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Method for measuring encapsulation efficiency of doxorubicin hydrochloride liposomal

A measurement method and technology of encapsulation efficiency, applied in the measurement of color/spectral characteristics, etc., can solve the problems of complicated operation and decreased accuracy, and achieve the effect of short measurement time, small error and good reproduction.

Active Publication Date: 2014-12-31
常州金远药业制造有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The technical problem to be solved by the present invention is: in the prior art, it is usually necessary to separate the liposome from the unencapsulated drug when measuring the encapsulation efficiency, the operation is complicated, and the accuracy rate decreases

Method used

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  • Method for measuring encapsulation efficiency of doxorubicin hydrochloride liposomal
  • Method for measuring encapsulation efficiency of doxorubicin hydrochloride liposomal
  • Method for measuring encapsulation efficiency of doxorubicin hydrochloride liposomal

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The encapsulation efficiency of doxorubicin hydrochloride liposome batch number 0344689 is about 80%

[0042] (1) Determination of total drug: Take 1ml of 2mg / ml doxorubicin hydrochloride liposome in a 50ml volumetric flask, add methanol to the mark and shake well. Take 1ml of it in a 10ml volumetric flask, add methanol to the mark, shake well, and use methanol as a blank to measure the absorbance at 254nm as A 1均 =0.382.

[0043] (2) Determination of free drug: Take 1ml of 2mg / ml doxorubicin hydrochloride liposomes from the same batch as step (1) in a 50ml volumetric flask, add water to the mark and shake well. Take 1ml of it in a 10ml volumetric flask, add 0.1mol / L sodium hydroxide to the mark at 2-8°C, shake well, and react for 5 minutes.

[0044] Take the same concentration (same batch) of doxorubicin hydrochloride liposome, take 1ml in a 50ml volumetric flask, add water to the mark and shake well, then take 1ml of it in a 10ml volumetric flask, add water to Scal...

Embodiment 2

[0051] Doxorubicin Hydrochloride Liposome Lot No. 0344466 The encapsulation efficiency is about 90%,

[0052] (1) Determination of total drug: Take 2ml of 2mg / ml doxorubicin hydrochloride liposome in a 50ml volumetric flask, add methanol to the mark and shake well. Take 1ml of it in a 10ml volumetric flask, add methanol to the mark, shake well, and use methanol as a blank to measure the absorbance at 259nm as A 1均 =0.453.

[0053] (2) Determination of free drug: Take 2 mg / ml of the same batch of doxorubicin hydrochloride liposome as in step (1) in a 50 ml volumetric flask, add water to the mark and shake well. Take 1ml of it in a 10ml volumetric flask, add 1mol / L potassium hydroxide to the mark at room temperature, shake well, measure immediately,

[0054] Take the same concentration (same batch) of doxorubicin hydrochloride liposome, take 2ml in a 50ml volumetric flask, add water to the mark and shake well, then take 1ml of it in a 10ml volumetric flask, add water to Scale...

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Abstract

The invention belongs to the field of chemical medicine detection and in particular relates to a method for measuring the encapsulation efficiency of doxorubicin hydrochloride liposomal. The doxorubicin hydrochloride liposomal is a nano small ball formed by wrapping doxorubicin hydrochloride with a phospholipid double-layer film, and the uncovered doxorubicin hydrochloride is free outside the ball. When alkaline liquid is added to a system, the free doxorubicin hydrochloride and alkaline react; the absorption wavelength of the free doxorubicin hydrochloride is long, and the doxorubicin hydrochloride in the film and the alkaline do not reacts due to isolation from the film, and an original absorption wavelength is kept. The encapsulation efficiency of the liposomal is calculated due to the change of the wavelengths through an ultraviolet-visible light photometer. The method has the characteristics of short measurement time, convenience, accuracy, small error and high reproducibility and is suitable for control on the industrial production process.

Description

technical field [0001] The invention belongs to the field of chemical drug testing, in particular to a method for measuring the encapsulation efficiency of doxorubicin hydrochloride liposomes. Background technique [0002] The encapsulation efficiency is an important indicator of the quality control of liposomes and nanoparticles, which reflects the degree of encapsulation of the drug by the carrier, the concentration of the drug and the carrier, and the conditions in the preparation process are the main factors affecting the encapsulation efficiency. The encapsulation rate includes the determination of the encapsulation percentage and the encapsulation volume, and the general literature mainly examines the encapsulation percentage (EN%). Its expression is EN%=(1-Cf / Ct)×100%. In the formula, Cf is the amount of free drug; Ct is the total amount of drug in nanoparticle or liposome suspension. Separation of nanoparticles or liposomes from free drug is a critical step for acc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/31G01N21/33
Inventor 朱瑶俊贺明符俊代光玉
Owner 常州金远药业制造有限公司
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