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Quantitative detection method for characteristic components in Shenmai injection

A technology for Shenmai injection and a determination method, which is applied in the field of quantitative determination of borneolside, a characteristic component of Ophiopogon japonicus in Shenmai injection, can solve the problems of less research on the effective components of Ophiopogon japonicus, and achieve high sensitivity and accuracy. The effect of good specificity and precision, specificity and high confirmation

Inactive Publication Date: 2012-09-19
CHIATAI QINGCHUNBAO PHARMA
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Problems solved by technology

[0003] The current implementation standard is the National Drug Standard (Revised) WS3-B-3428-98-2004, and its identification items only have the active ingredients ginsenoside Rb1, Rg1, Re For the identification of reference substances, the previous research on the identification of Shenmai injection and the determination of active ingredient content mainly focused on the active ingredients contained in red ginseng, and less research on the active ingredients of Ophiopogon japonicus

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  • Quantitative detection method for characteristic components in Shenmai injection
  • Quantitative detection method for characteristic components in Shenmai injection
  • Quantitative detection method for characteristic components in Shenmai injection

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Embodiment

[0038] Sample source: Produced by Zhengda Qingchunbao Pharmaceutical Co., Ltd. The production process is in accordance with the current national drug standards. The six liquid medicines are: finished product, batch number: 1103058; semi-finished product without adding isotonic regulator, batch number: 1101178; Ophiopogon japonicus medicinal material extract, batch number: 11062; red ginseng Ophiopogon japonicus ethanol extraction combined solution, batch number: 11063; extract liquid after activated carbon adsorption, batch number: 11064; injection diluent, batch number: 11065

[0039] Reagent: Acetonitrile for HPLC analysis is a product of Merck Reagent Company; water is water for injection;

[0040] Borneoside reference substance is prepared by self-separation, calibrated by Zhejiang Drug Control Institute, with a purity of 99.7%;

[0041] Sample pretreatment: Take six doses of medicinal liquid in the production process of Shenmai Injection, filter through a 0.2 μm microporo...

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Abstract

The invention discloses a liquid chromatography mass spectrometry quantitative detection method for determining effective components in Shenmai injection. A sample disclosed by the invention dispenses with a complex pretreatment process and is obtained by filtering through a microfiltration membrane with 0.2mum; in liquid chromatography separation, a water-acetonitrile system is used as a mobile phase and gradient elution is carried out; and the detection is realized by using a mass detector; and quantitative detection is carried out at the peak area by adopting an external reference method. The quantitative detection method disclosed by the invention has the advantages of high sensitivity, favorable accuracy and precision and simplicity, convenience and quickness in operation; and the real-time detection in the production process of medicines is better realized.

Description

technical field [0001] The invention relates to a quantitative detection method of characteristic components in traditional Chinese medicine injections, in particular to a quantitative detection method of borneoside, a characteristic component of Radix Ophiopogon japonicus in Shenmai injections. Background technique [0002] The active ingredients of Shenmai injection are mainly saponins (about 7.5% of solid content), flavonoids and sugar compounds, among which saponins have been found to be represented by ginsenosides-Re, Rb1, Rb2, Rg1, Rg3, etc. 39 kinds of ginsenosides and 7 kinds of radix radix saponins represented by ophiopogon saponin D, and the flavonoids that have been found so far are mainly methyl radix dihydrohomoisoflavone B, 2β- 8 kinds of high isoflavone components represented by hydroxymethyl radix dihydrohomoisoflavone A, 2α-hydroxymethyl radix dihydrohomoisoflavone A, etc. [0003] The current implementation standard is the National Drug Standard (Revised) ...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 凌益平王颖凌伫怡柴建国王木兰陈莉
Owner CHIATAI QINGCHUNBAO PHARMA
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