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Quality control method for Huang's sound pill

A technology of Huang's Xiangsheng pill and detection method, which is applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of quality inspection interference, inaccurate test results, and inability to accurately and comprehensively control product quality.

Active Publication Date: 2015-04-01
WUXI JIMIN KEXIN SHANHE PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The quality control methods of traditional Chinese medicine and Chinese medicine preparations in my country are mostly microscopic identification, thin-layer identification and content determination of single component types, which cannot accurately and comprehensively control product quality
The various components and various excipients of traditional Chinese medicine preparations will interfere with quality testing in many ways. If the sample pretreatment procedures are not scientifically verified, it is likely to cause inaccurate test results.

Method used

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  • Quality control method for Huang's sound pill
  • Quality control method for Huang's sound pill
  • Quality control method for Huang's sound pill

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] The content assay method of embodiment 1 free anthraquinone and combined anthraquinone

[0076] 1. Chromatographic conditions:

[0077] Chromatographic instrument: Waters H-class UPLC, chromatographic column: Phonomenex Gemini-NX C18 (150×4.6mm, 5um), column temperature: 30°C, flow rate: 1.0ml / min, mobile phase: acetonitrile-0.32% phosphoric acid aqueous solution 38: 62 hold for 15 minutes, adjust to 51:49, hold for 8 minutes, adjust to 55:45, hold for 12 minutes, detection wavelength: 254nm, injection volume: 10ul.

[0078] 2. Sample preparation

[0079] Preparation of the reference substance solution: Take an appropriate amount of the aloe-emodin reference substance and accurately weigh it, add methanol to make a reference substance solution containing 0.03 mg per 1 ml. Take an appropriate amount of emodin reference substance and accurately weigh it, add methanol to make a reference solution containing 0.05 mg per 1 ml. Take an appropriate amount of rhein reference...

Embodiment 2

[0105] The content assay method of embodiment 2 forsythin

[0106] 1. Chromatographic conditions: Chromatographic instrument: Waters H-class UPLC, chromatographic column: Phonomenex Gemini-NX C18 (150×4.6mm, 5um), column temperature: 40°C, flow rate: 1.0ml / min, mobile phase: acetonitrile-water (21:79), detection wavelength: 277nm, injection volume: 10ul

[0107] 2. Sample preparation

[0108] Preparation of the reference substance solution: Accurately weigh 5.64 mg of the reference substance forsythin, place it in a 25ml volumetric flask, dissolve the mobile phase, and constant volume. The reference substance stock solution (0.2150 mg / ml) was obtained.

[0109] Preparation of the test solution: Take 1g of Huangshi Xiangsheng pills, accurately weighed, put in a stoppered Erlenmeyer flask, add 20ml of methanol, seal it tightly, ultrasonicate for 30min, accurately measure 10ml of the subsequent filtrate, steam to nearly dry, add medium Mix 1.5 g of neutral alumina (100-200 mes...

Embodiment 3

[0133] The assay method of embodiment 3 ferulic acid

[0134] 1. Chromatographic conditions: chromatograph: Waters H-class UPLC, chromatographic column: Phonomenex Gemini-NX C18 (150×4.6mm, 5um), column temperature: 35°C, flow rate: 1.0ml / min, mobile phase: methanol-0.1 % phosphoric acid solution (20:80), detection wavelength: 321nm, injection volume: 10ul

[0135] 2. Sample preparation

[0136] Preparation of the reference substance solution: Take an appropriate amount of the ferulic acid reference substance and accurately weigh it, add 70% methanol to make a reference substance solution containing 0.05 mg per 1 ml.

[0137] Preparation of the test solution: Take 1g of Huangshi Xiangsheng Pills, accurately weighed, add 20ml of 70% methanol solution, ultrasonic treatment for 10min, filter, and get the filtrate.

[0138] Determination: Precisely pipette the reference substance solution and the test solution of the same volume for sample injection, the volume drawn is 10ul, an...

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Abstract

The invention relates to a quality control method for Huang's sound pill. The quality control method employs liquid chromatography to perform content determination, and the content processes comprises determination processes for free anthraquinone, combined anthraquinone, forsythol, ferulic acid and glycyrrhizic acid. The quality control method is sensitive and fast, is capable of timely accurately reflecting the quality of nonvolatile main compositions in Huang's sound pill and improving production monitoring level, and has more practical application meaning in industrial production.

Description

technical field [0001] The invention relates to a quality control method of Huangshi Xiangsheng pill preparation. technical background [0002] Huang's Xiangsheng Pills are developed based on nine generations of ancestral secret recipes dedicated by the chief physician Huang Shennong, a famous old Chinese doctor of laryngology. It can be used to treat acute and chronic laryngitis, vocal cord nodules, vocal cord polyps, and constipation. Its quality standards are recorded in the "Chinese Pharmacopoeia" 2010 edition, page 1064, in which the identification tests include rhubarb, Chuanxiong, and licorice, and the content determination detects peimin A and peimin B in Fritillaria japonicus. [0003] The quality control methods of traditional Chinese medicine and Chinese medicine preparations in my country are mostly microscopic identification, thin-layer identification and content determination of a single component type, which cannot accurately and comprehensively control produc...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/88
Inventor 朱音张禄
Owner WUXI JIMIN KEXIN SHANHE PHARMA
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