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Detection method for specific chromatogram of medicinal preparation and application thereof

A technology for characteristic maps and pharmaceutical preparations, which is applied in measuring devices, instruments, scientific instruments, etc., can solve the problem of less research on chemical components, achieve good reproducibility, reduce the possibility of artificial processing, and avoid one-sided effects.

Active Publication Date: 2021-09-28
HEHUANG PHARMA SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pharmaceutical preparations are mainly used to treat "lily disease" caused by emotional internal injury, and the pathogenesis of "lily disease" is heart-lung yin deficiency and internal heat, which is closely related to modern neuropsychiatric diseases. Lily disease symptoms and modern depression The clinical manifestations are similar to the clinical manifestations of modern medicine. The commonly used pharmaceutical preparations and their additions and subtractions in modern medicine or combined with antidepressant western medicines treat depression induced by various etiologies. but less

Method used

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  • Detection method for specific chromatogram of medicinal preparation and application thereof
  • Detection method for specific chromatogram of medicinal preparation and application thereof
  • Detection method for specific chromatogram of medicinal preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] 1. Preparation of the test solution

[0076] The pharmaceutical preparation samples were prepared according to the ancient method recorded in the classic famous prescription "Synopsis of the Golden Chamber", that is, the fresh lilies were washed with clean water to remove the floating water on the surface, and 7 lilies were weighed. Wash it with clean water and set it aside; take fresh rehmannia glutinosa and squeeze 200mL of fresh rehmannia glutinosa juice into a juicer and boil it for later use. Take the above-mentioned lilies, add 400mL of water to a beaker, place them in a medicine pot, heat and decoct to 200mL, filter, add the above-mentioned fresh rehmannia juice to the filtrate, stir evenly, heat and decoct to 300mL, and the product is ready.

[0077] Take 3g of the drug preparation sample, accurately weigh it, put it in a 50ml measuring bottle, add water to dissolve, and dilute to the scale constant volume, shake well, and filter through a 0.45μm microporous mem...

Embodiment 2

[0093] According to the method in Example 1, get 16 batches of pharmaceutical preparations and repeat the detection twice to obtain the characteristic spectra of a plurality of pharmaceutical preparation samples to generate a common contrast characteristic spectrum, and use the chromatographic peaks that exist in the spectra as the common characteristic peaks to determine the common characteristic peaks The relative retention time of the drug preparation is established to establish a standard characteristic map.

[0094] like figure 1 As shown, the standard feature spectrum of the pharmaceutical preparation includes 17 common fingerprint peaks, with No. 3 peak as the reference peak (S peak, retention time is 1.0000), and the relative retention time of other 16 common fingerprint peaks is No. 1 peak (0.6040 -0.6281), No. 2 peak (0.6840-0.7083), No. 4 peak (1.3314-1.3449), No. 5 peak (1.7815-1.9266), No. 6 peak (1.9625-2.1283), No. 7 peak (2.0377-2.2067), 8 No. peak (2.3913-2.5...

Embodiment 3

[0097] Remove any one of the medicinal materials from the pharmaceutical preparation samples containing rehmannia glutinosa and lily, and prepare according to step 1) of the detection method of the characteristic map of the pharmaceutical preparation in Example 1, and obtain 2 kinds of negative sample solutions without samples.

[0098] Adopt the high-performance liquid chromatography (HPLC) method of the same chromatographic condition in the step 3) of the detection method of the characteristic spectrum of the pharmaceutical preparation in Example 1 to measure 2 kinds of lacking sample negative sample solutions respectively, obtain 2 kinds of lacking sample negative samples respectively The characteristic spectrum of the solution.

[0099] Compare the characteristic spectra of the two kinds of lack-of-sample negative sample solutions with the standard characteristic spectra of pharmaceutical preparations established by the construction method of the standard characteristic map...

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Abstract

The invention provides a detection method for a specific chromatogram of medicinal preparation. The method comprises the following steps: 1) preparing a test solution; 2) preparing a reference substance solution; and 3) carrying out determination. The invention further provides application of the detection method of the specific chromatogram of the medicinal preparation in quality detection of the medicinal preparation, and a construction method of the standard specific chromatogram of the medicinal preparation, and a quality control method. The invention further provides a screening method of the specific chromatograms of multiple medicinal materials in the medicinal preparation. According to the method for detecting the specific chromatogram of the pharmaceutical preparation and the application of the method, the specific chromatogram of the pharmaceutical preparation containing 17 characteristic peaks can be obtained, 10 characteristic peaks in the specific chromatogram can be subjected to positioning attribution, the method is good in precision, stability and reproducibility, it is guaranteed that the amount of effective components in the pharmaceutical preparation is relatively stable, therefore, safety and effectiveness of clinical medication are guaranteed.

Description

technical field [0001] The invention belongs to the technical field of detection of traditional Chinese medicine components, and relates to a detection method of a characteristic map of a pharmaceutical preparation and an application thereof, in particular to an HPLC detection method of a characteristic map of a medicinal preparation and its application in quality detection. Background technique [0002] As the development of classic prescriptions of traditional Chinese medicine has become a research hotspot in the field of traditional Chinese medicine, relevant management departments have stipulated that classic prescriptions must be researched in strict accordance with the prescription, dosage and preparation process of ancient prescriptions. The drug preparation prescription of the research object of the present invention was first seen in the first part of "Synopsis of the Golden Chamber·The Syndrome and Treatment of Yin and Yang Poison of Lily and Fox Confusion" by Zhang...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N30/8668Y02A50/30
Inventor 但济修周宽詹常森李淞明周永全张正光
Owner HEHUANG PHARMA SHANGHAI
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