CN105380956B - A kind of pharmaceutical composition of Dana Delany containing Chinese mugwort for treating leukaemia and application - Google Patents
A kind of pharmaceutical composition of Dana Delany containing Chinese mugwort for treating leukaemia and application Download PDFInfo
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- CN105380956B CN105380956B CN201510738224.7A CN201510738224A CN105380956B CN 105380956 B CN105380956 B CN 105380956B CN 201510738224 A CN201510738224 A CN 201510738224A CN 105380956 B CN105380956 B CN 105380956B
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- LHDWRKICQLTVDL-UHFFFAOYSA-N methyl iridoid glycoside Natural products OC1C(O)C(O)C(CO)OC1OC1C2C3(CO)OC3C(O)C2C=CO1 LHDWRKICQLTVDL-UHFFFAOYSA-N 0.000 claims description 24
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Abstract
The present invention relates to a kind of pharmaceutical composition for treating leukaemia and its application, belong to field of medicaments.In order to reduce the poisonous side effect of medicine of existing medicament for treatment of leukemia Chinese mugwort Dana Delany, and further enhance its therapeutic effect to leukaemia, the present invention provides a kind of pharmaceutical composition of the Dana Delany containing Chinese mugwort, the pharmaceutical composition can not only significantly inhibit the growth of the early young cells of grain leukaemia MR 2 of people acute promyelocytic leukemic NK4 cells, chronic myelocytic leukemia K562 cells and ATRA-resistance, and two kinds of active constituents of medicine have significant synergy when treating leukaemia.The pharmaceutical composition has the advantages of definite ingredients, toxic side effect are small and therapeutic effect is good, is adapted to promote the treatment for treating leukaemia in clinic.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of pharmaceutical composition for treating leukaemia and application.
Background technology
At present, cancer is that current serious influences one of human health, the principal disease for threatening human life.Cancer and heart and brain
Vascular diseases and contingency together, form the three big cause of death of world today's All Countries.Therefore, World Health Organization and each
Hygiene department of government of state is all classified as a top priority cancer is captured.The method for treating leukaemia in the world mainly has three kinds,
First, using surgical excision, removal lesion tissue, prevent cancer cell from spreading；But chemotherapy or radiotherapy are used, it is thin to kill cancer
Born of the same parents；Third, use drug therapy.The pain of patient is added using the method for surgery excision, hinders its vigour, expense is huge.Use radiotherapy
Method, while cancer cell is killed, also injure red blood cell and leucocyte, patient suffers untold misery.
Leukaemia is to seriously endanger the Hematopoietic Malignancies of human life and health, is a kind of originating from hematopoiesis (or leaching
Bar) malignant disease of stem cell.Due to Stem cells injury, leukaemia, which loses, is further differentiated into ripe ability, Huo Zhezeng
Value is uneven with differentiation capability, and stops at the different phase of cell development, and be embodied in cell infinitely rises in value in vivo, and
Its differentiation and maturation and apoptosis are obstructed.Therefore, the treatment of leukaemia can start with terms of three：Inducing cell apoptosis, inducing cell
Hematopoiesis function is rebuild in differentiation and stem cell transplantation.The treatment of leukaemia so far still mainly uses traditional combined chemotherapy, but this is treated
Method side effect is very big, high recurrence rate, especially has larger infringement to immunity of organism and hemopoietic system.
Chinese mugwort Dana Delany be used to treat recurrent chronic lymphocytic leukemia, recurrent follicular B cell non-Hodgkin's
Lymthoma and recurrent SLL.Phase iii clinical trial supports the security and validity of Chinese mugwort Dana Delany.It is single
The phase of the clinic 2 experiment 101-09 of arm assesses the validity of Chinese mugwort Dana Delany piece, totally 125 inertia patients with non Hodgkin lymphoma ginsengs
With these subjects once received treatment [6].All patient's sustained oral 150mg dose drugs, 2 times a day.It is main effective
Property terminal be the independent evaluations committee (IRC) setting overall response rate (ORR).A crucial secondary validity terminal is loud
Answer the duration (DOR).For all patients for participating in experiment, ORR is 55% (95% confidential interval：46,64) DOR middle positions
It is worth for 12.5 months.According to lymphoma type, crucial validity terminal is as follows：For follicular lymphoma patient, ORR is
54% (having 39 to have response in 72 patients), DOR medians can not be estimated, follow up time median is 8.1 months；For small
Lymphocytic lympboma patient, ORR are 58% (having 15 to have response in 26 patients), and DOR medians are 11.9 months；It is and right
In FL and SLL crowds, because drug exposure is relatively short, the response duration is also short, causes efficacy data to have limitation.
The content of the invention
At present in the medicine for the treatment of leukaemia, the therapeutic effect for the Dana Delany that ends is preferable, but its toxic side effect is larger, and dialogue
The therapeutic effect of blood disease is not highly satisfactory.In order to reduce the toxic side effect of Chinese mugwort Dana Delany, and strengthen it to leukaemia
Therapeutic effect, the present invention provide a kind of pharmaceutical composition for treating leukaemia.The present inventor is in a long-term line clinical application
It was unexpectedly observed that Catalpol to Leukemia Patients has certain therapeutic action.But it is surprising that by itself and Chinese mugwort Dana Delany group
When being used for the treatment of leukaemia into pharmaceutical composition, two kinds of active constituents of medicine have significant collaboration in terms of leukaemia is treated
Effect, and the toxic side effect of medicine can be lowered significantly.This is significant in terms of clinical leukemia treating, is adapted to
Promoted in clinical practice.
In order to realize above-mentioned purpose of the present invention, inventor is studied by lot of experiments, is finally obtained following technical scheme：
The present invention provides a kind of pharmaceutical composition for treating leukaemia, and its active constituents of medicine contains Chinese mugwort Dana Delany and Catalpol.Preferably,
The pharmaceutical composition of above-mentioned treatment leukaemia, wherein described Chinese mugwort Dana Delany and the weight ratio of Catalpol are 1: 0.5-60.
It is further preferred that the pharmaceutical composition of above-mentioned treatment leukaemia, wherein described Chinese mugwort Dana Delany and the weight of Catalpol
Amount is than being 1: 1-16.
Still further preferably, the pharmaceutical composition of above-mentioned treatment leukaemia, wherein described Chinese mugwort Dana Delany and Catalpol
Weight ratio is 1: 4.
Pharmaceutical composition of the present invention can be prepared into the treatment that suitable pharmaceutical preparation is used for leukaemia, as it can be prepared
It is administered into liquid preparation, semisolid preparation or solid pharmaceutical preparation, the present invention preferably oral solid formulation, the oral solid formulation
The preferably tablet containing active constituents of medicine, capsule, granule etc..The preparation of above-mentioned preparation can refer in the prior art
The preparation method of corresponding formulation is made.
The pharmaceutical composition of the present invention, wherein active component Chinese mugwort Dana Delany have antileukemie cooperate with after combining with Catalpol
Effect, i.e., can not only suppress the growth of people's acute promyelocytic leukemic NK4 cells and chronic myelocytic leukemia K562 cells,
More amazing to be, it can suppress the growth of the early young grain leukaemia MR-2 cells of ATRA-resistance.Therefore, the present invention provides
A kind of application of application of pharmaceutical composition described above, i.e. aforementioned pharmaceutical compositions in the medicine for preparing treatment leukaemia.
More preferably a kind of technical scheme is：Aforementioned pharmaceutical compositions are preparing the medicine for the treatment of acute promyelocytic leukemic
In purposes.
More preferably another technical solution is：Aforementioned pharmaceutical compositions are preparing the medicine for the treatment of chronic myelocytic leukemia
Purposes in thing.
More preferably another technical solution is：Aforementioned pharmaceutical compositions are preparing the treatment ATRA-resistance early white blood of young grain
Purposes in the medicine of disease.
The embodiment of the present invention 1 shows, composition A groups, B groups and C groups of the invention and single medicine group (Chinese mugwort Dana Delany group and Catalpol
Group) compared to having significant difference (P ＜ 0.05) or pole significant difference (P ＜ 0.01), this shows, Chinese mugwort Dana Delany can with Catalpol
Suppress the growth of people's acute promyelocytic leukemic NK4 cells and chronic myelocytic leukemia K562 cells with collaboration, it might even be possible to
Suppress the growth of the early young grain leukaemia MR-2 cells of ATRA-resistance, this result for clinically acute promyelocytic leukemic,
The directive significance of the early young grain leukaemia own profound of chronic myelocytic leukemia and ATRA-resistance.The embodiment of the present invention 2 shows,
Pharmaceutical composition of the present invention can delay the quantity of leucocyte after tumor inoculation to increase significantly, its in terms of quantity growth with
Blank control group is compared compared to still Catalpol group has extremely significant difference, also has significant difference with Chinese mugwort Dana Delany group.
Pharmaceutical composition of the present invention has efficiently controlled the growth trend of leucocyte after inoculated tumour in 0-9 days, control the state of an illness
Development, wherein composition C groups are more advantageous in terms of leucocyte growth is suppressed；Pharmaceutical composition of the present invention can be significantly simultaneously
Delay leukaemia disease progression, increase the life-span of animal, its aspect and blank control in terms of the mouse survival time is extended
Group is compared compared to still Catalpol group has extremely significant difference, also has significant difference with Chinese mugwort Dana Delany group.Wherein combine
Thing C groups are more advantageous in terms of leukemia mouse life span is extended.
Compared with prior art, pharmaceutical composition of the present invention has following technical advantage：
1) pharmaceutical composition of the present invention suppresses the active higher of tumor growth rate, and two kinds of active constituents of medicine are pressing down
There is significant synergistic therapeutic effect in terms of the propagation and extension leukaemic's survival rate of leukaemia leucocyte processed.
2) pharmaceutical composition of the present invention can not only suppress people's acute promyelocytic leukemic NK4 cells and chronic granulocyte is white
The growth of blood disease K562 cells, the growth of the early young grain leukaemia MR-2 cells of ATRA-resistance can also be suppressed, this is for clinic
Upper acute promyelocytic leukemic, chronic myelocytic leukemia and ATRA-resistance early young grain leukaemia own profound guidance meaning
Justice.
3) pharmaceutical composition component of the present invention is clear and definite, and its synergistic therapeutic effect can be played when it is used for leukemia treating,
The dosage of two kinds of compositions is greatly reduced, so as to reduce toxic side effect of the Chinese mugwort Dana Delany during leukaemia is treated, and
Enhance its therapeutic effect.
Embodiment
Inhibitory action of 1 pharmaceutical composition of the present invention of embodiment to leukemia cell line
By people's acute promyelocytic leukemic NK4 cells, chronic myelocytic leukemia K562 cells, the early young grain of ATRA-resistance
Leukaemia MR-2 cells are inoculated in RPMI-1640 nutrient solutions respectively, contain 5%CO in 37 DEG C2Incubator in subculture, connect
Kind is added the medicine of respective concentration, per parallel 5 hole of concentration, MTT reduction reactions after 48h when 96 well culture plates, inoculation by group
Inhibition rate of tumor growth is determined, test data carries out statistical analysis with Excel systems, and specific test result is referring to table 1.
Experiment packet and administration final concentration are as follows：
Blank control group：Isometric excipient
End Dana Delany A groups：2.4mg/mL Chinese mugwort Dana Delanies
End Dana Delany B groups：9.6mg/mL Chinese mugwort Dana Delanies
Catalpol A groups：10mg/mL Catalpols
Catalpol B groups：40mg/mL Catalpols
Composition A groups：2.4mg/mL Chinese mugwort Dana Delany+10mg/mL Catalpols
Composition B groups：2.4mg/mL Chinese mugwort Dana Delany+40mg/mL Catalpols
Composition C groups：9.6mg/mL Chinese mugwort Dana Delany+10mg/mL Catalpols
Influence of the pharmaceutical composition of table 1 to leukemic cell growth
| Group | NK4 cell inhibitory rates | K562 cell inhibitory rates | MR-2 cell inhibitory rates |
| Blank control group | 0.81±0.14 | 0.45±0.06 | 0.64±0.08 |
| End Dana Delany A groups | 37.24±4.62 | 41.28±3.27 | 30.62±2.17 |
| End Dana Delany B groups | 49.65±4.82 | 52.63±4.18 | 35.21±5.18 |
| Catalpol A groups | 7.21±0.15 | 3.27±0.23 | 5.16±0.21 |
| Catalpol B groups | 10.24±1.01 | 8.24±0.79 | 6.72±0.35 |
| Composition A groups | 60.25±8.74*$$ | 63.95±12.08*$$ | 56.34±7.87**$$ |
| Composition B groups | 67.39±7.26**▲▲ | 70.32±11.06**▲▲ | 63.62±6.15**▲ |
| Composition C groups | 76.85±9.54%% $ $ | 82.64±8.25%% $ $ | 70.27±8.63% $ $ |
Compared with the Dana Delany A groups that end, * P ＜ 0.05, * * P ＜ 0.01；Compared with the Dana Delany B groups that end,%P ＜ 0.05,%%P ＜
0.01：
Compared with Catalpol A groups,$P ＜ 0.05,$$P ＜ 0.01；Compared with Catalpol A groups,▲P ＜ 0.05,▲▲P ＜ 0.01.
Composition A groups, B groups and the C groups and single medicine group (Chinese mugwort Dana Delany of the present invention is can be seen that by the result of above-mentioned table 1
Group and Catalpol group) to compare with significant difference (P ＜ 0.05) or pole significant difference (P ＜ 0.01), this shows, end Dana Delany
The growth for suppressing people's acute promyelocytic leukemic NK4 cells and chronic myelocytic leukemia K562 cells can be cooperateed with Catalpol,
The growth of the early young grain leukaemia MR-2 cells of ATRA-resistance can even be suppressed, this result is for clinically young grain of acute morning
The directive significance of the early young grain leukaemia own profound of leukaemia, chronic myelocytic leukemia and ATRA-resistance.
Therapeutic action of 2 pharmaceutical composition of the present invention of embodiment to Leukemia Model mouse
Kunming male mice 30,18~22g of body weight (are purchased from Tianjin blood disease research institute), give be subcutaneously injected respectively
L615K lymphocytic leukemia cells (being purchased from Tianjin blood disease research institute) form bearing mouse model.All mouse are divided into 6
Group, every group 5, each group gives following medicine respectively：
Blank control group：Isometric excipient
End Dana Delany A groups：2.5mg/kg Chinese mugwort Dana Delanies
End Dana Delany B groups：5mg/kg Chinese mugwort Dana Delanies
Catalpol A groups：10mg/kg Catalpols
Catalpol B groups：20mg/kg Catalpols
Composition A groups：2.5mg/kg Chinese mugwort Dana Delany+10mg/kg Catalpols
Composition B groups：2.5mg/kg Chinese mugwort Dana Delany+20mg/kg Catalpols
Composition C groups：10mg/kg Chinese mugwort Dana Delany+10mg/kg Catalpols
Each administration group is gastric infusion, is raised under home.Adopted after each group mouse inoculation tumour cell at interval of 3d
Tail blood meter leukocyte count.Observe tumor-bearing mice survival day.
Leukocyte count purpose after inoculated tumour is influenceed administration group and influence such as table 2 and table 3 to the mouse survival time
Shown, data compare using paired t-test between each group.
2 each administration group of table influences (unit to leukocyte count purpose after inoculated tumour：×109/L)
Compared with the Dana Delany B groups that end,%P ＜ 0.05,%%P ＜ 0.01；Compared with Catalpol A groups,$P ＜ 0.05,$$P ＜ 0.01：
As can be seen from Table 2, pharmaceutical composition of the present invention can delay the quantity growth of leucocyte after tumor inoculation significantly,
Still Catalpol group is compared with extremely significant difference, with Ai Dela compared with blank control group in terms of quantity growth for it
Buddhist nun's group also has significant difference.Pharmaceutical composition of the present invention has efficiently controlled leucocyte after inoculated tumour in 0-9 days
Growth trend, the development of the state of an illness is controlled, wherein composition C groups are more advantageous in terms of leucocyte growth is suppressed.
Therapeutic action of 3 pharmaceutical composition of the present invention of table to leukemia mouse
| Group | The average survival time number of days (d) |
| Blank control group | 10.2±1.5 |
| End Dana Delany A groups | 16.5±1.8* |
| End Dana Delany B groups | 18.9±2.0* |
| Catalpol A groups | 12.2±1.6 |
| Catalpol B groups | 14.5±1.2* |
| Composition A groups | 20.8±1.6**% |
| Composition B groups | 22.4±2.1**% |
| Composition C groups | 26.8±2.5**%% |
Compared with blank control group, * P ＜ 0.05, * * P ＜ 0.01；Compared with the Dana Delany B groups that end,%P ＜ 0.05,%%P ＜
0.01；
As can be seen from Table 3, pharmaceutical composition of the present invention can delay leukaemia disease progression significantly, increase the longevity of animal
Life, aspect is compared with blank control group in terms of the mouse survival time is extended or Catalpol group is compared with extremely notable for it
Sex differernce, also there is significant difference with Chinese mugwort Dana Delany group.Wherein composition C groups are in terms of leukemia mouse life span is extended
It is more advantageous.
It the above is only the preferred embodiment of the present invention, it is noted that above-mentioned preferred embodiment is not construed as pair
The limitation of the present invention, protection scope of the present invention should be defined by claim limited range.For the art
For those of ordinary skill, without departing from the spirit and scope of the present invention, some improvements and modifications can also be made, these change
Enter and retouch and also should be regarded as protection scope of the present invention.
Claims (8)
- A kind of 1. pharmaceutical composition for the Dana Delany containing Chinese mugwort for treating leukaemia, it is characterised in that the medicine in described pharmaceutical composition Thing active component includes Chinese mugwort Dana Delany and Catalpol, and the weight ratio of Chinese mugwort Dana Delany and Catalpol is 1: 1- wherein in described pharmaceutical composition 16。
- 2. pharmaceutical composition as claimed in claim 1, it is characterised in that end Dana Delany and Catalpol in described pharmaceutical composition Weight ratio is 1: 4.
- 3. pharmaceutical composition as claimed in claim 1 or 2, it is characterised in that it is oral solid formulation.
- 4. pharmaceutical composition as claimed in claim 3, it is characterised in that described oral solid formulation is its tablet, capsule Agent, granule.
- 5. pharmaceutical composition as claimed in claim 1 or 2 is preparing the purposes in treating leukemia medicament.
- 6. purposes of the pharmaceutical composition as claimed in claim 1 or 2 in the medicine for preparing treatment acute promyelocytic leukemic.
- 7. purposes of the pharmaceutical composition as claimed in claim 1 or 2 in the medicine for preparing treatment chronic myelocytic leukemia.
- 8. pharmaceutical composition as claimed in claim 1 or 2 is in preparation treatment the ATRA-resistance early medicine of young grain leukaemia Purposes.
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| CN105919957A (en) * | 2016-06-13 | 2016-09-07 | 佛山市腾瑞医药科技有限公司 | Idelalisib dispersible tablet and preparation method thereof |
| CN105943510A (en) * | 2016-06-13 | 2016-09-21 | 佛山市腾瑞医药科技有限公司 | Idelalisib preparation and application thereof |
| CN106074430A (en) * | 2016-06-13 | 2016-11-09 | 佛山市腾瑞医药科技有限公司 | A kind of Ai Dailalisi effervescent tablet and preparation method thereof |
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