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Quality control method of liu-wei tonic tablets dual-wavelength fingerprint chromatogram

A quality control method, the technology of Liuwei Dihuang Pills, is applied to medical preparations containing active ingredients, pill delivery, measuring devices, etc. It can solve problems such as inability to evaluate and control the quality of traditional Chinese medicine, mobile phase system and complex pretreatment, etc. Easy to master, improve quality control standards, and good reproducibility

Inactive Publication Date: 2008-07-30
天津海世达检测技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using this standard to determine paeonol in Moutan Cortex and loganin in Cornus officinalis as the content quality control standard is to measure separately under two different wavelengths using different pretreatment methods; this method cannot be evaluated and controlled as a whole The quality of traditional Chinese medicine, and the mobile phase system and pretreatment of loganin determination method in Pharmacopoeia are relatively complicated

Method used

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  • Quality control method of liu-wei tonic tablets dual-wavelength fingerprint chromatogram
  • Quality control method of liu-wei tonic tablets dual-wavelength fingerprint chromatogram
  • Quality control method of liu-wei tonic tablets dual-wavelength fingerprint chromatogram

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Take Liuwei Dihuang Pills, chop them into pieces, take 1.0g, accurately weigh them, put them in a stoppered Erlenmeyer flask, add 25mL of methanol precisely, seal them tightly, weigh them, extract them with ultrasound, treat them with ultrasound for 60 minutes, let cool, and weigh again Determine the weight, use methanol to make up the lost weight, shake well, filter, and take the filtrate to obtain the final product.

[0041] Preparation of reference substance solution: Accurately weigh appropriate amounts of loganin reference substance and paeonol reference substance, and add methanol to make solutions containing 14 μg of loganin reference substance and 18 μg of paeonol reference substance per 1 mL, respectively.

[0042] Determination method: According to the conditions of high performance liquid chromatography (Appendix VID of the Chinese Pharmacopoeia 2005 edition). Chromatographic conditions and system suitability test: Chromatographic column: Agilent SB C 18 (4....

Embodiment 2

[0050] Take Liuwei Dihuang concentrated pills, chop them up, take 1.0g, weigh them accurately, put them in a stoppered Erlenmeyer flask, add 25mL of methanol precisely, seal them tightly, and weigh them. Ultrasonic extraction is ultrasonic treatment for 120 minutes, let cool, and weigh again. Weight, use methanol to make up the lost weight, shake well, filter, and take the continued filtrate, that is.

[0051] Preparation of reference substance solution: Accurately weigh appropriate amounts of loganin reference substance and paeonol reference substance, and add methanol to make solutions containing 14 μg of loganin reference substance and 18 μg of paeonol reference substance per 1 mL, respectively.

[0052] Determination method: According to the conditions of high performance liquid chromatography (Appendix VID of the Chinese Pharmacopoeia 2005 edition). Chromatographic conditions and system suitability test: Chromatographic column: Agilent SB C 18 (4.6mm×250mm, 5μm); see Tab...

Embodiment 3

[0059] Comparative experiment of the same batch of Liuwei Dihuang pills determined by conventional method and dual-wavelength coverage fusion method:

[0060] normal method:

[0061] Take Liuwei Dihuang Pill sample ××× pharmaceutical company (batch number is B058220) according to the Pharmacopoeia method, respectively assay loganin and paeonol.

[0062] The assay method of loganin is: chromatographic conditions: using octadecylsilane bonded silica gel as filler; using THF-acetonitrile-methanol-0.05% phosphoric acid solution (1:8:4:87) as mobile phase; detection wavelength is 236nm; the column temperature is 40°C, and the number of theoretical plates should not be less than 3000 based on the loganin peak.

[0063] Preparation of the reference substance solution: Take an appropriate amount of the loganin reference substance, weigh it accurately, add 50% methanol to make a solution containing 20mg per 1mL, and obtain it.

[0064] Preparation of the test solution: take this prod...

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Abstract

The invention discloses a quality control method of dual-wavelength overlaying and fusing fingerprints of pills of six ingredients with rehmannia. By combining the technology of fingerprints and the characteristic of components to be detected, utilizing the detecting method that absorption peaks produced by maximum uv-absorption wavelengths of different components overlay and fuse, the invention can eliminate interferences of the absorption peak produced by various wavelengths and ensure the accuracy and reliability of detected components. By the application of dual-wavelength overlaying and fusing, the quality control method correctly grasps the qualities of related medicines, thereby effectively ensuring the safety, unity, stability, efficiency and being controllable of pills of six ingredients with rehmannia. The quality control method of the invention is simple, correct in result and good in reproducibility, and can be applied to the quality evaluation of Chinese medicines, the quality control of Chinese medicines and the new medicine development of Chinese medicines, in particular to being used as one of the indexes of the quality control and true-and-false identification of pills of six ingredients with rehmannia.

Description

field of invention [0001] The invention belongs to the technical field of detecting traditional Chinese medicine preparations by using modern analysis and detection instruments, and relates to a quality control method of traditional Chinese medicine, more specifically, a quality control method of Liuwei Dihuang Pills with dual-wavelength coverage and fusion fingerprints. Background technique [0002] Liuwei Dihuang Wan is a representative prescription for nourishing kidney yin in TCM tonics. Its formula is derived from classic ancient prescriptions, and it is composed of six medicinal materials: Rehmannia glutinosa, Cornus officinalis (made), Cortex Moutan, Alisma, Chinese yam, and Poria cocos. It has the main function of nourishing yin and tonifying kidney. Its legislation is based on the combination of kidney, liver, and spleen and nourishing the three yin, and mainly nourishing the kidney. Rehmannia glutinosa nourishes kidney yin, replenishes essence and marrow as the ma...

Claims

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Application Information

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IPC IPC(8): A61K36/8945A61K9/16A61K9/20A61K9/48A61P1/14A61P25/28A61P39/00G01N30/36G01N30/86
Inventor 罗国安孟宪生程奕赵洪芝叶挺祥刘征辉王勇黎莉
Owner 天津海世达检测技术有限公司
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