CN105748414A - Anti-infection micafungin freeze-drying composition and preparation method thereof - Google Patents
Anti-infection micafungin freeze-drying composition and preparation method thereof Download PDFInfo
- Publication number
- CN105748414A CN105748414A CN201610117206.1A CN201610117206A CN105748414A CN 105748414 A CN105748414 A CN 105748414A CN 201610117206 A CN201610117206 A CN 201610117206A CN 105748414 A CN105748414 A CN 105748414A
- Authority
- CN
- China
- Prior art keywords
- freeze
- mfg
- dried composition
- drying
- composition according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Abstract
The invention belongs to the technical field of medicines, and in particular relates to an anti-infection micafungin freeze-drying composition and a preparation method thereof. The anti-infection micafungin freeze-drying composition mainly consists of active components micafungin, mannitol, meglumine and a pH adjusting agent. The anti-infection micafungin freeze-drying composition provided by the invention is stable in quality and free of conspicuous light degradation phenomenon after being diluted, so that convenience can be brought to clinical medical operators to prepare medicines, and use security to patients can be improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to a kind of MFG freeze-dried composition and preparation method thereof.
Background technology
MFG is a class new type water-solubility echinocandin class lipopeptid of Teng Ze company of Japan exploitation, is fungal cell wall main composition composition 1,38 one n glucosan building-up process noncompetitive inhibitor.The deep fungal infection that Candida and Eurotium are caused by it has broad-spectrum antibacterial action, fluconazol and itraconazole drug resistance candidiasis also there is very strong vitro antibacterial activity, the spore of Eurotium is germinateed and mycelial growth has inhibitory action, be currently used primarily in the deep fungal infection caused by Candida and Eurotium.
Injection FK463, commodity are called meter Kai Min, are by the exploitation of Astellas Pharma Inc of Japan, within 2002, first list in Japan, within 2005, ratified by FDA, and entered China in 2006.nullMFG generally exists with the form of its salt FK463，Its chemical name: 5-[(1S，2S)-2-[(3S，6S，9S，11R，15S，18S，20R，21R，24S，25S，26S)-3-[(R)-2-carbamyl-1-ethoxy]-11，20，21，25-hydroxyl butyl-15-[(R)-1-ethoxy]-26-methyl-2，5，8，14，17，23-six oxo-18-[4-[5-(4-amoxy phenyl) isoxazole-3-base] benzamido]-1，4，7，13，16，22-six aza-tricycle [22.3.0.0 [sup] 9，13 [/sup]] 27-6-bases]-1，2-dihydroxy ethyl]-2-hydroxyphenyl sodium sulfate，Molecular formula: C56H70N9NaO23S，Molecular weight: 1292.26，Structural formula is as follows:
Chinese Patent Application No. 00801216.4 discloses the stable Pharmaceutical composition of a kind of lyophilized form, the invention discloses a kind of containing MFG, or the Pharmaceutical composition of its salt and one or more stabilizers composition selected from polysaccharide, disaccharidase and sodium chloride, wherein preferably lactose is excipient.
Chinese Patent Application No. 200410088076.0 discloses the stable Pharmaceutical composition of a kind of lyophilized form, the invention discloses a kind of containing MFG, or the Pharmaceutical composition of one or more stabilizers composition of its salt and polysaccharide, disaccharidase and sodium chloride, wherein preferably maltose is excipient.
Chinese Patent Application No. 201110034055.0 discloses a kind of Pharmaceutical composition containing echinocandin antifungal agent MFG and its production and use, the invention discloses a kind of containing MFG, or its salt and trehalose are as the Pharmaceutical composition of stabilizer.
Chinese Patent Application No. 201310150069.8 discloses the pharmaceutical composition of a kind of MFG or its salt, the invention discloses the pharmaceutical composition of a kind of MFG or its salt, said composition is with polysaccharide or monosaccharide or its mixture for excipient, and can contain qs pH adjuster.
Chinese Patent Application No. 201310151783.9 discloses the pharmaceutical composition containing MFG or its salt, the invention discloses a kind of pharmaceutical composition containing MFG or its salt, it is with polysaccharide or disaccharidase or its mixture for excipient, and can contain qs pH adjuster.
Chinese Patent Application No. 201510661316.X announces the phosphatide cpd of a kind of hydrophilic medicament, its pharmaceutical composition and application.Pharmaceutical composition is the composition of medicine compositions of acceptable carrier on the phosphatide cpd of hydrophilic medicament or the phosphatide cpd of hydrophilic medicament and pharmacodynamics, is liquid preparation, solid preparation, semi-solid preparation, capsule, granule, gel, injection.This pharmaceutical composition is the elaioplast nanometer particle that the phosphatide cpd of hydrophilic medicament or the phosphatide cpd of hydrophilic medicament and auxiliary agent are made, particle diameter 10-1000 nanometer.The phosphatide cpd of this hydrophilic medicament and elaioplast nanometer particle thereof can be used as liquid preparation, solid preparation, semi-solid preparation, sterilization preparation and sterile preparation, and toxicity is low, can be used for the efficient treatment of various tumors etc..The invention belongs to sustained-release preparation, technique is loaded down with trivial details.
Need to dilute with 0.9% sodium chloride solution or 5% glucose solution during MFG freeze-dried composition Clinical practice, its aqueous solution easily occurs that light degradation is reacted, its light degradation impurity becomes big along with the prolongation of standing time, this just makes troubles to the preparation of medical personnel's clinical medicine, too increase the application risk of patient simultaneously, inventor is by finding the investigation of prescription, and current technology all can not solve this problem.
Summary of the invention
For current deficiency, the invention provides a kind of MFG freeze-dried composition: be mainly made up of active component MFG, mannitol, meglumine and pH value regulator.
MFG freeze-dried composition provided by the invention: the mass ratio of described mannitol and active component MFG is 1.3 ~ 1.5:1, it is preferable to 1.4:1.
MFG freeze-dried composition provided by the invention: the mass ratio of described meglumine and active component MFG is 0.225 ~ 0.275:1, it is preferable to 0.25:1.
MFG freeze-dried composition provided by the invention: after described freeze-dried composition redissolves, pH value range is 8.2 ~ 8.8, it is preferred to 8.5.
MFG freeze-dried composition provided by the invention: described pH adjusting agent is the one in hydrochloric acid, acetic acid, phosphoric acid, citric acid, benzenesulfonic acid or sodium hydroxide or several, it is preferred to hydrochloric acid or sodium hydroxide.
The preparation method that invention further provides above-mentioned MFG freeze-dried composition, mainly comprises the steps that
1). the FK463 and the meglumine that weigh recipe quantity are dissolved in appropriate water for injection, are uniformly mixed；
2). the mannitol weighing recipe quantity is dissolved in appropriate water for injection；
3). by the solution 1 of preparation) join solution 2) in, it is uniformly mixed, regulates pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Present invention also offers the freeze-drying method of a kind of MFG freeze-dried composition；
The described freeze-drying method point three below stage carries out:
1). the pre-freeze stage: fill the semi-finished product partly jumped a queue being placed on the dividing plate in lyophilizing cabinet and carry out pre-freeze, and make semi-finished product reach pre-freezing temperature within the time short as far as possible, pre-freezing temperature ranges between-50～-40 DEG C, and the time is 120 ~ 180min about；Pre-freezing temperature is preferably-45 DEG C, and the pre-freeze time is preferably 150min；
2). the sublimation drying stage: when the vacuum in drying baker reaches 80mTorr～120mTorr, it is preferred to 100mTorr；Main baking temperature is risen to-18.0 ~-14.0 DEG C, it is preferred to-16 DEG C；Used time is 60～120min about, it is preferred to 90min；Temperature retention time is about 540min～660min, it is preferred to 600min；
3). drying stage again: 15 ~ 25 DEG C will be increased to by baking temperature again, it is preferred to 20 DEG C；Used time is 90 ~ 150min about, it is preferred to 120min；Vacuum in drying baker is evacuated to end vacuum, and temperature retention time is 210～270min about, it is preferred to 240min, obtains MFG freeze-dried composition.
Above-mentioned MFG freeze-dried composition of the present invention has the advantage that MFG freeze-dried composition steady quality prepared by the present invention, preparation did not find obvious light degradation phenomenon after redissolving within eight hours, in Clinical practice, facilitate medical personnel's preparation, medicine after preparation can the storage of long period, also improve the safety that patient uses simultaneously.
Detailed description of the invention
Embodiment 1:
Prescription
Preparation technology
1). the FK463 and the meglumine that weigh recipe quantity are dissolved in appropriate water for injection, stir mixed dissolution；
2). the mannitol weighing recipe quantity is dissolved in appropriate water for injection；
3). by the solution 1 of preparation) join solution 2) in, it is uniformly mixed, regulates pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve:
1). the pre-freeze stage: fill the semi-finished product partly jumped a queue being placed on the dividing plate in lyophilizing cabinet and carry out pre-freeze, and make semi-finished product reach pre-freezing temperature within the time short as far as possible, pre-freezing temperature is-45 DEG C, time 150min；
2). in the sublimation drying stage: the vacuum in drying baker reaches 100mTorr, main baking temperature being risen to-16 DEG C, used time 90min, temperature retention time is 600min；
3). drying stage again: 20 DEG C will be increased to by baking temperature again, used time 120min, the vacuum in drying baker is evacuated to end vacuum, temperature retention time is 240min, obtains MFG freeze-dried composition.
Embodiment 2:
Prescription
Preparation technology: with embodiment 1
Embodiment 3:
Prescription
Preparation technology: with embodiment 1
Embodiment 4:
Prescription
Preparation technology: with embodiment 1
Embodiment 5:
Prescription
Preparation technology: with embodiment 1
Embodiment 6:
Prescription
Preparation technology: with embodiment 1
Embodiment 7:
Prescription
Preparation technology: with embodiment 1
Comparative example 1:
Prescription
Preparation technology
The FK463 and the meglumine that weigh recipe quantity are dissolved in appropriate water for injection, stir mixed dissolution, regulate pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 2:
Prescription
Preparation technology
The FK463 and the mannitol that weigh recipe quantity are dissolved in appropriate water for injection, stir mixed dissolution, regulate pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 3:
Prescription
Preparation technology
1). the FK463 and the meglumine that weigh recipe quantity are dissolved in appropriate water for injection, stir mixed dissolution；
2). the mannitol weighing recipe quantity is dissolved in appropriate water for injection；
3). by the solution 1 of preparation) join solution 2) in, it is uniformly mixed, regulates pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 4:
Prescription
Preparation technology:
Dextran-20 and sucrose are dissolved in appropriate water for injection, add FK463, stir to crude drug dissolving complete；PH value is regulated to 5.5 with 0.1mol/L hydrochloric acid solution and/or 0.1mol/L sodium hydrate aqueous solution；Then being settled to total amount with water for injection, be uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 5:
Prescription
Preparation technology:
Dextran-20 and glucose are dissolved in appropriate water for injection, add FK463, stir to crude drug dissolving complete；PH value is regulated to 5.5 with 0.1mol/L hydrochloric acid solution and/or 0.1mol/L sodium hydrate aqueous solution；Then being settled to total amount with water for injection, be uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 6:
Prescription
Preparation technology:
Trehalose is dissolved in appropriate water for injection, adds FK463, stir and dissolve complete to crude drug, process is avoided produce bubble；Then being settled to total amount with water for injection, be uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 7:
Prescription
Preparation technology:
Lactose is dissolved in appropriate water for injection, adds FK463, stir and dissolve complete to crude drug, process is avoided produce bubble.After adding 2% aqueous solution of citric acid (9.5ml), in solution, add 0.4% sodium hydrate aqueous solution regulate the pH to 5.5 of medicinal liquid；Then being settled to total amount with water for injection, be uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Comparative example 8:
Prescription
Preparation technology:
Maltose is dissolved in appropriate water for injection, adds FK463, stir and dissolve complete to crude drug, process is avoided produce bubble.Add 2% aqueous solution of citric acid or the pH to 5.5 of 0.4% sodium hydrate aqueous solution adjustment medicinal liquid；Then being settled to total amount with water for injection, be uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
Freeze-drying curve is with embodiment 1
Accelerated test is investigated
The embodiment of the present invention 1～7 gained finished product preparation is placed in 40 DEG C of climatic chambers, respectively at the 0th, 6, December sampling investigate its appearance character, pH, moisture, Photodegradation Products, have the related substance change with content, result of the test is in Table 1
Table 1 embodiment 1～7 finished product preparation accelerated test investigates result
From experimental result: the preparation that the present invention prepares under acceleration conditions, appearance character, pH, moisture, Photodegradation Products, has the indices such as related substance and content all to conform to quality requirements.
The embodiment of the present invention 1～7 is become with the glucose injection dilution preparation of 0.9% sodium chloride injection and 5% respectively with comparative example 1～8 gained finished product preparation the intravenous drip solution of 50mg/100ml, measuring its Photodegradation Products and content respectively at 0,4,8 hours, result of the test is in Table 2
Table 2 embodiment 1～7 and comparative example 1～8 preparation are prepared intravenous drip stability of solution and are investigated result
From experimental result: the intravenous drip solution quality that the prepared preparation of the embodiment of the present invention 1～7 becomes 50mg/100ml with the glucose injection dilution preparation of 0.9% sodium chloride injection and 5% is stable, hence it is evident that be better than comparative example 1～8.
Claims (9)
1. a MFG freeze-dried composition, it is characterised in that be mainly made up of active component MFG, mannitol, meglumine and pH value regulator.
2. MFG freeze-dried composition according to claim 1, it is characterised in that the mass ratio of described mannitol and active component MFG is the mass ratio of the mannitol described in 1.3 ~ 1.5:1(and active component MFG is 1.4:1).
3. MFG freeze-dried composition according to claim 1, it is characterised in that the mass ratio of described meglumine and active component MFG is 0.225 ~ 0.275:1.
4. MFG freeze-dried composition according to claim 1, it is characterised in that the mass ratio of described mannitol and active component MFG is 0.25:1.
5. MFG freeze-dried composition according to claim 1, it is characterised in that after described freeze-dried composition redissolves, pH value range is that after the freeze-dried composition described in 8.2 ~ 8.8(redissolves, pH value is 8.5).
6. MFG freeze-dried composition according to claim 1, it is characterised in that described pH adjusting agent is the one in hydrochloric acid, acetic acid, phosphoric acid, citric acid, benzenesulfonic acid or sodium hydroxide or several.
7. the method preparing MFG freeze-dried composition, it is characterised in that step is as follows:
1). the FK463 and the meglumine that weigh recipe quantity are dissolved in appropriate water for injection, are uniformly mixed；
2). the mannitol weighing recipe quantity is dissolved in appropriate water for injection；
3). by the solution 1 of preparation) join solution 2) in, it is uniformly mixed, regulates pH value with appropriate dilute hydrochloric acid or diluted sodium hydroxide solution, it is settled to total amount with water for injection, is uniformly mixed, filter, fill, lyophilization, visual inspection gets product.
8. a kind of method preparing MFG freeze-dried composition according to claim 7, it is characterised in that include freeze-drying method as follows:
1). the pre-freeze stage: fill the semi-finished product partly jumped a queue being placed on the dividing plate in lyophilizing cabinet and carry out pre-freeze, and make semi-finished product reach pre-freezing temperature within the time short as far as possible, pre-freezing temperature ranges between-50～-40 DEG C, and the time is 120 ~ 180min about；
2). in the sublimation drying stage: when the vacuum in drying baker reaches 80mTorr～120mTorr, main baking temperature being risen to-18.0 ~-14.0 DEG C, the used time is 60～120min about, and temperature retention time is about 540min～660min；
3). drying stage again: 15 ~ 25 DEG C will be increased to by baking temperature again, used time about 90 ~ 150min, the vacuum in drying baker is evacuated to end vacuum, temperature retention time about 210～270min, obtain MFG freeze-dried composition.
9. a kind of method preparing MFG freeze-dried composition according to claim 7, its feature includes freeze-drying method and is preferably as follows:
1). the pre-freeze stage: fill the semi-finished product partly jumped a queue being placed on the dividing plate in lyophilizing cabinet and carry out pre-freeze, and make semi-finished product reach pre-freezing temperature within the time short as far as possible, pre-freezing temperature ranges for-45 DEG C, time 150min；
2). in the sublimation drying stage: the vacuum in drying baker reaches 100mTorr, main baking temperature being risen to-16 DEG C, the used time is about 90min, and temperature retention time is 600min；
3). drying stage again: 20 DEG C will be increased to by baking temperature again, used time 120min, the vacuum in drying baker is evacuated to end vacuum, temperature retention time is 240min, obtains MFG freeze-dried composition.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610117206.1A CN105748414A (en) | 2016-03-02 | 2016-03-02 | Anti-infection micafungin freeze-drying composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610117206.1A CN105748414A (en) | 2016-03-02 | 2016-03-02 | Anti-infection micafungin freeze-drying composition and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105748414A true CN105748414A (en) | 2016-07-13 |
Family
ID=56332328
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610117206.1A Pending CN105748414A (en) | 2016-03-02 | 2016-03-02 | Anti-infection micafungin freeze-drying composition and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105748414A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112741894A (en) * | 2019-10-31 | 2021-05-04 | 江苏恒瑞医药股份有限公司 | Novel echinocandin antifungal agent pharmaceutical composition |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258531A (en) * | 2011-04-12 | 2011-11-30 | 宁辉 | Medicinal composition containing adenosine cyclophosphate and meglumine and preparation method thereof |
| CN102512379A (en) * | 2011-12-16 | 2012-06-27 | 深圳市健元医药科技有限公司 | Novel Echinocandin antifungal pharmaceutical composition and preparation method thereof |
| CN104010658A (en) * | 2011-10-18 | 2014-08-27 | 科荣生生物科学公司 | Etanercept Formulations Stabilized With Meglumine |
-
2016
- 2016-03-02 CN CN201610117206.1A patent/CN105748414A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258531A (en) * | 2011-04-12 | 2011-11-30 | 宁辉 | Medicinal composition containing adenosine cyclophosphate and meglumine and preparation method thereof |
| CN104010658A (en) * | 2011-10-18 | 2014-08-27 | 科荣生生物科学公司 | Etanercept Formulations Stabilized With Meglumine |
| CN102512379A (en) * | 2011-12-16 | 2012-06-27 | 深圳市健元医药科技有限公司 | Novel Echinocandin antifungal pharmaceutical composition and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112741894A (en) * | 2019-10-31 | 2021-05-04 | 江苏恒瑞医药股份有限公司 | Novel echinocandin antifungal agent pharmaceutical composition |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| DK2618814T3 (en) | Caspofunginsammensætning | |
| US8980827B2 (en) | Medicinal composition containing echinocandin antifungal agent micafungin and preparation method and use thereof | |
| EP2170362A1 (en) | Lyophilized anti-fungal composition | |
| KR20090052920A (en) | Stable pharmaceutical composition containing taxane derivatives, and method of manufacturing the same | |
| CN102697795B (en) | Anti-tumor combined medicament | |
| WO2013142358A1 (en) | Formulations of bendamustine | |
| JP5723031B2 (en) | Liquid medicinal composition containing Mikafungin, an echinocandin antifungal agent | |
| EP2887953B1 (en) | Improved daptomycin injectable formulation | |
| CN104721155A (en) | Temozolomide lyophilized powder preparation and preparation method thereof | |
| US9149502B2 (en) | Low impurity content caspofungin preparation, method for preparing same, and use thereof | |
| CN106137985A (en) | A kind of stable Palmic acid 9-hydroxy-risperidone durative action preparation | |
| KR20230131815A (en) | Etoposide Tony Libate Formulation | |
| CN105748414A (en) | Anti-infection micafungin freeze-drying composition and preparation method thereof | |
| EP3040067A1 (en) | Chlorogenic acid powder-injection and preparation method thereof | |
| CN106667924A (en) | Stable S-(-)-ornidazol disodium phosphate freeze-dried preparation and preparation method thereof | |
| CN108261398A (en) | A kind of injection pharmaceutical preparation containing Levosimendan and preparation method thereof | |
| CN111465389B (en) | Pharmaceutical composition of docetaxel conjugate and preparation method thereof | |
| EP3054924B1 (en) | Stable pharmaceutical formulations of caspofungin | |
| US10080720B2 (en) | Pharmaceutical composition containing docetaxel | |
| CN110237039A (en) | A kind of paclitaxel freeze drying powder preparation technique and product | |
| WO2017198224A1 (en) | Pharmaceutical composition of remimazolam | |
| CN107362144A (en) | A kind of Lurasidone brain targeted liposome injection and preparation method thereof | |
| CN112451475B (en) | Long-acting sustained-release gel for treating cavernous pulmonary tuberculosis | |
| CN107789323B (en) | Delafloxacin meglumine freeze-dried preparation for injection and preparation method thereof | |
| CN107998084B (en) | Lansoprazole freeze-dried powder and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: Longshan road 033000 Shanxi city of Lvliang province Lishi District No. 633 Hualong District 1 building 2-102 Applicant after: Zhang Guangquan Address before: 250000 Ji'nan, China Hi tech Zone, Shandong Chong Hua Road, No. 11 Applicant before: Zhang Guangquan |
|
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20160713 |
|
| RJ01 | Rejection of invention patent application after publication |