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A kind of lyophilized composition containing caspofungin acetate and its preparation method

A technology of caspofungin acetate and composition, which is applied in the field of freeze-dried composition containing caspofungin acetate and its preparation, can solve the problems of unfavorable actual production, long total cycle of freeze-drying, and low drying efficiency, and achieve Energy saving, short freeze-drying cycle, and avoiding degradation

Active Publication Date: 2021-08-27
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This has resulted in low drying efficiency. In order to obtain a final product with lower moisture content, the total cycle of freeze-drying needs to be longer, resulting in high energy consumption, which is not conducive to actual production.

Method used

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  • A kind of lyophilized composition containing caspofungin acetate and its preparation method
  • A kind of lyophilized composition containing caspofungin acetate and its preparation method
  • A kind of lyophilized composition containing caspofungin acetate and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032]

[0033] Preparation:

[0034] (1) Preparation of solution for lyophilization:

[0035] ① Solution preparation: Add water for injection to the preparation container, cool to 8°C, add the prescribed amount of mannitol and sucrose, stir to dissolve, add glacial acetic acid and caspofungin acetate, stir to dissolve, and use 0.3mol / l sodium hydroxide solution Adjust the pH value to 5.8, continue to add water for injection to 1.3 g, and stir until the solution is clear by visual inspection.

[0036] ② Bacterial endotoxin removal: Add 0.3% medicinal charcoal to the above solution and stir for 25 minutes.

[0037] ③Decarbonization: Decarbonization by coarse filtration with titanium rods.

[0038] ④ Sterilization and filtration of medicinal liquid: the medicinal liquid is filtered through three 0.22μm filter membranes connected in series.

[0039] ⑤Inspection: Inspect the intermediate content, pH value and visible foreign matters.

[0040] ⑥Fillin...

Embodiment 2

[0047] prescription:

[0048]

[0049] Preparation method:

[0050] (1) Preparation of solution for lyophilization

[0051] ① Solution preparation: Add water for injection to the preparation container, cool to 2°C, add the prescribed amount of mannitol and sucrose, stir to dissolve, add glacial acetic acid and caspofungin acetate, stir to dissolve, and use 0.3mol / l sodium hydroxide solution Adjust the pH value to 5.0, continue to add water for injection to 1.3 g, and stir until the solution is clear by visual inspection.

[0052] ②-⑥ same as embodiment 1

[0053](2) Freeze-drying: the freeze-drying solution obtained in step (1) is placed in a freeze-drying machine, and the freeze-drying process is as follows:

[0054] ①The shelf temperature drops to -45°C;

[0055] ② The shelf temperature is maintained at -45°C for 3 hours;

[0056] ③ Turn on the vacuum, the vacuum degree drops to 0.1mbar, the shelf temperature rises to -30°C within 0.5 hours, then rises to -20°C withi...

Embodiment 3

[0063] prescription:

[0064]

[0065] Preparation method:

[0066] (1) Preparation of solution for lyophilization

[0067] ① Solution preparation: Add water for injection to the preparation container, cool to 6°C, add the prescribed amount of mannitol and sucrose, stir to dissolve, add glacial acetic acid and caspofungin acetate, stir to dissolve, and use 0.3mol / l sodium hydroxide solution Adjust the pH value to 6.2, continue to add water for injection to 1.3 g, and stir until the solution is clear by visual inspection.

[0068] ②-⑥ same as embodiment 1

[0069] (2) Freeze-drying: the freeze-drying solution obtained in step (1) is placed in a freeze-drying machine, and the freeze-drying process is as follows:

[0070] ①The shelf temperature drops to -45°C;

[0071] ② The shelf temperature is maintained at -45°C for 3 hours;

[0072] ③ Turn on the vacuum, the vacuum degree drops to 0.1mbar, the shelf temperature rises to -30°C within 0.5 hours, then rises to -20°C with...

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PUM

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Abstract

The invention discloses a freeze-dried pharmaceutical composition containing caspofungin acetate, which comprises caspofungin acetate, excipients, buffers, pH regulators and water for injection. The invention also discloses the preparation of the freeze-dried medicine The composition method, wherein the freeze-drying process includes pre-freezing, primary drying and secondary drying. The present invention regulates multiple process parameters in the freeze-drying process, so that the prepared freeze-dried pharmaceutical composition containing caspofungin acetate has low impurity content, good stability, low water content, and short freeze-drying cycle, which is more suitable for production and clinical applications.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a freeze-dried composition containing caspofungin acetate and a preparation method thereof. Background technique [0002] Caspofungin is a semi-synthetic macrocyclic lipopeptide, and it is a new type of echinocandin antifungal agent. The earliest formulation on the market is Caspofungin for injection from Merck, with the trade name "Kesaisi" . In clinical use, it is in the form of caspofungin acetate, that is, caspofungin acetate. Its chemical name is: 1-[(4R,5S)-5-[(2-aminoacetic acid) amino]-N2-(1012-dimethyl-1-carbonyltetradecyl)-4-hydroxyl-L- Ornithine]-5-[(3R)-3-Hydroxy-L-ornithine] pneumocycin B0-diacetate. The chemical structural formula is as follows: [0003] [0004] Caspofungin acetate is hygroscopic, white to off-white powder, easily soluble in water and methanol, slightly soluble in ethanol. Caspofungin acetate has very poor stability and is especia...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/26A61K38/12A61P31/10
CPCA61K9/19A61K38/12A61K47/26A61P31/10
Inventor 白海波张玉侠赵泓舒
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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