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Cortical hormone alkali metal phosphate composition

A composition and compound technology, which is applied in the direction of non-active ingredients of polymer compounds, medical preparations of non-active ingredients, powder delivery, etc., and can solve the problems of prone to spray bottles, high levels of related substances, and inability to prepare freeze-dried powder injections, etc. problem, achieve the effect of improving content stability and simplifying production process steps

Active Publication Date: 2015-04-08
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent application 200810053768.x discloses a dexamethasone sodium phosphate raw material and its production process. In this application, a spray drying process is used to produce dexamethasone aseptic raw material. However, the sterile raw material prepared by this application process is When preparing injections, the preparation steps required are basically the same as those of ordinary raw materials, and there is no obvious advantage
However, the lyophilized powder injection prepared by this application produced higher levels of related substances in the high-temperature accelerated test at 60°C for 10 days
[0005] Chinese patent application 200910250340.9 also discloses a dexamethasone sodium phosphate freeze-dried powder injection, but we found that, according to the process disclosed in the application specification, the temperature during the first freeze-drying (heating sublimation) of the powder injection was 4-6 ℃ is lower than the eutectic point of the medicinal solution. According to "Pharmacy" (Xi Nianzhu, People's Health Publishing House, the third edition in April 1995, 208-211), the temperature cannot exceed the eutectic point in the heating sublimation stage, otherwise Problems such as spray bottles are prone to occur, indicating that the preparation of freeze-dried powder cannot be carried out when the temperature is higher than the eutectic point
Even if the temperature of the part is lowered, the appearance of the prepared powder injection is poor, and the related substances produced during the high temperature accelerated test are also relatively high under the condition of other process conditions being unchanged

Method used

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  • Cortical hormone alkali metal phosphate composition
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  • Cortical hormone alkali metal phosphate composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2-1

[0061]

[0062] (1) Dissolve cyclodextrin in 20% prescription water for injection and add dexamethasone sodium phosphate to dissolve

[0063] (2) Dissolve phosphate in 80% prescription water for injection, add mannitol and make it dissolve

[0064] (3) Combine the above 2 solutions and mix well

[0065] (4) Add the prescribed amount of ethanol to the above solution and mix evenly, then filter and sterilize with a 0.22 μm filter element, and spray dry to obtain the dexamethasone sodium phosphate composition.

[0066] The spray drying conditions are as follows:

[0067] Hot air flow: 0.80m 3 / min

[0068] Inlet temperature: 100°C

[0069] Outlet temperature: 65°C

[0070] Spray pressure: 120kpa

[0071] Liquid flow rate: 5mL / min

[0072] (5) the dexamethasone sodium phosphate composition obtained in step (4) is subpackaged into powder injection, specification 5mg / 120.0mg (dexamethasone sodium phosphate / gross weight)

Embodiment 2-2

[0074]

[0075] (1) Dissolve phosphate in 20% prescription water for injection and add dexamethasone sodium phosphate to dissolve

[0076] (2) Dissolve mannitol in the remaining 80% water for injection

[0077] (3) Combine the above 2 solutions and mix well

[0078] (4) Add the prescribed amount of ethanol to the above solution and mix well, then pass the medicinal solution through a 0.22 μm filter element to filter and sterilize. Spray drying is carried out to obtain a dexamethasone sodium phosphate composition. Spray condition is the same as embodiment 2-1

[0079] (5) the dexamethasone sodium phosphate composition obtained in step (4) is subpackaged into powder injection, specification 5mg / 70.0mg (dexamethasone sodium phosphate / gross weight)

Embodiment 3-1

[0081]

[0082] (1) Dissolve cyclodextrin in half the prescription amount of water for injection and add betamethasone sodium phosphate to dissolve

[0083] (2) Dissolve phosphate in half the prescribed amount of water for injection, add mannitol and dissolve it

[0084] (3) Combine the above 2 solutions and mix well

[0085] (4) Add the prescribed amount of ethanol to the above solution, filter and sterilize through a 0.22 μm filter element, mix evenly, and spray dry to obtain the betamethasone sodium phosphate composition.

[0086] The spray drying conditions are as follows:

[0087] Hot air flow: 1.05m 3 / min

[0088] Inlet temperature: 100°C

[0089] Outlet temperature: 85°C

[0090] Spray pressure: 120kpa

[0091] Liquid flow rate: 8mL / min

[0092] (5) The betamethasone sodium phosphate composition obtained in step (4) is divided into powder injections, the specification is 5 mg / 110.0 mg (betamethasone sodium phosphate / total weight).

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Abstract

The invention relates to a cortical hormone alkali metal phosphate composition, which is prepared by a spray-drying method, and contains the following auxiliary materials by calculating the composition containing 1g Cortical hormone alkali metal phosphate: 0-100g of excipient, 0.01-59g of disodium hydrogen phosphate and 0-0.5g of sodium dihydrogen phosphate.

Description

Technical field: [0001] The invention relates to a corticosteroid preparation, in particular to a spray-dried corticosteroid alkali metal phosphate composition. Background technique: [0002] Glucocorticoids have anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects, and are widely used in the treatment of allergic and autoimmune inflammatory diseases, such as connective tissue diseases, active rheumatism, rheumatoid arthritis, erythema Lupus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc., are also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. Since glucocorticoids are mostly insoluble organic compounds, in order to facilitate the preparation of injections, they are often prepared as glucocorticoid alkali metal phosphates that are easily soluble in water. Common corticosteroid alkali metal phosphates, such as betamethasone sodium phosphate , Prednisolone S...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/661A61K9/14A61K47/04A61K47/40
Inventor 卢彦昌李静韩昆颖
Owner TIANJIN JINYAO GRP
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