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HPLC fingerprint spectrum and multi-index quantitative establishment method of gynecological blood-nourishing menstruation-regulating pill

A technology of gynecological reconstituted pills and fingerprints, which is applied in the establishment of HPLC fingerprints and multi-indicator quantification. It can solve the problems of high requirements for chromatographic columns, expensive detection equipment, and few common peaks, etc., and achieve good repeatability.

Inactive Publication Date: 2020-08-14
贵州德昌祥医药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the Chinese patent (application number: 201711083060.4) discloses a detection method for Fuke Zaizao Pills, which uses HPLC to establish the determination method for the content of paeonin, baicalin and salvianolic acid B in the product, and uses different chromatographic conditions for the determination of 3 components are tested, there are 3 components to be tested separately, the sample processing is cumbersome, and the detection cycle is long; the detection indicators are few, which cannot fully reflect the quality of Fukezaizao Pills
Chinese patent (application number: 201610304060.1) discloses a method for establishing the UPLC fingerprint of Fuke Zaizao Pills. It uses UPLC to establish the fingerprint of Fuke Zaizao Pills and determines 15 common peaks. However, it does not identify the common peaks. Composition, and quantitative analysis of index components, there are expensive testing equipment, less common peaks, no quantitative analysis of index components, which cannot fully reflect the quality of Fukezaizao Pills
Xu Jian and others established the UPLC fingerprint of Fuke Zaizao Pills, marked 15 common peaks, and determined the content of the index components hesperidin and baicalin. Feedback on the quality of Fuke Zaizao Pills, and ultra-high performance liquid chromatography (UPLC) is expensive and has high requirements for chromatographic columns. It is not yet common in Chinese pharmaceutical companies, and it is not yet the main method for quality control of traditional Chinese medicine.

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  • HPLC fingerprint spectrum and multi-index quantitative establishment method of gynecological blood-nourishing menstruation-regulating pill
  • HPLC fingerprint spectrum and multi-index quantitative establishment method of gynecological blood-nourishing menstruation-regulating pill
  • HPLC fingerprint spectrum and multi-index quantitative establishment method of gynecological blood-nourishing menstruation-regulating pill

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Embodiment Construction

[0117] The present invention will be further described below in conjunction with the accompanying drawings and embodiments, but it is not used as a basis for limiting the present invention.

[0118] Example. A method for establishing the HPLC fingerprint and multi-index quantification of Fuke Zaizao Pills, comprising the following steps:

[0119] (1) The preparation linear relationship of the reference substance solution:

[0120] Accurately weigh the appropriate amount of each reference substance, place them in 5ml volumetric flasks, add methanol to dissolve, and dilute to the mark, shake well, and prepare gallic acid 1.10-1.40mg / mL, chlorogenic acid 0.30-0.55mg / mL, dragon Chopicrin 0.45-0.60mg / mL, Hesperidin 0.45-0.65mg / mL, Baicalin 1.00-1.25mg / mL, Salvianolic acid B0.95-1.25mg / mL, Wogonin 0.25-0.50mg / mL , baicalein 0.65-0.85mg / mL, wogonin 0.40-0.65mg / mL, ligustilide A2.50-4.50mg / mL and Z-ligustilide 1.85-2.10mg / mL reference solution, instant;

[0121] Precisely draw an ...

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Abstract

The invention discloses an HPLC fingerprint spectrum and multi-index quantitative establishing method of a gynecological blood-nourishing menstruation-regulating pill. According to the method, an HPLC fingerprint of the whole formula is established, 35 characteristic chromatographic peaks with good separation degree are calibrated in one chromatogram, 15 components are pointed out, and a multi-index quantitative method for 11 target components is established. According to the method, the types and the quantities of the main components in products with different batch numbers from different manufacturers can be quickly and accurately identified; quantitative analysis is carried out on multi-index components, so that authenticity and quality of product are identified; and the method provided by the invention has the advantages of simplicity, high efficiency, high accuracy, high reliability and good repeatability, and can be used for quality control of gynecological blood-nourishing menstruation-regulating pill of enterprises and identification of advantages and disadvantages of products of different manufacturers.

Description

technical field [0001] The invention relates to a method for establishing an HPLC fingerprint and multi-index quantification, in particular to a method for establishing an HPLC fingerprint and multi-index quantification for Fuke Zaizao Pills. Background technique [0002] Fuke Zaizao Pill is derived from the experience of Mr. Wang Pinxian (1895~1964), the first of the four famous doctors in Guizhou, and contains Codonopsis pilosula, Radix Paeoniae Alba, Rhizoma Cyperi (stir-fried with vinegar), Radix Astragali, Rehmannia glutinosa, Poria cocos, Angelica (dried with wine), etc. 42 flavors of traditional Chinese medicine, which have the effects of nourishing the liver and kidney, nourishing blood and regulating menstruation, warming the palace and relieving pain. It is used for gynecological diseases such as irregular menstruation, prolonged menstruation, dysmenorrhea, leukorrhea, etc. It has been clinically used for more than 80 years and has a definite curative effect. The ...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/86G01N2030/047
Inventor 张仕林周雪葛发欢王雪莉王迅尚秘吴劲勇葛秋平
Owner 贵州德昌祥医药股份有限公司