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Establishing method of fingerprint of traditional Chinese medicinal composition preparation

A technology of fingerprint spectrum and establishment method, which can be used in measurement devices, instruments, scientific instruments, etc., and can solve the problems of inability to fully characterize the chemical characteristics and quality of Zhuangyao Jianshen Pills.

Active Publication Date: 2017-07-04
GUANGZHOU CHEN LI JI PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Obviously, the above drug standards cannot fully characterize the chemical characteristics and quality of Zhuangyao Jianshen Pills

Method used

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  • Establishing method of fingerprint of traditional Chinese medicinal composition preparation
  • Establishing method of fingerprint of traditional Chinese medicinal composition preparation
  • Establishing method of fingerprint of traditional Chinese medicinal composition preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Example 1 Establishment of the method for preparing the test solution

[0135] 1.1 Selection of extraction solvent:

[0136] Get the Zhuangyaojianshen pill sample 5g of batch number C08047, grind finely, accurately weigh, place in the Erlenmeyer flask with stopper of 50ml, add 25ml methyl alcohol, 75% methanol (volume percent concentration), 50% methanol (volume percent concentration) respectively accurately percent concentration), 95% ethanol (volume percent concentration), 50% ethanol (volume percent concentration), after ultrasonication for 45 minutes, let cool to room temperature, weigh, and use extraction solvent to supplement the lost weight respectively, shake well , filter, and take the continued filtrate, that is, too.

[0137] Under the following chromatographic conditions, measure the test solution prepared by different extraction solvents respectively, and record the chromatogram of 0-150min:

[0138] Column: Phenomenex Luna 5uC 18 (2) 100A chromatograp...

Embodiment 2

[0152] Example 2 Establishment of Chromatographic Conditions

[0153] 2.1 Determination of mobile phase

[0154] According to the preferred preparation method of the test solution in Example 1, about 5 g of the sample of batch number C08047 was taken to prepare the test solution. The column temperature is 30°C, the injection volume is 10 μl, the flow rate is 1ml / min, and the detection wavelength is 230nm. ), acetonitrile (A)-methanol (B)-water (C) and acetonitrile (A)-methanol (B)-0.1% phosphoric acid aqueous solution (C) are mobile phases, gradient elution, elution procedure is shown in Table 1. The elution time is 150min, and the chromatogram is recorded. Chromatogram see figure 2 .

[0155] The results showed that acetonitrile-methanol-0.1% phosphoric acid aqueous solution was the mobile phase, the baseline was relatively stable and the separation effect was the best. Therefore, acetonitrile-methanol-0.1% phosphoric acid aqueous solution was selected as the mobile p...

Embodiment 3

[0160] Example 3 Composition testing of Zhuangyaojianshen pills

[0161] 1. Column: Phenomenex Luna 5u C 18 (2) 100A chromatographic column (250×4.6mm, 5μm);

[0162] 2. Mobile phase: Acetonitrile-methanol-0.1% phosphoric acid aqueous solution is the mobile phase, and the gradient elution program is shown in Table 1;

[0163] 3. Flow rate: 1.0ml / min;

[0164] 4. Detection wavelength: 230nm;

[0165] 5. Column temperature: 30°C;

[0166] 6. the preparation of need testing solution: prepare according to the preferred method of embodiment 1;

[0167] 7. Preparation of reference solution: Precisely weigh protocatechuic acid, protocatechualdehyde, privetin, schizandrin A and (2′S)-schisandrin reference substance, and add methanol to prepare The concentration is a mixture of protocatechuic acid 120 μg / ml, protocatechualdehyde 130 μg / ml, privetin 140 μg / ml, Japanese Schizandrin A 40 μg / ml and (2′S)-Schisandra lignin 30 μg / ml Reference substance solution, to obtain;

[0168] ...

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Abstract

The invention provides an establishing method of the fingerprint of a traditional Chinese medicinal composition preparation, and a technology for detecting the components of the traditional Chinese medicinal composition preparation by using the fingerprint established through the method. The raw materials of the traditional Chinese medicinal composition preparation comprise Rhizoma Cibotii, Radix Kadsurae Coccineae,Philippine flemingia root, steamed Chinese Taxillus Twig, steamed Ligustri Lucidi Fructus, Caulis Spatholobi, Fructus Rosae Laevigatae, Radix millettiae Speciosae and brine processed semen cuscutae. The establishing method of the fingerprint is characterized in that the retention time of every compound in the traditional Chinese medicinal composition is detected through high performance liquid chromatography; and the conditions of the high performance liquid chromatography are as follows: octadecylsilane bonded silica is adopted as a stationary phase, a mobile phase comprises acetonitrile, methanol and a 0.1% aqueous phosphoric acid solution, gradient elution is carried out for 0-150 min, and the ultraviolet detection wavelength is 230 nm. The relative retention times and the relative peak areas of 43 common peaks in the fingerprint established through the method are calibrated by adopting the absorption peak of protocatechuic acid as a reference peak.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for establishing a fingerprint of a traditional Chinese medicine composition preparation, and the traditional Chinese medicine composition is Zhuangyao Jianshen Pill. Background technique [0002] Traditional Chinese medicine fingerprint is a comprehensive and quantifiable quality detection method. It is based on the systematic research on the chemical components of traditional Chinese medicine. Traditional Chinese medicine and its preparations are multi-component complex systems, so the evaluation of its quality should adopt a detection method that is suitable for it and can provide rich identification information. The type and quantity of chemical components, and then the overall description and evaluation of drug quality. Therefore, the research and establishment of TCM fingerprints are of great significance for improving the quality of TCM and promoti...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 杨能英何风雷彭富全苏赟
Owner GUANGZHOU CHEN LI JI PHARMA FACTORY
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