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Detection method of radix ginseng and folium perillae preparation

A detection method and preparation technology, which are applied in the detection field of ginseng preparations, can solve the problems such as the inability to better guarantee the clinical efficacy, the inability to effectively control the production process and product quality, etc.

Active Publication Date: 2017-05-10
KANGSHOU PHARMACY CO LTD HUNAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, there is no more comprehensive quality control method to reflect the quality status of existing Chinese medicinal materials, intermediates and finished products, nor can it effectively control the production process and product quality, and cannot better guarantee its clinical efficacy

Method used

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  • Detection method of radix ginseng and folium perillae preparation
  • Detection method of radix ginseng and folium perillae preparation
  • Detection method of radix ginseng and folium perillae preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] The detection method of embodiment 1 ginseng preparation

[0128] The detection method of ginseng preparation comprises the following steps:

[0129] (a) Preparation of the reference substance solution: weigh the puerarin reference substance, place it in a volumetric flask, add 50% to 100% methanol to dissolve it and set the volume to the scale, shake well, and prepare the reference substance solution;

[0130] (b) Preparation of the test solution: take the ginseng preparation, add 0% to 50% methanol or 0% to 50% ethanol 25 to 125mL, extract by conventional methods, filter with a microporous membrane, and take the subsequent filtrate, Get the test solution;

[0131] (c) Chromatographic conditions: the chromatographic column is C 18 Reverse-phase chromatographic column; using gradient elution, the mobile phase is a gradient eluent composed of mobile phase A and mobile phase B, mobile phase A is acetonitrile, mobile phase B is 0.05-0.1% phosphoric acid solution; detecti...

Embodiment 2

[0136] Example 2 Establishment of Characteristic Map of Shensu Preparation Oral Liquid

[0137] (1) Instruments and reagents

[0138] Agilent 1260 HPLC, including online vacuum degasser (G-1311C), binary pump (G-1311C), standard autosampler (G-1329B), intelligent column oven (G-1316A) , DAD detector (G-1314B), Agilent1260Infinity chromatographic workstation (Agilent Technologies Co., Ltd.); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.).

[0139] (2) Chromatographic conditions

[0140] The column is Thermo Syncronis-C 18 (5μm, 4.6×250mm) reverse-phase chromatographic column; column temperature is 25°C; detection wavelength is 285nm; mobile phase A is acetonitrile, mobile phase B is 0.08% phosphoric acid solution, the total flow rate is 1.0mL / min; analysis time is 60 minutes ; The elution gradient is shown in Table 2.

[0141] ...

Embodiment 3

[0170] Example 3 Establishment of Characteristic Maps of Shensu Preparation Intermediates

[0171] (1) Instruments and reagents

[0172] Agilent 1260 HPLC, including online vacuum degasser (G-1311C), binary pump (G-1311C), standard autosampler (G-1329B), intelligent column oven (G-1316A) , DAD detector (G-1314B), Agilent1260Infinity chromatographic workstation (Agilent Technologies Co., Ltd.); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.).

[0173] (2) Chromatographic conditions

[0174] The column is Thermo Syncronis-C 18 (5μm, 4.6×250mm) reverse-phase chromatographic column; column temperature is 30°C; detection wavelength is 283nm; mobile phase A is acetonitrile, mobile phase B is 0.05% phosphoric acid solution, the total flow rate is 1.0mL / min; analysis time is 60 minutes ; The elution gradient is shown in Table 4.

[017...

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Abstract

The invention relates to the technical field of pharmaceutical quality control and in particular relates to a detection method of a radix ginseng and folium perillae preparation. The detection method comprises the following steps: preparing the radix ginseng and folium perillae preparation into a test sample solution; taking puerarin as a reference object and detecting by adopting a high performance liquid chromatography to obtain the quality of the radix ginseng and folium perillae preparation, wherein chromatographic conditions are as follows: a chromatographic column is a C18 reverse-phase chromatographic column, a mobile phase A is acetonitrile, a mobile phase B is a phosphoric acid solution and gradient elution is adopted. The high performance liquid chromatography has relatively high precision, good repeatability and relatively short analysis time and has certain specificity; the separation effect of each characteristic peak in an obtained characteristic spectrum is relatively good, and the characteristic spectrum of the radix ginseng and folium perillae preparation and an intermediate characteristic spectrum have relatively good correlation; the characteristic spectrum established by the invention has 7 characteristic peaks, the information quantity is relatively great and effective components in a test solution are kept relatively completely; the method provided by the invention guarantees quality control of a whole process from raw materials to a final preparation.

Description

technical field [0001] The invention relates to the technical field of drug quality control, in particular to a detection method for ginseng preparations. Background technique [0002] The ginseng preparation is composed of Codonopsis pilosula, perilla leaf, kudzu root, peucedanum, poria cocos, pinellia (made), tangerine peel, aurantium fructus (stir-fried), platycodon grandiflorum, licorice, woody fragrance, ginger, and jujube. This prescription has the effects of replenishing qi, relieving the exterior, eliminating phlegm and relieving cough. It is mainly used to treat colds due to physical weakness, cold due to wind-cold, aversion to cold and fever, headache, stuffy nose, and cough with phlegm. Shensu Drink comes from the "Taiping Huimin Heji Bureau Prescription" in the Song Dynasty, and it is widely used in clinical practice. [0003] In the prior art, according to the traditional Chinese medicine prescription of ginseng, ginseng preparations in various dosage forms hav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 谈发金柳卓
Owner KANGSHOU PHARMACY CO LTD HUNAN
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