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Quality control method of Yixuean granules

A quality control method, the technology of Yixuan, is applied in the field of quality control of Yixuan granules, which can solve the problems of limited qualitative measurement and lack of identification of Motherwort

Active Publication Date: 2016-10-12
广西万寿堂药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The current quality standards for Yixuean Granules include the TLC identification of Diangui Ainaxiang, Corydalis Corydalis and Licorice Root, and the determination of the content of protocatechuic acid by high performance liquid chromatography, but this method lacks the identification of Motherwort , the determination of licorice is also limited to qualitative measurement

Method used

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  • Quality control method of Yixuean granules
  • Quality control method of Yixuean granules
  • Quality control method of Yixuean granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Embodiment 1 fingerprint spectrum: the optimization of chromatographic conditions

[0079] Preparation method of Yixuan granule extract: Weigh 5g of Yixuan granules, add 50mL of water to dissolve, add 0.3mL of dilute hydrochloric acid, stir well, let stand for 20min, filter, add water and extract with n-butanol for 5 times, 15mL each time , separate the n-butanol extracts, combine them, let stand for 1 hour, separate to obtain the n-butanol solution, recover the n-butanol, add 5 mL of methanol to the residue, centrifuge, and take the supernatant to obtain the Yixuean granule extract.

[0080] 1-1 Selection of chromatographic column

[0081] The other determination conditions of high performance liquid chromatography are the same. Welchrom C18 column (4.6mm×250mm, 5μm), Hypersil C18 column (4.6mm×250mm, 5μm) and Phenomenex Gemini C18 column (4.6mm×250mm, 5μm) three column, the resulting chromatograms are divided into figure 1 , figure 2 , image 3 shown by image 3...

Embodiment 2

[0090] Embodiment 2 Fingerprint: the optimization of sample pretreatment method

[0091] Chromatographic conditions of high-performance liquid chromatography: the chromatographic column adopts Phenomenex Gemini C18 column (4.6mm × 250mm, 5 μm); the guard column adopts Phenomenex C18 (4 × 3.0mm); mobile phase: methanol-0.1% glacial acetic acid; gradient elution Procedure: Time Gradient

[0092] 0min→11min→16min→29min→30min→35min→45min→55min→70min→95min; the corresponding gradient elution solution is composed of mobile phase A methanol and mobile phase B 0.1% glacial acetic acid according to the following volume ratio, mobile phase A Volume percentage gradient 5%→16%→17%→30%→34%→34%→35%→45%→45%→70%, mobile phase B volume percentage gradient 95%→84%→83%→70 %→66%→66%→65%→55%→55%→30%;; detection wavelength: 256nm; flow rate: 1.0mL·min-1; column temperature: 25°C; injection volume: 5μL.

[0093] 2-1 Selection of extraction solvent

[0094] Weigh 5g of Yixuan granules, select wate...

Embodiment 3

[0101] The quality detection of embodiment 3 Yixuan granules

[0102] 3-1 Preparation of reference substance solution: Weigh 0.81mg of protocatechuic acid standard substance and place it in a 10mL volumetric flask, add an appropriate amount of methanol to dissolve it and set the volume to the mark, shake well, and obtain a solution with a concentration of 0.081mg·mL-1 Protocatechuic acid standard solution

[0103] 3-2 Preparation of Yixuean Granules Extract: Weigh 5g of Yixuean Granules, add 50mL of water to dissolve, add 0.3mL of dilute hydrochloric acid, stir well, let stand for 20min, filter, add water-saturated n-butanol to extract 5 times, each Separate 15 mL of n-butanol extract, combine, stand still for 1 hour, separate to obtain n-butanol liquid, recover n-butanol, add 5 mL of methanol to the residue, centrifuge, take supernatant to obtain Yixuean granule extract.

[0104] 3-3 Chromatographic conditions of high performance liquid chromatography:

[0105] Chromatograp...

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Abstract

The invention discloses a quality control method of Yixuean granules. With protocatechuic acid serving as a reference substance, high performance liquid chromatography is adopted for carrying out gradient elution, and a fingerprint spectrum of a common pattern of the Zhuang medicine Blumea riparia material is obtained. The fingerprint spectrum has 21 chromatographic peaks in total and is capable of fully reflecting the chemical components of Yixuean granules and large in information amount, and the method is high in precision, repeatability and stability and has great significance on quality control over Yixuean granules and the clinical effect of Yixuean granules.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a quality control method for Yixuan granules. Background technique [0002] Yixue'an Granules is a Chinese patent medicine for treating gynecological anemia. Clinically, it is used for persistent postpartum lochia, unclean uterine bleeding after artificial abortion, and blood stasis syndrome in TCM. [0003] In order to ensure the quality of Yixuan Granules and the safety and effectiveness of clinical medication, the research and establishment of its quality standards are increasingly important. The current quality standards for Yixuean Granules include the TLC identification of Diangui Ainaxiang, Corydalis Corydalis and Licorice Root, and the determination of the content of protocatechuic acid by high performance liquid chromatography, but this method lacks the identification of Motherwort , The determination of licorice is also limited to qualitative measurements. Contents of ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 慕丽群李修善毛金玲农常东
Owner 广西万寿堂药业有限公司
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