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

A fingerprint and construction method technology, applied in the field of drug detection, can solve problems such as complex components, difficulty in comprehensively controlling the internal quality of hemostatic and menstruation-regulating compositions, and inability to fully characterize the material basis of prescriptions, so as to achieve good stability and controllability, and ensure The effect of clinical efficacy

Active Publication Date: 2019-05-24
湖南安邦制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 menstruation-regulating composition
  • Fingerprint construction method, quantitative detection method and quality detection method of hemostatic menstruation-regulating composition
  • Fingerprint construction method, quantitative detection method and quality detection method of hemostatic 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 with 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 me...

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, a quantitative detection method and a quality detection method of a hemostatic menstruation-regulating composition. The composition is composed of radix astragali, colla corii asini, radix codonopsis, radix paeoniae alba, Chinese angelica, herba agrimoniae, radix rubiae, fingered citron and radix dipsaci. The fingerprint construction method includes following steps: preparing the composition into a test solution, and adopting high performance liquid chromatography to detect the test solution to acquire a fingerprint of the compositionwith common feature peak. Test data are provided for quality study of the composition, a comprehensive quality evaluation method is provided for the composition, a good basis is provided for qualityinternal control and improvement of the composition, and extremely important significance in ensuring clinical effect of the composition is realized.

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 Applications(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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