Zishen Yutai pill fingerprint constructing method and application thereof in quality detection

A fingerprint and construction method technology, applied in the field of traditional Chinese medicine testing, can solve the problems of poor specificity, unreported, difficult to comprehensively evaluate the quality, etc., and achieve the effect of high accuracy, good repeatability, and good qualitative and quantitative detection

Active Publication Date: 2019-10-08
GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality standards of Zishen Yutai Pills are recorded in the sixteenth volume of "Drug Standards of the Ministry of Health of the People's Republic of China - Chinese Medicine Prescriptions" (WS3-B-3113-98). , no content determination items, poor specificity, it is difficult to comprehensively evaluate its quality
Based on its excellent clinical efficacy, the current research on Zishen Yutai Pills focuses on clinical and pharmacological research, and its quality research, such as content determination and fingerprint information, has not been reported

Method used

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  • Zishen Yutai pill fingerprint constructing method and application thereof in quality detection
  • Zishen Yutai pill fingerprint constructing method and application thereof in quality detection
  • Zishen Yutai pill fingerprint constructing method and application thereof in quality detection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1. Establishing the fingerprint of Zishen Yutai Pills with Dangyaoside as the reference substance

[0041] 1.1 Preparation of the test substance and reference substance solution

[0042] Preparation of the reference substance solution: Accurately weigh an appropriate amount of the glycoside reference substance, add methanol to dissolve and constant volume, and obtain a mass concentration of 0.1g L -1 of the reference solution.

[0043] Preparation of the test solution: Accurately weigh about 1.5g of Zishen Yutai pill powder (80 mesh, the same below), accurately weigh it, put it in a stoppered Erlenmeyer flask, accurately add 25mL of methanol, seal it tightly, and weigh it , sonicate (power 250W, frequency 40kHz) for 30min, let cool, weigh, make up for the weight loss with methanol, shake well, pass through a 0.22μm microporous membrane, and take the subsequent filtrate to obtain the test solution.

[0044] 1.2 Chromatographic conditions:

[0045] Using column...

Embodiment 2

[0062] Embodiment 2, using the fingerprint spectrum constructed in embodiment 1 to carry out quality inspection on Zishen Yutai Pills

[0063] 2.1 Preparation of the test substance and reference substance solution

[0064] Preparation of the reference substance solution: Accurately weigh an appropriate amount of chlorogenic acid, loganin, glucoside, loganinic acid, and Dipsacus saponin VI reference substance, add methanol to dissolve and constant volume, and obtain a mass concentration of 0.0204, 0.0121, 0.0332, 0.0532, 0.158mg·mL -1 The mixed reference substance solution, set aside. The type of reference product in this embodiment is selected with reference to the fingerprint of Zishen Yutai Pills constructed in Example 1 for quality inspection, mainly to select the chemical components that have been marked according to the retention time of the chromatographic peak of the reference product.

[0065] Preparation of the test solution: Accurately weigh about 1.0 g of Zishen...

Embodiment 3

[0096] Example 3. Using loganin as a reference substance to construct a fingerprint and to perform quality inspection on Zishen Yutai Pills

[0097] 3.1 Construction of fingerprints: The steps of constructing fingerprints in this embodiment are the same as in Example 1, except that loganin is used as a reference substance in this embodiment to construct fingerprints.

[0098] 3.2 Perform quality inspection: take the fingerprint spectrum constructed in item 3.1 of this example as a reference spectrum, and carry out quality inspection on Zishen Yutai Pills. The steps of quality inspection are the same as those in Example 2.

[0099] The construction result of fingerprint spectrum of this embodiment is the same as embodiment 1, see figure 1 and figure 2 . In this example, the Zishen Yutai Pill with batch number S00031 was tested for quality, and the results are the same as in Table 4. In the process of implementing the technical solution, the inventor also optimized the tec...

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Abstract

The invention provides a Zishen Yutai pill fingerprint constructing method and application thereof in quality detection. The constructing method comprises steps: any kind selected from chlorogenic acid, loganin, sweroside, loganic acid and asperosaponin VI is selected as a reference substance and is dissolved by using an organic solvent, and a reference substance solution is prepared; multiple batches of Zishen Yutai pills are selected and are dissolved by using the organic solvent respectively, and a test sample solution is prepared; high performance liquid chromatography is adopted to test the reference substance solution and the test sample solution for the multiple batches of Zishen Yutai pills, and a reference substance chromatogram peak and the test sample chromatogram peaks for themultiple batches of Zishen Yutai pills are obtained; and with reference to the reference substance chromatogram peak, the multiple test sample chromatogram peaks are subjected to similarity analysis,and a Zishen Yutai pill fingerprint is obtained. The fingerprint is used as the reference fingerprint for quality detection on the Zishen Yutai pill, the overall quality of the Zishen Yutai pill can be comprehensively evaluated, the repeatability and the stability are good, and the accuracy is high. The method can be used to examine production stability and batch-to-batch consistency.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine testing, in particular to a method for constructing a fingerprint of Zishen Yutai Pills and its application in quality testing. Background technique [0002] Zishen Yutai Pill is a Chinese patent medicine developed by Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd. based on the clinical experience of Professor Luo Yuankai, a famous expert in traditional Chinese medicine and gynecology in the early 1960s. Consists of 15 traditional Chinese medicines such as parasitic, donkey-hide gelatin (stir-fried), Shouwu, mugwort leaves, Morinda officinalis, Atractylodes macrocephala, Codonopsis antlers, Dipsacus, Eucommia, etc. It has the functions of nourishing kidney and spleen, nourishing qi and nourishing yuan, nourishing blood and anti-abortion, and strengthening the body The effect. Clinically, it is mainly used to prevent and treat habitual abortion and threatened abortion an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02Y02A50/30
Inventor 徐毅敏陈纹平刘晓谦马蕙文尹震王智民李春
Owner GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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