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Quality control method for shenmai injection mass spectrum finger prints

A mass spectrometry fingerprint, Shenmai injection technology, applied in measurement devices, pharmaceutical formulations, plant raw materials and other directions, can solve the problem of insufficient expression of Ophiopogon japonicus components, achieve good technical support, high sensitivity, ensure integrity and exclusivity Effect

Active Publication Date: 2013-06-12
ZHEJIANG UNIV
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  • 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 light scattering detectors. The spectrum mainly reflects the information of ginsenoside compounds, and the composition of Ophiopogon japonicus is insufficient.

Method used

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  • 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.

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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

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Application Information

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