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Freeze-dried preparation of cefditoren sodium for injection and preparation method thereof

A technology of cefditoren sodium and freeze-dried preparation, which is applied in the field of cefditoren sodium freeze-dried preparation for injection and its preparation field, can solve the problems of long dissolution time and poor stability of active ingredients, shorten dissolution time and improve stability , good solubilizing effect

Active Publication Date: 2016-08-24
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to overcome the disadvantages of long dissolving time and poor stability of the active ingredient of cefditoren sodium injection in the prior art, and provide a lyophilized preparation of cefditoren sodium for injection with shorter dissolving time and better stability of the active ingredient

Method used

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  • Freeze-dried preparation of cefditoren sodium for injection and preparation method thereof
  • Freeze-dried preparation of cefditoren sodium for injection and preparation method thereof
  • Freeze-dried preparation of cefditoren sodium for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Example 1 The freeze-dried preparation of cefditoren sodium for injection consists of 1 g of cefditoren sodium, 1 g of arginine, 0.2 g of citric acid and an appropriate amount of hydrochloric acid as a pH regulator.

[0024] The preparation method of this example cefditoren sodium freeze-dried preparation for injection: first dissolve arginine and citric acid with 50mL water for injection, adjust the pH value of the solution to neutrality with hydrochloric acid, then add the sterile cefditoren sodium raw material, stir After dissolving, add activated carbon; Pack the sterile, pyrogen-free medicinal solution into 10 bottles of vials, and freeze-dry it according to the freeze-drying process. Each bottle of vials contains 0.1 g of cefditoren sodium; the freeze-dried The process is: pre-freeze the liquid medicine to -30°C, evacuate to below 10Pa, and then raise the temperature in stages. The operating conditions of the step-by-step temperature increase are: the first stage: ...

Embodiment 2

[0031] The preparation method of the freeze-dried preparation in Example 2 is the same as the preparation method of the freeze-dried preparation in Example 1, the difference is that the operating conditions of the freeze-drying process in Example 2 are: the first stage: -30 ° C ~ -25 ° C , the heating time is 3h; the second stage: -25℃~-15℃, the heating time is 5h; the third stage: -15℃~25℃, the heating time is 5h, the temperature is raised to 25℃ and then kept for 4h. When preparing the freeze-dried formulation described in Example 2, dissolve the cefditoren sodium pharmaceutical composition with 50 mL of water for injection, and see Table 2 for the dissolution time.

Embodiment 3

[0032] The preparation method of the freeze-dried preparation in Example 3 is the same as the preparation method of the freeze-dried preparation in Example 1, the difference is that the operating conditions of the freeze-drying process in Example 3 are: the first stage: -30 ° C ~ -25 ° C , the heating time is 5h; the second stage: -25°C to -15°C, the heating time is 3h; the third stage: -15°C to 25°C, the heating time is 7h, the temperature is raised to 25°C and then kept for 6h. When preparing the freeze-dried formulation described in Example 3, dissolve the cefditoren sodium pharmaceutical composition with 50 mL of water for injection, and see Table 2 for the dissolution time.

[0033] The preparation method of the freeze-dried preparation of Examples 4-11 is the same as the preparation method of the freeze-dried preparation of Example 1. When preparing the freeze-dried formulations described in Examples 4-11, the cefditoren sodium pharmaceutical composition was dissolved wi...

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Abstract

The invention relates to the field of freeze-dried preparation for injection. The invention particularly discloses a cefditoren sodium freeze-dried preparation for injection and a preparing method thereof. The cefditoren sodium freeze-dried preparation for injection comprises cefditoren sodium, a dissolution-assisting agent and a proper amount of a pH regulator, wherein the dissolution-assisting agent is a mixture of arginine and citric acid. The cefditoren sodium freeze-dried preparation for injection adopts citric acid and arginine to be combined as the dissolution-assisting agent, and the dissolution-assisting agent has quite good dissolution-assisting property on cefditoren sodium, obviously improves the dissolution rate in water for injection, shortens the dissolution time, and improves the stability of the cefditoren sodium freeze-dried preparation; and the cefditoren sodium freeze-dried preparation can achieve the stability equal to the cefditoren sodium raw material.

Description

technical field [0001] The invention relates to a freeze-dried preparation for injection, in particular to a freeze-dried preparation of cefditoren sodium for injection and a preparation method thereof. Background technique [0002] Cefditoren sodium is the sodium salt of cefditoren, and cefditoren is the entity form of cefditoren pivoxil currently on the market that works in vivo. Its molecular structure is shown below. [0003] [0004] Cefditoren pivoxil (cefditoren pivoxil) is a third-generation new oral cephalosporin, developed by Japan Meiji Seika Co., Ltd., and first listed in Japan in 1994. In August 2000, cefditoren pivoxil tablets were first approved for marketing in China under the trade name "Meiike", produced by Japan's Meiji Seika and repackaged by Shantou Special Economic Zone Meiji Pharmaceutical Co., Ltd. Studies have shown that cefditoren axetil is effective in the treatment of community-acquired respiratory tract infections caused by five major pathog...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K47/18A61P31/04
Inventor 李明赵忠琼梁隆王利春沈鑫程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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