Children Kaihoujian spray as well as preparation and quality standard inspection method thereof

A technology of quality standards and inspection methods, applied in aerosol delivery, measuring devices, pharmaceutical formulations, etc., can solve the problem of lack of identification method of cinnabar and reference medicinal materials, lack of method for determination of leucovorin content, and complex preparation method of test samples, etc. problem, to achieve the effect of stable method, strong specificity and good reproducibility

Inactive Publication Date: 2018-05-08
贵州三力制药股份有限公司
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Problems solved by technology

[0002] The quality standard of Kaihoujian spray (child type) is now recorded in the National Drug Standard WS-10132(ZD-0132)-2002-2012Z of the State Food and Drug Administration, and the drug approval number is Z20025142; Composed of four flavors of traditional Chinese medicine, the original standard uses petracenin as a control for identification, the preparation method of th

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  • Children Kaihoujian spray as well as preparation and quality standard inspection method thereof
  • Children Kaihoujian spray as well as preparation and quality standard inspection method thereof
  • Children Kaihoujian spray as well as preparation and quality standard inspection method thereof

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Embodiment Construction

[0048] Embodiments of the invention:

[0049] Introduction of related Chinese herbal medicines in Kaihoujian Spray (Children Type)

[0050] 1.1 Main chemical components and physical and chemical properties of cinnabar root

[0051] The cinnabar root is the dried root of Ardisia crenata Sims, a purple gold bovine plant.

[0052] Chemical composition: Cinnabar root mainly contains triterpenoid saponins, coumarins and others; among them, the structural types of saponins are mainly pentacyclic triterpenoid oleanane derivatives, and there are two types of aglycones: epoxy ethers and 12-enes. The coumarins are mainly petogenins. It also contains some other ingredients: purple gold tauroquinone, terpene, β-sitosterol, carotamarin,.

[0053] Begenin

[0054] [structural formula]

[0055]

[0056] 【Molecular formula and molecular weight】C 14 h 16 o 9 ;328.27

[0057] 【Physical properties】White loose needle crystal or crystalline powder, melting point 232-240℃, soluble in m...

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Abstract

The invention discloses a children Kaihoujian spray as well as a preparation and quality standard inspection method thereof. The children Kaihoujian spray is prepared from four Chinese herbs such as ardisia crispa, radix sophorae subprostratae, periostracum cicada and menthol; in an identification process, the thin-layer identification of radix ardisiae crenataeis is corrected, in an original standard, the identification is performed by referring to bergenin, a test sample preparation method is complex, the original method is modified, a radix ardisiae crenataeis reference herb is added, so that the test sample preparation method is simplified, and the method is high in specificity and good in repetition and is listed in the standard text; the language description for identifying a mentholthin layer is standardized, and a reagent benzene used for the developing agent is replaced as methylbenzene; and the thin-layer identification of the radix ardisiae crenataeis is added, sophocarpidine is adopted as a reference, and by virtue of examination, the method is stable and good in repetition, thereby being listed in the standard text. In addition, the research is made for the thin-layeridentification of periostracum cicada.

Description

technical field [0001] The invention relates to the technical field of medicine preparation and quality control thereof, in particular to a children's Kaihoujian spray and its preparation and quality standard inspection method. Background technique [0002] The quality standard of Kaihoujian spray (child type) is now recorded in the National Drug Standard WS-10132(ZD-0132)-2002-2012Z of the State Food and Drug Administration, and the drug approval number is Z20025142; Composed of four flavors of traditional Chinese medicine, the original standard uses petracenin as a control for identification, the preparation method of the test sample is complicated, and lacks the identification method of cinnabar and the reference medicinal material, and lacks the content determination method of the active ingredient petracenin in cinnabar root; the original quality The developer used for menthol in the standard is the reagent benzene, and at the same time, it lacks the TLC identification ...

Claims

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Application Information

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IPC IPC(8): A61K36/534A61K9/12A61P11/04G01N30/90G01N30/02A61K35/64A61K31/045
CPCA61K9/12A61K31/045A61K36/185A61K36/489A61K36/534A61K2236/331A61K2236/39A61K2236/51A61K35/63G01N30/02G01N30/90A61K2300/00
Inventor 张海范晓波董秀
Owner 贵州三力制药股份有限公司
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