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Method for determining ephedrine hydrochloride content in lung-clearing inflammation pill by high-performance liquid phase

A technology for ephedrine hydrochloride and its determination method, which is applied in the field of ephedrine hydrochloride content, and can solve the problems of poor reproducibility of thin-layer scanning method and the like

Inactive Publication Date: 2012-10-03
津药达仁堂集团股份有限公司达仁堂制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the reproducibility of the TLC method is relatively poor

Method used

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  • Method for determining ephedrine hydrochloride content in lung-clearing inflammation pill by high-performance liquid phase
  • Method for determining ephedrine hydrochloride content in lung-clearing inflammation pill by high-performance liquid phase
  • Method for determining ephedrine hydrochloride content in lung-clearing inflammation pill by high-performance liquid phase

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] prescription:

[0100] 250 parts of ephedra, 750 parts of gypsum, 750 parts of earthworm

[0101] 250 parts of burdock seed, 250 parts of tingli seed, 100 parts of bezoar

[0102] Bitter almond (fried) 60 parts Antelope horn 30 parts

[0103] Preparation:

[0104] The above eight flavors, except the artificial bezoar, the antelope horn is crushed into fine powder, and the other six flavors such as ephedra are crushed into fine powder, blended with the above antelope horn and artificial bezoar powder, mixed, and sieved. For every 100g of powder, use 60~80g of refined honey and add appropriate amount of water pan pills to make water honey pills;

Embodiment 2

[0106] (1) Preparation of test solution:

[0107] 1) Preparation of reference substance solution: Take an appropriate amount of ephedrine hydrochloride reference substance, weigh it accurately, add methanol to make a solution containing 30 μg per 1 ml, and obtain it;

[0108] 2) Preparation of the test solution: take Qingfei Xiaoyan Pills, grind them finely, take about 2g, weigh them accurately, add 120ml of 5mol / L sodium hydroxide solution, 7.5g of sodium chloride, ultrasonicate for 10 minutes, and keep slightly boiling Under distillation, use a 5ml measuring bottle filled with 0.5mol / L hydrochloric acid solution to collect 90-98ml of distillate, add water to the mark, shake well, and you get it;

[0109] 3) Preparation of negative control solution: prepare a sample without ephedra according to the prescription and process, and prepare according to the preparation method of the test sample;

[0110] (2) Chromatographic conditions

[0111] Mobile phase: acetonitrile-0.02mol / ...

Embodiment 3

[0117] (1) Preparation of test solution:

[0118] 1) Preparation of reference substance solution: Take an appropriate amount of ephedrine hydrochloride reference substance, weigh it accurately, add methanol to make a solution containing 30 μg per 1 ml, and obtain it;

[0119] 2) Preparation of the test solution: take Qingfei Xiaoyan Pills, grind them finely, take about 2g, weigh them accurately, add 80ml of 5mol / L sodium hydroxide solution and 7.5g of sodium chloride, ultrasonicate for 10 minutes, and keep slightly boiling Under distillation, use a 5ml measuring bottle filled with 0.5mol / L hydrochloric acid solution to collect 90-98ml of the distillate, add water to the mark, shake well, and filter through a 0.45μm microporous membrane to obtain the product;

[0120] 3) Preparation of negative control solution: prepare a sample without ephedra according to the prescription and process, and prepare according to the preparation method of the test sample;

[0121] (2) Chromatogr...

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Abstract

The invention relates to a method for determining ephedrine hydrochloride content in a lung-clearing inflammation pill by a high-performance liquid phase, wherein the chromatographic condition mobile phase is acetonitrile and 0.02mol / L of monopotassium phosphate solution with pH2.7; the volume ratio is 4:96; the detection wavelength is 207nm; the flow speed is 1.0ml / min; the chromatographic column is Dikma 5mumC184.6*250mm, and the column temperature is 30 DEG C. The separating effect of ephedrine hydrochloride and pseudoephedrine hydrochloride peak is good under a flow phase condition; the quantity of the theoretical plates is 6976 according to the ephedrine hydrochloride peak, and 1g of the product contains ephedrine hydrochloride (C10H15NO.HCl) being not less than 0.65mg. According to the determination method disclosed by the invention, the controllability of content standard of the drug is improved; the internal content of the product is ensured, and the method has significance in the aspects of promoting product sales, increasing the market competitiveness of the product and ensuring the medication safety of a patient.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a quality detection method of Chinese patent medicines, in particular to a method for measuring the content of ephedrine hydrochloride in Qingfei Xiaoyan pills by using high performance liquid phase. Background technique [0002] In my country, traditional Chinese medicine identification is a relatively traditional traditional Chinese medicine inspection technology, which has gradually matured with the development of Chinese medicine theory in my country. Many identification methods have gradually exerted their unique advantages in the quality inspection of traditional Chinese medicine. In my country's 2000 edition of the Pharmacopoeia, 59 kinds of medicinal materials and 50 kinds of clinical Chinese patent medicines were selected for testing by high performance liquid chromatography, and high performance liquid chromatography is also increasingly ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 江永萍刘彤赵晨宋立平项芳韩晓辰
Owner 津药达仁堂集团股份有限公司达仁堂制药厂
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