CN104873909B - The herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer - Google Patents
The herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer Download PDFInfo
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- CN104873909B CN104873909B CN201510330301.5A CN201510330301A CN104873909B CN 104873909 B CN104873909 B CN 104873909B CN 201510330301 A CN201510330301 A CN 201510330301A CN 104873909 B CN104873909 B CN 104873909B
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Abstract
The present invention provides a kind of herbal composites for treating asymptomatic non-metastatic castration-resistant prostate cancer, according to parts by weight: 10-200 parts of Sculellaria barbata, 10-200 parts of oldenlandia diffusa, 9-150 parts of Radix Astragali, 9-150 parts of Rhizoma Atractylodis Macrocephalae, 9-150 parts of Radix Codonopsis, 6-120 parts of Poria cocos, 6-120 parts of Semen Cuscutae, 5-100 parts of radix glycyrrhizae preparata, 3-90 parts of psoralea corylifolia, 3-90 parts of turmeric.Chinese materia medica preparation of the invention is safe and reliable and has no toxic side effect, cure mainly asymptomatic non-metastatic castration-resistant prostate cancer, with the androgen synthesis prevented in testis, adrenal gland and prostate tumor cells, reduce prostate cancer specific antigen (prostate specific antigen, PSA function), the clinical deterioration rates for the metastatic prostate cancer patient for obviously delaying castration to resist extend the time for starting chemotherapy, and show the trend that improvement is always survived.
Description
Technical field
The invention belongs to anticancer drug fields, and in particular to a kind of to treat asymptomatic non-metastatic castration-resistant prostate
The herbal composite of cancer.
Background technique
Prostate cancer is common in elderly men, and internal organs qi and blood void increasingly declines, the outer excessive cult poison of sensible heat, stagnation of blood stasis and form cancer
It is swollen；It intervenes by modern medicines such as operation, chemicotherapy or endocrine therapies, though cancerous swelling is tentatively controlled, is usually lost
Human righteousness.The kidney being the origin of congenital constitution, and the spleen being the foundation of acquired constitution, Spleen-Qi Deficiency declines, and essence and blood biochemistry is passive, is difficult to support internal organs, and causes gas
Blood is become estranged；Deficiency of kidney-QI, helps yang transforming qi cannot, lead to imbalance of yin and yang.And then cancerous swelling is difficult to control, and develops into castration-resistant
Prostate cancer, disease initial stage, heresy just disaccord the stage, and healthy tendency still disaccords with disease and evil, and clinic does not embody symptom, imageological examination
Transfer sign is not found.But with progression of the disease, pathogen being excessive but vital QI weak also becomes the natural law of disease development.To sum up, heat toxin Yong Sheng,
Speen-kidney dificiency is the predisposing factors of asymptomatic non-metastatic castration-resistant prostate cancer, and healthy energy-evil struggle is the basic morbidity of disease
Mechanism.The disease inherence cause of disease is healthy tendency virtual loss, internal organs dystrophy, imbalance of yin and yang, secondly for exogenous disease cult poison is invaded and hemostasis is caused to stagnate.
The characteristics of asthenia in origin and asthenia in superficiality, simulataneous insufficiency and excessive, speen-kidney dificiency is asymptomatic non-metastatic castration-resistant prostate cancer etiology and pathogenesis.
Summary of the invention
The purpose of the present invention is to provide a kind of Chinese herbal medicines for treating asymptomatic non-metastatic castration-resistant prostate cancer
Composition is the interpretation of the cause, onset and process of an illness for asymptomatic non-metastatic castration-resistant prostate cancer " heat toxin Yong Sheng, speen-kidney dificiency ", with " heat-clearing
Removing toxic substances, tonifying speen and tonifying kidney " is the principles of formulating prescriptions, and compatibility is simple, safe and reliable and have no toxic side effect, and cures mainly asymptomatic non-metastatic castration
Repellence prostate cancer has the androgen synthesis prevented in testis, adrenal gland and prostate tumor cells, reduces prostate cancer
The function of specific antigen (prostate specific antigen, PSA), hence it is evident that delay castration to resist non-diverting
Property patients with prostate cancer clinical deterioration rates, extend the time for starting chemotherapy, and show and improve the trend always survived.
To achieve the above object, the present invention adopts the following technical scheme:
A kind of herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer, according to parts by weight:
10-200 parts of Sculellaria barbata, 10-200 parts of oldenlandia diffusa, 9-150 parts of Radix Astragali, 9-150 parts of Rhizoma Atractylodis Macrocephalae, 9-150 parts of Radix Codonopsis, Fu
6-120 parts of Siberian cocklebur, 6-120 parts of Semen Cuscutae, 5-100 parts of radix glycyrrhizae preparata, 3-90 parts of psoralea corylifolia, 3-90 parts of turmeric.
The peroral dosage form in any pharmacy is made in herbal composite, as decoction, capsule, pill, tablet or
Oral solution.
We reuse Sculellaria barbata, oldenlandia diffusa is monarch drug in a prescription, and the two is combined, and heat-clearing toxin-expelling functions are strong；Radix Astragali strengthening the spleen and replenishing qi,
Rhizoma Atractylodis Macrocephalae and middle QI invigorating；Radix Codonopsis tonifying middle-Jiao and Qi and taste；Poria cocos invigorating the spleen qi-restoratives；Fructus lycii is nourishing liver and kidney, benefiting essence-blood；Turtle shell enriching yin is latent
Sun；Semen Cuscutae kidney-replenishing, kidney-nourishing essence；The function of kidney and spleen invigorating is played altogether.Assistant is with radix glycyrrhizae preparata, psoralea corylifolia kidney tonifying temperature spleen, turmeric promoting blood circulation row
Gas, benefit are oiliness without stagnant, taste.The complete clearing heat and detoxicating dose in side is maximum, kidney and spleen invigorating takes second place, and the medicine of blood-activating and qi-promoting is minimum, level
It is apparent, it brings out the best in each other.
Remarkable advantage of the invention is: our good effect, and cure rate is high, has no toxic side effect.It is right by clinical use
Asymptomatic non-metastatic prostate cancer castration-resistant prostate cancer has significant curative effect, in irradiation image Progression free survival
The position time is 13.6 months；It is 25.2 months to the median time because of cancer pain application opioid drug；To beginning cell toxicant
Property chemotherapy median time be 18.7 months；The median time for declining at least 1 point to ECOG behavior scoring is 11.3 months；Extremely
The median time of PSA progress is 6.9 months；The median time aggravated to pain is 19.8 months.Preparation method is simple, it is ensured that
The stability of medicinal material effective component.On the basis of original soup agent, capsule, pill, tablet are developed into conjunction with modern preparation process
And oral agents, the curative effect of former prescription is saved, is easy to patient and saves carrying, clinical application facilitates more extensively.
Specific embodiment
Embodiment 1
A kind of herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer, according to parts by weight:
30 parts of Sculellaria barbata, 30 parts of oldenlandia diffusa, 27 parts of Radix Astragali, 27 parts of Rhizoma Atractylodis Macrocephalae, 27 parts of Radix Codonopsis, 18 parts of Poria cocos, Semen Cuscutae 18
Part, 15 parts of radix glycyrrhizae preparata, 9 parts of psoralea corylifolia, 9 parts of turmeric.The proportion can be used for east tumour cooperative groups (ECOG) behavior state and comment
Divide 0 point of asymptomatic non-metastatic castration-resistant prostate cancer patient.
Embodiment 2
A kind of herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer, according to parts by weight:
10 parts of Sculellaria barbata, 10 parts of oldenlandia diffusa, 9 parts of Radix Astragali, 9 parts of Rhizoma Atractylodis Macrocephalae, 9 parts of Radix Codonopsis, 6 parts of Poria cocos, 6 parts of Semen Cuscutae, toast
5 parts of Radix Glycyrrhizae, 3 parts of psoralea corylifolia, 3 parts of turmeric.The proportion can be used for east tumour cooperative groups (ECOG) KPS scale 1 and divide
Asymptomatic non-metastatic castration-resistant prostate cancer patient.
Embodiment 3
A kind of herbal composite for treating asymptomatic non-metastatic prostate cancer castration-resistant prostate cancer, by weight
Number meter: 20 parts of Sculellaria barbata, 20 parts of oldenlandia diffusa, 15 parts of Radix Astragali, 15 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of Radix Codonopsis, 12 parts of Poria cocos, Tu
Silk 12 parts, 10 parts of radix glycyrrhizae preparata, 9 parts of psoralea corylifolia, 9 parts of turmeric.The proportion is optimum proportioning, be can be used for all kinds of asymptomatic non-
Metastatic castration-resistant prostate cancer patient.
Embodiment 4
A kind of herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer, according to parts by weight:
200 parts of Sculellaria barbata, 200 parts of oldenlandia diffusa, 50 parts of Radix Astragali, 50 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Radix Codonopsis, 30 parts of Poria cocos, Semen Cuscutae 30
Part, 15 parts of radix glycyrrhizae preparata, 12 parts of psoralea corylifolia, 12 parts of turmeric.The proportion can be used for east tumour cooperative groups (ECOG) behavior state and comment
Divide and is greater than 1 point, the asymptomatic non-metastatic castration-resistant prostate cancer patient less than 4 points.
Extraction process: being mentioned using water or water, alcohol are combined and extracted.
Extraction process by water
Weigh in proportion Sculellaria barbata, oldenlandia diffusa, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Poria cocos, Semen Cuscutae, radix glycyrrhizae preparata, psoralea corylifolia,
Turmeric is extracted 1-3 times with the water of 5-20 times of volume, is extracted 0.5-2 hours every time, combined extract is concentrated to give extracting solution (1).
Water, alcohol, which combine, proposes technique
Weigh in proportion Sculellaria barbata, oldenlandia diffusa, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Poria cocos, Semen Cuscutae, radix glycyrrhizae preparata, psoralea corylifolia,
Turmeric is extracted 1-3 times with the water of 5-20 times of volume, is extracted 0.5-2 hours every time, combined extract is concentrated to give extracting solution (2)；
By remaining medicinal material, with 5-20 times of volume, concentration is the ethyl alcohol of 50%-90%, is extracted 1-3 times, is extracted 0.5-2 hours every time, is merged
Extracting solution, is concentrated and recycles ethyl alcohol and obtain extracting solution (3), combined extract (2) and (3) extracting solution (4).
Purifying process
It is purified, or is not purified extracting solution system directly using alcohol deposition method, Clarificant method, Flavonoids by Macroporous Adsorption Resin
At preparation.
Alcohol deposition method
Ethanol in proper amount is added in extracting solution (1) or (4), so that concentration of alcohol is reached 50%-80%, it is small that refrigeration stands 6-24
When, it is centrifuged or is filtered to remove precipitating, ethyl alcohol is recycled, obtains medical fluid (5).
Clarificant method
Old Region is added in extracting solution (1) or (4), stands or refrigerate certain time, it is heavy to be centrifuged or be filtered to remove
It forms sediment, obtains medical fluid (6).
Flavonoids by Macroporous Adsorption Resin
By extracting solution (1) or (4), using purification with macroreticular resin, the resin with resin medicinal material than 1: 1-8 is packed into resin
Column is cleaned with 2-10 times of water or 10% ~ 30% ethyl alcohol, and with 5-20 times of bed volume, concentration is the ethanol elution of 20%-90%, and collection is washed
De- liquid, recycles ethyl alcohol, obtains medical fluid (7).
Drying process
By medical fluid (1), (4), (5), (6), (7), powder is made using vacuum drying, spray drying or baking oven convection drying
(8), to prepare preparation.
Moulding process
Oral solution
Clear medical fluid (5), (6), (7) are made in purifying, are dispensed, oral solution is made in sterilizing.
Capsule
Powder (8) and dextrin, starch, lactose, soluble starch, microcrystalline cellulose, carboxymethyl starch are received, carboxymethyl fibre
It ties up that plain sodium is one of or several mixing, obtains powder (9), be made using water, ethyl alcohol, starch slurry or povidone solution as adhesive
Grain, and it is added that superfine silica gel powder, talcum powder, particle (10) are made in one or more in magnesium stearate, it will (8), (9) or (10) filling
Capsule is made in capsule.
Tablet
(8), (9) or (10) are pressed into tablet with tablet press machine.
Granule
By powder (8) and sucrose, dextrin, starch, lactose, soluble starch, microcrystalline cellulose, aspartame, Steviosin
One of or several mixing, dry or wet granulation, are made granule.
Pill
Powder (8) is made the water-bindered pill or appropriate refined honey is added using water, ethyl alcohol as wetting agent is general, is uniformly mixed and honey is made
Ball.
Chinese materia medica preparation of the present invention is curative for effect, and cure rate is high, is free of noxious material, without side-effects, right by clinical use
Castration-resistant prostate cancer has significant curative effect, and the median time of irradiation image Progression free survival is 13.6 months；To because of cancer
The median time of disease pain application opioid drug is 25.2 months；It is 18.7 to the median time for starting cytotoxic chemotherapies
Month；The median time for declining at least 1 point to ECOG behavior scoring is 11.3 months；The median time being in progress to PSA is 6.9
Month；The median time aggravated to pain is 19.8 months.
Chinese materia medica preparation of the invention can be made into capsule, oral agents, tablet and pill, easy to carry.
Pharmacodynamics summary:
1, general information
In June, 2003 in December, 2013, my section of going to a doctor meet patients with prostate cancer 120 that case is included in standard, with
Machine is divided into 3 groups (A, B, C).
2, treatment method
A group is using ketoconazole joint prednisolone piece (ketoconazole 400m, 1 times/day)；B group is (more using docetaxel chemotherapy
Xi Tasai 120mg ivgtt qd；Q21d)；C group Chinese herbal medicine compound of the invention takes orally and is equivalent to raw medicine for 6 grams every time
Preparation (preparation is determined according to patient profiles), 3 times a day, 28 days as a treatment course, each course for the treatment of interval seven days.
3, case is included in standard
Age >=18 year old, histology or cytology make a definite diagnosis non-metastatic prostate cancer gland cancer；According to prostate cancer clinic
Test irradiation image progress in the PSA progress or soft tissue or bone that the second Working Group Criteria determines；Lasting androgen-deprivation
State, level of serum testosterone < 50ng/dl(1.7nmol/L)；East tumour cooperative groups (ECOG) KPS scale 0 or 1(divide
Not Wei asymptomatic or physical exertion it is limited but can autonomic activities)；It is defined as according to simple pain scale (BPI-SF) asymptomatic
Or there are light symptoms；Hematological examination and biochemical indicator reach within 1.5 times of normal range (NR)；Previously received antiandrogen to control
It treats.
4, case exclusion criteria
Visceral metastases；Previously received 7 days or more Oral Treatment With Ketoconazoles；Transaminases levels >=Upper Limit of Normal Value 2.5
Again, activity or symptomatic disease virus hepatitis or chronic liver disease, the hypertension not controlled, hypophysis or dysadrenalsm
Medical history, clinic have obvious heart disease.
5, observation index
(1) adverse events and serious adverse events
Blood biochemistry, hematology, blood coagulation and lipid examination；Urinalysis；Electrocardiogram；Cardiac ejection fraction.
(2) observation of curative effect standard
A. Primary Endpoint: iconography Progression free survival and total existence.The wherein definition of iconography Progression free survival is: without each
The death of kind reason is got nowhere using computerization Tomography (CT) or magnetic resonance (MRI) evaluation soft tissue lesions.
B. secondary endpoints: to the time because of cancer-related pain application opioid drug；To start cytotoxic chemotherapy when
Between；The time deteriorated to ECOG behavior state；And the time to PSA progress.
C. PSA Evolution appraisal standard: in the patient for not occurring PSA reduction, to increase 25% and PSA compared with baseline value
Horizontal absolute value at least increases 5ng/ml(and detects 2 confirmations)；Have decline in PSA, but not up to effective standard (PSA≤
50%) in patient, if the PSA of detection confirmation twice, which is increased, considers the state of an illness when at least 5ng/ml, PSA increase 25% compared with minimum
Progress.Proportion of patients for PSA compared with baseline value decline >=50% before treating, and detection determines again after >=4 weeks.
D. pain scores: BPI-SF pain scores scale is used；The definition that pain aggravates is baseline pain in follow-up twice
Scoring increases >=30%
6, verification method
(1) efficiency evaluation includes imageological examination and the PSA detection of irradiation image Progression free survival；
(2) safety evaluatio: whole patients in group continuously detect blood biochemistry, hematological examination, blood coagulation, blood lipid and kidney
Function；By inspecting periodically electrocardiogram monitoring cardiac safety；Left Ventricular Ejection Fraction when establishment of base line.
7, verification result is as follows:
A, the median time of B, C each group irradiation image Progression free survival is respectively 10.3 VS, 13.8 VS 13.6
Month；It is 20.7 VS, 26.6 VS 25.2 months to the median time because of cancer pain application opioid drug；To beginning cell
The median time of cytotoxic chemotherapeutic is 14.2 VS, 20.1 VS 18.7 months；Decline at least 1 point of middle position to ECOG behavior scoring
Time is 10.7 VS, 12.2 VS 11.3 months；The median time being in progress to PSA is 4.8 VS, 8.2 VS 6.9 months；Extremely
The median time that pain aggravates is 18.2 VS, 22.4 VS 19.8 months.
8, safety evaluation
It is observed that drug of the present invention is conventional without influence on the hepatic and renal function for being included in standard patient, blood urine is met.
9, conclusion
Chinese materia medica preparation of the invention in the median time of irradiation image Progression free survival, to because of cancer pain application opium
The median time of class drug, to start cytotoxic chemotherapies median time, to ECOG behavior scoring decline at least 1 point of middle position
Time, being significantly better than that A group to the median time of PSA progress, to the median time that pain aggravates, (ketoconazole combines prednisone
Group).Curative effect and docetaxel no significant difference.
Chinese materia medica preparation of the invention is safe and reliable and has no toxic side effect, and cures mainly asymptomatic non-metastatic castration-resistant forefront
Gland cancer has the androgen synthesis prevented in testis, adrenal gland and prostate tumor cells, reduces the function of PSA, hence it is evident that delay
The clinical deterioration rates for the non-metastatic patients with prostate cancer that castration is resisted extend the time for starting chemotherapy, and show
Improve the trend always survived.
The foregoing is merely presently preferred embodiments of the present invention, all equivalent changes done according to scope of the present invention patent with
Modification, is all covered by the present invention.
Claims (3)
1. a kind of herbal composite for treating asymptomatic non-metastatic castration-resistant prostate cancer, it is characterised in that: by weight
Measure number meter: 20 parts of Sculellaria barbata, 20 parts of oldenlandia diffusa, 15 parts of Radix Astragali, 15 parts of Rhizoma Atractylodis Macrocephalae, 15 parts of Radix Codonopsis, Poria cocos
12 parts, 12 parts of Semen Cuscutae, 10 parts of radix glycyrrhizae preparata, 9 parts of psoralea corylifolia, 9 parts of turmeric.
2. the herbal composite of the asymptomatic non-metastatic castration-resistant prostate cancer for the treatment of according to claim 1,
It is characterized by: the peroral dosage form in any pharmacy is made in herbal composite.
3. the herbal composite of the asymptomatic non-metastatic castration-resistant prostate cancer for the treatment of according to claim 2,
It is characterized by: the dosage form is decoction, capsule, pill, tablet or oral solution.
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| CN104173950A (en) * | 2014-09-15 | 2014-12-03 | 程惠华 | Chinese herbal medicine composition for treating prostatic cancer |
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