CN108392470B - A kind of production technology of injection Calcium Levofolinate freeze-dried powder - Google Patents
A kind of production technology of injection Calcium Levofolinate freeze-dried powder Download PDFInfo
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- CN108392470B CN108392470B CN201810333843.1A CN201810333843A CN108392470B CN 108392470 B CN108392470 B CN 108392470B CN 201810333843 A CN201810333843 A CN 201810333843A CN 108392470 B CN108392470 B CN 108392470B
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
-
- 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 present invention provides a kind of production technology of injection Calcium Levofolinate freeze-dried powder, include the following steps: that 40 DEG C~50 DEG C of water for injection is added in (1) in Agitation Tank；(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 40 DEG C~50 DEG C of fluid temperature；(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 20 DEG C~30 DEG C, adjusts pH to 7.8-8.2, water for injection is added and is settled to 1000 parts；(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.The technique can effectively control the impurity level in finished product, it is made to grind medicine better than the commercially available original in the U.S..
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of production work of injection Calcium Levofolinate freeze-dried powder
Skill.
Background technique
Injection Calcium Levofolinate clinic is usually used in preventing caused serious after methotrexate (MTX) is excessive or large dosage treatment
Toxic effect.When oral folic acid unsatisfactory curative effect, it is also used for caused by sprue, malnutrition, the gestational period or infancy
Megaloblastic anemia, but to Vitamin B12 deficiency anemia and be not suitable for.Also apply Calciumlevofolinate as colon, directly in recent years
The adjuvant treatment of intestinal cancer can extend survival period with fluorouracil use in conjunction.
Patent of invention CN03121530.0 discloses a kind of injection medicament of Calcium Levofolinate, contains in injection medicament sweet
Reveal alcohol, dextran, glucose, sodium chloride, protein hydrolysate, at least one auxiliary material, water for injection is solvent, and main ingredient and auxiliary material
Weight proportion be 1: 0.5-1: 500.Injection medicament includes powder-injection after drying and the liquor directly produced.This is specially
Benefit reduces endotoxic technique using conventional carbon absorption, may introduce and pollute again and product content is caused to reduce；Technique
PH is adjusted after constant volume, be easy to cause medical fluid content relatively low, and not easy to control.
Summary of the invention
To solve problems of the prior art, the present invention provides a kind of injection Calcium Levofolinate freeze-dried powders
Production technology.The technique can effectively control the impurity level in finished product, it is made to grind medicine better than the commercially available original in the U.S..
In order to achieve the object of the present invention, the technical solution adopted by the present invention is that:
A kind of production technology of injection Calcium Levofolinate freeze-dried powder, includes the following steps:
(1) 40 DEG C~50 DEG C of water for injection is added in Agitation Tank；
(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 40 DEG C~50 DEG C of fluid temperature；
(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 20 DEG C~30 DEG C, adjusts pH
To 7.8-8.2, water for injection is added and is settled to 1000 parts；
(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
The endotoxin of endotoxin < 0.500EU/mg of bulk pharmaceutical chemicals of the present invention, mannitol are less than 2.5EU/g.Using control
It makes endotoxic supplementary material to be produced, the safety of product is effectively ensured.
Described (3) step adjusts pH value using 0.05mol/L sodium hydroxide solution or 0.05mol/L hydrochloric acid solution.
The water for injection of 90% demand is added in described (1) step, and the water for injection of remaining demand is added in (3) step.
Since technique is to adjust pH, Chu Jiashui 90% before constant volume, it is ensured that pH is almost the same before and after constant volume.
Aseptic filtration of the present invention refers to the filtering for first reduce to medical fluid microbial load with filter, then passes through
Two concatenated sterilizing filters carry out degerming to medical fluid.It ensure that the aseptic of product.
Lyophilized technique of the present invention is as follows:
A, 20 DEG C~25 DEG C feedings of room temperature are cooled to 0 DEG C~13 DEG C, keep 1h~3h；
B, continue to be cooled to -40 DEG C~-45 DEG C, retain 4h~8h；
C, -15~-10 DEG C are warming up to, 1h~5h is retained；
D, -40 DEG C~-45 DEG C are cooled to, 3h~6h is retained
E, 100~400 μ bar of vacuum degree is controlled, is warming up to -5 DEG C~0 DEG C, retains 15h~20h；
F, 100~400 μ bar of vacuum degree is controlled, is warming up to 35 DEG C~45 DEG C, retains 13h~20h；
G, 100~400 μ bar of vacuum degree is controlled, temperature is reduced to 20 DEG C~25 DEG C, retains 1.5h~3h.
Preferably, the step B is with 0.5 DEG C/min~1 DEG C/min rate slow cooling.
The beneficial effects of the present invention are:
1, present invention process is optimized with liquid stream journey, and pH to 7.8-8.2 is adjusted before constant volume, and stoste content is accurate；Just add
Water 90%, it is ensured that pH is almost the same before and after constant volume.
2, the present invention is produced by controlling endotoxic supplementary material, is saved steps of activated carbon adsorption, is effectively ensured
The safety of product, and secondary pollution will not be caused.
3, using 40 DEG C~50 DEG C dosing temperatures, bulk pharmaceutical chemicals dissolution time is faster than under room temperature at such a temperature, shortens
With the liquid process time, the stability of medical fluid ensure that
4, the present invention designs new lyophilized technique, in temperature-fall period 0 DEG C~13 DEG C holding 1h~3h hours, in order to
The forward horizontal stand fluid temperature of freezing, while with 0.5 DEG C/min~1 DEG C/min rate slow cooling, to guarantee that medical fluid freezing is equal
It is even, it is conducive to lyophilization, removes most of water in product.Lyophilization under the conditions of relatively high -5 DEG C of temperature~0 DEG C into
Row, at this temperature, product is not in melt back, more conducively the distillation of moisture.Product moisture is lower, stability placement process
In, turbidity is lower, more conducively the safety of product and effectively, grinds the finished products of product lower than state's exogenesis to obtain moisture content, more
Conducive to the stability of product.
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 production technology of injection Calcium Levofolinate freeze-dried powder, includes the following steps:
(1) 40 DEG C of water for injection is added in Agitation Tank；
(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 40 DEG C of fluid temperature；
(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 20 DEG C, adjusts pH to 7.8,
Water for injection is added and is settled to 1000 parts；
(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
Embodiment 2
A kind of production technology of injection Calcium Levofolinate freeze-dried powder, includes the following steps:
(1) 50 DEG C of water for injection is added in Agitation Tank；
(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 50 DEG C of fluid temperature；
(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 30 DEG C, adjusts pH to 8.2,
Water for injection is added and is settled to 1000 parts；
(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
The endotoxin of endotoxin < 0.500EU/mg of the bulk pharmaceutical chemicals, mannitol are less than 2.5EU/g.
Described (3) step adjusts pH value using 0.05mol/L sodium hydroxide solution.
Embodiment 3
A kind of production technology of injection Calcium Levofolinate freeze-dried powder, includes the following steps:
(1) 45 DEG C of water for injection of 90% demand is added in Agitation Tank；
(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 45 DEG C of fluid temperature；
(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 25 DEG C, adjusts pH to 8.0,
The water for injection that remaining demand is added is settled to 1000 parts；
(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products.
The endotoxin of endotoxin < 0.500EU/mg of the bulk pharmaceutical chemicals, mannitol are less than 2.5EU/g.
Described (3) step adjusts pH value using 0.05mol/L hydrochloric acid solution.
Embodiment 4
The present embodiment is on the basis of embodiment 3:
The aseptic filtration refers to the filtering for first reduce to medical fluid microbial load with filter, then passes through two strings
The sterilizing filter of connection carries out degerming to medical fluid.
Embodiment 5
The present embodiment is on the basis of embodiment 3:
The lyophilized technique is as follows:
A, 20 DEG C of DEG C of feedings of room temperature are cooled to 0 DEG C DEG C, keep 1h；
B, continue to be cooled to -40 DEG C, retain 4h；
C, -15 DEG C are warming up to, 1h is retained；
D, -40 DEG C are cooled to, 3h is retained
E, 100 μ bar of vacuum degree is controlled, is warming up to -5 DEG C, retains 15h；
F, 100 μ bar of vacuum degree is controlled, is warming up to 35 DEG C, retains 13h；
G, 100 μ bar of vacuum degree is controlled, temperature is reduced to 20 DEG C, retains 1.5h.
Embodiment 6
The present embodiment is on the basis of embodiment 3:
The lyophilized technique is as follows:
A, 25 DEG C of feedings of room temperature are cooled to 13 DEG C, keep 3h；
B, continue to be cooled to -45 DEG C, retain 8h；
C, -10 DEG C are warming up to, 5h is retained；
D, -45 DEG C are cooled to, 6h is retained
E, 400 μ bar of vacuum degree is controlled, is warming up to 0 DEG C, retains 20h；
F, 400 μ bar of vacuum degree is controlled, is warming up to 45 DEG C, retains 20h；
G, 400 μ bar of vacuum degree is controlled, temperature is reduced to 25 DEG C, retains 3h.
The step B is with the rate slow cooling of 0.5 DEG C/min.
Embodiment 7
The present embodiment is on the basis of embodiment 4:
The lyophilized technique is as follows:
A, 22 DEG C of feedings of room temperature are cooled to 10 DEG C, keep 2h；
B, continue to be cooled to -42 DEG C, retain 5h；
C, -12 DEG C are warming up to, 2h is retained；
D, -42 DEG C are cooled to, 5h is retained
E, 200 μ bar of vacuum degree is controlled, is warming up to -2 DEG C, retains 16h；
F, 200 μ bar of vacuum degree is controlled, is warming up to 35 DEG C~45 DEG C, retains 13h~20h；
G, 200 μ bar of vacuum degree is controlled, temperature is reduced to 22 DEG C, retains 2h.
The step B is with the rate slow cooling of 1 DEG C/min.
Embodiment 8
The present embodiment is on the basis of embodiment 4:
The lyophilized technique is as follows:
A, 22 DEG C of feedings of room temperature are cooled to 10 DEG C, keep 2h；
B, continue to be cooled to -42 DEG C, retain 5h；
C, -12 DEG C are warming up to, 3h is retained；
D, -42 DEG C are cooled to, 4h is retained
E, 300 μ bar of vacuum degree is controlled, is warming up to -3 DEG C, retains 15h~20h；
F, 300 μ bar of vacuum degree is controlled, is warming up to 38 DEG C, retains 15h；
G, 300 μ bar of vacuum degree is controlled, temperature is reduced to 22 DEG C, retains 2.5h.
The step B is with the rate slow cooling of 0.6 DEG C/min.
1 present invention process product of table and the former Comprehensive Correlation for grinding medicine
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 (5)
1. a kind of production technology of injection Calcium Levofolinate freeze-dried powder, which comprises the steps of:
(1) 40 DEG C~50 DEG C of water for injection is added in Agitation Tank；
(2) by mass, 1 portion of mannitol is added to stir to dissolution, is kept for 40 DEG C~50 DEG C of fluid temperature；
(3) 1 part of l-leucovorin calcium raw material drug is added to stir to dissolution, reduces fluid temperature to 20 DEG C~30 DEG C, adjust pH to
7.8-8.2 is added water for injection and is settled to 1000 parts；
(4) aseptic filtration, it is filling, after freeze-drying, obtain formulation products；
The water for injection of 90% demand is added in described (1) step, and the water for injection of remaining demand is added in (3) step；
Lyophilized technique is as follows:
A, 20 DEG C~25 DEG C feedings of room temperature are cooled to 0 DEG C~13 DEG C, keep 1h~3h；
B, continue to be cooled to -40 DEG C~-45 DEG C, retain 4h~8h；
C, -15~-10 DEG C are warming up to, 1h~5h is retained；
D, -40 DEG C~-45 DEG C are cooled to, 3h~6h is retained
E, 100~400 μ bar of vacuum degree is controlled, is warming up to -5 DEG C~0 DEG C, retains 15h~20h；
F, 100~400 μ bar of vacuum degree is controlled, is warming up to 35 DEG C~45 DEG C, retains 13h~20h；
G, 100~400 μ bar of vacuum degree is controlled, temperature is reduced to 20 DEG C~25 DEG C, retains 1.5h~3h.
2. the production technology of injection Calcium Levofolinate freeze-dried powder according to claim 1, which is characterized in that the raw material
The endotoxin of endotoxin < 0.500EU/mg of medicine, mannitol are less than 2.5EU/g.
3. the production technology of injection Calcium Levofolinate freeze-dried powder according to claim 1, which is characterized in that described
(3) step adjusts pH value using 0.05mol/L sodium hydroxide solution or 0.05mol/L hydrochloric acid solution.
4. the production technology of injection Calcium Levofolinate freeze-dried powder according to claim 1, which is characterized in that the degerming
Filtering refers to the filtering for first reduce to medical fluid microbial load with filter, then passes through two concatenated sterilizing filters pair
Medical fluid carries out degerming.
5. the production technology of injection Calcium Levofolinate freeze-dried powder according to claim 1, which is characterized in that the B step
Suddenly with 0.5 DEG C/min~1 DEG C/min rate slow cooling.
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| CN110314146A (en) * | 2019-08-11 | 2019-10-11 | 天津乾丰瑞科技有限公司 | A kind of pharmaceutical composition containing active constituent Calcium Levofolinate |
| CN112472673A (en) * | 2020-12-07 | 2021-03-12 | 南京海纳医药科技股份有限公司 | Freeze dried levofolinic acid powder for injection and its production process |
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| CN104546764A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Calcium folinate composition freezing-drying tablet and preparation method thereof |
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