CN1850236A - Method for preparing medicine for treating malignancy disease and use thereof - Google Patents
Method for preparing medicine for treating malignancy disease and use thereof Download PDFInfo
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Abstract
The present invention relates to a medicine for curing malignant tumor with obvious therapeutic effect, its preparation method and application. Said medicine is a capsule preparation made up by using the Chinese medicinal materials of astragalus root, lily bulb, ligustrum fruit, glehnia root and fenugreek seed, etc. through a certain preparation process.
Description
One, technical field:
The present invention relates to a kind of preparation method and application (purposes) that is used for the treatment of the medicine of malignancy disease.Former by name: as just to get recovering capsule.
Two, background technology:
According to World Health Organization (WHO) report, in the whole world 5,800,000,000 populations in 1996, because of cancer stricken dead have 600 surplus ten thousand people, account for the nearly 12% of total death toll, other adds and newly examines ten thousand people surplus the cancer patient 1000, ten thousand people surplus cancer patient's total number of persons has reached 4000.The statistics of China's Ministry of Public Health shows that also there is the newborn patient of malignant tumor about 1,060,000 every year in China at present, and the benign tumor patient about 106.7 ten thousand is arranged simultaneously, and both totals have 212.7 ten thousand approximately, and promptly the national sickness rate of tumor is about about 1.65 ‰.In every year, China has about 1,540,000 people approximately because of the tumor mortality number, and this number also will be with about 600,000 people's in every year speed expansion.Cancer (tumor) becomes the second largest disease of China behind cardiovascular and cerebrovascular disease.At present, China's tumor incidence presents following characteristics:
1. on the region, tumor will be apparently higher than the rural area at the prevalence and the mortality rate in city;
2. on the age, the crowd's two all prevalences in ill crowd about with 45～54 years old are the highest, this partly the patient that has with advancing age quite partly of people be transformed into malignant tumor by benign tumor;
3. on the type, mortality of malignant tumors amounts to and accounts for 99.38% of tumor mortality rate, and the benign tumor mortality rate has only 0.45%; The malignant tumor type of front three is followed successively by in mortality of malignant tumors: malignant tumor of lung, malignant tumor of liver, stomach malignancy.
Though over more than 40 year, the R﹠D and production of China's antitumor drug has obtained rapid progress, product also can not satisfy clinical growing needs far away, many dependence on import of going back, so Development and Production antitumor drug market potential is still huge.
In recent years, China antitumor medication market and hospital administration, plant alkaloid and this classification of other crude drug are the leading classifications of antitumor medication always, and the kind that plant alkaloid in 1999 and this classification before sales of other crude drug are 3 is followed successively by paclitaxel, hydroxyl happiness number alkali, Vinorebine.The market of antitumor auxiliary therapeutic agent is bigger, because tumor patient is generally through must carrying out auxiliary for a long time resuming treatment after the chemotherapy, radiotherapy, and in numerous auxiliary therapeutic agents, Chinese medicine has shown special advantages and clinical therapeutic efficacy preferably.Tool is in bigger tumour hospital of a few family statistics, and anti-swollen sick auxiliary therapeutic agent is more much bigger than the sales volume of antineoplastic agent.
Though, in recent years because the improvement and the use in conjunction of various treatment measures make more existing take on a new look of treatment for cancer effect, but about 70%～80% above patient have belonged to late period when going to a doctor, lose the surgical engine meeting, radiotherapy, chemotherapy have become the important means in the cancer patient treatment.But the chemotherapeutics weak point is not strong to cancerous cell and normal cell selectivity, and toxic reaction is bigger, and the damage hemopoietic function, and life quality is relatively poor.In a word, present conventional chemotherapy will make curative effect further quite limited, and especially patient with advanced cancer still lacks effective Therapeutic Method.Therefore; according to the middle and terminal cancer deficiency in origin and excess in superficiality; with the syndrome of deficiency of both qi and yin is most characteristics; just develop and to be used for the same of malignant tumor patient chemotherapy by recovering capsule; be aided with the toxicity that the treatment of traditional Chinese medical science the body resistance strengthening and constitution consolidating not only can alleviate chemotherapy, improve or protection leukocyte and immunologic function, improve life quality; and and chemotherapy and usefulness, also can increase curative effect.Domestic with the veriety situation, the Chinese medicine of antitumor auxiliary treatment is a lot of at present, and for example: rubescensin, KANGLAITE ZHUSHEYE, ZHENQI FUZHENG JIAONANG, golden bacterium curing capsule, ginseng one capsule, the multiple recovery oral liquid of gold, ginseng lotus capsule, peace are for gram capsule, PINGXIAO JIA0NANG etc.
State Intellectual Property Office disclosed " a kind of antitumor drug " on the 29th in December in 2004, and application number is 200410013911, and publication number is 1557392, and it is by the preparation that extracts two kinds of extract processing that contained active component respectively in Milkvetch Root.A kind of extract mainly contains Radix Astragali total saponins, and another kind of extract mainly contains astragalus polysaccharides, and two extracts are aided with adjuvant after by 1: 3～5 mixed and are processed into tablet, and granule becomes capsule.This invented technology is simple, steady quality, and significant antitumor and immunoregulation effect are arranged, and conduct is simultaneously put, the chemotherapy ancillary drug has significant attenuation, potentiation when using.
Three, summary of the invention:
Purpose of the present invention:
The objective of the invention is and will develop a kind of supplementing QI and nourishing YIN aspect the treatment malignancy disease, the kidney invigorating reinforcing is used for the preparation method and the application of the medicine of cancer patient's syndrome of deficiency of both qi and yin.The present invention is the characteristics of majority according to the theory of the traditional Chinese medical science " yin nourishing is long-pending from removing " with the tumor patient syndrome of deficiency of both qi and yin, is developed into based on QI invigorating, YIN nourishing middle and terminal cancer patients' such as treatment pulmonary carcinoma medicine.This product and chemotherapy are share the clinical syndrome that can improve tumor patient, improve immunologic function and quality of life, dwindle stable tumor focus, protection and improve peripheral hemogram and reduce the toxicity that chemotherapy causes.
Be the technical solution of the present invention that achieves the above object:
A kind of medicine that is used for the treatment of malignancy disease is characterized in that:
The composition by weight of medicine is: the Radix Astragali 430 to 650 grams, Bulbus Lilii 140 to 220 grams, Fructus Ligustri Lucidi 140 to 220 grams, Radix Glehniae 210 to 330 grams, Radix Asparagi 210 to 330 grams, Fructus Corni 140 to 220 grams, Semen Trigonellae 140 to 220 grams, Pericarpium Citri Reticulatae 40 to 70 grams.
Preparation is used for the treatment of the preparation method of the medicine of malignancy disease, it is characterized in that: get the Chinese crude drug that above-mentioned Fructus Ligustri Lucidi, Radix Glehniae and Fructus Corni three flavors are chosen, respectively through selecting, wash, after the drying, be mixed and be ground into coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 60% to 90% ethanol, flood after 24 hours, carry out percolation, collect percolate 4400 to 4800ml; Perhaps, make solvent, adopt heating reflux method to extract twice, each 1 to 2 hour with 8 times of amount 70% ethanol with above-mentioned three flavor coarse powder; The extracting solution decompression recycling ethanol of above-mentioned two kinds of methods is concentrated into relative density 1.06 to 1.10 (60 ℃ of surveys) to there not being the alcohol flavor, and is standby; All the other Radixs Astragali, Bulbus Lilii, Radix Asparagi, the Semen Trigonellae and the Pericarpium Citri Reticulatae five tastes add 10 times of water gagings at every turn and decoct 2 times, each 1 hour, merge medicinal liquid, filter, be concentrated into relative density 1.08 to 1.10 (20 ℃ of surveys), ultracentrifugal speed is 10000 rev/mins, adds above-mentioned Fructus Ligustri Lucidi again, the dextrin of Radix Glehniae and Fructus Corni three flavor ethanol extracts and 3% to 5% is after stirring, spray drying, import and outlet temperature are respectively 190～210 ℃ and 90～100 ℃, and pressure is 3.5～4.5Kg, and the dry extract that obtains adds appropriate amount of starch and granulates, dry, granulate, encapsulated, promptly.
Control the application of the medicine that is used for the treatment of malignancy disease as preparation, it is characterized in that: with the above-mentioned dry extract of obtaining that obtains, be prepared into solid form with existing mature technology, solid form is tablet, granule, powder, capsule, injectable powder; Wherein each preparation unit's effective site content of solid form is 0.1 gram～1.0 grams.
Advantage of the present invention and effect:
1. advantage:
Fructus Ligustri Lucidi, Radix Glehniae and Fructus Corni three flavor medium-height grass the effective elements of the medicines are ursolic acid, neat pier peracid, imperatorin, and the Radix Astragali, Bulbus Lilii, Radix Asparagi, Semen Trigonellae and the main effective ingredient of the Pericarpium Citri Reticulatae five tastes are astragaloside, colchicine, asparagine, trigonelline.
Just recovering capsule derive from clinical experience side, its prescription repeated screening, checking and try out in clinical practice decades in clinical, determined curative effect, and do not see toxic and side effects, just illustrate must recovering capsule to determined curative effects such as pulmonary carcinoma, hepatocarcinoma, intestinal cancer, safety is good.Just getting recovering capsule is compound Chinese medicinal preparation, and prescription meets theory of Chinese medical science and has one's own knack, and " yin nourishing is long-pending from removing " used the enriching yin and nourishing kidney medicine in the side, liver and kidney tonifying, the living sun of QI invigorating, benefiting QI for strengthening the superficies, strengthening vital QI to eliminate pathogenic factors.This medicine quality index is clear and definite, and active constituent content can be controlled exactly.It is effective to kinds of tumors just to get recovering capsule, can do deep development, will show permanent vitality.
2. just getting the recovering capsule pharmacological experiments:
1, acute toxicity, long term toxicity test result of study: rat does not see tangible toxicity.Illustrate that just getting recovering capsule does not have overt toxicity.
2, pharmacodynamic study result:
(1) to animal transplanting tumor mice S180 sarcoma, mice Lweis pulmonary carcinoma has obvious inhibitory action.
(2) merging application with chemotherapeutics has synergism, can improve therapeutic effect.
(3) leucocytes reduction due to the chemotherapeutic there is the effect of leukocyte increasing.
(4) obviously improve immunologic function, promote spleen lymphocyte proliferation, activate the generation of NK cytoactive and promotion interleukin II.
3. just getting clinical, III clinical trial phase conclusion of recovering capsule II phase:
Just get recovering capsule and having benefiting qi and nourishing yin; the function of the kidney invigorating reinforcing; by 616 routine clinical experimental studies; the result just shows to such an extent that recovering capsule and chemotherapy are share nonsmall-cell lung cancer patient to syndrome of deficiency of both qi and yin; has the clinical syndrome of improving tumor patient; improve immunologic function and quality of life; alleviate and stablize tumor focus; protection and improve effect such as peripheral hemogram; simultaneously can reduce the toxicity that the non-small cell cancer chemotherapy causes; and it is safe in utilization; no toxicity; showing just to get recovering capsule to nonsmall-cell lung cancer patients undergoing chemotherapy auxiliary treatment, is a kind of new Chinese medicine safely and effectively.
4. clinical research is summed up:
Just got recovering capsule since 1967. by the clinical treatment observation of thousands of examples, especially in the period of 1992～1994, the cancer inpatients such as primary lung cancer, gastric cancer, hepatocarcinoma, intestinal cancer and breast carcinoma of selecting 206 examples to confirm through cytopathology, the result shows, just getting health group (104 example), chemotherapy+just health group (51 example), all show after just getting health treats and obviously to improve patient's clinical symptoms, weight increase, improve life quality (KPS scoring), improve cellular immune function (NK cell, LAK cell, TL-2, CD4/CD8 ratio); Positive De Kangwu chemotherapy can also significantly alleviate the toxicity of chemotherapy, and protection bone marrow and improve the peripheral hemogram effect shows that just getting health has remarkable centralizing function.
Four specific embodiments:
Embodiment 1: the medical material that takes by weighing 2 recipe quantities, Fructus Ligustri Lucidi, Radix Glehniae, Fructus Corni three flavors are ground into coarse powder, with 8 times of amount ethanol of 70% as solvent, adopt percolation to extract, extracting solution reclaims ethanol to not having alcohol flavor, all the other Radixs Astragali, Bulbus Lilii, Radix Asparagi, the Semen Trigonellae and the Pericarpium Citri Reticulatae five tastes add 10 times of water gagings at every turn and decoct each 1 hour 2 times, merge medicinal liquid, filter, be concentrated into relative density 1.08 to 1.10 (20 ℃ of surveys), ultracentrifugal speed is 10000 rev/mins, add above-mentioned Fructus Ligustri Lucidi again, the dextrin of Radix Glehniae and Fructus Corni three flavor ethanol extracts and 3% to 5%, after stirring, spray drying, import and outlet temperature are respectively 190～210 ℃ and 90～100 ℃, pressure is 4.0Kg, the dry extract that obtains adds appropriate amount of starch and granulates drying, granulate, encapsulated, promptly.
Embodiment 2: the medical material that takes by weighing recipe quantity, Fructus Ligustri Lucidi, Radix Glehniae, Fructus Corni three flavors are ground into coarse powder, with 8 times of amount ethanol of 70% as solvent, adopt heating reflux method to extract 2 times, extracting solution reclaims ethanol to not having alcohol flavor, all the other Radixs Astragali, Bulbus Lilii, Radix Asparagi, the Semen Trigonellae and the Pericarpium Citri Reticulatae five tastes add 10 times of water gagings at every turn and decoct each 1 hour 2 times, merge medicinal liquid, filter, be concentrated into relative density 1.08 to 1.10 (20 ℃ of surveys), ultracentrifugal speed is 10000 rev/mins, add above-mentioned Fructus Ligustri Lucidi again, the dextrin of Radix Glehniae and Fructus Corni three flavor ethanol extracts and 3% to 5%, after stirring, spray drying, import and outlet temperature are respectively 200 ℃ and 95 ℃, pressure is 4.0Kg, the dry extract that obtains adds appropriate amount of starch and granulates drying, granulate, encapsulated, promptly.
Embodiment 3: get 23 parts of medicines as 23 components, its every component weight composition is respectively:
The Radix Astragali 430,440,450,460,470,480,490,500,510,520,530,540,550,560,570,580,590,600,610,620,630,640 and 650 grams,
Bulbus Lilii 140,145,150,155,160,162,165,168,170,173,175,178,180,182,185,188,190,193,195,200,205,210 and 220 grams,
Fructus Ligustri Lucidi 140,145,150,155,158,160,162,165,168,170,173,175,178,180,182,185,188,190,195,200,205,210 and 220 grams,
Radix Glehniae 210,215,220,225,230,235,240,245,250,255,260,265,270,275,280,285,290,295,300,305,310,320 and 330 grams,
Radix Asparagi 210,215,220,225,230,235,240,245,250,255,260,265,270,275,280,285,290,295,300,305,310,320 and 330 grams,
Fructus Corni 140,145,150,155,158,160,162,165,168,170,173,175,178,180,182,185,188,190,195,200,205,210 and 220 grams,
Semen Trigonellae 140,145,150,155,158,160,162,165,168,170,173,175,178,180,182,185,188,190,195,200,205,210 and 220 grams,
Pericarpium Citri Reticulatae 43,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65 and 70 grams.
Preparation is used for the treatment of the preparation method of the medicine of malignancy disease, above-mentioned 23 groups are prepared respectively, all get the Chinese herbal medicine that above-mentioned Fructus Ligustri Lucidi, Radix Glehniae and Fructus Corni three flavors are chosen for every group, respectively through selecting, wash, after the drying, being mixed is ground into coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 70% to 90% ethanol, flood after 24 hours, carry out percolation, collect percolate 4400 to 4800ml; Perhaps, make solvent, adopt heating reflux method to extract twice, each 1 to 2 hour with 8 times of amount 70% ethanol with above-mentioned three flavor coarse powder; The extracting solution decompression recycling ethanol of above-mentioned two kinds of methods is concentrated into relative density 1.06 to 1.10 (60 ℃ of surveys) to there not being the alcohol flavor, and is standby; All the other Radixs Astragali, Bulbus Lilii, Radix Asparagi, the Semen Trigonellae and the Pericarpium Citri Reticulatae five tastes add 10 times of water gagings at every turn and decoct 2 times, each 1 hour, merge medicinal liquid, filter, be concentrated into relative density 1.08 to 1.10 (20 ℃ of surveys), ultracentrifugal speed is 10000 rev/mins, add above-mentioned Fructus Ligustri Lucidi again, the dextrin of Radix Glehniae and Fructus Corni three flavor ethanol extracts and 3% to 5%, after stirring, spray drying, import and outlet temperature are respectively 190～210 ℃ and 90～100 ℃, pressure is 4.0Kg, the dry extract that obtains adds appropriate amount of starch and granulates drying, granulate, encapsulated, packing is up to the standards, and promptly gets 23 parts.
Implement 4: form and the adjuvant composition with the Chinese medicine ingredient of the foregoing description 1,2,3, be prepared into solid form with existing mature technology, solid form is tablet, granule, powder, capsule, injectable powder; Wherein each preparation unit's drug content of solid form is that 0.1 gram is to 1.0 grams; Capsule principal agent amount be 0.1 gram to 1.0 gram/grains, instructions of taking is every day 4 times, each 1～4.Tablet principal agent amount be 0.1 gram to 1.0 gram/sheets, instructions of taking is every day 4 times, each 1～4.Granule principal agent amount be 0.1 gram to 1.0 gram/bags, instructions of taking is every day 4 times, each 1～4.Powder principal agent amount be 0.1 gram to 1.0 gram/bags, instructions of taking is every day 4 times, each 1～4.Injectable powder principal agent amount for each preparation unit be 0.1 gram to 1.0 grams, using method is every day 4 times, each 1～4 preparation unit.
Claims (3)
1, a kind of medicine that is used for the treatment of malignancy disease, it is characterized in that: the composition by weight of medicine is: the Radix Astragali 430 to 650 grams, Bulbus Lilii 140 to 220 grams, Fructus Ligustri Lucidi 140 to 220 grams, Radix Glehniae 210 to 330 grams, Radix Asparagi 210 to 330 grams, Fructus Corni 140 to 220 grams, Semen Trigonellae 140 to 220 grams, Pericarpium Citri Reticulatae 40 to 70 grams.
2, preparation is used for the treatment of the preparation method of the medicine of malignancy disease, it is characterized in that: get the Chinese crude drug that above-mentioned Fructus Ligustri Lucidi, Radix Glehniae and Fructus Corni three flavors are chosen, respectively through selecting, wash, after the drying, be mixed and be ground into coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 60% to 90% ethanol, flood after 24 hours, carry out percolation, collect percolate 4400 to 4800ml; Perhaps, make solvent, adopt heating reflux method to extract twice, each 1 to 2 hour with 8 times of amount 70% ethanol with above-mentioned three flavor coarse powder; The extracting solution decompression recycling ethanol of above-mentioned two kinds of methods is concentrated into relative density 1.06 to 1.10 (60 ℃ of surveys) to there not being the alcohol flavor, and is standby; All the other Radixs Astragali, Bulbus Lilii, Radix Asparagi, the Semen Trigonellae and the Pericarpium Citri Reticulatae five tastes add 10 times of water gagings at every turn and decoct 2 times, each 1 hour, merge medicinal liquid, filter, be concentrated into relative density 1.08 to 1.10 (20 ℃ of surveys), ultracentrifugal speed is 10000 rev/mins, adds above-mentioned Fructus Ligustri Lucidi again, the dextrin of Radix Glehniae and Fructus Corni three flavor ethanol extracts and 3% to 5% is after stirring, spray drying, import and outlet temperature are respectively 190～210 ℃ and 90～100 ℃, and pressure is 3.5～4.5Kg, and the dry extract that obtains adds appropriate amount of starch and granulates, dry, granulate, encapsulated, promptly.
3, control the application of the medicine that is used for the treatment of malignancy disease as preparation, it is characterized in that: with above-mentioned obtain obtain in extract powder, be prepared into solid form with existing mature technology, solid form is tablet, granule, powder, capsule, injectable powder; Wherein each preparation unit's effective site content of solid form is 0.1 gram～1.0 grams.
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