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Methylprednisolone sodium succinate for injection

A technology of methylprednisolone sodium succinate and injection, which is applied in the field of medicine, can solve problems such as spray bottles and affecting the quality of freeze-dried powder injections, and achieve the effects of ensuring product quality, good product stability, and avoiding glass flakes

Active Publication Date: 2018-09-07
HUBEI RENMIN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The liquid medicine prepared by the formula in the prior art is under the high vacuum condition (1.33Pa) described in the application, and the eutectic point is also around -5°C, so when the freeze-drying temperature reaches above -5°C, some medicines will The liquid melts to produce liquid, which causes partial liquefaction under high vacuum conditions, causing spray bottles and affecting the quality of the obtained freeze-dried powder injection

Method used

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  • Methylprednisolone sodium succinate for injection
  • Methylprednisolone sodium succinate for injection
  • Methylprednisolone sodium succinate for injection

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Embodiment

[0087] Methylprednisolone sodium succinate for injection is methylprednisolone sodium succinate for injection with a specification of 40mg. The formula components are: methylprednisolone succinate 5.075g, sodium dihydrogen phosphate 0.16g, anhydrous disodium hydrogen phosphate 1.746g, 2.5g of lactose, appropriate amount of sodium hydroxide, adjust the pH to 7.6, and set the weight to 100ml of water for injection.

[0088] The method for preparing described methylprednisolone sodium succinate for injection comprises the steps:

[0089] Step 1: Pretreatment of bottles, stoppers and aluminum caps

[0090] Step 2: Dissolution

[0091] ① Preparation of 10% NaOH solution: Weigh a certain amount of sodium hydroxide, add appropriate amount of water for injection to prepare a 10% NaOH solution, cool to room temperature for later use;

[0092] ②Preparation of liquid medicine: Cool the water for injection to 15°C-25°C, weigh 70% of the formula amount of cooled water for injection and p...

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Abstract

The invention discloses methylprednisolone sodium succinate for injection. The specification of methylprednisolone sodium succinate for injection is 40 mg, and methylprednisolone sodium succinate forinjection is prepared from 50.75 mg of methylprednisolone hemisuccinate, 1.6 mg of sodium dihydrogen phosphate, 17.46 mg of anhydrous sodium hydrogen phosphate and 25 mg of lactose, the pH value is adjusted with a proper amount of sodium hydroxide, and the weight is metered to 1 g by adding water for injection. When the specification of methylprednisolone sodium succinate for injection is 125 mg,methylprednisolone sodium succinate for injection is prepared from 158.6 mg of methylprednisolone hemisuccinate, 1.6 mg of sodium dihydrogen phosphate and 17.4 mg of anhydrous sodium hydrogen phosphate, the pH value is adjusted with a proper amount of sodium hydroxide, and the weight is metered to 1.5 g by adding water for injection. Methylprednisolone sodium succinate for injection has the advantages of being high in stability and fewer in individual impurity and total impurity.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to methylprednisolone sodium succinate for injection. Background technique [0002] Methylprednisolone is an intermediate-acting glucocorticoid drug with pharmacological effects such as anti-inflammatory, immunosuppressive, anti-allergic, and anti-shock. The drug has a strong anti-inflammatory effect, which is 5 times that of hydrocortisone and 1.4 times that of prednisone. Among many glucocorticoids, methylprednisolone has the strongest affinity with glucocorticoid receptors, which is 12 times that of hydrocortisone and 23 times that of prednisone. Mineralocorticoid-like effects (such as water and sodium retention) are weak, about 1 / 200 of that of deoxycorticosterone, and significantly less than that of prednisone, and the inhibitory effect on the hypothalamus-pituitary-adrenal axis is weak. [0003] Methylprednisolone has a rapid onset of action and is easily absorbed from the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/02A61K47/26A61K31/573A61P37/08A61P37/06A61P29/00
CPCA61K9/0019A61K9/19A61K31/573A61K47/02A61K47/26A61P29/00A61P37/06A61P37/08
Inventor 朱胜节伍雄辉赵砥余记川李爱菊
Owner HUBEI RENMIN PHARMACEUTICAL CO LTD
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