CN105919934B - Allopurinol sodium ejection preparation and preparation method thereof - Google Patents
Allopurinol sodium ejection preparation and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/0012—Galenical forms characterised by the site of application
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- 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
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Abstract
The present invention relates to drug fields, more particularly to allopurinol sodium ejection preparation and preparation method thereof.The present invention provides a kind of aliopurinol in ailopurinol sodium for injection and preparation method thereof, by to its dissolubility, solution colour, testing result in relation to the projects such as substance and content, a kind of aliopurinol in ailopurinol sodium for injection obtained using preparation method provided by the invention, its dissolubility is good (dissolving in 40 seconds is complete), solution clear, colorless (turbidity is less than No. 0.5), related substance is low (always miscellaneous to be less than 1.0%), and adverse reaction rate is low；And external listing product dissolubility relatively poor (dissolving more than 50 seconds is complete), clarity of solution poor (turbidity is close to No. 1), related substance are higher (always miscellaneous to be more than 1.0%).It can be seen that a kind of aliopurinol in ailopurinol sodium for injection that preparation method provided by the invention obtains, the capability and performance of product is preferable, can ensure the drug safety of patient.
Description
Technical field
The present invention relates to drug fields, more particularly to allopurinol sodium ejection preparation and preparation method thereof.
Background technology
Allopurinol sodium (alopurinolsodium) structural formula is shown in formula I：
Chemical name is：1,5- dihydro -4H- pyrazoles [3,4-d] pyrimidine -4- mono-sodium salts.
Allopurinol is the height succeeded in developing in 1961 by Wellcome companies of Britain (existing GlaxoSmithKline companies)
Uricacidemia therapeutic agent, for first Application in 1962 in clinic, dosage form is tablet, U.S. FDA approval is obtained within 1966, at present in the world
There are sale in 107 countries.And aliopurinol in ailopurinol sodium for injection 1996 is developed in U.S.'s Initial Public Offering by DSM drugmakers,
Trade name ALOPRIM becomes the drug of first intravenously administrable treatment hyperuricemia, is sold at present by Nabi companies.2004
Bedford Laboratories companies of the U.S. Nian9Yue copy the medicine and obtain FDA approval listings.
China's import Allopurinol tablet for the first time in 1988, clinically uses it for primary and secondary hyperuricemia
(especially hyperuricemia caused by uric acid generation excessively), recurrent exerbation or chronic gout, tophus, uric acid kidney stone
And (or) uric acid nephropathy, the hyperuricemia etc. for having renal insufficiency.Since China only has the oral preparation of Allopurinol at present,
And injection still belongs to blank, so the present invention can be very good to fill the domestic gaps, meets clinical patients demand.Injection is not fast
Sodium alkoxide is that Allopurinol increases water solubility for intravenous injection by reacting into salt with sodium hydroxide, can not be taken orally for clinic
Drug person provides a convenient.It works after the product intravenous administration faster, effect is stronger, has preferably for patients with severe symptoms such as cancers
Specific aim.
Aliopurinol in ailopurinol sodium for injection is Allopurinol by reacting into salt with sodium hydroxide, through medicinal carbon decoloring, refined filtration degerming, is filled
It fills, be lyophilized.Currently, the domestic oral preparation for there was only Allopurinol, injection still belong to blank.
Invention content
In view of this, a kind of allopurinol sodium ejection preparation of present invention offer and preparation method thereof.Product produced by the present invention
Dissolubility is good, solution colour and clarity are preferable with veriety relative to foreign countries, related substance and adverse reaction rate compared with
It is low.Rapid-action after the drug intravenous administration, effect is strong, for clinic can not oral drugs person provide a convenient.
In order to achieve the above-mentioned object of the invention, the present invention provides following technical scheme：
The present invention provides a kind of ejection preparations, are made of Allopurinol, sodium hydroxide and water for injection.
In some specific embodiments of the present invention, the mass ratio of Allopurinol and sodium hydroxide is in the ejection preparation
50:(16~20).
In some specific embodiments of the present invention, in the ejection preparation, in terms of g/mL, the Allopurinol and injection
It is 5 with the mass volume ratio of water:80.
In some specific embodiments of the present invention, the ejection preparation is injection powder injection.
The present invention also provides the preparation methods of the ejection preparation, include the following steps：
Step 1：It takes water for injection to be mixed with sodium hydroxide, is mixed with Allopurinol after stirring and dissolving, adjusting pH value to 11~
12；
Step 2：It takes the liquid that step 1 obtains to be mixed with activated carbon, is sealed after decarburization filtering, degerming, filling, freeze-drying
Dress.
In some specific embodiments of the present invention, in the preparation method of the ejection preparation, filters and remove in decarburization
Further include the steps that measuring pH value and drug content between bacterium.
In some specific embodiments of the present invention, the temperature of decarburization filtering is room temperature, i.e., 15 DEG C~30 DEG C.
In some specific embodiments of the present invention, in the preparation method of the ejection preparation, the freeze-drying packet
Include the process of cooling, the first heating, the second heating and third heating；The temperature of the cooling is -50 DEG C~-60 DEG C, the drop
The soaking time of temperature is 3~5h.
In some specific embodiments of the present invention, in the preparation method of the ejection preparation, the first heating
Vacuum degree is 20Pa~30Pa, and the heating rate of the first heating is 10 DEG C/h~12 DEG C/h, the first heating it is final
Temperature is 0 DEG C, and the soaking time of the first heating is 10h.
In some specific embodiments of the present invention, in the preparation method of the ejection preparation, second heating
Heating rate is 1.5 DEG C/h~1.7 DEG C/h, and the final temperature of second heating is 5 DEG C, the soaking time of second heating
For 5h.
In some specific embodiments of the present invention, in the preparation method of the ejection preparation, the third heating
Heating rate is 11 DEG C/h~13 DEG C/h, and the final temperature of the third heating is 30 DEG C, the soaking time of the third heating
For 10h~15h.
The present invention provides a kind of aliopurinol in ailopurinol sodium for injection and preparation method thereof, by its dissolubility, solution colour, have
The testing result for the projects such as substance and content of closing is not it is found that fast using a kind of injection of preparation method provided by the invention acquisition
Sodium alkoxide, dissolubility is good (dissolving in 40 seconds is complete), solution clear, colorless (turbidity is less than No. 0.5), and related substance is low (total miscellaneous small
In 1.0%), adverse reaction rate is low；And external listing product dissolubility relatively poor (dissolving more than 50 seconds is complete), solution
Clarity poor (turbidity is close to No. 1), related substance are higher (always miscellaneous to be more than 1.0%).It can be seen that preparation provided by the invention
A kind of aliopurinol in ailopurinol sodium for injection that method obtains, the capability and performance of product is preferable, can ensure the drug safety of patient.
Specific implementation mode
The invention discloses a kind of allopurinol sodium ejection preparation and preparation method thereof, those skilled in the art can use for reference this
Literary content is suitably modified technological parameter realization.In particular, it should be pointed out that all similar substitutions and modifications are to art technology
It is it will be apparent that they are considered as being included in the present invention for personnel.The method of the present invention and application are by preferable
Embodiment is described, related personnel obviously can not depart from the content of present invention, in spirit and scope to side as described herein
Method and application are modified or suitably change and combine, to realize and apply the technology of the present invention.
The present invention provides a kind of aliopurinol in ailopurinol sodium for injection and preparation method thereof.The drug by Allopurinol by with hydroxide
Sodium reaction is at salt, and through medicinal carbon decoloring, refined filtration degerming, filling, freeze-drying, lid is rolled in tamponade, labeling forms.The drug has molten
Solution property is good, of light color, related substance is low and the advantages such as adverse reaction rate is low, and patient is allowed more to pacify on Clinical practice
Entirely, curative effect is relatively reliable.
In order to achieve the above-mentioned object of the invention, the present invention provides following technical scheme：
A kind of aliopurinol in ailopurinol sodium for injection, 0.5g specifications, prescription are as follows：
A kind of aliopurinol in ailopurinol sodium for injection, specific preparation process are：Allopurinol reacts into salt with sodium hydroxide, through medical charcoal
Decoloration, refined filtration degerming, filling, freeze-drying, lid is rolled in tamponade, labeling forms.
Preferably, freeze dryer temperature drops to -50 DEG C~-60 DEG C, kept for 3~5 hours.
Preferably, when preceding case vacuum degree reaches 20~30Pa, heating speed of the heat conduction oil temperature by 10~12 DEG C/h is adjusted
Rate is warming up to 0 DEG C and keeps the temperature 10 hours.
It is warming up to 5 DEG C preferably, adjusting heat conduction oil temperature by the heating rate of 1.5~1.7 DEG C/h and keeps the temperature 5 hours.
Preferably, adjust heat conduction oil temperature is warming up to 30 DEG C by the heating rate of 11~13 DEG C/h, heating while, beats
Aeration valve aeration is opened, aeration, heat preservation and dryness 10~15 hours are closed when doubling (temperature of charge close to heat conduction oil temperature).
The present invention provides a kind of aliopurinol in ailopurinol sodium for injection and preparation method thereof, by its dissolubility, solution colour, have
The testing result for the projects such as substance and content of closing is not it is found that fast using a kind of injection of preparation method provided by the invention acquisition
Sodium alkoxide, dissolubility is good (dissolving in 40 seconds is complete), solution clear, colorless (turbidity is less than No. 0.5), and related substance is low (total miscellaneous small
In 1.0%), adverse reaction rate is low；And external listing product dissolubility relatively poor (dissolving more than 50 seconds is complete), solution
Clarity poor (turbidity is close to No. 1), related substance are higher (always miscellaneous to be more than 1.0%).It can be seen that preparation provided by the invention
A kind of aliopurinol in ailopurinol sodium for injection that method obtains, the capability and performance of product is preferable, can ensure the drug safety of patient.
High performance liquid chromatography is filler with octadecylsilane chemically bonded silica；It is molten with 0.125% potassium dihydrogen phosphate
Liquid-methanol (90 ﹕ 10) is mobile phase；Column temperature is 30 DEG C；Detection wavelength is 230nm.Number of theoretical plate is calculated not low by Allopurinol peak
In 3500, Allopurinol peak and the separating degree at other impurities peak should meet the requirements.
Solvent for use in a kind of aliopurinol in ailopurinol sodium for injection drug provided by the invention and preparation method, reagent, bulk pharmaceutical chemicals and
Auxiliary material etc. is available on the market.
With reference to embodiment, the present invention is further explained：
The preparation of 1 aliopurinol in ailopurinol sodium for injection of embodiment
It is added at one time water for injection 800ml, sodium hydroxide 16g is added, Allopurinol 50g is added in stirring and dissolving after letting cool,
It is stirred to dissolve completely, with 2mol/L HCl solutions tune liquid pH value to 11.6 or so.Wait for that liquid PH value stablizes (liquid PH value company
Continuous deviation three times is in ± 0.03) after, it is added in medical charcoal 0.05% (g/ml) to liquid, stirs 30 minutes at room temperature, take off charcoal
Filtering surveys liquid pH value and drug content after having filtered.With 0.22 μm of miillpore filter refined filtration degerming, filtrate is filling, half tamponade, cold
It is lyophilized dry.
Operation freeze dryer drops temperature to -50 DEG C, is kept for 5 hours, it is ensured that the liquid in bottle freezes；Preceding case vacuum degree
When reaching 20Pa, adjusts heat conduction oil temperature and be warming up to 0 DEG C by the heating rate of 10 DEG C/h and keep the temperature 10 hours；Adjust heat conduction oil temperature
Degree is warming up to 5 DEG C by the heating rate of 1.5 DEG C/h and keeps the temperature 5 hours；Adjust the heating rate liter that heat conduction oil temperature presses 11 DEG C/h
For temperature to 30 DEG C, heating while, opens aeration valve aeration, and aeration is closed when doubling (temperature of charge close to heat conduction oil temperature), after
Continuous heat preservation and dryness 10 hours opens case before freeze drying box, discharging, tamponade, rolls lid.
Content, the detection in relation to substance, clarity of solution etc., phase are carried out to aliopurinol in ailopurinol sodium for injection obtained above
The detection data answered is shown in Table 1, table 2, table 3, table 4, table 5 and table 6.
1 aliopurinol in ailopurinol sodium for injection assay result (test sample -1) of table
2 aliopurinol in ailopurinol sodium for injection assay result (test sample -2) of table
3 aliopurinol in ailopurinol sodium for injection assay result (reference substance -1) of table
4 aliopurinol in ailopurinol sodium for injection assay result (reference substance -2) of table
The related substance-measuring result of 5 aliopurinol in ailopurinol sodium for injection of table
6 aliopurinol in ailopurinol sodium for injection testing result of table
By above-mentioned test result it is found that maximum contaminant 0.2% in the related substance of aliopurinol in ailopurinol sodium for injection, total miscellaneous 0.4%, contain
Amount 98.5%, solution clear, colorless meet quality standard regulation.
The preparation of 2 aliopurinol in ailopurinol sodium for injection of embodiment
It is added at one time water for injection 800ml, sodium hydroxide 18g is added, Allopurinol 50g is added in stirring and dissolving after letting cool,
It is stirred to dissolve completely, with 2mol/L HCl solutions tune liquid pH value to 11.6 or so.Wait for that liquid PH value stablizes (liquid PH value company
Continuous deviation three times is in ± 0.03) after, it is added in medical charcoal 0.05% (g/ml) to liquid, stirs 30 minutes at room temperature, take off charcoal
Filtering surveys liquid pH value and drug content after having filtered.With 0.22 μm of miillpore filter refined filtration degerming, filtrate is filling, half tamponade, cold
It is lyophilized dry.
Operation freeze dryer drops temperature to -55 DEG C, is kept for 4 hours, it is ensured that the liquid in bottle freezes；Preceding case vacuum degree
When reaching 25Pa, adjusts heat conduction oil temperature and be warming up to 0 DEG C by the heating rate of 11 DEG C/h and keep the temperature 10 hours；Adjust heat conduction oil temperature
Degree is warming up to 5 DEG C by the heating rate of 1.6 DEG C/h and keeps the temperature 5 hours；Adjust the heating rate liter that heat conduction oil temperature presses 12 DEG C/h
For temperature to 30 DEG C, heating while, opens aeration valve aeration, and aeration is closed when doubling (temperature of charge close to heat conduction oil temperature), after
Continuous heat preservation and dryness 13 hours opens case before freeze drying box, discharging, tamponade, rolls lid.
Content, the detection in relation to substance, clarity of solution etc., phase are carried out to aliopurinol in ailopurinol sodium for injection obtained above
The detection data answered is shown in Table 7, table 8, table 9, table 10, table 11 and table 12.
7 aliopurinol in ailopurinol sodium for injection assay result (test sample -1) of table
8 aliopurinol in ailopurinol sodium for injection assay result (test sample -2) of table
9 aliopurinol in ailopurinol sodium for injection assay result (reference substance -1) of table
10 aliopurinol in ailopurinol sodium for injection assay result (reference substance -2) of table
The related substance-measuring result of 11 aliopurinol in ailopurinol sodium for injection of table
12 aliopurinol in ailopurinol sodium for injection sodium testing result of table
By above-mentioned test result it is found that maximum contaminant 0.2% in the related substance of aliopurinol in ailopurinol sodium for injection, total miscellaneous 0.4%, contain
Amount 98.4%, solution clear, colorless meet quality standard regulation.
The preparation of 3 aliopurinol in ailopurinol sodium for injection of embodiment
It is added at one time water for injection 800ml, sodium hydroxide 20g is added, Allopurinol 50g is added in stirring and dissolving after letting cool,
It is stirred to dissolve completely, with 2mol/L HCl solutions tune liquid pH value to 11.6 or so.Wait for that liquid PH value stablizes (liquid PH value company
Continuous deviation three times is in ± 0.03) after, it is added in medical charcoal 0.05% (g/ml) to liquid, stirs 30 minutes at room temperature, take off charcoal
Filtering surveys liquid pH value and drug content after having filtered.With 0.22 μm of miillpore filter refined filtration degerming, filtrate is filling, half tamponade, cold
It is lyophilized dry.
Operation freeze dryer drops temperature to -60 DEG C, is kept for 3 hours, it is ensured that the liquid in bottle freezes；Preceding case vacuum degree
When reaching 30Pa, adjusts heat conduction oil temperature and be warming up to 0 DEG C by the heating rate of 12 DEG C/h and keep the temperature 10 hours；Adjust heat conduction oil temperature
Degree is warming up to 5 DEG C by the heating rate of 1.7 DEG C/h and keeps the temperature 5 hours；Adjust the heating rate liter that heat conduction oil temperature presses 13 DEG C/h
For temperature to 30 DEG C, heating while, opens aeration valve aeration, and aeration is closed when doubling (temperature of charge close to heat conduction oil temperature), after
Continuous heat preservation and dryness 15 hours opens case before freeze drying box, discharging, tamponade, rolls lid.
Content, the detection in relation to substance, clarity of solution etc., inspection are carried out to aliopurinol in ailopurinol sodium for injection obtained above
It surveys result and embodiment 1, embodiment 2 is almost the same.Corresponding detection data is shown in Table 13, table 14, table 15, table 16, table 17 and table
18。
13 aliopurinol in ailopurinol sodium for injection assay result (test sample -1) of table
14 aliopurinol in ailopurinol sodium for injection assay result (test sample -2) of table
15 aliopurinol in ailopurinol sodium for injection assay result (reference substance -1) of table
16 aliopurinol in ailopurinol sodium for injection assay result (reference substance -2) of table
The related substance-measuring result of 17 aliopurinol in ailopurinol sodium for injection of table
18 aliopurinol in ailopurinol sodium for injection testing result of table
By above-mentioned test result it is found that maximum contaminant 0.2% in the related substance of aliopurinol in ailopurinol sodium for injection, total miscellaneous 0.3%, contain
Amount 98.1%, solution clear, colorless meet quality standard regulation.
Embodiment 4
About dissolution time, clarity of solution and color and related substance detection project, we carry out with external listing product
Comparative study, test method and data are shown in Table 19.
Experimental group：Product prepared by 1~embodiment of the embodiment of the present invention 3；
Control group：External commercialized product；
19 test method of table and experimental data
It can be seen that from above-mentioned experimental data, the dissolution time of product of the present invention up to 40 seconds is most 33 seconds short, foreign countries' listing
Product dissolution time up to 50 seconds, most 45 seconds short, the dissolubility of product of the present invention is preferable, has significant difference (P≤0.05)；It is molten
Liquid clarity and color product of the present invention be clarification, colourless, and external listing product are close to No. 1 turbidity standard, the aobvious Huang of color
Color 1；3 batches of related substances total miscellaneous respectively less than 1.0%, much smaller than external listing product, have significant difference (P≤0.05).
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (1)
1. a kind of ejection preparation, which is characterized in that water for injection 800ml is added, sodium hydroxide 20g is added, stirring and dissolving is let cool
Allopurinol 50g is added afterwards, is stirred to dissolve completely, with 2mol/L HCl solutions tune liquid pH value to 11.6；Wait for that liquid PH value is steady
It after fixed, is added in medical charcoal 0.05% (g/ml) to liquid, stirs 30 minutes at room temperature, decarbonization filtering, liquid is surveyed after having filtered
PH value and drug content；With 0.22 μm of miillpore filter refined filtration degerming, filtrate is filling, half tamponade, freeze-drying；
Operation freeze dryer drops temperature to -60 DEG C, is kept for 3 hours, it is ensured that the liquid in bottle freezes；Preceding case vacuum degree reaches
When 30Pa, adjusts heat conduction oil temperature and be warming up to 0 DEG C by the heating rate of 12 DEG C/h and keep the temperature 10 hours；Heat conduction oil temperature is adjusted to press
The heating rate of 1.7 DEG C/h is warming up to 5 DEG C and keeps the temperature 5 hours；Heat conduction oil temperature is adjusted to be warming up to by the heating rate of 13 DEG C/h
30 DEG C, aeration valve aeration is opened while heating, aeration is closed when temperature of charge is close to heat conduction oil temperature, continues heat preservation and dryness
15 hours, open freeze drying box before case, discharging, tamponade, roll lid.
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| CN101023950A (en) * | 2007-03-23 | 2007-08-29 | 重庆医药工业研究院有限责任公司 | Allopurinol sodium sterilzed powder for injection and preparing method |
| CN104819622A (en) * | 2015-05-19 | 2015-08-05 | 湖南科伦制药有限公司 | Erythromycin lactobionate lyophilization method |
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| CN101023950A (en) * | 2007-03-23 | 2007-08-29 | 重庆医药工业研究院有限责任公司 | Allopurinol sodium sterilzed powder for injection and preparing method |
| CN104819622A (en) * | 2015-05-19 | 2015-08-05 | 湖南科伦制药有限公司 | Erythromycin lactobionate lyophilization method |
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