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Method for detecting leonurine hydrochloride content in nephritis elimination tablet

A technology for the detection of motherwortine hydrochloride and its detection method, which is applied in the detection field of active ingredients of Chinese patent medicines, can solve problems such as the inability to guarantee the safety and effectiveness of motherwort compound preparations, and the lack of research on the determination method of motherwortine content, and achieves simple operation, high sensitivity, and heavy weight. good effect

Active Publication Date: 2014-02-12
天津天士力圣特制药有限公司
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AI Technical Summary

Problems solved by technology

Although "Chinese Pharmacopoeia" 2010 edition has increased the content determination standard of motherwortine hydrochloride in the quality control of motherwort medicinal materials (National Pharmacopoeia Commission. "Chinese Pharmacopoeia" 2010 edition. Part [S].2010:272.), but in In the "Chinese Pharmacopoeia" and drug standards at all levels, the quality control of motherwort-containing preparations is mostly based on stachydrine, but there are few studies on the content determination method of motherwort, which cannot guarantee the safety and effectiveness of motherwort compound preparations.

Method used

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  • Method for detecting leonurine hydrochloride content in nephritis elimination tablet
  • Method for detecting leonurine hydrochloride content in nephritis elimination tablet
  • Method for detecting leonurine hydrochloride content in nephritis elimination tablet

Examples

Experimental program
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Effect test

experiment example 1

[0016] Experimental Example 1 Study on the Methodology of Determination of Leonurine Hydrochloride in Shenyanqing Tablets

[0017] 1 Instruments and test drugs

[0018] Instrument: Agilent1200 high performance liquid chromatography. Experimental drugs: Acetonitrile is chromatographically pure (MERCK), water is dipure water; Leonuri hydrochloride reference substance (Shanghai Dingrui Chemical Co., Ltd., purity ≥ 98%); Shenyanqing Tablets are prepared by Tasly Pharmaceutical Group Co., Ltd. according to the above method pilot test samples.

[0019] 2 Methods and results

[0020] 2.1 Chromatographic conditions

[0021] Chromatographic column: Agilent SB-C18 column (4.6×250mm, 5μm); flow rate: 1.0mL / min; column temperature: 30°C; mobile phase: acetonitrile-0.4% sodium octane sulfonate in 0.1% phosphoric acid solution (volume ratio 24 : 76); the detection wavelength is 277nm.

[0022] 2.2 Preparation of reference solution

[0023] Take an appropriate amount of motherwortine h...

Embodiment 1

[0046]1. Preparation of Shenyanqing Tablets Astragalus 400g Motherwort 400g, Imperata 200g Imperata 200g Qumai 200g Small Thistle 200g Shiwei 80g Burnet Charcoal 60g Rhubarb 200g Licorice 20g. Astragalus, add 6 times the amount of water to decoct for 1 hour, filter the decoction and concentrate to a thick paste, and vacuum dry to obtain the dry paste of Astragalus extract. Add 10 times the amount of 65% ethanol to reflux for extraction of rhubarb and small thistle, concentrate the decoction to a thick paste, and dry in vacuum to obtain a dry paste of rhubarb and small thistle extract. Add 6 times the amount of water to decoct the motherwort, Imperata rhizome, Liquor, Qumai, Shiwei, Burnet charcoal, and licorice. The decoction is concentrated to a relative density of 1.1 (60°C), add 3 times the amount of ethanol, and stand for 12 hours Above, filter, and recover ethanol from the filtrate to a thick paste, and vacuum-dry to obtain a dry paste of Qiwei extract. The above three d...

Embodiment 2

[0057] The preparation of Shenyanqing tablet and the qualitative determination of the effective components of Motherwort are the same as in Example 1.

[0058] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler; acetonitrile-0.4% sodium octanesulfonate in 0.1% phosphoric acid solution (40:60) was used as mobile phase; detection wavelength was 260nm. The number of theoretical plates should not be less than 4000 based on the peak of Leonurine Hydrochloride.

[0059] Preparation of Reference Substance Solution Take an appropriate amount of Leonurine Hydrochloride reference substance, accurately weigh it, add 40% ethanol to make a solution containing 20 μg per 1 ml, and obtain it.

[0060] Preparation of the test solution Take the contents of this product under the weight difference item, grind or pulverize, mix, take 2.0g, accurately weigh, put in a stoppered conical flask, add 25ml of 50% ethanol, weigh, Sonicate for 35 m...

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Abstract

The invention discloses a method for detecting the leonurine hydrochloride content in a nephritis elimination tablet. The detection method adopts a reversed phase ion pair chromatography method to measure the leonurine hydrochloride content in a nephritis elimination tablet, wherein the chromatographic condition adopts a C18 column, the mobile phase is acetonitrile-0.1% phosphoric acid solution of 0.2-0.6% sodium 1-octanesulfonate, and the detection wavelength is 260 to 290 nm. The detection method has the advantages of convenient operation, high sensitivity, and good repeatability, and provides a reference for establishment of quality standards for the nephritis elimination tablet.

Description

technical field [0001] The invention relates to the detection of active ingredients of Chinese patent medicines, in particular to a detection method of motherwortine hydrochloride in Shenyanqing tablets. Background technique [0002] Shenyanqing Tablet is a traditional Chinese medicine compound preparation made from Motherwort, Astragalus, Imperatae Rhizoma Imperatae, Rhizoma Imperatae, Qumai, Small Ji, Shiwei, Burnet Charcoal, Rhubarb Rhubarb, and Licorice. Motherwort is a traditional Chinese medicine, and its chemical components mainly include alkaloids, diterpenoids, sterols, flavonoids, organic acids, etc. (Zhang Xian, Peng Guoping. Research progress on chemical constituents of Motherwort[J]. Natural Product Research and Development, 2003, 15(2):162-166.), in which the main alkaloids are stachydrine and leonurine. Pharmacological studies have proved that the main active ingredient in motherwort, leonurine, can inhibit the aggregation of platelets , to prevent the format...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 周桂荣鄂秀辉李晴川张兰兰周水平
Owner 天津天士力圣特制药有限公司
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