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Quality control method for medicinal composition containing artemisine

A composition and technology of artemisinin, applied in the field of medicine, can solve the problems of affecting the test results, many impurities, poor stability, reproducibility and recovery rate, etc., and achieve the effect of strong controllability and simplified operation steps

Inactive Publication Date: 2010-04-21
CHENGDU WAGOTT PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above methods are mainly aimed at the detection of artemisinin. The TLC scanning method is a semi-quantitative method. Titration analysis and iodometric method are not ideal for the content control of artemisinin in the raw material of Artemisia annua. The main reason is that the raw materials contain multiple components, and after direct extraction, there are many impurities, which can easily interfere with the detection and affect the final detection results, resulting in poor stability, reproducibility and recovery; if the sample is refined, it will A lot of operation steps will be added, resulting in cumbersome operation, low recovery rate, and inconvenient quality control of medicinal materials and pharmaceutical preparations
Existing high-performance liquid chromatography uses a UV detector, and the UV terminal absorption intensity is very weak. Usually, it must undergo pre-column derivatization to produce UV absorption. This method can achieve satisfactory results for a single component, but for those containing artemisinin Due to the many influencing factors of the drug compound or crude drug, the test results after derivatization are not reproducible and stable

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  • Quality control method for medicinal composition containing artemisine
  • Quality control method for medicinal composition containing artemisine
  • Quality control method for medicinal composition containing artemisine

Examples

Experimental program
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Effect test

Embodiment 1

[0034] The HPLC collection of illustrative plates of embodiment 1 artemisinin of the present invention

[0035] 1. Detection method:

[0036] (1) Main instruments and reagents: HP1100 liquid chromatograph

[0037] Chromatographic methanol is chromatographically pure, chromatographic water is double-distilled water, and the rest are analytically pure.

[0038] (2) Instrument conditions

[0039] Detector: differential detector

[0040] Mobile phase: methanol-water (72:28)

[0041] Flow rate: 1.0ml / min

[0042] Column temperature: 30°C

[0043] Column: Kromasil KR100-5C18 250*4.6mm E17580

[0044] Injection volume: 20ul

[0045](3) Standard curve drawing: Weigh 82.43 mg of artemisinin reference substance into a 50 ml volumetric flask, dissolve in 95% methanol and make to volume. Pipette 0.5ml, 1ml, 3ml, 5ml, and 10ml of the prepared artemisinin reference solution into 10ml volumetric flasks, add 95% methanol to dilute to the mark, and inject samples to obtain the artemisi...

Embodiment 2

[0056] Embodiment 2: the HPLC collection of illustrative plates of artemisinin reference substance of the present invention

[0057] The chromatographic conditions are: detector: differential detector, mobile phase: methanol-water volume ratio of 72:28, flow rate: 1.0ml / min, chromatographic column: Kromasil KR100-5C18 250*4.6mm E17580 lower artemisinin reference substance The chromatogram, see Figure 1.

Embodiment 3

[0058] The quality control of embodiment 3 Artemisia annua of the present invention

[0059] Evenly take about 500g of Artemisia annua, crush it through a 60-mesh sieve. Precisely weigh 5.10847g of crushed medicinal material in a 250ml flat-bottomed flask, extract 3 times at 60°C, use 100ml n-hexane each time, extraction time is 2h, 1.5h, 1.5h, filter with suction, wash the residue three times with a little n-hexane , Combine the filtrate and washing liquid, concentrate the film at 55±5℃ until it is nearly dry, dissolve the concentrated residue with 95% methanol, fully dissolve it and put it into a 50ml volumetric flask, dilute to volume with 95% methanol, shake well, 0.45um Membrane filtration.

[0060] The quality control method is the same as in Example 1, and the chromatographic conditions are: detector: differential detector, mobile phase: the volume ratio of methanol-water is 72:28, flow rate: 1.0ml / min, chromatographic column: Kromasil KR100-5C18 250*4.6 The chromatog...

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Abstract

The present invention is quality control method for medicinal composition containing artemisine, and the quality control method is one HPLC method with a difference detector. The present invention also provides the corresponding medicine composition. The quality control method of the present invention adopts liquid phase column for effective separation of artemisine from other sweet wormwood components and difference detector to overcome the problem of ultraviolet end absorption of artemisine.

Description

technical field [0001] The invention relates to a quality control method of a pharmaceutical composition containing artemisinin, which belongs to the field of medicine. Background technique [0002] The detection method of artemisinin in the 2005 edition of "Chinese Pharmacopoeia" is ultraviolet spectrophotometry detection, and there are reports to detect artemisinin in Artemisia annua through pre-column derivatization, but these two methods have certain limits for the detection of raw material content. Because the raw materials contain various components, it is very easy to interfere with the ultraviolet color development and derivatization reactions, affecting the final detection results, resulting in poor stability, reproducibility and recovery. It has been reported in the literature that the detection method of artemisinin has iodometric method [1] , titration analysis [2] , TLC scanning method [3、4] , UV photometry [5] , high performance liquid chromatography [6-8]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/357A61P33/06G01N30/02G01N33/15
Inventor 张洁刘智宇张国芬
Owner CHENGDU WAGOTT PHARMA
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