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Detection method for encapsulation rate of propofol medium/long chain fat emulsion injection

A technology of long-chain fat emulsion and propofol, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high drug selectivity, cumbersome operation, and poor repeatability, and achieve good data repeatability, simple operation, and good The effect of practicality

Inactive Publication Date: 2018-07-06
SHANGAI PHARMA GRP CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a method for detecting drug encapsulation efficiency with simple method and strong operability, so as to overcome the high drug selectivity, cumbersome operation and poor repeatability commonly found in the determination of the existing fat emulsion preparation encapsulation efficiency And other issues

Method used

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  • Detection method for encapsulation rate of propofol medium/long chain fat emulsion injection
  • Detection method for encapsulation rate of propofol medium/long chain fat emulsion injection
  • Detection method for encapsulation rate of propofol medium/long chain fat emulsion injection

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Embodiment Construction

[0024] The present invention will be further described below in conjunction with specific examples, but the present invention is not limited.

[0025] 1. Instruments, materials and reagents

[0026] Agilent 1100 high performance liquid chromatography, Mettler XP56 millionth balance, sigma 3K15 centrifuge. Millipore Amicon Ultra-4Ultracel-100k (filter volume 4mL, NMWL: 100kDal) ultrafiltration tubes.

[0027] 1.2 Reagent

[0028] Sample to be tested: Propofol medium / long-chain fat emulsion injection, made by the inventor according to the ratio of raw materials disclosed in CN201210419120.6, the oil phase and water phase ① of the prescription amount enter the homogenizer through a peristaltic pump and mix evenly. Add the water phase ②, stir and mix to make colostrum, and then homogenize, filter, nitrogen, and sterilize to make the finished product. The specific configuration method of the sample to be tested is as follows:

[0029] (1) Configuration of oil phase:

[0030] We...

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Abstract

The invention provides a method for determining the encapsulation rate of propofol medium / long chain fat emulsion injection. The method provided by the invention combines ultrafiltration centrifugation and high performance liquid chromatography detection to determine the encapsulation rate of propofol medium / long chain fat emulsion injection, and is especially suitable for propofol medium / long chain fat emulsion injection. The method also has the advantages of good reproducibility, good accuracy, verifiability, short time and low experiment cost, and can reflect the actual encapsulation condition of propofol medium / long chain fat emulsion injection more truly and accurately.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting the encapsulation efficiency of propofol medium / long-chain fat emulsion injection. Background technique [0002] Propofol medium / long-chain fat emulsion injection is a fat emulsion preparation developed by our company. It was originally developed by Fresenius Kabi (Germany). Its product was launched in my country in 2007. Anesthesia for injection. In order to obtain the same drug efficacy, safety and preparation characteristics as the original research in the development of the preparation, we choose the particle size, particle size distribution, encapsulation rate and appearance of the emulsion as the inspection indicators to screen the prescription. Among these indicators, the encapsulation rate, which reflects the encapsulation degree of the drug, is an important quality index of microemulsion injections. The establishment of its detect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 贾国慧
Owner SHANGAI PHARMA GRP CO LTD
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