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HPLC-DAD based six-ingredient rehmannia pill prescription analysis and quality analysis method

A technology of Liuwei Dihuang Pills and a quality control method, which is applied in the field of quality control of the compound preparation Liuwei Dihuang Pills, which can solve the problems of cumbersome cost and methods, low TLC accuracy, and difficult DNA extraction and analysis operations

Inactive Publication Date: 2021-04-20
DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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AI Technical Summary

Problems solved by technology

However, distinguishing the microscopic characteristics of different medicinal materials requires considerable experience accumulation, and TLC needs to use different processing methods and solvent systems for different identification objects, the operation is cumbersome and time-consuming, and the accuracy of TLC is not high and lacks certain specificity; HPLC operation Simple, excellent separation effect and good repeatability, the fingerprint method based on HPLC has been more and more widely used in the field of quality control of traditional Chinese medicine preparations
At present, the research on the fingerprints of Liuwei Dihuang Pills mainly includes similarity analysis, and combined with mass spectrometry, ELSD, DAD and other detection technologies to conduct qualitative and multi-index components quantitative research on the main active ingredients of Liuwei Dihuang Pills [Xie B, Gong T, Tang M, et al.Journal of Pharmaceutical and Biomedical Analysis,2008,48(4):1261-1266.; Yan B,Sun G.Journal of Separation Science,2017,41(6).;Qiu Y,Huang J,Jiang X, et al. Journal of Separation Science, 2015, 38(21): 3720-3726.; Ye J, Zhang X, Dai W, et al. J Pharm Biomed Anal, 2009, 49(3): 638-645. ], failed to analyze and belong to the six prescription decoction pieces in Liuwei Dihuang Pills from the overall level, and it is difficult to truly analyze the quality difference of Liuwei Dihuang Pills from different manufacturers
At the same time, the quantification of multi-index components greatly increases the difficulty of obtaining reference substances, the cost and the cumbersomeness of the method
[0005] Chen et al. used micro-infrared spectroscopy to develop an identification method for Liuwei Dihuang Pills prescription based on attenuated total reflection infrared spectroscopy imaging, and realized the simultaneous identification of six decoction pieces in Liuwei Dihuang Pills [Chen J B, Sun S Q, ZhouQ.Analytical and Bioanalytical Chemistry, 2014, 406(18): 4513-4525.]; Bai and Cheng et al. used metagenomics methods to extract and amplify the DNA and compare it with the database to realize the identification of the prescription pieces [Bai H , Li X, Li H, et al.Scientific reports, 2019,9(1):5853.; Cheng X, Su X, ChenX, et al.Scientific Reports, 2014,4(1):5147.], the above Micro-infrared technology has high requirements for instruments and equipment, and DNA extraction and analysis operations are difficult and costly

Method used

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  • HPLC-DAD based six-ingredient rehmannia pill prescription analysis and quality analysis method
  • HPLC-DAD based six-ingredient rehmannia pill prescription analysis and quality analysis method
  • HPLC-DAD based six-ingredient rehmannia pill prescription analysis and quality analysis method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] (1) Preparation of model Liuwei Dihuang Pills: Weigh 10g each of Rehmannia glutinosa, wine cornus, Moutan cortex, Chinese yam, Poria cocos and Alisma alisma, crush them and pass through No. 1.0047g of wine cornus powder, 0.7528g of Moutan cortex powder, 1.0009g of Chinese yam powder, 0.7508g of Poria cocos powder, 0.7520g of Alisma powder, and the model Liuwei Dihuang Wan was prepared according to the regulations of "Chinese Pharmacopoeia" 2015 edition. The above decoction pieces Rehmannia glutinosa are produced in Henan, wine cornus is produced in Henan, peony bark is produced in Anhui, yam is produced in Henan, Poria cocos is produced in Anhui, Alisma is produced in Fujian;

[0048] (2) Extraction of single-taste decoction pieces: Weigh 1.0001g of Rehmannia glutinosa powder, 1.0004g of wine cornus powder, 1.0034g of Moutan bark powder, 1.0006g of Chinese yam powder, 1.0029g of Poria cocos powder, and 1.0032g of Alisma powder, respectively. , add 50mL of 50% methanol, ...

Embodiment 2

[0056] Embodiment 2: Except for the quality evaluation process of commercial Liuwei Dihuang Pills, other steps are the same as in Embodiment 1.

[0057] In the quality evaluation process of Erliuwei Dihuang Pills from the manufacturer, Q-Markers different from those in Example 2 were used: No. 4 characteristic peak of Rehmannia glutinosa, No. 2 characteristic peak of wine cornel, No. The No. 3 characteristic peak of Chinese yam, the No. 2 characteristic peak of Poria cocos, and the No. 2 characteristic peak of Alisma are Q-Markers for quality evaluation of the manufacturer Erliuwei Dihuang Pills. The evaluation results are shown in the attached Figure 20 .

Embodiment 3

[0058] Embodiment 3: Except for the extraction process of decoction pieces and Liuwei Dihuang Wan, other steps are the same as in Embodiment 1. The extraction process of single-flavor decoction pieces is to weigh 4.0012g of crushed Rehmannia glutinosa, 4.0005g of wine cornus, 4.0002g of Moutan cortex, 4.0017g of Chinese yam, 4.0025g of Poria cocos, 4.0014g of Alisma, add 200mL of 50% methanol, and heat to reflux Centrifuge after extraction for 60 min, and take the supernatant to pass through a 0.45 μm organic filter membrane for analysis.

[0059]The extraction process of Liuwei Dihuang Wan is to weigh the model Liuwei Dihuang Wan 4.0004g, manufacturer Yiliuwei Dihuang Wan 8.2016g, manufacturer Erliuwei Dihuang Wan 6.0007g, manufacturer Sanliuwei Dihuang Wan 6.0007g, manufacturer Siliuwei Dihuang Wan 8.2010 g, 6.0014g of Wuliuwei Dihuang Pills from the manufacturer, 8.2012g of Liuliuwei Dihuang Pills from the manufacturer, add 200mL of 50% methanol, heat and reflux for extract...

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Abstract

The invention relates to a quality control method of a traditional Chinese medicine compound preparation, in particular to a prescription analysis and quality analysis method of six-ingredient rehmannia pill based on a high performance liquid chromatography-diode array detection technology (HPLC-DAD). The method comprises the following two parts: firstly, respectively identifying the characteristic peaks of six prescription decoction pieces in a plurality of wavelength modes by utilizing the difference of ultraviolet absorption spectra of chemical components of the six decoction pieces in the six-ingredient rehmannia pill, and establishing a six-ingredient rehmannia pill prescription analysis method based on the characteristic peaks of the decoction pieces; and secondly, developing a quality marker (Q-Marker) of the six-ingredient decoction pieces on the basis of the characteristic peaks of the decoction pieces, and analyzing the current quality situation of the six decoction pieces in the six-ingredient rehmannia pill by using the Q-Marker. The prescription analysis and quality analysis method provided by the invention is simple and efficient, and lays a scientific foundation for the overall quality control of the six-ingredient rehmannia pill.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine compound preparations, and relates to a quality control method of the compound preparation Liuwei Dihuang Pills, specifically the analysis and quality of Liuwei Dihuang Pills based on high-performance liquid chromatography-diode array detection (HPLC-DAD) technology Analytical method. Background technique [0002] Traditional Chinese medicine compound preparations have unique curative effects, embody the holistic view and syndrome differentiation and treatment in the essence of Chinese medicine theory, and are the main forms and means of clinical medicine in Chinese medicine formed in long-term medical practice. , Traditional Chinese medicine compound preparations are usually composed of a variety of medicinal materials, which produce multi-component, multi-target, and multi-channel overall comprehensive regulatory therapeutic effects on the body. However, this combi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89G01N30/06G01N30/14G01N30/74G01N30/54
Inventor 梁鑫淼余文怡沈爱金刘艳芳
Owner DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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