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
View PDF3 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap