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Quality control method of rhizoma wenyujin concisum formula granules

A quality control method and technology of formulated granules, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of low polarity of gemmaconone, questionable quality index, poor water solubility, etc., to achieve improved peak shape, high detection efficiency, Accurate effect of quality judgment

Active Publication Date: 2021-12-07
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are few quality control studies on the content determination and characteristic map of turmeric slices, and no quality control research reports on turmeric powder formula granules have been found. Some scholars use HPLC The characteristic map method of turmeric medicinal materials and decoction pieces has been established, and gemmacone is mostly used as the index component, but gemmacone is less polar, poorly water-soluble, and hardly dissolves in standard decoctions. Therefore, in the prior art The disclosed method is only applicable to the detection of sliced ​​turmeric medicinal materials and semi-finished products, and its use as a quality index of sliced ​​turmeric formula granules is subject to discussion

Method used

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  • Quality control method of rhizoma wenyujin concisum formula granules
  • Quality control method of rhizoma wenyujin concisum formula granules

Examples

Experimental program
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Effect test

Embodiment 1

[0034] A quality control method for sliced ​​turmeric formula granules, comprising adopting high performance liquid chromatography to obtain the characteristic spectrum of the test solution, in which the chromatographic peak of curcumenol is used as the reference peak S, and the relationship between each characteristic peak and the reference peak S is calculated. The relative retention time of peak S, wherein the relative retention time of at least 3 characteristic peaks is within ±10% of the specified value, and the specified value is: 0.28, 0.76, 1.25.

[0035] The chromatographic conditions of the high performance liquid chromatography in this embodiment are: using octadecylsilane bonded silica gel as filler, Waters BEH C18 chromatographic column, the column length of the chromatographic column is 100mm, the inner diameter of the column is 2.1mm, the particle diameter with acetonitrile as mobile phase A and 0.1% phosphoric acid as mobile phase B, carry out gradient elution a...

Embodiment 2

[0063] In this embodiment, conventional methods are used to verify the precision, repeatability and stability of the characteristic map, as follows:

[0064] Take 6 parts of the test solution, obtain its characteristic spectrum, take the curcumenol peak as the reference peak, calculate its relative peak area and relative retention time. And calculate the RSD. Results The RSD of the relative retention time of each characteristic peak was in the range of 0.0%-0.1%, and the RSD of the relative peak area was in the range of 0.2%-2.4%, which indicated that the repeatability of the characteristic spectrum was good.

[0065] Using Waters UPLC H-Class, TUV detector, take the test solution, obtain its characteristic spectrum, take the curcumenol peak as the reference peak, calculate its relative peak area and relative retention time. And calculate the RSD. Results In the characteristic spectrum obtained by Waters UPLCH-Class and TUV detector, the relative retention time of each chara...

Embodiment 3

[0068] This embodiment provides the quality control method of the turmeric formula granules, which, in addition to the quality control of the characteristic spectrum recorded in Example 1, also includes the quantitative control of the quality evaluation index components in the turmeric formula granules, including the control of curcumenol The content in turmeric formula granules is not less than 4.5mg / g.

[0069] The chromatographic conditions used in this example are basically the same as those in Example 1, the only difference being that the detection wavelength is adjusted to 260nm for detection.

[0070] Using the chromatographic conditions of this example, first draw the standard curve of curcumenol, and obtain the regression equation of curcumenol as y=4542.0025x+1445.5373, R=1.0000, and its linear range is 6.844 μg / ml~219.010 μg / ml.

[0071] Then adopt the detection method of the present embodiment to carry out the detection of 20 batches of turmeric standard decoctio...

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Abstract

The invention provides a quality control method of rhizoma wenyujin concisum formula granules, which comprises the following steps: obtaining a characteristic chromatogram of a test solution by adopting high performance liquid chromatography, calculating the relative retention time of each characteristic peak and the reference peak S by taking the chromatographic peak of curcumenol in the characteristic chromatogram as the reference peak S, wherein the relative retention time of at least three characteristic peaks is within + / -10% of specified values, and the specified values are 0.28, 0.76 and 1.25. The curcumenol which is relatively high in content and relatively stable is selected as a quality evaluation index component of the rhizoma wenyujin concisum formula granule, and the overall quality control of the rhizoma wenyujin concisum formula granule is realized in combination with common control of other quality evaluation index components; the method has the advantages that judgment is more accurate and objective, and clinical medication requirements are met.

Description

technical field [0001] The invention relates to the field of preparation of traditional Chinese medicines, in particular to a quality control method for turmeric sliced ​​formula granules. Background technique [0002] Sliced ​​turmeric is the dry rhizome of turmeric, a plant of the ginger family, pungent, bitter, warm in nature, and returns to the spleen and liver meridians. It has the effects of dispelling blood and promoting qi, promoting menstruation and relieving pain. It is clinically used for amenorrhea due to blood stagnation, abdominal pain during menstruation, rheumatic arthralgia, shoulder and arm pain, and traumatic injuries. It is widely used clinically, and is often used to treat joint pain caused by rheumatoid arthritis and osteoarthritis, etc. It mainly contains sesquiterpenes, monoterpenes, and curcuminoids. Modern pharmacological studies have shown that it has anti-inflammatory, analgesic, anti-oxidant, anti-tumor, anti-thrombotic and coagulation effects, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8634
Inventor 张志强付静沈建梅王晓亚郭江玉
Owner BEIJING KANGRENTANG PHARMA
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