CN101301306A - Use of DFT in preparing medicament for treating and preventing shock - Google Patents
Use of DFT in preparing medicament for treating and preventing shock Download PDFInfo
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- CN101301306A CN101301306A CNA2008101260015A CN200810126001A CN101301306A CN 101301306 A CN101301306 A CN 101301306A CN A2008101260015 A CNA2008101260015 A CN A2008101260015A CN 200810126001 A CN200810126001 A CN 200810126001A CN 101301306 A CN101301306 A CN 101301306A
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- dft
- shock
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- injection
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- 239000003814 drug Substances 0.000 title claims abstract description 14
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- 239000007924 injection Substances 0.000 claims abstract description 18
- 238000002360 preparation method Methods 0.000 claims abstract description 8
- 239000000843 powder Substances 0.000 claims abstract description 5
- 230000002265 prevention Effects 0.000 claims abstract description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 9
- 239000008194 pharmaceutical composition Substances 0.000 claims description 7
- 230000037396 body weight Effects 0.000 claims description 5
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- 239000011780 sodium chloride Substances 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 239000001509 sodium citrate Substances 0.000 claims description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 3
- 229920002307 Dextran Polymers 0.000 claims description 2
- 108010010803 Gelatin Proteins 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- 239000004471 Glycine Substances 0.000 claims description 2
- 108010009736 Protein Hydrolysates Proteins 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 239000008273 gelatin Substances 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- 235000011852 gelatine desserts Nutrition 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 238000005259 measurement Methods 0.000 claims description 2
- JNWFIPVDEINBAI-UHFFFAOYSA-N [5-hydroxy-4-[4-(1-methylindol-5-yl)-5-oxo-1H-1,2,4-triazol-3-yl]-2-propan-2-ylphenyl] dihydrogen phosphate Chemical compound C1=C(OP(O)(O)=O)C(C(C)C)=CC(C=2N(C(=O)NN=2)C=2C=C3C=CN(C)C3=CC=2)=C1O JNWFIPVDEINBAI-UHFFFAOYSA-N 0.000 abstract description 29
- 229960004120 defibrotide Drugs 0.000 abstract description 29
- 229940079593 drug Drugs 0.000 abstract description 7
- 239000000203 mixture Substances 0.000 abstract description 7
- 230000000694 effects Effects 0.000 abstract description 3
- 239000002775 capsule Substances 0.000 abstract description 2
- 238000000034 method Methods 0.000 abstract description 2
- 239000000812 cholinergic antagonist Substances 0.000 abstract 1
- 230000002048 spasmolytic effect Effects 0.000 abstract 1
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- 208000032456 Hemorrhagic Shock Diseases 0.000 description 10
- 206010049771 Shock haemorrhagic Diseases 0.000 description 10
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- 210000004369 blood Anatomy 0.000 description 6
- 239000008280 blood Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 230000004872 arterial blood pressure Effects 0.000 description 4
- 238000001990 intravenous administration Methods 0.000 description 4
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- 206010040070 Septic Shock Diseases 0.000 description 3
- 238000010171 animal model Methods 0.000 description 3
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- 230000007935 neutral effect Effects 0.000 description 3
- 230000003449 preventive effect Effects 0.000 description 3
- 230000036303 septic shock Effects 0.000 description 3
- 206010002660 Anoxia Diseases 0.000 description 2
- 241000976983 Anoxia Species 0.000 description 2
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- WEXRUCMBJFQVBZ-UHFFFAOYSA-N pentobarbital Chemical compound CCCC(C)C1(CC)C(=O)NC(=O)NC1=O WEXRUCMBJFQVBZ-UHFFFAOYSA-N 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 210000003556 vascular endothelial cell Anatomy 0.000 description 2
- FRXSZNDVFUDTIR-UHFFFAOYSA-N 6-methoxy-1,2,3,4-tetrahydroquinoline Chemical compound N1CCCC2=CC(OC)=CC=C21 FRXSZNDVFUDTIR-UHFFFAOYSA-N 0.000 description 1
- 208000010444 Acidosis Diseases 0.000 description 1
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- 101000862089 Clarkia lewisii Glucose-6-phosphate isomerase, cytosolic 1A Proteins 0.000 description 1
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- 239000007864 aqueous solution Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
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- KAQKFAOMNZTLHT-OZUDYXHBSA-N prostaglandin I2 Chemical compound O1\C(=C/CCCC(O)=O)C[C@@H]2[C@@H](/C=C/[C@@H](O)CCCCC)[C@H](O)C[C@@H]21 KAQKFAOMNZTLHT-OZUDYXHBSA-N 0.000 description 1
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to an application of DTF (Defibrotide) in preparation of a drug for curing and preventing shock and a drug composition prepared by the method. The drug composition of the invention has notable cure and prevention effects on shock. The drug composition of the invention is usually used in the form of freeze-dried acanthopanax powder spasmolytic, injection or capsule.
Description
Technical field
The present invention relates to the pharmaceutical chemistry field.Particularly, the present invention relates to the novel medical use of DFT (Defibrotide), promptly DFT treats and/or prevents application in the shock drug in preparation.
Background technology
DFT (Defibrotide) is the strand polydeoxyribonucleotide sodium salt that the DNA that extracts from animal visceras such as pulmonis Bovis seu Bubali, pig small intestine makes through control degradation, mean molecule quantity 15-30kDa, average length 50 nucleotide.The effect of DFT comprises anti thrombotic action and to protective effect two aspects of vascular endothelial cell (EC); wherein anti thrombotic action produces with the generation that stimulates PGI2 and release, induction of vascular wall and to discharge t-PA etc. relevant, DFT suppress leukocyte to endotheliocyte adhere to, prevent oxygen-derived free radicals to the damage of tissue, can suppress function such as heparan enzymatic activity and then play effects such as protecting vascular endothelial cell.
Shock (shock) is a kind of clinical syndrome of critical circulatory insufficiency, be because the effective circulating blood volume that a variety of causes causes sharply reduces, and cause acute general microcirculation dysfunction, make the vitals blood supply insufficiency that earns a bare living, severe ischemic, anoxia, and produce dysbolismus and the impaired pathological state of cell.
Effectively the perfused tissue minimizing reaches the order of severity widely, can cause the reversibility cell injury, produces shock.If low perfusion is repaired lastingly and not, finally must cause the irreversibility cell injury.Perfused tissue is not enough and anoxia is the major issue of shock.
Have nothing in common with each other though cause the reason of shock, its pathophysiological change generally is identical:
(1) effective circulatory volume deficiency
(2) peripheral resistance changes
(3) microcirculatory variation
(4) DIC (especially suffering a shock late period)
(5) metabolism changes, and is organized under the anaerobic condition, and catabolism is strengthened, and sugar carries out anaerobic metabolism, is prone to acidosis
(6) vitals such as the heart, lung, kidney, brain, liver, gastrointestinal tract change
Contemporary medical science effectively treats and/or prevents medicine to suffering a shock also to lack.The inventor is through conscientiously research and animal experiment find that DFT has obvious treatment and/or preventive effect to shock.
Summary of the invention
The purpose of this invention is to provide the purposes that DFT is used to prepare treatment and prevention shock drug.
Another object of the present invention provides a kind of pharmaceutical composition that contains DFT that is used for the treatment of and prevents shock.
Pharmaceutical composition of the present invention has obvious treatment and preventive effect to shock.
DFT of the present invention generally uses with the form of pharmaceutical composition, and this compositions contains the DFT and the pharmaceutically acceptable auxiliaries as active component for the treatment of effective dose, contains the DFT of 50mg～1000mg and the pharmaceutically acceptable auxiliaries of 1mg～100mg in its every measurement unit.The pharmaceutical composition that contains DFT is usually with the intravenous injection administration, and main dosage form comprises lyophilized injectable powder and injection liquor, also can be by the oral capsule form administration that contains DFT.
Sterilization composition through intravenous administration, it generally is solid sterilization composition form, it is lyophilized injectable powder, the pharmaceutically acceptable auxiliaries that these compositionss contain is one or more in mannitol, dextran, gelatin hydrolysate, sodium citrate, the glycine etc., can be dissolved in use in sterilization or various other injection sterile medium.
Sterilization combination through intravenous administration also can be an aqueous solution, promptly injects liquor, and the pharmaceutically acceptable auxiliaries that these compositionss contain is one or more in sodium chloride, the glucose etc.
Use the dosage of DFT treatment shock and decide according to the order of severity, the treatment time of the state of an illness, general intravenous administration (intravenous injection or instillation), as ejection preparation, the dosage of DFT is generally in 5mg-200mg/ kg body weight/sky.As capsule, the intake of every day is at 100mg-20g.
The specific embodiment
The invention will be further described with specific embodiment below.
Embodiment 1 preparation DFT injection (200mg/3ml)
Get DFT40g, add injection water dissolving, regulate PH to neutral, add injection water to 600 milliliter, add sodium chloride adjusting etc. and ooze, aseptic filtration is in 200 ampoule bottles of packing, promptly.
Embodiment 2 preparation DFT lyophilized formulations
Get DFT40g, add injection water dissolving, regulate PH to neutral, add 1.5 gram mannitol, 1 gram sodium citrate dissolving is regulated PH to neutral, adds injection water to 600 milliliter, aseptic filtration, and in 200 ampoule bottles of packing, lyophilization under the aseptic condition, promptly.
Embodiment 3DFT is to the treatment experiment of hemorrhagic shock rats
Hemorrhagic shock rats model preparation method: fasting (can't help water) 12h (spending the night) before the SD art.With 2% pentobarbital through intraperitoneal injection of anesthesia (45mg/kg).Rat is fixed in operating-table, makes the cervical region median incision, separate left carotid, use Y type sealed venous detaining needle intubate No. 22, arterial cannulation is by the T joint blood pressure monitor, and monitoring and record arteriotony are simultaneously as the blood-letting buck channel; Separate right external jugular vein, use Y type sealed venous detaining needle intubate No. 22, being used to lose blood feeds back and fluid infusion.
After aforesaid operations is finished and is stablized 15min, the record arteriotony.Use 10ml syringe (putting into 125U/mL heparin sodium saline 1mL in advance) slowly to draw blood, in 10min, make mean arterial pressure be reduced to 40mmHg, and keep the rat mean arterial pressure at 40mmHg60 minute through the common carotid artery intubate.Keep the mean arterial pressure fluctuation during this by drawing blood repeatedly, infusing between 35～45mmHg, and record rat lose blood total amount and amount of infusion.Extracting arterial blood room temperature during this time is stored in the syringe.
Laboratory animal grouping: body weight is 30 of the SD rats of 250～300g, is divided into three groups at random, 10 every group.1. sham operated rats: 10 of SD rats, only anaesthetize, venous incubation, do not experience the hemorrhagic shock process; 2. hemorrhagic shock matched group, 3. DFT treatment group, at aforesaid operations, be that blood pressure is reduced to 40mmHg and kept 1h, the beginning vein is to (1gDFT is dissolved in the 20ml normal saline with DFT, speed according to 50mg/kg/hr is carried out venoclysis), the hemorrhagic shock matched group is then given normal saline with equivalent according to identical speed.
Observation index: keep the rat mean arterial pressure and began to calculate the survival rate of each time point laboratory animal thereafter at 40mmHg60 minute.
Experimental result sees Table one:
Table one: DFT is to the influence of each time point survival quantity of hemorrhagic shock rats
| 0 | 60 minutes | 120 minutes | 180 minutes | |
| Sham operated rats | 10 | 10 | 10 | 10 |
| Matched group | 10 | 7 | 3 | 0 |
| The treatment group | 10 | 9 | 6 | 3* |
* treatment group and matched group compare, P＜0.05
To the rat blood-letting, produce hemorrhagic shock after, we do not recover, but rat is continued to remain under the ischemic state, by adding DFT, study its influence to the rat ischemia toleration.At this moment, the amount of liquid of input all is no more than 1ml/kg.
Result of the test shows: at the hemorrhagic shock matched group, and after 120 minutes, laboratory animal survival rate only 30%, experimental group then is 60%, in the time of 180 minutes, control animals is all dead, and the survival rate of experimental group still has 30%.The result shows that DFT can increase the toleration of hemorrhagic shock rats tissue to ischemia, prolongs its time-to-live, and hemorrhagic shock rats is had obvious treatment and preventive effect.
Embodiment 4DFT prepares the treatment experiment of septic shock rat to the injection colibacillus deactivating
Get body weight and be 20 of the Wistar male rats of 180-230g, be divided into two groups at random, 10 every group.Matched group, colibacillus deactivating body (being equivalent to 200,000,000,000 thalline)/kg body weight of injection 40mg, experimental group, 10 minutes beginning intravenous drip DFT (50mg/kg/ hour) before injection escherichia coli body.After the coli somatic injection, observe the difference of different time two treated animal survival condition.
The influence that table 2DFT prepares septic shock survival of rats number to the injection colibacillus deactivating
| Before the injection | 30 minutes | 60 minutes | 120 minutes | 150 minutes | |
| Matched group | 10 | 6 | 3 | 1 | 1 |
| Experimental group | 10 | 10 | 9 | 9 | 8 |
(data are this moment survival rats quantity in the table)
Table 2 data show: injection DFT can obviously reduce the injection colibacillus deactivating and prepare the mortality rate of septic shock rat.Result of the test shows that DFT can treat and prevent shock.
Claims (10)
1.DFT the purposes in the medicine of preparation treatment and prevention shock.
2. purposes according to claim 1, wherein said medicine contain the DFT and the pharmaceutically acceptable auxiliaries as active component for the treatment of effective dose.
3, purposes according to claim 2, wherein said medicine is a lyophilized injectable powder.
4. purposes according to claim 3, wherein said pharmaceutically acceptable auxiliaries are one or more in mannitol, dextran, gelatin hydrolysate, sodium citrate, the glycine.
5. purposes according to claim 2, wherein said medicine are the injection liquors.
6. purposes according to claim 5, wherein said pharmaceutically acceptable auxiliaries are one or more in sodium chloride, the glucose.
7. according to claim 4 or 6 described purposes, the dosage of described medicine is 5mg-200mg/ kg body weight/sky.
8. one kind is used for the treatment of and prevents the pharmaceutical composition of suffering a shock, and it contains the DFT and the pharmaceutically acceptable auxiliaries as active component for the treatment of effective dose.
9. pharmaceutical composition according to claim 8 contains the DFT of 50mg～1000mg and the pharmaceutically acceptable auxiliaries of 1mg～100mg in its every measurement unit.
10. according to the pharmaceutical composition of claim 9, it is lyophilized injectable powder or injection liquor.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101260015A CN101301306A (en) | 2008-06-30 | 2008-06-30 | Use of DFT in preparing medicament for treating and preventing shock |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101260015A CN101301306A (en) | 2008-06-30 | 2008-06-30 | Use of DFT in preparing medicament for treating and preventing shock |
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| Publication Number | Publication Date |
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| CN101301306A true CN101301306A (en) | 2008-11-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2008101260015A Pending CN101301306A (en) | 2008-06-30 | 2008-06-30 | Use of DFT in preparing medicament for treating and preventing shock |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111132663A (en) * | 2017-08-03 | 2020-05-08 | 爵士制药爱尔兰有限公司 | Formulations comprising high concentrations of nucleic acids |
-
2008
- 2008-06-30 CN CNA2008101260015A patent/CN101301306A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111132663A (en) * | 2017-08-03 | 2020-05-08 | 爵士制药爱尔兰有限公司 | Formulations comprising high concentrations of nucleic acids |
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Open date: 20081112 |