CN106692081A - Pantoprazole sodium freeze-dried powder injection and preparation method thereof - Google Patents
Pantoprazole sodium freeze-dried powder injection and preparation method thereof Download PDFInfo
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- 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
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- 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
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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 invention provides a pantoprazole sodium freeze-dried powder injection which is composed of pantoprazole sodium and mannitol in a weight ratio of 1:(1-1.5). The method for preparing the powder injection comprises the following steps: adding a right amount of water for injection into pantoprazole sodium and mannitol, stirring until the solids are completely dissolved, regulating the pH value of the solution to 10-12, adding pretreated medicinal activated carbon which accounts for 0.2-0.5% of the total amount, stirring at room temperature for 20-30 minutes, filtering to remove the carbon under the protection of nitrogen, sterilizing, filling, carrying out half tamponing, and carrying out low-temperature freeze-drying to obtain the crystalline-water-free freeze-dried powder injection. The pretreated medicinal activated carbon is prepared by the following steps: adding 5-10 times of diluted acid with the pH value of 3-6 into medicinal activated carbon, stirring for 5-10 minutes, standing for 20-30 minutes, flushing with water for injection to a neutral state, and baking at 100 DEG C for 2-4 hours. The pantoprazole sodium freeze-dried powder injection has the advantages of simple and reasonable prescription, fewer auxiliary materials, stable and controllable quality and fewer side effects, and is suitable for long-term stable storage. The invention also provides a preparation method of the pantoprazole sodium freeze-dried powder injection.
Description
Technical field
The present invention relates to a kind of Antiulcer drugs, more particularly to a kind of Pantoprazole Sodium of injection, more specifically relate to
And a kind of freeze-dried powder injection of pantoprazole sodium.The invention further relates to the preparation method of above-mentioned freeze-dried powder injection of pantoprazole sodium.
Background technology
Disease of digestive system is common disease, is also the chronic disease for being easy to recurrence, the effective hand for not yet having thorough radical cure so far
One of section, thus also turn into the emphasis problem of medical domain research.Pantoprazole Sodium (Pantoprazole Sodium), chemistry
Entitled 5- difluoro-methoxies -2- [(3,4- dimethoxy-2-pyridinyl)-methyl]-sulfinyl -1H- benzimidazole sodium salts, be
Proton pump inhibitor class anti-ulcer agent.The Protonix form of listing has various at present, such as tablet, capsule, micropill etc.
Peroral dosage form, but the Pantoprazole Sodium of injection has special to the bleeding of the acute disease such as gastric ulcer, duodenal ulcer and prevention bleeding
Curative effect.Due to Pantoprazole poorly water-soluble, needed to use when ejection preparation is made into the salt of Pantoprazole as activity into
Point, and because it is all very sensitive to light, heat, oxygen, water etc., so being not suitable for being made liquid drugs injection and being suitable for being made powder-injection.
The existing method for preparing Pantoprazole powder-injection is a lot, but be substantially using Pantoprazole Sodium as activity into
Divide, freeze-dried powder injection of pantoprazole sodium is prepared as supporting agent using mannitol etc., because Pantoprazole system proton pump suppresses
Agent, with sulfonyl benzimidazole chemical constitution, stability is by many factors such as solution ph, light, metal ion, temperature
Influence, particularly in acid condition, Pantoprazole chemical constitution easily changes, and occurs being polymerized and metachromatism, therefore
The control of basicity must be strengthened in preparation process, while needing to add stability of other auxiliary materials to improve preparation.Prior art
In there are numerous studies to work to be devoted to the development of pantoprazole sodium freeze-drying powder pin and the work of improving stability, but these researchs are big
In the research and development focused on to supporting agent and auxiliary material, and the stability of gained preparation is still difficult to reach wanting for storage steady in a long-term more
Ask.
Due to freeze-dried powder injection of pantoprazole sodium in preparation process, it is necessary to remove insoluble impurities using activated carbon,
To improve product clarity and depyrogenation, and Fe is carried in activated carbon3+Deng metal ion, because Pantoprazole sodium solution is unstable
Fixed, it is sulfonyl that its sulfinyl is oxidizable under oxidant effect, and the bi-methoxy of sulfonyl is easily and Fe3+Deng metal ion network
Close and go bad, cause clinical toxic and side effect, it is therefore desirable to which adding EDTA etc. increases its stability as complexing agent.As clinic
The injection of injection, auxiliary material is added excessively, is likely to cause unknown side reaction, is influenceed to the safety belt of patient.
The content of the invention
To solve the problem present on, it is an object of the invention to provide a kind of prescription is simple, auxiliary material is few, it is adapted to long-term steady
The freeze-dried powder injection of pantoprazole sodium of fixed storage.
To realize object above, freeze-dried powder injection of pantoprazole sodium of the invention, be by active component Pantoprazole Sodium and
Water-soluble supporting agent composition, wherein water-soluble supporting agent is mannitol, Pantoprazole Sodium is 1 with the weight ratio of mannitol:1-
1.5, and obtained in following methods：
Pantoprazole Sodium, the mannitol of recipe quantity are weighed, plus appropriate water for injection is stirred to whole dissolvings, is adjusted with acid-base modifier
The pH value for saving solution is 10-12, adds the pretreated medicinal carbon of total amount 0.2~0.5%, is stirred at room temperature 20-30 points
Clock, nitrogen filled protection filters carbon removal, degerming and filling, half tamponade, and then frozen drying obtains the freeze-dried powder without the crystallization water
Injection；Wherein pretreated medicinal carbon is that the pickle that 5-10 times of pH value is 3-6, stirring are added in medicinal carbon
5-10 minutes, 20-30 minutes is stood, then rinsed to neutrality with water for injection, obtained within 2-4 hours in 100 DEG C of dry baking.
The preferred watery hydrochloric acid of pickle of above-mentioned treatment medicinal carbon.
It is cost-effective in order to reduce the consumption of auxiliary material as far as possible, the weight ratio preferably 1 of above-mentioned Pantoprazole Sodium and mannitol:
1-1.25。
The process of above-mentioned frozen drying includes（1）The pre-freeze phase, medicine is placed in freeze dryer, pre-freeze is protected to -45 DEG C
It is warm 1-2 hours；（2）The lyophilization phase, 15Pa is evacuated to, temperature rises to 0 DEG C by -45 DEG C, is kept for 5.5-6.5 hours, heats up
5 DEG C of value, is kept for 5.5-6.5 hours, is warming up to 10 DEG C, is kept for 1.5-2.5 hours；（3）Parsing-desiccation phase, temperature is risen to by 10 DEG C
40 DEG C, insulation vacuum drying 3~6 hours.
The pH value of above-mentioned solution preferably 10~11.5.
The above-mentioned preferred sodium acid carbonate of acid-base modifier, NaOH or sodium carbonate.
The content specification of above-mentioned freeze-dried powder injection of pantoprazole sodium every is 40mg.
Freeze-dried powder injection of pantoprazole sodium of the invention, carries out removing the pre- of metal ion using acid solution to medicinal carbon
Treatment, makes liquid in the case where that need not add the complexing agents such as EDTA, still with good stability, so as to greatly reduce auxiliary material
The clinical side effects that cause of increase, and carbon removal, degerming and filling is filtered under the protection of High Purity Nitrogen, it is ensured that Pantoprazole Sodium exists
From dioxygen oxidation during preparing and instiling, the stability of Pantoprazole Sodium is more preferably improved.Pantoprazole Sodium of the invention freezes
Dry powder injection, prescription advantages of simple, stable and controllable for quality, few side effects are adapted to storage steady in a long-term.
The present invention also provides a kind of preparation method of above-mentioned freeze-dried powder injection of pantoprazole sodium, and this includes following step successively
Suddenly：
（1）With liquid:
A. Pantoprazole Sodium, mannitol are weighed by recipe quantity in desinfection chamber to be placed in sterile chamber, is injected water to about complete
The 70-80% of amount, stirs and is allowed to dissolve, and the pH value that solution is adjusted with acid-base modifier is 10-12, is added to the full amount of water for injection,
Stir evenly；
B. it is the pretreated medicinal carbon of 0.2-0.5% to add total amount, is stirred 20-30 minutes；
C. preparing tank is first vacuumized, and is then injected into high pure nitrogen, adds liquid, filtering carbon removal, degerming, after determining content, is filled
Loaded in 10ml cillin bottles, every dress 2g, pressure half is filled in, and whole process is carried out under nitrogen protection；
The pretreated medicinal carbon of wherein b step is that the diluted acid that 5-10 times of pH value is 3-6 is added in medicinal carbon
Liquid, stirs 5-10 minutes, stands 20-30 minutes, then is rinsed to neutrality with water for injection, is obtained within 2-4 hours in 100 DEG C of dry baking；
(2) freeze-drying
A. it is quick-frozen：Freeze dryer temperature is first down to -45 ± 2 DEG C, then liquid is put into freeze dryer, treat that medicine minimizes temperature
Afterwards, kept for 1-2 hours or so；
B. lyophilization：15Pa is evacuated to, temperature rises to 0 DEG C by -45 DEG C, is kept for 5.5-6.5 hours, is warming up to 5 DEG C, keeps
5.5-6.5 hours, 10 DEG C are warming up to, are kept for 1.5-2.5 hours；
C. parsing-desiccation：By 10 DEG C to 40 DEG C, insulation is vacuum dried 3~6 hours temperature, plus plug, and jewelling lid obtains finished product.
The preparation method of freeze-dried powder injection of pantoprazole sodium of the invention, process is simple is easy to operation, is suitable for extensive
Industrialized production.
Specific embodiment
First, embodiment
Embodiment 1
1st, it is formulated（By instant component, the weight according to Pantoprazole Sodium and mannitol is than different preparations）
2nd, preparation method
Medicinal carbon is pre-processed：It is the hydrochloric acid solution of 3-6,5-10 points of stirring that 5-10 times of pH value is added in medicinal carbon
Clock, stands 20-30 minutes, then is rinsed to neutrality with water for injection, and 100 DEG C dry roasting 2-4 hours, stand-by；
70% for weighing the Pantoprazole Sodium of recipe quantity, mannitol by above-mentioned formula, adding to the full amount of water for injection, stirring and dissolving,
Using the pH value of appropriate sodium hydrate regulator solution to 10.5, benefit adds to the full amount of water for injection, and what plus 0.5% pretreated is medicinal
Activated carbon, is stirred at room temperature 20min；Preparing tank is first vacuumized, and is then injected into high pure nitrogen, then is input into above-mentioned liquid, nitrogen filled protection,
Common filtering carbon removal, it is degerming after filtering with microporous membrane, after determining content, filling in 10ml cillin bottles, every about 2g, half
Tamponade, is placed in freeze dryer, and pre-freeze is incubated 1-2 hours to -45 DEG C；Lyophilization, temperature rises to 0 DEG C by -45 DEG C, and holding 6 is small
When, 5 DEG C, kept for 6 hours, 10 DEG C, kept for 2 hours；Temperature rises to 40 DEG C and continues to be kept for 5 hours by 10 DEG C, plus plug, jewelling lid
Obtain product 1,2,3,4.
Embodiment 2
1st, it is formulated（It is formulated by this prescription 2, adds complexing agent to prepare）
2nd, prepare
Preparation method is same as Example 1, and EDTA-2Na dissolves together with Pantoprazole Sodium and mannitol.
Embodiment 3
1st, it is formulated（By the formula of prescription 2, different preparing process are taken）
2nd, prepare
Preparation method is same as Example 1, and whether medicinal carbon is pre-processed and whether inflated with nitrogen is protected is wanted according to prescription
Depending on asking, product 6,7,8 is obtained.
Embodiment 4
1st, it is formulated（By the formula of embodiment 2, different lyophilized techniques are taken）
2nd, prepare
Preparation method is same as Example 1, depending on lyophilized technique is according to prescription requirements, obtains product 9,10,11.
2nd, the quality investigation of each prescription products
Foundation《Chinese Pharmacopoeia》Version target levels of product quality in 2015 and the method for inspection, product is placed at 40 DEG C, from dried frozen aquatic products shape
Six indexs such as state, property of drug, the clarity of solution and color, impurity, moisture and content carry out accelerating within 1 month quality to examine
Examine.
1st, prescription 1-5 products investigate result as shown in Table 1
Table one：
By table one as can be seen that Pantoprazole Sodium is 1 with the weight ratio of mannitol:1-1.5, indices all meet quality will
Ask, and without EDTA-2Na complexing agents, product quality is not impacted, integrated cost prescription 2 is optimal, therefore dissolves Tuo La
The weight ratio preferably 1 of azoles sodium and mannitol:1-1.25.
2nd, prescription 6-8 products investigate result as shown in Table 2
Table two：
By table two as can be seen that without being protected using nitrogen and medicinal carbon being pre-processed, product does not meet matter
Amount is required.
3rd, prescription 9-11 products investigate result as shown in Table 3
Table three：
By table three as can be seen that prescription 9 is when distillation and finally dried time are inadequate, product does not meet quality requirement, prescription
10th, 11 quality requirement is satisfied by, but " impurity " index of prescription 10,11 has larger rising trend, therefore use temperature by -45
0 DEG C DEG C is risen to, is kept for 5.5-6.5 hour, 5 DEG C, kept for 5.5-6.5 hours, 10 DEG C, holding 1.5-2.5 hours, temperature is by 10 DEG C
40 DEG C are risen to, the technique of insulation vacuum drying 3~6 hours is preferred.
Claims (8)
1. a kind of freeze-dried powder injection of pantoprazole sodium, is made up of active component Pantoprazole Sodium and water-soluble supporting agent, wherein
Water-soluble supporting agent is mannitol, and Pantoprazole Sodium is 1 with the weight ratio of mannitol:1-1.5, and obtained in following methods：
Pantoprazole Sodium, the mannitol of recipe quantity are weighed, plus appropriate water for injection is stirred to whole dissolvings, is adjusted with acid-base modifier
The pH value for saving solution is 10-12, adds the pretreated medicinal carbon of total amount 0.2~0.5%, is stirred at room temperature 20-30 points
Clock, nitrogen filled protection filters carbon removal, degerming and filling, half tamponade, and then frozen drying obtains the freeze-dried powder without the crystallization water
Injection；Wherein pretreated medicinal carbon is that the pickle that 5-10 times of pH value is 3-6, stirring are added in medicinal carbon
5-10 minutes, 20-30 minutes is stood, then rinsed to neutrality with water for injection, obtained within 2-4 hours in 100 DEG C of dry baking.
2. freeze-dried powder injection of pantoprazole sodium according to claim 1, it is characterised in that：The Pantoprazole Sodium and sweet dew
The weight ratio preferably 1 of alcohol:1-1.25.
3. freeze-dried powder injection of pantoprazole sodium according to claim 1 and 2, it is characterised in that：The treatment medical active
The pickle of charcoal is watery hydrochloric acid.
4. freeze-dried powder injection of pantoprazole sodium according to claim 3, it is characterised in that：The mistake of the frozen drying
Journey includes（1）The pre-freeze phase, medicine is placed in freeze dryer, pre-freeze is incubated 1-2 hours to -45 DEG C；（2）The lyophilization phase, take out true
Empty to 15Pa, temperature rises to 0 DEG C by -45 DEG C, is kept for 5.5-6.5 hours, is warming up to 5 DEG C, and holding 5.5-6.5 hours is warming up to
10 DEG C, kept for 1.5-2.5 hours；（3）Parsing-desiccation phase, temperature rises to 40 DEG C, insulation vacuum drying 3~6 hours by 10 DEG C.
5. freeze-dried powder injection of pantoprazole sodium according to claim 4, it is characterised in that：The pH value of the solution be 10~
11.5。
6. freeze-dried powder injection of pantoprazole sodium according to claim 5, it is characterised in that：The acid-base modifier is carbonic acid
Hydrogen sodium, NaOH or sodium carbonate.
7. freeze-dried powder injection of pantoprazole sodium according to claim 6, it is characterised in that：The pantoprazole sodium freeze-drying powder
The content specification of injection every is 40mg.
8. a kind of preparation method of freeze-dried powder injection of pantoprazole sodium described in claim 1, in turn includes the following steps：
（1）With liquid:
A. Pantoprazole Sodium, mannitol are weighed by recipe quantity in desinfection chamber to be placed in sterile chamber, is injected water to about complete
The 70-80% of amount, stirs and is allowed to dissolve, and the pH value that solution is adjusted with acid-base modifier is 10-12, is added to the full amount of water for injection,
Stir evenly；
B. it is the pretreated medicinal carbon of 0.2-0.5% to add total amount, is stirred 20-30 minutes；
C. preparing tank is first vacuumized, and is then injected into high pure nitrogen, then is input into liquid, filtering carbon removal, degerming, after determining content, is filled
Loaded in 10ml cillin bottles, every dress 2g, pressure half is filled in, and whole process is carried out under nitrogen protection；
The pretreated medicinal carbon of wherein b step is that the diluted acid that 5-10 times of pH value is 3-6 is added in medicinal carbon
Liquid, stirs 5-10 minutes, stands 20-30 minutes, then is rinsed to neutrality with water for injection, is obtained within 2-4 hours in 100 DEG C of dry baking；
(2) freeze-drying
A. it is quick-frozen：Freeze dryer temperature is first down to -45 ± 2 DEG C, then liquid is put into freeze dryer, treat that medicine minimizes temperature
Afterwards, kept for 1-2 hours or so；
B. lyophilization：15Pa is evacuated to, temperature rises to 0 DEG C by -45 DEG C, is kept for 5.5-6.5 hours, is warming up to 5 DEG C, keeps
5.5-6.5 hours, 10 DEG C are warming up to, are kept for 1.5-2.5 hours；
C. parsing-desiccation：By 10 DEG C to 40 DEG C, insulation is vacuum dried 3~6 hours temperature, plus plug, and jewelling lid obtains finished product.
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| CN201611256704.0A CN106692081B (en) | 2016-12-30 | 2016-12-30 | A kind of freeze-dried powder injection of pantoprazole sodium and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115444826A (en) * | 2022-10-14 | 2022-12-09 | 海南锦瑞制药有限公司 | Preparation method of pantoprazole sodium for injection |
| CN116077446A (en) * | 2022-12-16 | 2023-05-09 | 上药东英（江苏）药业有限公司 | Rabeprazole sodium freeze-dried powder injection and preparation method thereof |
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| CN102085190A (en) * | 2011-01-28 | 2011-06-08 | 海南锦瑞制药股份有限公司 | Pantoprazole sodium freeze-dried powder injection and preparation method thereof |
| CN102328928A (en) * | 2011-10-10 | 2012-01-25 | 浙江兴达活性炭有限公司 | Equipment for producing active carbon |
| CN102973501A (en) * | 2012-12-25 | 2013-03-20 | 山西普德药业股份有限公司 | Tranexamic acid injection and preparation method of same |
| CN104118875A (en) * | 2014-07-30 | 2014-10-29 | 江苏捷峰高科能源材料股份有限公司 | Method and special device for cleaning active carbon of supercapacitor |
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| CN102085190A (en) * | 2011-01-28 | 2011-06-08 | 海南锦瑞制药股份有限公司 | Pantoprazole sodium freeze-dried powder injection and preparation method thereof |
| CN102328928A (en) * | 2011-10-10 | 2012-01-25 | 浙江兴达活性炭有限公司 | Equipment for producing active carbon |
| CN102973501A (en) * | 2012-12-25 | 2013-03-20 | 山西普德药业股份有限公司 | Tranexamic acid injection and preparation method of same |
| CN104118875A (en) * | 2014-07-30 | 2014-10-29 | 江苏捷峰高科能源材料股份有限公司 | Method and special device for cleaning active carbon of supercapacitor |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115444826A (en) * | 2022-10-14 | 2022-12-09 | 海南锦瑞制药有限公司 | Preparation method of pantoprazole sodium for injection |
| CN115444826B (en) * | 2022-10-14 | 2023-07-21 | 海南锦瑞制药有限公司 | Preparation method of pantoprazole sodium for injection |
| CN116077446A (en) * | 2022-12-16 | 2023-05-09 | 上药东英（江苏）药业有限公司 | Rabeprazole sodium freeze-dried powder injection and preparation method thereof |
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| CN106692081B (en) | 2019-09-13 |
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Denomination of invention: Pantoprazole sodium freeze-dried powder injection and preparation method Effective date of registration: 20230602 Granted publication date: 20190913 Pledgee: Bank of China Limited by Share Ltd. Shantou branch Pledgor: GUANGDONG JIANXIN PHARMACEUTICAL Corp.,Ltd. Registration number: Y2023980042689 |