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Methylprednisolone sodium succinate for injection and preparation method thereof

A technology of methylprednisolone sodium succinate and methylprednisolone succinate, applied in the field of medicine, can solve the problems of shortened freeze-drying time, low production efficiency, and affecting the quality of preparations, so as to shorten the freeze-drying time, improve production efficiency, and improve appearance uniform effect

Active Publication Date: 2020-05-15
天津梅花生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, in the solution preparation process, the methylprednisolone succinate is first reacted with the lye, and then the pH is adjusted with a buffer salt, which may lead to partial ester bond loss of the methylprednisolone succinate in the case of instantaneous contact with a large amount of lye. Fracture, resulting in free methylprednisolone, affecting the quality of preparations
[0004] Chinese patent CN200610076703.8 discloses a methylprednisolone sodium succinate freeze-dried composition and its preparation method, but its freeze-drying time is time-consuming and the production efficiency is low
[0005] Chinese patent application 201410670438.0 discloses a preparation method of methylprednisolone sodium succinate freeze-dried powder for injection, which greatly shortens the freeze-drying time, but does not disclose the control of vacuum degree, a key influencing factor in the freeze-drying process of the preparation, and The total freeze-drying time is also longer

Method used

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  • Methylprednisolone sodium succinate for injection and preparation method thereof
  • Methylprednisolone sodium succinate for injection and preparation method thereof

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Effect test

Embodiment 1

[0039] Methylprednisolone sodium succinate for injection, its specification is 125mg according to methylprednisolone, and the prescription composition of each is as follows:

[0040] Methylprednisolone succinate 158.4mg

[0041] Sodium dihydrogen phosphate 1.8mg

[0042] Disodium hydrogen phosphate 17.5mg

[0043] Sodium hydroxide 13.4mg

[0044] Mannitol 0mg

[0045] Lactose 0mg

[0046] Water for injection, fixed weight to 1.5g

[0047] The preparation process of medicinal liquid comprises the following steps:

[0048] (1) Prepare the prescribed amount of sodium hydroxide into lye with a concentration of 10% for later use,

[0049] (2) Add water for injection with 70% of the total volume of the liquid into the liquid preparation tank, cool down to 15°C,

[0050] (3) Add the prescribed amount of sodium dihydrogen phosphate and disodium hydrogen phosphate into the liquid mixing tank, stir to dissolve,

[0051] (4) Add the prescribed amount of methylprednisolone succina...

Embodiment 2

[0065]Methylprednisolone sodium succinate for injection, its specification is recorded as 40mg by methylprednisolone, and the prescription composition of each is as follows:

[0066] Methylprednisolone Succinate 50.7mg

[0067] Sodium dihydrogen phosphate 1.84mg

[0068] Disodium hydrogen phosphate 17.5mg

[0069] Sodium hydroxide 4.27mg

[0070] Mannitol 0mg

[0071] Lactose 25mg

[0072] Water for injection, fixed weight to 1g

[0073] The preparation process of medicinal liquid comprises the following steps:

[0074] (1) Prepare the prescribed amount of sodium hydroxide into lye with a concentration of 10% for later use,

[0075] (2) Add water for injection with 60% of the total amount of liquid in the liquid preparation tank, cool down to 15°C,

[0076] (3) Add the prescribed amount of sodium dihydrogen phosphate and disodium hydrogen phosphate into the liquid mixing tank, stir to dissolve,

[0077] (4) Add the prescribed amount of methylprednisolone succinate into...

Embodiment 3

[0092] Methylprednisolone sodium succinate for injection, its specification is recorded as 40mg by methylprednisolone, and the prescription composition of each is as follows:

[0093] Methylprednisolone Succinate 50.7mg

[0094] Sodium dihydrogen phosphate 1.84mg

[0095] Disodium hydrogen phosphate 17.5mg

[0096] Sodium hydroxide 4.27mg

[0097] Mannitol 25mg

[0098] Lactose 0mg

[0099] Water for injection fixed to 1g

[0100] The preparation process of medicinal liquid comprises the following steps:

[0101] (1) Prepare the prescribed amount of sodium hydroxide into lye with a concentration of 10% for later use,

[0102] (2) Add water for injection with 60% of the total amount of liquid in the liquid preparation tank, cool down to 15°C,

[0103] (3) Add the prescribed amount of sodium dihydrogen phosphate and disodium hydrogen phosphate into the liquid mixing tank, stir to dissolve,

[0104] (4) Add the prescribed amount of methylprednisolone succinate into the li...

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Abstract

The invention discloses a methylprednisolone sodium succinate preparation for injection and a preparation method thereof. The methylprednisolone sodium succinate preparation has a prescription composed of methylprednisolone succinate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide, mannitol, lactose and water for injection, which are different in usage amounts accordingto the specification of methylprednisolone sodium succinate for injection. According to the invention, the control of the dispersion rotating speed of methylprednisolone succinate, particularly the control of related parameters like the rotating speed and time of an alkali liquor adding program is emphasized in the preparation process of a liquid medicine; freeze-drying is carried out at a top speed; a process of gradient staged drying is adopted; the prepared methylprednisolone sodium succinate for injection is loose and powdery in appearance, good in re-solubility, free of opalescence through light inspection after re-dissolution, qualified in insoluble particle inspection, small in content of free methylprednisolone and related substances and capable of meeting the quality standard requirements; meanwhile, the freeze-drying time is greatly shortened; and the production efficiency is improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a methylprednisolone sodium succinate preparation for injection and a preparation method thereof. Background technique [0002] Methylprednisolone is a synthetic glucocorticoid. Methylprednisolone and its derivatives are mainly used for anti-inflammation, immunosuppression, treatment of blood diseases and tumors, shock treatment, endocrine disorders and other diseases. Since methylprednisolone is an organic substance that is insoluble in water, it needs to be made into sodium salt, potassium salt or calcium salt of methylprednisolone succinic acid to increase its solubility and facilitate administration. The current clinical application is mainly sodium succinate of methylprednisolone. Methylprednisolone sodium succinate is the precursor compound of methylprednisolone, which can be hydrolyzed into free methylprednisolone by cholinesterase in the body to exert its drug effect, ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/573A61K47/10A61K47/26A61P5/00A61P7/00A61P29/00A61P35/00A61P37/06
CPCA61K9/0019A61K9/19A61K31/573A61K47/10A61K47/26A61P5/00A61P7/00A61P29/00A61P35/00A61P37/06
Inventor 梅开忠
Owner 天津梅花生物医药科技有限公司
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