CN104224959A - Medicament composition for treating leukemia and preparation method of medicament composition - Google Patents

Medicament composition for treating leukemia and preparation method of medicament composition Download PDF

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CN104224959A
CN104224959A CN201410515252.8A CN201410515252A CN104224959A CN 104224959 A CN104224959 A CN 104224959A CN 201410515252 A CN201410515252 A CN 201410515252A CN 104224959 A CN104224959 A CN 104224959A
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volatile oil
extract
medicament composition
filtrate
leukemia
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CN104224959B (en
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王彦厚
董芳
王嘉南
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ZIBO FOOD DRUG TESTING INSTITUTE
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ZIBO FOOD DRUG TESTING INSTITUTE
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Abstract

The invention discloses a medicament composition for treating leukemia and a preparation method of the medicament composition. The composition is obtained by distilling lancea tibetica and dracocephalum tanguticum, collecting volatile oil to prepare a volatile oil clathrate compound, concentrating and drying filtrate and an ethanol extracting solution of anemone rivularis and ranunculus brotherusii to obtain an extract, and then uniformly mixing the volatile oil clathrate compound with the extract. According to the medicament composition disclosed by the invention, the survival time of a mice serving as a leukemia model can be obviously prolonged, so that the proportion of a T cell subset of the model mice tends to be normal, the secretion level of cell factors such as IL-2, IL-6 and IFN-gamma is increased, and the immunosuppression caused by tumors is recovered. The medicament composition can still improve the activity of naturally killing cells (NKC) and interleukin-2(IL-2) of the leukemia mice P388 which is subjected to chemotherapy, and the immunosuppression caused by the chemotherapy is gradually recovered; therefore the medicament composition has a positive significance for treatment of leukemia, reconstruction of the immunity and prevention of the immunosuppression caused by the tumor chemotherapy.

Description

One is used for the treatment of leukemic pharmaceutical composition and preparation method thereof
Technical field
The present invention relates to one and be used for the treatment of leukemic pharmaceutical composition and preparation method thereof, belong to medical art.
Background technology
Leukemia is a class hematopoietic stem cell malignant clone disease.Clinical visible anemia in various degree, hemorrhage, infectious fever and liver, spleen, lymphadenectasis and skeleton pain.It is reported, the leukemic sickness rate in China each department accounts for the 6th in various tumor.Because leukaemia comes from blood system, there is again the feature of tumor cell, so people are called leukemia traditionally.Leukemic distribution is global, accounts for about 5% of cancer total incidence, fall ill with child and youth in the majority.China leukaemic is about 3-4 people/100,000 populations, and male is more than women.In the mortality rate of each age group malignant tumor of China, leukemia accounts for the 6th (male) and the 8th (women), in the crowd of child and less than 35 years old, then account for the 1st.
There is the leukemic product of a lot for the treatment of at present on the market, comprise chemical drugs and Chinese patent medicine.Chemical drugs therapeutical effect is obvious, but its side effect is also many.Chinese patent medicine by regulating function of human body, to reach the balance of negative and positive, some the composition energy enhancing immunity in medicine, but its curative effect not rapidly, have the shortcomings such as taking dose is large.Therefore, rapid, that taking dose is little, side effect the is little Chinese medicine composition of curative effect is researched and developed extremely urgent.
Summary of the invention
The object of this invention is to provide one and be used for the treatment of leukemic pharmaceutical composition and preparation method thereof.
Technical scheme of the present invention is as follows:
One is used for the treatment of leukemic pharmaceutical composition, and this pharmaceutical composition is made up of following crude drug:
Preferably, pharmaceutical composition described above, is made up of following crude drug:
The preparation method of aforementioned pharmaceutical compositions, step is as follows:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 5-6 hour, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) beta-schardinger dextrin-being 5-7 times of weight by the volatile oil of collection employing envelope-bulk to weight ratio carries out enclose to volatile oil, obtains volatile oil clathrate compound;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.15-1.25, adds ethanol furnishing percent by volume 70% determining alcohol, 2-10 DEG C of standing 24-48 hour, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract;
(5) by above-mentioned volatile oil clathrate compound, extract mixing, to obtain final product.
The present invention is preferred, and in the preparation method of aforementioned pharmaceutical compositions, in step (5), the weight ratio of volatile oil clathrate compound, extract is 1:1 ~ 1:2.
The present invention is preferred, and in the preparation method of aforementioned pharmaceutical compositions, in step (5), the weight ratio of volatile oil clathrate compound, extract is 1:2.
The unit corresponding relation of volume of the present invention and weight is ml:g or l:kg.
The levels of cytokine secretion such as the life span of pharmaceutical composition energy significant prolongation Leukemia Model mice of the present invention, makes model mice T cell subset proportions be tending towards normal, IL-2, IL-6, IFN-γ go up, and recover the immunosuppressant that tumor causes.Especially the weight ratio of volatile oil clathrate compound and extract is the pharmaceutical composition of 1:2 composition, and effect is more remarkable; Pharmaceutical composition of the present invention can also improve P 388the activity of natural killer cell (NKC), interleukin-2 (IL-2) after leukemia mouse chemotherapy, the immunosuppressant that chemotherapy is caused recovers gradually, thus to leukemic treatment and immunity function restructuring, there is positive meaning for the immunosuppressant caused by control chemotherapy of tumors.
Detailed description of the invention
Following embodiment is used for illustrating pharmaceutical composition of the present invention and preparation method thereof; but it does not form any restriction to protection scope of the present invention; all equivalent variations utilizing technology contents of the present invention to do, still belong to the protection domain of technical solution of the present invention.
Experimental example 1, pharmaceutical composition of the present invention are to L 615the test of pesticide effectiveness of leukemia mouse
One, sample preparation
1, preparation is extracted
(1) prepare volatile oil and clathrate thereof: get 150g Fructus Lanceae tibeticae and 98g tangut dragonhead, add 2500ml water, adopt steam distillation to prepare volatile oil (3h), filter, filtrate and filtering residue are separately gone bail for and are deposited;
(2) the volatile oil 5ml of collection is added 30g beta-schardinger dextrin-and enclose is carried out to volatile oil, obtain volatile oil clathrate compound 33g;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.15-1.25, adds ethanol furnishing percent by volume 70% determining alcohol, and 2 DEG C leave standstill 24 hours, filter, discard precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, add 300g Herba Veronicastri Sibirici and 175g Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, first time adds 4700ml, extract 2 hours, second time adds 3600ml, extracts 1 hour, merge extractive liquid, and step (3) gained filtrate A, filter, decompression recycling ethanol, concentrated, drying, obtains extract 84g;
2, sample preparation
? Volatile oil clathrate compound (g) Extract (g)
Sample 1 15 0
Sample 2 8 8
Sample 3 5 10
Sample 4 0 15
Above-mentioned each group of sample becomes 1g medical material/ml with normal saline before use.
Two, zoopery
1, modeling method: aseptically get L 615leukemia mouse spleen makes 25% normal saline cell suspension, gives the L that grows up 615mouse hypodermic inoculation, all there is leukemia in result, transplants continuously, set up stable L with morbidity mice spleen oncocyte at Syngenic mice 615leukemia Model.
L 615the foundation of leukemia cell line: get L 615the spleen of leukemia mouse, shreds spleen in Hanks liquid, makes leukaemia free out, by collected by centrifugation free cell, then uses RPMI1640 culture fluid (containing 10% calf serum) to be diluted to 8*10^ 6the Cell sap of/ml, cultivates at 37 DEG C.Cultivate 20d and find there is adherent spindle cell in culture, around it, have the round cell island of propagation.When separately being cultivated by cells different for two kinds of forms, spindle cell can normal adherent growth, and suspension cell growth is slow; Again by two kinds of cells Mixed culture again, two kinds of Growth of Cells are vigorous, after 45d, by the round cell of suspension growth single culture again, pass to for 12 generations always, and Growth of Cells is good, thus sets up this cell strain.
2, the test of pesticide effectiveness
Material: Kunming mouse (Shandong Province's Experimental Animal Center).(lot number is respectively sample 1-4: 20140321,20140322,20140323 and 20140324), cyclophosphamide (Hengrui Medicine Co., Ltd., Jiangsu Prov.), standard RhIL-2 (Beijing Shuanglu Pharmaceutical Co., Ltd.), Yackl and IL-2 dependent cells strain CTLL (school of life and health sciences cellular resources center, Chinese Academy of Sciences Shanghai), RPMII640 cell culture fluid and hyclone (Huamei Bio-Engrg Co.); Tetramethyl azo azoles salt (MTT), dodecyl sodium sulfate and canavaline, dimethyl formamide is (Sigma Products); Sample injector, CO 2incubator, ELX-800 microplate reader (Bio-Tek company of the U.S.); The 96 flat Tissue Culture Plates in hole, Epics flow cytometer (Beckman company of the U.S.).
Method: modeling as stated above.Experiment grouping first group is Normal group, 20 mices, after conventional raising 1w, and intraperitoneal injection of saline 0.2ml/d, normal saline gavage 0.3ml, each 1 time of upper and lower noon.2nd group is model group, 20, after conventional raising 1w, and inoculation L 615leukaemia, the same Normal group of inoculation post processing.3rd group is Western medicine group, and 20 conventional raisings, after one week, inoculate L 615leukaemia, after inoculation the 3rd day starts ip cyclophosphamide, 200mg/kg, 1 time/d.4th group of-7 groups is respectively sample 1-4 group, get respectively 20 conventional raise 1d after, inoculation L 615leukaemia, gives sample 1-4 gavage in after inoculation the 3rd day respectively, each 0.3ml (content of dispersion conversion is 300mg to medical material), each 1 time of upper and lower noon.Above each treated animal often group get 10 in the 5th day put to death, get spleen and carry out related immune Indexs measure, remaining each animal carries out observation life cycle.
Observation index: 1. observe life cycle.2. T cell Subsets.3. IL-2, IL-6, IFN-gamma activity measures.
Statistical method: data with represent, adopt SPSS17 to carry out t inspection.
Result:
Life cycle: sample 1-3 group and Western medicine group all have significant prolongation than model group, wherein sample 3 groups of life cycles, comparatively Western medicine group obviously extended, statistics there were significant differences P<0.01, and 2 groups, sample and Western medicine group there was no significant difference.In table 1.
Table 1 each experimental group compares life cycle
Group Number of elements Life span (d)
Model group 10 6.50±0.57
Western medicine group 10 17.43±1.34 *
1 group, sample 10 14.00±3.14 *
2 groups, sample 10 18.23±3.62 *
3 groups, sample 10 27.45±3.28 *△
4 groups, sample 10 9.48±2.78
Note: * is P<0.01 compared with model group, △ is P<0.01 compared with Western medicine group.
T cell subgroup: 2,3 groups, sample can make CD4 +cell comparatively model group and Western medicine group significantly increases; And sample 1-4 group CD8 +leukopenia, 1-4 respectively organizes sample all can make CD4/CD8 ratio be tending towards normal, and especially sample 3 groups of effects are better.In table 2.
Table 2 respectively group T cell subgroup change
Group Number of elements CD3 + CD4 + CD8 + CD4/CD8
Normal group 10 67.56±2.18 35.28±2.13 24.01±1.26 1.47±0.15
Model group 10 52.75±2.34 * 22.33±2.18 * 29.56±1.32* 0.76±0.08 *
Western medicine group 10 42.45±2.02 16.32±1.98 33.78±0.63 0.48±0.07
1 group, sample 10 64.37±2.10 ▲△ 22.21±1.90 27.42±1.43 0.82±0.07
2 groups, sample 10 60.63±2.12 ▲△ 27.03±1.87 ▲△ 25.04±1.53 ▲△ 1.08±0.06 ▲△
3 groups, sample 10 61.45±2.34 ▲△ 30.20±1.88 ▲△ 24.35±1.62 ▲△ 1.24±0.06 ▲△
4 groups, sample 10 62.60±2.32 ▲△ 21.16±1.78 25.76±1.48 ▲△ 0.81±0.05
Note: * is P<0.01 compared with Normal group, △ is P<0.01 compared with model group, ▲ compared with Western medicine group P<0.01.
IL-2, IL-6, IFN-gamma activity: after leukemia mouse Western medicine chemotherapy, it secretes IL-2, IL-6, the level of IFN-γ significantly declines, and sample 2,3,4 groups of IL-2, IL-6, the secretion level of IFN-γ obviously increases, especially 2,3 groups better, both have significant difference (P<0.01), in table 3 at contrast.
Table 3 respectively organizes IL-2, and IL-6, IFN-gamma activity changes
Group Number of elements IL-2 IL-6 IFN-γ
Normal group 10 22.38±2.14 45.53±5.55 10.68±1.55
Model group 10 8.88±2.23 * 15.48±4.13 * 5.87±2.11 *
Western medicine group 10 6.08±1.76 10.36±3.86 4.02±1.24
1 group, sample 10 9.26±2.11 17.44±1.90 6.02±1.19
2 groups, sample 10 14.42±2.09 ▲△ 25.67±2.06 ▲△ 8.11±1.16 ▲△
3 groups, sample 10 13.12±1.98 ▲△ 28.14±1.97 ▲△ 8.23±1.14 ▲△
4 groups, sample 10 10.44±1.88 26.55±1.99 ▲△ 7.28±1.21
Note: * is P<0.01 compared with Normal group, △ is P<0.01 compared with model group, ▲ compared with Western medicine group P<0.01.
The whether normal of immunologic function be one of key factor of tumor development, and immunologic function is that the ratio of T cell subgroup also plays an important role in stable regulation immunologic function by performed by the cytokine secreted by immunocyte.T cell subset proportions imbalance after leukemia mouse chemotherapy, IL-2, IL-6, the levels of cytokine secretion such as IFN-γ decline, and by after use each group of sample treatment, T cell subset proportions is tending towards normal, IL-2, IL-6, the levels of cytokine secretion such as IFN-γ go up, illustrate that drug regimen matter sample of the present invention (especially sample 2,3) is by regulatory T-cell subset proportions and promote that the secretion of these cytokines plays its immunoregulation effect, has certain effect to leukemic therapy apparatus immunity function restructuring.
Experimental example 2: to P 388the pharmacodynamics test of leukemia mouse
1. modeling method: get ascitic type P 388leukemia mouse, de-cervical vertebra is put to death, and abdominal part is sterilized, suction ascites, add normal saline mixing, microscope lower intact cells concentration be (1-1.5) * 10 (^7) individual/ml, every Mus 0.2ml (inoculum density of Kunming mouse and dosage) carry out lumbar injection.
2. couple P 388the impact of natural killer cell (NKC), interleukin-2 (IL-2) activity after leukemia mouse chemotherapy.
Material: Kunming kind one-level mice (Shandong Province's Experimental Animal Center), 50, male and female half and half, body weight 18-22g.Sample 1-4 is (with experimental example 1 sample, lot number is respectively 20140321,20140322,20140323 and 20140324), cyclophosphamide (Hengrui Medicine Co., Ltd., Jiangsu Prov.), standard RhIL-2 (Beijing Shuanglu Pharmaceutical Co., Ltd.), Yackl and IL-2 dependent cells strain CTLL (school of life and health sciences cellular resources center, Chinese Academy of Sciences Shanghai), RPMII640 cell culture fluid and hyclone (Huamei Bio-Engrg Co.); Tetramethyl azo azoles salt (MTT), dodecyl sodium sulfate and canavaline, dimethyl formamide is (Sigma Products); Sample injector, CO2 incubator, ELX-800 microplate reader (Bio-Tek company of the U.S.); The 96 flat Tissue Culture Plates in hole, Epics flow cytometer (Beckman company of the U.S.).
Modeling and group technology: get 40 mices, inoculation P388 Lymphocytic leukemia tumor strain (inoculation method: get ascitic type P388 leukemia mouse, de-cervical vertebra is put to death, abdominal part is sterilized, suction ascites, adds normal saline mixing, microscope lower intact cells concentration be 1.5*10 (^7) individual/ml, every mice right oxter injection 0.2ml), be divided into 4 groups at random.Another 10 is normal blank group.
Processing method: 1. normal blank group: with 0.4ml/20g normal saline ig; 2. P 388leukemia Model group: with 0.4ml/20g normal saline ig; 3. chemotherapy group: with 0.4ml/20g normal saline ig; 4. chemotherapy adds 2 groups, sample: be dissolved in 0.4ml normal saline ig with 50mg sample 2; 5. chemotherapy adds 3 groups, sample: be dissolved in 0.4ml normal saline ig with 100mg sample 3.3. the continuous ig14d of each group above, give simultaneously, 4., 5. organize ip cyclophosphamide 35mg/kg/d, be used in conjunction 6d.In the 15th day, de-cervical vertebra was put to death, and aseptically got spleen NKC, IL-2 active.
Detection method: NKC Activity determination is with reference to Jiang Zhonghua method: the external test [J] of the NK cell words property of lepromatous leprosy animal model. the assorted poison of China Immunology, 1985,4 (1): 238; IL-2 activity test method is with reference to Qian Yukun method: practical immunology new technique [M]. Beijing: Beijing combined publication society of China Concord Medical Science University of Ya Ke university .1994.49.
Statistical method: adopt many group means to compare, namely first do variance analysis, remake T inspection.
Result shows, it is active that sample 2 and sample 3 can improve NKC and IL-2, especially 3 groups, sample.In table 4
Table 4 is group NKC and IL-2 expression activitiy respectively
Group n NKC activity (%) IL-2 activity (Iu/ml)
Normal group 10 44.54±5.96 17.75±2.49
Model control group 10 35.64±6.15* 13.81±2.56**
Chemotherapy group 10 28.10±5.44**△△ 10.85±1.84**△
Chemotherapy adds 2 groups, sample 10 34.18±4.20**## 13.24±2.05**
Chemotherapy adds 3 groups, sample 10 39.47±5.93*## 15.97±2.64##
Note: compare with normal group, * P<0.05, * * P<0.01; Compare with model group, △ P<0.05, △ △ P<0.01;
Compare with chemotherapy group, #P<0.05, ##P<0.01.
Result shows, P 388leukemia mouse self and immunity function after chemotherapy are suppressed, NKC and IL-2 activity all has reduction in various degree, P after Treated with Chemotherapy with Cyclophosphamide 388nKC and the IL-2 activity of leukemia mouse is starkly lower than normal group and model group, and after giving sample 2, sample 3 treatment, NKC and IL-2 all has rebound significantly, and after wherein giving sample 3, IL-2 is active compares with normal group without obviously distinguishing.Show that pharmaceutical composition 2 and 3 of the present invention has and strengthen NKC active function, pharmaceutical composition 3 of the present invention has enhancing IL-2 active function, points out two kinds of pharmaceutical compositions to P after chemotherapy 388the immunosuppressant of leukemia mouse has certain protective effect, for the immunosuppressant caused by control chemotherapy of tumors, effectively ensures completing of chemotherapy, has positive meaning.
The following example all can realize the effect of above-mentioned experimental example.
Embodiment 1
One is used for the treatment of leukemic pharmaceutical composition, is made up of following crude drug: Herba Veronicastri Sibirici 300g, Ranunculus tanguticus (Maxim) Orcz. 175g, Fructus Lanceae tibeticae 150g, tangut dragonhead 98g.
Its preparation method is:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 5 hours, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) beta-schardinger dextrin-being 6 times of weight by the volatile oil 5.5ml of collection employing envelope-bulk to weight ratio carries out enclose to volatile oil, obtains volatile oil clathrate compound 36g;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.20, adds ethanol furnishing percent by volume 70% determining alcohol, and 2-10 DEG C leaves standstill 24 hours, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract 88g;
(5) above-mentioned volatile oil clathrate compound 36g, extract 72g (1:2) are mixed, to obtain final product.
Embodiment 2
One is used for the treatment of leukemic pharmaceutical composition, is made up of following crude drug: Herba Veronicastri Sibirici 270g, Ranunculus tanguticus (Maxim) Orcz. 150g, Fructus Lanceae tibeticae 170g, tangut dragonhead 120g.
Its preparation method is:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 6 hours, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) beta-schardinger dextrin-being 5 times of weight by the volatile oil 5.5ml of collection employing envelope-bulk to weight ratio carries out enclose to volatile oil, obtains volatile oil clathrate compound 31g;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.25, adds ethanol furnishing percent by volume 70% determining alcohol, and 2-10 DEG C leaves standstill 24 hours, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract 81g;
(5) above-mentioned volatile oil clathrate compound 31g, extract 31g (1:1) are mixed, to obtain final product.
Embodiment 3
One is used for the treatment of leukemic pharmaceutical composition, is made up of following crude drug: Herba Veronicastri Sibirici 330g, Ranunculus tanguticus (Maxim) Orcz. 200g, Fructus Lanceae tibeticae 130g, tangut dragonhead 80g.
Its preparation method is:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 6 hours, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) the volatile oil 4.5ml that will collect, employing envelope-bulk to weight ratio is that the beta-schardinger dextrin-of 6 times of weight carries out enclose to volatile oil, obtains volatile oil clathrate compound 29g;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.15, adds ethanol furnishing percent by volume 70% determining alcohol, and 2-10 DEG C leaves standstill 48 hours, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract 92g;
(5) above-mentioned volatile oil clathrate compound 28g, extract 42g (1:1.5) are mixed, to obtain final product.
Embodiment 4
One is used for the treatment of leukemic pharmaceutical composition, is made up of following crude drug: Herba Veronicastri Sibirici 300g, Ranunculus tanguticus (Maxim) Orcz. 175g, Fructus Lanceae tibeticae 170g, tangut dragonhead 80g.
Its preparation method is:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 6 hours, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) the volatile oil 4ml that will collect, employing envelope-bulk to weight ratio is that the beta-schardinger dextrin-of 7 times of weight carries out enclose to volatile oil, obtains volatile oil clathrate compound 28g;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.15, adds ethanol furnishing percent by volume 70% determining alcohol, and 2-10 DEG C leaves standstill 24 hours, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract 85g;
(5) above-mentioned volatile oil clathrate compound 28g, extract 56g (1:2) are mixed and get final product.

Claims (5)

1. be used for the treatment of a leukemic pharmaceutical composition, it is characterized in that, be made up of the crude drug of following weight portion:
2. be according to claim 1ly used for the treatment of leukemic pharmaceutical composition, it is characterized in that, be made up of the crude drug of following weight portion:
3. the preparation method being used for the treatment of leukemic pharmaceutical composition described in claim 1 or 2, it is characterized in that, step is as follows:
(1) get Fructus Lanceae tibeticae and tangut dragonhead, add the water of 10 times amount volumes of medical material gross weight, adopt steam distillation to decoct 5-6 hour, collect volatile oil, filter, filtrate and filtering residue save and stand-by;
(2) beta-schardinger dextrin-being 5-7 times of weight by the volatile oil of collection employing envelope-bulk to weight ratio carries out enclose to volatile oil, obtains volatile oil clathrate compound;
(3) get the filtrate of step (1) gained, being evaporated to relative density at 50 DEG C is the clear paste of 1.15-1.25, adds ethanol furnishing percent by volume 70% determining alcohol, 2-10 DEG C of standing 24-48 hour, filters, discards precipitation, obtain filtrate A;
(4) get the medicinal residues of step (1) gained, then add Herba Veronicastri Sibirici and Ranunculus tanguticus (Maxim) Orcz., secondary is extracted in the ethanol boiling adding percent by volume 80%, add 10 times amount volumes of described medical material gross weight for the first time, extract 2 hours, second time adds 8 times amount volumes of described medical material gross weight, extracts 1 hour, the filtrate A that merge extractive liquid, and step (3) obtain, filter, decompression recycling ethanol, concentrated, drying, obtains extract;
(5) by above-mentioned volatile oil clathrate compound, extract mixing, to obtain final product;
The unit corresponding relation of the volume described in this method and weight is ml:g or l:kg.
4. the preparation method being used for the treatment of leukemic pharmaceutical composition according to claim 3, is characterized in that, the volatile oil clathrate compound described in step (5) is 1:1 ~ 1:2 with the mixed weight ratio of extract.
5. the preparation method being used for the treatment of leukemic pharmaceutical composition according to any one of claim 3 or 4, is characterized in that, the volatile oil clathrate compound described in step (5) is 1:2 with the mixed weight ratio of extract.
CN201410515252.8A 2014-09-29 2014-09-29 One is used for the treatment of leukemic pharmaceutical composition and preparation method thereof Expired - Fee Related CN104224959B (en)

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CN102100892A (en) * 2009-12-17 2011-06-22 苏州知微堂生物科技有限公司 Preparation technology and production method of integrated Xiaojianzhong decoction novel dosage form
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