Preparation process of antifungal itraconazole containing freeze dried powder injection and transfusion

A technology for itraconazole and freeze-dried powder injections, which is applied in the field of preparation of antifungal freeze-dried powder injections and infusions containing itraconazole, can solve the problems of restricted use, injection type transportation and inconvenient use, and achieve performance Stability, no preparation process, convenient storage and transportation

Inactive Publication Date: 2006-06-21
烟台同和医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the inconvenience of transportation and use of the injection form, its use is limited.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1: Take 1 part (3.53 grams per part) of itraconazole, 4.36 parts (15.4 grams) of hydroxypropyl β-cyclodextrin and 0.156 parts (0.55 grams) of hydrochloric acid, put them into a container, Then add 50ml of distilled water, mix to form a solution, stir for 30 minutes under the heating condition of 50° C., and then use ultrasonic treatment for 20 minutes, filter the solution, and freeze-dry the filtrate to obtain the final product.

Embodiment 2

[0016] Embodiment 2: Get 1 part (0.5 gram\every part) itraconazole, 8.8 parts (4.4 gram) hydroxypropyl β-cyclodextrin, 0.7 part (0.07 gram) glacial acetic acid, add them in the triangular beaker, Then add 50ml of ethanol to dissolve it, stir at 80°C for 1 hour, then lower the temperature to room temperature, filter and dry the filtrate under reduced pressure.

Embodiment 3

[0017] Embodiment 3: get 1 part (1 gram\every part) itraconazole, 9 parts (9 gram) hydroxypropyl β-cyclodextrin, 0.35 part (0.35 gram) citric acid, add them in the Erlenmeyer flask, Then add 100ml of ethanol to dissolve it, stir at 80°C for 1 hour, lower the temperature to room temperature, filter, and dry the filtrate under reduced pressure.

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PUM

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Abstract

The invention relates to a preparation method of antifungal freeze-dried powder injection and transfusion containing itraconazole, which belongs to the preparation method of antifungal drug dosage forms. Before preparing the freeze-dried powder injection and the infusion solution, the itraconazole composition needs to be prepared and the process is the same. In the process of preparing itraconazole composition, the weight ratio of itraconazole: cyclodextrin: acid is: 1: 2~22: 0.1~2.0, they are dissolved with distilled water, methanol, etc., and then heated and stirred , freeze-dried and filtered clear liquid to obtain itraconazole composition; in the process of preparing freeze-dried powder injection, the weight ratio of itraconazole composition to cyclodextrin is 1: 0.5~10, after dissolving with distilled water, use Adjust the pH value of the solution to 4-9 with NaOH, depyrogenate with activated carbon, filter and freeze-dry to obtain itraconazole freeze-dried powder injection. The freeze-dried powder has stable performance and is convenient for storage and transportation. Infusion can effectively avoid infection that may be caused when powders and injections are injected into saline solution due to the preparation of infusion.

Description

Field of invention: [0001] The invention relates to a preparation method of antifungal freeze-dried powder injection and transfusion of itraconazole, which can obviously improve the water solubility of itraconazole and improve bioavailability, and belongs to the preparation method of antifungal drug dosage form. Background technique: [0002] Itraconazole (itraconazole) is a triazole antifungal drug with broad-spectrum activity and good tolerance. Its capsules have been used clinically for many years. Excellent efficacy in the treatment of superficial and subcutaneous fungal infections. Recent studies have shown that itraconazole capsules are also effective in the prevention of systemic fungal infections, especially in patients with long-term significant neutropenia. However, the unstable absorption and low bioavailability of capsules limit its application. In order to provide treatment for critically ill patients who are difficult to swallow and patients with invasive in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/19A61P31/10
Inventor 吴新华张传林张晓亮孙兰亭
Owner 烟台同和医药科技有限公司
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