Quality control method for shenmai injection mass spectrum finger prints

A quality control method and mass spectrometry fingerprint technology, applied in the field of fingerprint analysis, can solve problems such as insufficient expression of Ophiopogon japonicus components, achieve good technical support, ensure integrity and specificity, and have the effect of strong specificity

Active Publication Date: 2011-07-27
ZHEJIANG UNIV
View PDF3 Cites 12 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing studies use high-performance liquid chromatography technology to analyze the fingerprints of Shenmai injection with ultraviolet or evaporative ...

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
  • Quality control method for shenmai injection mass spectrum finger prints
  • Quality control method for shenmai injection mass spectrum finger prints
  • Quality control method for shenmai injection mass spectrum finger prints

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Analysis of Fingerprint I of Shenmai Injection

[0035] 1. Preparation of the test solution

[0036] Take an appropriate amount of Shenmai injection, centrifuge at 10,000 rpm for 10 min, and take the supernatant for later use;

[0037] 2. LC / MS Fingerprint of Shenmai Injection Ⅰ Chromatographic Conditions

[0038] Using C 18 Bonded Fast LC Column Edipse Plus C 18 (100 mm×4.6 mm i.d., 1.8 μm), the mobile phase is 0.06% formic acid aqueous solution A and acetonitrile B, the gradient elution program is: 0-10 min, 5-15% B; 10-25 min, 15-25% B; 25-30 min, 25-30% B; 30-45 min, 30-35% B; 45-50 min, 35-45% B; 50-70 min, 45-70% B; 70-75 min , 70-90% B, column temperature: 30°C, injection volume: 5μl;

[0039] 3. LC / MS Fingerprint Ⅰ Mass Spectrometry Conditions of Shenmai Injection

[0040] Atomization pressure: 45 psi; Nitrogen flow rate: 12 L / min; Capillary voltage: 3000 V; In-source pyrolysis voltage: 250 V; Nitrogen temperature: 250, 300 and 350°C; -1400; ...

Embodiment 2

[0042] Example 2 Analysis of Fingerprint I of Shenmai Injection

[0043] The preparation of the test solution and the chromatographic conditions are as in Example 1, except for the mass spectrometry conditions. Mass spectrometry conditions: Nitrogen temperature: 350°C; Nebulization pressure: 45 psi; Nitrogen flow rate: 12 L / min; In-source cracking voltage: 250 V; Capillary voltage: 2500, 3000, 3500 and 4000 V; Negative ion scanning detection mode, scanning m / z range: 200-1400;

[0044] The results of the analysis are attached figure 2 , Total ion chromatogram of fingerprint Ⅰ of Shenmai injection at different capillary voltages.

Embodiment 3

[0045] Example 3 Analysis of Fingerprint I of Shenmai Injection

[0046] The preparation of the test solution and the chromatographic conditions are as in Example 1, except for the mass spectrometry conditions.

[0047] Mass spectrometry conditions: Nitrogen temperature: 350°C; Nebulization pressure: 45 psi; In-source cracking voltage: 250 V; Capillary voltage: 3500; Nitrogen flow rate: 9, 10, 11, 12 L / min; negative ion scanning detection mode, scanning m / Z range: 200-1400;

[0048] The results of the analysis are attached image 3 , total ion chromatogram of fingerprint Ⅰ of Shenmai injection at different nitrogen flow rates.

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 provides a quality control method for shenmai injection mass spectrum finger prints. Liquid chromatogram is adopted as a separation measure, and a mass spectrum detector is taken as a detection measure so as to obtain two finger prints for representing compound information of red ginseng and radix ophiopogonis in shenmai injection; and the similarity is calculated by adopting a correlation coefficient method, and samples with the similarity more than or equal to 0.9 are judged as products with stable quality. In the quality control method, the characteristics that the mass spectrum detector has high sensitivity and strong specificity, and can sample in multiple channels are utilized, and a method for detecting in the multiple channels and with different modes is selected, sothat the two finger prints can be obtained by one-time analysis, the compound information of red ginseng and radix ophiopogonis in a preparation can be reflected simultaneously, the completeness and the specificity of the information of the finger prints of the preparation are ensured, the repeatability is good, and the technical guarantee is provided for the quality control of the shenmai injection.

Description

technical field [0001] The invention belongs to the technical field of fingerprint analysis, in particular to a method for quality control of the mass spectrum fingerprint of Shenmai injection. Background technique [0002] Fingerprinting is a methodology for studying complex material systems as a whole. In the field of quality control of traditional Chinese medicine, because the existing methods for determining the content of one or several chemical components cannot make an accurate evaluation of the overall quality of traditional Chinese medicine, it is difficult to achieve the purpose of controlling "quality" based on "quantity". and ambiguity, which has attracted extensive attention from researchers in the industry, and has been widely accepted by the US FDA, the State Food and Drug Administration and other agencies to evaluate the batch-to-batch quality stability of herbal medicines or traditional Chinese medicines. At present, traditional Chinese medicine fingerprint...

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
IPC IPC(8): A61K36/8968G01N30/88A61P9/00A61P35/00
Inventor 范骁辉邵青聂晶沈培强张建兵
Owner ZHEJIANG UNIV
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