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Determination method and application of ephedrine hydrochloride content in Maxing Shigan Oral Liquid

A technology of Shigan oral liquid and ephedrine hydrochloride, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as inability to separate ephedrine and pseudoephedrine, long sample analysis time, inaccurate content determination, etc., to achieve good guidance for production , Improving quality control standards, strict and reasonable process control

Active Publication Date: 2016-01-20
PULIKE BIOLOGICAL ENG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

None of these methods can separate ephedrine and pseudoephedrine, the peak shape is not good, and the tailing is serious, resulting in inaccurate content determination and long sample analysis time

Method used

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  • Determination method and application of ephedrine hydrochloride content in Maxing Shigan Oral Liquid
  • Determination method and application of ephedrine hydrochloride content in Maxing Shigan Oral Liquid
  • Determination method and application of ephedrine hydrochloride content in Maxing Shigan Oral Liquid

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Experimental program
Comparison scheme
Effect test

preparation example Construction

[0036] (2) Preparation of reference substance solution

[0037] Accurately weigh 10 mg of ephedrine hydrochloride reference substance, put it in a 100 ml measuring bottle, dissolve and dilute to the mark with 0.1% hydrochloric acid methanol, and shake well. Accurately measure 2ml, put it in a 10ml measuring bottle, dilute to the mark with mobile phase, shake well, and obtain (every 1ml contains 20 μg of ephedrine hydrochloride).

[0038] (3) Preparation of the test solution

[0039] Precisely measure 1ml of this product, put it in a 25ml measuring bottle, add mobile phase to dilute to the mark, shake well, and you get it.

[0040] (4) measure the content of ephedrine hydrochloride in need testing solution

[0041] Accurately draw 5 μl each of the reference substance solution and the test solution respectively, inject it into the liquid chromatograph, measure it, and obtain it.

[0042] The content index of ephedrine hydrochloride in Maxing Shigan oral liquid of the present ...

Embodiment 1

[0045] Embodiment 1: the assay of ephedrine hydrochloride

[0046] (1) Instruments and reagents, samples

[0047] Instrument: Waters UPLCACQUITY system, WATERSACQUITY UPLC BEHC18 chromatographic column (2.1×50mm, 1.7μm).

[0048] Reagents: Acetonitrile is chromatographically pure; water is double distilled water; other reagents are analytically pure.

[0049] Reference substance: ephedrine hydrochloride was purchased from China Veterinary Drug Administration.

[0050] Sample: The sample of Maxing Shigan Oral Liquid was produced by Luoyang Huizhong Veterinary Medicine Co., Ltd.

[0051] (2) Selection of mobile phase

[0052] Mobile phase 1: 0.1% phosphoric acid-acetonitrile (95:5);

[0053] Mobile phase 2: 0.1% phosphoric acid (containing 0.1% triethylamine)-acetonitrile (95:5);

[0054] Mobile phase 3: 0.02mol / L potassium dihydrogen phosphate (containing 0.1% triethylamine, phosphoric acid to adjust pH to 2.5)-acetonitrile (95:5);

[0055] Mobile phase 4: 0.02mol / L ammoniu...

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Abstract

The invention relates to a measuring method of content of ephedrine hydrochloride in ephedra, bitter almond, gypsum and liquoric root oral liquid and application of the measuring method. According to the method, the content of the ephedrine hydrochloride in the ephedra, bitter almond, gypsum and liquoric root oral liquid is detected by using high performance liquid chromatography; the number of theoretical plates of a liquid chromatographic system of the high performance liquid chromatography is calculated to be not less than 6,000 according to the peak of the ephedrine hydrochloride. According to the method, ephedrine can be separated from pseudoephedrine, and the content of the ephedrine can be accurately detected so as to accurately detect the quality of the ephedra, bitter almond, gypsum and liquoric root oral liquid and improve the quality control standard of the ephedra, bitter almond, gypsum and liquoric root oral liquid. Thus, the method is used for detecting the quality of the ephedra, bitter almond, gypsum and liquoric root oral liquid to guide production better and enable more strict and rational process control, so that the quality of the product can be effectively controlled, and the curative effect of the product is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of drug testing, and relates to a method for determining the content of ephedrine hydrochloride in Maxing Shigan oral liquid and its application in the quality detection of Maxing Shigan oral liquid. Background technique [0002] Maxing Shigan Oral Liquid is made by extracting ephedra, bitter almond, gypsum, and licorice. It has the effects of clearing away heat, clearing the lungs, and relieving asthma. It is mainly used to treat poultry infectious rhinitis, infectious bronchitis, and infectious laryngotracheitis. and other chronic respiratory diseases. In the formula, ephedra and gypsum are the monarch drug, bitter almond is the minister drug, and licorice is the envoy drug. The basic research of modern pharmacodynamic substances shows that ephedrine is the main active ingredient of the formula. [0003] But, in the existing Maxing Shigan oral liquid quality standard, only provide the TLC identification m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 张许科刘兴金张晓会
Owner PULIKE BIOLOGICAL ENG INC
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