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Method for establishing fingerprint of lame impediment treating pills and method for identifying lame impediment treating pills by using fingerprint method

A technology of fingerprint spectrum and establishment method, which is applied in the identification of Erbi tablets and the establishment of fingerprints of Erbi tablets, can solve the problems of complex effective chemical components, single chemical components cannot fully reflect the overall information, etc., and achieves good reproducibility, high precision effect

Inactive Publication Date: 2017-05-10
LIAONING HUANREN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation is now implementing the standard (2015 edition of "Chinese Pharmacopoeia") to quantitatively analyze the ingredients, but its effective chemical ingredients are complex, and the quantitative analysis of a single chemical ingredient cannot fully reflect the overall information of the drug.

Method used

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  • Method for establishing fingerprint of lame impediment treating pills and method for identifying lame impediment treating pills by using fingerprint method
  • Method for establishing fingerprint of lame impediment treating pills and method for identifying lame impediment treating pills by using fingerprint method
  • Method for establishing fingerprint of lame impediment treating pills and method for identifying lame impediment treating pills by using fingerprint method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] The present embodiment provides a method for establishing fingerprints of Miaobi Tablets, which includes:

[0076] Preparation of reference solution: Accurately weigh 5.01mg of icariin, place it in a 10ml measuring bottle, add methanol to dissolve, dilute to the mark, shake well; then accurately measure 1ml from it, place it in a 10ml measuring bottle, add Dissolve in methanol, dilute to the mark, and shake well to obtain a 0.05 mg / ml reference substance solution.

[0077] Preparation of the sample solution: get about 1.0 g of the Mubi Tablet sample (coating removed, finely ground), accurately weighed, add 25 ml of dilute ethanol solution to the Erlenmeyer flask with a stopper, weigh, and ultrasonically process (power 200W, Frequency 40kHz) 1h, take it out and let it cool, then weigh it, make up the lost weight with dilute ethanol, shake well, filter, get the filtrate to get the sample solution; prepare the sample solutions of each batch of Mianbi Tablets respectively. ...

Embodiment 2

[0085] The present embodiment provides a method for identifying Lubi Tablets by utilizing the fingerprints of Lubi Tablets obtained in Example 1, specifically:

[0086] (1) Take the sample to be tested, take the coating and grind it into powder, accurately weigh 1.0g, add 25ml of dilute ethanol solution to the conical flask with a stopper, weigh it, and ultrasonically treat it at a frequency of 40kHz for 60min, take it out and let it cool , weigh again, make up the lost weight with dilute ethanol, shake well, filter, and take the filtrate to obtain the sample solution to be tested;

[0087] (2) The sample solution to be tested is injected with 10 μl, using octadecylsilane bonded silica gel as a filler, and acetonitrile and 0.1% phosphoric acid aqueous solution to form a mobile phase, at a mobile phase flow rate of 1ml / min and a column temperature of 30 Under the condition of ℃, the gradient elution is carried out in the following manner, and the detection is carried out at the...

experiment example 1

[0094] Experimental example 1: Chromatographic conditions and system suitability test

[0095] 1) Inspection of chromatographic column

[0096] Selected Agilent Extend-C 18 (250×4.6mm, 5μm) chromatographic column, Agela Durashell C 18 (250×4.6mm, 5μm) column and Luna(2)C 18 (250×4.6mm, 5μm) chromatographic column Three kinds of chromatographic columns were investigated, and the results showed that Agela Durashell C 18 (250×4.6mm, 5μm) chromatographic column has better separation effect and peak shape, so AgelaDurashell C 18 (250×4.6mm, 5μm) chromatographic column. Chromatogram see figure 2 .

[0097] 2) Investigation of detection wavelength

[0098] Except that the detection wavelength conditions are other, the chromatographic detection steps are basically the same as those of the test product. By scanning the sample at a full wavelength of 190-600nm and comparing the isoabsorption diagrams, it was found that each peak can be well reflected at 235nm, and the baseline ...

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Abstract

The invention relates to a method for establishing a fingerprint of lame impediment treating pills. The method comprises the steps of obtaining chromatograms of the lame impediment treating pills of different production batches by adopting high-performance liquid chromatography, selecting a chromatographic peak, which is present in the chromatograms of the lame impediment treating pills of all the batches, as a common peak, and generating the fingerprint of the lame impediment treating pills by using an average value computation method, wherein a stationary phase is octadecylsilane chemically bonded silica, an organic phase of a flowing phase is acetonitrile, and a water phase is an aqueous solution of phosphoric acid. The invention further relates to a method for identifying the lame impediment treating pills by using a fingerprint method. According to the method provided by the invention, the comprehensive monitoring on drug quality is facilitated, the sequential order and mutual relationship of all characteristic peaks forming the fingerprint are emphasized, and the global appearance characteristic is emphasized, so that the one sidedness caused by judging the quality of the lame impediment treating pills through determining individual chemical ingredient is avoided, and the possibility that artificial processing is carried out in order to enable the quality to reach the standards is reduced; the method can be applied to the true and false identification, production process control and quality evaluation of lame impediment treating pill products and has the advantages of simplicity, convenience, high precision, good stability and good reproducibility.

Description

technical field [0001] The invention relates to the field of quality control of traditional Chinese medicines, in particular to a method for establishing the fingerprint of Miaobi tablets and a method for identifying Miaobi tablets by using the fingerprint method. Background technique [0002] Lunbi tablets are composed of Rehmannia glutinosa, Rehmannia glutinosa, Dipsacus, Aconite (made), Duhuo, Rhizoma drynariae, Guizhi, Epimedium, Fangfeng, Clematis, Soapthorn, sheep bone, white peony root, Dogji (made ), Zhimu, Shenjincao, and safflower seventeen medicinal materials have the effects of nourishing liver and kidney, strengthening bones and muscles, dispelling rheumatism, and dredging meridians. It is used for liver and kidney deficiency, chronic arthralgia, joint pain, and local swelling , Stiff deformity, unfavorable stretching and rheumatoid arthritis see those with the above symptoms. The preparation is now implementing the standard (2015 edition of "Chinese Pharmacopo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34
Inventor 屠鹏飞张文涛高云佳周书繁郭艳李为理郑继宇孙云超秦培红王艳敏
Owner LIAONING HUANREN PHARMA
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