CN103040893B - Pharmaceutical composition for treating liver cancers and preparation method thereof - Google Patents
Pharmaceutical composition for treating liver cancers and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating liver cancers, and relates to the technical field of traditional Chinese medicines. The pharmaceutical composition is prepared by taking poria cocos, fructus arctii, ganoderma lucidum, ginseng and atorvastatin calcium as raw materials. The invention provides a bran-new pharmaceutical composition for treating liver cancers; and the pharmaceutical composition is low in cost, good in curative effect, and simple and practicable in preparation process, and has good social and economic values.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of pharmaceutical composition of Hepatoma therapy.
Background technology
Hepatocarcinoma refers to the malignant tumor that betides liver, comprises two kinds of primary hepatocarcinoma and secondary liver cancers, and mostly the hepatocarcinoma of the daily theory of people is primary hepatocarcinoma if referring to.Primary hepatocarcinoma is one of modal malignant tumor clinically, and according to recent statistics, the annual new liver cancer patient approximately 600,000 in the whole world, occupies the 5th of malignant tumor.Primary hepatocarcinoma can be divided into Hepatocellular carcinoma, intrahepatic cholangiocarcinoma and mixed carcinoma of liver by cell typing.
It is high that Chinese patent CN 102302663 records Primary Hepatic mortalities of carcinoma, is only second to stomach, esophagus and occupies the 3rd in mortality of malignant tumors cis-position, accounts for second in the rural area of Electric Field At Ground In Partial Region, is only second to gastric cancer.China dies from hepatocarcinoma approximately 110,000 people every year, accounts for 45% of whole world PLC mortality number.Therefore, strengthen the research of primary liver cancer, extend the survival of patients phase, improve curative effect, improving patients ' life quality is clinical tumor worker's the task of top priority.Hepatocarcinoma primary treatment means are excision, and early stage postoperative 1 year, 3 years and 5 years survival rates are respectively 80%-92%, 61%-86% and 41%-75%.But 90% patient loses surgical engine meeting compared with large or liver cirrhosis because of tumor; Normal liver cell is responsive to lonizing radiation, and hepatoma carcinoma cell sensitivity is poor, needs > 4000cGy just may obtain certain Partial controll; Local ablation therapy can play the effects such as Partial controll tumor, relief of symptoms, and the treatment that can be used as the excision patient that can not undergo surgery is selected, but it is effective only tumor to be less than to the hepatocarcinoma of 5cm; Chemotherapeutics is to the partial rcsponse rate of hepatocarcinoma all below 20%, and curative effect is undesirable; Trans-hepatic artery conduit chemoembolization (TACE) or TACE add portal vein embolization (PVE) improves effective percentage, also be improved life cycle, but still need further research at whether complete, the best medication combined and best aspects such as thromboembolism type of arterial thrombosis; Biological targeting is treated the effective percentage of primary hepatocarcinoma all lower than 10%.
To sum up, existing medical skill still needs to strengthen the further research to liver cancer treatment.Treatment by Chinese herbs hepatocarcinoma has obtained significant progress in recent years, but combination of Chinese and Western medicine medicine is also very rare in the market, has potential advantages.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition of Hepatoma therapy, for the treatment of hepatocarcinoma provides a kind of new effective medicine.
The present invention is achieved through the following technical solutions:
The pharmaceutical composition of a kind of Hepatoma therapy provided by the invention, is made by the medical material of following weight portion: Poria 2500-8000 part, Fructus Arctii 1000-3000 part, Ganoderma 500-1500 part, Radix Panacis Quinquefolii 500-2000 part, Atorvastatin calcium 0.05-1.
Preferably, the pharmaceutical composition of above-mentioned Hepatoma therapy, is made by the medical material of following weight portion: Poria 3000-6000 part, Fructus Arctii 1500-2000 part, Ganoderma 500-1000 part, Radix Panacis Quinquefolii 1000-1500 part, Atorvastatin calcium 0.1-0.5 part.
Most preferably, the pharmaceutical composition of above-mentioned Hepatoma therapy, is made by the medical material of following weight portion: 3800 parts, Poria, 1600 parts of Fructus Arctiis, 600 parts of Ganodermas, 1000 parts of Radix Panacis Quinquefoliis, 0.2 part of Atorvastatin calcium.
Side of the present invention separates:
Poria: be commonly called as Poria, Song Ling, Poria, for colonizing in the fungi plant on pinaster root, nature and flavor: sweet, light, flat.Gui Jing: GUIXIN warp, lung meridian, spleen channel, kidney channel.Be used as medicine there is promoting diuresis to eliminate damp pathogen, the function of strengthening the spleen stomach function regulating, mind tranquilizing and the heart calming.Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
Fructus Arctii: be Compositae biennial herb plant Fructus Arctii (formal name used at school: dry mature fruit Arctium lappa L.).Acrid in the mouth; Bitter; Cold in nature.Return lung; Stomach warp.Modern study, Fructus Arctii also can be used for preventing and treating diabetic nephropathy; The arctigenin that Fructus Arctii fruit generates through hydrolysis containing arctigenin has active anticancer.
Ganoderma: claiming again Ganoderma lucidum seu Japonicum, Ganoderma, Ganoderma lucidum seu Japonicum, Herba mesonae chinensis, Ganoderma, is the Herb of Polyporaceae plant Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma.Property be sweet, flat.GUIXIN, liver, spleen, lung, the kidney Five Classics.Cure mainly asthenia, cough, asthma, insomnia, dyspepsia, malignant tumor etc.Modern pharmacology through scientific research institution many decades studies confirm that, Ganoderma, for strengthening body immunity, regulates blood glucose, controls blood pressure, auxiliary tumor chemoradiotherapy, and hepatoprotective, the aspects such as hypnotic all have significant curative effect.
Radix Panacis Quinquefolii: formal name used at school: Panax quinquefolius is a kind of of Radix Ginseng, claims again panacis quinquefolii radix.Property, sweet, micro-hardship, cool.GUIXIN, lung, kidney channel.Can regulate central nervous system's excitement and inhibition, comparatively give prominence to suppressing; Energy resisting fatigue, anti-hypoxia, enhancing body adaptive capacity; There is arrhythmia, resist myocardial ischemia, strengthen the effect of myocardial contraction; There is the effect that promotes adrenocortical hormone secretion; Energy enhancing human body immunity function; There are diuresis and anastalsis.
Atorvastatin calcium, is statins, and research shows statins energy inhibition tumor cell propagation, induces its differentiation or apoptosis, and to normal cell without obvious toxic-side effects.
Pharmaceutical composition of the present invention can add one or more pharmaceutically acceptable carriers, is applied to the patient of this treatment of needs in the mode of oral or parenteral.When oral, can be made into conventional solid preparation, as tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, make liquid preparation if water or oil-suspending agent or other liquid preparation are as syrup etc.; During for parenteral, can be made into solution, water or the oil-suspending agent etc. of injection, as liquid drugs injection, freeze-dried powder, aseptic powder injection, transfusion etc.The preferred dosage form of this compositions is oral formulations or injection, as sheet, capsule, granule, powder pin, liquid drugs injection, transfusion etc.
Pharmaceutical composition of the present invention can adopt the conventional method in existing pharmaceutical field to produce, and when needing, can add various pharmaceutically acceptable carriers.Described carrier comprises excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant of pharmaceutical field routine etc.
Pharmaceutical composition of the present invention is when making oral formulations, and selectable filler has: starch, Icing Sugar, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Selectable binding agent has: sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Selectable disintegrating agent has: dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Selectable lubricant has; Magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
Pharmaceutical composition of the present invention, when making injection, in order to increase its dissolubility, can add the solubilizing agents such as polyoxyethylene sorbitan monoleate.In transfusion, can add for regulating the isoosmotic adjusting agent of osmotic pressure, for example, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, xylitol, sorbitol and dextran etc., preferably sodium chloride or glucose.In powder pin, can add excipient, for example, mannitol, glucose etc.
Pharmaceutical composition of the present invention is preferably oral formulations, and described oral formulations is preferably tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule.
The pharmaceutical composition preparation technology of Hepatoma therapy of the present invention comprises following steps:
1) by the present invention's prescription, take the medical materials such as Poria, Fructus Arctii, Ganoderma, Radix Panacis Quinquefolii, pulverized 80 mesh sieves, add 8-10 doubly to measure alcohol reflux secondary, each 2-4 hour, merge extractive liquid,, filters, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.
2) get medicinal residues after step 1) alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.
3) get step 1) gained ethanol extract, step 2) gained water extract, jointly pulverize, cross 120 mesh sieves, add Atorvastatin calcium mix homogeneously, add pharmaceutically acceptable carrier, by the conventional formulation method in existing pharmaceutical field, be prepared into above-mentioned oral formulations, be preferably granule or capsule.
The present composition has the following advantages:
1) provide a kind of brand-new cancer treatment drug, met urgent clinical needs.
2) pharmaceutical composition of the present invention has significant inhibitory action to the growth of tumor, and total effective rate can reach more than 80%.
3) drug regimen raw material of the present invention is easy to get, and preparation technology is simple, is easy to promote.
the inhibition experiment of pharmaceutical composition of the present invention to tumor cells of hepatocellular carcinoma strain
One, material
1, medicine: the medicine that the present invention most preferably writes out a prescription and prepares.
2, animal: Kunming mouse, body weight 18-22 gram.
3, tumor strain: hepatocarcinoma HepS22, is provided by Chinese Academy of Medical Sciences's biotechnology.
Two, experimental technique:
Get the lotus tumor de-cervical vertebra of Mus that goes down to posterity and put to death, be fixed on plate, cut skin, select tumor growth good, without cancerous tissue downright bad or liquefaction, by 1: 3, add physiological saline solution, with Potter-Elvehjem Tissue Grinders, make cell suspension, in experiment mice axillary fossa subcutaneous vaccination 0.2ml.55 male mouses of each experiment inoculation, use female Mus instead while repeating to test, inoculation rear next day of random packet, 11 every group.High, medium and low three dosage groups and matched group and positive drug control group are established in experiment, and wherein high dose is 1g/kg body weight, and middle dosage is 0.5g/kg body weight, and low dosage is 0.25g/kg body weight.Positive drug is cyclophosphamide 20mg/kg body weight, gastric infusion, and once a day, administration is put to death for 10 days afterwards.Weigh, pluck tumor, weigh, calculate tumour inhibiting rate, computing formula is as follows:
Three, experimental result
Table 1: the impact of medicine on HepS solid tumor
Above-mentioned experimental result shows, pharmaceutical composition of the present invention has obvious inhibitory action to mouse experiment hepatocarcinoma tumor.
the routine clinical experimental data of pharmaceutical composition 180 of the present invention
One, case selection
1, diagnostic criteria
1.1 Western medicine diagnose standards
With reference to China Ministry of Public Health Department of Medical Administration, compile the primary hepatic carcinoma diagnosis standard of < < China common cancer diagnosis and treatment standard > > (second edition, 1991).
1.2 Standards of Chinese Medical Syndrome Differentiation
Syndrome of deficiency of both qi and yin, blood stasis liver depression, with reference to the < < of State Bureau of Technical Supervision traditional Chinese medical science disease classification and code > > (Beijing: state standard publishing house, 1995,21)
2, case inclusive criteria
2.1 have the primary hepatocarcinoma of clarifying a diagnosis, and belong to the patient of clinical II phase and III phase;
2.2 Chinese medical discriminations belong to the patient of deficiency of both QI and YIN, blood stasis stagnation of liver-QI pattern of syndrome;
2.3 estimate that existence is more than 3 months person;
2.4 ages, the patient in 18-70 year, were got rid of Pregnant and lactant women;
3, test method:
Patient takes the granule that the embodiment of the present invention 1 makes, and each 5 grams, every day 3 times, warm boiled water.Within 2 months, be 1 course for the treatment of, 1 course for the treatment of of medication.
Curative effect determinate standard:
Effective: cardinal symptom is obviously improved or disappeared, and focus is dwindled more than 1/2, and continue more than 1 month.
Effective: cardinal symptom makes moderate progress or obviously improves, and focus is dwindled more than 1/4, and continues more than 1 month.
Invalid: cardinal symptom is without improving or increasing the weight of, the unchanged or development of focus.
4
,result of the test:
Table 1: therapeutic efficacy for hepatic carcinoma analysis
| Criterion of therapeutical effect | Case load | Effective | Effectively | Invalid | Effective percentage |
| Hepatocarcinoma disease | 180 | 19 | 126 | 35 | 80.6% |
Pharmaceutical composition of the present invention can play fine treatment or relief of symptoms effect to hepatocarcinoma, has 19 routine patient's focuses and dwindles more than 1/2, and effective case can reach more than 10%, and the total effective rate of Hepatoma therapy reaches more than 80.6%.Visible the present invention has healing effect to some cases, but because the concrete reason of morbidity is difficult to determine and patient's individual variation be now difficult to determine which concrete patient is had to specially good effect, needs numerous medical personnels do in this respect further experimentation.Nonetheless, pharmaceutical composition of the present invention is still a kind of comparatively ideal Hepatoma therapy medicine.
The specific embodiment
Below will further illustrate the present invention by specific embodiment, but and not limit the present invention in any way.
The preparation of embodiment 1 granule of the present invention
By the present invention's prescription, take Poria 3800g, Fructus Arctii 1600g, Ganoderma 600g, Radix Panacis Quinquefolii 1000g, pulverized 80 mesh sieves, add 8 times of amount alcohol reflux secondaries, each 4 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.2g mix homogeneously, according to common process, add the agent of conventional adjuvant granulation.
Embodiment 2: the preparation of capsule of the present invention
By the present invention's prescription, take Poria 3800g, Fructus Arctii 1600g, Ganoderma 600g, Radix Panacis Quinquefolii 1000g, pulverized 80 mesh sieves, add 8 times of amount alcohol reflux secondaries, each 4 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.3g mix homogeneously, according to common process, add conventional adjuvant to make capsule.
Embodiment 3: the preparation of granule of the present invention
By the present invention's prescription, take Poria 3000g, Fructus Arctii 1500g, Ganoderma 500g, Radix Panacis Quinquefolii 1200g, pulverized 80 mesh sieves, add 10 times of amount alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.1g mix homogeneously, according to common process, add the agent of conventional adjuvant granulation.
Embodiment 4: the preparation of capsule of the present invention
By the present invention's prescription, take Poria 6000g, Fructus Arctii 2000g, Ganoderma 1000g, Radix Panacis Quinquefolii 1500g, pulverized 80 mesh sieves, add 8 times of amount alcohol reflux secondaries, each 4 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.5g mix homogeneously, according to common process, add conventional adjuvant to make capsule.
Embodiment 5: the preparation of tablet of the present invention
By the present invention's prescription, take Poria 4500g, Fructus Arctii 1800g, Ganoderma 800g, Radix Panacis Quinquefolii 1200g, pulverized 80 mesh sieves, add 8 times of amount alcohol reflux secondaries, each 4 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.4g mix homogeneously, according to common process, add conventional adjuvant to make tablet.
Embodiment 6: the preparation of tablet of the present invention
By the present invention's prescription, take Poria 3200g, Fructus Arctii 1200g, Ganoderma 800g, Radix Panacis Quinquefolii 1000g, pulverized 80 mesh sieves, add 10 times of amount alcohol reflux secondaries, each 3 hours, merge extractive liquid,, filtered, decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract.Get medicinal residues after alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying is water extract.Ethanol extract and water extract are pulverized jointly, crossed 120 mesh sieves, add Atorvastatin calcium 0.2g mix homogeneously, according to common process, add conventional adjuvant to make tablet.
Claims (6)
1. a pharmaceutical composition for Hepatoma therapy, is characterized in that being made by the medical material of following weight portion: Poria 2500-8000 part, Fructus Arctii 1000-3000 part, Ganoderma 500-1500 part, Radix Panacis Quinquefolii 500-2000 part, Atorvastatin calcium 0.05-1 part.
2. the pharmaceutical composition of a kind of Hepatoma therapy as claimed in claim 1, is characterized in that being made by the medical material of following weight portion: Poria 3000-6000 part, Fructus Arctii 1500-2000 part, Ganoderma 500-1000 part, Radix Panacis Quinquefolii 1000-1500 part, Atorvastatin calcium 0.1-0.5 part.
3. the pharmaceutical composition of a kind of Hepatoma therapy as claimed in claim 2, is characterized in that being made by the medical material of following weight portion: 3800 parts, Poria, 1600 parts of Fructus Arctiis, 600 parts of Ganodermas, 1000 parts of Radix Panacis Quinquefoliis, 0.2 part of Atorvastatin calcium.
4. the preparation method of the pharmaceutical composition of the Hepatoma therapy as described in as arbitrary in claim 1-3, is characterized in that comprising following processing step:
1) take Poria, Fructus Arctii, Ganoderma, Radix Panacis Quinquefolii, pulverized 80 mesh sieves, add 8-10 and doubly measure alcohol reflux secondary, each 2-4 hour, merge extractive liquid,, filters, and decompression recycling ethanol is also concentrated into thick paste, and vacuum drying obtains ethanol extract;
2) get medicinal residues after step 1) alcohol extraction, add 10 times of water gagings and decoct three times, each 2 hours, collecting decoction, it is 1.15～1.20 that filtrate decompression is concentrated into relative density, vacuum drying obtains water extract;
3) get step 1) gained ethanol extract, step 2) gained water extract, jointly pulverize, cross 120 mesh sieves, add Atorvastatin calcium mix homogeneously, add pharmaceutically acceptable carrier, by the conventional formulation method in existing pharmaceutical field, be prepared into oral formulations.
5. the preparation method of the pharmaceutical composition of Hepatoma therapy as claimed in claim 4, is characterized in that: described pharmaceutically acceptable carrier is one or more in filler, binding agent, wetting agent, disintegrating agent, lubricant.
6. the pharmaceutical composition of Hepatoma therapy as claimed in claim 4, is characterized in that: described oral formulations is soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet or controlled release capsule.
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Non-Patent Citations (4)
| Title |
|---|
| 中医新八法在抗肿瘤中的应用;胡世林等;《中国药业》;20071231;第16卷(第18期);第53-54页 * |
| 刘蔚等.阿托伐他汀抑制肝癌细胞增殖作用的研究.《天津医药》.2010,第38卷(第6期),第502-504页. |
| 胡世林等.中医新八法在抗肿瘤中的应用.《中国药业》.2007,第16卷(第18期),第53-54页. |
| 阿托伐他汀抑制肝癌细胞增殖作用的研究;刘蔚等;《天津医药》;20100630;第38卷(第6期);第502-504页 * |
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