CN103393701B - Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone sodium phosphate - Google Patents
Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone sodium phosphate Download PDFInfo
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- CN103393701B CN103393701B CN201310332617.9A CN201310332617A CN103393701B CN 103393701 B CN103393701 B CN 103393701B CN 201310332617 A CN201310332617 A CN 201310332617A CN 103393701 B CN103393701 B CN 103393701B
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- sodium phosphate
- navoban
- soz
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Abstract
The invention relates to a pharmaceutical composition containing containing tropisetron hydrochloride and dexamethasone sodium phosphate, and particularly relates to a combined application package containing a tropisetron hydrochloride injection and a dexamethasone sodium phosphate injection. When the combined application package is in use, the tropisetron hydrochloride injection and the dexamethasone sodium phosphate injection are co-dissolved in normal saline, a Ringer's solution, 5% glucose injection, a fructose solution and the like for intravenous infusion, so that a curative effect of stopping vomit can be increased.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of hydrochloric tropisetron and dexamethasone sodium phosphate, be specifically related to a kind of medicinal applied in any combination packaging compositions being formed by Navoban (Soz) injection and Decameth, belong to medical technical field.
Background technology
Former and the central nervous system's 5-hydroxy tryptamine 3(5-HT3 of a kind of peripheral nervous of Navoban (Soz)) efficient, the high selectivity competition antagonist of receptor.Cucumber comprises that some chemotherapeutic can excite the class pheochromocyte of internal organs mucosa to discharge 5-hydroxy tryptamine, thereby brings out the vomiting reflex that companion is nauseating.Navoban (Soz) mainly suppresses vomiting reflex by optionally blocking the former presynaptic 5-HT3 receptor of peripheral nervous, in addition, its antiemetic effect also may be relevant by the direct blocking-up of maincenter 5-HT3 receptor being suppressed to vagal stimulation of area postrema with it.
Navoban (Soz) Metabolism of Normal person's the elimination half-life (β phase) is about 7~10 hours, and in the bad person of metabolism, this value may extend to 45 hours.The CLTB of this product is about 1 liter/min, and that wherein removes through kidney is about 10%.In the bad patient of metabolism, although the constant rate of removing through kidney, CLTB is reduced to 0.1~0.2 liter/min.This reduction can cause eliminating approximately 4~5 times of Increased Plasma Half-lifes, AUC value improves 5~7 times, and Cmax and distribution volume and homergy person are without marked difference.In the bad person of metabolism, the medicine prototype ratio of discharging through urine is large compared with Metabolism of Normal person.
Navoban (Soz) is for preventing and treat the nausea and vomiting that cancer chemotherapy causes.
Dexamethasone sodium phosphate is Aeroseb-Dex.Have antiinflammatory, antiallergic, rheumatism, immunosuppressive action, its mechanism of action is: (1) antiinflammatory action: alleviate and prevent the reaction of tissue to inflammation, thus the performance reducing inflammation.Can inflammation-inhibiting cell, comprise that macrophage and leukocyte are in the gathering of inflammation part, and suppress the synthetic of the release of phagocytosis, lysosomal enzyme and inflammation chemistry mediator and discharge.(2) immunosuppressive action: comprise and prevent or suppress cell-mediated immunoreation, the anaphylaxis of retardance, reduce T lymphocyte, mononuclear cell, bite the number of acid cell, reduce the binding ability of immunoglobulin and cell surface receptor, and suppress the synthetic of interleukin and discharge, thereby reduce T lymphocyte to lymphoblastic transformation, and alleviate that feelings are former sends out expansion immunoreactive.Dexamethasone sodium phosphate also reduces immunity and checks thing by basement membrane, and can reduce the concentration of complement component and immunoglobulin.
Dexamethasone sodium phosphate is mainly used in anaphylaxis and autoimmune inflammation disease.Be used for connective tissue disease, activeness rheumatism, rheumatoid arthritis, lupus erythematosus, serious bronchial asthma, serious dermatitis, ulcerative colitis, acute leukemia etc., also for some severe infections and Comprehensive Treatment poisoning, malignant lymphoma.
Prior art is write in Navoban (Soz) operation instructions: Special use, when alone this product unsatisfactory curative effect, does not increase drug dose and share dexamethasone simultaneously and can improve antiemetic effect.But, directly use Navoban (Soz) and dexamethasone still to have multiple side effect, such as constipation, headache, giddy, dizzy, stomachache, glucocorticoid syndrome etc.
Summary of the invention
In order to overcome the series of problems existing in prior art, the inventor has creatively found to adopt Navoban (Soz) injection and the Decameth compatibility use in conjunction by particular excipient, not only can improve the curative effect of emesis, can also overcome in prior art the defect that the side effect such as existing constipation, headache, giddy, dizzy, stomachache, glucocorticoid syndrome cause.Especially, have been surprisingly found that be beneficial to the side effect that reduces dexamethasone sodium phosphate the therapeutic activity that improves Navoban (Soz) the adding of glycine in Navoban (Soz) injection.
One of object of the present invention, provides the pharmaceutical composition of a kind of Navoban (Soz) and dexamethasone sodium phosphate.
One of object of the present invention, a kind of medicinal applied in any combination packaging compositions being made up of Navoban (Soz) injection and Decameth is provided, wherein, Navoban (Soz) injection is sterile freeze-drying preparation or aseptic parenteral solution, and Decameth is sterile freeze-drying preparation or aseptic parenteral solution.
Applied in any combination packaging provided by the invention, usage is for to be jointly dissolved in the venoclysises such as normal saline, ringer's solution, 5% glucose injection or fructose soln by Navoban (Soz) injection and Decameth.
Applied in any combination packing specification provided by the invention is that Navoban (Soz) injection 2mg or 5mg or 2ml:2mg or 5ml:5mg(are by C
17h
20n
2o
2meter), Decameth 0.5-5ml or 1-20mg.
Navoban (Soz) injection of the present invention comprises Navoban (Soz) injection and hydrochloride for injection tropisetron, the sterile freeze-drying preparation that adds the formulated aseptic parenteral solution of appropriate adjuvant or add appropriate excipient to make for Navoban (Soz).
As one of specific embodiment, concrete component and consumption are as follows:
The present invention also provides a kind of preparation method of Navoban (Soz) injection, and concrete steps are:
(1) the first water for injection that adds recipe quantity 80% in material-compound tank, 10 DEG C~20 DEG C of temperature controls;
(2) add the glycine of recipe quantity, stirring and dissolving is complete;
(3) add the Navoban (Soz) of recipe quantity, stirring and dissolving is complete, and regulating pH with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution is 4.5-5.5;
(4) add total amount 0.02%(g/ml) injection-use activated carbon, add residue water for injection, standardize solution, stirring and adsorbing 30 minutes;
(5) the de-charcoal of solution coarse filtration, through 0.45 μ m cartridge filter coarse filtration, then uses 0.22 μ m microporous filter membrane aseptic filtration qualified to visible foreign matters;
(6) fill, sealing, sterilizing, obtains Navoban (Soz) injection; Or, fill, lyophilization, obtains hydrochloride for injection tropisetron.
As the present invention's one preferred embodiment, wherein in preparation method, lyophilized injectable powder freeze drying process is:
1. the pre-freeze phase, is cooled to shelf temperature-40 DEG C ± 2 DEG C, in the time that products temperature reaches-35 DEG C ± 2 DEG C, (approximately needs 3 hours), is incubated approximately 2 hours, makes product freeze reality completely;
2. distil the phase, in the time that case internal pressure value reaches below 10Pa, it is-4 DEG C ± 2 DEG C that flaggy temperature is set, and it is 30Pa that dry case vacuum is set, slowly heat up to flaggy, product starts distillation (plate temperature rises to-4 DEG C ± 2 DEG C by-40 DEG C ± 2 DEG C) under vacuum condition.Shelf temperature rises to-4 DEG C ± 2 DEG C, after ice crystal disappears, is incubated approximately 2 hours;
3. dry period, it is 30 DEG C that flaggy temperature is set, and flaggy continues slowly to heat up, and product is dried (plate temperature rises to 30 DEG C ± 1 DEG C by-4 DEG C ± 2 DEG C and approximately needs 2 hours) under vacuum condition; Shelf temperature reaches 30 DEG C ± 1 DEG C, and products temperature is warming up to approximately 20 DEG C ± 2 DEG C, is incubated approximately 2~3 hours, finishes lyophilizing, presses full plug.
Decameth of the present invention comprises dexamethasone sodium phosphate injection and injection freezing-drying powder-injection contg. dexamethasone.
As one of specific embodiment, concrete component and consumption are as follows:
The present invention also provides a kind of preparation method of Decameth, and concrete steps are:
(1) to the water for injection that adds recipe quantity 50% in Agitation Tank, add sodium sulfite and propylene glycol or sodium sulfite and the mannitol of recipe quantity, stirring makes it to dissolve, add the dexamethasone sodium phosphate of recipe quantity again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.5-8.5, then add recipe quantity 0.05%(g/ml) moistening medicinal charcoal, benefit adds to the full amount of water for injection, and stirs filtering decarbonization 30 minutes;
(2) with the microporous filter membrane fine straining of 0.22 μ m, fill, seals, and sterilizing, obtains dexamethasone sodium phosphate injection; Or with the microporous filter membrane fine straining of 0.22 μ m, fill, lyophilization, obtains injection freezing-drying powder-injection contg. dexamethasone.
The present invention also provides the applied in any combination of a kind of Navoban (Soz) injection and Decameth to be packaged in the nausea and vomiting that preparation treatment cancer chemotherapy causes, postoperatively feels sick, application in vomiting etc.In not increasing drug dose, dexamethasone sodium phosphate can improve the antiemetic effect of Navoban (Soz).
Detailed description of the invention
embodiment 1the preparation of hydrochloride for injection tropisetron lyophilized injectable powder
Prescription:
Preparation process:
(1) first in container, add 2800ml water for injection, 10 DEG C~20 DEG C of temperature controls;
(2) add 105g glycine, stirring and dissolving is complete;
(3) add Navoban (Soz) 7g(by C
17h
20n
2o
2meter), stirring and dissolving is complete, and regulating pH with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution is 4.9;
(4) add 0.7g injection-use activated carbon, add residue water for injection, be settled to 3500ml, stirring and adsorbing 30 minutes;
(5) the de-charcoal of solution coarse filtration, through 0.45 μ m cartridge filter coarse filtration, then uses 0.22 μ m microporous filter membrane aseptic filtration qualified to visible foreign matters;
(6) fill.
(7) lyophilization
1. the pre-freeze phase, is cooled to shelf temperature-40 DEG C ± 2 DEG C, in the time that products temperature reaches-35 DEG C ± 2 DEG C, (approximately needs 3 hours), is incubated approximately 2 hours, makes product freeze reality completely;
2. distil the phase, in the time that case internal pressure value reaches below 10Pa, it is-4 DEG C ± 2 DEG C that flaggy temperature is set, and it is 30Pa that dry case vacuum is set, slowly heat up to flaggy, product starts distillation (plate temperature rises to-4 DEG C ± 2 DEG C by-40 DEG C ± 2 DEG C) under vacuum condition.Shelf temperature rises to-4 DEG C ± 2 DEG C, after ice crystal disappears, is incubated approximately 2 hours;
3. dry period, it is 30 DEG C that flaggy temperature is set, and flaggy continues slowly to heat up, and product is dried (plate temperature rises to 30 DEG C ± 1 DEG C by-4 DEG C ± 2 DEG C and approximately needs 2 hours) under vacuum condition; Shelf temperature reaches 30 DEG C ± 1 DEG C, and products temperature is warming up to approximately 20 DEG C ± 2 DEG C, is incubated approximately 2~3 hours, finishes lyophilizing, presses full plug.
(8) roll lid, to obtain final product.
embodiment 2the preparation of Navoban (Soz) injection
Prescription:
Preparation process:
(1) first in container, add 5600ml water for injection, 10 DEG C~20 DEG C of temperature controls;
(2) add Navoban (Soz) 7g(by C
17h
20n
2o
2meter), stirring and dissolving is complete, and regulating pH with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution is 5.0;
(4) add 1.4g injection-use activated carbon, add residue water for injection, be settled to 7000ml, stirring and adsorbing 30 minutes;
(5) the de-charcoal of solution coarse filtration, through 0.45 μ m cartridge filter coarse filtration, then uses 0.22 μ m microporous filter membrane aseptic filtration qualified to visible foreign matters;
(6) fill, sealing, sterilizing.
embodiment 3the preparation of dexamethasone sodium phosphate injection
Prescription:
Preparation process:
(1) in beaker, add 500ml water for injection, add 2g sodium sulfite and 300ml propylene glycol, stirring makes it to dissolve, add 1g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.8, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ props up, sealing; 121 DEG C of pressure sterilizings 15 minutes, spraying cooling, offers for sale fast, naturally cools to room temperature.
(2) in beaker, add 500ml water for injection, add 2g sodium sulfite and 300ml propylene glycol, stirring makes it to dissolve, add 2g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.7, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ props up, sealing; 121 DEG C of pressure sterilizings 15 minutes, spraying cooling, offers for sale fast, naturally cools to room temperature.
(3) in beaker, add 500ml water for injection, add 2g sodium sulfite and 300ml propylene glycol, stirring makes it to dissolve, add 5g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.6, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ props up, sealing; 121 DEG C of pressure sterilizings 15 minutes, spraying cooling, offers for sale fast, naturally cools to room temperature.
embodiment 4the preparation of injection freezing-drying powder-injection contg. dexamethasone
Prescription:
Preparation process:
(1) in beaker, add 500ml water for injection, add 2g sodium sulfite and 50g mannitol, stirring makes it to dissolve, add 1g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.7, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ bottle, lyophilization, obtains injection freezing-drying powder-injection contg. dexamethasone.
(2) in beaker, add 500ml water for injection, add 2g sodium sulfite and 50g mannitol, stirring makes it to dissolve, add 2g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.9, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ bottle, lyophilization, obtains injection freezing-drying powder-injection contg. dexamethasone.
(3) in beaker, add 500ml water for injection, add 2g sodium sulfite and 50g mannitol, stirring makes it to dissolve, add 5g dexamethasone sodium phosphate again, stir and make to dissolve completely, regulating pH with the hydrochloric acid solution of 0.1mol/L or the sodium hydroxide solution of 0.1mol/L is 7.8, then add the moistening medicinal charcoal of 0.5g, benefit injects water to 1000ml, stirs filtering decarbonization 30 minutes; With the microporous filter membrane fine straining of 0.22 μ m, fill, 1ml/ bottle, lyophilization, obtains injection freezing-drying powder-injection contg. dexamethasone.
embodiment 5the preparation of assembly packaging medicine
Combination 1: hydrochloride for injection tropisetron freeze-dried powder 2mg and dexamethasone sodium phosphate injection 1ml:1mg.
Combination 2: hydrochloride for injection tropisetron freeze-dried powder 2mg and dexamethasone sodium phosphate injection 1ml:2mg.
Combination 3: hydrochloride for injection tropisetron freeze-dried powder 2mg and dexamethasone sodium phosphate injection 1ml:5mg.
Combination 4: hydrochloride for injection tropisetron freeze-dried powder 5mg and dexamethasone sodium phosphate injection 1ml:1mg.
Combination 5: hydrochloride for injection tropisetron freeze-dried powder 5mg and dexamethasone sodium phosphate injection 1ml:2mg.
Combination 6: hydrochloride for injection tropisetron freeze-dried powder 5mg and dexamethasone sodium phosphate injection 1ml:5mg.
Combination 7: Navoban (Soz) injection 2ml:2mg and dexamethasone sodium phosphate injection 1ml:1mg.
Combination 8: Navoban (Soz) injection 2ml:2mg and dexamethasone sodium phosphate injection 1ml:2mg.
Combination 9: Navoban (Soz) injection 2ml:2mg and dexamethasone sodium phosphate injection 1ml:5mg.
Combination 10: Navoban (Soz) injection 5ml:5mg and dexamethasone sodium phosphate injection 1ml:1mg.
Combination 11: Navoban (Soz) injection 5ml:5mg and dexamethasone sodium phosphate injection 1ml:2mg.
Combination 12: Navoban (Soz) injection 5ml:5mg and dexamethasone sodium phosphate injection 1ml:5mg.
Combination 13: hydrochloride for injection tropisetron freeze-dried powder 2mg and injection freezing-drying powder-injection contg. dexamethasone 1mg.
Combination 14: hydrochloride for injection tropisetron freeze-dried powder 2mg and injection freezing-drying powder-injection contg. dexamethasone 2mg.
Combination 15: hydrochloride for injection tropisetron freeze-dried powder 2mg and injection freezing-drying powder-injection contg. dexamethasone 5mg.
Combination 16: hydrochloride for injection tropisetron freeze-dried powder 5mg and injection freezing-drying powder-injection contg. dexamethasone 1mg.
Combination 17: hydrochloride for injection tropisetron freeze-dried powder 5mg and injection freezing-drying powder-injection contg. dexamethasone 2mg.
Combination 18: hydrochloride for injection tropisetron freeze-dried powder 5mg and injection freezing-drying powder-injection contg. dexamethasone 5mg.
Combination 19: Navoban (Soz) injection 2ml:2mg and injection freezing-drying powder-injection contg. dexamethasone 1mg.
Combination 20: Navoban (Soz) injection 2ml:2mg and injection freezing-drying powder-injection contg. dexamethasone 2mg.
Combination 21: Navoban (Soz) injection 2ml:2mg and injection freezing-drying powder-injection contg. dexamethasone 5mg.
Combination 22: Navoban (Soz) injection 5ml:5mg and injection freezing-drying powder-injection contg. dexamethasone 1mg.
Combination 23: Navoban (Soz) injection 5ml:5mg and injection freezing-drying powder-injection contg. dexamethasone 2mg.
Combination 24: Navoban (Soz) injection 5ml:5mg and injection freezing-drying powder-injection contg. dexamethasone 5mg.
Test example 1 pharmacology irritant test
32 of the New Zealand Journal of Health Physical Education does of getting body weight 2.0-2.5kg, are divided into eight groups at random.New zealand rabbit is placed in holder, inject respectively the medicine of the the the the the 1st, 6,7,12,13,18,19,24 combinations in the embodiment of the present invention 5 for every group, every new zealand rabbit injection 4ml, during injection and after injection, note observing injection site and have or not redness, hyperemia, the stimulation such as hemorrhage and downright bad., after 24 hours, by sacrifice of animal, drawn materials in injection site in last administration, carry out histopathologic examination.
Result of the test:
Perusal: eight groups all do not occur the significantly irritant reaction such as red and swollen, congested, downright bad.
Pathological examination: eight groups of skin histology structures are normal, epidermis is without thickening, and subcutaneous tissue has no the morphological changes such as hyperemia, edema, has no the changes such as inflammatory cell infiltration.
Conclusion: assembly packaging product of the present invention with respect to the effect of one-component application of stimulus without obvious increase.
Test example 2 antiemetic effect tests
Choose nausea and vomiting patient 120 examples that certain hospital's cancer chemotherapy causes, be divided at random six groups, every group of 20 examples:
The hydrochloride for injection tropisetron freeze-dried powder 2mg+5% glucose 250ml of first group of venoclysis embodiment 1, once a day;
The Navoban (Soz) injection 2ml:2mg+5% glucose 250ml of second group of venoclysis embodiment 2, once a day;
In the 3rd group of venoclysis embodiment 5, combine 8 Navoban (Soz) injection 2ml:2mg+ dexamethasone sodium phosphate injection 1ml:2mg+5% glucose 250ml, once a day;
In the 4th group of venoclysis embodiment 5, combine 20 Navoban (Soz) injection 2ml:2mg+ injection freezing-drying powder-injection contg. dexamethasone 2mg+5% glucose 250ml, once a day.
In the 5th group of venoclysis embodiment 5, combine 2 hydrochloride for injection tropisetron freeze-dried powder 2mg+ dexamethasone sodium phosphate injection 1ml:2mg+5% glucose 250ml, once a day;
In the 6th group of venoclysis embodiment 5, combine 14 hydrochloride for injection tropisetron freeze-dried powder 2mg+ injection freezing-drying powder-injection contg. dexamethasone 2mg+5% glucose 250ml, once a day;
Continuous use 6 days.Efficacy result is as following table:
Six groups of patients' of table 1 clinical effectiveness
Group | Number of cases | Effective | Effectively | Invalid | Total effective rate | Untoward reaction |
First group | 20 | 9 | 5 | 6 | 70% | 12 |
Second group | 20 | 10 | 6 | 4 | 80% | 14 |
The 3rd group | 20 | 16 | 3 | 1 | 95% | 8 |
The 4th group | 20 | 17 | 1 | 2 | 90% | 7 |
The 5th group | 20 | 17 | 3 | 0 | 100% | 5 |
The 6th group | 20 | 18 | 2 | 0 | 100% | 4 |
Six groups of patients' of table 2 untoward reaction contrast
Can find out by above result, the 3rd group to the 6th group of six groups of patients' total effective rate is apparently higher than to first group and second group; Illustrate that assembly packaging Navoban (Soz) injection of the present invention and Decameth share better than independent use Navoban (Soz) injection antiemetic effect, the less adverse effect that side effect causes.
In addition, the effect that adopts the 5th group of glycine and the 6th group also will, due to the 3rd and four groups, show the unforeseeable technique effect of the present invention.
Claims (2)
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