CN1872159A - Application of red sage root in preparing medication for preventing prostatic csarcinoma from occurring - Google Patents
Application of red sage root in preparing medication for preventing prostatic csarcinoma from occurring Download PDFInfo
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Abstract
An application of red sage root in preparing the medicines in the form of tablet, capsule, oral liquid, aerosol, or suppository for preventing prostatic cancer is disclosed.
Description
Technical field
The present invention relates to field of medicaments, relate more specifically to the application of Radix Salviae Miltiorrhizae in the medicine that preparation prevention carcinoma of prostate takes place.
Background technology
Carcinoma of prostate is U.S. male one of the tumor of normal generation, and is U.S. male's second largest cancer mortality reason.There is 1/5 U.S. male being diagnosed as carcinoma of prostate in life approximately.In 2004, estimate to have approximately the New Development cases for prostate cancer of 230,000 many cases, 29,900 carcinoma of prostate death is arranged approximately.On the other hand, the ratio of the carcinoma of prostate that manifests on the pathology among the U.S. male is higher, and is about 34% in 50 years old male, in the male more than 80 years old then up to 70%.Have the new diagnosed SARS case more than 60% constantly to make progress on pathology approximately, prognosis is not good.Along with The development in society and economy, spectrum takes place also more and more near developed country in the tumor of China, and the carcinoma of prostate sickness rate raises year by year.Because sickness rate height, the death toll of carcinoma of prostate are many, the effective measures of therefore seeking the prevention carcinoma of prostate are most important.In the process that carcinoma of prostate takes place (comprising that precancerous lesion, canceration begin and make progress), take suitable intervention prevention and interrupt the measure that cancer takes place, will reduce the sickness rate of the incidence rate and the carcinoma of prostate of prostate precancerous lesion effectively.Research about the carcinoma of prostate prevention at present mainly concentrates on chemoprophylaxis and diet prevention.Find in the practice, the generation development of tumor is postponed, clinical incidence rate that can detected carcinoma of prostate is reduced greatly by pharmaceutical intervention.Found at present multiple carcinoma of prostate to be had the material of preventive effect, wherein the natural materials that toxic and side effects is little especially receives publicity, as green tea, vitamin E etc.(American Cancer Society[Online].CancerFacts & Figures(2004)http：//www.cancer.org/docroot/STT/stt_0.asp[accessedJuly 28，2004].)(Thompson I，et al.Chemoprevention of prostate cancer withfinasteride.Important Adv Oncol 1995；57-76.)(Nelson PS，et al.Chemoprevention for prostatic intraepithelial neoplasia.Eur Urol1996；30(2)：269-278.)(Thompson IM，et al.The influence of finasteride on thedevelopment of prostate cancer.N Engl J Med 2003；349：215-224.)(Nelson WG，et al.Prostate cancer.N Engl J Med 2003；349：366-381.)(Adhami VM，et al.Molecular targets for green tea in prostate cancer prevention.J Nutr2003；133：2417S-2424S.)(Thompson TA，et al.Androgen antagonist activity by theantioxidant moiety of vitamin E，2，2，5，7，8-pentamethyl-6-chromanol in humanprostate carcinoma cells.Molecular Cancer Therapeutics.2003；2：797-803.)。
Radix Salviae Miltiorrhizae (Radix Salviae Miltiorrhizae) is the dry root of labiate Radix Salviae Miltiorrhizae, is the Chinese medicine of China, has the effect of promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, tranquilizing by nourishing the heart.The Main Ingredients and Appearance of Radix Salviae Miltiorrhizae has protocatechualdehyde, protocatechuic acid, salviol, TANSHINONES etc.
Sun Jing Base-on-environment, etc. Radix Salviae Miltiorrhizae is to the research of hepatoma Metastasis recurrence preventive and therapeutic effect. Chinese combination of Chinese and Western medicine magazine .1999; 19 (5): disclose cancerometastasis and recurrence after Radix Salviae Miltiorrhizae can prevent the rat liver cancer hepatectomy among the 292-5.
Yan Ruiqi, etc. the journal .1986 of Guangxi Medical College; 3 (1): disclose Radix Salviae Miltiorrhizae in 21 and brought out the positive liver cell proliferation kitchen range of rats'liver precancerous lesion gamma glutamyl transpeptidase for flavacin inhibitory action is arranged.
The water-soluble components salvianolic acid B that discloses Radix Salviae Miltiorrhizae in the Chinese patent application 02136970.4 " application of salvianolic acid B in preparation medicine for treating tumor thing " in vitro study to the lethal effect of kinds of tumor cells and in rat liver cancer model to the tumor treatment effect.
Medicine has therapeutical effect or preventive effect to tumor, and research method is different with judgment criteria.The research medicine is to the zoopery of oncotherapy effect, be by the intact animal being used chemical inducer or direct inoculation tumor carry out the tumor modeling, after the modeling success, to suffering from the animals administer of tumor, through certain administration after date, observe medicine to the tumor treatment effect, observation index is the inhibition (comprising slowing down, stop or disappearing of growth) of tumor growth and the improvement of the ill sign of animal.The research medicine is to the zoopery of tumor prevention effect, be to normal animals administer, in long term administration, use the generation of derivant induced tumor, not after the matched group modeling of the administration success, stop to induce, observe the preventive effect of medicine to tumor, observation index is tumor incidence rate and the precancerous lesion incidence rate of animal.Usually, the administration phase in tumor prevention research will be grown than the time in the oncotherapy research.
Because having by force to tumor cell usually, the medicine of lethal effect also can produce damage to normal tissue cell simultaneously, therefore can not long-term prescription, and also there is not medicine can thoroughly cure tumor effectively at present, only can suppress growth of tumor and improve patient's symptom to a certain extent, thus majority can be used for treating the medicine of tumor can not prophylaxis of tumours.
Three huge scientific research plans are arranged since the dawn of human civilization, be respectively Apollo Moon-landing Project, capture the cancer plan and the Human Genome Project, wherein the 1st, 3 plan all finished smoothly, the plan at cancer of having only can be described as to attack for a long time is unable to, and the mint of money of input but be can not see clear and definite repayment.Therefore, people have had basic change on the idea of antagonism cancer in recent years, from before heavily treatment change present heavily prevention into.
The idea of modern antagonism cancer is " target and control " (Target and control), its strategy is to follow the tracks of Susceptible population with hereditism and EPDML knowledge and technology, with the method adjustment of chemoprophylaxis (Chemoprevention) and the pathological changes behavior of reverse cancer, thus the M ﹠ M of reduction cancer.2002, the U.S. has issued state-run institute of oncology tumor research direction and 2005 yearly budget motions, motion is with the prevention of cancer, the early diagnosis of cancer, and delay even reverse aspects such as carcinogenic process, classify as from now on the primary direction of tumor research (Gu Xinbin is etc. the anticancer New Policy of the U.S.: chemoprophylaxis. science 2004; 56 (3): 8-11).
Cancerous cell has been compared two big characteristics with normal cell: out of control cell competence for added value; Soak into adjacent tissue and the ability of transferring to other organ.Analyze from cytogenetics, most cancers originate from an independent mutant.This has the variation cancerous cell experience multistage of hereditary potency and for a long time after the birth process, just develop into can be fatal cancer.(Epithelial malignancy) is example with cell carcinoma, and the malignant tumor of human body more than 80% comprises the malignant tumor of organs such as lung, intestinal, mammary gland, prostate, pancreas and ovary all betiding epithelial cell.Cancer patient more than 50% is died from cell carcinoma.Generally speaking, clinical under X ray observed cell carcinoma entity, assemble forming at least by 100,000,000 epithelial cells.In human body, rise in value to 100,000,000 epithelial cancer cells from the epithelial cell of a variation, need 10 years even longer time.Yet, continue to rise in value to 10,000,000,000 epithelial cancer cells from 100,000,000 epithelial cancer cells, may only need the time of some months.And being enough to cause patient's whole body to die of exhaustion, 10,000,000,000 epithelial cancer cells die.
This Bonn (M.Sporn) doctor is the people that starts of a generally acknowledged modern chemistry anti-cancer, he just proposed in 1976, the target of control cancer should not be the stage after cancer forms, and should be in the process of carcinogenic early stage and canceration, the cell transformation of prevention variation is the cancerous cell that infiltration and transfer ability are arranged.The notion of cancer chemoprotective is to adopt pharmacological method to control evolution process with inverse cancer cell, thereby reaches the purpose of control cancer.Prove that with experiment in vitro the cancer of 50-80% can be prevented in a large amount of bodies, chemoprophylaxis is a kind of effective control method for cancer.The effect of this control cancer may not be to show real elimination or eradicate cancerous cell, and more is to show the generation that delays cancer.According to the result of epidemiology statistics, cancer is mainly in the crowd more than 55 years old.It is this that to delay the effect that cancer takes place particularly important concerning the older.It can for the older before other can life-threatening disease (as cardiovascular disease) arrives, quality of life preferably is provided.To be that development is natural be used for prophylaxis of cancer with synthetic chemical substance to the target of cancer chemoprotective, rather than go to treat the cancer that has existed with the chemotherapeutics in the traditional concept.The cancer chemoprotective agent of such class, but necessary long term administration possess safety and effective characteristics, and possess easy route of administration.The present invention is intended to satisfy this demand.
In addition, the precancerous lesion of carcinoma of prostate is meant the proliferative lesion that may develop into carcinoma of prostate.At present the prostate precancerous lesion of comparatively generally acknowledging has two classes: prostatic intraepithelial neoplasm (PIN) is meant the paraplasm of prostate acinus and ductal epithelium to be also referred to as the prostatic epithelium cancer in situ.Another is atypical adenomatoid hyperplasia (AAH), is meant that new body of gland forms, and is the paraplasm result of body of gland.
(1) the peak age of prostatic intraepithelial neoplasm (PIN): PIN generation is early than carcinoma of prostate, if evaluate the generation of PIN with prostatic subregion, then PIN incidence rate in transitional areas is minimum is 2.6%, perimeter region is then up to 68.80%, this generation to carcinoma of prostate is similar, though the incidence rate of China prostate PIN is lower than western countries, and the trend of cumulative year after year is also arranged.
(2) atypical adenomatoid hyperplasia (AAH): the incidence rate of AAH is lower than PIN, because of benign prostatic hyperplasia (BPH) is passed through in the specimen of urethra TURP, the case of 3.7-19.60% can detect AAH, and in the postmortem prostate of 20-40 year age group, the recall rate of AAH is 15-24%, wherein have in the postmortem prostate of carcinoma of prostate, the recall rate of AAH is up to 31%.
The existence of prostate precancerous lesion has increased the danger of suffering from carcinoma of prostate, and its unique diagnosis methods is a prostate living tissue pathologic finding.Because the restriction of diagnostic measures will accomplish that " early finding " is very difficult, therefore " prevention early " is control and the effective measures that delay that carcinoma of prostate takes place.
But the medicine that this area presses for a kind of life-time service, has no side effect and prevent safely and effectively carcinoma of prostate to take place.
Summary of the invention
The objective of the invention is to confirm that Radix Salviae Miltiorrhizae has the effect of prevention carcinoma of prostate, the present invention also aims to provide Radix Salviae Miltiorrhizae is developed to the medicine that the prevention carcinoma of prostate takes place that described medicine contains the main component that Radix Salviae Miltiorrhizae takes place as the prevention carcinoma of prostate.
In a first aspect of the present invention, the new purposes of Radix Salviae Miltiorrhizae is provided, it is used to prepare the medicine of prevention prostate precancerous lesion and carcinoma of prostate generation.
In another preference, described medicine is dry root or its ground product of plant Radix Salviae Miltiorrhizae.
In another preference, described medicine is a Radix Salviae Miltiorrhizae extract, and described Radix Salviae Miltiorrhizae extract is selected from down group: Radix Salviae Miltiorrhizae extract, concentrate or dry thing.
In another preference, the dosage form of described medicine is the above a dosage form of any pharmaceutics.
In another preference, described medicine is with the oral way administration.
In a second aspect of the present invention, the new purposes of Radix Salviae Miltiorrhizae is provided, it is used to prepare the health food of prevention prostate precancerous lesion and carcinoma of prostate generation.
In another preference, described health food is dry root or its ground product of plant Radix Salviae Miltiorrhizae.
In another preference, described health food is a Radix Salviae Miltiorrhizae extract, and described Radix Salviae Miltiorrhizae extract is selected from down group: Radix Salviae Miltiorrhizae extract, concentrate or dry thing.
In another preference, described health food is with the oral way administration.
The specific embodiment
The inventor finds that through extensive and deep research Radix Salviae Miltiorrhizae can effectively prevent the generation of carcinoma of prostate, has extremely excellent comprehensive performance, gets final product life-time service, has no side effect and safe and effective.Finished the present invention on this basis.
Radix Salviae Miltiorrhizae
As used herein, term " Radix Salviae Miltiorrhizae " refers to dry root or its ground product after grinding of labiate Radix Salviae Miltiorrhizae (Salvia miltiorrhiza Bge.).
Radix Salviae Miltiorrhizae extract
As used herein, term " Radix Salviae Miltiorrhizae extract " refers to extracting solution, extracting solution concentrate or the dry thing of plant Radix Salviae Miltiorrhizae.
Pharmaceutical composition
The present invention also comprises the pharmaceutical composition that contains Radix Salviae Miltiorrhizae.Radix Salviae Miltiorrhizae of the present invention and pharmaceutical composition thereof can be used for preventing carcinoma of prostate, promptly give Radix Salviae Miltiorrhizae or its extract of the safe and effective amount of administration.
When Radix Salviae Miltiorrhizae or its extract are used to prevent carcinoma of prostate, it can with one or more pharmaceutically acceptable carrier or mixed with excipients, as solvent, diluent etc., thereby form pharmaceutical composition.
Solid-state carrier comprises: starch, lactose, calcium hydrogen phosphate, microcrystalline Cellulose, sucrose and kaolin, and liquid carrier comprises: sterilized water, Polyethylene Glycol, nonionic surfactant and edible oil (as Semen Maydis oil, Oleum Arachidis hypogaeae semen and Oleum sesami), as long as be fit to the characteristic of active component and required specific administration mode.Normally used adjuvant also can advantageously be comprised in pharmaceutical compositions, for example flavoring agent, pigment, antiseptic and antioxidant such as vitamin E, vitamin C, 2,6 ditertiary butyl p cresol (BHT) and butylhydroxy anisole (BHA).
Usually; pharmaceutical composition of the present invention comprises following dosage form: the tablet of oral administration, capsule, dispersible powder, granule or suspension (suspensoid) (containing 0.05-5% suspending agent (cosolvent) according to appointment), syrup (containing 10-50% sugar according to appointment) and elixir (containing the 20-50% ethanol of having an appointment); the suppository of rectum or vagina administration perhaps carries out the parenteral administration with sterile injectable solution or suspensoid form (containing the 0.05-5% cosolvent of having an appointment in the medium waiting to ooze).These pharmaceutical preparatioies can contain and the blended about 0.01-99.9wt% of carrier usually, 0.1-99.5wt% preferably, and the more preferably Radix Salviae Miltiorrhizae of 1-99wt% (weight) or its extract are by the gross weight of compositions.
The Radix Salviae Miltiorrhizae that the present invention is used or its extract can be by oral, intravenous, intramuscular or subcutaneous route administrations.The preferred oral administering mode.
But the Radix Salviae Miltiorrhizae that the present invention is used or its extract parenteral or intraperitoneal administration.Also can in glycerol, liquid, Polyethylene Glycol and the mixture in oil thereof, prepare dispersion liquid.Under routine storage and service condition, contain antiseptic in these preparations to prevent growth of microorganism.
When using Radix Salviae Miltiorrhizae of the present invention or its extract, also can with the means or other medicines (as the toremifene) coupling of other prophylaxis of tumours.
The effective dose of used active component can change with the order of severity of the pattern of administration and disease to be prevented.Yet, usually when The compounds of this invention every day with about 0.1-8000mg/kg the weight of animals (5-5000mg/kg body weight preferably, when dosage more preferably 20-3000mg/kg body weight administration) gives, can obtain gratifying effect, preferably give with 1-4 time dosage every day, or with the slow release form administration.For most of large mammal, the accumulated dose of every day is about 1-16000mg or higher, preferably 10-8000mg.Be applicable to dosage form for oral administration, comprise Radix Salviae Miltiorrhizae with the blended about 0.1-8000mg of solid-state or liquid pharmaceutically acceptable carrier.This dosage of scalable is replied so that optimal treatment to be provided.For example, by an urgent demand of treatment situation, but give the dosage that several times separate every day, or dosage is reduced pari passu.
From being easy to prepare the position with administration, preferred pharmaceutical composition is solid-state or fluid composition.The oral administration of Radix Salviae Miltiorrhizae or its extract is preferred.
Health food or food supplement
Except Radix Salviae Miltiorrhizae being used to prepare the medicine that prevents carcinoma of prostate, in the present invention, also Radix Salviae Miltiorrhizae or its extract can be used to prepare health food or dietary supplement (or food additive).
So-called dietary supplement (dietary supplement) is the goods that utilize plant to make, its also the same science and clinical research of passing through strictness with chemicals, generally say less expensive, safety, the treatment chronic disease is more effective than Western medicine, and does not need just can go on the market through the FDA approval in the U.S..
In the present invention, health food and dietary supplement are used interchangeably, and they contain the Radix Salviae Miltiorrhizae of safe and effective amount or the carrier of its extract and pharmaceutically acceptable (or can accept on the health food).
Health food of the present invention or dietary supplement can equally with pharmaceutical composition contain Radix Salviae Miltiorrhizae or its extract of same amount.Usually, the content of Radix Salviae Miltiorrhizae or its extract can be more lower slightly in health food or the dietary supplement, for example contains 0.1-98wt% Radix Salviae Miltiorrhizae or its extract.
Health food of the present invention or dietary supplement can be made the dosage form of any routine by conventional method, preferably tablet, oral liquid, granule and capsule preparations.
Major advantage of the present invention is:
1) can effectively prevent the generation of carcinoma of prostate, reduce the incidence rate of prostate precancerous lesion and carcinoma of prostate;
2) Radix Salviae Miltiorrhizae is the Chinese medicine that China widely uses, and safety is good, but life-time service has no side effect to human body;
3) oral administration can reach the effect of good preventing tumor, and is easy to use.
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition, or the condition of advising according to manufacturer.
Embodiment 1
The preparation of the aqueous extract of Radix Salviae Miltiorrhizae, concentrated solution and dry thing
Radix Salviae Miltiorrhizae is ground into 20 order powder after removing impurity such as silt, with the water infiltration of 2.3 times of amounts 12 hours, uses the flow velocity percolation of 8 times of water gagings with 0.6BV/h then, obtains percolate (being extracting solution).With the percolate reclaim under reduced pressure, filter, get concentrated solution.Dry thing will be obtained after the concentrated solution drying.
Embodiment 2
The preparation of the alcohol extract of Radix Salviae Miltiorrhizae, concentrated solution and dry thing
Be ground into 20 order powder behind the impurity such as Radix Salviae Miltiorrhizae removal silt, after 12 hours, emit soak (being extracting solution) in 20 ℃ of immersions with 80% ethanol of 4 times of amounts.Medicinal residues after 12 hours, are emitted soak (being extracting solution) in 20 ℃ of immersions with 80% ethanol of 4 times of amounts once more.2 extracting solution are merged, reclaim, filter, get concentrated solution.Dry thing will be obtained after the concentrated solution drying.
Embodiment 3
Radix Salviae Miltiorrhizae and water extract thereof and alcohol extract are to the preventive effect laboratory observation of rat prostate cancer
1. experiment material
(1) laboratory animal: F344 male rat, 5 ages in week, about 90 grams of body weight;
(2) carcinoma of prostate chemical inducer: 3,2 '-dimethyl-4-amino aniline (3,2 '-dimethyl-4-aminobiphenyl, DMAB) (available from Japanese Nard academy);
(3) experiment medicine
A. Danshen Root;
B. the dry thing (be called for short Radix Salviae Miltiorrhizae water extract) of the Radix Salviae Miltiorrhizae aqueous extract of preparation among the embodiment 1;
C. the dry thing (be called for short tanshinol extract) of the tanshinol extracting solution of preparation among the embodiment 2;
2. experiment grouping: laboratory animal is divided into 14 groups.
(1) blank group (normal feedstuff, no DMAB chemical induction): 1 group, 6/group;
(2) Danshen Root matched group (Danshen Root mixed fodder, no DMAB chemical induction): 1 group (2.4g/kg/day dosage group), 6/group;
(3) Radix Salviae Miltiorrhizae water extract matched group (Radix Salviae Miltiorrhizae water extract mixed fodder, no DMAB chemical induction): 1 group (1.6g/kg/day dosage group), 6/group;
(4) tanshinol extract matched group (tanshinol extract mixing feedstuff, no DMAB chemical induction): 1 group (1.6g/kg/day dosage group), 6/group;
(5) DMAB model control group (normal feedstuff has the DMAB chemical induction): 1 group, 30/group;
(6) Danshen Root experimental group (the Danshen Root mixed fodder has the DMAB chemical induction): 3 groups (0.6,1.2,2.4g/kg/day dosage group), 30/group;
(7) Radix Salviae Miltiorrhizae water extract experimental group (Radix Salviae Miltiorrhizae water extract mixed fodder has the DMAB chemical induction): 3 groups (0.4,0.8,1.6g/kg/day dosage group), 30/group.
(8) tanshinol extract experimental group (tanshinol extract mixing feedstuff has the DMAB chemical induction): 3 groups (0.4,0.8,1.6g/kg/day dosage group), 30/group.
3. medication
Prepare the mixed fodder of Danshen Root or its extract according to different dosing dosage, Danshen Root or the content of its extract in the feedstuff of each dosage group are as follows:
(1) Danshen Root mixed fodder (0.6g/kg/day): Danshen Root content is 0.75%;
(2) Danshen Root mixed fodder (1.2g/kg/day): Danshen Root content is 1.5%;
(3) Danshen Root mixed fodder (2.4g/kg/day): Danshen Root content is 3%;
(4) Radix Salviae Miltiorrhizae water extract mixed fodder (0.4g/kg/day): the Radix Salviae Miltiorrhizae water extractable content is 0.5%;
(5) Radix Salviae Miltiorrhizae water extract mixed fodder (0.8g/kg/day): the Radix Salviae Miltiorrhizae water extractable content is 1%;
(6) Radix Salviae Miltiorrhizae water extract mixed fodder (1.6g/kg/day): the Radix Salviae Miltiorrhizae water extractable content is 2%;
(7) tanshinol extract mixing feedstuff (0.4g/kg/day): the tanshinol extractive content is 0.5%;
(8) tanshinol extract mixing feedstuff (0.8g/kg/day): the tanshinol extractive content is 1%;
(9) tanshinol extract mixing feedstuff (1.6g/kg/day): the tanshinol extractive content is 2%;
Begin give rat the last week with mixed fodder in modeling, let alone ad libitum access, when experiment finishes, stop.
4. experimental period: begin to finish totally 60 weeks to experiment from Danshen Root or its extract administration.
5. experimental procedure
(1) rat is bought the back and raises a week, conforms.Divide into groups subsequently, begin to Danshen Root matched group and Danshen Root experimental group rat feeding Danshen Root mixed fodder, give Radix Salviae Miltiorrhizae water extract matched group and Radix Salviae Miltiorrhizae water extract experimental group rat feeding Radix Salviae Miltiorrhizae water extract mixed fodder, give tanshinol extract matched group and tanshinol extract experimental group rat feeding tanshinol extract mixing feedstuff, blank group and the normal feedstuff of DMAB model control group rat feeding, finish until experiment, the food-intake of rat respectively organized in record weekly;
(2) mixed fodder of feeding Danshen Root or its extract is after one week, Danshen Root experimental group, Radix Salviae Miltiorrhizae water extract experimental group, tanshinol extract experimental group and DMAB model control group rat skin lower injection DMAB (is solvent with the Semen Maydis oil), dosage is 50mg/kg, every the injection of 2 weeks once, inject altogether 10 times.Blank group, Danshen Root matched group, Radix Salviae Miltiorrhizae water extract matched group and tanshinol extract control rats subcutaneous injection do not contain the excipient (Semen Maydis oil) of DMAB, every the injection of 2 weeks once, inject altogether 10 times;
(3) per 2 weeks are measured rat body weight once in the experiment.Observe the rat state once every day in the experiment, for the rat of before experiment finishes, promptly being at death's door put to death and set by step (4) perform an autopsy on sb and histological examination;
(4) Danshen Root or after its 60 weeks of extract administration feeding stops administration, puts to death all rats, and perusal main organs organ to define no abnormal variation, performs an autopsy on sb and histological examination subsequently.During postmortem, take out rat prostate and seminal vesicle, formalin solution with 10% is fixed, use paraffin embedding subsequently, ventral prostate is cut into slices by the longitudinal section direction by cross-sectional direction, front side prostate and seminal vesicle by sagittal direction, back of the body outside prostate, with carrying out histological examination after hematoxylin and the eosin dyeing.
6. experimental result
(1) body weight inspection: the rat average weight of respectively organizing to different Zhou Jilu is added up, and the results are shown in Table 1.
Table 1. is respectively organized the body weight change of rat
| Grouping | The rat average weight (g) of different Zhou Jilu | ||||||
| 0w | 4w | 12w | 24w | 40w | 50w | 60w | |
| Blank group Danshen Root control group (2.4g/kg/d) Danshen control group (1.6g/kg/d) tanshinol extract control group (1.6g/kg/d) DMAB model control group Danshen Root experimental group (0.6g/kg/d) Danshen Root experimental group (1.2g/kg/d) Danshen Root experimental group (2.4g/kg/d) Danshen experimental group (0.4g/kg/d) Danshen experimental group (0.8g/kg/d) Danshen experimental group (1.6g/kg/d) tanshinol extract experimental group (0.4g/kg/d) tanshinol extract experimental group (0.8g/kg/d) tanshinol extract experimental group (1.6g/kg/d) | 91 90 91 92 91 91 92 92 92 91 92 91 92 92 | 205 206 210 212 188 190 192 193 194 197 195 196 198 191 | 286 289 290 293 235 241 248 245 244 246 249 248 247 245 | 340 345 349 350 266 295 298 296 297 300 301 296 298 300 | 400 407 411 413 289 350 354 352 355 359 361 352 350 359 | 420 430 432 435 305 366 370 365 368 369 371 370 367 373 | 437 445 450 452 318 374 379 372 375 380 382 378 377 385 |
(2) histological examination: the incidence rate to each group prostate precancerous lesion and carcinoma of prostate is added up, and the results are shown in Table 2.
Table 2. Radix Salviae Miltiorrhizae and water extract thereof and alcohol extract are to the preventive effect of the inductive rat prostate cancer of chemical carcinogens
| Grouping | Effectively observe the animal sum a) | The number of animals of prostate precancerous lesion and carcinoma of prostate takes place | |||||||||
| Prostate | Seminal vesicle | The animal sum of precancerous lesion takes place | The animal sum of cancer takes place | ||||||||
| Veutro | The back of the body outside | The front side | |||||||||
| Precancerous lesion b) | Cancer | Precancerous lesion | Cancer | Precancerous lesion | Cancer | Precancerous lesion | Cancer | ||||
| Blank group Danshen Root control group (2.4g/kg/d) Danshen control group (1.6g/kg/d) tanshinol extract control group (1.6g/kg/d) DMAB model control group Danshen Root experimental group (0.6g/kg/d) Danshen Root experimental group (1.2g/kg/d) Danshen Root experimental group (2.4g/kg/d) Danshen experimental group (0.4g/kg/d) Danshen experimental group (0.8g/kg/d) Danshen experimental group (1.6g/kg/d) tanshinol extract experimental group (0.4g/kg/d) tanshinol extract experimental group (0.8g/kg/d) tanshinol extract experimental group (1.6g/kg/d) | 6 6 6 6 23 24 26 25 26 27 26 25 26 26 | 0(0) c) 0(0) 0(0) 0(0) 18(78) 16(67) 17(65) 15(60) 17(65) 16(59) 17(65) 18(72) 16(62) 17(65) | 0(0) 0(0) 0(0) 0(0) 4(17) 3(13) 4(15) 3(12) 3(12) 3(11) 3(12) 3(12) 3(12) 2(8) | 0(0) 0(0) 0(0) 0(0) 4(17) 2(8) 4(15) 3(12) 3(12) 4(15) 2(8) 3(12) 4(15) 3(12) | 0(0) 0(0) 0(0) 0(0) 2(9) 1(4) 2(8) 1(4) 2(8) 1(4) 2(8) 1(4) 1(4) 2(8) | 0(0) 0(0) 0(0) 0(0) 20(87) 18(75) 18(69) 18(72) 19(73) 18(67) 17(65) 18(72) 19(73) 19(73) | 0(0) 0(0) 0(0) 0(0) 5(22) 4(17) 4(15) 4(16) 4(15) 4(15) 3(12) 4(16) 3(12) 4(15) | 0(0) 0(0) 0(0) 0(0) 19(83) 16(67) 18(69) 16(64) 17(65) 17(63) 16(62) 18(72) 17(65) 17(65) | 0(0) 0(0) 0(0) 0(0) 7(30) 6(25) 5(19) 5(20) 6(23) 5(19) 4(15) 5(20) 6(23) 5(19) | 0(0) 0(0) 0(0) 0(0) 21(91) 18(75) 19(73) 18(72) 19(73) 18(67) 18(69) 18(72) 19(73) 19(73) | 0(0) 0(0) 0(0) 0(0) 14(61) 12(50) 11(42) 11(44) 13(50) 12(44) 10(38) 13(52) 12(46) 13(50) |
A) effectively observe the animal sum: each group is got rid of in the experimentation because of the sum behind the animal of the former cause death of non-tumor;
B) precancerous lesion comprises prostatic intraepithelial neoplasm (PIN) and atypical adenomatoid hyperplasia (AAH);
C) incidence rate (unit: %) of prostate precancerous lesion or carcinoma of prostate during expression is respectively organized in the round parentheses;
7. interpretation of result: the result shows that the prostate precancerous lesion and the carcinoma of prostate sickness rate of Danshen Root, Radix Salviae Miltiorrhizae water extract and tanshinol extract experimental group significantly are lower than the DMAB model control group, the prostate precancerous lesion and the carcinoma of prostate sickness rate of DMAB model control group are respectively 91% and 61%, after the Danshen Root administration, can distinguish near 72% and 42%, after the administration of Radix Salviae Miltiorrhizae water extract, can reduce to 67% and 38% respectively, after the administration of tanshinol extract, can reduce to 72% and 46% respectively.Rat after Danshen Root or its extract high dose long term administration does not have untoward reaction such as significantly lose weight.
More than explanation Danshen Root and water extract thereof and alcohol extract have the good preventing effect to carcinoma of prostate, but and high dose long term administration.
Embodiment 4
The preparation of Radix Salviae Miltiorrhizae water extract oral capsule
The oral capsule prescription:
The dry thing of 300 milligrams of Radix Salviae Miltiorrhizae aqueous extracts.
Embodiment 5
The capsular preparation of tanshinol extract oral
The oral capsule prescription:
The dry thing of 300 milligrams of tanshinol extracting solution.
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (10)
1. the new purposes of Radix Salviae Miltiorrhizae is characterized in that, is used to prepare the medicine of prevention prostate precancerous lesion and carcinoma of prostate generation.
2. purposes as claimed in claim 1 is characterized in that, described medicine is dry root or its ground product of plant Radix Salviae Miltiorrhizae.
3. purposes as claimed in claim 1 is characterized in that described medicine is a Radix Salviae Miltiorrhizae extract, and described Radix Salviae Miltiorrhizae extract is selected from down group: the extracting solution of Radix Salviae Miltiorrhizae, extracting solution concentrate or dry thing.
4. purposes as claimed in claim 1 is characterized in that, the dosage form of described medicine is the above a dosage form of any pharmaceutics.
5. purposes as claimed in claim 1 is characterized in that described medicine is with the oral way administration.
6. the new purposes of Radix Salviae Miltiorrhizae is characterized in that, is used to prepare the health food of prevention prostate precancerous lesion and carcinoma of prostate generation.
7. purposes as claimed in claim 6 is characterized in that, described health food is dry root or its ground product of plant Radix Salviae Miltiorrhizae.
8. purposes as claimed in claim 6 is characterized in that described health food is a Radix Salviae Miltiorrhizae extract, and described Radix Salviae Miltiorrhizae extract is selected from down group: the extracting solution of Radix Salviae Miltiorrhizae, extracting solution concentrate or dry thing.
9. purposes as claimed in claim 6 is characterized in that, the dosage form of described medicine is the above a dosage form of any pharmaceutics.
10. purposes as claimed in claim 6 is characterized in that described health food is with the oral way administration.
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| CN 200510026456 CN1872159A (en) | 2005-06-03 | 2005-06-03 | Application of red sage root in preparing medication for preventing prostatic csarcinoma from occurring |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102218140A (en) * | 2010-04-15 | 2011-10-19 | 上海天甲生物医药有限公司 | Tumor resistance effect of medicine combination of salvianolic acid B and coxib medicaments |
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2005
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102218140A (en) * | 2010-04-15 | 2011-10-19 | 上海天甲生物医药有限公司 | Tumor resistance effect of medicine combination of salvianolic acid B and coxib medicaments |
| CN102218140B (en) * | 2010-04-15 | 2013-03-27 | 上海天甲生物医药有限公司 | Tumor resistance effect of medicine combination of salvianolic acid B and coxib medicaments |
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Open date: 20061206 |