CN103860458A - Injection palonosetron hydrochloride medicine composition - Google Patents
Injection palonosetron hydrochloride medicine composition Download PDFInfo
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- CN103860458A CN103860458A CN201210528805.4A CN201210528805A CN103860458A CN 103860458 A CN103860458 A CN 103860458A CN 201210528805 A CN201210528805 A CN 201210528805A CN 103860458 A CN103860458 A CN 103860458A
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- palonosetronhydrochloride
- injection
- citric acid
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Abstract
The invention belongs to the technical field of medicines, and concretely relates to an injection palonosetron hydrochloride medicine composition. Palonosetron hydrochloride injection obtained through a preparation method also provided in the invention can resist light and has a good stability. The preparation method has the advantages of product yield improvement, cost reduction, and industrialization realization, and enables the product to be well clinically applied and have obvious advantages.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical composition and preparation method of PalonosetronHydrochloride of injection.
Background technology
Along with the raising of chemotherapy status in oncotherapy and the application of more and more new chemotherapeutics, people are also more deep to the understanding of chemotherapy adverse effect.The untoward reaction of chemotherapy can be temporarily or the Long-term Effect patient's quality of life, the dosage of possible limit treatment and the course for the treatment of, serious also entail dangers to life of situation.What chemotherapy caused feels sick, vomits is the untoward reaction that cancer patient is the most frightened, controls deficiency can produce a series of relevant complication to feeling sick, vomitting.Serious feel sick, vomiting can make patient forbidding to later chemotherapy, even occurs being reluctant or abandons the thought of further chemotherapy, makes chemotherapy hard to carry on.Nauseating, the vomiting that chemotherapy causes can be divided into acute reaction, retardance reaction and expection property and react three classes.
The nausea and vomiting of property chemotherapy induction refers to previously in treatment, occur unmanageable patient in advance, before new round treatment cycle starts, nausea and vomiting occurs, and this reaction can appear in approximately 25% patients undergoing chemotherapy.The nausea and vomiting of this type of chemotherapy induction and tumor type and the chemotherapy regimen that is about to carry out have nothing to do, the main cause that psychentonia causes this type of vomiting to occur often.The patient of nausea and vomiting once occurred in previous treatment cycle, and the probability that property chemotherapy induction nausea and vomiting in advance occurs is very high.And once the nausea and vomiting of property chemotherapy induction occurs in advance, existing antiemetic is substantially invalid, therefore, patient is carried out to behavior adjusting and the systematic desensitization, is this type of patient's better treatment means.In addition,, for preventing property nausea and vomiting in advance, effectively control vomiting in chemotherapy, to alleviate patients ' psychological shade most important.
Nauseating, vomiting that chemotherapeutics causes mainly cause digestive tract Mongolia membrane damage to start by these medicines, and especially ileum is eaten the damage of film.All membrane damage causes enteric epithelium to have a liking for inscription cell release 5-HT, irritates and imports vagal 5-HT into
3receptor, the reaction thereby excited vomiting center causes vomiting, or be passed to vomiting center by excited chemoreceptor and cause vomiting.5-HT
35-HT and 5-HT that receptor antagonist mainly discharges by blocking competitively digestive tract Mongolia film
3receptors bind, thus the effect of resisting emesis there is.
5-HT
3receptor antagonist, since 1986, has had nearly 10 kinds of medicines such as ondansetron, granisetron, tropisetron to drop into clinical research and use.5-HT
3receptor antagonist may be by acting on the 5-HT on vagus nerve
3receptor and by acting on the 5-HT in central nervous system (AP) and nucleus solitarius (NTS)
3receptor, suppresses both excitements, and blocking-up, to the afferent impulse of vomiting center, has suppressed vomiting.Utilize all 5-HT of studies confirm that of radioligand
3receptor antagonist all optionally with 5-HT
3receptor combines, and ondansetron, granisetron, tropisetron are directly and 5-HT
3receptor combines, and and 5-HT
1, 5-HT
2, dopamine D 1, D2 receptor, M-ChR and histamine H
1receptor is all without combination.Thereby its side effect incidence rate is low, almost without extrapyramidal system.There are some researches show tropisetron and 5-HT
4receptor has weak adhesion.At present, to various 5-HT
3the clinical experimental study that receptor antagonist carries out has confirmed their relative safety and effectiveness in DDP treatment.This type of clinical drug is used for preventing of acute CINV.
PalonosetronHydrochloride (Palonosetron Hydrochloride)
Chemistry 2-[(S by name) the pungent a heatable brick bed-3-yl of-1-azabicyclo [2,2,2]]-2,3,3a (S), 4,5,6-, six hydrogen-IH-benzisoquinoline-1-keto hydrochloride.Chemical constitution is:
Molecular formula: C
19h
24n
2oHCl
Molecular weight: 332.87
PalonosetronHydrochloride is the 5-HT that Helsinn Hea1thcare company of Switzerland develops
3receptor antagonist, in JIUYUE, 2003 is at the U.S.'s its injection (aqueous injection) that goes on the market, and trade name is Aloxi
tM, the vomiting reaction while being mainly used in clinically treating cancer chemotherapy, radiotherapy.PalonosetronHydrochloride is a kind of 5-HT of potent, high selectivity
3receptor antagonist, is characterized in 5-HT
3receptor affinity is high, blocking effect is strong, and toxic and side effects is little, and biology declines the phase long (approximately 40h) in vivo, to vomitting than existing other 5-HT period of delay
3receptor antagonist is effective, be a kind of safe, effective, act on lasting antiemetic.
The palonosetron hydrochloride for injection that prior art is produced is all tighter to the requirement of storage, lucifuge, has inconvenience in use, preservation and transportation commercial city.Also added a large amount of other pharmaceutic adjuvants of non-injection stage, for the safety of clinical application increases hidden danger simultaneously.
The inventor is through studying for a long period of time, unexpected discovery, apply special adjuvant, PalonosetronHydrochloride compositions prepared by specific technique, light resistance is good, good stability, the problem that has successfully solved the poor stability of PalonosetronHydrochloride, reduces production costs, easy to implement, can realize industrialization, remarkable in economical benefits.
Summary of the invention
The first object of the present invention is to provide a kind of PalonosetronHydrochloride pharmaceutical composition of injection, and this PalonosetronHydrochloride injectable powder is stable to light, good stability, to improving product yield, reduce costs, realize industrialization, better be applied to clinically, there is more obvious advantage.
The second object of the present invention is the preparation method of the PalonosetronHydrochloride pharmaceutical composition that injection of the present invention is provided, and the method is simple, and prepared PalonosetronHydrochloride pharmaceutical composition is stable to light, good stability.
For realizing the first object of the present invention, the present invention adopts following technical scheme:
A PalonosetronHydrochloride pharmaceutical composition for injection, the PalonosetronHydrochloride pharmaceutical composition described in every 1000, its formula consists of:
PalonosetronHydrochloride 0.25g
Sodium chloride 2.25g
Citric acid 0.1-10g
Water for injection adds to 5L
Be preferably, the PalonosetronHydrochloride pharmaceutical composition described in every 1000, its formula consists of:
PalonosetronHydrochloride 0.25g
Sodium chloride 2.25g
Citric acid 0.5g
Water for injection adds to 5L
PalonosetronHydrochloride pharmaceutical composition of the present invention is adopted preparation with the following method:
Get recipe quantity water for injection 95%, temperature is at 30-40 ℃, pass into carbon dioxide to pH value in 3.0-3.5 scope, add sodium chloride, the citric acid of recipe quantity, after stirring and dissolving; Add the PalonosetronHydrochloride of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope at 3.0-3.5 with 4% sodium hydroxide solution and 10% citric acid soln; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
In the present invention, the consumption of described medicinal charcoal is 0.01-0.2%.
In the present invention, described stirring is at 30-40 ℃, to stir 30 minutes.
In the present invention, described sterilizing is at 121 ℃ of pressure sterilizing 10-30 minute.
In the present invention, described sterilizing is 121 ℃ of pressure sterilizings 15 minutes.
For realizing the second object of the present invention, the present invention adopts following technical scheme:
The preparation method of PalonosetronHydrochloride pharmaceutical composition of the present invention, wherein, the method comprises the steps:
Get recipe quantity water for injection 95%, temperature is at 30-40 ℃, pass into carbon dioxide to pH value in 3.0-3.5 scope, add sodium chloride, the citric acid of recipe quantity, after stirring and dissolving; Add the PalonosetronHydrochloride of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope at 3.0-3.5 with 4% sodium hydroxide solution and 10% citric acid soln; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
Below to the more detailed elaboration of the present invention:
One aspect of the present invention provides a kind of PalonosetronHydrochloride pharmaceutical composition of injection, the PalonosetronHydrochloride pharmaceutical composition described in every 1000, and its formula consists of:
PalonosetronHydrochloride 0.25g
Sodium chloride 2.25g
Citric acid 0.5g
Water for injection adds to 5L
Traditional palonosetron hydrochloride for injection, photostability is poor, easily degraded, quality cannot guarantee.
In the present invention, in the stability study process to palonosetron hydrochloride for injection light, discovery selects carbon dioxide to pass into water for injection to substantially saturated, pH value is after 3.0-3.5 scope, add sodium chloride, the citric acid of recipe quantity, dissolve PalonosetronHydrochloride again, can effectively improve the stability of said preparation to light, related substance is unchanged.Through the screening of test recipe and the summary of test data of tens of times, optimize its recipe quantity, not only solve the poor problem of photostability, and constant product quality.
The inventor finds through a large amount of experimental study, when PalonosetronHydrochloride pharmaceutical composition is above-mentioned formula, and described injection the best in quality, stability is best.
Another aspect of the present invention provides the preparation method of palonosetron hydrochloride for injection of the present invention, and the method is simple, and prepared palonosetron hydrochloride for injection is stable to light, good stability.
Preparation method provided by the present invention comprises: get recipe quantity water for injection 95%, temperature is at 30-40 ℃, pass into carbon dioxide to pH value in 3.0-3.5 scope, add sodium chloride, the citric acid of recipe quantity, after stirring and dissolving; Add the PalonosetronHydrochloride of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope at 3.0-3.5 with 4% sodium hydroxide solution and 10% citric acid soln; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
The palonosetron hydrochloride for injection making according to the inventive method is through industrial amplification production machine study on the stability, proves that product is stable, and through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body without injury.
In preparation method of the present invention, the consumption of described medicinal charcoal is 0.01-0.2%.
In preparation method of the present invention, described stirring is at 30-40 ℃, to stir 30 minutes.
Add appropriate medicinal charcoal can improve the clarity of solution, can adsorb again thermal source, pigment, medicinal charcoal there is no absorption to PalonosetronHydrochloride, the inventor adopts UV-VIS spectrophotometry to measure the content of PalonosetronHydrochloride, has investigated medicinal charcoal, temperature, the impact of adsorption time on PalonosetronHydrochloride content in injection.Result shows, medicinal charcoal consumption is at 0.01-0.2%, and adsorption time is at 30 minutes, and adsorption temp is at 30-40 ℃, best results.
In preparation method of the present invention, described sterilizing is at 121 ℃ of pressure sterilizing 10-30 minute, is preferably 121 ℃ of pressure sterilizings 15 minutes.
Product of the present invention is the sterile water solution of PalonosetronHydrochloride, and sterilising conditions is very crucial, should reach sterilization effect, can not destroy again solution, and the inventor investigates sterilising conditions, refers to test example.Result shows, at 121 ℃ of pressure sterilizing 15-20 minute, and wherein 121 ℃ of pressure sterilizings 15 minutes, best results.
Compared with prior art, tool of the present invention has the following advantages:
1) new PalonosetronHydrochloride compositions provided by the present invention has thoroughly solved the stability problem of PalonosetronHydrochloride.
2) palonosetron hydrochloride for injection provided by the present invention is for improving the yield of this product, the market risk of reduction product, and being better applied to clinical treatment has very large help.
3) new PalonosetronHydrochloride compositions provided by the present invention, through industrialized great production and study on the stability, proves constant product quality, through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body without injury.
4) preparation method of new PalonosetronHydrochloride compositions provided by the present invention, the method is simple, and prepared palonosetron hydrochloride for injection is stable to light, good stability.
The specific embodiment
Below in conjunction with embodiment, the present invention is described in further detail
Embodiment 1
PalonosetronHydrochloride pharmaceutical composition described in every 1000, its formula consists of:
PalonosetronHydrochloride 0.25g
Sodium chloride 2.25g
Citric acid 0.5g
Water for injection adds to 5L
Preparation technology: get recipe quantity water for injection 95%, temperature is at 30-40 ℃, pass into carbon dioxide to pH value in 3.0-4.0 scope, add sodium chloride, the citric acid of recipe quantity, after stirring and dissolving; Add the PalonosetronHydrochloride of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record initial pH value, according to initial pH value, regulate pH value scope at 3.0-4.0 with 4% sodium hydroxide solution and 10% citric acid soln; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
Embodiment 2
PalonosetronHydrochloride pharmaceutical composition described in every 1000, its formula consists of:
PalonosetronHydrochloride 0.25g
Sodium chloride 7g
Citric acid 0.5g
Water for injection adds to 5L
Preparation technology: with embodiment 1.
Comparing embodiment 1
PalonosetronHydrochloride 0.25g
Sodium chloride 7g
Water for injection adds to 5L
Preparation technology: get recipe quantity water for injection 95%, temperature, at 30-40 ℃, adds the PalonosetronHydrochloride of recipe quantity, is stirred to and dissolves completely; In above-mentioned solution, add medicinal charcoal, stir; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record initial pH value, according to initial pH value, regulate pH value scope at 3.0-4.0 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
Test example 1
This test example is for investigating stability of solution and influence factor's situation of prescription.
Prescription composition
| Solution prescription | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 |
| PalonosetronHydrochloride | 0.25g | 0.25g | 0.25g | 0.25g | 0.25g |
| Sodium chloride | _ | 2.25g | 2.25g | 2.25g | 2.25g |
| Citric acid | _ | _ | 0.25g | 0.5g | 1g |
| Water for injection | Add to 5L | Add to 5L | Add to 5L | Add to 5L | Add to 5L |
| Make | 1000 | 1000 | 1000 | 1000 | 1000 |
5 illumination that are placed in 4500LX ± 500LX of prescription 1-prescription are placed 24 hours hours, respectively at 0 hour, 24 hours, its character, pH value and related substance are checked.The results are shown in following table:
Above result of the test shows, writes out a prescription 4 most preferably in illumination after 24 hours.
Test example 2
This test example is to investigate the stability of PalonosetronHydrochloride compositions provided by the present invention.
The accelerated test of palonosetron hydrochloride for injection
Prepare three batches of palonosetron hydrochloride for injections (lot number is respectively HK1205005, HK1205006, HK1205007) according to commercially available back according to the method for the embodiment of the present invention 1, at 40 ℃ ± 2 ℃, the condition of RH75% ± 5% is placed 6 months, during this time respectively at the 1st, sampling in 2,3,6 months, according to stability inspection item detect, and with 0 day data comparison.
1, investigation project
High spot reviews: character, pH value, visible foreign matters, osmotic pressure molar density, related substance and content.
2, test data sees the following form
Accelerated test result
Above conclusion (of pressure testing) can be found out: this product long term test with under accelerated test condition, place 6 months every detection indexs no significant difference compared with 0 month, good stability.
Test example 3
This test example is to investigate medicinal charcoal consumption, temperature, the impact of adsorption time on PalonosetronHydrochloride content in injection.
1. the preparation of PalonosetronHydrochloride sample solution: precision takes PalonosetronHydrochloride 10g and is placed in 2000ml volumetric flask, dilute with water scale, shakes up, and measures content, adds a certain amount of pyrogen, as reserve liquid.
2. the impact of different time different amounts medicinal charcoal on PalonosetronHydrochloride absorption: add respectively medicinal charcoal 0,0.05,0.1,0.2g, in every group, in 40 ℃ of thermostat water baths, heat 15,30 minutes respectively, be cooled to room temperature, get subsequent filtrate according to measuring trap containing under quantifier, calculate content, detect pyrogen, the results are shown in Table:
Medicinal charcoal different amounts and the impact of different mixing time on PalonosetronHydrochloride content and pyrogen
From showing, can find out, the consumption of medicinal charcoal is 0.2%, and the content of PalonosetronHydrochloride obviously declines, adsorption time is longer, and content declines more obvious, therefore in preparation process, is guaranteeing the quality of the pharmaceutical preparations in the situation that, select medicinal charcoal consumption 0.1%, adsorption time was at 30 minutes.
Test example 4
This test example is to investigate the impact of temperature on palonosetron hydrochloride for injection content under sterilising conditions:
This product is the sterile water solution of PalonosetronHydrochloride, sterilising conditions is very crucial, should reach sterilization effect, can not destroy again solution, the inventor investigates sterilising conditions, after the PalonosetronHydrochloride solution of prescription preparation certain volume, be packaged in ampoule bottle respectively at 115 ℃ 30 minutes, 121 ℃ 20 minutes, 121 ℃ 15 minutes, 121 ℃ of sterilizings in 20 minutes, drug content result following table in solution after observation sterilizing:
The impact of sterilising conditions on palonosetron hydrochloride for injection content
As can be seen from the above tests: sterilising temp condition is little on this product impact, selects 121 ℃ 15 minutes, F0>12, reaches sterilization effect, on solution content almost without affecting.
[0041] comparative test example 1 and embodiment 1 are placed in respectively to the calorstat 10 days of the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ of high temperature, respectively at 0 day, 10 days, its character, pH value and related substance are checked.The results are shown in following table:
Comparative test example 1
Known according to result of the test, embodiment 1 and comparative example 1 place 10 days in the calorstat of the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ of high temperature, embodiment 1 is under different condition, each check item has no significant change, comparative example is all comparatively responsive to light, heat, related substance, pH obviously increases trend, and the present invention has obvious quality stability.
Claims (7)
1. a PalonosetronHydrochloride pharmaceutical composition for injection, is made up of PalonosetronHydrochloride, sodium chloride and citric acid, it is characterized in that, wherein the weight ratio of PalonosetronHydrochloride and citric acid is 1:0.05-5.
2. pharmaceutical composition according to claim 1, is characterized in that, described PalonosetronHydrochloride and the weight ratio of citric acid are 1:0.5-10.
3. according to the pharmaceutical composition described in claim 1,2 any one, it is characterized in that, the PalonosetronHydrochloride pharmaceutical composition described in it, every 1000 its formulas consist of:
PalonosetronHydrochloride 0.25g(is in palonosetron)
Sodium chloride 2.25g
Citric acid 0.5g
Water for injection adds to 5L.
4. the preparation method of PalonosetronHydrochloride pharmaceutical composition according to claim 1, is characterized in that, the method comprises the steps:
Get recipe quantity water for injection 95%, temperature is at 30-45 ℃, pass into carbon dioxide to pH value in 3.0-3.5 scope, add sodium chloride, the citric acid of recipe quantity, after stirring and dissolving; Add the PalonosetronHydrochloride of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope at 3.0-3.5 with 4% sodium hydroxide solution and 10% citric acid soln; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
5. preparation method according to claim 4, is characterized in that, the consumption of described medicinal charcoal is 0.01-0.2%.
6. preparation method according to claim 4, is characterized in that, described sterilizing is at 121 ℃ of pressure sterilizing 10-30 minute.
7. preparation method according to claim 6, is characterized in that, described sterilizing is 121 ℃ of pressure sterilizings 15 minutes.
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Citations (1)
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| CN101849904A (en) * | 2009-04-03 | 2010-10-06 | 南京长澳医药科技有限公司 | Palonosetron injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101849904A (en) * | 2009-04-03 | 2010-10-06 | 南京长澳医药科技有限公司 | Palonosetron injection and preparation method thereof |
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Application publication date: 20140618 |