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Method for simultaneously determining contents of two active ingredients in Salvia miltiorrhiza-pseudo-ginseng preparation

A preparation, the technology of notoginseng, applied in the field of medicine, can solve the problems of effective quality control, time-consuming, and inability to realize prescriptions, and achieve the effect of fast method and improved work efficiency

Inactive Publication Date: 2018-11-30
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality control of Danqi preparations in the prior art only controls the components of notoginseng saponins. For example, Danqi Tablets (Chinese Pharmacopoeia 2015 Edition Part One, page 676) only controls notoginsenoside R1, ginsenoside Rg1 and ginsenoside Re These methods are all one-sided to a certain extent, and cannot effectively control the overall quality of the prescription; there are also methods that control danshensu and notoginsenoside R1, ginsenoside Rg1 and ginsenoside Re, but due to the combination of danshensu and three The chemical structure of heptasaponins is quite different, and the detection wavelengths of the two substances are quite different when they are detected by chromatography, and they cannot be detected at the same wavelength. page), the two types of substances need to be detected by two different chromatographic methods, and the quality control steps are cumbersome and time-consuming

Method used

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  • Method for simultaneously determining contents of two active ingredients in Salvia miltiorrhiza-pseudo-ginseng preparation
  • Method for simultaneously determining contents of two active ingredients in Salvia miltiorrhiza-pseudo-ginseng preparation
  • Method for simultaneously determining contents of two active ingredients in Salvia miltiorrhiza-pseudo-ginseng preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Detection of the content of two types of four active ingredients in Danqi Soft Capsules

[0024] (1) Instrument

[0025] Ultra-high performance liquid chromatography (UPLC, Waters, USA); series API 5500 triple quadrupole mass spectrometer (Applied Biosystems, USA), equipped with Waters UPLC autosampler, column thermostat, and data acquisition was completed by Analyst software.

[0026] (2) Instrument operating conditions

[0027] Liquid chromatography conditions: Waters ACQUITY UPLC BEH C18 column (2.1mm×50mm, 1.7μm); injection volume is 1μL; flow rate is 0.4mL / min; column temperature is 30°C; mobile phase A has a volume ratio of 0.1: 99.9 mixed solution of formic acid and water, mobile phase B is a mixed solution of formic acid and acetonitrile with a volume ratio of 0.1:99.9; carry out gradient elution, the gradient conditions are:

[0028]

[0029] Mass spectrometry conditions: ion source is Turbo V; ionization mode is ESI - The air curtain gas volum...

Embodiment 2

[0045] Example 2 Determination of Dissolution Rates of Two Kinds of Four Active Components of Danqi Soft Capsules

[0046] (1) Conditions and determination of dissolution rate

[0047] Measure 900ml of degassed dissolution medium (1% SDS aqueous solution), heat the medium temperature up to (37±0.5)°C, take 6 Danqi soft capsules, 6 Danqi tablets and 6 Danqi tablets Seven capsules, 1 capsule in each basket, 6 repetitions of each preparation, test at 100r / min, 2mL samples were taken at fixed points at 1, 5, 10, 20, 30, 45, 60, 70, 90min, At the same time, add the same medium at the same temperature and the same amount, add methanol to the sample to 4mL, shake well to pass through a 0.22μm PTFE filter membrane, take the subsequent filtrate, inject 1μL by UPLC-TQ MS method, measure the content of the target compound, and calculate the target compound cumulative dissolution rate. Taking time as the abscissa and the cumulative dissolution rate as the ordinate, the dissolution curve...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a method for simultaneously determining contents of two active ingredients in a Salvia miltiorrhiza-pseudo-ginseng preparation. The method uses UPLC-TQ MS to simultaneously determine the four active components of Danshensu, Salvianolic acid A, Notoginsenoside Re and Notoginsenoside R1 in the Salvia miltiorrhiza-pseudo-ginseng preparation. The method is proved to be fast, stable and reliable, and can provide an important basis for the quality evaluation of the Salvia miltiorrhiza-pseudo-ginseng preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for simultaneously measuring the contents of two types of active ingredients in Danqi preparations. Background technique [0002] The whole prescription of Danqi Preparation is composed of Danshen and Panax notoginseng. It has the functions of dispelling blood stasis and hemostasis, reducing swelling and relieving pain; the combined use of the two medicines has the effect of promoting blood circulation, dissipating blood stasis, reducing swelling and relieving pain. Clinically, it is mostly used for diseases caused by congestion, such as: chest obstruction and heartache, congestion headache, bruises, irregular menstruation, lower abdominal pain caused by postpartum stasis, traumatic hematoma, dysmenorrhea, lochia, coronary heart disease, angina pectoris, high blood pressure etc. In addition to the earliest Danqi tablets, the types of Danqi preparations als...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 林德良杨健
Owner BEIJING RED SUN PHARMA
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