A method for determining the encapsulation efficiency of dexamethasone palmitate injection

By using weakly polar solvents such as petroleum ether to extract dexamethasone palmitate injection, combined with high performance liquid chromatography, the problem of incomplete separation of fat emulsion and free drug in the prior art has been solved, ensuring the accuracy of encapsulation rate detection and the integrity of fat emulsion structure.

CN117761191BActive Publication Date: 2026-06-30CHENGDU QISHENG HEYAN PHARM TECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
CHENGDU QISHENG HEYAN PHARM TECH CO LTD
Filing Date
2023-12-22
Publication Date
2026-06-30

AI Technical Summary

Technical Problem

Existing technologies are insufficient to effectively separate fat emulsions from free drug in dexamethasone palmitate injections, and conventional methods may damage the liposome structure, leading to inaccurate encapsulation rate test results.

Method used

Using the principle of "like dissolves like," dexamethasone palmitate injection is extracted with weakly polar solvents such as petroleum ether. The fat emulsion and free drug are then separated by high-performance liquid chromatography to ensure that the fat emulsion structure is not damaged during the detection process.

Benefits of technology

Effective separation of fat emulsion and free drug was achieved, with high accuracy in encapsulation rate detection. The extraction process caused less than 1% damage to the fat emulsion, and the recovery rate was between 90-108%, meeting the requirements of the Chinese Pharmacopoeia.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention discloses a method for detecting the encapsulation efficiency of dexamethasone palmitate injection, belonging to the technical field of encapsulation efficiency detection. The method involves mixing dexamethasone palmitate injection with a solvent for extraction; the dexamethasone palmitate injection comprises a fat emulsion and free dexamethasone palmitate; after extraction, the fat emulsion and free dexamethasone palmitate are separated, and the encapsulation efficiency is calculated by quantitative analysis using HPLC; the polarity of the solvent is similar to that of the dexamethasone palmitate. This invention utilizes the principle of "like dissolves like" to develop a method for determining the encapsulation efficiency of dexamethasone palmitate injection extracted with an organic solvent. This method effectively separates the fat emulsion from the free dexamethasone palmitate while ensuring that the structure of the fat emulsion is not damaged during the measurement process, thus avoiding falsely low encapsulation efficiency due to drug leakage.
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