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Quality control method of xiaojiean preparation

A quality control method and preparation technology, which is applied in the field of TLC identification and content determination of Smilax smilax in Xiaojie'an preparations, and can solve the problems that there are no identification methods and content determination methods for Smilax smilax

Active Publication Date: 2011-09-28
云南神威施普瑞药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no identification method and content determination method for the components of Smilax smilax in Xiaojie'an preparations

Method used

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  • Quality control method of xiaojiean preparation
  • Quality control method of xiaojiean preparation
  • Quality control method of xiaojiean preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Embodiment 1: Take the test product (for example, weigh 1.5 g of the content of 09090505 Pixiaojie’an Capsule), which contains 5 mg of Astilbin; solution 10ml), the test sample contains astilbin 5mg, concentrated to dryness; add methanol 15ml to the above test sample, ultrasonically place for 15 minutes, let cool, filter, and the filtrate is concentrated to 2ml, as the test solution. Another astilbin reference substance 3mg, add methanol 1ml to dissolve, as the reference substance solution. Then take 1 g of Smilax smilax as reference medicinal material, and prepare the reference medicinal material solution in the same way. According to the thin-layer chromatography (Appendix VI B of "Chinese Pharmacopoeia") test, draw 2 μl of each of the above three solutions, respectively spot on the same silica gel G thin-layer plate, and mix with chloroform-methanol-formic acid (4:1: 0.05) as the developer, develop, take out, dry in the air, spray with 5% vanillin and 10% sulfuric a...

Embodiment 2

[0090] Embodiment 2: The color developer described in embodiment 1 is replaced with 2% ferric chloride ethanol solution, after spraying with the color developer, it is inspected under sunlight, and other is the same as embodiment 1.

Embodiment 3

[0091] Embodiment 3: The color developer described in Example 1 was replaced with 1% aluminum chloride ethanol solution, after spraying with the color developer, it was inspected under an ultraviolet lamp (365nm), and the others were the same as in Example 1.

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Abstract

The invention relates to a quality control method of a medicine preparation, and especially relates to thin layer chromatogram authentication and content determination of smilax glabra in a xiaojiean preparation. The method is a thin layer chromatogram authentication and / or content determination method formulated by using a special component in the smilax glabra of the xiaojiean preparation as an index component, wherein the special component is astilbin, and the xiaojiean preparation is a traditional Chinese medicine compound preparation prepared from 1100 parts of leatherleaf mahonia, 750 parts of thin evodia, 750 parts of motherwort, 750 parts of spatholobus stem, 900 parts of smilax glabra and 750 parts of fructus forsythiae. The thin layer chromatogram authentication method with a strong specialization can authenticate smilax glabra accurately and reliably, and a generally employed HPLC can determine the astilbin content in the xiaojiean preparation, so as to produce valuable significance for monitoring and controlling medicinal material purchase, preparation production process and preparation quality in market, and ensuring product safety, effectiveness and quality stabilization. According to the method, problem of confused smilax glabra basic material provided in the market can be solved effectively to ensure that xiaojiean preparation meets the national medicine standards strictly.

Description

technical field [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to thin-layer chromatographic identification and content determination of Smilax smilax in Xiaojie'an preparations. Background technique [0002] Xiaojie'an (formerly known as Rupi'anxiao) is a traditional Chinese medicine compound preparation composed of six medicinal materials such as Gongluomu, Sanchaku, Leonurus, Mildew Spatholobus, Smilax Smilax, and Forsythia, including capsules, oral liquids and other dosage forms. Xiaojie'an The current quality standards for capsules are recorded in the "National Compilation of Chinese Patent Medicine Standards" Landmark National Standard Oral Oncology Pediatric Volume (411-414 pages), standard number: WS-10433(ZD-0433)-2002, the current quality standards for Xiaojie'an Oral Liquid It is recorded in the "National Compilation of Chinese Proprietary Medicine Standards" Landmark Upgrade National Standard Oral Oncology P...

Claims

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Application Information

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IPC IPC(8): A61K36/896A61P15/00A61P15/14A61P35/00G01N30/02G01N30/90
Inventor 杨增明
Owner 云南神威施普瑞药业有限公司
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