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Near infrared spectrum online detection method of etimicin sulfate column separation process

A technology of etimicin sulfate and near-infrared spectroscopy, applied in the field of near-infrared detection, can solve problems such as no relevant reports, and achieve the effect of simple operation and rapid evaluation

Active Publication Date: 2016-03-02
WUXI JIMIN KEXIN SHANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the field of drug quality control and production application, the application of near-infrared spectroscopy technology to the detection of key indicators in the process of raw medicinal materials, chemical drug separation, finished products, distillation, concentration, alcohol precipitation, and chromatography has related patent documents, such as patent (patent Application No.: 200510130631.6, 200810050095.2, 201010125515.6, 200910228468.5, 201010577454.7), etc. However, there are no relevant reports on the use of near-infrared spectroscopy for the determination of key indicators in the separation process of etimicin sulfate column

Method used

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  • Near infrared spectrum online detection method of etimicin sulfate column separation process
  • Near infrared spectrum online detection method of etimicin sulfate column separation process
  • Near infrared spectrum online detection method of etimicin sulfate column separation process

Examples

Experimental program
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Embodiment 1

[0102] (1) Collection of eluent samples

[0103] Collect the eluate samples in the separation process of the etimicin sulfate column of multiple batches;

[0104]The etimicin hydrolyzate was loaded on a separation column, washed with no saline, eluted with low-concentration ethanol, and washed with no saline. The content of etimicin sulfate, C1a content and total substance content were determined respectively in the eluate samples. Repeat 5 batches, each batch of experiments were sampled in the same way, a total of 600 samples were obtained.

[0105] (2) Determination of key indicators

[0106] Liquid chromatography conditions: use octadecylsilane bonded silica gel as filler (pH range 0.8~8.0); use 0.2mol / L trifluoroacetic acid-methanol (84:16) as mobile phase; flow rate is 0.5ml per minute ; Detect with an evaporative light scattering detector (reference conditions; drift tube temperature 100° C., carrier gas flow rate 2.6 L per minute). Take the appropriate amount of eti...

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Abstract

The invention discloses a near infrared spectrum online detection method of etimicin sulfate column separation process. The method of the invention comprises the following steps: (1) collecting different batches of eluant samples during the etimicin sulfate column separation process; (2) measuring contents of etimicin sulfate, C1a component and the like in the eluant samples by liquid chromatography or ion chromatography; (3) acquiring near infrared spectral data of the eluant samples; (4) establishing a key index rapid analysis model; and (5) rapidly measuring etimicin sulfate in unknown eluant samples, C1a component and liquid-phase total peak area. The near infrared spectroscopy technology is applied to the etimicin sulfate column separation process. In comparison with a traditional liquid phase and gas phase chromatography, the established analysis method of the invention is rapid and effective, can be used for rapidly measuring etimicin sulfate, C1a component and total matter quantity during the etimicin sulfate column separation process, and is suitable for real-time analysis and online monitoring during the production process of etimicin sulfate.

Description

technical field [0001] The invention belongs to the field of near-infrared detection, and in particular relates to an online near-infrared spectrum detection method in the column separation process of etimicin sulfate. Background technique [0002] Etimicin sulfate is the latest generation of aminoglycoside antibiotics, and it is also the only national first-class new drug of antibiotics with independent intellectual property rights since the founding of the People's Republic of China. This product is an important drug for the treatment of Gram-negative bacterial infections and drug-resistant pathogenic bacteria infections. Clinical results show that etimicin sulfate has good curative effect on bacterial infection and low incidence of adverse reactions. It is a safe and effective new variety of aminoglycoside antibiotics developed in recent years, and has played an important role in the prevention and treatment of infectious diseases. [0003] As a fast and non-destructive ...

Claims

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Application Information

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IPC IPC(8): G01N21/359G01N21/3577
Inventor 甘国锋刘薇薇
Owner WUXI JIMIN KEXIN SHANHE PHARMA
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