CN103720644A - Betamethasone sodium phosphate injection - Google Patents
Betamethasone sodium phosphate injection Download PDFInfo
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- CN103720644A CN103720644A CN201310363097.8A CN201310363097A CN103720644A CN 103720644 A CN103720644 A CN 103720644A CN 201310363097 A CN201310363097 A CN 201310363097A CN 103720644 A CN103720644 A CN 103720644A
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- sodium phosphate
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- betamethasone sodium
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Abstract
The invention belongs to the technical field of drug preparations and in particular relates to a betamethasone sodium phosphate injection. Every 1,000 ml of the betamethasone sodium phosphate injection contains 4.734-5.786 g of betamethasone sodium phosphate, 0.2-0.3 g of sodium hydrogen sulfite, 250-350 g of propanediol, a proper amount of a sodium hydroxide solution and the balance of injection water. The betamethasone sodium phosphate injection is good in stability, and the content of an effective ingredient-betamethasone sodium phosphate in the injection is basically stable and is not remarkably reduced through long-term experimental observation; a preparation process is simple and easy to control, the requirement on equipment is low, and the production cost can be reduced.
Description
technical field
The invention belongs to technical field of medicine, be specifically related to a kind of bentamethasone sodium phosphate inj.
background technology
Betamethasone sodium phosphate is glucocorticoid medicine, and glucocorticoid medicine has the effect of anti-immunity and anti-inflammatory, and applying clinical for many years.Betamethasone sodium phosphate is a long-acting hormone medicine, is used for anti-inflammatory treatment, immune disease treatment, antiviral and shock treatment in clinical.Its effect is more extensive, with other glucocorticoid medicine, compare have that dosage is little, the feature such as long half time, effect are obvious.
There is at present people to be studied the formulation and technology of bentamethasone sodium phosphate inj, result is as follows, specification is that the best prescription technique of the right bentamethasone sodium phosphate inj of l mL:5.26 mg is: by recipe quantity, take right betamethasone sodium phosphate 5.26 g and disodium edetate 0.3 g, add in the approximately 900 mL waters for injection of 60～80 ℃, constantly stir make molten after, with 10% disodium phosphate soln, adjust in right amount pH to 7.5-8.5, then by preparation total amount, add 0.05% needle-use activated carbon, heated and boiled l5 min, while hot sucking filtration; De-charcoal, mends and injects water to 100 mL, sampling and measuring medicinal liquid pH and content, after qualified, fine straining, embedding is in l mL ampoule, 100 ℃ of circulation steam sterilization 30 min, the qualified rear packing of clarity test (wear intelligent, Li Jianhe, Li Yinbo, Wan little Min, the preparation of right bentamethasone sodium phosphate inj, quality control and study on the stability, Chinese Pharmaceutical, the 18th the 5th phase of volume in 2009).The deficiency that this technique exists is to need heated and boiled, higher to equipment requirements, and in technique, adds active carbon, and principal agent is had to absorption.
CN200710164299.4(< < compound betamethasone suspension injection > >) invention provides a kind of compound betamethasone suspension injection, the compound preparation that this injection is comprised of low-solubility betamethasone dipropionate and highly dissoluble betamethasone sodium phosphate.CN200510011071.2(< < betamethasone sodium phosphate powder injection and preparation method > >) invention relate to the freeze-dried powder that a kind of betamethasone sodium phosphate is made.
summary of the invention
The object of the present invention is to provide a kind of stay-in-grade bentamethasone sodium phosphate inj.
The present invention is by the following technical solutions:
A bentamethasone sodium phosphate inj, contains the betamethasone sodium phosphate of 4.734-5.786g in every 1000ml injection, the water for injection of the propylene glycol of the sodium sulfite of 0.2-0.3g, 250-350g, appropriate sodium hydroxide solution and surplus.
The consumption of sodium hydroxide solution be take regulator solution pH value and is as the criterion as 7.0 ~ 9.0, and the mass concentration of sodium hydroxide solution is 5%.
Bentamethasone sodium phosphate inj of the present invention adopts following methods while preparing, get in proportion each raw material, adds the water for injection of 600-800ml in batch tank, then propylene glycol is added and in batch tank, forms propylene glycol solution; From batch tank, get appropriate propylene glycol solution betamethasone sodium phosphate is dissolved, after dissolving, refund in batch tank and mix; Sodium sulfite is dissolved with appropriate water for injection, after dissolving, pour in batch tank and mix; With appropriate sodium hydroxide solution, adjust pH to 7.0 ~ 9.0, add to the full amount of water for injection; Filtration, embedding, sterilizing.
Having good stability of the bentamethasone sodium phosphate inj that employing the present invention system of filling a prescription is prepared, observes through long-term experiment, and in this injection, the content of effective ingredient betamethasone sodium phosphate is basicly stable, there is no significantly reduction; Preparation technology is simple and easy to control, low for equipment requirements, can reduce production costs.
the specific embodiment
Embodiment 1
Bentamethasone sodium phosphate inj, contains the betamethasone sodium phosphate of 5.26g in every 1000ml, the water for injection of the propylene glycol of the sodium sulfite of 0.2g, 300g, appropriate sodium hydroxide solution and surplus.
The preparation method of bentamethasone sodium phosphate inj, first in preparing tank, add 600ml water for injection and be cooled to 50 ℃, add 300g propylene glycol to form propylene glycol solution, stir after 30 minutes, from preparing tank, access appropriate propylene glycol solution in stainless steel cask, taking 5.26g betamethasone sodium phosphate pours in stainless steel cask stirring and dissolving into and refunds in preparing tank after completely and mix, then take 0.2g sodium sulfite, pour stirring and dissolving in the stainless steel cask that fills appropriate water for injection into, after dissolving, pour in preparing tank, with water for injection, rinse after stainless steel cask, flushing water is poured in preparing tank, stir 20 minutes, with appropriate 5% sodium hydroxide solution, adjust pH to 8.2, inject water to 1000 ml, stir 30 minutes, survey semi-finished product pH, qualified rear use 0.8 μ m titanium rod filter (material is high purity titanium and the porous titanium alloy) coarse filtration of content, it is qualified rear for embedding that 0.45 μ m and 0.22 μ m folding tube filter (polyethersulfone millipore filter) are filtered to visible foreign matters.To be that cross is overlapping put sterilizing cabinet charging means, and sterilising conditions is 100 ℃ of moist heat sterilizations 15 minutes.
Embodiment 2
Bentamethasone sodium phosphate inj, contains the betamethasone sodium phosphate of 4.734g in every 1000ml, the water for injection of the propylene glycol of the sodium sulfite of 0.25g, 250g, appropriate sodium hydroxide solution and surplus.
The preparation method of bentamethasone sodium phosphate inj, first in preparing tank, add 700ml water for injection and be cooled to 60 ℃, add 250g propylene glycol to form propylene glycol solution, stir after 40 minutes, from preparing tank, access appropriate propylene glycol solution in stainless steel cask, taking 4.734g betamethasone sodium phosphate pours in stainless steel cask stirring and dissolving into and refunds in preparing tank after completely and mix, then take 0.25g sodium sulfite, pour stirring and dissolving in the stainless steel cask that fills appropriate water for injection into, after dissolving, pour in preparing tank, with water for injection, rinse after stainless steel cask, flushing water is poured in preparing tank, stir 20 minutes, with appropriate 5% sodium hydroxide solution, adjust pH to 7.5, inject water to 1000 ml, stir 40 minutes, survey semi-finished product pH, qualified rear use 0.8 μ m titanium rod filter (material is high purity titanium and the porous titanium alloy) coarse filtration of content, it is qualified rear for embedding that 0.45 μ m and 0.22 μ m folding tube filter (polyethersulfone millipore filter) are filtered to visible foreign matters.To be that cross is overlapping put sterilizing cabinet charging means, and sterilising conditions is 100 ℃ of moist heat sterilizations 15 minutes.
Embodiment 3
Bentamethasone sodium phosphate inj, contains the betamethasone sodium phosphate of 5.786g in every 1000ml, the water for injection of the propylene glycol of the sodium sulfite of 0.3g, 350g, appropriate sodium hydroxide solution and surplus.
The preparation method of bentamethasone sodium phosphate inj, first in preparing tank, add 800ml water for injection and be cooled to 45 ℃, add 350g propylene glycol to form propylene glycol solution, stir after 20 minutes, from preparing tank, access appropriate propylene glycol solution in stainless steel cask, taking 5.786g betamethasone sodium phosphate pours in stainless steel cask stirring and dissolving into and refunds in preparing tank after completely and mix, then take 0.3g sodium sulfite, pour stirring and dissolving in the stainless steel cask that fills appropriate water for injection into, after dissolving, pour in preparing tank, with water for injection, rinse after stainless steel cask, flushing water is poured in preparing tank, stir 30 minutes, with appropriate 5% sodium hydroxide solution, adjust pH to 8.5, inject water to 1000 ml, stir 30 minutes, survey semi-finished product pH, qualified rear use 0.8 μ m titanium rod filter (material is high purity titanium and the porous titanium alloy) coarse filtration of content, it is qualified rear for embedding that 0.45 μ m and 0.22 μ m folding tube filter (polyethersulfone millipore filter) are filtered to visible foreign matters.To be that cross is overlapping put sterilizing cabinet charging means, and sterilising conditions is 100 ℃ of moist heat sterilizations 15 minutes.
Through the tests of 3 years and the stability observing that keeps sample, constant product quality of the present invention, occurs without denaturalization phenomenon in storage process.Through accelerated test and long-term reserved sample observing, product quality all meets the regulation under two " bentamethasone sodium phosphate inj " normal terms of Chinese Pharmacopoeia version in 2010, and product is reliable and stable.
Stability data
(1) accelerated test
Embodiment 1 batch: 13.2 ten thousand specification: 1ml:5.26mg(are equivalent to betamethasone 4mg)
Packing: low borosilicate glass ampoule
Investigation condition: 40 ± 2 ℃ of temperature, relative humidity 75 ± 5%; Result is as following table 1
(2) long term test
Embodiment 1 batch: 13.2 ten thousand specification: 1ml:5.26mg(are equivalent to betamethasone 4mg)
Packing: low borosilicate glass ampoule
Investigation condition: 25 ± 2 ℃ of temperature, relative humidity 60 ± 10%; Result is as following table 2
by table 1,2, found out, in accelerated test and long term test, in injection, the content of the effective ingredient betamethasone sodium phosphate of side is basicly stable, does not significantly reduce, and short-term and the long-time stability of the bentamethasone sodium phosphate inj that the present invention makes are good.
Claims (2)
1. a bentamethasone sodium phosphate inj, is characterized in that: in every 1000ml injection, contain the betamethasone sodium phosphate of 4.734-5.786g, the water for injection of the propylene glycol of the sodium sulfite of 0.2-0.3g, 250-350g, appropriate sodium hydroxide solution and surplus.
2. bentamethasone sodium phosphate inj as claimed in claim 1, is characterized in that: the consumption of sodium hydroxide solution be take regulator solution pH value and is as the criterion as 7.0 ~ 9.0, and the mass concentration of sodium hydroxide solution is 5%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310363097.8A CN103720644A (en) | 2013-08-20 | 2013-08-20 | Betamethasone sodium phosphate injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310363097.8A CN103720644A (en) | 2013-08-20 | 2013-08-20 | Betamethasone sodium phosphate injection |
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| CN103720644A true CN103720644A (en) | 2014-04-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201310363097.8A Pending CN103720644A (en) | 2013-08-20 | 2013-08-20 | Betamethasone sodium phosphate injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105476965A (en) * | 2014-09-18 | 2016-04-13 | 蚌埠丰原涂山制药有限公司 | Method for preparing betamethasone sodium phosphate freeze-dried powder injection |
| WO2022223058A3 (en) * | 2022-07-27 | 2023-01-12 | 济宁学院 | Betamethasone sodium phosphate crystal, and preparation method therefor and use thereof |
-
2013
- 2013-08-20 CN CN201310363097.8A patent/CN103720644A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 无: "倍他米松磷酸钠注射液说明书", 《河南省食品药品监督管理局HTTP://WWW.HDA.GOV.CN/CL0113/4009.HTML》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105476965A (en) * | 2014-09-18 | 2016-04-13 | 蚌埠丰原涂山制药有限公司 | Method for preparing betamethasone sodium phosphate freeze-dried powder injection |
| WO2022223058A3 (en) * | 2022-07-27 | 2023-01-12 | 济宁学院 | Betamethasone sodium phosphate crystal, and preparation method therefor and use thereof |
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Application publication date: 20140416 |