Quality control method of Fuzi Lizhong Wan

A technology of aconite theory and detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effect of strengthening uniformity and stability

Inactive Publication Date: 2018-09-07
CHENGDU UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no report on the quality co

Method used

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  • Quality control method of Fuzi Lizhong Wan
  • Quality control method of Fuzi Lizhong Wan
  • Quality control method of Fuzi Lizhong Wan

Examples

Experimental program
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Embodiment 1

[0031] Embodiment 1 Fuzi Lizhong Pill Dissolution Quality Control Method

[0032] (1) Dissolution operation: connect the power of the dissolution apparatus, measure 900ml of 0.25% sodium lauryl sulfate newly prepared and ultrasonically placed in each dissolution cup, and wait for the dissolution medium (dissolution medium is water, 0.25% dodecane) Sodium sulfate solution, 0.5% hydrochloric acid water solution or phosphate buffer solution with pH6.8) After the temperature is kept constant at 37±0.5°C, set the rotation speed at 100 rpm, take 6 pills of Fuzi Lizhong Pills, and put them into 6 dissolution cups respectively Inside, close the lid tightly, start the propeller immediately and count the time; at 0.5, 1, 1.5, 2, 4, 12, 24, 48h, take 2mL of dissolution liquid (add 2ml of dissolution medium), and quickly use 0.22μm microporous Filter through a membrane to obtain the test solution.

[0033] (2) Determination of dissolution rate:

[0034] Chromatographic conditions: the c...

experiment example 1

[0044] Experimental example 1 evaluates the quality of commercially available Fuzi Lizhong Pills by the inventive method

[0045] (1) Instruments and reagents:

[0046] ZRS-8G Intelligent Dissolution Apparatus (Tianjin Tianda Tianfa Technology Co., Ltd.), METTLERTOLEDOPH Detector, ARSS4CN1 / 10 Analytical Balance (Ohaus Instruments Co., Ltd.), ARSS4CN1 / 1 Analytical Balance (Ohaus Instruments Co., Ltd.) , DL-720D Ultrasonic Machine (Shanghai Zhixin Instrument Co., Ltd.), Agilent-1260 High Performance Liquid Chromatography System (Agilent Corporation, USA), Chromatographic Column Agilent HC-C18 (250×4.6mm, 5.0μm);

[0047] Glycyrrhizic acid reference substance (Chengdu Pusi Biotechnology Co., Ltd. 1050-0025), liquiritin reference substance (Chengdu Pusi Biotechnology Co., Ltd. 161213-04), commercially available Fuzi Lizhong Pills (concentrated pills) batch number: manufacturer 1: 1605081, 1602053, 1605052, manufacturer 2: 1605211, 1605201, 1609231, manufacturer 3: 81151215, 81140...

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Abstract

The invention discloses a quality control method, which uses a high-performance liquid chromatography to determine the dissolving-out amount of liquiritin and glycyrrhizic acid in Fuzi Lizhong Wan ata specific time point and draws a dissolution curve based on the determination result so as to evaluate the product quality consistency, of the Fuzi Lizhong Wan. The method disclosed by the inventionfills a gap in the dissolution quality control item of the Fuzi Lizhong Wan, and enhances the product quality control of the Fuzi Lizhong Wan, thus providing a basis for clinical medication.

Description

technical field [0001] The invention relates to a quality control method of aconite lizhong pills. Background technique [0002] Aconite Lizhong Pill is recorded in the "Pharmacopoeia of the People's Republic of China" 2015 edition. It is composed of aconite (made), Codonopsis, fried Atractylodes macrocephala, dried ginger and licorice. It has the effect of warming the spleen and strengthening the spleen. It is used for spleen and stomach deficiency and cold pain in the abdomen. , Vomiting and diarrhea, cold hands and feet. [0003] Drug quality is the key to ensuring the effectiveness, safety and stability of drugs. In the quality control methods under the item of Fuzi Lizhong Pills in the Pharmacopoeia, the microscopic identification method and thin-layer chromatography were used to qualitatively identify part of the medicinal taste. Liquiritin minimum limit standard. In order to better control the quality of Fuzi Lizhong Pills, it has been reported in the literature th...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 张臻江茂源石金凤高天慧傅超美章津铭傅舒
Owner CHENGDU UNIV OF TRADITIONAL CHINESE MEDICINE
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