CN1326551C - Therapy assisting agent and its preparation - Google Patents
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- CN1326551C CN1326551C CNB2004100133512A CN200410013351A CN1326551C CN 1326551 C CN1326551 C CN 1326551C CN B2004100133512 A CNB2004100133512 A CN B2004100133512A CN 200410013351 A CN200410013351 A CN 200410013351A CN 1326551 C CN1326551 C CN 1326551C
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Abstract
The present invention relates to a Fukangai preparation which is characterized in that the present invention contains the following raw medicinal material by weight percentage: 5 to 7 parts of ginseng, 4 to 6 parts of ganoderma, 8 to 10 parts of coix seed, 8 to 10 parts of hairyvein agrimonia herd, 2 to 4 parts of paris root, 8 to 10 parts of oldenlandia, 11 to 13 parts of barbed skullcap herb, 8 to 10 parts of ophiopogon root, 8 to 10 parts of glabrous greenbrier rhizome, 8 to 10 parts of glehnia root and 11 to 13 parts of reed rhizome. The present invention can be used for treating tumor or is used as an auxiliary agent for treatment. When the present invention is used for matching with radiotherapy, the present invention can be used for preventing leukopenia; when the preparation is used for matching with radiotherapy, the preparation is capable of enhancing curative effects and preventing immunosuppression caused by chemotherapy; when the preparation is used after operative treatment, the preparation can prevent the diversion and the diffusion of cancer cells.
Description
Technical field
The present invention relates to Chinese patent medicine, particularly a kind of preparation that is used for adjuvant therapy of malignant tumor and preparation method thereof.
Background technology
The main means of treatment tumor are operations at present, chemotherapy and radiotherapy.Three kinds of method synthesis treatments of general employing.But radiotherapy and chemotherapy have tangible infringement to human body.Especially to hemopoietic system, immunologically competent cell toxic reaction, local response and digestive tract reaction often force the patient to postpone or stopped treatment, seriously delay or influence treatment and carry out.
Before the present invention proposes, Patent Office of the People's Republic of China once disclosed a kind of name and had been called " Aifukang electuary and preparation method thereof ", application number is 96119639.4 application for a patent for invention, this patent application belongs to health care medicine, the property of medicine is poor slightly with respect to accurate font size medicine, and the specific aim that is used for the treatment of is short of to some extent.
Summary of the invention
The present invention seeks in order to solve the deficiency that the above-mentioned background technology exists, a kind of preparation that is used for adjuvant therapy of malignant tumor with prepared from traditional Chinese medicines is proposed, make it can eliminate or alleviate malignant tumor patient in operation, the side effect that takes place in chemotherapy and the radiotherapy process, humoral immunization and cellular immunization there is certain potentiation, the energy leukocyte increasing, and have notable therapeutic effect.
The objective of the invention is to realize by the prescription of following Chinese herbal medicine.A kind of preparation that is used for adjuvant therapy of malignant tumor, it is characterized in that it is made up of following material medicine: Radix Ginseng, Ganoderma, Semen Coicis, Herba Agrimoniae, Rhizoma Paridis, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Ophiopogonis, Rhizoma Smilacis Glabrae, Radix Adenophorae (Radix Glehniae), Rhizoma Phragmitis, the weight proportion of above-mentioned raw materials medicine is: 5-7: 4-6: 8-10: 8-10: 2-4: 8-10: 11-13: 8-10: 8-10: 8-10: 11-13.
Preferred feedstock drug weight proportioning of the present invention: Radix Ginseng 60, Ganoderma 48, Semen Coicis 90, Herba Agrimoniae 90, Rhizoma Paridis 30, Herba Hedyotidis Diffusae 90, Herba Scutellariae Barbatae 120, Radix Ophiopogonis 90, Rhizoma Smilacis Glabrae 90, Radix Adenophorae (Radix Glehniae) 90, Rhizoma Phragmitis 120.
Another object of the present invention provides a kind of particulate preparation method of adjuvant therapy of malignant tumor that is used for.
This method starches preparation method by mother and the finished product preparation method is formed, and it is characterized in that:
Described female slurry preparation method is to adopt in the above-mentioned raw materials prescription that all the other 9 flavor material medicines decoct with water secondary except that Radix Ginseng, Semen Coicis, adds 10 times of amounts of water for the first time and decocts 2 hours, adds 8 times of amounts of water for the second time and decocts collecting decoction, standing over night, filtration 1.5 hours.Filtrate is concentrated under 50-60 ℃, the clear paste of relative density 1.20-1.28, and qinghuo reagent and Radix Ginseng, Coix Seed through pulverizing 60 mesh sieves are mixed into female slurry.
Described finished product preparation method is add sucrose, starch, dextrin in will the be above-mentioned female slurry, make granule, drying, and it is an amount of to spray into the fragrance cellulose solution, mixing.
The present invention develops on the theory and practice basis of Chinese medicine tumor.It has the effect of invigorating qi and benefiting blood, strengthening vital QI to eliminate pathogenic factors from organic conception.Can improve immunologic function, strengthen the body disease-resistant physiological reaction, eliminate the adverse effect of virulence factor, quicken poisonous substance and drain, can promote the reparation of illing tissue and the improvement of function body.
The present invention can be used for the treatment of or do the treatment adjuvant to tumor patient.When being used to cooperate radiotherapy, can being used to rescue white blood body and reducing; When being used to cooperate radiotherapy, except that heightening the effect of a treatment, can also prevent the immunosuppressant that causes because of chemotherapy; After being used for operative treatment, can prevent the transfer and the diffusion of cancerous cell.
The adjuvant therapy of malignant tumor granule that is used for of the present invention is a light brown or faint yellow, gas perfume (or spice), and it is sweet to distinguish the flavor of.
Using method: oral, three times on the one, a 15-30g.
The preparation that is used for adjuvant therapy of malignant tumor of the present invention can also be other common formulations such as unguentum, water preparation, capsule or pill.
Experimental example: be used for the clinical observation of patient after adjuvant therapy of malignant tumor electuary treatment tumor radiotherapy and the chemotherapy
One, physical data
(1) case source
Include case 193 examples altogether in, wherein: attached second hospital of Hubei medical college 75 examples, Tumour Hospital, Hubei Prov.'s department of Chinese medicine 33 examples, radiotherapy section of Tumour Hospital, Hubei Prov. 39 examples, 161 central hospitals of the Chinese People's Liberation Army, 26 examples, the hospital of traditional Chinese hospital, Wuhan City 20 examples.Major part is inpatient, and a part is a clinic case.Western medicine diagnose is patient after tumor radiotherapies such as pulmonary carcinoma, hepatocarcinoma, gastric cancer, head-neck malignant tumor, chest and mediastinum tumor, rectal cancer, bladder cancer, cervical cancer, breast carcinoma, cancer of pancreas and the chemotherapy.
(2) sex and age
In 193 routine patients, male's 123 examples, women's 70 examples.The age minimum is 11 years old, and the oldest is 70 years old, average out to 39.42 ± 29.49 years old.
Two, case is selected and curative effect determinate standard
(1) diagnostic criteria
With reference to " new Chinese medicine clinical research guideline ", Western medicine diagnose is pulmonary carcinoma, hepatocarcinoma, gastric cancer, head-neck malignant tumor, chest and mediastinum tumor, rectal cancer, bladder cancer, cervical cancer, breast carcinoma, cancer of pancreas etc.All case diagnosis all should be made a definite diagnosis with pathological diagnosis.
(2) case is included standard in:
1, meet above-mentioned diagnostic criteria:
2, side effect is obvious after tumor radiotherapy and the chemotherapy.
3, estimate life cycle more than 6 months, experimenter's muscle power is fair.
(3) case is rejected standard:
1, the age is at under-18s, over-65s, trimester of pregnancy or women breast-feeding their children or to this medicine allergy sufferers.
2, serious protopathy of the heart, liver, kidney, brain and hemopoietic system and psychotic.
3, do not meet the standard of including in, do not take medicine in accordance with regulations, can't judge the complete and judgement person that affects the treatment of curative effect or data.
(4) observe indication:
1, health giving quality index:
(1) clinical symptoms and sign: in radiotherapy, chemotherapy process, the dry pharynx of appearance, feel sick, vomiting or oral ulcer, inappetence, mistake eye and listlessness etc.;
(2) routine blood test, platelet;
(3) lymhocyte transformation rate, immunoglobulin, rosette.
2, safety indexes:
(1) blood, urine, stool routine chemical examination;
(2) liver function (ALT), renal function (BUN), electrocardiogram (EKG) are checked;
(3) the general physical examination and the untoward reaction that may occur.
3, untoward reaction is observed
Symptom appears in anaphylaxis and all non-expectations.Record is also analyzed reason, the symptom degree, and occurrence frequency, the persistent period etc., need drug withdrawal as serious symptom, take corresponding self-care measure.
(5) curative effect determinate standard:
By the evaluation of keeping the score of KARNOFSKY standards of grading, on original scoring basis, be divided into stable, improve, descend.
The KARNOFSKY standards of grading:
All are normal, no discomfort or symptom 100 minutes
Can carry out normal activity, slight symptom 90 minutes are arranged
Can carry out normal activity reluctantly, some Sxs 80 minutes are arranged
Take care of oneself, but can not keep normal activity or worked 70 fens
The life idol needs help, but can look after most of individual 60 minutes
Need a lot of help and frequent medical treatment to protect 50 fens
Lose mobility, need look after especially and help 40 fens
Seriously lose mobility, live hospital, but dead prestige 30 minutes are not arranged temporarily
Seriously ill, needed hospital and active treatment 20 minutes
Critically ill 10 minutes
Dead 0 minute
Three, the Therapeutic Method and the course of treatment:
Select for use by Central China, Wuhan City health food Research Institute be used for adjuvant therapy of malignant tumor electuary (15g/ bag), each 1-2 bag, every day 3 times, it is oral that boiled water is in harmonious proportion the back, 30-90 days is a course of treatment.Observational technique: fill in unified charting, diagnosis in accordance with regulations, fill in record front and back symptom, Signs and untoward reaction by the form regulation weekly after the treatment.Treatment before and after look routine blood test, platelet, lymhocyte transformation rate, immune globulin Pseudobulbus Bletillae (Rhizoma Bletillae) urine, stool routine, liver function (ALT), renal function (BUN), electrocardiogram (EKG) are checked.Stopping using during all case medications, all may influence the medicine of this research pharmaceutical effectiveness.Finishing the back course of treatment evaluates curative effect and safety index.
Four, result of the test
(1) efficacy analysis:
1, curative effect relatively
Curative effect relatively before and after table 4 treatment
| The example number | Stable (routine %) | Improve (routine %) | Descend (routine %) | Effective percentage (%) |
| 193 | 94(48.70) | 81(41.97) | 18(9.33) | 90.67 |
2, integration relatively
Integration comparison before and after table 5 treatment (X ± S)
| The example number | Integration before the treatment | Treatment back integration | The t value | The p value |
| 193 | 50±100 | 60±20 | 2.31 | ＜0.05 |
Through the t check, integration relatively has significant difference, P＜0.05 before and after the treatment.
3, cardinal symptom is relatively:
Cardinal symptom relatively before and after table 6 treatment
| The example number | Dry pharynx | Feel sick | Exert one's utmost effort | Oral ulcer | |
| 193 | After treating before the treatment | 79 17 | 98 28 | 39 13 | 15 7 |
Through X
2Check, cardinal symptom relatively all has significant difference, P＜0.01 before and after the treatment.
4, symptomes complice is relatively:
Symptomes complice relatively before and after table 7 treatment
| The example number | Spirit | Appetite | Sleep | |
| 193 | Stable | 36 | 31 | 38 |
| Take a turn for the better and worsen | 46 3 | 52 3 | 42 2 |
Through X
2Check, symptomes complice relatively has significant difference, P＜0.05 before and after the treatment.
5, lymhocyte transformation rate, immunoglobulin are relatively
Lymhocyte transformation rate, immunoglobulin compare (example) before and after table 8 treatment
| The example number | Project | Before the treatment | After the treatment |
| 193 | Lymhocyte transformation rate (＞50%) lgG (12 ± 2.5mg/ml) lgA (12 ± 2.5mg/ml) lgM (12 ± 2.5mg/ml) | 59 34 34 62 | 64 46 36 59 |
Through X
2Check, lymhocyte transformation rate, immunoglobulin are relatively before and after the treatment; There was no significant difference, P＞0.05.Illustrate that the Aifukang electuary has certain protective role to body's immunity.
6, platelet, erythrocyte situation
Platelet, erythrocyte situation are relatively before and after table 9 treatment
| The example number | Project | Increase | Stable | Effective percentage |
| 193 | After treating before the treatment | 85 64 | 70 106 | 80.31 88.08 |
Through X
2Check, platelet, erythrocyte situation relatively have significant difference, P＜0.05 before and after the treatment.
(2) safety indexes analysis
1, routine blood test
Hb and WBC comparison before and after table 10 treatment (X ± S)
| The example number | Hb(g/L) | WBC(x10 9/L) | |
| 193 | T value P value in treatment back before the treatment | 126.87±15.86 125.00±13.15 0.09 ＞0.05 | 3.82±1.22 5.47±2.14 2.14 ＜0.05 |
Through the t check, Hb compares there was no significant difference, P＞0.05 before and after the treatment.WBC relatively has significant difference, P＜0.05 before and after the treatment.
2, routine urinalysis
Routine urinalysis relatively before and after table 11 treatment
| The example number | Unusually | Normally | X 2 | The P value |
| 193 | After treating before the treatment | 28 13 | 48 63 | 25.21 | ＜0.05 |
Through X
2Check, routine urinalysis has significant difference, P＜0.05 before and after the treatment.
3, liver function
ALT comparison before and after table 12 treatment (X ± S)
| The example number | ALT | The t value | The P value | |
| 193 | After treating before the treatment | 16.07±5.46 17.17±5.71 | 0.334 | ＞0.05 |
Through the t check, ALT there was no significant difference before and after the treatment, P＞0.05
4, renal function
Look into BUN 126 examples before the treatment, normal 103 examples are looked into BUN 98 examples after the treatment, normal 91 examples.
5, electrocardiogram
Look into EKG 145 examples before the treatment, normal 95 examples are looked into EKG 112 examples after the treatment, normal 97 examples.
Five, untoward reaction
The lab testing contrast is found before and after treatment, blood, urine, stool routine (change that dehematize, urine, stool routine itself take place after because of tumor radiotherapy and chemotherapy), liver, renal function no abnormality seen change, do not find anaphylaxis, only there is 1 routine patient to take medicine to occur after 3 weeks stomach discomfort (1 week back disappear), surplusly do not see other side effect of digestive tract.
Six, follow up a case by regular visits to
To effective case, after drug withdrawal, follow up a case by regular visits to January, do not see obvious change.
Seven, curative effect assessment
The comprehensive statistics of result of the test shows: patient after auxilliary Conair electuary treatment tumor radiotherapy and the chemotherapy, coefficient of stabilization 48.7%, raising rate 41.97%, total effective rate 90.67%.The curative effect of auxilliary Conair electuary is through having compared significant difference, P＜0.05.
Eight, conclusion
By attached second hospital of Hubei medical college; Tumour Hospital, Hubei Prov.; 161 central hospitals of the Chinese People's Liberation Army; the tame hospitals in the hospital of traditional Chinese hospital, Wuhan City etc. four participate in is used for the clinical trial of patient after adjuvant therapy of malignant tumor electuary treatment tumor radiotherapy and the chemotherapy; adopt the method for contrast; observe qualified experimenter's 193 examples; confirmation is used for adjuvant therapy of malignant tumor electuary patient's after tumor radiotherapy and chemotherapy treatment; can improve clinical symptoms; sign; alleviate radiotherapy and the nervous system of chemotherapy and the side effect of digestive system; can protect erythrocyte; leukocyte and platelet, effect significantly is better than matched group.Body's immunity there is the certain protection effect.Effect with strengthening the body resistance, blood circulation promoting and blood stasis dispelling, benefiting qi and nourishing blood, heat-clearing and toxic substances removing, benefiting vital QI for tranquillizing.And taking convenience, fragrant and sweet good to eat, patient is easy to long-term treatment.Do not find apparent side effect.Therefore, being used for the adjuvant therapy of malignant tumor electuary is a kind of adjuvant therapy of tumors medicine, and the certain social benefit is arranged, and can be used for the treatment of patient behind the tumor radiotherapy.
Description of drawings
Accompanying drawing is a process chart of the present invention.
The specific embodiment
Embodiment 1
Material medicine prescription: Radix Ginseng 60g, Ganoderma 48g, Semen Coicis 90g, Herba Agrimoniae 90g, Rhizoma Paridis 30g, Herba Hedyotidis Diffusae 90g, Herba Scutellariae Barbatae 120g, Radix Ophiopogonis 90g, Rhizoma Smilacis Glabrae 90g, Radix Adenophorae (Radix Glehniae) 90g, Rhizoma Phragmitis 120g.
Preparation method: referring to accompanying drawing.
More than ten simply in the material medicine, Radix Ginseng, Semen Coicis pulverize separately are crossed 60 mesh sieves and are become fine powder; All the other 9 flavor material medicines decoct with water secondary, add 10 times of amounts of water (7680g) for the first time and decoct 2 hours, and add 8 times of amounts of water (6144g) for the second time and decocted 1.5 hours, collecting decoction, standing over night is filtered; Filtrate is concentrated under 50-60 ℃, the clear paste of relative density 1.20-1.28; Qinghuo reagent and above-mentioned Radix Ginseng, Semen Coicis fine powder mixing; According to the habitual method for making of granule medicine, add sucrose 250g, starch 450g, dextrin 100g at last, make granule, it is an amount of to spray into the fragrance cellulose solution, and mixing makes 1000g and is used for the adjuvant therapy of malignant tumor granule.
Embodiment 2
Material medicine prescription: Radix Ginseng 50g, Ganoderma 60g, Semen Coicis 100g, Herba Agrimoniae 80g, Rhizoma Paridis 40g, Herba Hedyotidis Diffusae 100g, Herba Scutellariae Barbatae 110g, Radix Ophiopogonis 100g, Rhizoma Smilacis Glabrae 80g, Radix Adenophorae (Radix Glehniae) 100g, Rhizoma Phragmitis 130g.
Preparation method: referring to accompanying drawing.
More than ten simply in the material medicine, Radix Ginseng, Semen Coicis pulverize separately are crossed 60 mesh sieves and are become fine powder; All the other 9 flavor material medicines decoct with water secondary, add 10 times of amounts of water for the first time and decoct 2 hours, and add 8 times of amounts of water for the second time and decocted 1.5 hours, collecting decoction, standing over night is filtered; Filtrate is concentrated under 50-60 ℃, the clear paste of relative density 1.20-1.28; Qinghuo reagent and above-mentioned Radix Ginseng, Semen Coicis fine powder mixing; According to the habitual method for making of granule medicine, add sucrose 250g, starch 450g, dextrin 100g, make granule at last, it is an amount of to spray into the fragrance cellulose solution, and mixing makes 1000g and is used for the adjuvant therapy of malignant tumor granule.
Embodiment 3
Material medicine prescription: Radix Ginseng 70g, Ganoderma 40g, Semen Coicis 80g, Herba Agrimoniae 100g, Rhizoma Paridis 20g, Herba Hedyotidis Diffusae 80g, Herba Scutellariae Barbatae 130g, Radix Ophiopogonis 80g, Rhizoma Smilacis Glabrae 100g, Radix Adenophorae (Radix Glehniae) 80g, Rhizoma Phragmitis 110g..
Preparation method: referring to accompanying drawing.
More than ten simply in the material medicine, Radix Ginseng, Semen Coicis pulverize separately are crossed 60 mesh sieves and are become fine powder; All the other 9 flavor material medicines decoct with water secondary, add 10 times of amounts of water for the first time and decoct 2 hours, and add 8 times of amounts of water for the second time and decocted 1.5 hours, collecting decoction, standing over night is filtered; Filtrate is concentrated under 50-60 ℃, the clear paste of relative density 1.20-1.28; Qinghuo reagent and above-mentioned Radix Ginseng, Semen Coicis fine powder mixing; According to the habitual method for making of granule medicine, add sucrose 250g, starch 450g, dextrin 100g, make granule at last, it is an amount of to spray into the fragrance cellulose solution, and mixing makes 1000g and is used for the adjuvant therapy of malignant tumor granule.
Claims (4)
1, a kind of preparation that is used for adjuvant therapy of malignant tumor, the material medicine that it is characterized in that it is: Radix Ginseng, Ganoderma, Semen Coicis, Herba Agrimoniae, Rhizoma Paridis, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Ophiopogonis, Rhizoma Smilacis Glabrae, Radix Adenophorae (Radix Glehniae), Rhizoma Phragmitis, the weight proportion of above-mentioned raw materials medicine is: 5-7: 4-6: 8-10: 8-10: 2-4: 8-10: 11-13: 8-10: 8-10: 8-10: 11-13.
2, according to the described a kind of preparation that is used for adjuvant therapy of malignant tumor of claim 1, it is characterized in that the weight proportion of its material medicine is: Radix Ginseng 60, Ganoderma 48, Semen Coicis 90, Herba Agrimoniae 90, Rhizoma Paridis 30, Herba Hedyotidis Diffusae 90, Herba Scutellariae Barbatae 120, Radix Ophiopogonis 90, Rhizoma Smilacis Glabrae 90, Radix Adenophorae (Radix Glehniae) 90, Rhizoma Phragmitis 120.
3, according to claim 1 or 2 described a kind of preparations that are used for adjuvant therapy of malignant tumor, the dosage form that it is characterized in that said preparation is a granule.
4, a kind ofly be used for the particulate preparation method of adjuvant therapy of malignant tumor as described in claim 3, this method starches preparation method by mother and the finished product preparation method is formed, and it is characterized in that:
A, described female slurry preparation method are to adopt in the above-mentioned raw materials prescription that all the other 9 flavor material medicines decoct with water secondary except that Radix Ginseng, Semen Coicis, add 10 times of amounts of water for the first time and decoct 2 hours, add 8 times of amounts of water for the second time and decoct collecting decoction, standing over night, filtration 1.5 hours; Filtrate is concentrated under 50-60 ℃, the clear paste of relative density 1.20-1.28, and qinghuo reagent and Radix Ginseng, Coix Seed through pulverizing 60 mesh sieves are mixed into female slurry;
B, described finished product preparation method are add sucrose, starch, dextrin in will the be above-mentioned female slurry, make granule, drying, and it is an amount of to spray into the fragrance cellulose solution, mixing.
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| CN101073611B (en) * | 2006-05-15 | 2010-11-10 | 山东轩竹医药科技有限公司 | Medicinal composition for preventing tumor |
| CN101428120B (en) * | 2007-11-06 | 2011-10-05 | 天津天士力制药股份有限公司 | Effective component of phragmites communis trin, preparation method and use thereof |
| CN103948821A (en) * | 2014-04-17 | 2014-07-30 | 刘德清 | Chinese herbal medicine pharmaceutical composition for preventing intestinal cancer |
| CN104306805B (en) * | 2014-10-22 | 2017-08-25 | 圣原健康产业有限公司 | Chinese medicine composition of strengthen immunity and preparation method and application after chemicotherapy |
| CN109224005A (en) * | 2017-07-10 | 2019-01-18 | 曾令元 | It is a kind of to treat liver cancer Chinese medicine composition and preparation method thereof |
| CN113559222A (en) * | 2021-09-14 | 2021-10-29 | 临沧宏胜生物科技开发有限公司 | Traditional Chinese medicine composition for inhibiting breast cancer cell metastasis and preparation method thereof |
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| CN1144691A (en) * | 1996-09-25 | 1997-03-12 | 周森 | Aifukang soluble granules and its preparation method |
| CN1488297A (en) * | 2003-07-28 | 2004-04-14 | 郑伟达 | Health food for cancer patient and preparing method thereof |
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| CN1144691A (en) * | 1996-09-25 | 1997-03-12 | 周森 | Aifukang soluble granules and its preparation method |
| CN1488297A (en) * | 2003-07-28 | 2004-04-14 | 郑伟达 | Health food for cancer patient and preparing method thereof |
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