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A detection method for β-elemene and its related substances

A technology of 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: 2022-06-07
四川弘合生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • A detection method for β-elemene and its related substances
  • A detection method for β-elemene and its related substances
  • A detection method for β-elemene and its related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Example 1 β - detection of olive eleuline API

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

[0093] 2. Preparation of the test solution: the same pair ratio 1.

[0094] 3. Chromatographic conditions:

[0095] Columns: 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: 10 μL

[0100] Detection wavelength: 210nm

[0101] 4. Determination method: separately pipette control and sample solution into the liquid chromatograph, according to the high performance liquid chromatography determination.

[0102] 5. Test results: See Table 3 and Figure 14. β-elecene and related substances can be effectively separated, drugs and all related substances can be detected within 40 minutes, and the separation degree is ≥ 1.5, and the repeatability is go...

Embodiment 2

[0106]Example 2 β - detection of olive eleutherene API

[0107] 1. Preparation of the test solution: the same pair ratio 1.

[0108] 2. Chromatographic conditions:

[0109] Columns: 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: 5 μL

[0114] Detection wavelength: 210nm

[0115] 3. Determination method: aspirate the test solution into the liquid chromatograph, and determine it according to high performance liquid chromatography.

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

[0117] Table 4 Chromatographic peak retention time and resolution of β-elecene and related substances

[0118] Peak name Retention time (min) Resolution 1 11.223 — 2 12.4 2.6 3 13.207 1.7 4 17.654 7.9 5 20.477 4.3

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Abstract

The invention provides a detection method for β-elemene and related substances thereof, the method adopts a polysaccharide whose surface material is amylose-tris(3-chloro-5-methylphenylcarbamate) The chromatographic column with derivatives as packing material uses acetonitrile-water as mobile phase for isocratic elution. The method can effectively separate β-elemene from adjacent impurities and each impurity, and has good reproducibility, can accurately detect β-elemene and its related substances, and effectively solve the problem of β-elemene And the problem that the separation of related substances is difficult, thereby ensuring that the quality of β-elemene is controllable.

Description

Technical field [0001] The present invention relates to a β - eleulinene and related substance detection methods, belonging to the field of pharmaceutical analytical chemistry. Background [0002] Elecene is a natural anti-cancer drug with anti-cancer activity sesquiterpene extracted from gingeraceae plant Wencuro in China, of which β-Elecene (β-elemene) is the main material basis of the anti-tumor effect of Wencuro, which is a non-cytotoxic broad-spectrum anticancer drug, with the outstanding advantages of wide anti-tumor spectrum and mild toxic side effects. Elecene emulsion injection with β-elecene as the main component is a class II anti-tumor new drug independently developed in China, and is currently clinically used for malignant serous effusion, lung cancer, gastrointestinal tumors, brain tumors, etc. [0003] β-olive eleulene, chemically known as 1-methyl-1-vinyl-2,4-diisopropenylcycloethane, contains 3 chiral carbon atoms. In the process of preparing β-olive eleulinene, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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