CN108272755B - A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof - Google Patents
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof Download PDFInfo
- Publication number
- CN108272755B CN108272755B CN201810273774.XA CN201810273774A CN108272755B CN 108272755 B CN108272755 B CN 108272755B CN 201810273774 A CN201810273774 A CN 201810273774A CN 108272755 B CN108272755 B CN 108272755B
- Authority
- CN
- China
- Prior art keywords
- parts
- mycophenolate mofetil
- injection
- sodium hydroxide
- hydrochloric acid
- 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.)
- Active
Links
Classifications
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, raw material includes mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous citric acid, hydrochloric acid, dehydrated alcohol and sodium hydroxide, and parts by weight recipe ratio is：5~200 parts of mycophenolate mofetil, 1~10 part of polyoxyethylene sorbitan monoleate, 0.1~2 part of anhydrous citric acid, 1~10 part of hydrochloric acid, 5~200 parts of dehydrated alcohols and 0.1~1 part of sodium hydroxide.The present invention also provides the preparation methods of above-mentioned hydrochloride for injection mycophenolate mofetil lyophilized preparation.The present invention is by changing the key problem in technology points such as product charging sequence, dosing temperature, solvent formula, lyophilized technique, the impurity level of product can be effectively controlled, and raising is to the tolerance degree of the influence factors such as light, heat, to extend the validity period of product, the storage condition requirement for expanding product, improves the economy and validity of product.
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and its
Preparation method.
Background technique
Neotype immunosuppressant --- mycophenolate mofetil is a kind of 2- ethyl ester derivative of mycophenolic acid, after degreasing
Being formed has the mould powder of the metabolite of immunosuppressive activity sour (MPA).MPA reversibly inhibits guanylic acid (GMP) to pass through
Rate-limiting enzyme in allusion quotation route of synthesis --- carnine acidohydrogenase (IMPDH), to block the warp of guanylic acid
Allusion quotation route of synthesis, exhausts guanylic acid, and then the synthesis of blocking dna and RNA.Therefore, MMF is by exhausting GMP selection
Property block the classical synthesis of T and the galloping purine nucleotide of bone-marrow-derived lymphocyte bird, to inhibit T lymph and B lymphocyte proliferation.It replaces
Mycophenolate has the characteristics that mechanism of action is unique, anti-repulsive interaction is strong, pharmacokinetics are superior, safety is good, cost performance is high
Deng, it has also become the important component in the postoperative new triple therapy of organ transplant.
Currently, mycophenolate mofetil listing dosage form has capsule, tablet, oral administration mixed suspension etc., but these oral preparations are often drawn
Play the adverse reactions such as nausea,vomiting,diarrhea.In addition, constitution decline can not be administered orally after patient carries out transfer operation, because
This, injection type becomes the preferred dosage form of clinical application.Mycophenolate mofetil is prepared into sterile lyophilized powder, facilitate preservation,
Transport and clinical application.
Publication number CN101953807A, entitled " a kind of Mycophenolate mofetil lyophilized powder injection for injection and its preparation side
The patent of invention of method " provides a kind of Mycophenolate mofetil lyophilized powder injection for injection, and active constituent is used to examine phenol for wheat
Ester is made with solubilizer polyethylene glycol -12- hydroxy stearic acid ester, and weight ratio is 250~1250: 100~500.In the patent
The stability data of announcement is worse than the former data for grinding drug, and impurity content is higher than original and grinds drug, according to the non-bad of Conformance Assessment
The requirement that effect property compares, the product will not pass through Conformance Assessment.
Publication number CN106913531A, the hair of entitled " a kind of mycophenolate mofetil freeze-dried composition and preparation method thereof "
Bright patent is mainly made of active constituent mycophenolate mofetil, stabilizer, cosolvent, pH adjusting agent and water for injection.The patent
Long-time stability data difference, the safety of product and validity leaves a question open,
Summary of the invention
To solve problems of the prior art, the present invention provides a kind of freeze-dryings of hydrochloride for injection mycophenolate mofetil
Preparation and preparation method thereof.The effectively impurity level of control product produces the lyophilized preparation that stability grinds product better than state's exogenesis
Product.
In order to achieve the object of the present invention, the technical solution adopted by the present invention is that：
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, raw material include mycophenolate mofetil, polyoxyethylene sorbitan monoleate, nothing
Citric acid monohydrate, hydrochloric acid, dehydrated alcohol and sodium hydroxide, parts by weight recipe ratio are：5~200 parts of mycophenolate mofetil, 1~10
Part polyoxyethylene sorbitan monoleate, 0.1~2 part of anhydrous citric acid, 1~10 part of hydrochloric acid, 5~200 parts of organic solvents and 0.1~1 part of hydroxide
Sodium.
Preferably, a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, raw material include mycophenolate mofetil, poly- sorb
Ester 80, anhydrous citric acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：80~
120 parts of mycophenolate mofetil, 3~7 parts of polyoxyethylene sorbitan monoleates, 0.5~1.5 part of anhydrous citric acid, 5~10 parts of hydrochloric acid, 10~120 parts
Organic solvent and 0.3~0.5 part of sodium hydroxide.
Polyoxyethylene sorbitan monoleate reduces the turbidity of solution as the clarifying agent of solution, and as excipient to form specific nothing
Crystalline structure provides stable base structure, to prevent or slow down the decomposition of therapeutic agent.Anhydrous citric acid as buffer,
As addition H+And OH-The compound of pH variation is resisted when ion, it is ensured that pH value of solution is in particular range, when improving its production and using
Stability.Hydrochloric acid is compounded to form the villaumite of relative medicine with therapeutic agent as salt forming agent, anion chloride ion value.Sodium hydroxide
As pH adjusting agent, for solution to be adjusted to specific pH value.
Organic solvent of the present invention is one of ethyl alcohol, normal propyl alcohol, isopropanol, the tert-butyl alcohol and hydroxyl alcohol.
The present invention increases product stability by changing product solvent formula, passes through ethyl alcohol, normal propyl alcohol, isopropanol, uncle
The alcohols of butanol or other hydroxyls forms specific stabilized matrix knot as the auxiliary agent for forming specific anhydrous crystalline structure, auxiliary
Structure.
Preferably, the organic solvent is ethyl alcohol.Ethyl alcohol is formed as the auxiliary agent for forming specific anhydrous crystalline structure, auxiliary
Specific stabilized matrix structure.
The present invention also provides the methods for preparing above-mentioned hydrochloride for injection mycophenolate mofetil lyophilized preparation, including walk as follows
Suddenly：
(1) water for injection of 60% demand is added in Agitation Tank；
(2) sequentially add 0.1~2 part of anhydrous citric acid, 1~10 part of hydrochloric acid, 5~200 parts of dehydrated alcohols, 1~10 part it is poly-
Sorb ester 80 and 5~200 part mycophenolate mofetil, stirring is to forming uniform opalescence solution；
(3) medical fluid pH is adjusted to 3.0~4.0 using sodium hydroxide solution；
(4) the water for injection constant volume of remaining 40% demand is added, and fluid temperature is reduced to 20~25 DEG C；
(5) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
Preferably, the temperature of Agitation Tank is 40 DEG C~45 DEG C in step (1)~(3).
Technique is controlled by temperature, so that polyoxyethylene sorbitan monoleate is formed the micella of specific dimensions at a certain temperature to wrap up treatment
Agent, and the base structure for intersecting firm microparticle dispersion system is formed in freeze-drying process.
Preferably, the step (5) carries out aseptic filtration to medical fluid by two concatenated sterilizing filters.
The beneficial effects of the invention are as follows：
1, the present invention, which passes through, changes the key problem in technology points such as product charging sequence, dosing temperature, solvent formula, lyophilized technique,
The impurity level that product can be effectively controlled produces the lyophilized preparation product that stability grinds product better than state's exogenesis.
2, the product stability that the technique is produced significantly increases, can be by product more than the stability that state's exogenesis grinds product
The effect phase was promoted to 5 years from 3 years.Hydrochloric acid mycophenolate mofetil can be replaced in ester linkage breaking formation under light, thermocatalytic in the product
Mycophenolic Acid, if active pharmaceutical ingredient and polyoxyethylene sorbitan monoleate pass through the charging sequence of technology controlling and process such as production process, match liquid temperature
The formation such as degree, solvent formula intersect the solid structure of firm smaller size of microparticle dispersion system, can effectively prevent product
Ester linkage breaking reduces impurity to enhance the stability of product.
3, polyoxyethylene sorbitan monoleate is used as in freeze-drying finished product and generates as surfactant and association agent in this product solution
The excipient of the anhydrous crystal object of specific structure.The concentration of polyoxyethylene sorbitan monoleate is more than its critical micelle concentration in inventive formulation,
It is to exist in the form of micella wraps up therapeutic agent, therefore make poly- mountain by controlling specific charging sequence in medical fluid and redissolution liquid
Pear ester 80 wraps up therapeutic agent with the micella of uniform-dimension, and the base of uniformly firm microparticle dispersion system is formed in freeze-drying process
Body structure, the freeze-drying prods of institute's output can effectively prevent the ester linkage breaking of product to enhance the stability of product.It sequentially adds
Anhydrous citric acid, hydrochloric acid, dehydrated alcohol, polyoxyethylene sorbitan monoleate, and so that polyoxyethylene sorbitan monoleate is formed uniform-dimension by technological parameter
Therapeutic agent is added in micella, is allowed to dissolution and is scattered in micella, and is formed in freeze-drying process and intersect firm microparticle dispersion system
Base structure.
Specific embodiment
In order to it is clearer, explain purpose of the present invention technical solution in detail, below by related embodiment to this hair
It is bright to be described further.Following embodiment is only to illustrate implementation method of the invention, does not limit protection of the invention
Range.
Embodiment 1
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, raw material include mycophenolate mofetil, polyoxyethylene sorbitan monoleate, nothing
Citric acid monohydrate, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：100 parts are examined for wheat
Phenolic ester, 5 parts of polyoxyethylene sorbitan monoleates, 1 part of anhydrous citric acid, 8.42 parts of hydrochloric acid, 100 parts of dehydrated alcohols and 0.4 part of sodium hydroxide.
Embodiment 2
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, including mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous Chinese holly
Rafter acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：50 parts of mycophenolate mofetil,
1 part of polyoxyethylene sorbitan monoleate, 0.1 part of anhydrous citric acid, 1 part of hydrochloric acid, 50 parts of dehydrated alcohols and 0.1 part of sodium hydroxide.
Embodiment 3
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, including mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous Chinese holly
Rafter acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：200 parts are examined phenol for wheat
Ester, 10 parts of polyoxyethylene sorbitan monoleates, 2 parts of anhydrous citric acids, 15 parts of hydrochloric acid, 200 parts of dehydrated alcohols and 1 part of sodium hydroxide.
Embodiment 4
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, including mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous Chinese holly
Rafter acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：80 parts of mycophenolate mofetil,
3 parts of polyoxyethylene sorbitan monoleates, 0.5 part of anhydrous citric acid, 5 parts of hydrochloric acid, 80 parts of dehydrated alcohols and 0.3 part of sodium hydroxide.
Embodiment 5
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, including mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous Chinese holly
Rafter acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：120 parts are examined phenol for wheat
Ester, 7 parts of polyoxyethylene sorbitan monoleates, 1.5 parts of anhydrous citric acids, 9 parts of hydrochloric acid, 120 parts of dehydrated alcohols and 0.5 part of sodium hydroxide.
Embodiment 6
A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation, including mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous Chinese holly
Rafter acid, hydrochloric acid, dehydrated alcohol, sodium hydroxide, water for injection and nitrogen, parts by weight recipe ratio are：110 parts are examined phenol for wheat
Ester, 6 parts of polyoxyethylene sorbitan monoleates, 1.1 parts of anhydrous citric acids, 10 parts of hydrochloric acid, 110 parts of dehydrated alcohols and 0.4 part of sodium hydroxide.
Embodiment 7
The present embodiment on the basis of embodiment 1, provides a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation
Preparation method includes the following steps：
(1) water for injection of 60% demand is added in Agitation Tank；
(2) be added 1 part of anhydrous citric acid, 8.42 parts of hydrochloric acid, 100 parts of dehydrated alcohols, 5 parts of polyoxyethylene sorbitan monoleates, 100 parts replace
Mycophenolate, stirring is to forming uniform opalescence solution；
(3) medical fluid pH is adjusted to 3.6 using sodium hydroxide solution；
(4) the water for injection constant volume of remaining 40% demand is added, and fluid temperature is reduced to 22 DEG C；
(5) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
Wherein, the temperature of Agitation Tank is 42 DEG C in step (1)~(3).
Embodiment 8
The present embodiment provides a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation on the basis of embodiment 2
Preparation method includes the following steps：
(1) water for injection of 60% demand is added in Agitation Tank；
(2) be added 0.1 part of anhydrous citric acid, 1 part of hydrochloric acid, 50 parts of dehydrated alcohols, 1 part of polyoxyethylene sorbitan monoleate, 50 parts replace wheat
Examine phenolic ester, stirring is to forming uniform opalescence solution；
(3) medical fluid pH is adjusted to 3.5 using sodium hydroxide solution；
(4) the water for injection constant volume of remaining 40% demand is added, and fluid temperature is reduced to 20 DEG C；
(5) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
Wherein, the temperature of Agitation Tank is 40 DEG C in step (1)~(3), and the step (5) concatenated is removed by two
Bacterium filter carries out aseptic filtration to medical fluid.
Embodiment 9
The present embodiment provides a kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation on the basis of embodiment 3
Preparation method includes the following steps：
(1) water for injection of 60% demand is added in Agitation Tank；
(2) be added 2 parts of anhydrous citric acids, 15 parts of hydrochloric acid, 200 parts of dehydrated alcohols, 10 parts of polyoxyethylene sorbitan monoleates, 200 parts replace
Mycophenolate, stirring is to forming uniform opalescence solution；
(3) medical fluid pH is adjusted to 3.8 using sodium hydroxide solution；
(4) the water for injection constant volume of remaining 40% demand is added, and fluid temperature is reduced to 25 DEG C；
(5) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
Wherein, the temperature of Agitation Tank is 45 DEG C in step (1)~(3), and the step (5) concatenated is removed by two
Bacterium filter carries out aseptic filtration to medical fluid.
The Detection of Stability of product under 1 illumination condition of table
The Detection of Stability of product under 2 hot conditions of table
The Detection of Stability of product under 3 acceleration environment of table
The Detection of Stability of product under 4 long-term conditions of table
By table 1- table 4 as it can be seen that lyophilized preparation and original that the present invention by the optimization to production technology, produces grind drug matter
Amount is consistent with curative effect, meets the fundamental requirement of national drug Conformance Assessment, and stability grinds the drug of product better than original, reduces
The genotoxicity hidden danger of related impurities in impurity spectrum.And it improves to the tolerance degrees of the influence factors such as light, heat, to extend product
Validity period, expand the storage condition requirement of product, improve the economy and validity of product.
A specific embodiment of the invention above described embodiment only expresses, the description thereof is more specific and detailed, but simultaneously
Limitations on the scope of the patent of the present invention therefore cannot be interpreted as.It should be pointed out that for those of ordinary skill in the art
For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to guarantor of the invention
Protect range.
Claims (3)
1. a kind of preparation method of hydrochloride for injection mycophenolate mofetil lyophilized preparation, which is characterized in that raw material includes replacing wheat
Phenolic ester, polyoxyethylene sorbitan monoleate, anhydrous citric acid, hydrochloric acid, dehydrated alcohol and sodium hydroxide are examined, parts by weight recipe ratio is：5~200
Part mycophenolate mofetil, 1~10 part of polyoxyethylene sorbitan monoleate, 0.1~2 part of anhydrous citric acid, 1~10 part of hydrochloric acid, 5~200 parts it is anhydrous
Ethyl alcohol and 0.1~1 part of sodium hydroxide；
Include the following steps：
(1) water for injection of 60% demand is added in Agitation Tank；
(2) 0.1~2 part of anhydrous citric acid, 1~10 part of hydrochloric acid, 5~200 parts of dehydrated alcohols, 1~10 portion of poly- sorb are sequentially added
Ester 80 and 5~200 part mycophenolate mofetil, stirring is to forming uniform opalescence solution；
(3) medical fluid pH is adjusted to 3.0~4.0 using sodium hydroxide solution；
(4) the water for injection constant volume of remaining 40% demand is added, and fluid temperature is reduced to 20~25 DEG C；
(5) aseptic filtration, it is filling, after freeze-drying, obtain formulation products；
The temperature of Agitation Tank is 40 DEG C~45 DEG C in step (1)~(3).
2. a kind of preparation method of hydrochloride for injection mycophenolate mofetil lyophilized preparation according to claim 1, feature
It is, raw material includes mycophenolate mofetil, polyoxyethylene sorbitan monoleate, anhydrous citric acid, hydrochloric acid, dehydrated alcohol and sodium hydroxide, heavy
Measuring part recipe ratio is：80~120 parts of mycophenolate mofetil, 3~7 parts of polyoxyethylene sorbitan monoleates, 0.5~1.5 part of anhydrous citric acid, 5~
10 parts of hydrochloric acid, 10~100 parts of dehydrated alcohols and 0.3~0.5 part of sodium hydroxide.
3. a kind of preparation method of hydrochloride for injection mycophenolate mofetil lyophilized preparation according to claim 1, feature
It is, the step (5) carries out aseptic filtration to medical fluid by two concatenated sterilizing filters.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810273774.XA CN108272755B (en) | 2018-03-29 | 2018-03-29 | A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810273774.XA CN108272755B (en) | 2018-03-29 | 2018-03-29 | A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108272755A CN108272755A (en) | 2018-07-13 |
| CN108272755B true CN108272755B (en) | 2018-11-27 |
Family
ID=62810615
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810273774.XA Active CN108272755B (en) | 2018-03-29 | 2018-03-29 | A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108272755B (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953807A (en) * | 2010-10-09 | 2011-01-26 | 山西普德药业有限公司 | Mycophenolate mofetil lyophilized powder injection for injection and preparation method thereof |
| CN106913531B (en) * | 2015-12-25 | 2020-05-01 | 山东新时代药业有限公司 | Mycophenolate mofetil freeze-dried composition and preparation method thereof |
| CN106943359B (en) * | 2016-01-06 | 2020-05-01 | 山东新时代药业有限公司 | Stable mycophenolate mofetil for injection and preparation method thereof |
-
2018
- 2018-03-29 CN CN201810273774.XA patent/CN108272755B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN108272755A (en) | 2018-07-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105434373B (en) | A kind of injection Oxiracetam lyophilized preparation and preparation method thereof | |
| CN104721155B (en) | A kind of temozolomide freeze-dried powder preparation and preparation method thereof | |
| CN114869848B (en) | Butylphthalide micelle composition and preparation process thereof | |
| CN106265536A (en) | Bortezomib pharmaceutical composition and preparation method thereof | |
| CN110812334A (en) | Voriconazole pharmaceutical composition for injection and preparation method thereof | |
| CN110464846A (en) | A kind of Meloxicam composition, preparation and the preparation method and application thereof | |
| CN108272755B (en) | A kind of hydrochloride for injection mycophenolate mofetil lyophilized preparation and preparation method thereof | |
| CN103214382B (en) | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof | |
| CN114886848B (en) | Preparation method of nano micelle composition and prepared nano micelle composition | |
| CN104936592A (en) | Hpph lyophilized powder injection for injection and preparation method thereof | |
| CN107137349B (en) | Gambogic acid nanosuspension and preparation method thereof | |
| CN103980279B (en) | A kind of methotrexate compound and methotrexate for injection | |
| CN1919339B (en) | Cucurbitacin nano preparation comprising protein, preparation method and use thereof | |
| EP3287140B1 (en) | Nerve growth factor composition and powder injection | |
| CN107412170B (en) | Cefalonium nanosuspension freeze-dried powder and preparation method thereof | |
| CN101491495B (en) | Salvianolic acid B magnesium injection, preparation method and use thereof | |
| EP3679925A1 (en) | Pharmaceutical composition of docetaxel conjugate and preparation method | |
| CN116898814A (en) | Esaconazole sulfate freeze-dried powder injection and preparation method thereof | |
| CN103877010A (en) | Preparation method of Romidepsin solution | |
| CN1285335C (en) | Pyrithioxine hydrochloride freeze-dried composition and its preparing method | |
| CN116098861A (en) | Milrinone injection and preparation method thereof | |
| EP3287141B1 (en) | Nerve growth factor composition and injection powder | |
| CN116251168A (en) | Pharmaceutical composition of echinocandin analogue and preparation method thereof | |
| JPWO2003099288A1 (en) | Pharmaceutical composition | |
| CN118236330A (en) | Rubitidine freeze-dried composition, rubitidine injection and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |