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HPLC characteristic map of Sanjin preparation and its construction method

A characteristic map and construction method technology, applied in the direction of instruments, measuring devices, scientific instruments, etc., can solve the problems that cannot truly reflect the quality of medicinal materials, and cannot evaluate the main material basis

Active Publication Date: 2021-05-04
GUILIN SANJIN PHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As the applicant's exclusive variety, Sanjin Tablets has been the first brand of similar Chinese patent medicines for treating urinary tract infections in recent years. Its current "Chinese Pharmacopoeia" standards include the TLC identification of the four medicinal materials in the prescription and the content of madecassoside Determination, but it is not yet possible to make an overall evaluation of the main material basis of this product
[0006] However, the detection of its components can not really reflect the quality of medicinal materials

Method used

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  • HPLC characteristic map of Sanjin preparation and its construction method
  • HPLC characteristic map of Sanjin preparation and its construction method
  • HPLC characteristic map of Sanjin preparation and its construction method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1、 3

[0043] Embodiment 1, the establishment of the high-performance liquid chromatography of Sanjin preparation HPLC characteristic collection of spectra

[0044] 1. Instruments and reagents

[0045] 1.1 Instrument

[0046] Waters2695 high-performance liquid chromatography, Waters2998 detector; METTLER TTOLEDO XP404S electronic balance; BRANSON S7500 ultrasonic cleaner.

[0047] 1.2 Reagent

[0048] The reference substance asiaticoside (batch number: 110892-201505, purity: 91.2%) was provided by China National Institutes for Food and Drug Control. 15 batches of Sanjin Tablets were produced by Guilin Sanjin Pharmaceutical Co., Ltd., with batch numbers 1602001, 1604011, 1606001, 1608001, 1610001, 1503002, 1505001, 1507002, 1509003, 1512002, 170227, 170308, 170304, 43007. Acetonitrile was imported chromatographically pure, water was ultrapure water, and the rest of the reagents were analytically pure.

[0049] 2. Methods and results

[0050] 2.1 Chromatographic conditions

[005...

Embodiment 2

[0073] Example 2. Methodological investigation of high performance liquid chromatography for establishing the HPLC characteristic spectrum of Sanjin preparation

[0074] The high performance liquid chromatography of the HPLC characteristic spectrum of the Sanjin preparation established in Example 1 was investigated in the following aspects.

[0075] 1. Precision test

[0076] Get same batch of samples (batch number 170227), prepare need testing solution by the preparation method of need testing solution in embodiment 1, test under chromatographic conditions in embodiment 1, continuous sampling 6 times, record chromatogram, visible 6 Peak No. 1 is the reference substance Asiaticoside, the peak time is in the middle, the surrounding interference is small, and the content is relatively high, so the peak of Asiaticoside is selected as the reference peak S, and the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (V2 .0)" for evaluation. The results show...

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Abstract

The invention belongs to the technical field of medicine, in particular, it relates to an HPLC characteristic spectrum of Sanjin preparation and a construction method thereof. The HPLC characteristic spectrum includes 9 characteristic peaks, wherein No. 6 peak is the asiaticoside reference peak, and the relative retention times of the other 8 characteristic peaks are: No. 1 peak 0.41, No. 2 peak 0.53, No. 3 peak 0.13, Peak No. 4 is 0.12, Peak No. 5 is 0.26, Peak No. 7 is 0.14, Peak No. 8 is 0.13, and Peak No. 9 is 0.12. The present invention establishes the characteristic map of n-butanol part of Sanjin tablet for the first time, which can synchronously track and detect multiple main components of the 4 flavors of the prescription under simple conditions, comprehensively improve the quality control standard of Sanjin preparation, and enhance the core competitiveness of the product. Lay a solid foundation to ensure the product quality and clinical efficacy of Sanjin Tablets are stable. In addition, the establishment method of the HPLC characteristic map has strong operability and good reproducibility, which provides a scientific basis for better controlling the quality of Sanjin preparations.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an HPLC characteristic spectrum of Sanjin preparation and a construction method thereof. Background technique [0002] Sanjin Tablet is composed of 5 traditional Chinese medicines such as Rosaceae root and Centella asiatica. It has the functions of clearing away heat and detoxification, promoting dampness and treating stranguria, and benefiting the kidney. It is mainly used to treat acute and chronic pyelonephritis, cystitis and urinary tract infection. As the applicant's exclusive variety, Sanjin Tablets has been the first brand of similar Chinese patent medicines for treating urinary tract infections in recent years. Its current "Chinese Pharmacopoeia" standards include the TLC identification of the four medicinal materials in the prescription and the content of madecassoside Determination, but it is not yet possible to make an overall evaluation of the main materi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 邹节明周艳林石媛慧
Owner GUILIN SANJIN PHARMACEUTICALS CO LTD
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