HPLC measurement method for content of multi-index components in rhizoma corydalis pain relieving drop pills

A technology of Yuanhu Zhitong dripping pills and its determination method, which is applied in the field of content determination of Chinese patent medicines, can solve the problems that it is difficult to fully reflect the quality of Yuanhu Zhitong dripping pills, restrict market expansion, and the internationalization of clinical applications, and achieve the reduction of testing costs and Time, accurate control, taking safe and effective effect

Inactive Publication Date: 2016-04-06
GANSU LONGSHENRONGFA PHARMACEUTICAL INDUSTRY CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current quality standard of Yuanhu Zhitong Dropping Pills is recorded in the second supplement of "Chinese Pharmacopoeia" (2010 edition), which only stipulates the TLC identification method of Angelica dahurica and Corydalis Corydalis, and HPLC of the content of tetrahydropalmatine and imperatorin The determination method is difficult to fully reflect the quality of Yuanhu Zhitong Dropping Pills, which seriously restricts the market expansion, clinical application and internationalization process of this product.

Method used

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  • HPLC measurement method for content of multi-index components in rhizoma corydalis pain relieving drop pills
  • HPLC measurement method for content of multi-index components in rhizoma corydalis pain relieving drop pills
  • HPLC measurement method for content of multi-index components in rhizoma corydalis pain relieving drop pills

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Experimental program
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preparation example Construction

[0046] 3.1 Preparation of mixed reference solution

[0047] Take an appropriate amount of reference substances of proto-opiateline, palmatine, dehydrocordate, corydaline, imperatorin, imperatorin and isoimperatorin, weigh them accurately, and add methanol solution to make each mL of A mixed solution of 20 μg of opium, 10 μg of palmatine, 80 μg of dehydrocordate, 40 μg of corydalidin, 40 μg of corydalidin, 20 μg of imperatorin, and 10 μg of isoimperatorin, and shake well to obtain the product.

[0048] 3.2 Preparation of the test solution

[0049] Take Yuanhu Zhitong Dropping Pills and grind them finely, take 1g of Yuanhu Zhitong Dropping Pills fine powder, weigh them accurately, put them in a stoppered conical flask, add 50ml of methanol solution, and weigh them; ultrasonically treat for 30min, let cool, and weigh Determine the weight, make up the lost weight with methanol solution, shake well, filter; accurately measure 25ml of the filtrate, steam to nearly dry, dissolve the...

Embodiment 1

[0090] A kind of HPLC assay method of multi-index component content in Yuanhu Zhitong dripping pill, the method comprises the following steps:

[0091] (1) Chromatographic conditions: the chromatographic column is DiamonsilC 18 Column (250mm×4.6mm, 5μm), the chromatographic column is filled with octadecylsilane bonded silica gel; detection wavelength: 280nm; mobile phase: phase A is acetonitrile, phase B is glacial acetic acid solution with a volume concentration of 0.2%, Triethylamine was used to adjust the pH of glacial acetic acid solution to 5.0; using gradient elution, the volume ratio of acetonitrile to mobile phase was: 0min, 20%; 10min, 22%; 30min, 30%; 60min, 80%; 65min, 100%; Flow rate: 1.0 mL / min; column temperature: 35°C.

[0092] (2) Preparation of mixed reference substance solution: Take appropriate amount of reference substances of protopine, patellae, dehydrotetrahydrotetrahydropalmatine, corydaline, imperatorin and isoimperatorin, and weigh them precisely. ,...

Embodiment 2

[0101] A kind of HPLC assay method of multi-index component content in Yuanhu Zhitong dripping pill, the method comprises the following steps:

[0102] (1) Chromatographic conditions: the chromatographic column is DiamonsilC 18 Column (250mm×4.6mm, 5μm), the chromatographic column is filled with octadecylsilane bonded silica gel; detection wavelength: 300nm; mobile phase: phase A is acetonitrile, phase B is glacial acetic acid solution with a volume concentration of 1.0%, Triethylamine was used to adjust the pH of glacial acetic acid solution to 5.0; using gradient elution, the volume ratio of acetonitrile to mobile phase was: 0min, 20%; 10min, 22%; 30min, 30%; 60min, 80%; 65min, 100%; Flow rate: 1.0 mL / min; column temperature: 40°C.

[0103] (2) Preparation of mixed reference substance solution: Take appropriate amount of reference substances of protopine, patellae, dehydrotetrahydrotetrahydropalmatine, corydaline, imperatorin and isoimperatorin, and weigh them precisely. ,...

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Abstract

The invention discloses an HPLC measurement method for content of multi-index components in rhizoma corydalis pain relieving drop pills. A high performance liquid chromatography (HPLC) method is adopted; a mixed contrast solution is used as a contrast, and tetrahydropalmatine is used as a reference; meanwhile, 7 main components, including protopine, palmatine, dehydro-corydaline, tetrahydropalmatine, corydaline, imperatorin and isoimperatorin, in the rhizoma corydalis pain relieving drop pills are measured simultaneously. According to the method, QAMS is realized; measurement of multiple components is realized by adopting relative correction factors among the components; the quality of the multiple components of a traditional Chinese medicine is controlled, thus realizing evaluation on quality of multiple indexes of the rhizoma corydalis pain relieving drop pills. The method is easy and convenient to operate, and quick; the detection cost and time are greatly reduced; the working efficiency and the practicability of the method are improved; the quality of traditional Chinese medicinal products can be controlled more effectively, comprehensively and accurately; stability and uniformity of the product quality are guaranteed, so that the aim of safe and effective taking of the product is fulfilled.

Description

technical field [0001] The invention belongs to the technical field of content determination of Chinese patent medicines, and in particular relates to an HPLC method for determining the content of multi-index components in Yuanhu Zhitong dripping pills. Background technique [0002] Traditional Chinese medicine and its preparations are multi-component complex systems, and it is difficult for a single component and index to accurately and comprehensively reflect the inherent quality of the drug. The quality control of traditional Chinese medicine is showing a trend from simple single-component content determination to comprehensive evaluation and content control of multiple components and multiple indicators by means of advanced technology. However, the multi-indicator quality control and evaluation model of traditional Chinese medicine requires reference substances of various components, but some of the reference substances of traditional Chinese medicine are difficult to se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 张喜民张铁军任一杰许浚邓月婷魏晋君贾继禧张政
Owner GANSU LONGSHENRONGFA PHARMACEUTICAL INDUSTRY CO LTD
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