Methylprednisolone sodium succinate powder for injection and preparation method thereof

A technology for methylprednisolone sodium succinate and injection, which is applied in the field of methylprednisolone sodium succinate powder for injection and its preparation, can solve the problems of long freeze-drying cycle, cumbersome, low production efficiency, etc., and achieve quality improvement and Stability, reduced freeze-drying time, and improved production efficiency

Active Publication Date: 2020-06-09
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the freeze-drying preparation method of methylprednisolone sodium succinate powder injection mainly uses methylprednisolone succinate as raw material. Free methylprednisolone and other impurities
For example, Chinese patent CN200610076703.8 discloses a method for preparing methylprednisolone sodium succina

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The specification of the methylprednisolone sodium succinate freeze-dried powder for injection provided in this example is 40 mg / bottle, and its raw and auxiliary material formula is composed as follows:

[0059]

[0060] Its preparation method is as follows:

[0061] (1) Weigh 5.3g methylprednisolone sodium succinate, 0.16g sodium dihydrogen phosphate monohydrate, 1.746g anhydrous disodium hydrogen phosphate and 2.5g lactose, dissolve with 50ml water for injection in a 10°C water bath with magnetic stirring, stir The speed is 280rpm. After clarification, the pH is adjusted to 7.6 with 10% sodium hydroxide solution, and the volume is adjusted to 100ml with water for injection.

[0062] (2) Filter the solution obtained in step (1) successively through 0.45 μm and 0.22 μm microporous membranes, then divide into vials, 1 ml in each bottle, and half stopper.

[0063] (3) The subpackaged solution in step (2) is freeze-dried according to the freeze-drying curve (see Table...

Embodiment 2

[0065] The specification of the methylprednisolone sodium succinate freeze-dried powder for injection provided in this example is 40 mg / bottle, and its raw and auxiliary material formula is composed as follows:

[0066]

[0067]

[0068] Its preparation method is as follows:

[0069] (1) Weigh 5.3 g of methylprednisolone sodium succinate, 0.16 g of sodium dihydrogen phosphate monohydrate, 1.746 g of anhydrous disodium hydrogen phosphate and 2.5 g of lactose, and dissolve them with 50 ml of water for injection in a 40°C water bath with magnetic stirring, stirring The speed is 280rpm. After clarification, the pH is adjusted to 7.6 with 10% sodium hydroxide solution, and the volume is adjusted to 100ml with water for injection.

[0070] (2) Filter the solution obtained in step (1) successively through 0.45 μm and 0.22 μm microporous membranes, then divide into vials, 1 ml in each bottle, and half stopper.

[0071] (3) The subpackaged solution in step (2) is freeze-dried ac...

Embodiment 3

[0073] The specification of the methylprednisolone sodium succinate freeze-dried powder for injection provided in this example is 500 mg / bottle, and its raw and auxiliary material formula is composed as follows:

[0074]

[0075] Its preparation method is as follows:

[0076] (1) Weigh 16.56g of methylprednisolone sodium succinate, 0.16g of sodium dihydrogen phosphate monohydrate, and 1.74g of anhydrous disodium hydrogen phosphate, and dissolve them with 60ml of water for injection with magnetic stirring in a water bath at 10°C at a stirring speed of 280rpm. Finally, adjust the pH to 7.6 with 10% sodium hydroxide solution, and dilute to 100 ml with water for injection.

[0077] (2) Filter the solution obtained in step (1) successively through 0.45 μm and 0.22 μm microporous membranes, and then divide into vials, 4 ml in each bottle, and half stopper.

[0078] (3) The subpackaged solution in step (2) is freeze-dried according to the freeze-drying curve (see Table 1), plugge...

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Abstract

The invention relates to methylprednisolone sodium succinate powder for injection and a preparation method thereof. The preparation method includes the following steps: weighing methylprednisolone sodium succinate and a buffer agent (or weighing the methylprednisolone sodium succinate, the buffer agent and lactose) according to specifications, performing dissolution under stirring by using water for injection in a water bath with temperature of less than 50 DEG C, after the solution is clarified, adjusting the pH to 7.4-7.8 by using a sodium hydroxide solution, and adjusting a volume by usingwater for injection; (2) filtering the solution obtained in the step (1) by using a microporous filter membrane, and performing sub-package in penicillin bottles; and (3) performing freeze-drying on the sub-packaged solution in the step (2) to obtain the methylprednisolone sodium succinate freeze-dried powder for injection, wherein the freeze-drying operation includes pre-freezing, primary dryingand secondary drying, and the pre-freezing stage includes annealing operation. The methylprednisolone sodium succinate powder injection prepared by the method has less free methylprednisolone and total impurities, so that the quality of the drug can be greatly improved, the freeze-drying time can be reduced, and the production efficiency can be improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a methylprednisolone sodium succinate powder for injection and a preparation method thereof. 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 strong anti-inflammatory effect and weak water and sodium retention, and is widely used clinically. Because it is a poorly soluble compound, it is often prepared as a sodium salt injection that is easily soluble in water. [0003] At present, the freeze-drying preparation method of methylprednisolone sodium succinate powder injection mainly uses methylprednisolone succinate as raw material. Free methylprednisolone and other impurities. For example, Chinese patent CN200610076703.8 discloses a method for preparing methylprednisolone sodium succinate powder injection u...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/02A61K47/26A61K31/573A61P37/06A61P37/08A61P29/00
CPCA61K9/19A61K9/0019A61K47/02A61K47/26A61K31/573A61P37/06A61P37/08A61P29/00
Inventor 张茜洪丽付静邓霞飞唐维刘红华方智田瀚刘艳红
Owner 武汉人福药业有限责任公司
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