Quality control method of concentrated-type oral liquid for treating cough and asthma of children

A quality control method and technology for Kechuanling oral liquid are applied in the field of quality control of traditional Chinese medicine oral liquid, which can solve the problems of inaccurate quality control and imperfect drug quality standards.

Inactive Publication Date: 2018-04-10
HARBIN KANGLONG PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of quality control method of children's Kechuanling oral liquid, to improve the problem that the quality standard of existing medicine is not perfect, quality control is inaccurate, wherein to the ephedrine hydrochloride and ephedrine hydrochloride in Xiaoer's Kechuanling oral liquid The detection method of pseudoephedrine hydrochloride content requires negative solution without interference, strong specificity, good separation effect, high accuracy and good reproducibility

Method used

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  • Quality control method of concentrated-type oral liquid for treating cough and asthma of children
  • Quality control method of concentrated-type oral liquid for treating cough and asthma of children
  • Quality control method of concentrated-type oral liquid for treating cough and asthma of children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0150] High performance liquid chromatography identification method of Radix isatidis in Xiaoer Kechuanling Oral Liquid

[0151] 1) Preparation of the test solution

[0152] Take 10mL of the oral solution, shake and extract twice with ethyl acetate, 20mL each time, combine the ethyl acetate solution, evaporate the ethyl acetate in it to dryness, and accurately configure the residue into 5mL methanol solution to obtain the test solution ;

[0153] 2) Preparation of reference substance solution

[0154] Take (R,S)-Gaoyichun 10.80mg, add methanol to a 10mL volumetric flask, and shake well; accurately measure 3mL, add methanol to a 100mL volumetric flask, and shake well to prepare the reference substance solution 2;

[0155] 3) Preparation of the reference medicinal material solution

[0156] Take 1.05g of Radix Radix, add 50mL of water, decoct for 2h, let cool, filter, take 10mL of the filtrate, and prepare the reference medicinal material solution with the preparation method...

Embodiment 2

[0172] Detection method and methodological investigation of ephedrine hydrochloride and pseudoephedrine hydrochloride content

[0173] 1. Instruments and reagents

[0174] 1.1 Reference substances: ephedrine hydrochloride (National Institute for the Control of Pharmaceutical and Biological Products), pseudoephedrine hydrochloride (National Institute for the Control of Pharmaceutical and Biological Products).

[0175] 1.2 Reagents: Acetonitrile is chromatographically pure, water is purified water, and other reagents are analytically pure.

[0176] 1.3 Instruments: Agilent 1100 high performance liquid chromatograph, ultraviolet detector; AS10200A ultrasonic oscillator. LABOROTA-4000 rotary evaporator. Chromatographic column: phenomenonex, packing particle size 4μm, length 250mm, inner diameter 4.6mm;

[0177] 2. Preparation of the test solution

[0178] Precisely measure 10mL of oral liquid and put it in a separatory funnel, add 1mL of ammonia water, shake well; shake and ex...

Embodiment 3

[0232] The identification of ephedra includes the following steps:

[0233] 1) Preparation of the test solution

[0234] Take 10 mL of oral liquid, add 1 mL of ammonia water, extract with ether, add 1 mL of 0.6 mol / L ethanol hydrochloric acid solution to the ether phase, evaporate the solvent to dryness, dissolve the residue with 1 mL of methanol, and use it as the test solution;

[0235] 2) Preparation of reference substance solution

[0236] Get ephedrine hydrochloride reference substance 1.10mg, add methanol 1mL to dissolve, as reference substance solution;

[0237] 3) Preparation of the reference medicinal material solution

[0238] Take 1.05g of the ephedra reference medicinal material, add water to decoct for 1h, concentrate to 40mL, cool, and then prepare the reference medicinal material solution according to the preparation method of the test solution described in step 1);

[0239] 4) Preparation of negative control solution

[0240] According to the prescription p...

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Abstract

The present invention relates to a quality control method of traditional Chinese medicine oral liquid, in particular to a quality control method of children's Kechuanling oral liquid. Alkaline and pseudoephedrine hydrochloride content detection. The quality control method has high accuracy, good stability, and good reproducibility; it improves the current situation that there is no accurate quality control method for Xiaoer Kechuanling Oral Liquid, and ensures the accuracy and comprehensiveness of the quality control of Xiaoer Kechuanling Oral Liquid ; Ensure the quality of Kechuanling oral liquid for children, thereby ensuring the safety and effectiveness of medication for patients.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine oral liquid, in particular to a quality control method of an infant Kechuanling oral liquid. Background technique [0002] The current basic mode of quality control of traditional Chinese medicine is established by referring to the quality control methods of foreign botanical medicines and the mode of quality control of chemical drugs. The main content is chemical qualitative identification and index component detection. For chemical drugs, their molecular structure is clear and the structure-activity relationship is clear. Identification, inspection, and content determination can be directly used as indicators for curative effect evaluation. None of them can reflect its overall curative effect, which is the fundamental difference between the quality standards of traditional Chinese medicine and chemical drugs. What's more, so far, the active ingredients of most tradit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02
CPCG01N30/90G01N30/02
Inventor 穆滨
Owner HARBIN KANGLONG PHARM CO LTD
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