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Establishment of Xiasangju preparations fingerprint pattern and fingerprint pattern thereof

A fingerprint, the technology of Xia Sangju, applied in the field of standard fingerprint, the construction of Xia Sangju preparation high-performance liquid chromatography fingerprint, can solve the problem of difficulty in comprehensively characterizing the physical and chemical characteristics of Xia Sangju preparation and the like

Active Publication Date: 2009-12-23
GUANGZHOU XINGQUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] All of the above are methods for identification or content determination of individual components, and it is difficult to fully characterize the physical and chemical characteristics of the Xiasangju preparation. Therefore, the quality control method for the compound Xiasangju preparation needs to be further improved

Method used

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  • Establishment of Xiasangju preparations fingerprint pattern and fingerprint pattern thereof
  • Establishment of Xiasangju preparations fingerprint pattern and fingerprint pattern thereof
  • Establishment of Xiasangju preparations fingerprint pattern and fingerprint pattern thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Example 1. Detection of the fingerprints of Xiasangju sugar-containing granules

[0066] 1. Instruments and reagents

[0067] 1.1 Instruments Waters2695 high-performance liquid chromatography, Waters 2996 ultraviolet detector, Empower chromatography workstation, AE-200 electronic analytical balance.

[0068] 1.2 Reagents Chlorogenic acid reference substance; Methanol (chromatographically pure), twice redistilled water, acetic acid (analytical pure).

[0069] 2. High performance liquid chromatography

[0070] 2.1 Chromatographic conditions: Chromatographic conditions: the chromatographic column is filled with octadecylsilane bonded silica gel (SunfrieC 18 , analytical column 150mm×4.6mm, 5um); the mobile phase is a gradient eluent composed of 1% acetic acid and methanol, column temperature: 30°C; UV detection: wavelength 290nm; flow rate 1.0m L.min -1 ; Analysis time: 65min. Injection volume: 10 μL each of the test solution and the reference solution. The number of ...

Embodiment 2

[0077] Example 2. Detection of fingerprints of 10 batches of Xiasangju sugar-containing granules

[0078] Get 10 batches of Xia Sangju granules, detect according to the conditions of Example 1, get the HPLC collection of illustrative plates of 10 batches of samples, such as figure 2 shown. Through the comparison of 10 batches of HPLC chromatograms, the similarity evaluation is carried out, and the characteristic common peaks are determined:

[0079] There are 20 common peaks in the fingerprint spectrum. Now the retention time of the spectrum, the average value of the peak area and the total peak area are summarized, as follows:

[0080] For peak No. 1, the average retention time RT is 1.57min, the RSD is 2.06%, the peak area is 1542541, the RSD is 23.75%, accounting for 2.46% of the total peak area.

[0081] For peak No. 2, the average retention time RT is 1.91min, the RSD is 1.08%, the peak area is 1660403, the RSD is 23.47%, accounting for 2.72% of the total peak area.

...

Embodiment 3

[0108] Example 3 The determination method of fingerprint of Xia Sangju sugar-containing granule

[0109] Reference solution: same as embodiment 1

[0110] (b) Preparation of the test solution: Accurately weigh 2.0 g of Xia Sangju granules and place in a stoppered conical flask, accurately add 20 ml of methanol, stopper tightly, soak for 2 hours, and after ultrasonic treatment for 30 minutes, put it to room temperature and make up the reduced volume with methanol. Shake well, filter, evaporate the filtrate to dryness, dissolve the residue with methanol, put it in a 2mL volumetric flask, and add methanol to the mark. Shake well and filter with a pinhole microporous membrane to obtain the test solution.

[0111] (c) Chromatographic conditions: the chromatographic column is filled with octadecylsilane bonded silica gel (Sunfrie C 18 , analytical column 150mm × 4.6mm, 5um); using gradient elution, the mobile phase is a gradient elution solution (phase B) composed of 1% L sodium a...

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Abstract

The establishment of the fingerprint spectrum of the Xiasangju preparation and the fingerprint spectrum relate to the quality control method of the traditional Chinese medicine preparation, specifically the method for establishing the HPLC fingerprint spectrum to detect the alcohol extract in the Xiasangju preparation. The method comprises: (a) preparation of the reference substance solution; (b) preparation of the test solution; (c) chromatographic conditions: the chromatographic column is filled with octadecylsilane bonded silica gel; gradient elution is adopted, and the mobile phase is Gradient eluent composed of 0.1-3% acetic acid and methanol; column temperature: 25-50°C; UV detection wavelength: 285-295nm; flow rate: 0.5-1.5mL min-1; time: 30-80min; (d) Determination: fingerprints obtained by high performance liquid chromatography. The beneficial effect of the present invention: it can effectively characterize the quality of the Xiasangju preparation, which is beneficial to monitor the quality of the product; the method is simple, stable, high in precision and good in reproducibility; it can quickly and accurately identify the authenticity of the product.

Description

technical field [0001] The invention relates to a quality control method of traditional Chinese medicine preparations, in particular to a method for constructing high-performance liquid chromatography fingerprints and standard fingerprints of Xiasangju preparations. Background technique [0002] Xiasangju preparation is made from traditional Chinese medicinal materials Prunella vulgaris, mulberry leaves, and wild chrysanthemums, which are extracted with water and made according to conventional pharmaceutical processes. Wind-heat cold, conjunctival congestion and headache, high blood pressure, dizziness and tinnitus, sore throat, treatment of sores and swollen toxins. Xiasangju preparations are listed in the fifteenth volume of Chinese medicine prescription preparations of the Ministry of Health of the People's Republic of China. Xiasangju granules are very popular traditional Chinese medicine preparations. Now there are Xiasangju sugar-free granules, Xiasangju oral liquid, X...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N1/28G01N30/86
Inventor 孙维广柯雪红许招懂苏广丰方铁铮符素平
Owner GUANGZHOU XINGQUN PHARMA
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