CN1634499A - Traditional Chinese medicine composition, its preparation method and application for preparing medicine to treat cancer - Google Patents
Traditional Chinese medicine composition, its preparation method and application for preparing medicine to treat cancer Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicinal composition, its preparation method and use in preparing medicament for treating tumors. The traditional Chinese medicinal composition is prepared from astragalus root, gen-seng, flavescent sophora root, black nightshade and paeonia obovata maxim by a finite weight proportion.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, its preparation method and the application in preparation medicine for treating tumor thing thereof.
Background technology
Tumor incidence and mortality rate rise year by year, and the serious threat human health has become one of human main causes of death.All dropped into a large amount of human and material resources both at home and abroad at present, financial resources are captured the research of tumor, but still lack effective medicine.The inoperable tumor of western medical treatment is many, and its shortcoming is: 1, the toxicity of chemicotherapy is obvious based on chemicotherapy, and the patient is difficult to bear; 2, weak old person and non-chemicotherapy eligible patients lack medicine.Above problem just is the advantage of Chinese traditional treatment tumor, and motherland's medical science has accumulated a large amount of experiences in secular clinical practice, and the toxicity and the late tumor medication that solve chemicotherapy are the characteristics of Chinese traditional treatment tumor.The traditional Chinese medical science thinks that mostly tumorigenic main cause is the deficiency of vital energy, blood stasis, poison knot, the sick vital QI being weakened and pathogen being violent that belongs to; Treatment benefit is invigorated blood circulation in QI invigorating, detoxifcation, need hold up just, eliminating the pathogen can prove effective.The advantage of Chinese traditional treatment tumor is that dialectical opinion controls, and different medicines make up, and reach combined therapy effect.Chinese medicine has long history and rich experience, is the important component part of combined therapy of tumour.The advantage of Chinese medicine tumor be mainly reflected in following some:
1, uses the effect that Chinese medicine can play attenuation synergistic during the chemicotherapy;
2, postoperative is put, is adhered to taking Chinese medicine for a long time after the chemotherapy and can stablize the state of an illness, improves long-term effect, and reducing relapse and metastasis may;
3, for not undergoing surgery late period and patient's Chinese medicine of chemicotherapy can improve symptom, improve life quality, prolong life.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition, this Chinese medicine composition has that QI invigorating is set upright, the effect of detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, can improve the chemotherapy of tumors curative effect, alleviates chemotherapy side effect, is used for tumor chemoradiotherapy and late tumor auxiliary treatment.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
A further object of the invention provides the application of this Chinese medicine composition in preparation medicine for treating tumor thing.
Chinese medicine composition provided by the invention is prepared from by the following weight proportion raw material:
Radix Astragali 10-15 part Radix Ginseng 3-5 part Radix Sophorae Flavescentis 8-12 part
Herba Solani Nigri 8-12 part Radix Paeoniae Rubra 5-8 part.
Chinese medicine composition of the present invention preferably is prepared from by the following weight proportion raw material:
10 parts of 4 parts of Radix Sophorae Flavescentiss of 13.3 parts of Radix Ginsengs of the Radix Astragali
6.7 parts of 10 parts of Radix Paeoniae Rubra of Herba Solani Nigri.
Chinese medicine composition of the present invention can be prepared into various preparations by the ordinary skill in the art, comprises oral formulations, as capsule, tablet, electuary, powder or oral liquid.
The present invention also provides the preparation method of this Chinese medicine composition, and this method comprises the steps:
1) get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add the ethanol extraction twice of 70%-90%, add pure 6-8 at every turn and doubly measure, filter, merging filtrate reclaims ethanol, and drying is ground into fine powder, and is standby;
Residue water 8-10 doubly measures, and extracts 40-60 minute, filters, filtrate is concentrated into the fluid extract of relative density 1.06-1.10 (60 ℃), add 40% ethanol precipitation of equivalent, get supernatant, reclaiming ethanol to relative density is the fluid extract of 1.05-1.08 (60 ℃), adding ethanol makes and contains alcohol amount and reach 70%, leave standstill, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
2) get Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion in addition, extracting in water twice adds water 5-8 at every turn and doubly measures respectively, filters, merging filtrate is concentrated into the fluid extract of relative density 1.10-1.14 (60 ℃), adds the ethanol of 4 times of amounts, places, get supernatant, reclaim ethanol, drying is ground into fine powder;
Above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
The preferred for preparation method of Chinese medicine composition of the present invention comprises the steps:
1) get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add 6 times of amounts of 90% ethanol, extract secondary, filter, merge secondary filtrate, reclaim ethanol, drying is ground into fine powder, and is standby;
Residue adds 10 times of amounts of water and extracted 1 hour, filters, and filtrate is concentrated into the fluid extract of relative density 1.08-1.10 (60 ℃), 40% alcoholic solution that adds equivalent, place, get supernatant, reclaim the fluid extract of ethanol to relative density 1.05-1.08 (60 ℃), continue and add 4 times of amount ethanol, place, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
2) get Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion in addition, add 7 times of amounts of water respectively and 5 times of amounts are extracted secondaries, filter merging filtrate, be concentrated into the fluid extract of relative density 1.10～1.14 (60 ℃), add 4 times of amount ethanol again, place, get supernatant, reclaim ethanol, drying is ground into fine powder;
3) above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
Chinese medicine composition of the present invention has been brought into play the multi-section position of Chinese medicine, the effect of many target spots, according to tumor take place, the main cause and the rule of development, utilization is set upright and the eliminating evil principle that combines, and QI invigorating, detoxifies, invigorates blood circulation, and is eliminating evil and just do not hinder; Flavour of a drug are few, but effect is complete, clinical confirmation not only can alleviate the toxicity of chemicotherapy, increase the curative effect of chemicotherapy, to controlling tumor growth with the patient who is not suitable for chemicotherapy late period, improve symptom, improve the quality of living, prolong life span, given full play to the effect of Chinese medicine in combined therapy of tumour.
The main effect of Chinese medicine composition of the present invention is to set upright consolidating superficial resistance, detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, is applicable to fatigue and weakness, deficiency of QI with disinclination to talk, the costa sternales distension, lack of appetite is indigestion and loss of appetite, heating, the tumor patient of diseases such as pain can improve the chemicotherapy curative effect of tumor patient, alleviates the chemicotherapy side effect; Be applicable to the auxiliary treatment of tumor chemoradiotherapy and late tumor.
The present invention also provides the application of this Chinese medicine composition in preparation medicine for treating tumor thing.
Below by the research of several aspects the beneficial effect of technical solution of the present invention is described.
1, pharmacodynamics test
1), improves the tumor-bearing mice immunologic function
Its immunologic function is obviously low behind the animal inoculation S180, behind oral capsule of the present invention, tumor animal HC50 splenocyte NK cytoactive and ConA respond and serum il-2 and TNF content all have obvious potentiation, with lotus tumor group significantly (P＜0.05) and highly significant (P＜0.01) property difference are arranged relatively respectively, and certain dose-effect relationship is arranged, point out capsule of the present invention that the tumor-bearing mice raise immunity is had significantly effect.
2), improve immune function of mice
Oral capsule of the present invention can make because of the cell of injection caused by cyclophosphamide immunologic hypofunction mice and humoral immune function and be restored and improve.Wherein improve the most obvious with immune function of mice after the administration of middle and high dosage group.
3), to tumor-bearing mice tumour inhibiting rate efficacy of medicine observing
Capsule of the present invention all has the obvious suppression effect to Lewis lung cancer mice, H22 liver cancer mouse tumor growth.Its tumour inhibiting rate is respectively 72.9-29.7% and 69.2-21.5%, has compared significantly or highly significant difference (P＜0.05 or 0.01) contrasting group with blank respectively, and dose-effect relationship is preferably arranged.The high dose administration also has certain inhibitory action to S180 sarcoma Mus tumor growth, and its tumour inhibiting rate is 47.2-6.6%.(under the experimental result shown in the subordinate list 1,2,3)
Table 1, capsule of the present invention are observed the tumour inhibiting rate of Lewis lung cancer mice:
Number of animals body weight (g)The heavy tumour inhibiting rate of tumor
Group P value
Begin to finish to begin to finish (g) (%)
Blank group 12 12 19.7 ± 1.21+2.5 2.52 ± 0.86--------
High dose group 12 12 20.7 ± 0.98+1.0 0.74 ± 0.24 70.6＜0.01
Middle dosage group 12 12 20.0 ± 1.21+0.9 1.07 ± 0.42 57.5＜0.01
Low dose group 12 12 19.8 ± 1.03+1.8 1.37 ± 0.30 45.6＜0.01
Cyclophosphamide group 12 12 20.0 ± 1.21+0.5 0.52 ± 0.12 88.9＜0.01
Table 2, capsule of the present invention are to H
22The tumour inhibiting rate of liver cancer mouse is observed
Number of animals body weight (g)The heavy tumour inhibiting rate of tumor
Group P value
Begin to finish to begin to finish (g) (%)
Blank group 12 12 18.9 ± 2.48+8.1 2.23 ± 0.61--------
High dose group 12 12 18.3 ± 2.81+6.7 0.82 ± 0.27 63.0＜0.01
Middle dosage group 12 12 18.7 ± 2.74+5.8 1.07 ± 0.58 52.1＜0.01
Low dose group 12 12 18.2 ± 2.48+9.0 1.75 ± 0.90 21.5＞0.05
Cyclophosphamide group 12 12 19.0 ± 2.13+6.7 0.60 ± 0.24 73.1＜0.01
Table 3, capsule of the present invention are to lotus tumor S
180The tumour inhibiting rate of sarcoma mice is observed
Number of animals body weight (g)The heavy tumour inhibiting rate of tumor
Group P value
Begin to finish to begin to finish (g) (%)
Blank group 12 12 18.3 ± 1.15+7.9 3.04 ± 0.63--------
High dose group 12 12 18.5 ± 0.90+7.3 2.12 ± 0.63 29.2＜0.05
Middle dosage group 12 12 19.7 ± 0.78+4.8 2.68 ± 0.68 15.1＞0.05
Low dose group 12 12 19.2 ± 1.59+7.8 2.84 ± 1.41 6.6＞0.05
Cyclophosphamide group 12 12 19.2 ± 1.03+5.3 0.80 ± 0.31 73.7＜0.01
4), efficacy enhancing and toxicity reducing test
The synergism experiment result shows: cyclophosphamide group tumour inhibiting rate is 50.96%, and cyclophosphamide and its tumour inhibiting rate of capsule drug combination group of the present invention are 61.06%-66.82%, compares difference highly significant (P＜0.01) with lotus tumor group respectively; Drug combination compares with the cyclophosphamide group respectively, and it is 20.59%-32.39% that this product presses down tumor potentiation rate.Low dose group significant difference (P＜0.05) wherein.If drug combination compares with simple this product group respectively, show that also drug combination obviously improves the tumour inhibiting rate effect than merely with this product, wherein drug combination 1.5g/Kg group tumour inhibiting rate better effects if (P＜0.05).
The attenuation result of the test shows, administration the 6th day, three dosage groups of capsule of the present invention WBC counting is apparently higher than cyclophosphamide group (P＜0.01), administration the 9th day, each organizes the bottom out of WBC counting, wherein high, middle dosage group WBC counting gos up fast than cyclophosphamide group, through comparing difference remarkable (P＜0.05).Drug withdrawal 24h bone marrow has the nuclear born of the same parents to count check result and also show: three dosage group bone marrow nucleated cell numbers also are higher than the cyclophosphamide group, and through relatively, administration height, middle dosage group difference highly significant (P＜0.01) low dose group also have significant difference (P＜0.05).The above results shows that capsule of the present invention has protective effect to caused by cyclophosphamide rat peripheral blood WBC and the decline of bone marrow nucleated cell counting, and promotes peripheral blood WBC to go up.Administration 10 days is carried out check result to animal liver function and kidney merit and is shown and do not see obvious influence.
2, acute, long term toxicity test
1) acute toxicity test
Trial test: divide three dosage groups, 20g/Kg group, 10g/Kg and 5g/Kg group, every group of 3 animals, drug level is respectively 20g/Kg (0.5g/ml), 10g/Kg (0.25g/ml), 5g/Kg (0.125g/ml).The animal fasting is 12 hours before the administration, presses the 0.4ml/10g gastric infusion.
Result: do not see each treated animal death.
According to the trial test result, determine with 20g/Kg to be formal test at last.Get 20 animals, male and female half and half, animal average weight ♂ 20.0 ± 0.2g, ♀ 20.2 ± 1.5g presses 0.4ml/10g body weight gastric infusion.
The result: after the administration animal behavior activity normal, two weeks were not found animal dead after administration.Two weeks were put to death animal, body weight ♂ 31.5 ± 1.8g, ♀ 28.1 ± 2.2g.Therefore, the acute toxicity test dosage of an oral administration of capsule of the present invention is 20g/Kg.
2) long term toxicity test
The Wistar rat is used in test, high dose group, middle dosage group, low dose group and matched group are established in test, through 12 weeks of gastric infusion, each group of drug withdrawal 24h is put to death the part animal, all the other animal drug withdrawals continued to observe two weeks and put to death, to inspections such as the general ergasia state of animal, defecation, body weight gain situation, blood and biochemical indicator, organ index, histopathologies, every inspection index is compared with matched group respectively and is not seen notable difference (P＞0.05), does not see that the relevant pathomorphology that is caused by capsule of the present invention changes.
3, stability test
Test method: according to quality standard and the Pharmacopoeia of the People's Republic of China (the 2 years versions) microbial limit test and appendix capsule (IL) following pertinent regulations of Chinese medicinal composition capsules of the present invention.
Result of the test: adopt room temperature to investigate 24 months, character, discriminating, moisture, limit test of microbe and assay are all up to specification as a result.
Conclusion: this product room temperature was placed 24 months, and inherent quality meets quality standard and relevant every regulation, illustrates that this product quality is basicly stable.
The specific embodiment
The following examples are only in order to further specify technical scheme of the present invention, rather than restriction the present invention.
Embodiment 1
10 parts of 5 parts of Radix Sophorae Flavescentiss of 12 parts of Radix Ginsengs of the Radix Astragali
7 parts of 10 parts of Radix Paeoniae Rubra of Herba Solani Nigri
Get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add 8 times of amounts of 70% ethanol, extract secondary, filter, merge secondary filtrate, reclaim ethanol, drying is ground into fine powder, and is standby; Residue adds 10 times of amounts of water and extracted 1 hour, filters, and filtrate is concentrated into the fluid extract of relative density 1.08～1.10 (60 ℃), add equimultiple 40% alcoholic solution, place, get supernatant, reclaim the clear paste of ethanol to relative density 1.05～1.08 (60 ℃), continue and add 4 times of amount ethanol, place, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
Other gets Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion, adds 7 times of amounts of water and 5 times of amount extraction secondaries respectively, filters merging filtrate, be concentrated into the clear paste of relative density 1.10～1.14 (60 ℃), continue and add 4 times of amount ethanol, place, get supernatant, reclaim ethanol, drying is ground into fine powder;
Above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
Embodiment 2
10 parts of 4 parts of Radix Sophorae Flavescentiss of 13 parts of Radix Ginsengs of the Radix Astragali
7 parts of 10 parts of Radix Paeoniae Rubra of Herba Solani Nigri
Get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add 6 times of amounts of 90% ethanol, extract secondary, filter, merge secondary filtrate, reclaim ethanol, drying is ground into fine powder, and is standby; Residue adds 10 times of amounts of water and extracted 1 hour, filters, and filtrate is concentrated into the fluid extract of relative density 1.06～1.10 (60 ℃), add equimultiple 40% alcoholic solution, place, get supernatant, reclaim the clear paste of ethanol to relative density 1.05～1.08 (60 ℃), continue and add 4 times of amount ethanol, place, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
Other gets Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion, adds 7 times of amounts of water and 5 times of amount extraction secondaries respectively, filters merging filtrate, be concentrated into the clear paste of relative density 1.10～1.14 (60 ℃), continue and add 4 times of amount ethanol, place, get supernatant, reclaim ethanol, drying is ground into fine powder;
Above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.。
Embodiment 3
9 parts of 4 parts of Radix Sophorae Flavescentiss of 15 parts of Radix Ginsengs of the Radix Astragali
7 parts of 9 parts of Radix Paeoniae Rubra of Herba Solani Nigri
Get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add 8 times of amounts of 80% ethanol, extract secondary, filter, merge secondary filtrate, reclaim ethanol, drying is ground into fine powder, and is standby; Residue adds 10 times of amounts of water and extracted 1 hour, filters, and filtrate is concentrated into the fluid extract of relative density 1.06～1.10 (60 ℃), add equimultiple 40% alcoholic solution, place, get supernatant, reclaim the clear paste of ethanol to relative density 1.05～1.08 (60 ℃), continue and add 4 times of amount ethanol, place, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
Other gets Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion, adds 7 times of amounts of water and 5 times of amount extraction secondaries respectively, filters merging filtrate, be concentrated into the clear paste of relative density 1.10～1.14 (60 ℃), continue and add 4 times of amount ethanol, place, get supernatant, reclaim ethanol, drying is ground into fine powder;
Above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
Embodiment 4
Radix Astragali 1333g Radix Ginseng 400g Radix Sophorae Flavescentis 1000g
Herba Solani Nigri 1000g Radix Paeoniae Rubra 666g
Get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add 6 times of amounts of 90% ethanol, extract secondary, filter, merge secondary filtrate, reclaim ethanol, be dried to driedly, be ground into fine powder, standby; Residue adds 10 times of amounts of water and extracted 1 hour, filters, and filtrate is concentrated into the fluid extract of relative density 1.08～1.10 (60 ℃), add equimultiple 40% alcoholic solution, place, get supernatant, reclaim the clear paste of ethanol to relative density 1.05～1.08 (60 ℃), continue and add 4 times of amount ethanol, place, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
Other gets Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion, adds 7 times of amounts of water and 5 times of amount extraction secondaries respectively, filters merging filtrate, be concentrated into the clear paste of relative density 1.10～1.14 (60 ℃), continue and add 4 times of amount ethanol, place, get supernatant, reclaim ethanol, be dried to driedly, be ground into fine powder;
Above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
Claims (6)
1, a kind of Chinese medicine composition for the treatment of tumor, it is characterized in that: it is prepared from by the following weight proportion raw material:
Radix Astragali 10-15 part Radix Ginseng 3-5 part Radix Sophorae Flavescentis 8-12 part
Herba Solani Nigri 8-12 part Radix Paeoniae Rubra 5-8 part.
2, Chinese medicine composition as claimed in claim 1 is characterized in that: it is prepared from by the following weight proportion raw material:
10 parts of 4 parts of Radix Sophorae Flavescentiss of 13.3 parts of Radix Ginsengs of the Radix Astragali
6.7 parts of 10 parts of Radix Paeoniae Rubra of Herba Solani Nigri.
3,, it is characterized in that this method comprises the steps: as the preparation method of claim 1,2 described Chinese medicine compositions
1) get the Radix Ginseng and the Milkvetch Root of above-mentioned weight portion, add the ethanol extraction twice of 70%-90%, add pure 6-8 at every turn and doubly measure, filter, merging filtrate reclaims ethanol, and drying is ground into fine powder, and is standby;
Residue water 8-10 doubly measures, and extracts 40-60 minute, filters, relative density was the fluid extract of 1.06-1.10 when filtrate was concentrated into 60 ℃, add 40% ethanol precipitation of equivalent, get supernatant, relative density is the fluid extract of 1.05-1.08 when reclaiming ethanol to 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, leave standstill, filter, with precipitate at 60 ℃ of following drying under reduced pressure, be ground into fine powder, standby;
2) get Radix Sophorae Flavescentis, Herba Solani Nigri and the Radix Paeoniae Rubra of above-mentioned weight portion in addition, extracting in water twice adds water 5-8 at every turn and doubly measures respectively, filters, merging filtrate, relative density is the fluid extract of 1.10-1.14 when being concentrated into 60 ℃, adds the ethanol of 4 times of amounts, places, get supernatant, reclaim ethanol, drying is ground into fine powder;
3) above-mentioned three kinds of fine powders are mixed, add microcrystalline Cellulose and reach 1% magnesium stearate in right amount, granulate, packing, promptly.
4,, it is characterized in that it is an oral formulations as claim 1,2 described Chinese medicine compositions.
5, Chinese medicine composition as claimed in claim 4 is characterized in that it is capsule, tablet, electuary, powder or oral liquid.
6, as claim 1, the application of 2 described Chinese medicine compositions in the medicine of preparation treatment tumor.
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