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Method for simultaneously detecting contents of five components of traditional Chinese medicine for treating infantile enuresis

A technology of enuresis in children and traditional Chinese medicine, applied in the direction of measuring devices, material separation, and analysis of materials, can solve the problems of inability to objectively reflect and evaluate the quality consistency of traditional Chinese medicine, the inability to fully control the internal quality of products, large manpower and material resources, and testing equipment. Achieve the effect of improving accuracy and sensitivity, large peak area, and short peak time

Active Publication Date: 2020-07-10
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There is following defect in above quality control method: (1) need to extract and detect respectively to product, cause detection period long, need a large amount of manpower and material resources and detection equipment; (2) only quantitatively detect ephedrine hydrochloride, other composition all only Qualitative, unable to fully control the internal quality of the product, unable to objectively reflect and evaluate the consistency of the quality of traditional Chinese medicine

Method used

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  • Method for simultaneously detecting contents of five components of traditional Chinese medicine for treating infantile enuresis
  • Method for simultaneously detecting contents of five components of traditional Chinese medicine for treating infantile enuresis
  • Method for simultaneously detecting contents of five components of traditional Chinese medicine for treating infantile enuresis

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Embodiment 1

[0032] The preparation of embodiment 1 need testing solution

[0033] Before the HPLC content determination, the drug to be tested needs to be extracted. The purpose of the extraction is to reduce the detected impurities in the preparation, including the extracted components in the traditional Chinese medicine that are not related to the detected components, as well as the excipients in the preparation, so as to reduce the impurities as much as possible. The interference of the peak shape of the characteristic peak of the measured object makes the characteristic peak have a better resolution; the second is to extract the component to be tested from the drug as much as possible, thereby increasing the peak area of ​​the characteristic peak and ensuring the accuracy of the detection. According to the prescription and preparation characteristics of Xiaoer Yima Granules, combined with the solubility, polarity, and stability of the drug ingredients, we respectively investigated the ...

Embodiment 2

[0045] Embodiment 2 chromatographic column is selected

[0046] (1) The chromatographic column is InertSustain NH 2 (5μm, 250×4.6mm)

[0047] (2) The chromatographic column is Kromasil C18 (5μm, 250×4.6mm)

[0048] Detection wavelength: 210nm

[0049] Other conditions are identical with embodiment 1.

[0050] Result: by figure 2 , 5 It can be seen by comparison that Figure 5 Among them, ephedrine hydrochloride and cinnamic acid were obviously not completely separated from the adjacent peaks, and there were more impurities around the cinnamic aldehyde peak. Therefore, the amino chromatographic column is selected as the stationary phase, and the obtained liquid chromatogram has a stable baseline, a more symmetrical peak shape, and a better peak separation.

Embodiment 3

[0051] The selection of embodiment 3 mobile phases

[0052] (1) A is acetonitrile-B containing 0.1% (volume) THF is 0.1% (volume) triethylamine solution

[0053] (2) A is acetonitrile-B is 0.1% triethylamine solution

[0054] (3) A is acetonitrile-B containing 0.1% tetrahydrofuran for water

[0055] (4) A is acetonitrile-B is water

[0056] Detection wavelength: 210nm

[0057] Other conditions are identical with embodiment 1.

[0058] Result: by figure 2 , 6 , 7, 8 can be seen, Figure 6 and Figure 7 No ephedrine hydrochloride chromatographic peak, and Figure 7 Mobile phase baseline drift; Figure 8 The mobile phase baseline drifts, and there are few components detected in the chromatographic peaks, so the acetonitrile-0.1% triethylamine solution system with 0.1% tetrahydrofuran as the mobile phase is selected. Larger area and better peak resolution.

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Abstract

The invention discloses a method for simultaneously detecting contents of five components of a traditional Chinese medicine for treating infantile enuresis. The traditional Chinese medicine for treating infantile enuresis is prepared from six traditional Chinese medicinal materials including ephedra, cinnamon, alpinia oxyphylla, ginkgo, semen cuscutae and endothelium corneum gigeriae galli, the five components include ephedrine hydrochloride, cinnamaldehyde, cinnamic acid, quercetin and ginkgolide C. The detection method comprises the steps that the traditional Chinese medicine is extracted through an extraction solvent and then detected through a high performance liquid chromatograph. Compared with the methods in the prior art, the method has the advantages of high detection sensitivity,high speed, simplicity in operation and the like, the detection efficiency and the detection accuracy are greatly improved, and the internal quality of the traditional Chinese medicine can be more comprehensively controlled.

Description

technical field [0001] The invention belongs to the field of drug detection and relates to a method for simultaneously detecting the contents of five components of a traditional Chinese medicine for treating enuresis in children. Background technique [0002] CN 1593496A discloses a traditional Chinese medicine for treating enuresis in children. It is made of six traditional Chinese medicinal materials including ephedra, cinnamon, yizhi, ginkgo, dodder, and gallinaceous gold. It is mainly used to treat children with enuresis and deficiency of kidney qi. This traditional Chinese medicine is an exclusive variety of Jianmin Pharmaceutical Group Co., Ltd., and its trade name is Xiaoer Yima Granules. [0003] Xiaoer Yima Granule is a commonly used drug for enuresis in children. It has definite clinical curative effect and a large market demand, but its quality standard is simple. Only four medicinal materials, Cuscuta, Cinnamon, Yizhi and Ginkgo, were qualitatively identified by...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 李霞黄志军赵刚吴木琴向阳陈鹏熊登科
Owner JIANMIN PHARMA GRP CO LTD
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