CN104825485A - Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition - Google Patents
Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition Download PDFInfo
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- CN104825485A CN104825485A CN201510238838.9A CN201510238838A CN104825485A CN 104825485 A CN104825485 A CN 104825485A CN 201510238838 A CN201510238838 A CN 201510238838A CN 104825485 A CN104825485 A CN 104825485A
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- injection
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- sodium chloride
- navoban
- soz
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Abstract
The invention provides a pharmaceutical composition of a tropisetron hydrochloride injection and a fructose-sodium chloride injection, and particularly provides a composite application package comprising a tropisetron hydrochloride injection and a fructose-sodium chloride injection. When in use, after the tropisetron hydrochloride injection is dissolved in the fructose-sodium chloride injection, the obtained product is applied to intravenous infusion, so that the pharmaceutical composition not only has an effect of treating postoperative nausea and vomiting, but also can replenish energy and body fluids to a human body.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of hydrochloric tropisetron, fructose sodium chloride, be specifically related to a kind of pharmaceutical composition be made up of Navoban (Soz) injection and fructose sodium chloride injection, belong to medical art.
Background technology
A kind of peripheral nervous of Navoban (Soz) former and central nervous system's 5-hydroxy tryptamine 3 (5-HT3) receptor efficient, high selectivity compete antagonist.Cucumber comprises some chemotherapeutic and the class pheochromocyte of internal organs mucosa can be excited to discharge 5-hydroxy tryptamine, thus brings out the nauseating vomiting reflex of companion.Navoban (Soz) suppresses vomiting reflex mainly through optionally blocking the former presynaptic 5-HT3 receptor of peripheral nervous, in addition, its antiemetic effect also may suppress vagal stimulation of area postrema relevant by the direct blocking-up to maincenter 5-HT3 receptor with it.
The elimination half-life (β phase) of Navoban (Soz) Metabolism of Normal person 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 patient that metabolism is bad, although the constant rate removed through kidney, CLTB reduces to 0.1 ~ 0.2 liter/min.This reduction can cause eliminating Increased Plasma Half-life about 4 ~ 5 times, AUC value raising 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 used for the nausea and vomiting that prevention and therapy cancer chemotherapy causes.Treat postoperative Nausea and vomiting.
Fructose (D-fructose) is a kind of left-handed hexose, is the isomer of glucose, energy and body fluid supplement.Fructose more easily forms glycogen than glucose, and mainly pass through fructokinase metabolism at liver, being easy to metabolism is fruit acid, is converted into energy rapidly.Pharmacokinetic data shows, Healthy People continues input fructose can reach steady plasma-drug concentration 6 ~ 8 mM/ls, in body, ATP and Phos all drop to steady-state level, hepatic clearance be 0.53 ml/g (liver is heavy)/minute, endocellular metabolism meets first order kinetics process.Fructose pharmacological action is substantially identical with glucose, has direct heat supply, supplements effect of body fluid and nutrition whole body.After fructose intravenously administrable, metabolism is but fast than glucose in vivo, is easily absorbed by body, and does not rely on insulin, little to blood sugar influence, is more suitable for diabetes, hepatopathy patients supply energy, supplements body fluid.
Fructose is under the insulin-resistant states such as postoperative infection of burning or be not suitable for the body fluid supplement therapy of patient that need keep the skin wet when using glucose.
Sodium chloride is for needing the body fluid supplement therapy of the patient of sodium salt or the energy under the insulin-resistant states such as postoperative infection of burning.
Prior art treats postoperative nausea and vomiting in Navoban (Soz) operation instructions, venoclysis (be dissolved in normal saline, Ringers solution, 5% glucose solution or fructose soln etc.) or slowly intravenous injection (more than 30 seconds).
The applicant has patent application CN201310332615.X Navoban (Soz) and fructose share, which disclose a kind of pharmaceutical composition comprising Navoban (Soz) injection and fructose injection, it is characterized in that Navoban (Soz) injection comprises Navoban (Soz) injection and hydrochloride for injection tropisetron, add the aseptic parenteral solution of appropriate auxiliaries for Navoban (Soz) or add the sterile freeze-drying preparation that appropriate excipient makes; Fructose injection is the aseptic parenteral solution adding appropriate auxiliaries; But find, owing to only having Navoban (Soz) and fructose in compositions, also to there are some defects in further studying, such as, need the body fluid supplement therapy of the patient of sodium salt or the energy under not being suitable for the insulin-resistant states such as burn postoperative infection.
Applicant is in follow-up research, against expectation find, the Navoban (Soz) injection formed by adopting particular excipient and the combination of fructose sodium chloride injection, at raising medicine stability, reduce in the side effect such as lesions of liver and kidney, minimizing gastrointestinal reaction (stomachache and diarrhoea), there is unforeseeable technique effect.
Summary of the invention
An object of the present invention, provides the pharmaceutical composition of a kind of hydrochloric tropisetron, fructose sodium chloride.
The present inventor, by research, is surprised to find that in the present invention, sodium chloride is not only osmotic pressure regulator, and can also produces the function of the lesions of liver and kidney of unforeseeable reduction Navoban (Soz) with fructose combined effect; Especially to gastrointestinal reaction (stomachache and diarrhoea), there is significant Prevention effect.
An object of the present invention, provide a kind of pharmaceutical composition be made up of Navoban (Soz) injection and fructose sodium chloride injection, wherein, Navoban (Soz) injection is sterile freeze-drying preparation or aseptic parenteral solution, fructose sodium chloride injection fructose and the formulated aseptic parenteral solution of sodium chloride.
Combination application packaging provided by the invention, usage is for be dissolved in fructose sodium chloride injection posterior vein infusion by Navoban (Soz) injection.
Combination application packing specification provided by the invention is that Navoban (Soz) injection 2mg, 5mg are (by C
17h
20n
2o
2meter), fructose sodium chloride injection 50-1000ml.
Navoban (Soz) injection of the present invention comprises Navoban (Soz) injection and hydrochloride for injection tropisetron lyophilized injectable powder, adds the aseptic parenteral solution of appropriate auxiliaries or add the sterile freeze-drying preparation that appropriate excipient makes for Navoban (Soz).
As one of specific embodiment, concrete component and consumption as follows:
Wherein the proportioning of xylitol and glycine is 1:2.
Present invention also offers a kind of preparation method of Navoban (Soz) injection, concrete steps are:
(1) in material-compound tank, the water for injection of recipe quantity 80% is first added, temperature control 10 DEG C ~ 20 DEG C;
(2) add xylitol and the glycine of recipe quantity, stirring and dissolving is complete;
(3) add the Navoban (Soz) of recipe quantity, stirring and dissolving is complete, regulates pH to be 4.5-5.5 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(4) add the injection-use activated carbon of total amount 0.02% (g/ml), add residue water for injection, standardize solution, stirring and adsorbing 30 minutes;
(5) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of 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 one preferred embodiment, wherein in preparation method, lyophilized injectable powder freeze drying process is:
1. the pre-freeze phase, shelf temperature is cooled to-40 DEG C ± 2 DEG C, when products temperature reaches-35 DEG C ± 2 DEG C, (approximately needs 3 hours), be incubated about 2 hours, make product freeze reality completely;
2. distil the phase, when in case, force value reaches below 10Pa, arranging flaggy temperature is-4 DEG C ± 2 DEG C, and arranging dry case vacuum is 30Pa, slowly heat up to flaggy, product starts to distil (plate temperature rises to-4 DEG C ± 2 DEG C by-40 DEG C ± 2 DEG C) under vacuum.Shelf temperature rises to-4 DEG C ± 2 DEG C, after ice crystal disappears, be incubated about 2 hours;
3. dry period, arranging flaggy temperature is 30 DEG C, and flaggy continues slowly to heat up, and product carries out drying (plate temperature rises to 30 DEG C ± 1 DEG C by-4 DEG C ± 2 DEG C and about needs 2 hours) under vacuum; Shelf temperature reaches 30 DEG C ± 1 DEG C, and products temperature is warming up to about 20 DEG C ± 2 DEG C, is incubated about 2 ~ 3 hours, terminates lyophilizing, carries out pressing full plug.
Fructose sodium chloride injection of the present invention is the formulated sterile water solution of fructose and sodium chloride.
As one of specific embodiment, concrete component and consumption as follows:
Present invention also offers a kind of preparation method of fructose sodium chloride injection, concrete steps are:
(1) densely to join: the water for injection adding recipe quantity 30% in dense preparing tank, add fructose and the sodium chloride of recipe quantity, stirring makes it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 90%, be 3.8-4.0 by 0.1mol/L hydrochloric acid solution adjust ph, add the moistening medicinal charcoal of recipe quantity 0.1% (g/ml), stir 30 minutes, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
The Combination application that present invention also offers a kind of Navoban (Soz) injection and fructose sodium chloride injection is packaged in the nausea and vomiting prepared Therapeutic cancer chemotherapy and cause, the application in postoperative Nausea and vomiting etc.Not only there is the effect for the treatment of postoperative nausea and vomiting, and energy and the body fluid of human body can also be supplemented.
Detailed description of the invention
embodiment 1the preparation of hydrochloride for injection tropisetron
Prescription:
Preparation process:
(1) first 2800ml water for injection is added in a reservoir, temperature control 10 DEG C ~ 20 DEG C;
(2) add 35g xylitol and 70g glycine, stirring and dissolving is complete;
(3) Navoban (Soz) 7g is added (by C
17h
20n
2o
2meter), stirring and dissolving is complete, regulates pH to be 5.1 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(4) add 0.7g injection-use activated carbon, add residue water for injection, be settled to 3500ml, stirring and adsorbing 30 minutes;
(5) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(6) fill, 1ml/ bottle and 2.5ml/ bottle.
(7) lyophilization
1. the pre-freeze phase, shelf temperature is cooled to-40 DEG C ± 2 DEG C, when products temperature reaches-35 DEG C ± 2 DEG C, (approximately needs 3 hours), be incubated about 2 hours, make product freeze reality completely;
2. distil the phase, when in case, force value reaches below 10Pa, arranging flaggy temperature is-4 DEG C ± 2 DEG C, and arranging dry case vacuum is 30Pa, slowly heat up to flaggy, product starts to distil (plate temperature rises to-4 DEG C ± 2 DEG C by-40 DEG C ± 2 DEG C) under vacuum.Shelf temperature rises to-4 DEG C ± 2 DEG C, after ice crystal disappears, be incubated about 2 hours;
3. dry period, arranging flaggy temperature is 30 DEG C, and flaggy continues slowly to heat up, and product carries out drying (plate temperature rises to 30 DEG C ± 1 DEG C by-4 DEG C ± 2 DEG C and about needs 2 hours) under vacuum; Shelf temperature reaches 30 DEG C ± 1 DEG C, and products temperature is warming up to about 20 DEG C ± 2 DEG C, is incubated about 2 ~ 3 hours, terminates lyophilizing, carries out pressing full plug.
(8) roll lid, to obtain final product.
comparative example 1the preparation of hydrochloride for injection tropisetron
Prescription:
Preparation process prepares according to the technique of embodiment 1.
embodiment 2the preparation of Navoban (Soz) injection
Prescription:
Preparation process:
(1) first 5600ml water for injection is added in a reservoir, temperature control 10 DEG C ~ 20 DEG C;
(2) add 35g xylitol and 70g glycine, stirring and dissolving is complete;
(3) Navoban (Soz) 7g is added (by C
17h
20n
2o
2meter), stirring and dissolving is complete, regulates pH to be 5.0 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(4) add 1.4g injection-use activated carbon, add residue water for injection, be settled to 7000ml, stirring and adsorbing 30 minutes;
(5) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(6) fill, 2ml/ props up and props up with 5ml/, sealing, sterilizing.
comparative example 2the preparation of Navoban (Soz) injection
Prescription:
Preparation process is prepared into according to embodiment 2.
embodiment 3the preparation of fructose sodium chloride injection
Prescription:
Preparation process:
(1) densely to join: the water for injection adding 30L in dense preparing tank, adds 10kg fructose and 0.9kg sodium chloride, stir and make it to dissolve, add the moistening medicinal charcoal of 100g, stir 30 minutes, filtering decarbonization, filter into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to 90L, be 3.8 by 0.1mol/L hydrochloric acid solution adjust ph, adds the moistening medicinal charcoal of 100g, stirs 30 minutes, filtering decarbonization, mend and inject water to 100L;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, 250ml/ bottle and 500ml/ bottle, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
comparative example 3the preparation of fructose injection
Prescription:
Preparation process:
(1) densely to join: the water for injection adding 30L in dense preparing tank, adds 10kg fructose, stir and make it to dissolve, add the moistening medicinal charcoal of 100g, stir 30 minutes, filtering decarbonization, filter into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to 90L, be 3.8 by 0.1mol/L hydrochloric acid solution adjust ph, adds the moistening medicinal charcoal of 100g, stirs 30 minutes, filtering decarbonization, mend and inject water to 100L;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, 250ml/ bottle and 500ml/ bottle, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
comparative example 4the preparation of sodium chloride injection
Prescription:
Preparation process:
(1) densely to join: the water for injection adding 30L in dense preparing tank, adds 0.9kg sodium chloride, stir and make it to dissolve, add the moistening medicinal charcoal of 100g, stir 30 minutes, filtering decarbonization, filter into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to 90L, be 3.8 by 0.1mol/L hydrochloric acid solution adjust ph, adds the moistening medicinal charcoal of 100g, stirs 30 minutes, filtering decarbonization, mend and inject water to 100L;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, 250ml/ bottle and 500ml/ bottle, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
embodiment 4the preparation of assembly packaging medicine
Combination 1: embodiment 1A preparation 2mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 2: embodiment 1B preparation 5mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 3: embodiment 2C preparation 2ml:2mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 4: embodiment 2D preparation 2ml:5mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 5: comparative example 1A preparation 2mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 6: comparative example 1B preparation 5mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 7: comparative example 2C preparation 2ml:2mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 8: comparative example 2D preparation 2ml:5mg and embodiment 3 fructose sodium chloride injection 250ml.
Combination 9: embodiment 1A preparation 2mg and comparative example 3 fructose injection 250ml.
Combination 10: embodiment 1B preparation 5mg and comparative example 3 fructose injection 250ml.
Combination 11: embodiment 2C preparation 2ml:2mg and comparative example 3 fructose injection 250ml.
Combination 12: embodiment 2D preparation 2ml:5mg and comparative example 3 fructose injection 250ml.
Combination 13: embodiment 1A preparation 2mg and comparative example 4 sodium chloride injection 250ml.
Combination 14: embodiment 1B preparation 5mg and comparative example 4 sodium chloride injection 250ml.
Combination 15: embodiment 2C preparation 2ml:2mg and comparative example 4 sodium chloride injection 250ml.
Combination 16: embodiment 2D preparation 2ml:5mg and comparative example 4 sodium chloride injection 250ml.
Test example 1 pharmacology irritant test
Get the New Zealand Journal of Health Physical Education doe 48 of body weight 2.0-2.5kg, be divided into eight groups at random.New zealand rabbit is placed in holder, first group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 2, second group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 3, 3rd group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 6, 4th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 7, 5th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 10, 6th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 11, 7th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 14, 8th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 15, every new zealand rabbit injection 3ml, during injection and after injection, note observing injection site with or without redness, congested, the stimulation such as hemorrhage and downright bad.In last administration after 24 hours, by sacrifice of animal, drawn materials in injection site, carry out histopathologic examination.
Result of the test:
Perusal: first group and second group does not occur the irritant reaction such as obvious redness, hyperemia, necrosis, there is the irritant reaction such as a small amount of redness and necrosis in the new zealand rabbit injection site of the 3rd group to the 8th group.
Pathological examination: first group and second group: skin texture is normal, and 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.
3rd group to the 8th group: epidermis thickens, subcutaneous tissue is congested, edema, has inflammatory cell infiltration.
Conclusion: assembly packaging product of the present invention is without obvious stimulation effect, and zest is far smaller than the combination product of prior art and comparative example.
Test example 2 pharmacodynamics test
Get 80 rats, body weight (205 ± 10) g, be divided into 8 groups at random, first group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 2, second group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 3, 3rd group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 6, 4th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 7, 5th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 10, 6th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 11, 7th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 14, 8th group of abdominal part hypodermic embodiment of the present invention 4 combines the medicine of 15.
After administration, 2h takes a blood sample 48 hours.
High performance liquid chromatography is adopted to detect the blood drug level of Navoban (Soz).Use software 3p87 and WT1.4 to carry out data analysis, relevant pharmacokinetic parameters result is as following table.
As can be seen from the above experimental data, in eight groups of compatible solution, first group and second group of solution and the embodiment of the present invention 4 combine 2 and the sample of combination 3 greatly improve than other six groups of sample bioavailability, absolutely prove the intravenous benefit of assembly packaging of Navoban (Soz) injection of the present invention and fructose sodium chloride injection, injection is made to improve bioavailability widely, add drug effect, obtain unexpected technical effect.
The proof of test example 3 hepatic and renal function
Get the New Zealand Journal of Health Physical Education doe of 24 body weight 2.0-2.5kg, be divided into four groups at random, wherein first group of intravenous injection embodiment of the present invention 4 combines the medicine of 2, second group of intravenous injection embodiment of the present invention 4 combines the medicine of 6,3rd group of intravenous injection embodiment of the present invention 4 combines the medicine of 10, and the 4th group of intravenous injection embodiment of the present invention 4 combines the medicine of 14.Continuous use 7 days, detect the every Testing index of hepatic and renal function, result is as follows:
As can be seen from the above results, the every Testing index data of renal function in four groups of compatible solution, first group is obviously better than second group to the 4th group, absolutely prove that the damage of assembly packaging intravenous injection to hepatic and renal function of Navoban (Soz) injection of the present invention and fructose sodium chloride injection is minimum, obtained unexpected technical effect.
The proof (stomachache and diarrhoea) of test example 4 gastrointestinal reaction
Get the New Zealand Journal of Health Physical Education doe of 24 body weight 2.0-2.5kg, be divided into four groups at random, wherein first group of intravenous injection embodiment of the present invention 4 combines the medicine of 2, second group of intravenous injection embodiment of the present invention 4 combines the medicine of 6,3rd group of intravenous injection embodiment of the present invention 4 combines the medicine of 10, and the 4th group of intravenous injection embodiment of the present invention 4 combines the medicine of 14.Continuous use 7 days, observe gastrointestinal reaction situation, result is as follows:
| Stomachache | Diarrhoea | |
| First group | 0 | 1 |
| Second group | 3 | 4 |
| 3rd group | 4 | 2 |
| 4th group | 2 | 3 |
As can be seen from the above results, gastrointestinal reaction data in four groups of compatible solution, first group is obviously better than second group to the 4th group, absolutely prove that the assembly packaging intravenous injection of Navoban (Soz) injection of the present invention and fructose sodium chloride injection is to the good action reducing gastrointestinal reaction (stomachache and diarrhoea), obtains unexpected technical effect.
Claims (4)
1. one kind comprises the pharmaceutical composition of Navoban (Soz) injection and fructose sodium chloride injection, it is characterized in that Navoban (Soz) injection comprises Navoban (Soz) injection and hydrochloride for injection tropisetron, add the aseptic parenteral solution of appropriate auxiliaries for Navoban (Soz) or add the sterile freeze-drying preparation that appropriate excipient makes; Fructose sodium chloride injection is the formulated aseptic parenteral solution of fructose and sodium chloride.
2. pharmaceutical composition according to claim 1, is characterized in that the specification of Navoban (Soz) injection is with tropisetron (C
17h
20n
2o
2meter) 2mg, 5mg prop up/bottle; The specification of fructose sodium chloride injection is 50-1000ml.
3. pharmaceutical composition according to claim 1, is characterized in that this pharmaceutical composition can be packed for Combination application.
4. pharmaceutical composition according to claim 1 reduces Navoban (Soz) to the function of lesions of liver and kidney especially to the application in the medicine of gastrointestinal reaction in preparation.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2033632A1 (en) * | 2007-09-10 | 2009-03-11 | Novasearch AG | 5-HT3 receptor antagonists for the teatment of myocardial infarction, stroke, thrombosis and atherosclerosis |
| CN101838266A (en) * | 2009-02-17 | 2010-09-22 | 回音必集团抚州制药有限公司 | Citric acid tropisetron raw material medicine and preparation technology of raw material medicine and injection liquid |
| CN102302495A (en) * | 2011-07-07 | 2012-01-04 | 天津市汉康医药生物技术有限公司 | Tropisetron hydrochloride medicament composition for injection |
| CN103385883A (en) * | 2013-08-02 | 2013-11-13 | 海南灵康制药有限公司 | Pharmaceutical composition containing tropisetron hydrochloride and fructose |
| CN103446046A (en) * | 2013-08-12 | 2013-12-18 | 回音必集团抚州制药有限公司 | High-purity tropisetron citrate injection |
| CN104274395A (en) * | 2014-09-19 | 2015-01-14 | 威海爱威制药有限公司 | Ondansetron hydrochloride sodium chloride injection and preparation method thereof |
-
2015
- 2015-05-12 CN CN201510238838.9A patent/CN104825485A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2033632A1 (en) * | 2007-09-10 | 2009-03-11 | Novasearch AG | 5-HT3 receptor antagonists for the teatment of myocardial infarction, stroke, thrombosis and atherosclerosis |
| CN101838266A (en) * | 2009-02-17 | 2010-09-22 | 回音必集团抚州制药有限公司 | Citric acid tropisetron raw material medicine and preparation technology of raw material medicine and injection liquid |
| CN102302495A (en) * | 2011-07-07 | 2012-01-04 | 天津市汉康医药生物技术有限公司 | Tropisetron hydrochloride medicament composition for injection |
| CN103385883A (en) * | 2013-08-02 | 2013-11-13 | 海南灵康制药有限公司 | Pharmaceutical composition containing tropisetron hydrochloride and fructose |
| CN103446046A (en) * | 2013-08-12 | 2013-12-18 | 回音必集团抚州制药有限公司 | High-purity tropisetron citrate injection |
| CN104274395A (en) * | 2014-09-19 | 2015-01-14 | 威海爱威制药有限公司 | Ondansetron hydrochloride sodium chloride injection and preparation method thereof |
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Application publication date: 20150812 |