Method for detecting a plurality of small molecular chemical components in Xuebijing injection

A technology of chemical composition and detection method, applied in the field of analysis of pharmaceutical composition, can solve the problem of lack of comprehensive quantitative/semi-quantitative detection of Xuebijing Injection

Active Publication Date: 2019-12-31
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In view of the shortcomings of the prior art described above, the purpose of the present invention is to provide a detection method for multiple small molecule chemical components in Xuebijing injection, w...

Method used

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  • Method for detecting a plurality of small molecular chemical components in Xuebijing injection
  • Method for detecting a plurality of small molecular chemical components in Xuebijing injection
  • Method for detecting a plurality of small molecular chemical components in Xuebijing injection

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Experimental program
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Effect test

Embodiment 1

[0204] 1. Pretreatment

[0205] The Xuebijing Injection was diluted with 50% (v / v) aqueous methanol solution and then constant volume to prepare a sample solution. The volume ratio of Xuebijing injection to solvent is 1:1-1:5000.

[0206] 2. Qualitative and quantitative analysis

[0207] Dilute safflower flavonoids, paeoniae monoterpene glycosides, salvia catechins, and at least one standard component of the fifth category of components with a solvent and then dilute to volume as the first standard solution. A total of 46 chemical components can be included in the first standard solution, see above for details.

[0208] Dilute one or more standard components of Rhizoma Chuanxiong and Angelica phthalides with a solvent and then make up to volume as the second standard solution. There are 11 kinds of chemical components that can be included in the second standard solution, see above for details.

[0209] The sample solution, the first standard solution, and the second standa...

Embodiment 2

[0218] Prepare the first standard solution whose concentration range of each component is 7.8~4000nM, carry out HPLC / MS detection respectively, take the chromatographic peak area as the ordinate (Y axis), the safflower flavonoids component, Radix Paeoniae Rubra in the corresponding first standard solution The mass concentration of monoterpene glycoside components, salvia catechin components, and the fifth type of components is the abscissa (X axis), and regression analysis is carried out to obtain the regression equation and its correlation coefficient, as shown in Table 5.

[0219]It can be seen from Table 5 that the linear relationship of the above regression equation is good when the sample is injected within the corresponding concentration range, and the correlation coefficient r>0.99. For the response signal of the target substance in the standard solution, the lowest concentration standard sample was used to repeat the injection 3 times for HPLC / MS analysis.

[0220] Tab...

Embodiment 3

[0224] To investigate the accuracy and precision of the determination methods of representative safflower flavonoids, red paeoniae monoterpene glycosides, salvia catechins, and the fifth category of ingredients in Xuebijing injection. The sample recovery rate of the analysis method is expressed by the ratio of the actual concentration of the injection component to its labeled concentration, and the precision of the analysis method is expressed by the RSD value of the analysis results of 3 test samples with the same concentration.

[0225] The representative safflower flavonoids, red paeoniae monoterpene glycosides, salvia catechins, and the fifth category were selected for determination. The specific results are shown in Table 6. It can be seen from Table 6 that the average recovery rate of the selected safflower flavonoids, paeoniae paeoniae monoterpene glycosides, salvia catechins, and the fifth type of ingredients is between 88.5-114.4%, indicating that this method can incre...

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Abstract

The invention provides a method for detecting a plurality of small molecular chemical components in a Xuebijing injection. The method comprises the following steps: step one, preparing a sample solution; step two, preparing a first standard solution; step three, preparing a second standard solution; and step four, carrying out measurement on the sample solution, the first standard solution and thesecond standard solution by using a high performance liquid chromatography-mass spectrometry method, quantifying 57 kinds of small molecule chemical components in the sample solution by using a standard curve method and then determining contents of other 66 kinds of small molecule chemical components with structures similar to those of the 57 small molecule chemical components that are determinedin a quantified mode in a semi-quantitative manner. According to the method provided by the invention, 123 traditional Chinese medicine small molecule compounds can be quantitatively or semi-quantitatively detected with high flux and high sensitivity and a key technical way is provided for optimizing the preparation process of Xuebijing and improving the product quality uniformity.

Description

technical field [0001] The invention belongs to the technical field of analysis of medicinal components, and relates to a method for detecting multiple small molecule chemical components in Xuebijing injection, in particular to a method for simultaneously detecting 123 small molecule chemical components in Xuebijing injection method. Background technique [0002] Sepsis is an organ dysfunction syndrome resulting from a systemic host response to infection and is characterized by high lethality (25-50%) and a poor prognosis. The conventional treatment of sepsis (including septic shock) mainly relies on timely and reasonable antibiotic anti-infection treatment and regulation of abnormal response of patients, but there is still a lack of effective chemical drugs for the latter. Xuebijing, a traditional Chinese medicine injection, is currently the only Class II new drug of traditional Chinese medicine approved for the treatment of sepsis in China (2004). About 600,000 sepsis pat...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/72
CPCG01N30/7266G01N30/88G01N2030/047G01N2030/8809G01N2030/884G01N2030/885
Inventor 程晨李川余玄王亚亚贺容容董凯张桂萍姚小青
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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