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Methylprednisolone sodium succinate powder for injection and preparation method thereof

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

Active Publication Date: 2022-05-06
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 succinate powder injection using methylprednisolone succinate as a raw material. The method is to form a salt during the preparation process. There is no detailed control method for the solution preparation process. The drying cycle is long, the production efficiency is very low, and the quality of the prepared product is unstable

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 a methylprednisolone sodium succinate powder for injection and a preparation method thereof. The preparation method comprises the following steps: taking methylprednisolone sodium succinate and buffer (or weighing methylprednisolone sodium succinate, buffer and lactose) according to specifications, stirring and dissolving in a water bath less than 50°C with water for injection, After clarification, adjust the pH to 7.4-7.8 with sodium hydroxide solution, and constant volume with water for injection; (2) filter the solution obtained in step (1) with a microporous membrane and pack into vials; (3) divide the step ( 2) Freeze-dry the solution after subpackaging to obtain the methylprednisolone succinic acid freeze-dried powder for injection; the freeze-drying includes pre-freezing, primary drying and secondary drying, and the pre-freezing stage includes annealing operate. The methylprednisolone sodium succinate powder injection prepared by the method has less free methylprednisolone and total impurities, can greatly improve the quality of the medicine, and simultaneously reduce the freeze-drying time and improve the production efficiency.

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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Patent Type & Authority Patents(China)
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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