CN104188924A - Pantoprazole sodium medicine composition for injection - Google Patents
Pantoprazole sodium medicine composition for injection Download PDFInfo
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- CN104188924A CN104188924A CN201410441516.XA CN201410441516A CN104188924A CN 104188924 A CN104188924 A CN 104188924A CN 201410441516 A CN201410441516 A CN 201410441516A CN 104188924 A CN104188924 A CN 104188924A
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Abstract
The invention provides a pantoprazole sodium medicine composition for injection. The composition is prepared from pantoprazole sodium, mannitol, edetate disodium, sodium hydroxide and injection water. According to the pantoprazole sodium medicine composition for injection, the product is extremely excellent in clarity and re-dissolving performance, and the quality and stability of the product can be improved.
Description
Technical field
The present invention relates to a kind of Pantoprazole sodium drug composition and preparation method thereof, be specifically related to a kind of injection Pantoprazole sodium drug composition and preparation method thereof.
Background technology
Pantoprazole Sodium; English name: Pantoprazole Sodium; its chemical name is: 5-difluoro-methoxy-2-[[(3,4-dimethoxy-2-pyridinyl)-methyl] sulfinyl]-1H-benzimidazole sodium salt is a kind of proton pump inhibitor class antiulcerative.The less stable of Pantoprazole Sodium, all very sensitive to light, heat, oxygen, water, metal ion etc., especially, in the time of acid condition, can there is destructive variation in its chemical constitution, there is variable color and polymerism, thereby be unsuitable for making water agent for injecting and be applicable to making lyophilized injectable powder.
Existing much about the patent documentation of freeze-dried powder injection of pantoprazole sodium is reported in prior art.As CN 102846559A provides a kind of pantoprazole sodium freeze-drying preparation, wherein: the raw material that comprises following weight portion: 1 part of Pantoprazole Sodium, mannitol 0.5-1.2 part, disodium edetate 0.02-0.1 part, sodium sulfite 0.03-0.06 part, sodium hydroxide 0.01-0.02 part, 50 parts of waters for injection; The preparation method of this lyophilized formulations is provided simultaneously, according to prescription obtain solution, and has carried out fill lyophilizing after utilizing active carbon to process configured solution.As CN 102085190A provides a kind of preparation method of freeze-dried powder injection of pantoprazole sodium: the Pantoprazole Sodium and the mannitol that take recipe quantity, first add the water for injection of dosing total amount 80% in Agitation Tank, the mannitol and the Pantoprazole Sodium that add successively recipe quantity, be stirred to dissolve into clear and bright solution; Add water for injection to full dose, mix homogeneously, to between 10.5-11.0, add medicinal carbon stirring and adsorbing with sodium hydroxide solution regulator solution pH value, through de-charcoal and 0.22 μ m aseptic filtration for the first time, after intermediate detection is qualified, medicinal liquid basin between medicinal liquid filter pressing to medicinal liquid is accepted, then medicine liquid tank is moved to and under hundred grades of laminar flow hood of filling machine, carries out 0.22 μ m secondary terminals degerming and filter to medicinal liquor barrel, fill, half tamponade, lyophilization.As CN103463636A, CN102525960A, CN102743351A and CN102552186A etc. all disclose pantoprazole sodium freeze-drying preparation and preparation method thereof.
Because Pantoprazole Sodium nature is extremely unstable, even Pantoprazole Sodium is prepared into lyophilized formulations, can not ensure the stability of its preparation, transport and storage process, the content of its preparation still has obvious decline, related substance obviously to increase.And due to the difference of freeze-dry process, also can cause end product quality to have notable difference, directly affect the various performances of product.
Summary of the invention
A kind of injection Pantoprazole sodium drug composition provided by the invention, has not only guaranteed that by specific freeze-dry process the profile of pantoprazole sodium freeze-drying product is full, and the clarity of product, solubility are splendid, has improved quality and the stability of product.
The invention provides a kind of injection Pantoprazole sodium drug composition, comprise Pantoprazole Sodium, mannitol, disodium edetate, sodium hydroxide and water for injection, each component is carried out to dosing, lyophilizing, wherein the lyophilizing stage is divided into pre-freeze, first phase distillation and the second stage of drying stage, it is characterized by: the pre-freeze stage is down to-30 DEG C for shelf temperature was set in 30 minutes, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep 2-3 hour.
A kind of injection Pantoprazole sodium drug composition provided by the invention, wherein 1 part of Pantoprazole Sodium (in pantoprazole), 0.0375 part of disodium edetate, 1 part, mannitol, sodium hydroxide is appropriate, and the pH value of regulator solution is between 11.4-11.6.
The invention provides a kind of injection Pantoprazole sodium drug composition, comprise Pantoprazole Sodium, mannitol, disodium edetate, sodium hydroxide and water for injection, the ratio of weight and number of wherein said each component is:
1 part of Pantoprazole Sodium (in pantoprazole), 0.0375 part of disodium edetate, 1 part, mannitol, sodium hydroxide is appropriate, and the pH value of regulator solution is between 11.4～11.6, and concrete preparing process is as follows:
(1) Pantoprazole Sodium that takes recipe quantity is dissolved in water for injection, and the amount of water for injection accounts for 60% of gross weight;
(2) prepare respectively disodium edetate solution and mannitol according to recipe quantity, disodium edetate solution is slowly joined in pantoprazole sodium solution, again the mannitol solution of recipe quantity is joined in pantoprazole sodium solution, add 98% of water for injection ad pond om;
(3) prepare appropriate sodium hydroxide solution and join in above-mentioned solution, the pH value of regulator solution, between 11.4～11.6, is mended and is injected water to regulation gross weight;
(4) after aseptic filtration, divide and be filled in cillin bottle, lyophilizing, tamponade outlet, rolls aluminium lid, obtains described pantoprazole sodium freeze-drying medicinal composition for injection;
It is characterized in that, freeze-drying process is:
The pre-freeze stage: shelf temperature is set in 30 minutes and is down to-30 DEG C, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep 2-3 hour;
First phase distillation: freeze drying box vacuum is evacuated to 20-22Pa and starts subliming by heating, with 5 hours, shelf temperature is risen to-8 DEG C, and keep 8-10 hour, then with 3 hours, shelf temperature is risen to 0 DEG C and keep 2-3 hour, then shelf temperature is risen to 15 DEG C and keep 1 hour;
Second phase is dry: shelf temperature is risen to 25-27 DEG C, keeps shutdown in 2-4 hour, fill tamponade after 30% high pure nitrogen.
Because freeze-dry process directly affects product appearance, clarity and solubility etc., inventor by the difference control parameter in pre-freeze stage, first phase sublimation stage and the second stage of drying stage carry out repeatedly, long term test research, finally determine freeze-dry process provided by the invention, ensure that freeze-drying prods profile is full, and clarity and the solubility of product are splendid, improve quality and the stability of product.
Related Pantoprazole sodium drug composition in following test example, all adopts following methods preparation: take 1 part of Pantoprazole Sodium (in pantoprazole) and be dissolved in water for injection; Take after 1 part of 0.0375 part of disodium edetate, mannitol dissolves with water for injection respectively and slowly join in pantoprazole sodium solution, add 98% of water for injection ad pond om; , between 11.4～11.6, mend and inject water to regulation gross weight with the pH value of appropriate sodium hydrate regulator solution; After aseptic filtration, divide to be filled in cillin bottle and carry out lyophilizing, wherein concrete freeze-dry process is shown in that each test example is listed.
The 1 pre-freeze stage of test example exists--and 30 DEG C keep the comparison of different time product quality
Get the complete pantoprazole sodium solution of subpackage and carry out pre-freeze, shelf temperature is set in 30 minutes and is down to-30 DEG C, keep different time as shown in table 1 below, and then be set in 30 minutes and be down to below-40 DEG C, keep 2-3 hour.
Product quality while shelf temperature being down to fast to-30 DEG C of maintenance different times according to 2010 editions observations of Chinese Pharmacopoeia in the pre-freeze stage, concrete outcome is shown in Table 1:
Table 1 pre-freeze stage shelf temperature-30 DEG C keep the product quality of different time
Wherein, near the pre-freeze stage: while shelf temperature being down to fast to-30 DEG C, now products temperature is about-14 DEG C～-16 DEG C, and compound of pantoprazole sodium eutectic point is-16 DEG C～-19 DEG C.Due to the upper and lower two parts of medicinal liquid in bottle in pre-freeze process, can to produce thermograde poor, in the process that an ice face advances from bottom to top, in solution, solute upwards moves, cause the solute of upper epidermis often more, density is higher, and lower bottom density is loose compared with minor structure, therefore the product surface of finished product there will be harder one deck thin layer, if now continue to reduce shelf temperature, can cause goods upper surface out-of-flatness phenomenon to occur because cooling is too fast, finally cause percent defective greatly to increase, cause production cost to increase.Applicant is through a large amount of experimental studies have found that, in pre-freeze process on eutectic point-14 DEG C～-16 DEG C keep 1 hour, the levels that just can ensure medicinal liquid is even, and then fast cooling, goods can freeze in moment, goods after lyophilizing are even up and down like this, prevent due to the too fast irregular phenomenon of goods upper surface causing of cooling.
Shelf temperature is down to fast to-30 DEG C and keeps 1 hour, and then to be down to fast-40 DEG C of following maintenances 2-3 hour be solid in order to ensure to freeze state, reach fully charge.As real in there is no fully charge at these stage goods, when evacuation, product can emit bottle outlet to cause spray bottle outward, causes waste product to increase, and strengthens production cost; If simultaneously long in this retention time in stage, can cause again lyophilization cycle to increase, increase equally production cost.
The product quality comparative study of the different distillation of test example 2 first phase sublimation stages vacuum
Get the complete pantoprazole sodium solution of subpackage and carry out pre-freeze, shelf temperature is set in 30 minutes and is down to-30 DEG C, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep carrying out after 2.5 hours first phase distillation: freeze drying box vacuum is evacuated to vacuum as listed in following table 2 and starts subliming by heating, with 5 hours, shelf temperature is risen to-8 DEG C, and keep 9 hours, with 3 hours, shelf temperature is risen to 0 DEG C and keep 2 hours again, then shelf temperature is risen to 15 DEG C and keep 1 hour, first phase distillation finishes.
Product quality according to 2010 editions observations of Chinese Pharmacopoeia in the time that first phase sublimation stage adopts different distillation vacuum, concrete outcome is shown in Table 2:
The comparison of the different distillation of table 2 first phase sublimation stage vacuum product quality
Identical through test pre-freeze parameter, first phase distillation baffle temperature arranges identical, and vacuum is under 20-22Pa, and lyophilizing product quality is out best.
First phase sublimation stage: sublimation temperature, vacuum determine the speed of distillation, for ensureing to accelerate rate of sublimation, need to improve temperature and vacuum, excess Temperature exceedes subsiding when temperature of goods, can cause goods to occur subsiding and stop up the passage of diffusion of vapor, reduce the speed of distillation, so the temperature control of distillation phase is very crucial.Applicant finally finds through a large amount of experimentatioies: select, with 5 hours, shelf temperature is risen to-8 DEG C by-40 DEG C, and keep 8-10 hour, with 3 hours, shelf temperature is risen to 0 DEG C and keep 2-3 hour again, then shelf temperature being risen to 15 DEG C keeps one hour, the product appearance that finally obtains is full evenly, solubility is good, do not occur drenching the phenomenons such as bottle, improved product yield and ensured freeze-dried products quality.
When sublimation stage pressure is too low, unfavorable to conducting heat, product is difficult for obtaining heat, and rate of sublimation reduces.The convection heat transfer' heat-transfer by convection of pressure gas within suitable scope can obviously increase.At same flaggy temperature, product easily obtains heat, thereby rate of sublimation increases.In the present invention, first phase distillation vacuum maintains 20-22Pa, has not only been beneficial to the transmission of heat but also has been beneficial to the carrying out of distillation, can relatively shorten time distillation phase, reduces production costs as far as possible, reduces percent defective, under the prerequisite that ensures product quality, shortens freeze-drying time.
The product quality comparative study of the second stage of drying stage different temperatures of test example 3
Get the complete pantoprazole sodium solution of subpackage and carry out pre-freeze, shelf temperature is set in 30 minutes and is down to-30 DEG C, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep carrying out after 2.5 hours first phase distillation: freeze drying box vacuum is evacuated to vacuum as listed in following table 2 and starts subliming by heating, with 5 hours, shelf temperature is risen to-8 DEG C, and keep 9 hours, with 3 hours, shelf temperature is risen to 0 DEG C and keep 2 hours again, then shelf temperature is risen to 15 DEG C and keep 1 hour, first phase distillation finishes; Second phase is dry: shelf temperature is risen to 25-27 DEG C, keeps shutdown in 2-4 hour, fill tamponade after 30% high pure nitrogen.
Product quality according to 2010 editions observations of Chinese Pharmacopoeia in the time that the second stage of drying stage adopts different temperatures, concrete outcome is shown in Table 3:
Product quality comparison under the second stage of drying stage different temperatures of table 3
Drying stage to 25-27 DEG C, keeps 2-4 hour by plate temperature rise, and the product quality that obtains is best, cost is minimum.
The interior ice distillation of product is complete, the dry second stage that just entered of product.Although do not exist and freeze ice in this stage product, but in product, also there is the moisture of 10% left and right, in order to make product reach qualified residual moisture content, must be further dry to product, can make product temperature rise to rapidly the maximum permissible temperature of this product, and till this temperature is maintained to lyophilizing and finishes.Improving rapidly product temperature is conducive to reduce product residual moisture content and shortens the adsorption stripping and dry time.
Drying stage to 25-27 DEG C, keeps plate temperature rise to shut down for 2-4 hour, fills tamponade after 30% high pure nitrogen, can obtain injection pantoprazole sodium freeze-drying product, and vacuum state undershoot nitrogen rolls lid, has ensured the steady quality in whole effect duration of product.
In above-mentioned preparation method step (3), by clarity, solubility, visible foreign matters, content, related substance after repeatedly contrasting freeze-drying prods that different pH value make and dissolving, experiment show be the final products that 11.4-11.6 obtains within the scope of this at pH value, its clarity, visible foreign matters is best, solubility is best, related substances (being impurity) content is also minimum.
The injection Pantoprazole sodium drug composition that the application provides, owing to adopting specific proportion of composing and preparation method, especially adopt specific freeze-dry process, the profile of not only having guaranteed product is full, and the clarity of product, solubility are splendid, the quality and the stability that have improved product, reduce product percent defective greatly, saves production cost.
Freeze-dried powder composition and method of making the same of the present invention can improve the stability of pantoprazole sodium solution greatly, be no matter configuration, subpackage or the related substance of preparing pantoprazole sodium solution in freeze-drying process all without increasing, content is without obvious decline, the freeze-dried powder injection of pantoprazole sodium of preparation has good stability in transport and storage process, when clinical use, compatibility solution can be placed the long period, make clinically to become more convenient the problem such as drug safety hidden danger and side effect of also greatly reduced because impurity increases, degradation bringing under content to patient.
Detailed description of the invention
The specific embodiment of the present invention only limits to further explain and explanation the present invention, and does not mean that limitation of the present invention.
Embodiment 1 injection Pantoprazole Sodium
Take Pantoprazole Sodium (in pantoprazole) 60g, disodium edetate 2.25g, mannitol 60g, sodium hydroxide is appropriate, and the pH value of regulator solution is 11.5, and concrete preparing process is as follows:
(1) Pantoprazole Sodium that takes recipe quantity is dissolved in water for injection, and the amount of water for injection accounts for 60% of gross weight;
(2) prepare respectively disodium edetate solution and mannitol according to recipe quantity: disodium edetate solution is slowly joined in pantoprazole sodium solution, again the mannitol solution of recipe quantity is joined in pantoprazole sodium solution, add 98% of water for injection ad pond om;
(3) take the sodium hydroxide of recipe quantity, be mixed with sodium hydroxide solution and join in above-mentioned solution, the pH value of regulator solution, between 11.4～11.6, is mended and is injected water to regulation gross weight;
(4) after aseptic filtration, divide and be filled in cillin bottle, lyophilizing, tamponade outlet, rolls aluminium lid, obtains described pantoprazole sodium freeze-drying medicinal composition for injection;
(5) freeze-drying process is:
The pre-freeze stage: shelf temperature is down to fast to-30 DEG C, keeps 1 hour, and then be down to fast below-40 DEG C, keep 2.5 hours;
First phase distillation: freeze drying box vacuum is evacuated to 20-22Pa and starts subliming by heating, rose to shelf temperature with 5 hours-8 DEG C, and keeps 8-10 hour, then with 3 hours, shelf temperature was risen to 0 DEG C and keep 2 hours, then shelf temperature was risen to 15 DEG C of maintenances 1 hour;
Second phase is dry: shelf temperature is risen to 25-27 DEG C, keeps shutdown in 3 hours, fill tamponade after 30% high pure nitrogen.
Claims (3)
1. an injection Pantoprazole sodium drug composition, comprise Pantoprazole Sodium, mannitol, disodium edetate, sodium hydroxide and water for injection, each component is carried out to dosing, lyophilizing, wherein the lyophilizing stage is divided into pre-freeze, first phase distillation and the second stage of drying stage, it is characterized by: the pre-freeze stage is down to-30 DEG C for shelf temperature was set in 30 minutes, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep 2-3 hour.
2. Pantoprazole sodium drug composition according to claim 1, it is characterized by: 1 part of Pantoprazole Sodium (in pantoprazole), 0.0375 part of disodium edetate, 1 part, mannitol, sodium hydroxide is appropriate, and the pH value of regulator solution is between 11.4-11.6.
3. an injection Pantoprazole sodium drug composition, comprise Pantoprazole Sodium, mannitol, disodium edetate, sodium hydroxide and water for injection, the ratio of weight and number of wherein said each component is: 1 part of Pantoprazole Sodium (in pantoprazole), 0.0375 part of disodium edetate, 1 part, mannitol, sodium hydroxide is appropriate, the pH value of regulator solution is between 11.4～11.6, concrete preparing process is as follows: the Pantoprazole Sodium that takes recipe quantity is dissolved in water for injection, and the amount of water for injection accounts for 60% of gross weight; Prepare respectively disodium edetate solution and mannitol according to recipe quantity, disodium edetate solution is slowly joined in pantoprazole sodium solution, then the mannitol solution of recipe quantity is joined in pantoprazole sodium solution, add 98% of water for injection ad pond om; Prepare appropriate sodium hydroxide solution and join in above-mentioned solution, the pH value of regulator solution, between 11.4～11.6, is mended and is injected water to regulation gross weight; After aseptic filtration, divide and be filled in cillin bottle, lyophilizing, tamponade outlet, rolls aluminium lid, obtains described pantoprazole sodium freeze-drying medicinal composition for injection; It is characterized in that, freeze-drying process is: the pre-freeze stage: shelf temperature is set in 30 minutes and is down to-30 DEG C, keep 1 hour, and then be set in 30 minutes and be down to below-40 DEG C, keep 2-3 hour; First phase distillation: freeze drying box vacuum is evacuated to 20-22Pa and starts subliming by heating, with 5 hours, shelf temperature is risen to-8 DEG C, and keep 8-10 hour, then with 3 hours, shelf temperature is risen to 0 DEG C and keep 2-3 hour, then shelf temperature is risen to 15 DEG C and keep 1 hour; Second phase is dry: shelf temperature is risen to 25-27 DEG C, keeps shutdown in 2-4 hour, fill tamponade after 30% high pure nitrogen.
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| CN105193745A (en) * | 2015-09-18 | 2015-12-30 | 康普药业股份有限公司 | Pantoprazole sodium freeze-drying medicine composition for injection and preparation method thereof |
| CN106474076A (en) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | The preparation method of Pantoprazole sodium for injection |
| CN112587486A (en) * | 2020-12-29 | 2021-04-02 | 南京健友生化制药股份有限公司 | Pantoprazole sodium freeze-dried powder injection for injection and preparation method thereof |
| CN114177148A (en) * | 2021-12-17 | 2022-03-15 | 海南皇隆制药股份有限公司 | Preparation method of pantoprazole sodium for injection and product thereof |
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| CN112587486B (en) * | 2020-12-29 | 2022-05-13 | 南京健友生化制药股份有限公司 | Pantoprazole sodium freeze-dried powder injection for injection and preparation method thereof |
| CN114177148A (en) * | 2021-12-17 | 2022-03-15 | 海南皇隆制药股份有限公司 | Preparation method of pantoprazole sodium for injection and product thereof |
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