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HPLC-ELSD characteristic chromatogram of motherwort injection and establishment method ofchromatogram

A technology of characteristic atlas and establishment method, applied in the HPLC-ELSD characteristic atlas of motherwort injection and its establishment field, can solve problems such as inability to control quality, and achieve the effect of good durability and good repeatability

Pending Publication Date: 2021-06-25
CHENGDU FIRST PHARMACEDTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the detector used in the establishment method of the HPLC characteristic map reported in this document is an ultraviolet spectrophotometer, and the HPLC characteristic map can only be used for quality control of substances with ultraviolet chromogenic groups in Leonurus injection, but cannot Effective quality control of the remaining substances in the injection without UV chromogenic groups

Method used

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  • HPLC-ELSD characteristic chromatogram of motherwort injection and establishment method ofchromatogram
  • HPLC-ELSD characteristic chromatogram of motherwort injection and establishment method ofchromatogram
  • HPLC-ELSD characteristic chromatogram of motherwort injection and establishment method ofchromatogram

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1, preparation motherwort injection

[0042]Take motherwort and add 3 times the weight of water to decoct three times, the first time is 2 hours, the second time is 1.7 hours, the third time is 1.5 hours, filter, and the filtrate is concentrated under reduced pressure to a clear liquid with a relative density of 1.36-1.38 (80°C). Let it cool, add water to dilute to a water content of 35%; then use ethanol precipitation treatment three times, add ethanol for the first time to make the alcohol content reach 78%, add ethanol for the second time to make the alcohol content reach 88%, and add ethanol for the third time to make the alcohol content reach 88%. Add ethanol to make the alcohol content reach 92%; let it stand still, take the supernatant to recover the ethanol to a thick paste (named alcohol precipitation paste).

[0043] Take alcohol sedimentation paste, add 3 to 5 times of water for injection, stir, stand still, take the supernatant and decolorize it w...

Embodiment 2

[0046] Embodiment 2, the establishment method of the HPLC-ELSD characteristic collection of motherwort injection of the present invention

[0047] In this example, a Thermo Dionex U3000 high performance liquid chromatograph and an Alltech 6000ELSD evaporative light scattering detector are used to suggest the HPLC-ELSD characteristic spectrum of Motherwort Injection. Specific steps are as follows:

[0048] (1) Preparation of the test solution: take 1 mL of motherwort injection (prepared according to the method of Example 1), put it in a 10 ml volumetric flask, add water to dissolve and dilute to the mark, shake well, and get ready.

[0049] (2) Preparation of reference substance solution:

[0050] Weigh 1mg of D-arabitol reference substance, weigh it accurately, place it in a 10mL volumetric flask, add water to dissolve and make it to volume, and then obtain the D-arabitol reference substance solution; in the D-arabitol reference substance solution, D - the concentration of a...

experiment example 1

[0062] Experimental example 1 is to the analysis of motherwort injection HPLC-ELSD characteristic collection of the present invention

[0063] 1. Experimental method

[0064] Taking 12 batches of Motherwort Injection prepared in Example 1 as test samples, according to the method of Example 2, detect the HPLC-ELSD characteristic spectrum of 12 batches of Motherwort Injection.

[0065] 2. Experimental results

[0066] The characteristic spectra of 12 batches of motherwort injection detected by the present invention all present four common characteristic peaks, which are named characteristic peak 1, characteristic peak 2, characteristic peak 3 and characteristic peak 4 in ascending order of retention time. Among them, characteristic peak 1 is an unknown peak, characteristic peak 2 is the absorption peak of D-arabitol, characteristic peak 3 is the absorption peak of fructose, and characteristic peak 4 is the absorption peak of D-mannitol.

[0067] With characteristic peak 2 (D-a...

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Abstract

The invention provides an HPLC-ELSD characteristic chromatogram of a motherwort injection and an establishment method of thechromatogram. Common characteristic peaks of the HPLC-ELSD characteristic chromatogram of the motherwort injection, which is established according to the method disclosed by the invention, comprise three or four of the following No.1 to No.4 peaks: the No.2 peak is taken as a reference peak, the relative retention time of the No.1 peak is 0.80 + / -0.05, the relative retention time of the No.2 peak is 1.00 + / -0.05, the relative retention time of the No.3 peak is 1.08 + / -0.05, and the relative retention time of the No.4 peak is 1.30 + / -0.05. The establishment method of the HPLC-ELSD characteristic chromatogram of the motherwort injection provided by the invention is high in precision, repeatability and durability, and the HPLC-ELSD characteristic chromatogram can be used for effectively controlling the quality of sugar and sugar alcohol substances without ultraviolet chromogenic groups in the motherwort injection, so that the preparation is more stable and controllable. The HPLC-ELSD characteristic chromatogram of the motherwort injection, which is established by the invention, provides a novel quality control method for the motherwort injection.

Description

technical field [0001] The invention belongs to the field of quality control of injection preparations, and in particular relates to an HPLC-ELSD characteristic map of motherwort injection and a method for establishing the same. Background technique [0002] Motherwort Injection is a commonly used clinical traditional Chinese medicine for treating obstetrics and gynecology diseases. Studies have shown that motherwort injection can reduce postpartum hemorrhage after abortion, because motherwort injection, as a uterine contraction drug, has a very strong effect of stimulating uterine smooth muscle, and it can help restore and regenerate the trauma of the endometrium in abortion patients , reduce the amount of vaginal bleeding and shorten the bleeding time; in addition, motherwort injection also has the effect of treating dysmenorrhea, and can treat menstrual migraine. [0003] The main active ingredient of Motherwort Injection is total alkaloids. According to the results of m...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74G01N30/86
CPCG01N30/02G01N30/74G01N30/8631G01N30/8679
Inventor 宋艳艳史平伍杨莲吴庆江刘昭华
Owner CHENGDU FIRST PHARMACEDTICAL CO LTD
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