Content determination method for radix ophiopogonis total saponins in Yixinshu preparation

The technology of total saponins of Ophiopogon japonicus and Yixinshu preparation is applied in the field of content determination of total saponins of Ophiopogon japonicus in Yixinshu preparation, and can solve the problems such as no relevant patents and literature reports.

Inactive Publication Date: 2019-02-01
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Abstract
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Problems solved by technology

[0003] Yixinshu traditional Chinese medicine preparation contains ginseng, Ophiopogon japonicus, etc., wherein saponins are the main active ingredients of the traditional Chinese medicine preparation. At present, the determination of the content of total ginsenosides in Yixinshu capsules by HPLC is relatively mature in the prior art, but for There are no related patents and literature reports on the HPLC method for the determination of total saponins of Ophiopogon japonicus. In order to further improve the quality inspection standards of Yixinshu traditional Chinese medicine preparations to ensure the quality of its drugs, and to reduce the number of separate determinations of different total saponins of Ophiopogon japonicus If the content of multiple components can be determined at one time, it will not only save time and cost, but also make the test results under the same system conditions more stable and reliable. Method for content of Ophiopogon japonicus total saponins in Shu preparations

Method used

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  • Content determination method for radix ophiopogonis total saponins in Yixinshu preparation
  • Content determination method for radix ophiopogonis total saponins in Yixinshu preparation
  • Content determination method for radix ophiopogonis total saponins in Yixinshu preparation

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Embodiment 1

[0079] Embodiment 1 of the present invention: a method for determining the content of Ophiopogon japonicus total saponins in Yixinshu preparations, the steps are as follows:

[0080](1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol is used as mobile phase A, 0.02% phosphoric acid aqueous solution is used as mobile phase B, gradient elution, elution condition: 0 ~5min: A:B=25:75; 5~35min: A:B=25~35:75~65; 35~70min: A:B=35~50:65~50; 70~80min: A:B =50~25: 50~75; 80~110min: A: B=25: 75; Detection wavelength is 397nm, and flow rate is 0.8mL / min, and column temperature is 25 ℃, and number of theoretical plates is expressed as ruscogenin (C 27 h 42 0 4 ) peak calculation is not less than 3000;

[0081] (2) Preparation of reference substance solution: get ruscogenin (C 27 h 42 0 4 ) appropriate amount of reference substance, accurately weighed, add methanol respectively to make a solution containing 50ug per...

Embodiment 2

[0084] Embodiment 2 of the present invention: a method for determining the content of Ophiopogon japonicus total saponins in Yixinshu preparation, the steps are as follows:

[0085] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol is used as mobile phase A, 0.2% phosphoric acid aqueous solution is used as mobile phase B, gradient elution, elution condition: 0 ~5min: A:B=25:75; 5~35min: A:B=25~35:75~65; 35~70min: A:B=35~50:65~50; 70~80min: A:B =50~25: 50~75; 80~110min: A: B=25: 75; The detection wavelength is 397nm, the flow velocity is 0.9mL / min, the column temperature is 30 ℃, and the number of theoretical plates is expressed as ruscogenin (C 27 h 42 0 4 ) peak calculation is not less than 3000;

[0086] (2) Preparation of reference substance solution: get ruscogenin (C 27 h 42 0 4 ) appropriate amount of reference substance, accurately weighed, add methanol respectively to make a solution containi...

Embodiment 3

[0089] Embodiment 3 of the present invention: a method for determining the content of Yixinshu preparation Ophiopogon japonicus total saponins, the steps are as follows:

[0090] (1) Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; use methanol as mobile phase A, 1% phosphoric acid aqueous solution as mobile phase B, gradient elution, elution condition: 0 ~5min: A:B=25:75; 5~35min: A:B=25~35:75~65; 35~70min: A:B=35~50:65~50; 70~80min: A:B =50~25:50~75; 80~110min: A:B=25:75; the detection wavelength is 203nm, the flow rate is 1.0mL / min, the column temperature is 35°C, the number of theoretical plates is not low based on the peak of ginsenoside Re at 3000;

[0091] (2) Preparation of reference substance solution: get ruscogenin (C 27 h 42 0 4 ) amount of reference substance, accurately weighed, add methanol respectively to make every 1mL containing ruscogenin (C 27 h 42 0 4 ) 50ug of the solution, to obtain;

[0092...

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Abstract

The invention relates to a content determination method for radix ophiopogonis total saponins in Yixinshu traditional Chinese medicine preparation. The content determination method comprises the stepsthat high performance liquid chromatography is adopted to determine, the radix ophiopogonis total saponins contrasts with ruscogenin (C27H4204) as a reference substance, methyl alcohol is taken as mobile phase A, and 0.02% to 2% phosphoric acid aqueous solution is taken as mobile phase B gradient elute to determine by adopting the high performance liquid chromatography. The content determinationmethod has high specificity, high accuracy, good repeatability, high recovery, high stability and accurate measuring results, the aim that the drug quality is effectively controlled is achieved, and the stability of the product quality and the safety and effectivity of clinical medication are guaranteed.

Description

technical field [0001] The invention relates to a content determination method of Ophiopogon japonicus total saponins in Yixinshu preparations, belonging to the technical field of traditional Chinese medicine detection. Background technique [0002] Yixinshu traditional Chinese medicine preparation is composed of ginseng, astragalus, salvia miltiorrhiza, Ophiopogon japonicus, Schisandra chinensis, Chuanxiong, hawthorn and other seven herbs. It is widely used clinically to treat angina pectoris, myocardial ischemia, various types of arrhythmia, atrial premature beats, chest pain and angina pectoris of coronary heart disease. [0003] Yixinshu traditional Chinese medicine preparation contains ginseng, Ophiopogon japonicus, etc., wherein saponins are the main active ingredients of the traditional Chinese medicine preparation. At present, the determination of the content of total ginsenosides in Yixinshu capsules by HPLC is relatively mature in the prior art, but for There are ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 安怀略
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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