Fingerprint construction method, quantitative detection method and quality detection method of hemostatic and menstruation regulating composition

A technology of fingerprint spectrum and construction method, applied in the field of drug testing, can solve the problems such as the inability to fully characterize the material basis of the prescription, and the difficulty in comprehensively controlling the intrinsic quality and complex components of the composition for hemostasis and menstruation regulation.

Active Publication Date: 2021-07-27
湖南安邦制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the composition of Zhixue Tiaojing Granules is complex, consisting of 9 traditional Chinese medicines. The test results of only two or three components cannot fully characterize the material basis of the prescription, and it is difficult to fully control the internal quality of the composition.

Method used

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  • Fingerprint construction method, quantitative detection method and quality detection method of hemostatic and menstruation regulating composition
  • Fingerprint construction method, quantitative detection method and quality detection method of hemostatic and menstruation regulating composition
  • Fingerprint construction method, quantitative detection method and quality detection method of hemostatic and menstruation regulating composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Chromatographic conditions: Thermo Acclaim TM 120 C18 column, 4.6mm×250mm, 5μm; mobile phase: A is pure water, B is acetonitrile; elution gradient: 0~5min, 5%B; 5~40min, 5%~35%B; 40~60min, 35%-95% B; detection wavelength: 254nm; column temperature: 30°C; flow rate: 1ml / min; injection volume: 10μL. Regarding the detection wavelength, the DAD full-wavelength scanning method is adopted, and a wavelength of 254nm with relatively obvious peak areas is selected. See the full-wavelength spectrum figure 1 and figure 2 .

[0069] Preparation of the test solution: Take an appropriate amount of 10 batches of hemostatic menstruation regulating granule samples (S1~S10 samples), pulverize them, take about 2.5g, weigh them accurately, add 20mL of methanol to a 25mL Erlenmeyer flask, and weigh them , after ultrasonic extraction for 30min, let it cool, make up the lost mass with methanol, shake well and let it stand, take the supernatant and pass it through a 0.22μm microporous mem...

Embodiment 2~5

[0110] The method of embodiment 2~5 is substantially the same as embodiment 1, and difference only is that when preparing need testing solution, solvent is respectively water, 30% volume percent methanol aqueous solution, 50% volume percent methanol aqueous solution and 80% volume percent methanol aqueous solution, Chromatographic results such as Figure 9 Shown, wherein A is embodiment 1, B is embodiment 5, C is embodiment 4, D is embodiment 3, E is embodiment 2.

Embodiment 6~8

[0112] The method of embodiment 6~8 is basically the same as embodiment 1, and difference only is that detection wavelength is respectively 210nm, 230nm and 270nm, and chromatographic result is as follows Figure 10 shown.

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Abstract

The invention relates to a fingerprint construction method, quantitative detection method and quality detection method of a composition for hemostasis and menstruation regulation. The composition for hemostasis and menstruation regulation consists of astragalus, donkey-hide gelatin, codonopsis, white peony root, angelica, agrimony, madder, bergamot and diphtheria Composition, the method for constructing fingerprints includes the following steps: making the hemostatic and menstruation regulating composition into a test solution, using high performance liquid chromatography to detect the test solution, and obtaining the hemostatic and menstruation regulating combination with common characteristic peaks fingerprints of objects. The quality research of the hemostatic and menstruation regulating composition of the present invention provides an experimental basis, and the hemostatic and menstruation regulating composition provides a comprehensive quality evaluation method, which provides a good basis for the internal quality control and improvement of the composition, and at the same time ensures its Clinical efficacy is of great significance.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a fingerprint construction method, quantitative detection method and quality detection method of a hemostatic and menstruation regulating composition. Background technique [0002] The hemostatic and menstrual regulating composition is composed of 9 traditional Chinese medicines such as astragalus, donkey-hide gelatin, codonopsis, white peony root, angelica, Agrimony, madder, bergamot and Dipsacus. The function of nourishing blood, stopping bleeding and regulating menstruation is used for those who have prolonged menstrual period due to the upper ring and the deficiency of Qi and blood. Pale, thready and weak pulse, specific products include Zhixue Tiaojing Granules, etc. [0003] At present, in the enterprise quality standard method of hemostasis and menstruation regulating composition, only thin-layer chromatography (TLC) is used to qualitatively identify the two components of ga...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 陈秧易小兰文迎艺屈金艳高尚
Owner 湖南安邦制药股份有限公司
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