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Method for determining content of active ingredients such as ephedrine hydrochloride and pseudoephedrine hydrochloride in pinellia ternata syrup

A technology of pseudoephedrine hydrochloride and ephedrine hydrochloride, which is applied in the field of determining the content of ephedrine hydrochloride and pseudoephedrine hydrochloride, the active ingredients in Banxia syrup, can solve the problems of not being able to effectively control the internal quality of medicines, and achieve high stability and accuracy, control Good quality and separation effect

Inactive Publication Date: 2015-07-08
HUBEI DUANZHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] This standard has no content determination items, and cannot effectively control the internal quality of the drug. According to relevant requirements, it is necessary to add content determination standards for this preparation to better control product quality.

Method used

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  • Method for determining content of active ingredients such as ephedrine hydrochloride and pseudoephedrine hydrochloride in pinellia ternata syrup
  • Method for determining content of active ingredients such as ephedrine hydrochloride and pseudoephedrine hydrochloride in pinellia ternata syrup
  • Method for determining content of active ingredients such as ephedrine hydrochloride and pseudoephedrine hydrochloride in pinellia ternata syrup

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Embodiment Construction

[0019] Below in conjunction with accompanying drawing and specific embodiment the present invention will be described in further detail:

[0020] The invention provides a method for measuring the content of active ingredients ephedrine hydrochloride and pseudoephedrine hydrochloride in Banxia syrup, comprising the following steps:

[0021] (1) Preparation of reference substance solution: take appropriate amounts of ephedrine hydrochloride reference substance and pseudoephedrine hydrochloride reference substance, accurately weigh, add mobile phase to make a mixed solution containing 20 μg each in 1 mL, and obtain ephedrine hydrochloride and pseudoephedrine hydrochloride reference substance solution.

[0022] (2) Preparation of the test solution: Accurately draw 5 mL of pinellia syrup, add 5 mL of water to dilute, adjust the pH above 11 with ammonia water, extract 4 times with 80 mL of anhydrous ether, 20 mL each time, evaporate the ether until the solution is nearly dry, and th...

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Abstract

The invention discloses a method for determining the content of active ingredients such as ephedrine hydrochloride and pseudoephedrine hydrochloride in pinellia ternata syrup. The method comprises the following steps of: preparation of reference solution, preparation of to-be-tested sample solution and high-performance liquid chromatographic determination; and if every 1mL of product contains more than or equal to 30 micrograms of ephedrine hydrochloride and pseudoephedrine hydrochloride in total, the product is qualified. The method adopts the high-performance liquid chromatography to determine the content of the ephedrine hydrochloride and the pseudoephedrine hydrochloride which are used for investigating the quality of the pinellia ternata syrup product; and compared with the existing standard in absence of a content determining item, the method can control the internal quality of medicines directly by detecting the content of ephedrine hydrochloride and pseudoephedrine hydrochloride; in the method, the separating effect for ephedrine hydrochloride and pseudoephedrine hydrochloride is good, the stability and the accuracy are high, and the repeatability is good, so that the quality of the pinellia ternata syrup product can be well controlled.

Description

technical field [0001] The invention relates to a method for detecting medicines, in particular to a method for measuring the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride as active ingredients in pinellia chinensis syrup. Background technique [0002] Pinellia Syrup is a traditional Chinese medicine preparation recorded in the eighth volume of traditional Chinese medicine prescriptions in the "Drug Standards of the Ministry of Health". It has the function of relieving cough and reducing phlegm. Since the original drug standard only stipulates routine inspection, specifically: (1) Take 10mL of this product, add 5mL of methanol, shake well, add 10mL of petroleum ether, shake and extract, separate the petroleum ether liquid, evaporate to dryness with slight heat, and the residue Add 1-2 drops of 1% vanillin sulfuric acid solution, gradually turning red, purple, and finally reddish purple; (2) Take 0.5mL of this product, add 2mL of methanol, shake well, ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 余国斌
Owner HUBEI DUANZHENG PHARMA CO LTD
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