CN109276685B - The Chinese medicine composition and preparation method thereof of preventing/treating prostate class disease - Google Patents
The Chinese medicine composition and preparation method thereof of preventing/treating prostate class disease Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention discloses a kind of prevention or/and the Chinese medicine compositions and preparation method thereof for the treatment of prostatic disorders, the Chinese medicine composition is by the following raw material: raw Radix Astragali, psoralea corylifolia, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are prepared, the mutual synergistic effect of the active constituent of the Chinese medicine composition plurality of Chinese of the prevention or/and treatment prostate cancer disease, prevention is alleviated, treatment prostate class disease, it is easy to use, effect is rapid, curative effect is high, it the recurrence after healing can be avoided, it is no allergy, without any side effects suitable for the long-time service of various prostate class illnesss.
Description
Technical field
The invention belongs to pharmaceutical sanitary field, be related to a kind of Chinese medicine composition and preparation method thereof, in particular to it is a kind of pre-
Anti- or/and treatment prostatic disorders Chinese medicine compositions and preparation method thereof.
Background technique
Prostate-cancer incidence gradually increases in recent years, and the 2nd is ranked in the suffered from malignant tumour of whole world male.2011
The quantity of the new prostate cancer in year China is about 4.9 ten thousand, and the speed of growth is more quicker than developed countries such as America and Europes,
The disease incidence in male of China's prostate cancer in 2018 has risen to rapidly the 6th, and it is first to become male urinary system malignant tumour
Position.And with the progress of society and economic development, the change of people's lives habit, diet is irregular, overfeeding delicious food savoury,
Labor is intended to immoderate, the relatively flourishing regional severely afflicated area that will also be increasingly becoming national forefront gland cancer of economy.Most of prostate carninomatosis
People can benefit early stage from endocrine therapy, but by treatment in 18-24 months, prostate gland cancer cell gradually shelled androgen
Take generation tolerance by force, finally developing to the prostate cancer of Androgen-dependent is castration-resistant prostate cancer, endocrine agents occurs
The resistance for the treatment of, so as to cause traditional endocrine agents to this kind of patients almost without therapeutic effect.
Cell toxicity medicament (docetaxel, Cabazitaxel), novel anti-male drug (the miscellaneous Shandong amine of abiraterone, grace), Bone tumour
Treatment, immunization therapy etc. are the primary treatment regimens of current castration-resistant prostate cancer.However, said medicine is only capable of limited
Time in control tumour, patient can not obtain more preferable longer existence by these drug therapies, and have different side effects.
In addition, there is also cross resistance between novel anti-male drug and chemotherapeutics, the price of novel anti-male drug valuableness can also be given
Patient and family cause huge economy and mental burden, and some patientss are abandoned because that can not undertake its huge medical expense
Treatment.The survival region of castration-resistant prostate cancer patient is all undesirable, and median survival interval is no more than 12 months, and final dead
In prostate cancer.
Chinese medicine is controlled from the angle of organic conception and diagnosis and treatment, patients with prostate cancer by traditional Chinese medicine cooperation endocrine
It treats, even if progression of disease is resisted the stage to castration, the treatment of traditional Chinese medicine even can be used as the main of castration-resistant prostate cancer
One for the treatment of means.Healthy tendency can be not only promoted using traditional Chinese medicine treatment castration-resistant prostate cancer, cancer stove is consolidated, reduces and suffer from
The level of the prostate cancer antigen of person, drop prevent relapse and metastasis, can also improve clinical efficacy, and quality of making the life better extends life
Deposit the phase.Such as using raw Radix Astragali, wilsonii, Psoralen in the research such as Mu Rui space " invigorating spleen to remove dampness Huayu prescription " treatment advanced prostate cancer
Rouge is monarch drug in a prescription, right supporting anticancer；Use amethyst, Asiatic plantain for ministerial drug, promoting urination and removing dampness；Use rheum officinale, turmeric for adjutant, stagnation resolvation solution
Poison；The seed of cowherb is used to make medicine, blood circulation, inducing diuresis for treating strangurtia；All medicines share, and play the function of inducing diuresis for treating strangurtia, right supporting anticancer altogether；Grandson
Tumor-inhibiting action of the refined vivid equal research " invigorating spleen to remove dampness Huayu prescription " to human prostata cancer PC-3 cell tumor-bearing mice, wherein using yellow
Stilbene, the seed of cowherb are monarch drug in a prescription, righting invigorating the spleen, blood stasis-eliminating and stagnation-dissipating；It is promoting blood circulation and removing obstruction in channels using turmeric, rheum officinale as ministerial drug；With psoralea corylifolia, thorn five
Add, SHENLIUGU, bittersweet be adjuvant, eliminating damp, detoxifying, all medicines share, play the function of mass dissipating and swelling eliminating, detoxicating and fighting cancer altogether.
Jia Yingjie professor is on the basis of consulting ancient doctor's ancient books and records document and combining the Meta analysis of Modern Literature then to going
The gesture repellence prostate cancer essence interpretation of the cause, onset and process of an illness is summarized and is concentrated, it is believed that its sick position in prostate, lesion correlation internal organs and liver,
Spleen, kidney are closely related, and " void, poison, the stasis of blood, wet " is the elements of pathogenesis of the disease, before " water retention due to hypofunction of the spleen, the deficiency of vital energy poison stasis of blood " is castration-resistant
The column gland cancer core interpretation of the cause, onset and process of an illness.However part kidney-nourishing tcm drug contains similar to androgen sample material effect, such as pilose antler, Herba Cistanches, therefore
Traditional kidney tonifying method may promote testosterone levels, and hastily use may aggravate the state of an illness, promote testosterone levels, and aggravate disease
Feelings.Accordingly, professor Jia Yingjie proposes the theory of " kidney tonifying is kidney tonifying not as good as invigorating the spleen, invigorating the spleen " treatment prostate cancer, with " invigorating the spleen
Dampness removing, detoxification and removing stasis " is the big method of castration-resistant prostate cancer base therapy, and Fang Congfa goes out, prescription raw Radix Astragali, psoralea corylifolia, king
Do not stay row etc. for the square foundation for the treatment of castration-resistant prostate cancer.
Summary of the invention
The purpose of the present invention is for present in existing prostate cancer disease especially castration-resistant prostate cancer treatment
Deficiency provides a kind of Chinese medicine composition, Its Preparation Method And Use prevented or/and treat prostate class disease.The present invention
Chinese medicine composition and treatment prostate cancer disease especially castration-resistant prostate cancer western medical treatment combination therapies,
Reach increase therapeutic effect, mitigate adverse reaction, improve the quality of living, extends life span, inhibitory hormone dependent/non-dependent forefront
Adenocarcinoma cell proliferation, the effect of invasion, transfer.
To achieve the purpose of the present invention, one aspect of the present invention provide it is a kind of prevention or/and treatment prostate class disease in
Drug composition, including the following raw material: raw Radix Astragali, psoralea corylifolia, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata.
Wherein, the prostate related disease is hyperplasia of prostate, in hypertrophy of the prostate, prostatitis, prostate cancer
It is one or more.
In particular, the prostate related disease is prostate cancer.
Especially, the prostate cancer is hormone-independent prostate cancer or castration-resistant prostate cancer, is preferably gone
Gesture repellence prostate cancer.
In particular, the weight of the raw material are as follows:
Especially, the weight of the raw material are as follows:
The composition for preventing, treating prostate class disease of the invention selects raw Radix Astragali, psoralea corylifolia, wilsonii, turmeric, king
Row, radix glycyrrhizae preparata is not stayed to be prepared.Chinese medicine composition of the invention to give birth to Radix Astragali invigorating the spleen to mend congenital, real spleen dampness removing as monarch drug in a prescription,
Using wilsonii, psoralea corylifolia warming kidney and strengthening spleen, to help Li Shui as ministerial drug, be altogether adjutant with turmeric, seed of cowherb stagnation resolvation eliminating mass scattered plot,
Radix Glycyrrhizae tonifying spleen stomach function regulating, coordinating the drug actions of a prescription are to make medicine.These Chinese medicines are applied in combination, so that the active constituent in each medicinal material generates association
Same-action is mutually promoted, to play prevention, alleviation, treatment prostate cancer illness.
Wherein, Radix Astragali is the dry root of astragalus mongholicus or astragalus membranaceus of leguminous plant, warm-natured, sweet in flavor, return lung, the spleen channel, tool
There are an invigorating qi, consolidating exterior, promoting urination and detoxification, apocenosis, the function of expelling pus and promoting granulation is mainly used for deficiency of vital energy and acking in strength, anorexia and loose stool, the sinking of qi of middle-jiao, long
Rush down rectal prolapse, uterine bleeding of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy and edema, ulcer is difficult to burst, burst for a long time and does not holds back, flaccidity of limbs due to deficiency of blood is yellow, Heat Diabetes；Chronic renal
Scorching albuminuria, diabetes etc..Radix Astragali contains various trace elements.Modern pharmacological studies have shown that: Radix Astragali can dramatically increase in blood
Total white blood cells promote the phagocytic function and sterilizing ability of neutrophil leucocyte and macrophage.Astragalus membranaceus gastric infusion energy
The activity of natural killer cells in mice is remarkably reinforced；Astragalus polyose can stimulate the proliferation of NK cell, and cell body is made to become larger, Radix Astragali pair
The facilitation of NK cell activity is parallel with the antiviral activity that it is induced；Radix Astragali can enhance peripheral blood lymphocytes to IL-2
Reactivity, its proliferation index increases after stimulating peripheral blood lymphocytes by IL-2.Radix Astragali can enhance the flesh of rat and mouse
Power；Enhance the fatigue proof effect of rats'swimming, and stress rats plasma cortisol obviously increases, enhances rat resisting stress
Ability is realized by enhancing adrenal cortex function.
Psoralea corylifolia, bitter, property are pungent, warm, the function with warming kidney and strengthening spleen, can also astringent sperm contracting urine, gas of receiving relieving asthma, spleen kidney can be treated
The disease of soreness and weakness of waist and knees caused by the deficiency of yang, the enuresis, frequent micturition.Modern pharmacological studies have shown that psoralea corylifolia, which has, reinforces contractile force, increase
The effect of coronary artery and peripheral vessel blood flow；Antibacterial action；Psoralea corylifolia extracting solution has excited work to intestinal tube in vitro and in place
With to isolated guinea-pig uterus then relexation；And estrogen-like action.
Wilsonii, can nourishing liver and kidney, strengthening the bones and muscles, inducing diuresis for removing edema, can be used for treating difficult urination, edema of lower extremity, furthermore pierce five
Internal organs qi and blood function can also be adjusted by adding, and improved blood circulation, boosted metabolism, and modern pharmacological research is shown, wilsonii is anti-
Cancer composition is mainly glycosides compound and polysaccharide, and water extract is able to suppress adenocarcinoma cell, promotes apoptosis of tumor cells, and can prolong
Slow cell carcinogenesis.
Turmeric taste is acrid in flavour and warm in nature, nontoxic, its function of turmeric is promoting the circulation of qi, promoting menstruation, analgesic, can be used for all kinds of qi depressions to blood stasis and is led
The pain of cause is demonstrate,proved.Turmeric main ingredient curcumin can lure modern pharmacological studies have shown that curcumin has specific antitumor action
Lead apoptosis of tumor cells, antineoplastic invasion and transfer, reversing tumor cellular drug resistance and increase chemosensitivity.
The seed of cowherb, mild-natured, bitter return liver, stomach meridian.With blood circulation, lower cream detumescence, the benefits of inducing diuresis for treating strangurtia." book on Chinese herbal medicine
Detailed outline " in it is also on the books, say its " diuresis ", " seed of cowherb can walk blood system ", be the medicine that the bright punching of sun is appointed, custom has ' pangolin, king
Do not stay row, married woman has taken newborn long stream ' language, it is seen that its property row and incessantly.Divided by systematically extract to the seed of cowherb
From obtaining two kinds of higher ingredients of activity, be accredited as seed of cowherb cyclic peptide A, seed of cowherb cyclic peptide E, and confirm two kinds of ingredients
Have the function of inhibiting angiogenesis.Research finds that seed of cowherb cyclic peptide A has the function of inhibiting angiogenesis.The seed of cowherb is also
The relative expression quantity that p-ERk, p-Akt can be reduced is related.
Radix glycyrrhizae preparata, it is sweet in flavor, it is mild-natured.Return heart, spleen, lung, stomach meridian.With tonifying spleen stomach function regulating, the effect of Yiqi and vein recovery.Modern times grind
Study carefully, radix glycyrrhizae preparata contains a variety of chemical components such as glycyrrhizin, enoxolone, licorice polysaccharide, liquorice chalcone, has anti-inflammatory and anti-
Allergy effect, is adjusted body's immunity, antitumor and analgesic effect.It is thin that licochalcone A can reinforce prostate cancer
Born of the same parents reinforce the activity of TRAIL apoptosis pathway to the sensibility of TRAIL, promote Apoptosis.Licochalcone A can inhibit forefront
Cyclin B1, cdc2, CDKs4, CDKs6 expression, increase the expression of cyclinE, will hinder the cell cycle in gland cancer PC-3 cell
It is stagnant in the G2/M phase；Secondly licochalcone A can also reduce peroxophosphoric acid Rb protein level in PC-3 cell, with transcription factor
E2F can promote cell Proliferation after combining, peroxophosphoric acid Rb protein level declines the proliferation for directly inhibiting PC-3 cell.
Another aspect of the present invention provides the preparation side of a kind of prevention or/and the Chinese medicine composition for treating prostate class disease
Method includes the steps that carrying out as follows:
1) prepare raw material according to following weight:
2) heating water after mixing by raw material, is carried out to mixed raw material to extract, and collects extracting solution；
3) by the extracting solution of collection carry out concentration to get.
Wherein, the weight of raw material described in step 1) are as follows:
In particular, the extraction of heating water described in step 2) includes the steps that following sequence carries out:
Water 2A) is added into mixed raw material, is impregnated, the weight of the water of addition and the weight ratio of mixed raw material are 5-
10:1 carries out first time heating extraction after impregnating 1-3 hours, and first time extracting solution is made, and heating temperature is 100 DEG C, and heating mentions
Taking the time is 0.5-2 hours；
2B) first time extracting solution is filtered, collects filtrate；
It 2C) is added water into filter residue, carries out second of heating extraction, wherein the weight of the water of addition and mixed raw material
Weight ratio is 3-7:1, and heating temperature is 100 DEG C, and the heating extraction time is 20-90min；
It 2D) filters, the filtrate filtered twice is merged.
Wherein, step 2A) in soaking time be 2h；The weight of the water of addition and the weight ratio of mixture are preferably 7-8:
1；Step 2C) in be added water weight and mixture weight ratio be 5-7:1.
In particular, controlled at 80-100 DEG C during concentration described in step 3).
Especially, the relative density of the concentrate in step 3) after concentration is 1.05-1.3, preferably 1.1-1.3.
Especially, concentration to the ratio between the weight of concentrate and the total weight of raw medicinal material is 1:1 in step 3).
In particular, further including step 2A), the heating water extraction process is carried out after the raw material is crushed again.
Especially, the raw material is ground into and carries out the heating water extraction process after coarse powder again.
Another aspect of the invention provides a kind of above-mentioned Chinese medicine composition in preparation prevention or/and treatment prostate class disease
Application in drug or health care product.
Wherein, the prostate class pathological disorders are hyperplasia of prostate, hypertrophy of the prostate, the associated diseases such as prostate cancer
One of or a variety of, preferably one of prostate cancer or a variety of, especially castration-resistant prostate cancer.
The prostate cancer pathological disorders are one of hormone-independent prostate cancer, castration-resistant prostate cancer
Or a variety of, preferably castration-resistant prostate cancer.
" pharmaceutically acceptable excipient " available in pharmaceutical composition in the present invention can be in field of pharmaceutical preparations
The selection of any conventional excipient, particular excipient will depend on the administration mode or disease type that are used to treat particular patient
And state.The preparation method of said synthetic processes for specific administration mode is completely in the knowledge of drug field technical staff
In range.For example, can be used as diluent, carrier, filler that pharmaceutically acceptable excipient includes pharmaceutical field routine,
Adhesive, wetting agent, disintegrating agent, sorbefacient, surfactant, absorption carrier and lubricant etc..It when necessary, can also be
Flavouring agent, preservative and sweetener etc. are added in pharmaceutical composition.
The diversified forms such as tablet, pulvis, granule, capsule, oral solution can be made in pharmaceutical composition of the invention.
The present invention has following obvious advantage:
1, Chinese medicine composition of the invention has the function of significantly preventing and treating castration-resistant prostate cancer.This hair
Bright Chinese medicine composition is administered orally in the patient of castration-resistant prostate cancer, before clinical observation on the therapeutic effect significant decrease patient is total
Column gland cancer specific antigen (tPSA) value reduces free serum testosterone value, reduces QLQ-C30 scale score, mitigates patient clinical
Symptom improves patients ' life quality, significantly improves tcm clinical practice symptom.
2, in vitro test research of the invention has shown that Chinese medicine composition has significant killing hormone-independent prostate cancer
The effect of cell.Selection PC-3 cell, DU-145 cell have carried out experiment in vitro, the experimental results showed that Chinese medicine composition can be significant
The proliferation of inhibitory hormone dependent/non-dependent prostate gland cancer cell, invasion, transfer.
3, the pharmacological action of Chinese medicine composition of the invention is strong, for preventing, alleviating and/or treating prostate class disease
Obvious effect, toxic side effect is small, safety is good, can take for a long time, and its antineoplastic action can be analyzed with modern pharmacology
Mechanism has prospect in medicine.
4, products material abundance of the invention, inexpensive, clinical use is safe, preparation process is simple, and dose is small,
It is easy to use therefore easy to spread.
Detailed description of the invention
Fig. 1 is the comparable situation figure of two groups of patients tPSA value in different time periods before and after treatment.
Fig. 2 is the pretherapy and post-treatment different time sections free serum testosterone figure of changing of two groups of patients.
Fig. 3 is the pretherapy and post-treatment different time sections QLQ-C30 scale score figure of changing of two groups of patients.
Fig. 4 is tumour inhibiting rate figure of the different traditional Chinese herbal decoction concentration to PC-3 cell.
Specific embodiment
Present invention will be further explained below with reference to specific examples.But these embodiments be only limitted to illustrate the present invention without
For limiting the scope of the invention.The experimental method of specific experiment condition is not specified in the following example, usually according to conventional strip
Part, or according to condition proposed by manufacturer.
Before the preventing/treating castration-resistant of the present invention will be further illustrated by the following test examples the Chinese medicine composition
The effect of column gland cancer, these test examples include the pharmacodynamics test of the traditional chinese medicine composition of the invention.
Before the present invention verifies Chinese medicine composition preventing/treating castration-resistant using clinical observation on the therapeutic effect, in vitro test
The effect of column gland cancer.
1 clinical observation on the therapeutic effect of test example
1, research object
Choose Chinese The First Affiliated Hospital of Tianjin University of Traditional Chinese Medic's oncology in January, 2012 in June, 2016 outpatient service and
Inpatient is clarified a diagnosis as castration-resistant prostate cancer patient, is met diagnosis and is included in standard, and the age 18-80 years old, voluntarily
Receive observation treatment.
Castration-resistant prostate cancer patient 240 for meeting the standard of being included in are collected, patient is randomly divided into control group (dimension
Hold castration horizontal group) and treatment group's (oral " invigorating spleen to remove dampness Huayu prescription " combination therapy is given on the basis of control group), every group is each
120.2 groups of cases the course of disease, in terms of there are no significant difference, be comparable.
2, treatment method
Control group treatment method: being carried out using the standard treatments of doctor trained in Western medicine, specific as follows:
1. not with the CRPC (castration-resistant prostate cancer, M0) of transfer: adjusting endocrine on the basis of periodical evaluation and control
It treats.First generation antiandrogen drug (Flutamide, Bicalutamide), Estramustine, steroid hormone can be selected according to patient profiles
Treatment or antiandrogen withdraw treatment；For some patientss, it is contemplated that implementing local treatment hand under the premise of it is sufficiently known
Section, such as subtracts tumor prostatectomy or the radiotherapy for prostate.2. the metastatic CRPC of without pain or mild pain symptom:
Simple castration: adding use or uses first generation antiandrogen drug or corticosteroids instead；Row combined androgen blockade is controlled
The patient for the treatment of suspends with antiandrogen drug is used, and observation anti-androgen therapy withdrawal is reacted；Abiraterone 1000mg (1 time/d) connection
It closes prednisone 5mg (2 times/d)；The miscellaneous Shandong amine 160mg of grace (1 time/d)；Docetaxel 75mg/m2 (every 3 weeks 1 time) combines prednisone
5mg (2 times/d).3. the metastatic CRPC: docetaxel 75mg/m2 (every 3 weeks 1 time) with significant pain symptom combines prednisone
5mg (2 times/d)；(1 time/d) joint prednisone 5mg (2 times/d) of abiraterone 1000mg；The miscellaneous Shandong amine 160mg of grace (1 time/d).④
Bone related therapeutic: supportive treatment: occur using zoledronic acid 4mg prevention bone dependent event within every 4 weeks.
The treatment method for the treatment of group:
Patient gives oral " invigorating spleen to remove dampness Huayu prescription " decoction on the basis of control group, carries out combination therapy, i.e., to trouble
Person had both used the standard method of doctor trained in Western medicine to treat, while decoction of medicinal ingredients prepared by the also oral embodiment of the present invention 3, and daily 1 dose, daily
2 times, and deactivate its other medicine.
3, observation index and method
Before observation treatment and after treatment in the 2nd, 4,6,8 week blood samples of patients always prostate cancer specific antigen (tPSA) value,
Free serum testosterone value (T), and surveyed by same researcher according to the Life Quality of Cancer Patients that European cancer research tissue is specified
Quantitative table (EORTC QLQ-C30) carries out QLQ-C30 scale score and according to tcm clinical practice symptom evaluation criterion to trouble to patient
Person, which carries out tcm clinical practice symptom, improves therapeutic evaluation.
4, result of study
Data analysis is carried out using SPSS13.0 software package.Continuous data indicates that comparison among groups are examined using t with (± s),
Cross-reference data uses paired t-test.Enumeration data is analyzed with Chi-square Test.Ranked data use rank sum test.P<
0.05 is variant for statistics, and P < 0.001 is that difference is extremely significant.
Influence of 4.1 Chinese medicine compositions to the total prostate cancer specific antigen of CRPC patient (tPSA) value
Control group and treatment group patient total prostate cancer specific antigen (tPSA) value measurement result are as shown in table 1, Fig. 1.
Table 1 treat before, treatment after tPSA value comparison(unit: ng/mL) (n=120)
| Group | TPSA enters group | TPSA the 2nd week | TPSA the 4th week | TPSA the 6th week | TPSA the 8th week |
| Control group | 46.22±16.60 | 46.00±16.50 | 41.88±13.47 | 39.94±13.07 | 38.46±13.86 |
| Treatment group | 48.63±19.16□ | 42.74±15.61▲ | 30.37±10.88△ | 33.58±15.71▼ | 32.32±18.73▽ |
Compared with the control group△P、▼P、▽P is < 0.05.
Before treatment, the tPSA value of two groups of patients is respectively as follows: 46.2217 ± 16.5953ng/mL of control group, treatment group
48.6273 ± 19.15867ng/mL,*P=0.300 > 0.05, no significant difference are comparable.Two groups of patient's warps
After spending different therapeutic schemes treatment 2 weeks, two groups of tPSA are declined, but treatment group is compared with the control group,▲P=0.117 >
0.05, no significant difference.Comparing within the 4th week after the treatment, the 6th week, the 8th week, two groups of tPSA values compare,△P=0.000
、▼P=0.001,▽< 0.05, difference has statistical significance to P=0.004.
Chinese medicine composition and standard western medical treatment of the invention, can significantly reduce total prostate cancer specific antigen in blood
(tPSA) value has significant inhibiting effect to the expression of total prostate cancer specific antigen, and standard western medical treatment drug combination,
Have the function of synergy, promotes the lethal effect to tumour.
Influence of 3.2 Chinese medicine compositions to castration-resistant prostate cancer patients serum's free testosterone value
Control group and treatment group patients serum free testosterone value measurement result are as shown in table 2, Fig. 2.
Table 2 treat before, treatment after free serum testosterone situation of change(unit: ng/dL) (n=120)
Compared with the control group▼P、▽P is < 0.01.
Before treatment, the free serum testosterone levels of two groups of patients are suitable□P=0.222 > 0.05, no significant difference,
It is comparable.Two groups of patients are after the treatment of different therapeutic schemes, after the 2nd week, the 4th week, two groups of free serum testosterone value ratios
It does not change significantly, compared with each period control group,▲P=0.704 > 0.05,△P=0.164 > 0.05, difference without
Statistical significance.But the 6th week after the treatment, the 8th week compares, and two groups▼P=0.002,▽< 0.01, difference has P=0.000
Statistical significance.
Chinese medicine composition and standard western medical treatment of the invention, can significantly reduce free serum testosterone levels in blood, right
The synthesis of testosterone has significant inhibiting effect, with drug combination, has the function of synergy, and the killing to tumour is promoted to make
With.
Influence of 3.3 Chinese medicine compositions to castration-resistant prostate cancer patient's QLQ-C30 scale score
Control group and experimental group patient's QLQ-C30 scale score measurement result are as shown in table 3, Fig. 3.
Table 3 treat before, treatment after different time sections QLQ-C30 scale score situation of change(N=120)
| Group | Before treatment | The 2nd week after treatment | The 4th week after treatment | The 6th week after treatment | 8 weeks after treatment |
| Control group | 70.55±19.09 | 74.23±21.81 | 73.56±16.56 | 77.33±20.65 | 80.41±21.00 |
| Treatment group | 73.18±19.04□ | 78.55±21.10▲ | 74.75±16.91△ | 75.62±22.07▼ | 65.89±18.68▽ |
Compared with the control group▽P<0.01。
Before treatment, the QLQ-C30 scale score of two groups of patients compares,□P=0.287 > 0.05, no significant difference,
It is comparable.The 2nd week after treatment, the 4th week, the 6th week, two groups of QLQ-C30 scale scores compare,▲P=0.120,△P=
0.582、▼P=0.536 is equal > and 0.05, no significant difference.And in treatment the 8th week, two groups of patient's QLQ-C30 scale scores
Compare,▽P=0.000 < 0.01, difference have statistical significance.
Chinese medicine composition and standard western medical treatment drug combination of the invention, has the function of synergy, reduces patient
QLQ-C30 scale score, improve the quality of life of patient.
The influence that 3.4 Chinese medicine compositions improve castration-resistant prostate cancer patient's tcm symptom
According to the tcm clinical practice symptom evaluation criterion of prostate cancer, is evaluated and marked according to tcm clinical practice symptom by same researcher
Standard patient is treated before, score after treatment, pretherapy and post-treatment symptom total mark situation compares (before treatment/treat after):
Effective: symptom disappears or symptom integral reduces >=2/3；Effective: symptom mitigates, and integral reduces >=1/3 ,≤2/3；
Invalid: symptom is without mitigation or mitigates < 1/3.
It is as shown in table 4 that control group and treatment group's patient's tcm symptom improve measurement result.
The therapeutic evaluation (N=120) that 4 two groups of table is improved based on tcm symptom after the treatment
| Group | It is effective | Effectively | In vain | Improvement rate |
| Control group | 4 (3.45%) | 15 (12.07%) | 101 (84.48%) | 15.52% |
| Treatment group | 23 (18.97%) | 56 (46.55%) | 41 (34.48%) | 65.52% △ △ |
Compared with the control group△△P<0.05。
The 8th week after the treatment, situation is improved based on tcm symptom and carries out therapeutic evaluation, control group tcm clinical practice symptom improves
Effective percentage be 15.52%, and treatment group's tcm clinical practice symptom improve effective percentage be 65.52%,△△P < 0.05, difference have
Statistical significance.
Test result shows that Chinese medicine composition can 4 weeks, the 6th week, the 8th week reduction castration-resistant prostate after the treatment
The tPSA value of cancer patient, and compared with the control group has statistical difference (P < 0.05)；Chinese medicine composition can after the treatment the 6th
Reduce the free serum testosterone value of castration-resistant prostate cancer patient in week, the 8th week, and compared with the control group has significant system
Meter learns difference (P < 0.01)；In treatment the 8th week, two groups of patient's QLQ-C30 scale scores compared Chinese medicine composition, had significant system
Meter learns difference (P < 0.01)；Chinese medicine composition the 8th week improvement tcm symptom after the treatment, and compared with the control group has statistics
It learns difference (P < 0.05).
Chinese medicine composition and standard western medical treatment drug combination of the invention, has the function of synergy, reduces patient
Tcm symptom scoring, improve patient's tcm symptom, improve the quality of life of patient.
2 experiment in vitro of test example
1 test material
1.1 experimental cell strains
PC-3 cell strain (ATCC company, lot number CRL-1435) applied by testing.
1.2 reagents and drug
Test medicine: invigorating spleen to remove dampness stagnation resolvation decoction (1g crude drug/ml) prepared by the embodiment of the present invention 3；
" invigorating spleen to remove dampness Huayu prescription " decoction (Radix Astragali, wilsonii, psoralea corylifolia, turmeric, the seed of cowherb, radix glycyrrhizae preparata) (Chinese medicinal decoction
Agent is boiled by Tianjin University Of Traditional Chinese Medicine's Chinese medicine preparation laboratory).It is boiled using reflux extraction and is concentrated into 1g/ml.In it is medicinal
DMEM in high glucose culture medium is made into 100mg/ml solution, dispenses spare.
0.25% pancreatin.The tetraacethyl diamino-vinyl (EDTA) of 0.5M.Penicillin and streptomycin liquid.Fetal calf serum
(Gibco)；L-Glutamine；Complete DMEM in high glucose culture medium (Life Technologies)；Phosphate buffer (PBS): 70%
Ethyl alcohol；BD, 354480)；CCK-8 kit (silent picogram).
1.3 instruments, equipment
Superclean bench (Purifying Equipment Co., Ltd., Suzhou)；CO2Cell incubator (311 type of Thermo)；It is inverted fluorescence
Microscope (NikonTiU)；High-speed low temperature refrigerated centrifuge (Sigma Co., USA)；0.2 2 μm of sterile filters (Millipore
Company)；Acid-base balance instrument (Shanghai precision scientific instrument company)；High-pressure steam sterilizing pan (Shenan Medical Appliances Factory, Shanghai)；Electricity
Hot thermostatic drying chamber (Beijing experimental facilities factory)；Constant temperature culture oscillator (Beijing experimental facilities factory)；Electric heating constant temperature sink (Beijing
61 instrument plants)；4 DEG C of refrigerator/- 20 DEG C refrigerator/- 80 DEG C refrigerator (REVCO company, the U.S.)；Pipettor (Thermo company)；From
Heart pipe (50ml), Tissue Culture Dish (BIGCO company, the U.S.)；Disposable Tissue Culture Dish (the limited public affairs of Shanghai Vivotek biotechnology
Department)；Electronic balance (QHAUS company).
2 experimental methods
The traditional chinese medicine composition of the invention is made into 100mg/ml Chinese medicine composition solution with DMEM in high glucose culture medium, is dispensed standby
With.Exponential phase people forefront cancer PC-3 cell Fusion Strain to be grown to nearly is taken, is digested with 0.25% trypsin solution, suction pipe is anti-
Multiple piping and druming counts at single cell suspension, tally, after being made into the cell suspension of 10000/ml, cell is connect by 4000/hole
Kind is placed in 37 DEG C, 5%CO in 96 orifice plates, the RPMI-1640 culture medium containing 10% fetal calf serum2Incubator culture is for 24 hours；The
Two days, Chinese medicine composition solution 10000rpm is centrifuged 5min, 0.22 μm of filter degerming of supernatant is taken, is diluted to culture medium
Concentration be 50 μ g/ml, 100 μ g/ml, 200 μ g/ml, 300 μ g/ml, 400 μ g/ml, 500 μ g/ml, 600 μ g/ml, 800 μ g/ml,
96 orifice plates, the 200 every holes μ l are added in the solution of 1000 μ g/ml, and each concentration repeats 6 holes, cultivate 48h；After 48h, each concentration is taken
20 μ l CCK-8 solution are added in 4 holes, stay 2 holes as negative control, and 37 DEG C of incubation 4h are each at microplate reader measurement wavelength 450nm
The OD value (OD value) in hole, and following inhibitory rate of cell growth is calculated by formula:
Inhibiting rate (%)=(1- tests OD value/control OD value) × 100%,
Experiment is repeated 3 times altogether every time, reduces experimental error, and respectively with each group concentration (Concentration/ μ g/ml)
Horizontal axis is the growth inhibition curve that the longitudinal axis describes each group PC-3 cell with inhibiting rate (inhibitionrate).
3 experimental results
" invigorating spleen to remove dampness Huayu prescription " decoction significantly inhibits effect to PC-3 cell
Various concentration " invigorating spleen to remove dampness Huayu prescription " decoction is to the inhibiting rate measurement result of PC-3 cell as shown in table 5, Fig. 4.
Inhibiting rate (%) of the 5 the traditional chinese medicine composition of the invention various concentration of table to PC-3 cell
| Composition concentration (μ g/ml) | Inhibiting rate (%) |
| 0 | 0±1.46 |
| 50 | 2.63±1.42 |
| 100 | 7.28±1.35 |
| 200 | 27.08±1.06 |
| 300 | 44.81±0.81 |
| 400 | 58.52±0.61 |
| 500 | 61.35±0.56 |
| 600 | 64.25±0.52 |
| 800 | 65.93±0.49 |
| 1000 | 66.79±0.48 |
Comparison among groups, P < 0.05 indicate that difference has statistical significance.
Effect of the traditional Chinese herbal decoction of various concentration to PC-3 cell Proliferation, as a result different degrees of suppression is presented in cell Proliferation
System.Compared with control group is intervened in non-dosing, after various concentration group traditional Chinese herbal decoction handles cell 48h, each processing group OD value is presented
Different degrees of decline out, and the increase of the concentration for the treatment of with traditional Chinese herbal decoction, OD value are also gradually reduced, i.e. traditional Chinese herbal decoction pair
The inhibited proliferation of PC-3 cell has apparent docs-effect dependence.According to formula: inhibiting rate (%)=(1- experiment
OD value/control OD value) × 100%, calculated inhibitory rate of cell growth is gradually increased, and such docs-effect is also presented and relies on
Relationship.Compared with the control group, the traditional Chinese herbal decoction of various concentration group all has statistical significance (P to PC-3 cell inhibitory rate difference
< 0.05).
In summary: it is special that Chinese medicine composition joint castration scheme group can further reduce the total prostate cancer of patient
Specific Antigen (tPSA) value reduces free serum testosterone value, reduces QLQ-C30 scale score, significantly improve tcm clinical practice disease, subtract
Light patient clinical symptom improves patients ' life quality.Chinese medicine composition inhibitory hormone dependent/non-dependent prostate cancer PC- of the invention
3 cel l proliferations are strong.Hence, it can be determined that Chinese medicine composition has the work of significant anti-castration-resistant prostate cancer tumour
With may be used as the drug of preventing/treating castration-resistant prostate cancer.
Embodiment 1
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 30, psoralea corylifolia 15, wilsonii 15, turmeric 15, the seed of cowherb 8, radix glycyrrhizae preparata 8, wherein by raw Radix Astragali, mend
After bone fat, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, coarse powder mixture standby is made
With；
2) uniformly mixed coarse powder mixture is placed in Chinese medicine extracting tank, tap water is added and impregnates 2 hours (usually 1-
3h), wherein the weight ratio of the weight for the tap water being added and coarse powder mixture is 6:1 (usually 5-10:1)；
3) it opens extractor power supply to be heated, is heated to 100 DEG C, constant temperature extracts 45min (usually at this temperature for holding
It for 30-120min), then filters, it is spare to obtain first time extracting solution；
4) tap water is added into filter residue, the weight of the tap water of addition and the weight ratio of coarse powder mixture are 3:1 (logical
Often it is 3-7:1), heating extraction, heating temperature is 100 DEG C, and extraction time is 30min (usually 20-90min), is obtained by filtration
Second of extracting solution；
5) No. 2 extracting solution merging are placed on triple effect vacuum high energy to be concentrated by evaporation in tank, carry out concentration, the phase of concentration
It is -0.07MPa to pressure, temperature is 80 DEG C；It is concentrated to get the medicinal extract that relative density is 1.1；
6) concentrated extract is dried and (is usually dried in vacuo), and pulverization process obtains pharmaceutical composition powder of the invention
Then supplementary product starch is added in end into pharmaceutical composition powder, alcohol granulation is dry, pressing cost invention pharmaceutical composition piece
Agent.
Embodiment 2
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 20, psoralea corylifolia 10, wilsonii 20, turmeric 20, the seed of cowherb 6, radix glycyrrhizae preparata 6, wherein by raw Radix Astragali, mend
After bone fat, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, coarse powder mixture standby is made
With；
Step 2) -5) it is same as Example 1；
6) it is dried and (is usually dried in vacuo) processing to medicinal extract, the solid after drying is crushed, and the present invention is obtained
Pharmaceutical composition powder.
Embodiment 3
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 30, psoralea corylifolia 10, wilsonii 10, turmeric 15, the seed of cowherb 15, radix glycyrrhizae preparata 10, wherein will raw Radix Astragali,
After psoralea corylifolia, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, after coarse powder mixture is made
It is spare；
2) uniformly mixed coarse powder mixture is placed in Chinese medicine extracting tank, tap water is added and impregnates 2 hours, wherein being added
Tap water weight and coarse powder mixture weight ratio be 8:1 (usually 5-10:1)；
3) it opens extractor power supply to be heated, is heated to 100 DEG C, constant temperature extracts 60min (usually at this temperature for holding
It for 30-120min), then filters, it is spare to obtain first time extracting solution；
4) tap water is added into filter residue, the weight of the tap water of addition and the weight ratio of coarse powder mixture are 6:1 (logical
Often it is 3-7:1), heating extraction, heating temperature is 100 DEG C, and extraction time is 60min (usually 20-90min), is obtained by filtration
Second of extracting solution；
5) merging of No. 2 extracting solutions triple effect vacuum high energy being placed on to be concentrated by evaporation in tank, the relative pressure of concentration is-
0.07MPa, temperature are 80 DEG C, and being concentrated into the ratio between the weight of concentrate and the total weight of raw medicinal material is 1:1, i.e., concentrate is total
Weight is 8.6kg, and the total weight of raw medicinal material is 8.6kg, and pharmaceutical composition decoction of the invention is made.
Embodiment 4
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 40, psoralea corylifolia 10, wilsonii 20, turmeric 10, the seed of cowherb 6, radix glycyrrhizae preparata 10, wherein by raw Radix Astragali, mend
After bone fat, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, coarse powder mixture standby is made
With；
2) uniformly mixed coarse powder mixture is placed in Chinese medicine extracting tank, tap water is added and impregnates 1 hour, wherein being added
Tap water weight and coarse powder mixture weight ratio be 10:1 (usually 5-10:1)；
3) it opens extractor power supply to be heated, is heated to 100 DEG C, constant temperature extracts 30min (usually at this temperature for holding
It for 30-120min), then filters, it is spare to obtain first time extracting solution；
4) tap water is added into filter residue, the weight of the tap water of addition and the weight ratio of coarse powder mixture are 3:1 (logical
Often it is 3-7:1), heating extraction, heating temperature is 100 DEG C, and extraction time is 90min (usually 20-90min), is obtained by filtration
Second of extracting solution；
5) No. 2 extracting solution merging are placed on triple effect vacuum high energy to be concentrated by evaporation in tank, carry out concentration, the phase of concentration
It is -0.07MPa to pressure, temperature is 80 DEG C；It is concentrated to get the medicinal extract that relative density is 1.3；
6) concentrated extract is dried and (is usually dried in vacuo), and pulverization process obtains pharmaceutical composition powder of the invention
Then microcrystalline cellulose excipients are added in end into pharmaceutical composition powder, alcohol granulation is dry, and pharmaceutical composition of the present invention is made
Composition granule agent.
Embodiment 5
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 15, psoralea corylifolia 5, wilsonii 10, turmeric 30, the seed of cowherb 5, radix glycyrrhizae preparata 15, wherein by raw Radix Astragali, mend
After bone fat, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, coarse powder mixture standby is made
With；
2) uniformly mixed coarse powder mixture is placed in Chinese medicine extracting tank, tap water is added and impregnates 1 hour, wherein being added
Tap water weight and coarse powder mixture weight ratio be 5:1 (usually 5-10:1)；
3) it opens extractor power supply to be heated, is heated to 100 DEG C, constant temperature extraction 120min is (logical at this temperature for holding
Often it is 30-120min), it then filters, it is spare to obtain first time extracting solution；
4) tap water is added into filter residue, the weight of the tap water of addition and the weight ratio of coarse powder mixture are 7:1 (logical
Often it is 3-7:1), heating extraction, heating temperature is 100 DEG C, and extraction time is 40min (usually 20-90min), is obtained by filtration
Second of extracting solution；
5) No. 2 extracting solution merging are placed on triple effect vacuum high energy to be concentrated by evaporation in tank, carry out concentration, the phase of concentration
It is -0.07MPa to pressure, temperature is 80 DEG C；It is concentrated to get the medicinal extract that relative density is 1.2；
6) concentrated extract is dried and (is usually dried in vacuo), and pulverization process obtains pharmaceutical composition powder of the invention
Then supplementary product starch is added in end into pharmaceutical composition powder, alcohol granulation is dry, and particle is made, and superfine silica gel powder is added, and mixes
It is even, it is packed into hungry area softgel shell, medicament composition capsule agent of the present invention is made.
Embodiment 6
1) raw material (unit: × 100g) is weighed according to following proportion
Raw Radix Astragali 60, psoralea corylifolia 30, wilsonii 25, turmeric 5, the seed of cowherb 15, radix glycyrrhizae preparata 5, wherein by raw Radix Astragali, mend
After bone fat, wilsonii, turmeric, the seed of cowherb, radix glycyrrhizae preparata are respectively crushed into coarse powder, it is uniformly mixed, coarse powder mixture standby is made
With；
2) uniformly mixed coarse powder mixture is placed in Chinese medicine extracting tank, tap water is added and impregnates 1 hour, wherein being added
Tap water weight and coarse powder mixture weight ratio be 7:1 (usually 5-10:1)；
3) it opens extractor power supply to be heated, is heated to 100 DEG C, constant temperature extracts 60min (usually at this temperature for holding
It for 30-120min), then filters, it is spare to obtain first time extracting solution；
4) tap water is added into filter residue, the weight of the tap water of addition and the weight ratio of coarse powder mixture are 5:1 (logical
Often it is 3-7:1), heating extraction, heating temperature is 100 DEG C, and extraction time is 20min (usually 20-90min), is obtained by filtration
Second of extracting solution；
5) No. 2 extracting solution merging are placed on triple effect vacuum high energy to be concentrated by evaporation in tank, carry out concentration, the phase of concentration
It is -0.07MPa to pressure, temperature is 80 DEG C；It is concentrated to get the medicinal extract that relative density is 1.2；
6) concentrated extract is dried and (is usually dried in vacuo), and pulverization process obtains pharmaceutical composition powder of the invention
Then microcrystalline cellulose excipients are added in end into pharmaceutical composition powder, alcohol granulation is dry, and pharmaceutical composition of the present invention is made
Composition granule agent.
Claims (8)
1. a kind of Chinese medicine composition for treating castration-resistant prostate cancer, characterized in that by weight as described below
Raw material is made:
2. composition as described in claim 1, characterized in that the weight of the raw material are as follows:
3. a kind of preparation method for the Chinese medicine composition for treating castration-resistant prostate cancer, characterized in that including carrying out as follows
The step of:
1) prepare raw material according to following weight:
Raw Radix Astragali 15-60
Psoralea corylifolia 5-30
Wilsonii 10-25
Turmeric 5-30
Seed of cowherb 5-15
Radix glycyrrhizae preparata 5-15
2) heating water after mixing by raw material, is carried out to mixed raw material to extract, and collects extracting solution；
3) by the extracting solution of collection carry out concentration to get.
4. preparation method as claimed in claim 3, characterized in that the weight of the raw material are as follows:
5. preparation method as claimed in claim 3, characterized in that in the step 2), mixed after each raw material is crushed
It closes, the heating water extraction includes the steps that following sequence carries out:
A water) is added into mixed raw material, is impregnated, the weight of the water of addition and the weight ratio of mixed raw material are 5-10:1,
First time heating extraction is carried out after impregnating 1-3 hours, first time extracting solution is made, and heating temperature is 100 DEG C, the heating extraction time
It is 0.5-2 hours；
B) first time extracting solution is filtered, collects filtrate；
C) be added water into filter residue, carry out second of heating extraction, wherein the weight of the weight of the water of addition and mixed raw material it
Than for 3-7:1, heating temperature is 100 DEG C, the heating extraction time is 20-90min；
D it) filters, the filtrate filtered twice is merged.
6. preparation method as claimed in claim 5, characterized in that step A) in soaking time be 2h；The weight of the water of addition
Weight ratio with mixture is preferably 7-8:1；Step C) in be added water weight and mixture weight ratio be 5-7:
1。
7. preparation method as claimed in claim 3, characterized in that during concentration described in step 3) controlled at
80-100℃。
8. Chinese medicine composition as claimed in claim 1 or 2 is in preparing the drug for treating castration-resistant prostate cancer
Application.
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