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Method for determining HPLC (High Performance Liquid Chromatography) fingerprint spectrum of six-ingredient appetite-increasing paste for children

A technology of fingerprint spectrum and determination method, which is applied in the field of drug analysis of Xiaoer Liuweizengshi ointment, can solve the problems of reporting and recording the method of HPLC fingerprint spectrum, and achieves the effect of effectively controlling drug quality, strong specificity and high stability

Pending Publication Date: 2022-02-18
RONGCHANG PHARM ZIBO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Fingerprint is a quantifiable and visual detection method of traditional Chinese medicine, which can be used to identify the authenticity and evaluate the uniformity and stability of the quality of traditional Chinese medicine. HPLC fingerprint technology is widely used in the field of quality control of traditional Chinese medicine. In terms of quality control, there is no report and record of HPLC fingerprint method

Method used

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  • Method for determining HPLC (High Performance Liquid Chromatography) fingerprint spectrum of six-ingredient appetite-increasing paste for children
  • Method for determining HPLC (High Performance Liquid Chromatography) fingerprint spectrum of six-ingredient appetite-increasing paste for children
  • Method for determining HPLC (High Performance Liquid Chromatography) fingerprint spectrum of six-ingredient appetite-increasing paste for children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144] 1. Chromatographic conditions

[0145] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol is used as mobile phase A, 0.1% phosphoric acid aqueous solution is used as mobile phase B, gradient elution is carried out, and ultraviolet detection wavelength: 0 ~ 7min: 215nm; 7~78min: 330nm, flow rate: 0.8mL / min, column temperature 30°C, injection volume 10μL, the number of theoretical plates is not less than 3000 based on chlorogenic acid peak. For the determination method of the HPLC fingerprint of the above-mentioned Xiaoer Liuwei Zengshi Ointment, the specific conditions of the gradient elution are: 0~25min: A:B=5~20:95~80; 25~45min: A:B=20~25 :80~75; 45~58min: A:B=25~40:75~60; 58~65min: A:B=40~45:60~55; 65~68min: A:B=45~5:55 ~95; 68~78min: A:B=5:95.

[0146] 2. Preparation of reference substance, reference medicinal material, test sample and negative solution

[0147] Preparation of reference substance ...

Embodiment 2

[0162] 1. Chromatographic conditions

[0163] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol is used as mobile phase A, 0.1% phosphoric acid aqueous solution is used as mobile phase B, gradient elution is carried out, and ultraviolet detection wavelength: 0 ~ 7min: 215nm; 7~78min: 330nm, flow rate: 0.8mL / min, column temperature 30°C, injection volume 10μL, the number of theoretical plates is not less than 3000 based on chlorogenic acid peak. For the determination method of the HPLC fingerprint of the above Xiaoer Liuwei Zengshi Ointment, the specific conditions of the gradient elution are: 0~25min: A:B=5~20:95~80; 25~45min: A:B=20~25 :80~75; 45~58min: A:B=25~40:75~60; 58~65min: A:B=40~45:60~55; 65~68min: A:B=45~5:55 ~95; 68~78min: A:B=5:95.

[0164] 2. Preparation of reference substance, reference medicinal material, test sample and negative solution

[0165] Preparation of the reference substance soluti...

Embodiment 3

[0180] Precisely draw the need testing solution of Xiaoer Liuwei Zengshi Plaster in Example 1, after placing 0h, 2h, 6h, 10h, 22h respectively, measure by the chromatographic conditions in Example 1, take chlorogenic acid peak as reference peak (S peak), analyze the relative retention time and relative peak area of ​​the characteristic peaks, and calculate the RSD.

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Abstract

The invention belongs to the field of medicine analysis of six-ingredient appetite-increasing paste, and particularly relates to a method for determining the HPLC (High Performance Liquid Chromatography) fingerprint spectrum of six-ingredient appetite-increasing paste for children. By investigating the weighed sample amount, an extraction solvent, an extraction mode and extraction time, it is determined that a method for preparing a test solution comprises the following steps of: heating, refluxing and extracting six-ingredient appetite-increasing paste for children, filtering, and taking a subsequent filtrate, thus obtaining a test solution. A gradient elution high performance liquid chromatography method is adopted for determination to obtain a fingerprint spectrum of the six-ingredient appetite-increasing paste for children. The detection wavelength of the high performance liquid chromatography is 215nm within 0-7min and 330nm within 7-78min, and the flow velocity is 0.8 mL / min. According to the method, the fingerprint spectrum of the six-ingredient appetite-increasing paste for children is established through the high performance liquid chromatography, the fingerprint spectrum has 10 common peaks, the method is high in specificity, high in precision, good in repeatability and high in stability, the purpose of effectively controlling the medicine quality is achieved, and the stability of the product quality is ensured.

Description

technical field [0001] The invention belongs to the field of drug analysis of Xiao'er Liuwei Zengshi Ointment, in particular to a method for determining the HPLC fingerprint of Xiaoer Liuwei Zengshi Ointment. Background technique [0002] Anorexia in children refers to long-term not greedy for food, loss of appetite, and even refusal to eat. Children with anorexia are often accompanied by clinical manifestations such as pale complexion, spontaneous night sweats, nausea and vomiting, abdominal pain and bloating, irregular stool, weight loss, and pica. These children have weak constitutions, low immune function, and are prone to colds or recurrent oral ulcers. In severe cases, the symptoms of malnutrition can be seen, such as listlessness, thin neck and large abdomen, dry skin and so on. If the disease persists, it will inevitably affect the growth and nutritional status of children; and this disease has been increasing in cities in recent years. [0003] The theory of trad...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8686G01N2030/047
Inventor 苏欣王荔强姜存敏高娇孔静王爱云王丽马文静
Owner RONGCHANG PHARM ZIBO CO LTD