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Fingerprint spectrum detection method of Yiya spleen-tonifying gel

A technology of fingerprints and determination methods, which is applied in the field of HPLC fingerprint detection of Yiya Jianpi Gel, can solve the problem of low content, inability to guarantee the effectiveness of clinical use, safety and quality controllability, and inability to completely Reflecting problems such as the detection method of Yiya Jianpi Gel, achieving high accuracy

Active Publication Date: 2021-06-11
YABAO PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the characteristics of the medicinal taste, process and auxiliary materials of this product, the medicinal flavor contained in the existing pharmacopoeia may not be tested in the finished product, or the content is too low to be included in the standard, and other active ingredients are not clear, so the standard stipulates the properties , identification, and routine item inspection according to the general rules of preparations, but the content determination only stipulates the detection of allantoin in yam (stir-fried), and there is no determination of other flavors, and there is no method that can fully reflect the overall quality of Yiya Jianpi Gel The detection method cannot guarantee the effectiveness, safety and quality controllability of clinical use

Method used

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  • Fingerprint spectrum detection method of Yiya spleen-tonifying gel
  • Fingerprint spectrum detection method of Yiya spleen-tonifying gel
  • Fingerprint spectrum detection method of Yiya spleen-tonifying gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Embodiment 1 Fingerprint is established

[0060] 1.1 Instrument

[0061] LC-20AT Shimadzu high performance liquid chromatography, Agilent1200 high performance liquid chromatography, Agilent1260 high performance liquid chromatography, JY20002 electronic balance (one percent, Shanghai Sunny Hengping Scientific Instrument Co., Ltd.), JY2003 electronic balance (thousand points One, Shanghai Sunny Hengping Scientific Instrument Co., Ltd.), MSA125P-CE electronic balance (1 / 100,000, sartorius), ultrasonic cleaner (KQ-500DE, Kunshan Ultrasonic Instrument Co., Ltd.), double-row four-hole water bath (DK-98-П, Tianjin Test Instrument Co., Ltd.), chromatographic columns: Waters XBridge C18 (4.6×250mm, 5μm), Waters Atiantis T3 (250*4.6mm, 5μm), Agilent ZORBAX C18 (4.6×250mm, 5μm), Inertsil ODS-3 (250*4.6mm, 5μm), Unitary C18 (250*4.6mm, 5μm), Thermo ODS-2HYPERSIL (250*4.6mm, 5μm), Thermo Syncronis HILIC (250*4.6mm, 5μm) , Phenomenex Gemini C18 (250*4.6mm, 5μm).

[0062] 1.2 Reage...

Embodiment 2

[0074] Embodiment 2 The preparation investigation of need testing product

[0075] The preparation of the reference solution is the same as in Example 1.

[0076] Investigate the solvent of the test product, mainly investigate methanol, ethanol, ethyl acetate, ethyl acetate methanol mixed reagent (4:1, 6:1, 8:1, 10:1).

[0077] Preparation of the test solution: take about 50g of this product, weigh it accurately, heat it in a water bath until it melts, add 200ml of the corresponding solvent while it is hot, shake it well, cool to room temperature, filter, evaporate the filtrate to dryness, add 65% methanol to the residue Dissolve, transfer to a 5ml measuring bottle, add 65% methanol to the mark, shake well, filter, and obtain.

[0078] Chromatographic conditions: Octadecylsilane bonded silica gel as filler (chromatographic column: Phenomenex Gemini-C18, 250mm×4.6mm, 5μm); flow rate 0.8ml / min, acetonitrile as mobile phase A, 0.2% phosphoric acid solution The mobile phase is B...

Embodiment 3

[0084] The best chromatographic conditions of embodiment 3 are investigated

[0085] Apparatus and reagents are the same as in Example 1.

[0086] 3.1 Selection of detection wavelength

[0087] The preparation of reference substance solution, the preparation of need testing solution are with embodiment 1.

[0088] Chromatographic conditions: Octadecylsilane bonded silica gel as filler (chromatographic column: Phenomenex Gemini-C18, 250mm×4.6mm, 5μm); flow rate 0.8ml / min, acetonitrile as mobile phase A, 0.2% phosphoric acid solution The mobile phase is B, and the gradient elution is carried out according to the gradient elution program in Table 3, and the column temperature is 30°C.

[0089] Table 3 Mobile phase gradient elution conditions

[0090]

[0091] Accurately draw 10 μl each of the reference substance solution and the test solution, inject it into a high-performance liquid chromatograph for detection, and obtain image 3 .

[0092] Collect full-band chromatogra...

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Abstract

The invention provides a high performance liquid chromatography fingerprint spectrum determination method and a fingerprint spectrum establishment method of a Yiya spleen-tonifying gel. The quality of the Yiya spleen-tonifying gel can be described and reflected on the whole through the fingerprint spectrum, and the overall quality of a medicine can be effectively controlled. According to the fingerprint spectrum of the Yiya spleen-tonifying gel, allantoin at the second peak serves as a control peak, 18 common peaks are shown in total, and the relative retention time of each peak is given. The control fingerprint spectrum established by the invention is beneficial to comprehensively monitoring the quality of the medicine and ensuring the stability, the consistency and the controllability of the quality of the medicine, so that the safety and the effectiveness of the medicine are ensured.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to the detection of high-efficiency liquid phase fingerprints of coix bud invigorating spleen gel. Background technique [0002] Yiya Jianpi Gel is an exclusive product of Yabao Pharmaceutical Guiyang Pharmaceutical Co., Ltd. The current standard is the National Drug Standard (Revised) Promulgation (2019), standard number WS-5946(B-0946)-2014Z-2019. Coix sprouts invigorating the spleen gel is a traditional Chinese medicine preparation prepared by extracting seven flavors of yam (stir-fried), coix seed, jujube, white lentils (stir-fried), hawthorn (burnt), malt (stir-fried), and radish seeds (stir-fried). The effect of invigorating the spleen and stomach, dispelling dampness and eliminating stagnation, is used for children with anorexia, sallow complexion, weight loss, fatigue, anorexia, abdominal distension, diarrhea and loose stools, etc., and the clinical effect is remarkable. The s...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/8686
Inventor 袁晨琳杨芮平周海燕
Owner YABAO PHARMA GRP CO LTD
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