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Method for establishing infantile stagnation-removing and cough-relieving oral solution-HPLC (High Performance Liquid Chromatography) fingerprint spectrum and infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum

A technology for eliminating accumulation and relieving cough and fingerprinting in children, which is applied in measurement devices, instruments, scientific instruments, etc., to achieve high stability, quality assurance, and good reproducibility.

Active Publication Date: 2014-07-30
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the quality of Xiaoer Xiaoji Zhike Oral Liquid is controlled by fingerprints, and there are no patent publications and literature reports at home and abroad.

Method used

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  • Method for establishing infantile stagnation-removing and cough-relieving oral solution-HPLC (High Performance Liquid Chromatography) fingerprint spectrum and infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum
  • Method for establishing infantile stagnation-removing and cough-relieving oral solution-HPLC (High Performance Liquid Chromatography) fingerprint spectrum and infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum
  • Method for establishing infantile stagnation-removing and cough-relieving oral solution-HPLC (High Performance Liquid Chromatography) fingerprint spectrum and infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Establishment of HPLC Standard Fingerprint of Xiaoer Xiaoji Zhike Oral Liquid

[0020] 1 Instruments and reagents

[0021] 1.1 Instrument

[0022] Agilent1100 high performance liquid chromatography (USA); DAD detector, quaternary low pressure gradient pump, Agilent1100 chromatographic workstation.

[0023] 1.2 Reagent

[0024] Xiaoer Xiaoji Zhike Oral Liquid was provided by Lunan Houpu Pharmaceutical Co., Ltd. (see Table 1); acetonitrile was chromatographically pure, water was double distilled water, and the rest of the reagents were analytically pure.

[0025] Table 1 Batch No. of Test Samples of Xiaoer Xiaoji Zhike Oral Liquid

[0026]

[0027] 2 Methods and results

[0028] 2.1 Chromatographic conditions: Chromatographic column: Tianjin Turner Kromasil C 18 (4.6x250mm, 5μm) column; mobile phase: acetonitrile is used as mobile phase A, and 0.1% phosphoric acid aqueous solution is used as mobile phase B, and the gradient elution is carried out as foll...

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Abstract

The invention discloses a method for establishing an infantile stagnation-removing and cough-relieving oral solution-HPLC (High Performance Liquid Chromatography) fingerprint spectrum. The method comprises the following steps: preparing a tested product solution; determining an HPLC chromatographic condition; making an HPLC standard fingerprint spectrum. The invention also discloses the standard infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum obtained by adopting the method. The standard infantile stagnation-removing and cough-relieving oral solution-HPLC fingerprint spectrum has 19 common peaks, the relative retention times tR of the 19 common peaks are sequentially as follows: 0.066, 0.077, 0.088, 0.124, 0.157, 0.166, 0.192, 0.220, 0.229, 0.275, 0.481, 0.837, 0.872, 0.890, 0.962, 1.000, 1.026, 1.061 and 1.203. The method disclosed by the invention has the advantages of easiness and convenience for operation, high stability and good repeatability; the obtained spectrum has the multiple characteristic peaks, can be used for comprehensively evaluating the quality of an infantile stagnation-removing cough-relieving oral solution through the comparison of the common peaks of the standard fingerprint spectrum, is favorable to stabilizing the quality of products and ensuring the safety and the effectiveness of clinical medications.

Description

technical field [0001] The invention relates to a method for establishing an HPLC fingerprint of Xiaoer Xiaoji Zhike Oral Liquid and its HPLC standard fingerprint, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Pediatric Xiaoji Zhike Oral Liquid is included in the first supplement of the 2010 edition of the Chinese Pharmacopoeia. It is prepared from ten traditional Chinese medicines of Alice and cicada. It has the functions of clearing away heat and relieving lung, eliminating stagnation and relieving cough. The exact clinical efficacy has been included in the "National Essential Drug List (2012 Edition)". [0003] The quality control methods for Xiaoer Xiaoji Zhike Oral Liquid in the current "Chinese Pharmacopoeia" mainly include identification and content determination. Among them, the identification item adopts thin-layer chromatography to identify betel nut, forsythia, citrus aurantium, and bellflower in th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 赵志全苏瑞强刘武占李蔚群
Owner LUNAN PHARMA GROUP CORPORATION
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