CN104873909A - Chinese herbal medicine composition for curing asymptomatic non-metastatic castration resisting prostatic cancer - Google Patents
Chinese herbal medicine composition for curing asymptomatic non-metastatic castration resisting prostatic cancer Download PDFInfo
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- CN104873909A CN104873909A CN201510330301.5A CN201510330301A CN104873909A CN 104873909 A CN104873909 A CN 104873909A CN 201510330301 A CN201510330301 A CN 201510330301A CN 104873909 A CN104873909 A CN 104873909A
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Abstract
The invention provides a Chinese herbal medicine composition for curing asymptomatic non-metastatic castration resisting prostatic cancer. The Chinese herbal medicine composition for curing the asymptomatic non-metastatic castration resisting prostatic cancer is prepared from crude medicines of, by weight part, 10-200 parts of sculellaria barbata, 10-200 parts of oldenlandia diffusa, 9-150 parts of astragalus membranaceus, 9-150 parts of white atractylodes rhizome, 9-150 parts of codonopsis pilosula, 6-120 parts of poria cocos, 6-120 parts of semen cuscutae, 5-100 parts of baked licorice, 3-90 parts of fructus psoraleae and 3-90 parts of turmeric. The Chinese herbal medicine composition for curing the asymptomatic non-metastatic castration resisting prostatic cancer is safe and reliable, and free of toxic and side effects, mainly cures the asymptomatic non-metastatic castration resisting prostatic cancer, has functions of preventing androgen in a testis, an adrenal gland and prostatic cancer cells from being synthesized, and reducing PSA (prostate cancer specific antigen) performance, obviously delays clinical deterioration of a metastatic prostatic cancer patient resistant to castration, prolongs time before starting of chemotherapy, and shows a tendency of improving overall survival.
Description
Technical field
The invention belongs to cancer therapy drug field, be specifically related to a kind of herbal composite for the treatment of asymptomatic non-metastatic castration-resistant prostate cancer.
Background technology
Carcinoma of prostate is common in elderly men, and internal organs QI and blood increasingly void declines, outer sensible heat excessive QI poison, stagnation of blood stasis and form cancerous protuberance; Get involved through modern medicines such as operation, chemicotherapy or endocrine therapies, though cancerous protuberance is tentatively controlled, usually loss human righteousness.The kidney being the origin of congenital constitution, the spleen being the foundation of acquired constitution, and deficiency of spleen-QI declines, and essence and blood biochemistry is passive, is difficult to moisten foster internal organs, and causes qi-blood disharmony; Deficiency of kidney-QI, supporing yang activating QI can not, cause imbalance of YIN and YANG.And then cancerous protuberance is difficult to control, develop into castration-resistant prostate cancer, at the disease initial stage, heresy just disaccords the stage, and healthy energy still can disaccord with pathogenic factor, does not clinically embody symptom, imaging examination do not find to shift sign.But along with PD, pathogen being excessive but vital QI weak also becomes the natural law of disease progression.To sum up, pyretic toxicity Yong Sheng, asthenia of both the spleen and kidney are the predisposing factorss of asymptomatic non-metastatic castration-resistant prostate cancer, and excess and weakness of pathogen and vital QI is the basic pathogeny of disease.Secondly this sick inherent cause of disease is healthy energy virtual loss, and internal organs lose supports, imbalance of YIN and YANG, is evil poison invasion and attack of diseases caused by exogenous pathogenic factor and cause blood stasis and stagnate.Deficiency in origin and excess in superficiality, simulataneous insufficiency and excessive, asthenia of both the spleen and kidney is the feature of asymptomatic non-metastatic castration-resistant prostate cancer etiology and pathogenesis.
Summary of the invention
The object of the present invention is to provide a kind of herbal composite for the treatment of asymptomatic non-metastatic castration-resistant prostate cancer, for asymptomatic non-metastatic castration-resistant prostate cancer " pyretic toxicity Yong Sheng, asthenia of both the spleen and kidney " be pathogenesis, with " heat-clearing and toxic substances removing, tonifying speen and tonifying kidney " be the principles of formulating prescriptions, compatibility is simple, safe and reliable and have no side effect, cure mainly asymptomatic non-metastatic castration-resistant prostate cancer, there is prevention testis, androgen synthesis in adrenal gland and prostate tumor cells, reduce PSA (prostate specific antigen, PSA) function, obviously delay the clinical deterioration rates of the metastatic prostate cancer patient of castration opposing, extend the time starting chemotherapy, and show the trend improving total existence.
For achieving the above object, the present invention adopts following technical scheme:
Treat a herbal composite for asymptomatic non-metastatic castration-resistant prostate cancer, count by weight: Herba Scutellariae Barbatae 10-200 part, Herba Hedyotidis Diffusae 10-200 part, Radix Astragali 9-150 part, Rhizoma Atractylodis Macrocephalae 9-150 part, Radix Codonopsis 9-150 part, Poria 6-120 part, Semen Cuscutae 6-120 part, Radix Glycyrrhizae Preparata 5-100 part, Fructus Psoraleae 3-90 part, Rhizoma Curcumae Longae 3-90 part.
Herbal composite is made the peroral dosage form on any one pharmaceutics, as decoction, capsule, pill, tablet or oral liquid.
We reuse Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae is monarch drug, the two coupling, and heat-clearing toxin-expelling functions is strong; Radix Astragali invigorating the spleen and benefiting QI, the Rhizoma Atractylodis Macrocephalae and middle QI invigorating; Radix Codonopsis invigorating the spleen and replenishing QI and taste; Poria spleen invigorating tonify deficiency; Fructus Lycii nourishing the liver and kidney, benefiting essence-blood; Carapax Trionycis nourishing YIN for suppressing the hyperactive YANG; Semen Cuscutae kidney-replenishing, kidney tonifying essence; Play the merit of kidney and spleen invigorating altogether.Assistant with Radix Glycyrrhizae Preparata, Fructus Psoraleae the kidney invigorating warming the spleen, Rhizoma Curcumae Longae blood-activating and qi-promoting, tonify without causing stagnation, taste and oiliness.Full side's heat-clearing and toxic substances removing dose is maximum, kidney and spleen invigorating takes second place, and the medicine of blood-activating and qi-promoting is minimum, and level is distinct, brings out the best in each other.
Remarkable advantage of the present invention is: our good effect, and cure rate is high, has no side effect.By clinical use, have significant curative effect to asymptomatic non-metastatic carcinoma of prostate castration-resistant prostate cancer, the median time of irradiation image Progression free survival is 13.6 months; Extremely because the median time of cancer pain application opioid drug is 25.2 months; It is 18.7 months to the median time starting cytotoxic chemotherapies; Median time to ECOG behavior scoring decline at least 1 point is 11.3 months; Median time to PSA progress is 6.9 months; The median time increased the weight of to pain is 19.8 months.Preparation method is simple, can ensure the stability of medical material effective ingredient.On the basis of former decoction, be developed into capsule, pill, tablet and oral agents in conjunction with modern preparation technology, save the curative effect of former prescription, be easy to patient's preservation and carry, clinical practice more extensively facilitates.
Detailed description of the invention
embodiment 1
Treat a herbal composite for asymptomatic non-metastatic castration-resistant prostate cancer, count by weight: Herba Scutellariae Barbatae 30 parts, Herba Hedyotidis Diffusae 30 parts, the Radix Astragali 27 parts, the Rhizoma Atractylodis Macrocephalae 27 parts, Radix Codonopsis 27 parts, 18 parts, Poria, Semen Cuscutae 18 parts, Radix Glycyrrhizae Preparata 15 parts, Fructus Psoraleae 9 parts, 9 parts, Rhizoma Curcumae Longae.This proportioning can be used for the asymptomatic non-metastatic castration-resistant prostate cancer patient of east tumor cooperative groups (ECOG) KPS scale 0 point.
embodiment 2
Treat a herbal composite for asymptomatic non-metastatic castration-resistant prostate cancer, count by weight: Herba Scutellariae Barbatae 10 parts, Herba Hedyotidis Diffusae 10 parts, the Radix Astragali 9 parts, the Rhizoma Atractylodis Macrocephalae 9 parts, Radix Codonopsis 9 parts, 6 parts, Poria, Semen Cuscutae 6 parts, Radix Glycyrrhizae Preparata 5 parts, Fructus Psoraleae 3 parts, 3 parts, Rhizoma Curcumae Longae.This proportioning can be used for the asymptomatic non-metastatic castration-resistant prostate cancer patient of east tumor cooperative groups (ECOG) KPS scale 1 point.
embodiment 3
Treat a herbal composite for asymptomatic non-metastatic carcinoma of prostate castration-resistant prostate cancer, count by weight: Herba Scutellariae Barbatae 20 parts, Herba Hedyotidis Diffusae 20 parts, the Radix Astragali 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Codonopsis 15 parts, 12 parts, Poria, Semen Cuscutae 12 parts, Radix Glycyrrhizae Preparata 10 parts, Fructus Psoraleae 9 parts, 9 parts, Rhizoma Curcumae Longae.This proportioning is optimum proportioning, can be used for all kinds of asymptomatic non-metastatic castration-resistant prostate cancer patient.
embodiment 4
Treat a herbal composite for asymptomatic non-metastatic castration-resistant prostate cancer, count by weight: Herba Scutellariae Barbatae 200 parts, Herba Hedyotidis Diffusae 200 parts, the Radix Astragali 50 parts, the Rhizoma Atractylodis Macrocephalae 50 parts, Radix Codonopsis 30 parts, 30 parts, Poria, Semen Cuscutae 30 parts, Radix Glycyrrhizae Preparata 15 parts, Fructus Psoraleae 12 parts, 12 parts, Rhizoma Curcumae Longae.This proportioning can be used for east tumor cooperative groups (ECOG) KPS scale and is greater than 1 point, is less than the asymptomatic non-metastatic castration-resistant prostate cancer patient of 4 points.
Extraction process: adopt water extraction or water, alcohol combines and extract.
Extraction process by water
Take Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Poria, Semen Cuscutae, Radix Glycyrrhizae Preparata, Fructus Psoraleae, Rhizoma Curcumae Longae in proportion, with the water of 5-20 times of volume, extract 1-3 time, each extraction 0.5-2 hour, merge extractive liquid, concentrates and to obtain extracting solution (1).
Water, alcohol combine and put forward technique
Take Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Poria, Semen Cuscutae, Radix Glycyrrhizae Preparata, Fructus Psoraleae, Rhizoma Curcumae Longae in proportion, with the water of 5-20 times of volume, extract 1-3 time, each extraction 0.5-2 hour, merge extractive liquid, concentrates and to obtain extracting solution (2); To remain medical material, with 5-20 times of volume, concentration is the ethanol of 50%-90%, extracts 1-3 time, each extraction 0.5-2 hour, merge extractive liquid, concentrates and reclaim ethanol to obtain extracting solution (3), and merge extractive liquid, (2) obtains extracting solution (4) with (3).
Purifying process
Adopt alcohol deposition method, Clarificant method, Flavonoids by Macroporous Adsorption Resin to carry out purification, or extracting solution is not directly made preparation by purification.
Alcohol deposition method
In extracting solution (1) or (4), add ethanol in proper amount, make concentration of alcohol reach 50%-80%, cold preservation leaves standstill 6-24 hour, and centrifugal or mistake filters precipitation, reclaims ethanol, obtains medicinal liquid (5).
Clarificant method
In extracting solution (1) or (4), add Old Region, leave standstill or cold preservation certain hour, centrifugal or mistake filters precipitation, obtains medicinal liquid (6).
Flavonoids by Macroporous Adsorption Resin
By extracting solution (1) or (4), adopt purification with macroreticular resin, load resin column with the resin of resin medical material than 1: 1-8, with 2-10 times of water or 10% ~ 30% ethanol purge, with 5-20 times of bed volume, concentration is the ethanol elution of 20%-90%, collect eluent, reclaim ethanol, obtain medicinal liquid (7).
Drying process
By medicinal liquid (1), (4), (5), (6), (7), vacuum drying, spraying dry or baking oven convection drying is adopted to make powder (8), to prepare preparation.
Moulding process
Oral solution
Purification is obtained the medicinal liquid (5) of clarification, (6), (7), subpackage, sterilizing, makes oral solution.
Capsule
Powder (8) is received with dextrin, starch, lactose, soluble starch, microcrystalline Cellulose, carboxymethyl starch, wherein one or more mix sodium carboxymethyl cellulose, obtain powder (9), with water, ethanol, starch slurry or povidone solution for binding agent makes granule, and add in micropowder silica gel, Pulvis Talci, magnesium stearate that one or more make granule (10), by (8), (9) or (10) filled capsules, make capsule.
Tablet
(8), (9) or (10) are pressed into tablet with tablet machine.
Granule
By powder (8), wherein one or more mix with sucrose, dextrin, starch, lactose, soluble starch, microcrystalline Cellulose, aspartame, steviosin, and dry method or wet granulation, make granule.
Pill
Powder (8) being made the watered pill with water, ethanol for wetting agent is general or adds appropriate refined honey, mix homogeneously makes honeyed pill.
Chinese medicine preparation determined curative effect of the present invention, cure rate is high, and not containing noxious substance, have no side effect, by Clinical practice, have significant curative effect to castration-resistant prostate cancer, the median time of irradiation image Progression free survival is 13.6 months; Extremely because the median time of cancer pain application opioid drug is 25.2 months; It is 18.7 months to the median time starting cytotoxic chemotherapies; Median time to ECOG behavior scoring decline at least 1 point is 11.3 months; Median time to PSA progress is 6.9 months; The median time increased the weight of to pain is 19.8 months.
Chinese medicine preparation of the present invention can be made into capsule, oral agents, tablet and pill, easy to carry.
Pharmacodynamics is summarized:
1, physical data
In June, 2003 to 2013 year December, my section medical meets patients with prostate cancer 120 example of case inclusive criteria, is divided at random 3 groups (A, B, C).
2, Therapeutic Method
A group adopts ketoconazole associating prednisolone sheet (ketoconazole 400m, 1 times/day); B group adopts docetaxel chemotherapy (docetaxel 120mg ivgtt qd; Q21d); C group Chinese herbal medicine complex of the present invention, oral each 6 grams of preparations (preparation determines according to patient profiles) being equivalent to former medicine, every day 3 times 28 days is a course for the treatment of, each course for the treatment of seven days, interval.
3, case inclusive criteria
Age >=18 years old, histology or cytology make a definite diagnosis metastatic prostate cancer adenocarcinoma; Irradiation image progress in the PSA progress determined according to carcinoma of prostate clinical trial second Working Group Criteria or soft tissue or bone; The androgen-deprivation state continued, level of serum testosterone < 50ng/dl(1.7nmol/L); East tumor cooperative groups (ECOG) KPS scale 0 or 1(is respectively asymptomatic or physical exertion is limited but can autonomic activities); Be defined as asymptomatic according to simple and easy pain scale (BPI-SF) or there is light symptoms; Hematological examination and biochemical indicator reach within normal range 1.5 times; Previously accepted anti-androgen therapy.
4, case exclusion standard
Visceral metastases; Previously accepted more than 7 days Oral Treatment With Ketoconazoles; Transaminases levels >=Upper Limit of Normal Value 2.5 times, activeness or symptomatic disease virus hepatitis or chronic hepatopathy, the hypertension, hypophysis or the dysadrenalsm medical history that do not obtain controlling, clinically there is obvious heart change.
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 with always survive.Wherein the definition of iconography Progression free survival is: without the death of a variety of causes, adopts computerization Tomography (CT) or magnetic resonance (MRI) to evaluate soft tissue lesions and gets nowhere.
B. secondary endpoints: to the time because of cancer-related pain application opioid drug; To the time starting cytotoxic chemotherapy; To the time that ECOG behavior state worsens; And to the time that PSA is in progress.
C. PSA Evolution appraisal standard: do not occurring in the patient that PSA reduces, for adding 25% compared with baseline value and the absolute value of PSA level at least increases 5ng/ml(detects 2 confirmations); There is decline at PSA, but do not reach in the patient of effective standard (PSA≤50%), if twice detection confirms that PSA increases at least 5ng/ml, PSA and considers disease progression when comparatively minimum raises 25%.For PSA comparatively treat front baseline value decline >=50% Proportion of patients, and through >=4 weeks after again detection determine.
D. pain scores: adopt BPI-SF pain scores scale; The definition that pain increases the weight of follows up a case by regular visits to the scoring of middle baseline pain for twice to increase >=30%
6, verification method
(1) efficiency evaluation comprises imaging examination and the PSA detection of irradiation image Progression free survival;
(2) safety evaluatio: all enter to organize the equal continuous detecting blood biochemistry of patient, hematological examination, blood coagulation, blood fat and renal function; By making regular check on electrocardiogram monitoring cardiac safety; Left Ventricular Ejection Fraction during establishment of base line.
7, the result is as follows:
The median time that A, B, C respectively organize irradiation image Progression free survival is respectively 10.3 VS 13.8 VS 13.6 months; Extremely because the median time of cancer pain application opioid drug is 20.7 VS 26.6 VS 25.2 months; Be 14.2 VS 20.1 VS 18.7 months to the median time starting cytotoxic chemotherapies; Median time to ECOG behavior scoring decline at least 1 point is 10.7 VS 12.2 VS 11.3 months; Median time to PSA progress is 4.8 VS 8.2 VS 6.9 months; The median time increased the weight of to pain is 18.2 VS 22.4 VS 19.8 months.
8, safety evaluation
Through observing medicine of the present invention to the hepatic and renal function, the conventional nothing impact of hematuria that meet inclusive criteria patient.
9, conclusion
Chinese medicine preparation of the present invention irradiation image Progression free survival median time, to because of cancer pain application opioid drug median time, to start cytotoxic chemotherapies median time, to decline to ECOG behavior scoring at least 1 point median time, be all obviously better than A group (ketoconazole combines prednisone group) to the median time of PSA progress, the median time that increases the weight of to pain.Curative effect and docetaxel no significant difference.
Chinese medicine preparation of the present invention is safe and reliable and have no side effect, cure mainly asymptomatic non-metastatic castration-resistant prostate cancer, there is the androgen synthesis stoped in testis, adrenal gland and prostate tumor cells, reduce the function of PSA, obviously delay the clinical deterioration rates of the metastatic prostate cancer patient of castration opposing, extend the time starting chemotherapy, and show the trend improving total existence.
The foregoing is only preferred embodiment of the present invention, all equalizations done according to the present patent application the scope of the claims change and modify, and all should belong to covering scope of the present invention.
Claims (4)
1. treat a herbal composite for asymptomatic non-metastatic castration-resistant prostate cancer, it is characterized in that: count by weight: Herba Scutellariae Barbatae 10-200 part, Herba Hedyotidis Diffusae 10-200 part, Radix Astragali 9-150 part, Rhizoma Atractylodis Macrocephalae 9-150 part, Radix Codonopsis 9-150 part, Poria 6-120 part, Semen Cuscutae 6-120 part, Radix Glycyrrhizae Preparata 5-100 part, Fructus Psoraleae 3-90 part, Rhizoma Curcumae Longae 3-90 part.
2. the herbal composite of the asymptomatic non-metastatic castration-resistant prostate cancer for the treatment of according to claim 1, is characterized in that: count by weight: Herba Scutellariae Barbatae 20 parts, Herba Hedyotidis Diffusae 20 parts, the Radix Astragali 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Codonopsis 15 parts, 12 parts, Poria, Semen Cuscutae 12 parts, Radix Glycyrrhizae Preparata 10 parts, Fructus Psoraleae 9 parts, 9 parts, Rhizoma Curcumae Longae.
3. the herbal composite of the asymptomatic non-metastatic castration-resistant prostate cancer for the treatment of according to claim 1, is characterized in that: herbal composite is made the peroral dosage form on any one pharmaceutics.
4. the herbal composite of the asymptomatic non-metastatic castration-resistant prostate cancer for the treatment of according to claim 4, is characterized in that: described dosage form is decoction, capsule, pill, tablet or oral liquid.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114642695A (en) * | 2020-12-17 | 2022-06-21 | 华子昂 | Big data traditional Chinese medicine composition for regulating and controlling prostate cancer |
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| US20130171263A1 (en) * | 2006-01-20 | 2013-07-04 | Pedro J. Lecca | Snake Powder Extract For Treatment Of Cancer |
| CN104173950A (en) * | 2014-09-15 | 2014-12-03 | 程惠华 | Chinese herbal medicine composition for treating prostatic cancer |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130171263A1 (en) * | 2006-01-20 | 2013-07-04 | Pedro J. Lecca | Snake Powder Extract For Treatment Of Cancer |
| CN104173950A (en) * | 2014-09-15 | 2014-12-03 | 程惠华 | Chinese herbal medicine composition for treating prostatic cancer |
Non-Patent Citations (1)
| Title |
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| 谢永玉: "《中医效验方荟萃》", 31 January 2012 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114642695A (en) * | 2020-12-17 | 2022-06-21 | 华子昂 | Big data traditional Chinese medicine composition for regulating and controlling prostate cancer |
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