～60 parts, Herba Taraxaci 40～60 parts, Fructus Forsythiae 20～60 parts, Radix Rhapontici 12～36 parts, pool
Blue 12～48 parts, Fructus Trichosanthis 36～60 parts, Fructus Liquidambaris 12～40 parts, Radix Bupleuri 12～40 parts, Radix Angelicae Sinensis 20～48 parts, the Radix Paeoniae Alba 12～60
Part, Radix Salviae Miltiorrhizae 24～60 parts, Squama Manis 4～40 parts, Semen Vaccariae 12～40 parts.
Preferably, described Chinese medicine compound is made up of the Chinese medicine ingredients of following weight portion: Bulbus Fritillariae Thunbergii 24 parts, Rhizoma Bolbostematis 24
Part, Pseudobulbus Cremastrae Seu Pleiones 20 parts, Spica Prunellae 24 parts, Herba Taraxaci 48 parts, Fructus Forsythiae 24 parts, Radix Rhapontici 24 parts, Herba Lycopi 24 parts, Fructus Trichosanthis 48 parts, Lu Lu
Logical 24 parts, Radix Bupleuri 24 parts, Radix Angelicae Sinensis 24 parts, the Radix Paeoniae Alba 24 parts, Radix Salviae Miltiorrhizae 40 parts, Squama Manis 6 parts, Semen Vaccariae 24 parts.
It is a further object to provide the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma of the present invention
Preparation method, its step is as follows:
1) 40-60 mesh sieve pulverized by Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Pseudobulbus Cremastrae Seu Pleiones, Squama Manis, Radix Salviae Miltiorrhizae, and the water soaking 1-2 adding 2 times amount is little
Time, obtain medicated powder soak standby；20-40 mesh sieve pulverized by Radix Angelicae Sinensis, Fructus Forsythiae, added 5 times amount water soaking 0.5 hour, and steam steams
Evaporating 2 hours and collect volatile oil, obtain distillate standby, other nine tastes medicine boiling such as medicinal residues and Spica Prunellae twice, each 1-2 is little
Time, decocting liquid filters, and merging filtrate, filtrate is concentrated into the volume being equivalent to the medicated powder 3-10 times amount such as above-mentioned Bulbus Fritillariae Thunbergii, obtains concentrated solution
a；
2) the medicated powder soak band medicinal residues such as above-mentioned Bulbus Fritillariae Thunbergii are mixed with concentrated solution a, add the glucose of different ratio, albumen
Peptone, yeast extract, yeast powder, inorganic salt, regulation pH value, to 7.0, in 115 DEG C of autoclave sterilizations 1 hour, obtains aseptic Chinese medicine compound
Extract；
3) when above-mentioned aseptic Chinese medicinal compound extract temperature is down to 39 DEG C, inoculate pre-incubated each percent by volume be 0.5%～
One or both and the above bacillus bifidus bacterium solution of 1.0%, cellar culture, after about 2～6 hours, inoculates pre-incubated each body again
Long-pending percentage ratio is one or both and the above lactobacillus bacterium solution of 0.5%～1.0%, continues to cultivate 20～26 hours；Or simultaneously
Inoculate one or both and above bacillus bifidus bacterium solution and each volume hundred that pre-incubated each percent by volume is 0.5%～1.0%
Proportion by subtraction is 0.5%～1.0% one or both and above lactobacillus bacterium solution, ferments 22～30 hours, when pH value is down to less than 4.1
Time, terminate fermentation, obtain fermentation liquid；
4) centrifugal liquid of above-mentioned fermentation liquid centrifugal treating must being fermented is standby, and medicinal residues add 75% alcohol reflux two of 5 times amount
Secondary, each 1 hour, filtrate merged to obtain alcohol extract, and decompression Distillation recovery ethanol is 1.04-1.08 to relative density, obtains concentrated solution
B, mixes with the distillate of above-mentioned fermentation centrifugal liquid and step 1), constant volume, in 115 DEG C of autoclave sterilization 40min, obtains described
Probiotics fermention Traditional Chinese medicine compound composition.
Described bacillus bifidus is selected from bifidobacterium bifidum, bifidobacterium breve, bifidobacterium adolescentis or bifidobacteria infantis；
Described lactobacillus is selected from bacillus acidophilus, Deshi Lactobacillus, Lactobacillus plantarum, lactobacillus casei or lactobacillus rhamnosus.Bacterium
Plant and derive from China typical culture collection center (CCTCC) (China, Wuhan) or China General Microbiological culture presevation management
Center (CGMCC) (China, Beijing) or from the feces or intestinal submucosa tissue of normal person these bacterial isolateses of isolated.
The addition of described glucose is 0.7g/100ml, and the addition of described yeast extract is 0.13g/100ml, institute
The addition of the yeast powder stated is 0.07g/100ml, and the addition of described peptone is 0.28g/100ml.
Described inorganic salt is K2HPO4•3H2O 0.1g/100ml、KH2PO4 0.1g/100ml, ferrous sulfate 7H2O
5.0mg/100ml, zinc sulfate 7H2O 4.4mg/100ml, magnesium sulfate 7H2O 50mg/100ml。
In order to improve mouthfeel, can the concentrated solution a in the step 2 of described preparation method or the concentrated solution b in step 4 add
Entering sweeting agent, sweeting agent kind and addition is sucrose 0～3.5g/100ml and/or sucralose 0～0.02g/100ml.
It is also another object of the present invention to provide probiotics fermention Traditional Chinese medicine compound composition of the present invention to control in preparation
Treat the application in the medicine of breast carcinoma.
The probiotics fermention Traditional Chinese medicine compound composition of the present invention can also add one or more have identical, similar or
Different biological activity, and auxiliary existing to primary activity component list or synergism, but the most not antagonism is natural
Or the other drug composition of synthesis or its mixture, be configured to be suitable to the liquid preparation such as water or oil-suspending agent of oral administration or its
Its liquid preparation such as mixture, Emulsion, syrup etc..
Also solid powder can be prepared by the probiotics fermention Traditional Chinese medicine compound composition of the present invention by suitable drying means
End, adds one or more and has identical, similar or different biological is active, and auxiliary existing to primary activity component list or association
Same-action, but the most naturally occurring or synthetic other drug composition of antagonism or its mixture, be configured to be suitable to be administered orally
The medicine of the solid dosage formss such as the capsule of administration, tablet, granule.
Beneficial effect:
1, the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma of the present invention is according to Chinese medical theory and breast tumor disease
Sick characteristics of incidence, uses the theory of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out Chinese prescription screening, has blood-supplementing blood-nourishing, anti-inflammatory analgetic, heat clearing away solution
Poison, the effect such as dispersing swelling and dissipating binds.
2, the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma of the present invention is by Chinese medicine and probiotic bacteria combined treatment
Breast carcinoma, while treatment disease, can improve the digestive system of patient, alleviate gastricism that patient produces because of chemicotherapy,
Health is weak waits ill symptoms, and mouthfeel is moderate, it is easy to patient takes, and absorbs fast good effect, to reach strengthening vital QI to eliminate pathogenic factors, strengthens certainly
The effect of body resistance against diseases.
3, the content of total flavones during the preparation method of the present invention can improve Traditional Chinese medicine compound composition involved in the present invention,
Such that it is able to strengthen effect of Traditional Chinese medicine compound composition treatment disease involved in the present invention in terms of total flavones；And the present invention
Preparation method can improve the total effective rate of Traditional Chinese medicine compound composition involved in the present invention treatment breast carcinoma.
4, the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma of the present invention can improve the quality of life of patient, carries
The improvement of the immunity of high patient, the beneficially state of an illness, extends patient vitals's phase, and cure rate is about 85%, and safely and effectively, nontoxic
Side effect.
Detailed description of the invention
Embodiment 1: the preparation of probiotics fermention Traditional Chinese medicine compound composition A
Medical material, Bulbus Fritillariae Thunbergii 24g, Rhizoma Bolbostematis 24g, Pseudobulbus Cremastrae Seu Pleiones 20g, Spica Prunellae 24g, Herba Taraxaci 48g, company is weighed by following recipe quantity
Stick up 24g, Radix Rhapontici 24g, Herba Lycopi 24g, Fructus Trichosanthis 48g, Fructus Liquidambaris 24g, Radix Bupleuri 24g, Radix Angelicae Sinensis 24g, Radix Paeoniae Alba 24g, Radix Salviae Miltiorrhizae 40g, Chuan Shan
First 6.0g, Semen Vaccariae 24g.Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Pseudobulbus Cremastrae Seu Pleiones, Squama Manis, Radix Salviae Miltiorrhizae are pulverized 40 mesh sieves, adds 2 times amount
Water soaking 1 hour, obtains medicated powder soak standby；40 mesh sieves pulverized by Radix Angelicae Sinensis, Fructus Forsythiae, added 5 times amount water soaking 1 hour, and water steams
Volatile oil is collected in steam distillation 2 hours, obtains distillate 80ml standby, other nine tastes medicine boiling such as medicinal residues and Spica Prunellae twice,
Each 1 hour, decocting liquid filtered, and merging filtrate, filtrate is concentrated into 500ml, obtains concentrated solution a；The medicated powder such as above-mentioned Bulbus Fritillariae Thunbergii are soaked
Liquid band medicinal residues mix with concentrated solution a, add glucose 0.7g/100ml, yeast extract 0.13g/100ml, yeast powder 0.07g/
100ml, peptone 0.28g/100ml, inorganic salt (K2HPO4•3H2O 0.1g/100ml、KH2PO4 0.1g/100ml, sulphuric acid are sub-
Ferrum 7H2O 5.0mg/100ml, zinc sulfate 7H2O 4.4mg/100ml, magnesium sulfate 7H2O 50mg/100ml), sucrose 30g, adjusts
Joint pH value, to 7.0, in 115 DEG C of autoclave sterilizations 1 hour, obtains aseptic Chinese medicinal compound extract；When above-mentioned aseptic Chinese medicine compound
When extract temperature is down to 39 DEG C, inoculate bifidobacterium breve (AS 1.2213) bacterium solution that pre-incubated percent by volume is 1.0%,
After cellar culture about 3 hours, again inoculate Lactobacillus plantarum (AS 1.19) bacterium solution that pre-incubated percent by volume is 1.0%,
Continue to cultivate 23 hours, when pH value is down to below 4.1, terminates fermentation, obtain fermentation liquid；Above-mentioned fermentation liquid centrifugal treating must be sent out
Ferment centrifugal liquid is standby, and medicinal residues add 75% alcohol reflux twice of 5 times amount, and each 1 hour, filtrate merged to obtain alcohol extract, subtracts
Pressure Distillation recovery ethanol is 1.04-1.08 to relative density, obtains concentrated solution b, mixes with above-mentioned distillate, fermentation centrifugal liquid, adds
Water is settled to 1000ml, in 115 DEG C of autoclave sterilization 40min, obtains described probiotics fermention Traditional Chinese medicine compound composition A.
Embodiment 2: the preparation of probiotics fermention Traditional Chinese medicine compound composition B
Medical material, Bulbus Fritillariae Thunbergii 12g, Rhizoma Bolbostematis 40g, Pseudobulbus Cremastrae Seu Pleiones 12g, Spica Prunellae 60g, Herba Taraxaci 40g, company is weighed by following recipe quantity
Stick up 60g, Radix Rhapontici 12g, Herba Lycopi 48g, Fructus Trichosanthis 36g, Fructus Liquidambaris 40g, Radix Bupleuri 12g, Radix Angelicae Sinensis 48g, Radix Paeoniae Alba 12g, Radix Salviae Miltiorrhizae 60g, Chuan Shan
First 4.0g, Semen Vaccariae 40g.45 mesh sieves pulverized by Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Pseudobulbus Cremastrae Seu Pleiones, Squama Manis, Radix Salviae Miltiorrhizae, added the water of 2 times amount
Soak 1.5 hours, obtain medicated powder soak standby；30 mesh sieves pulverized by Radix Angelicae Sinensis, Fructus Forsythiae, added 5 times amount water soaking 1 hour, and water steams
Volatile oil is collected in steam distillation 2 hours, obtains distillate 100ml standby, other nine tastes medicine boiling such as medicinal residues and Spica Prunellae twice,
Each 1.5 hours, decocting liquid filtered, and merging filtrate, filtrate is concentrated into 600ml, obtains concentrated solution a；By medicated powder leachings such as above-mentioned Bulbus Fritillariae Thunbergiis
Bubble liquid band medicinal residues mix with concentrated solution a, add glucose 0.7g/100ml, yeast extract 0.13g/100ml, yeast powder 0.07g/
100ml, peptone 0.28g/100ml, inorganic salt (K2HPO4•3H2O 0.1g/100ml、KH2PO4 0.1g/100ml, sulphuric acid are sub-
Ferrum 7H2O 5.0mg/100ml, zinc sulfate 7H2O 4.4mg/100ml, magnesium sulfate 7H2O 50mg/100ml), regulation pH value is extremely
7.0, in 115 DEG C of autoclave sterilizations 1 hour, obtain aseptic Chinese medicinal compound extract；When above-mentioned aseptic Chinese medicinal compound extract temperature
When degree is down to 39 DEG C, inoculate bifidobacterium adolescentis (AS 1.2190) and baby couple that pre-incubated each percent by volume is 0.5%
Discrimination bacillus (AS1. 853) bacterium solution, cellar culture is after about 2 hours, again inoculate pre-incubated percent by volume be 0.7% addicted to acid
Lactobacillus (AS 1.1854) bacterium solution, continues to cultivate 22 hours, when pH value is down to below 4.1, terminates fermentation, obtains fermentation liquid；Will
Above-mentioned fermentation liquid centrifugal treating centrifugal liquid of must fermenting is standby, and medicinal residues add 75% alcohol reflux twice of 5 times amount, each 1 little
Time, filtrate merges to obtain alcohol extract, and decompression Distillation recovery ethanol is 1.04-1.08 to relative density, obtains concentrated solution b, with above-mentioned steaming
Distillate, fermentation centrifugal liquid mixing, add sucrose 30g and sucralose 0.1g, and mixing is dissolved, added water and be settled to 1000ml, in 115
DEG C autoclave sterilization 40min, obtains described probiotics fermention Traditional Chinese medicine compound composition B.
Embodiment 3: the preparation of probiotics fermention Traditional Chinese medicine compound composition C
Medical material, Bulbus Fritillariae Thunbergii 40g, Rhizoma Bolbostematis 12g, Pseudobulbus Cremastrae Seu Pleiones 36g, Spica Prunellae 20g, Herba Taraxaci 60g, company is weighed by following recipe quantity
Stick up 20g, Radix Rhapontici 36g, Herba Lycopi 12g, Fructus Trichosanthis 60g, Fructus Liquidambaris 12g, Radix Bupleuri 40g, Radix Angelicae Sinensis 20g, Radix Paeoniae Alba 60g, Radix Salviae Miltiorrhizae 24g, Chuan Shan
First 40g, Semen Vaccariae 12g.60 mesh sieves pulverized by Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Pseudobulbus Cremastrae Seu Pleiones, Squama Manis, Radix Salviae Miltiorrhizae, added the water of 2 times amount
Soak 2 hours, obtain medicated powder soak standby；20 mesh sieves pulverized by Radix Angelicae Sinensis, Fructus Forsythiae, added 5 times amount water soaking 1 hour, steam
Distill 2 hours and collect volatile oil, obtain distillate 60ml standby, other nine tastes medicine boiling such as medicinal residues and Spica Prunellae twice, often
Secondary 2 hours, decocting liquid filtered, and merging filtrate, filtrate is concentrated into 650ml, obtains concentrated solution a；By medicated powder soaks such as above-mentioned Bulbus Fritillariae Thunbergiis
Band medicinal residues mix with concentrated solution a, add glucose 0.7g/100ml, yeast extract 0.13g/100ml, yeast powder 0.07g/100ml,
Peptone 0.28g/100ml, inorganic salt (K2HPO4•3H2O 0.1g/100ml、KH2PO4 0.1g/100ml, ferrous sulfate 7H2O
5.0mg/100ml, zinc sulfate 7H2O 4.4mg/100ml, magnesium sulfate 7H2O 50mg/100ml), regulation pH value to 7.0, in
115 DEG C of autoclave sterilizations 1 hour, obtain aseptic Chinese medicinal compound extract；When above-mentioned aseptic Chinese medicinal compound extract temperature is down to
When 39 DEG C, inoculate simultaneously pre-incubated percent by volume be respectively 0.5% bifidobacterium bifidum (normal human separate, through China section
Institute of microbiology of institute identifies), lactobacillus rhamnosus (AS 1.22) and Deshi Lactobacillus (AS 1.1480) bacterium solution, conventional train
Support 24 hours, when pH value is down to below 4.1, terminates fermentation, obtain fermentation liquid；Above-mentioned fermentation liquid centrifugal treating must be fermented centrifugal
Liquid is standby, and medicinal residues add 75% alcohol reflux twice of 5 times amount, and each 1 hour, filtrate merged to obtain alcohol extract, decompression distillation
Reclaiming ethanol is 1.04-1.08 to relative density, obtains concentrated solution b, mixes with above-mentioned distillate, fermentation centrifugal liquid, and add water constant volume
To 1000ml, in 115 DEG C of autoclave sterilization 40min, obtain described probiotics fermention Traditional Chinese medicine compound composition C.
Determination of total flavonoids before and after experimental example 1, fermentation
Flavone compound is the class polyphenolic substance being widely present in nature, has many potential medical values, anti-
Tumor promotion is one of its study hotspot.Its antitumor action is mainly manifested in suppression cell proliferation, inducing cell apoptosis, intervention
Signal transduction, affect cell cycle, affect angiogenesis, overcome the aspects such as tumor multidrug-resistance.This experimental example measures
General flavone content in the probiotics fermention Traditional Chinese medicine compound composition of the present invention and correspondence non-fermentation composition, it is intended to explanation
The changes of contents situation of total flavones in Traditional Chinese medicine compound composition involved after being fermented by the preparation method of the present invention.
1, sample: in embodiment preparation probiotics fermention Traditional Chinese medicine compound composition A, B, C (numbered A, B, C) with
And the unfermentable Traditional Chinese medicine compound composition (numbered a, b, c) of correspondence.
2, assay method: this assay method uses the general flavone content of Chinese Pharmacopoeia one middle Radix Schefflerae Arboricolae sheet of version in 2015 to survey
Determine method.
The preparation of 2.1 reference substance solution: accurately weigh 102mg control substance of Rutin and put in 50ml volumetric flask, add 60% second
Alcohol 35ml, supersound process makes to be completely dissolved, lets cool, and adds 60% ethanol to scale, shakes up.Obtaining mass concentration is 2.04mg/ml
Reference substance solution.Precision measures 5ml, puts in 50ml volumetric flask, adds water to scale, shakes up, and obtains mass concentration and is
The reference substance dilute solution of 0.204mg/ml.
The preparation of 2.2 standard curves: precision measures reference substance dilute solution 1ml, 2ml, 3ml, 4ml, 5ml, 6ml, respectively
Put in 25ml volumetric flask, add water to 6ml, add 5% sodium nitrite solution 1ml, mixing, place 6 minutes, add 10% aluminum nitrate solution
1ml, shakes up, and places 6 minutes, adds 4% sodium hydroxide test solution 10ml, add water to scale, shake up, and places 15 minutes, with accordingly
Reagent make blank, according to ultraviolet visible spectrophotometry, at 500nm wavelength measure absorbance.Mark is calculated according to measurement result
Directrix curve.
The regression equation of gained standard curve is: Y=0.0092+0.0113X, R=0.9998 (X unit is ug/ml).
2.3 measure general flavone content: the pH value of each fermentation composition is adjusted to the water identical with corresponding non-fermentation composition
Flat, shake up each sample, precision measures sample liquid 10ml respectively, is slowly added into dehydrated alcohol 15ml, and limit edged shakes, and places 10 points
Zhong Hou, seals, and centrifugal, supernatant is transferred in 25ml volumetric flask, adds a small amount of 60% ethanol purge and precipitates and be settled to scale.Essence
The close 5ml of measuring adds water and is settled to 100ml, shakes up, and obtains need testing solution.Accurate absorption need testing solution 5ml, puts 25ml capacity
In Ping, the method under the preparation of sighting target directrix curve, from " adding water to 6ml ", operate, another accurate absorption need testing solution in accordance with the law
5ml, is diluted with water to 25ml, shakes up, and makees blank, measures absorbance in accordance with the law, reads rutin in test sample from standard curve
Amount, calculates, to obtain final product.
3, result: determination of total flavonoids the results are shown in Table 1
Table 1 each group determination of total flavonoids results contrast
4, conclusion: respectively group fermentation composition compares with corresponding non-fermentation composition, each group of fermentation composition
General flavone content showed increased, illustrates that the preparation method of the present invention can improve in Traditional Chinese medicine compound composition involved in the present invention
The content of total flavones, such that it is able to strengthen the merit of Traditional Chinese medicine compound composition treatment disease involved in the present invention in terms of total flavones
Effect.
Experimental example 2, clinical trial:
1, case selection:
Selecting patient with breast cancer 140 example made a definite diagnosis to carry out clinical observation, patient is randomly divided into treatment group and matched group, and treatment group is again
It is divided into treatment a group, treatment A group, treatment b group, treatment B group, treatment c group, treatment C group, each group patient to be women, respectively organize patient
Essential information be shown in Table 2, essential information and the clinical features degree of two groups of cases are basically identical, without significant difference, involved
And data has comparability.
Patient basis's statistics respectively organized by table 2
2, medicament selection:
Treatment A, B, component C do not take probiotics fermention Traditional Chinese medicine compound composition A, B, C of the present invention, and treatment a, b, c group takes respectively
With non-fermentation composition a, b, the c corresponding with probiotics fermention Traditional Chinese medicine compound composition A, B, C of the present invention, oral, every day
250ml, divides and sooner or later takes for twice；Within 30 days, being 1 course for the treatment of, the person of being in a bad way follows the doctor's advice the meal with wine amount of adding.
Matched group takes medroxyprogesterone acetate tablets, oral, a 100mg, 3 times on the one, or oral 500mg, every day 1～2
Secondary, as the maintenance dose after intramuscular injection.
3, efficacy determination:
(1) cure: lump disappears, and physical recovery is normal.
(2) effective: lump is obviously reduced, health is clearly better.
(3) effective: lump has reduced, and health has taken a turn for the better.
(4) invalid: to be expanded or without reducing by lump after treatment.
4, result: (see Table 3)
Result shows, the cure rate of each treatment group and total effective rate are apparently higher than matched group, and fermentation composition treatment group
Total effective rate is above the non-fermentation composition treatment group of correspondence, illustrates that the preparation method of the present invention can improve involved by the present invention
And Traditional Chinese medicine compound composition treatment breast carcinoma total effective rate.
Comparison of therapeutic respectively organized by table 3
5, typical clinical case
Clinical case 1, Lee, female, 51 years old, patient realized that right breast is uncomfortable to right oxter, goes to examination in hospital, is diagnosed as right mammary gland
Cancer, patient's emaciated physique, shortness of breath and palpitation, dim complexion, fatigue and weakness, thin fur matter is red, thready pulse, takes probiotics fermention of the present invention
After Traditional Chinese medicine compound composition A treats a course for the treatment of, complexion makes moderate progress, and the mental status takes a turn for the better, and continues to take a course for the treatment of, appetite
Take a turn for the better, Normal-weight, muscle power such as ordinary person, check that Tumor invasion is the most normal.
Clinical case 2, Chen, female, 63 years old, it is diagnosed as breast carcinoma, gives mammary gland radical correction simultaneously, row chemotherapy regimen of being admitted to hospital is controlled
Treat, but because the gastrointestinal reactions such as nausea and vomiting are strong, be off one's feed, immunity degradation, terminate Chemotherapeutic treatments, change and take the present invention
Probiotics fermention Traditional Chinese medicine compound composition B treats, and can normally take food after one week, after taking a course for the treatment of, and health on inspection
Well, and appetite is preferable, all goes well, this medicine of long-term taking, stable disease, recurrence of following up a case by regular visits to that so far there are no.
Clinical case 3, grandson, female, 42 years old, patient's chest had lump, surface irregularity, and edge boundary is unclear, pushes away it
Motionless, axillary gland enlargement, and with pain, the symptoms such as health is weak, inappetence, poor sleeping quality, it is hospitalized for treatment really
Examining as breast carcinoma, after taking one course for the treatment of of probiotics fermention Traditional Chinese medicine compound composition C treatment of the present invention, lump has reduced,
Pain relief, appetite makes moderate progress, and sleep quality improves, and can be engaged in simple physical work.After continuing to take a course for the treatment of, pain
Pain disappears, and mass reduction is obvious.After taking again a course for the treatment of, lump all disappears, and the mental status is preferable, follows up a case by regular visits to the most not multiple
Send out.
6, conclusion:
The probiotics fermention Traditional Chinese medicine compound composition of the present invention can improve Traditional Chinese medicine compound composition treatment involved in the present invention
The total effective rate of breast carcinoma, can alleviate the symptoms such as gastricism that patient produces because of chemicotherapy, health be weak, and mouthfeel is moderate,
It is prone to patient take, absorbs fast good effect, and can effectively suppress the growth of breast tumor, improve health and the life of patient
Quality, improves the immunity of patient, the beneficially improvement of the state of an illness, extends patient vitals's phase, and cure rate is about 85%, and safety has
Effect, has no side effect.
Claims (10)
1. the probiotics fermention Traditional Chinese medicine compound composition treating breast carcinoma, it is characterised in that said composition is by Chinese medicine compound
Add nutrient and the inorganic salt of different ratio, high temperature sterilize after medical material is extracted, access composite probiotics ferment rear stabilization
Process and prepare；
Described Chinese medicine compound is made up of the Chinese medicine ingredients of following weight portion: Bulbus Fritillariae Thunbergii 12～40 parts, Rhizoma Bolbostematis 12～40 parts, mountain
Rhizoma sagittariae sagittifoliae 12～36 parts, Spica Prunellae 20～60 parts, Herba Taraxaci 40～60 parts, Fructus Forsythiae 20～60 parts, Radix Rhapontici 12～36 parts, Herba Lycopi 12～
48 parts, Fructus Trichosanthis 36～60 parts, Fructus Liquidambaris 12～40 parts, Radix Bupleuri 12～40 parts, Radix Angelicae Sinensis 20～48 parts, the Radix Paeoniae Alba 12～60 parts, Radix Salviae Miltiorrhizae
24～60 parts, Squama Manis 4～40 parts, Semen Vaccariae 12～40 parts；
Described nutrient is glucose, peptone, yeast extract and yeast powder；
Described probiotic bacteria is bacillus bifidus and lactobacillus.
The probiotics fermention Traditional Chinese medicine compound composition for the treatment of breast carcinoma the most according to claim 1, it is characterised in that described
Chinese medicine compound be made up of the Chinese medicine ingredients of following weight portion: Bulbus Fritillariae Thunbergii 24 parts, Rhizoma Bolbostematis 24 parts, Pseudobulbus Cremastrae Seu Pleiones 20 parts, Spica Prunellae
24 parts, Herba Taraxaci 48 parts, Fructus Forsythiae 24 parts, Radix Rhapontici 24 parts, Herba Lycopi 24 parts, Fructus Trichosanthis 48 parts, Fructus Liquidambaris 24 parts, Radix Bupleuri 24 parts, Radix Angelicae Sinensis
24 parts, the Radix Paeoniae Alba 24 parts, Radix Salviae Miltiorrhizae 40 parts, Squama Manis 6 parts, Semen Vaccariae 24 parts.
The probiotics fermention Traditional Chinese medicine compound composition for the treatment of breast carcinoma the most according to claim 1, it is characterised in that described
The addition of glucose is 0.7g/100ml, and the addition of described yeast extract is 0.13g/100ml, the addition of described yeast powder
For 0.07g/100ml, the addition of described peptone is 0.28g/100ml.
The probiotics fermention Traditional Chinese medicine compound composition for the treatment of breast carcinoma the most according to claim 1, it is characterised in that described
Inorganic salt be K2HPO4•3H2O 0.1g/100ml、KH2PO4 0.1g/100ml, ferrous sulfate 7H2O 5.0mg/100ml, sulfur
Acid zinc 7H2O 4.4mg/100ml, magnesium sulfate 7H2O 50mg/100ml。
The probiotics fermention Traditional Chinese medicine compound composition for the treatment of breast carcinoma the most according to claim 1, it is characterised in that described
Bacillus bifidus selected from bifidobacterium bifidum, bifidobacterium breve, bifidobacterium adolescentis or bifidobacteria infantis；Described lactobacillus
Selected from bacillus acidophilus, Deshi Lactobacillus, Lactobacillus plantarum, lactobacillus casei or lactobacillus rhamnosus.
6. according to the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma described in any one of claim 1-5, its feature
Being, in probiotics fermention Traditional Chinese medicine compound composition, can add or without sweeting agent, described sweeting agent is 0～3.5g/
The sucrose of 100ml and/or the sucralose of 0～0.02g/100ml.
7. the preparation method of the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma described in any one of claim 1-6,
It is characterized in that, step is as follows:
1) 40-60 mesh sieve pulverized by Bulbus Fritillariae Thunbergii, Rhizoma Bolbostematis, Pseudobulbus Cremastrae Seu Pleiones, Squama Manis, Radix Salviae Miltiorrhizae, and the water soaking 1-2 adding 2 times amount is little
Time, obtain medicated powder soak standby；20-40 mesh sieve pulverized by Radix Angelicae Sinensis, Fructus Forsythiae, added 5 times amount water soaking 0.5 hour, and steam steams
Evaporating 2 hours and collect volatile oil, obtain distillate standby, other nine tastes medicine boiling such as medicinal residues and Spica Prunellae twice, each 1-2 is little
Time, decocting liquid filters, and merging filtrate, filtrate is concentrated into the volume being equivalent to the medicated powder 3-10 times amount such as above-mentioned Bulbus Fritillariae Thunbergii, obtains concentrated solution
a；
2) the medicated powder soak band medicinal residues such as above-mentioned Bulbus Fritillariae Thunbergii are mixed with concentrated solution a, add the glucose of different ratio, albumen
Peptone, yeast extract, yeast powder, inorganic salt, regulation pH value, to 7.0, in 115 DEG C of autoclave sterilizations 1 hour, obtains aseptic Chinese medicine compound
Extract；
3) when above-mentioned aseptic Chinese medicinal compound extract temperature is down to 39 DEG C, inoculate pre-incubated each percent by volume be 0.5%～
One or both and the above bacillus bifidus bacterium solution of 1.0%, cellar culture, after about 2～6 hours, inoculates pre-incubated each body again
Long-pending percentage ratio is one or both and the above lactobacillus bacterium solution of 0.5%～1.0%, continues to cultivate 20～26 hours；Or simultaneously
Inoculate one or both and above bacillus bifidus bacterium solution and each volume hundred that pre-incubated each percent by volume is 0.5%～1.0%
Proportion by subtraction is 0.5%～1.0% one or both and above lactobacillus bacterium solution, ferments 22～30 hours, when pH value is down to less than 4.1
Time, terminate fermentation, obtain fermentation liquid；
4) fermentation liquid centrifugal treating step 3) obtained centrifugal liquid of must fermenting is standby, and medicinal residues add 75% alcohol reflux of 5 times amount
Extracting twice, each 1 hour, filtrate merges to obtain alcohol extract, and decompression Distillation recovery ethanol to relative density is 1.04-1.08,
Concentrated solution b, concentrated solution b mix with the distillate of above-mentioned fermentation centrifugal liquid and step 1), constant volume, in 115 DEG C of autoclave sterilizations
40min, obtains described probiotics fermention Traditional Chinese medicine compound composition.
The preparation method of the probiotics fermention Traditional Chinese medicine compound composition for the treatment of breast carcinoma the most according to claim 7, it is special
Levy and be, in order to improve mouthfeel, can be in the step 2 of described preparation method) concentrated solution a in or the concentrated solution b of step 4) in add
Entering sweeting agent, the addition of described sweeting agent is sucrose 0～3.5g/100ml and/or sucralose 0～0.02g/100ml.
9. the probiotics fermention Traditional Chinese medicine compound composition of the treatment breast carcinoma described in any one of claim 1-6 is at preparation treatment breast
Application in the medicine of adenocarcinoma.
Application the most according to claim 9, it is characterised in that by probiotics fermention Traditional Chinese medicine compound composition according to routine
Pharmaceutical methods, be configured to be suitable to the medicine of the liquid preparation of oral administration or solid dosage forms.
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