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Method for detecting beta-elemene and related substances thereof

A technology for related substances and detection methods, which is applied in the field of detection of β-elemene and its related substances, can solve the problems of failure to achieve effective separation and detection of β-elemene and its related substances, and achieve simple detection methods Convenient and repeatable effect

Active Publication Date: 2021-01-12
四川弘合生物科技有限公司
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  • Abstract
  • Description
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Problems solved by technology

Qiao Li etc. have established the method that HPLC method has measured β-elemene content, adopts Diamonsil C18 chromatographic column, acetonitrile-water (90:10) is mobile phase, and ultraviolet spectrophotometry detects sample peak [RP-HPLC method measures β-elemene The content of -elemene and related substances[J]. Chinese Modern Medicine Application, 2010,4(5):1-2.]; Wang Yanzhi et al. used Hyper sil BDSC18 chromatographic column, acetonitrile-water (88:12) as mobile Phase, UV spectrophotometry to detect sample peaks[RP-HPLC method to determine the content of β-elemene in solid lipid nanoparticles[J].Journal of Shenyang Pharmaceutical University,2005,22(4):286-288.] , but the inventors failed to achieve effective separation and detection of β-elemene and its related substances by using the methods in these two documents

Method used

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  • Method for detecting beta-elemene and related substances thereof
  • Method for detecting beta-elemene and related substances thereof
  • Method for detecting beta-elemene and related substances thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] The detection of embodiment 1 β-elemene crude drug

[0092] 1. Preparation of reference substance solution: Weigh an appropriate amount of β-elemene reference substance, dissolve it in ethanol, and prepare a liquid with a concentration of about 1 mg / ml.

[0093] 2. Preparation of the test solution: same as Comparative Example 1.

[0094] 3. Chromatographic conditions:

[0095] Column: IG (5μm, 4.6×150mm)

[0096] Mobile phase: acetonitrile: water = 55: 45

[0097] Flow rate: 0.8mL / min

[0098] Column temperature: 30°C

[0099] Injection volume: 10μL

[0100] Detection wavelength: 210nm

[0101] 4. Determination method: draw the reference substance and the test solution respectively and inject them into the liquid chromatograph, and measure according to the high performance liquid chromatography.

[0102] 5. Test results: see Table 3 and Figure 14. β-elemene and its related substances can be effectively separated, and the drug and all related substances can be ...

Embodiment 2

[0106] The detection of embodiment 2 β-elemene crude drug

[0107] 1. Preparation of the test solution: same as Comparative Example 1.

[0108] 2. Chromatographic conditions:

[0109] Column: IG (3μm, 2.1×150mm)

[0110] Mobile phase: acetonitrile: water = 55: 45

[0111] Flow rate: 0.3mL / min

[0112] Column temperature: 30°C

[0113] Injection volume: 5μL

[0114] Detection wavelength: 210nm

[0115] 3. Measuring method: draw the test solution and inject it into the liquid chromatograph, and measure it according to the high performance liquid chromatography.

[0116] 4. Test results: the results are shown in Table 4 and Figure 15 , drugs and related substances can be effectively separated, and the separation degree is greater than 1.5.

[0117] Table 4 Retention time and resolution of chromatographic peaks of β-elemene and its related substances

[0118] peak name retention time (min) Separation 1 11.223 — 2 12.4 2.6 3 13.207 1.7 ...

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Abstract

The invention provides a method for detecting beta-elemene and related substances thereof, which comprises the following steps of: performing isocratic elution by taking a polysaccharide derivative ofwhich the surface material is amylose-tris (3-chloro-5-methylphenyl carbamate) as a filler and acetonitrile water as a mobile phase. According to the method, beta-elemene can be effectively separatedfrom adjacent impurities and all the impurities, the reproducibility is good, beta-elemene and related substances thereof can be accurately detected, the problem that beta-elemene and related substances thereof are difficult to separate is effectively solved, and therefore it is guaranteed that the quality of beta elemene is controllable.

Description

technical field [0001] The invention relates to a detection method for β-elemene and its related substances, belonging to the field of pharmaceutical analytical chemistry. Background technique [0002] Elemene is the first sesquiterpene natural anticancer drug with anticancer activity extracted from the Zingiberaceae plant Ezhu in my country, among which β-elemene is the main material basis for the antitumor effect of Ezhu , is a non-cytotoxic broad-spectrum anticancer drug, which has the outstanding advantages of broad anti-tumor spectrum and mild side effects. Elemene emulsion injection with β-elemene as the main component is a second-class anti-tumor new drug independently developed in my country. It is currently clinically used for malignant serous cavity effusion, lung cancer, gastrointestinal tumors, brain tumors, etc. [0003] β-Elemene, chemical name 1-methyl-1-vinyl-2,4-diisopropenylcycloethane, contains 3 chiral carbon atoms. In the process of preparing β-elemene,...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 柯潇唐俏欣李海馨
Owner 四川弘合生物科技有限公司
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