Kangshen granule fingerprint construction method and standard fingerprint thereof

A standard fingerprint and construction method technology, applied in the construction method of Kangshen granule fingerprint and its standard fingerprint field, can solve the problems of shortage, simple quality standard, inability to control the quality of Kangshen granule, etc., and achieve good stability, The effect of effective quality control

Active Publication Date: 2017-02-15
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Kangshen Granules is included in the National Drug Standards of the State Food and Drug Administration, and its existing quality standards are relatively simple, making it impossible to conduct comprehensive quality control on Kangshen Granules
[0004] For Kangshen Granules, there is currently a lack of methods to fully reflect its q

Method used

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  • Kangshen granule fingerprint construction method and standard fingerprint thereof
  • Kangshen granule fingerprint construction method and standard fingerprint thereof
  • Kangshen granule fingerprint construction method and standard fingerprint thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] 1. Preparation of the test solution: take about 2.0 g of the sample, accurately weigh it, put it in a stoppered conical flask, add 25 ml of 75% methanol accurately, weigh it, extract it by ultrasonic extraction for 30 minutes, let it cool, and weigh it again. Determine the weight, make up the lost weight with 75% methanol, shake well, filter, and take the filtrate to obtain the final product.

[0055] 2. Preparation of reference substance solution: take puerarin, caffeic acid, daidzin, rosmarinic acid, hesperidin, daidzein reference substance, accurately weighed, add methanol to prepare a concentration of puerarin 90.0 μg / ml, A mixed reference solution of caffeic acid 52.6 μg / ml, daidzin 127.2 μg / ml, rosmarinic acid 80.4 μg / ml, hesperidin 19.1 μg / ml, daidzein 42.8 μg / ml.

[0056] 3. High performance liquid chromatography conditions: the chromatographic column uses octadecylsilane bonded silica gel as filler; the detection wavelength is 280nm; the column temperature is 2...

Embodiment 2

[0065] 1. Preparation of the test solution: take about 0.5g of this product, accurately weigh it, put it in a stoppered conical flask, add 15ml of 50% methanol accurately, weigh it, extract it by ultrasonic extraction for 15 minutes, let it cool, and then Weigh the weight, make up the lost weight with 50% methanol, shake well, filter, and take the filtrate to obtain the final product.

[0066] 2. Preparation of reference substance solution: take puerarin, caffeic acid, daidzin, rosmarinic acid, hesperidin, daidzein reference substance, accurately weighed, add methanol to prepare a concentration of puerarin 90.0 μg / ml, A mixed reference solution of caffeic acid 52.6 μg / ml, daidzin 127.2 μg / ml, rosmarinic acid 80.4 μg / ml, hesperidin 19.1 μg / ml, daidzein 42.8 μg / ml.

[0067] 3. High performance liquid chromatography conditions: the chromatographic column uses octadecylsilane bonded silica gel as filler; the detection wavelength is 270nm; the column temperature is 20°C; acetonitri...

Embodiment 3

[0076] 1. Preparation of the test solution: take about 5.0 g of this product, accurately weigh it, put it in a stoppered conical flask, add 50 ml of 100% methanol accurately, weigh it, extract by heating and reflux for 60 minutes, let it cool, and then Weigh the weight, make up the lost weight with 100% methanol, shake well, filter, and take the filtrate to obtain the final product.

[0077] 2. Preparation of reference substance solution: take puerarin, caffeic acid, daidzin, rosmarinic acid, hesperidin, daidzein reference substance, accurately weighed, add methanol to prepare a concentration of puerarin 90.0 μg / ml, A mixed reference solution of caffeic acid 52.6 μg / ml, daidzin 127.2 μg / ml, rosmarinic acid 80.4 μg / ml, hesperidin 19.1 μg / ml, daidzein 42.8 μg / ml.

[0078] 3. High performance liquid chromatography conditions: the chromatographic column uses octadecylsilane bonded silica gel as filler; the detection wavelength is 290nm; the column temperature is 40°C; acetonitrile...

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Abstract

The invention belongs to the technical field of traditional Chinese medicinal preparation quality control, and concretely discloses a Kangshen granule fingerprint construction method. The method comprises the following steps: preparing a sample solution and a reference substance solution, determining high performance liquid chromatography conditions, and determining fingerprint; and the high performance liquid chromatography conditions are as follows: octadecylsilane chemically bonded silica is adopted as a filler, the detection wavelength is 270-290 nm, the column temperature is 20-40 DEG C, the flow velocity is 0.8-1.2 ml/min, a mobile phase is composed of a mobile phase A and a mobile phase B, acetonitrile is adopted as the mobile phase A, 0.5-1.5% of a formic acid-water solution is adopted as the mobile phase, and linear gradient elution is carried out. The Kangshen granule fingerprint constructed in the invention is formed by chromatographic information of multiple common peaks, a technology for controlling the quality by using a single index component is changed, and the substance of the granule is systemically and comprehensively reflected, so comprehensive and effective quality control is realized, and the established method good precision, repeatability and stability, and can be used for controlling the inner quality of the Kangshen granule.

Description

technical field [0001] The invention belongs to the technical field of quality control of traditional Chinese medicine preparations, and more specifically relates to a method for constructing a fingerprint of Kangshen granules and a standard fingerprint thereof. Background technique [0002] Traditional Chinese medicine in my country is complex and has complex chemical components, and its medicinal effects are often difficult to express with a single component. The existing quality standards of traditional Chinese medicine and its preparations in my country are relatively simple, most of them are limited to appearance, traits and identification. Some varieties have established chemical composition determination methods. Even in the established methods for chemical composition determination of medicinal materials, the measured components also have specificity. Not strong, not directly related to drug efficacy, it is difficult to make a comprehensive description of the effectiv...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 李捍雄庄满贤曾晓燕王霆
Owner GUANGZHOU YIPINHONG PHARMA
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