Medicinal composition containing echinocandin antifungal agent and its preparing method and its use

A composition and antifungal technology, which can be applied in the directions of antifungal agents, medical preparations of inactive ingredients, pharmaceutical formulations, etc., and can solve the problems of not providing stability and the like

Active Publication Date: 2012-06-27
SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no data is provided to reflect the stability of the composition at higher temperatures

Method used

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  • Medicinal composition containing echinocandin antifungal agent and its preparing method and its use
  • Medicinal composition containing echinocandin antifungal agent and its preparing method and its use
  • Medicinal composition containing echinocandin antifungal agent and its preparing method and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 3

[0104] Caspofungin formulation preparation

[0105] The preparation process is similar to Comparative Example 1, except that glacial acetic acid is not added during the preparation process, but a phosphate buffer is added, and the pH is adjusted to 5.5-6.5. By changing the concentration of caspofungin acetate and / or adding The concentration of excipient obtains different formulas, and the composition of each formula of composition before freeze-drying is as follows:

[0106]

[0107]

[0108] After each formulation was freeze-dried, the same stability investigation as described in Comparative Example 1 was carried out.

Embodiment 4

[0110] Caspofungin formulation stability

[0111] After the samples of Comparative Examples 1, 2 and Example 3 were tested for stability, the active substances were analyzed by HPLC, and the analysis method used was as above.

[0112] The results of the 40°C stability test are shown in the table below:

[0113]

[0114] The results of the stability test at 30°C are shown in the table below:

[0115]

[0116] The results of the stability test at 2-8°C are shown in the table below:

[0117]

[0118]

[0119] By comparing the above stability test data, it can be seen that each formulation is very stable at 2-8°C, and the content of caspofungin does not decrease significantly after 12 weeks and 24 weeks. The 2-8°C stability data provided by the present invention is carried out on the basis of the raw material medicine produced by our company, wherein the raw material medicine contains process impurities such as RRT0.95 (relative retention time is 0.95), which has a h...

Embodiment 7

[0136] Micafungin formulation preparation

[0137] The preparation process is similar to Comparative Example 5, except that citric acid is not added during the preparation process, but pH adjustment is carried out with phosphate, and different concentrations of micafungin sodium and / or excipients are obtained by changing the concentration of micafungin sodium. The formula, the composition of each formula of the composition before freeze-drying is as follows:

[0138]

[0139]

[0140] After each formula was freeze-dried, the stability test described in Comparative Example 5 was also carried out.

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Abstract

The invention discloses a medicinal composition containing an echinocandin antifungal agent, wherein the pharmaceutical composition contains a pharmaceutically acceptable amount of excipient, and a pharmaceutically acceptable amount of phosphate buffer agent. The invention provides the medicinal composition having good stability.

Description

technical field [0001] The present invention relates to pharmaceutical compositions for the treatment and / or prevention of fungal infections. More specifically, the present invention relates to an echinocandin antifungal compound, or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable amount of excipients, and a phosphate pH regulator. It is a lyophilized composition. Background technique [0002] Echinocandin, also known as echinocandin, is a new type of antifungal drug. Its structure is as shown in formula I. It belongs to the acetyl hexacyclic group. It is a glucan synthase inhibitor and non-competitively inhibits the - The synthesis of β(1,3)-D-glucan plays a bactericidal effect. Dextran is a fungal cell wall polysaccharide and an important component of the cell wall, which can maintain the integrity of the cell wall and stabilize its osmotic pressure. [0003] [0004] In the formula, R 1 is an acyl-containing group, R 2 is hydroxyl, R 3 i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K9/19A61K47/26A61K47/04A61P31/10
Inventor 洪云海薛颖季晓铭
Owner SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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