CN104274766A - Traditional Chinese medicine composition with toxicity attenuation and synergy effects on tumor chemotherapy and preparation method thereof - Google Patents
Traditional Chinese medicine composition with toxicity attenuation and synergy effects on tumor chemotherapy and preparation method thereof Download PDFInfo
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- CN104274766A CN104274766A CN201310291439.XA CN201310291439A CN104274766A CN 104274766 A CN104274766 A CN 104274766A CN 201310291439 A CN201310291439 A CN 201310291439A CN 104274766 A CN104274766 A CN 104274766A
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a traditional Chinese medicine composition with toxicity attenuation and synergy effects on tumor chemotherapy and a preparation method thereof and belongs to the field of the modernization of traditional Chinese medicines. An active ingredient of the traditional Chinese medicine composition with the toxicity attenuation and synergy effects on the tumor chemotherapy is prepared from the following raw materials in parts by weight: 678 parts of astragalus roots, 226 parts of angelica sinensis, 678 parts of climbing nightshade, 678 parts of black nightshade, 226 parts of salvia miltiorrhiza, 678 parts of barbat skullcap, 339 parts of duchesnea indica and 226 parts of radix curcumae. The traditional Chinese medicine composition and the preparation method thereof have the characteristics that by adopting the technical scheme of the invention, the quality of prepared medicines is stable and controllable, and the treatment effect of the prepared medicines is remarkably improved compared with that of the existing dosage forms on the market. Through treating liver cancer, stomach cancer, rectal cancer and colonic cancer in a manner of being matched with chemotherapy, the traditional Chinese medicine symptoms of patients can be improved, the quality of life (karnofsky score) of the patients is improved, the weight of the tumor patients is increased, and the immunologic function of an organism is improved; shown by studies, an experimental group is obviously better than a control group and has obvious statistical significance compared with the control group. Thus, the traditional Chinese medicine composition and the preparation method thereof have remarkable economic and social benefits.
Description
Technical field
The present invention relates to a kind of to chemotherapy of tumors Chinese medicine composition with attenuation synergistic and preparation method thereof, belong to modern Chinese traditional medicine field.
Background technology
Cancer (Cancer), also known as malignant tumor (Malignant neoplasm), for by controlling the not normal and disease that causes of growth and proliferation of cell mechanism.Cancerous cell except grow out of control except, arround also locally invading, normal structure even transfers to other parts of health via body-internal-circulation system or lymphsystem.Cancer is the main lethal cause of disease in a whole world, and within 2004, number of cancer deaths reaches 7,400,000 (accounting for 13% of all death tolls).Pulmonary carcinoma, gastric cancer, colon cancer, hepatocarcinoma and breast carcinoma are the arch-criminals of annual most of cancer mortality.But the cancer mortality more than 30% is avoidable.Cancer is caused by a unicellular variation.This variation can be caused by extrinsicfactor and genetic factor.The whole world number of cancer deaths increase continuation, and the year two thousand thirty death toll expectation will reach 1,200 ten thousand.
The common method for the treatment of tumor has surgical operation, radiotherapy, chemotherapy, biotherapy, TCM Therapy etc. both at home and abroad at present, but therapeutic effect is not significantly improved recent decades, and total cure rate is about 10%.Especially chemotherapy, its therapeutic effect is better, but often with larger toxic and side effects for cost, the quality of life of patient obviously declines.
Summary of the invention
First technical problem that the present invention will solve is to provide a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic.
Another technical problem that the present invention will solve is to provide the preparation method of above-mentioned Chinese medicine composition.
For achieving the above object, the present invention by the following technical solutions;
Chemotherapy of tumors is had to a Chinese medicine composition for attenuation synergistic, its active component is made up of the raw material of following parts by weight: the Radix Astragali 678 parts, Radix Angelicae Sinensis 226 parts, Herba Solani Lyrati 678 parts, Herba Solani Nigri 678 parts, Radix Salviae Miltiorrhizae 226 parts, Herba Scutellariae Barbatae 678 parts, Herba Duchesneae Indicae 339 parts, Radix Curcumae 226 parts.
Described active component adopts following method to prepare:
1, each raw material is taken by proportioning raw materials: Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
2, each raw material is taken by proportioning raw materials: Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, first time adds water by 15 times of medical material weight, decoct 2 hours, second time adds water by 10 times of medical material weight, decoct 1 hour, merge extractive liquid, filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time press 8 extraordinarily ethanol of medical material weight, and reflux, extract, 1.5 hours, filters, and reclaims ethanol: second time press 8 extraordinarily 50% ethanol of medical material weight, reflux, extract, 1.5 hours, filtration, recovery ethanol; Third time adds water by 10 times of medical material weight, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
Described pharmaceutical composition is also containing the acceptable adjuvant of pharmaceutics.
The acceptable adjuvant of described pharmaceutics be selected from starch, microcrystalline Cellulose, sucrose, aspartame, dextrin, lactose, Icing Sugar, glucose, sodium chloride, Carboxymethyl cellulose sodium, crospolyvinylpyrrolidone, magnesium stearate, micropowder silica gel, vitamin C, cysteine, citric acid and sodium sulfite any one or a few.
The dosage form of described Chinese medicine composition is peroral dosage form, includes but not limited to pill, tablet, capsule or oral liquid.The selection of dosage form and the consumption of adjuvant all belong to prior art.
A kind of preparation method chemotherapy of tumors to the Chinese medicine composition of attenuation synergistic:
Take the Radix Astragali 678 parts, Radix Angelicae Sinensis 226 parts, Herba Solani Lyrati 678 parts, Herba Solani Nigri 678 parts, Radix Salviae Miltiorrhizae 226 parts, Herba Scutellariae Barbatae 678 parts, Herba Duchesneae Indicae 339 parts, Radix Curcumae 226 parts.Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, and first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, and filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
Preferred preparation method is: take each raw material by proportioning raw materials; Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, and first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, and filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
Chemotherapy of tumors is had to a preparation for the Chinese medicine composition of attenuation synergistic, said preparation adds the acceptable adjuvant of pharmaceutics with above-mentioned active constituents of medicine, makes the acceptable dosage form of pharmaceutics.During the various dosage form of medicine needed for the active fraction preparation of the Chinese medicine composition utilizing the present invention to obtain, can prepare according to the conventional production process of art of pharmacy.As mixed with one or more carriers by this active component, then make corresponding dosage form.
Advantage of the present invention is: the present invention uses theory of Chinese medical science to analyze prescription composition, and according to physicochemical property and the pharmacological action of each flavour of a drug ingredient, research obtains the preparation method of reasonable, stable active component.Adopt technical scheme of the present invention, on duty go out stable and controllable for quality, curative effect significantly improves compared with existing commercial dosage forms, patient's taking dose reduces pharmaceutical preparation, there is significant economic and social benefit.
Describe technical solution of the present invention in detail by the following examples, do not limit practical range of the present invention with this.
Detailed description of the invention
Embodiment 1: prepare Chinese medicine extract
One, prescription: Radix Astragali 678g, Radix Angelicae Sinensis 226g, Herba Solani Lyrati 678g, Herba Solani Nigri 678g, Radix Salviae Miltiorrhizae 226g, Herba Scutellariae Barbatae 678g, Herba Duchesneae Indicae 339g, Radix Curcumae 226g
Two, method for making:
Each raw material is taken by proportioning raw materials; Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, and first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, and filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A and amount to 640g.
Embodiment 2: prepare Chinese medicine extract
One, prescription: Radix Astragali 678kg, Radix Angelicae Sinensis 226kg, Herba Solani Lyrati 678kg, Herba Solani Nigri 678kg, Radix Salviae Miltiorrhizae 226kg, Herba Scutellariae Barbatae 678kg, Herba Duchesneae Indicae 339kg, Radix Curcumae 226kg
Two, method for making:
Each raw material is taken by proportioning raw materials; Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, first time adds water by 15 times of medical material weight, decoct 2 hours, second time adds water by 10 times of medical material weight, decoct 1 hour, merge extractive liquid, filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time press 8 extraordinarily ethanol of medical material weight, and reflux, extract, 1.5 hours, filters, recovery ethanol; Second time press 8 extraordinarily 50% ethanol of medical material weight, and reflux, extract, 1.5 hours filters, recovery ethanol; Third time adds water by 10 times of medical material weight, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A and amount to 640kg.
Embodiment 3: prepare tablet
The active component 100g that embodiment 1 obtains, adds microcrystalline Cellulose 10g, cross-linked pvp 5g, and tabletting, obtains tablet, the heavy 0.65g of every sheet.
Embodiment 4: prepare capsule
The active component 1000g that embodiment 1 obtains, adds starch 250g, and encapsulating capsule, obtains capsule, every heavy 0.50g.
Embodiment 5: clinical experiment
Tablet---the purple imperial gold plaque that experiment adopts technical solution of the present invention to make.
This clinical trial adopts purple imperial gold plaque to randomized, double-blind, placebo, the parallel control multi-center clinical trial of Chemotherapy of Tumor Patients attenuation.Observation index comprises curative effect index: tcm symptom curative effect, life quality, body weight, immunologic function, chemotherapy completion rate.Safety indexes comprises general health check-up project, routine blood test, urine, feces routine examination, liver function, renal function (BUN, Cr) inspection, adverse events.
This test adopts the research method of multicenter, random, double blinding, placebo parallel control, amounts to selected 566 routine patients, is divided into two groups at random, that is: test group 281 example, matched group (placebo) 285 example, the course for the treatment of, 42 days, jointly completed by 8 centers.
Test mass controls, and comprises the Quality Control measure of laboratory, and each clinical trial hospital laboratory of participating in sets up unified experiment Testing index, standard operating procedure and Quality Control Procedure, and special examined project must be responsible for detection by special messenger.The researcher participating in clinical trial must have the professional speciality of clinical trial, qualification and ability, and through title examination, personnel requirement is relatively fixing.Clinical trial starts front training: make research worker for clinical trial protocol and each specific targets thereof by training before clinical trial. and intension fully understands and is familiar with.And carried out the measure ensureing experimenter's compliance.Adopt various ways to carry out the quality assurance to clinical research process, case report records every content in CRF strictly according to the facts, in detail, conscientiously, to guarantee that case report form content is true, reliable.For ensureing the reliability of data, observed results all in clinical trial all being examined, is guaranteed that in clinical trial, every conclusion derives from initial data.
Statistical analysis technique adopts data on bulk analysis collection (Full Analysis Set, FAS), meets protocol collection (Per-Protocol Set, PPS), data of safety collection (Safety Set, SS)
Analyze.
Following result is obtained by above Clinical design, quality control process, statistical analysis technique:
1. test group and matched group analysis of comparable: comprise sex, age, sick to plant, tumor locus and transfer case, histological type and antineoplaston, baseline clinical symptom, baseline Karnofsky mark, baseline immune indexes and the indices such as body weights, baseline routine blood test (WBC, Hb, PLT, GR) hepatic and renal function carry out statistics description etc. by stages, previously.The statistics display of quantitative target: test, matched group baseline clinical symptom total score situation comparative test group are 5.69, and matched group is 5.45, and test group clinical symptoms total score is a little more than matched group, but statistics no significant difference.Illustrate after randomized grouping, better harmonious between two groups.
2. purple imperial gold plaque can obviously improve the symptoms such as tumor patient pain, lack of appetite, diarrhea with loose stool, spiritlessness and weakness, abdominal distention, bitter taste, nausea and vomiting
The comparison of tumor patient cardinal symptom change, test group treats front Average symptom integration 5.69, is 2.39 after treatment; Matched group treat before Average symptom integration 5.45, after treating 5.19, compare that there were significant differences before and after test group treatment, P value is (0.000), compares no significant difference before and after treatment of control group, and P value is (0.183).After two groups of treatments, there were significant differences for cardinal symptom integral contrast, and P value is (0.000).Test group effective percentage is 85.73%, and matched group effective percentage is 25.96%, the analysis of deduction center effect, and treat rear symptom analysis test group significantly better than matched group for two groups, P value is (0.000).It is similar that PPS collection and FAS assemble fruit.
Hepatocarcinoma symptom integral, test group effective percentage is 81.43%, and matched group effective percentage is 23.61%, the analysis of deduction center effect, and treat rear symptom analysis test group significantly better than matched group for two groups, P value is (0.000).Gastric cancer test group effective percentage is 88.89%, and matched group effective percentage is 30.56%, the analysis of deduction center effect, and treat rear symptom analysis test group significantly better than matched group for two groups, P value is (0.000).Rectal cancer test group effective percentage is 88.41%, and matched group effective percentage is 28.17%, the analysis of deduction center effect, and treat rear symptom analysis test group significantly better than matched group for two groups, P value is (0.000).Colon cancer test group effective percentage is 84.29%, and matched group effective percentage is 21.43%, the analysis of deduction center effect, and treat rear symptom analysis test group significantly better than matched group for two groups, P value is (0.000).
Single symptom effective percentage mass in the abdomen test group 52.22%, matched group 44.07%; Pain test group 69.77%, matched group 28.80%; Lack of appetite test group 70.26%, matched group 27.91%; Diarrhea with loose stool test group 75.00%, matched group 54.55%; Spiritlessness and weakness test group 69.10%, matched group 27.44%; Abdominal distention test group 72.39%, matched group 45.45%; Bitter taste test group 73.55%, matched group 47.32%; Nausea and vomiting test group 72.55%, matched group 49.12%; Through statistical analysis, except mass in the abdomen, other each symptom test group effective percentage, significantly better than matched group, has significant difference.
Improve result display by the tcm symptom of pathological staging: II, III, IV phase patient test organizes symptom effective percentage significantly better than matched group, two groups are compared and have significant difference, and P value is 0.000.
3. purple imperial gold plaque can improve the life quality of tumor patient
Average quality of life score, after treatment in 42 days, test group significantly improves, and brings up to 85.6 by 80.4, and matched group drops to 79.1 by improving by 81.4, and before and after two groups of treatments, more all there were significant differences, and test group is significantly better than matched group.It is similar that PPS collection and FAS assemble fruit.
Muscle power situation score increase rate, test group increase rate 51.91%, matched group increase rate 10.69%, test group is significantly better than matched group, and deduction center effect analysis, two groups are compared and have significant difference, P value, 0.000.It is similar that PPS collection and FAS assemble fruit.
Hepatocarcinoma muscle power situation score increase rate, test group increase rate 39.39%, matched group increase rate 12.31%, test group is significantly better than matched group, and deduction center effect analysis, two groups are compared and have significant difference, P value, 0.000.Gastric cancer muscle power situation score increase rate, test group increase rate 59.42%, matched group increase rate 20.00%, test group is significantly better than matched group, and deduction center effect analysis, two groups are compared and have significant difference, P value, 0.000.Rectal cancer muscle power situation score increase rate, test group increase rate 52.31%, matched group increase rate 7.69%, test group is significantly better than matched group, and deduction center effect analysis, two groups are compared and have significant difference, P value, 0.000.Colon cancer muscle power situation score increase rate, test group increase rate 56.45%, matched group increase rate 2.99%, test group is significantly better than matched group, and deduction center effect analysis, two groups are compared and have significant difference, P value, 0.000.
4. purple imperial gold plaque can increase the body weight of tumor patient
Body weight, change after treating, test group increase rate 42.15%, matched group increase rate 15.97%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.000.It is similar that PPS collection and FAS assemble fruit.
Body weight change, test group weight average brings up to 64.92kg by 64.32kg, on average improves 0.60kg, and matched group drops to 62.52kg by 63.28kg, and on average decline 0.76kg, more all has notable difference before and after two groups of treatments.Before and after two groups of treatments, changing values compare, and test group weight average improves 0.60kg, and matched group on average declines 0.76kg, two groups are compared, test group, significantly better than matched group, has obvious statistical significance (P value=0.000), and it is similar that PPS collection and FAS assemble fruit.
Hepatocarcinoma body weight treat after change, test group increase rate 43.94%, matched group increase rate 12.12%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.000.Gastric cancer body weight treat after change, test group increase rate 39.13%, matched group increase rate 21.54%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.004.Rectal cancer body weight treat after change, test group increase rate 56.25%, matched group increase rate 9.23%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.000.Colon cancer body weight treat after change, test group increase rate 29.03%, matched group increase rate 20.90%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.001.
5. purple imperial gold plaque can improve the immunologic function of patient
NK test cell line group increase rate 37.84%, matched group increase rate 21.76%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.000.It is similar that PPS collection and FAS assemble fruit.
CD4+/CD8+ test group increase rate 38.31%, matched group increase rate 30.92%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.006.It is similar that PPS collection and FAS assemble fruit.
Hepatocarcinoma NK test cell line group increase rate 38.46%, matched group increase rate 17.91%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.006.Hepatocarcinoma CD4+/CD8+ test group increase rate 38.46%, matched group increase rate 22.39%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.009.
Gastric cancer NK test cell line group increase rate 32.35%, matched group increase rate 27.69%, test group is better than matched group, and center effect is analyzed two groups and compared no significant difference, P value, 0.218.Gastric cancer CD4+/CD8+ test group increase rate 42.03%, matched group increase rate 29.23%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.035.
Rectal cancer NK test cell line group increase rate 43.75%, matched group increase rate 17.19%, test group is significantly better than matched group, and center effect is analyzed two groups and compared and have significant difference, P value, 0.001.Rectal cancer CD4+/CD8+ test group increase rate 40.00%, matched group increase rate 43.75%, test group is similar to matched group result, and center effect is analyzed two groups and compared no significant difference, P value, 0.835.
Colon cancer NK test cell line group increase rate 37.10%, matched group increase rate 24.24%, test group is better than matched group, and center effect is analyzed two groups and compared and have notable difference, P value, 0.045.Colon cancer CD4+/CD8+ test group increase rate 32.26%, matched group increase rate 28.79%, test group is better than matched group, but center effect is analyzed two groups and compared no significant difference, P value, 0.324.
Research shows, purple imperial gold plaque righting is that master carries out whole body therapeutic, Promote cell's growth metabolism, conditioner body immunity function, strengthens the stimulation to bone marrow hematogenesis function and protection.Promote T lymphocyte transformation, strengthen NK cytoactive and produce anticancer and press down cancer effect.Human body immune function is low; its change not only has T cell quantity to reduce and functional defect; more show as subset proportions imbalance; chemotherapy can cause secondary immunodeficiency; purple imperial gold plaque then can be protected and strengthen immunologic function; CD4/CD8 is raised, thus plays the synergism and attenuation to chemotherapy, this result of study confirms research in the past.
6. purple imperial gold plaque can improve the objective curative effect of tumor patient
The objective curative effect of tumor: after 6 weeks or treatment in 8 weeks, test group, matched group clinical effective rate are respectively 23.30%, 16.67%, and test group is better than matched group, but center effect is analyzed two groups and compared no significant difference, P value, 0.120.
Liver cancer patient clinical effective rate is respectively 13.64%, 8.95%, and test group is better than matched group, and center effect is analyzed two groups and compared no significant difference, P value, P=0.209.
In current cancer therapy drug development, purple imperial gold plaque forms a global theory system oncogene, antioncogene, cyclin (Cyclin), cyclin-dependent kinase (CDK), cyclin-dependent kinases inhibitive factor (CKI) and signal path and studies, and the mutual relation answered between these factors, in cancer therapy drug research, purple imperial gold plaque dynamically illustrates signal transmission and multiple gene molecule from cyto-dynamics angle and is expressing the cycle sensitivity changing and dyskinetic.Purple imperial gold plaque is directly by the effect of Chinese medicine to cancerous cell, effectively set forth the antagonism of traditional Chinese medical science yin-yang theory, mutually root, growth and decline and the conversion philosophic theory change in cell in multi-level molecular regulation on a molecular scale, the tumor-inhibiting action of purple imperial gold plaque may be relevant therewith.
7. purple imperial gold plaque medication is safer, has no serious untoward reaction
In process of the test except the general chemotherapy toxic side effect of appearance, test group has 1 routine patient to occur nausea and vomiting, relevant with medicine, incidence rate 0.36%, the order of severity, slightly, alleviates after oral metoclopramide 2 times; There is not serious adverse events.
8. purple imperial gold plaque has no significant effect patient's routine blood test, Liver and kidney function
Result of the test shows, to vital sign patient's check the value after test group, matched group medication, and systolic pressure, diastolic pressure, resting heart rate, body temperature no significant difference, statistical procedures p > 0.05.To patient's Liver and kidney function after test group, matched group medication, the indexs such as glutamate pyruvate transaminase, alkali phosphatase, bilirubin, blood urea nitrogen, creatinine have no significant effect, statistical procedures no significant difference.
Being benefited and risk of Clinical practice
This result of study proves that purple imperial gold plaque and chemotherapy are share, and can improve the symptom of hepatocarcinoma, gastric cancer, rectal cancer, colon cancer tumours patient, and purple imperial gold plaque can also improve the life quality of patient, increase the body weight of patient, improves the immunologic function of patient.Purple imperial gold plaque medication is safer, has no serious untoward reaction.For tumor patient provides more choice, this medicine of clinical practice can not bring risk to patient.
Conclusion
Purple imperial gold plaque combined with chemotherapy Hepatoma therapy, gastric cancer, rectal cancer, colon cancer can improve patient's TCM syndrome, improve the life quality (karnofsky scoring) of patient, increase the body weight of tumor patient, improve the immunologic function of body, research display test group is significantly better than matched group, there is obvious statistical significance compared with matched group, do not observe the change of this medicine safety aspect.
Claims (8)
1. chemotherapy of tumors is had to a Chinese medicine composition for attenuation synergistic, it is characterized in that: its active component is made up of the raw material of following parts by weight: the Radix Astragali 678 parts, Radix Angelicae Sinensis 226 parts, Herba Solani Lyrati 678 parts, Herba Solani Nigri 678 parts, Radix Salviae Miltiorrhizae 226 parts, Herba Scutellariae Barbatae 678 parts, Herba Duchesneae Indicae 339 parts, Radix Curcumae 226 parts.
2. a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic according to claim 1, is characterized in that old point of described activity adopts following method to prepare: take each raw material by proportioning raw materials; Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, and first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, and filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
3. a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic according to claim 2, it is characterized in that: Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, first time adds water by 15 times of medical material weight, decoct 2 hours, second time adds water by 10 times of medical material weight, decocts 1 hour, merge extractive liquid, filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time press 8 extraordinarily ethanol of medical material weight, and reflux, extract, 1.5 hours, filters, recovery ethanol; Second time press 8 extraordinarily 50% ethanol of medical material weight, and reflux, extract, 1.5 hours filters, recovery ethanol; Third time adds water by 10 times of medical material weight, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
4. according to a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic in claims 1 to 3 described in any one, it is characterized in that: affiliated medicine is also containing the acceptable adjuvant of pharmaceutics.
5. a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic according to claim 4, is characterized in that: the acceptable adjuvant of described pharmaceutics be selected from starch, microcrystalline Cellulose, sucrose, aspartame, dextrin, lactose, Icing Sugar, glucose, sodium chloride, Carboxymethyl cellulose sodium, crospolyvinylpyrrolidone, magnesium stearate, micropowder silica gel, vitamin C, cysteine, citric acid and sodium sulfite any one or a few.
6. a kind of Chinese medicine composition chemotherapy of tumors to attenuation synergistic according to claim 4, is characterized in that: the dosage form of described Chinese medicine composition is peroral dosage form, comprises pill, tablet, capsule or oral liquid.
7. chemotherapy of tumors is had to a preparation method for the Chinese medicine composition of attenuation synergistic, take the Radix Astragali 678 parts, Radix Angelicae Sinensis 226 parts, Herba Solani Lyrati 678 parts, Herba Solani Nigri 678 parts, Radix Salviae Miltiorrhizae 226 parts, Herba Scutellariae Barbatae 678 parts, Herba Duchesneae Indicae 339 parts, Radix Curcumae 226 parts.Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, and first time decocts 2 hours, and second time decocts 1 hour, merge extractive liquid, and filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time adds alcohol reflux 1.5 hours, filters, and reclaims ethanol; Second time adds ethanol, reflux, extract, 1.5 hours, filters, and reclaims ethanol; Third time adds water, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
8. a kind of preparation method chemotherapy of tumors to the Chinese medicine composition of attenuation synergistic according to claim 7, it is characterized in that: Radix Angelicae Sinensis, the Radix Astragali, Radix Curcumae, Herba Scutellariae Barbatae, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Solani Nigri decoct with water secondary, first time adds water by 15 times of medical material weight, decoct 2 hours, second time adds water by 10 times of medical material weight, decocts 1 hour, merge extractive liquid, filter, filtrate is concentrated into relative density 1.00-1.18 (55 DEG C); Radix Salviae Miltiorrhizae extracts three times, and first time press 8 extraordinarily ethanol of medical material weight, and reflux, extract, 1.5 hours, filters, recovery ethanol; Second time press 8 extraordinarily 50% ethanol of medical material weight, and reflux, extract, 1.5 hours filters, recovery ethanol; Third time adds water by 10 times of medical material weight, and decoct 2 hours, filtrate and alcohol concentrated solution merge, and are concentrated into relative density 1.01-1.15 (55 DEG C); Above-mentioned water, alcohol concentrated solution are merged, is spray dried to dried cream powder, obtains dry thing A.
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| CN113648361A (en) * | 2021-08-12 | 2021-11-16 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Composition for patient to use in auxiliary chemotherapy stage after intestinal cancer radical treatment and application |
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| CN113648361A (en) * | 2021-08-12 | 2021-11-16 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Composition for patient to use in auxiliary chemotherapy stage after intestinal cancer radical treatment and application |
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Application publication date: 20150114 |