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Quality detection method of cough syrup for children

A technology for children's cough syrup and quality inspection methods, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot truly reflect the internal quality of children's cough syrup, product quality consistency, cannot fully reflect product quality, and cannot evaluate product batches. Whether it is consistent with the batch quality, etc., to ensure consistency, stable fingerprint detection method for children's cough syrup, and good repeatability

Active Publication Date: 2014-12-10
华润三九(郴州)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, Chinese patent medicine is a complex of many ingredients extracted from Chinese herbal pieces, and its efficacy does not work through a single active substance, and its quality cannot be determined by an individual ingredient. Therefore, the detection of a single ingredient does not Can not fully reflect the quality of the product
Moreover, under such a one-sided judgment on quality, it is easy for people to use other means to meet the quality standard, but the quality of the obtained product does not meet the expected therapeutic effect.
In addition, since the current detection method can only evaluate the quality of each individual sample batch, it cannot evaluate whether the quality of the product batch is consistent from batch to batch
[0011] Therefore, the current quality control standards for children's cough syrup can no longer truly reflect the internal quality of children's cough syrup and the consistency of product quality between batches

Method used

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  • Quality detection method of cough syrup for children
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  • Quality detection method of cough syrup for children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] 1. Selection of detection wavelength

[0046]The HPLC method is adopted to detect the same sample. The high-performance liquid chromatograph model used by the HPLC method is WaterS2695-2489. The four wavelengths are investigated with the ultraviolet-visible light detector as a multi-wavelength detection means. The selected 4 detection wavelengths are λ= 237nm, λ=254nm, λ=283nm and λ=345nm, evaluated by the number of chromatographic peaks, resolution, etc. Other detection conditions of HPLC are: with octadecylsilane bonded silica gel as filler; With acetonitrile as mobile phase A, 0.1mol / L dipotassium hydrogen phosphate (phosphoric acid adjusts about pH=6.5) acetic acid as mobile phase B, according to The gradient in Table 1 was used for elution, the injection volume was 10 μl, the flow rate was 0.8ml / min, and the column temperature was 30°C. The gradient program is as follows:

[0047] Table 1 Gradient 1 elution program

[0048] time min

Acetonitrile%

...

Embodiment 2

[0068] The detection method that embodiment 1 obtains is specifically:

[0069] After diluting the test sample of Xiaoerzhi cough syrup 50 times with methanol, take 10 μl and inject it into the liquid chromatograph for determination;

[0070] The detection condition of described liquid chromatograph is:

[0071] Octadecylsilane-bonded silica gel was used as filler, acetonitrile was used as mobile phase A, and 1% acetic acid solution was used as mobile phase B, and gradient elution was performed according to the following procedure:

[0072]

[0073] The detection wavelength is 254nm, the flow rate is 0.8ml / min, the column temperature is 30°C, and the number of theoretical plates is not less than 3000 based on the ammonium glycyrrhizinate peak. The detection method was carried out methodological investigation.

[0074] 1. Blank test

[0075] In order to investigate the interference of each chromatographic peak in the fingerprint chromatogram by the dissolving solvent of t...

Embodiment 3

[0093] Determination of Control Fingerprints

[0094] Take children's cough syrup samples, batch numbers 1301006N, 1301007N, 1303013N, 1303014N, 1305007N, 1305008N, 1309005N, 1309006N, 1401013N, 1401014N, a total of 10 batches of samples were prepared according to the proposed preparation method of the test product, as follows:

[0095] After diluting the test sample of Xiaoerzhi cough syrup 50 times with methanol, take 10 μl and inject it into the liquid chromatograph for determination;

[0096] The detection conditions of the liquid chromatograph are:

[0097] Octadecylsilane-bonded silica gel was used as filler, acetonitrile was used as mobile phase A, and 1% acetic acid solution was used as mobile phase B, and gradient elution was performed according to the following procedure:

[0098]

[0099]The detection wavelength is 254nm, the flow rate is 0.8ml / min, the column temperature is 30°C, and the number of theoretical plates is not less than 3000 based on the ammonium g...

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Abstract

The invention relates to the field of traditional Chinese medicine preparation detection, in particular to a quality detection method of cough syrup for children. The quality detection method comprises the following steps: diluting a sample to be detected with methanol, and filling into a liquid chromatograph for detection, and comparing an obtained chromatogram with a reference fingerprint chromatogram so as to judge the quality of the sample to be detected, wherein the detection conditions of the liquid chromatograph are as follows: octadecylsilane chemically bonded silica is adopted as a filling agent, acetonitrile is adopted as a flow phase A, a 1% acetic acid solution is adopted as a flow phase B, the above components are eluted according to specific programs in a gradient manner, the wavelength is 252-256 nm, the flowing speed is 0.8-0.9 ml / min, the column temperature is 29-31 DEG C, and the number of theoretical plates is no less than 3000 according to the peak of ammonium glycyrrhetate. As multiple influence factors are controlled, the quality detection method of cough syrup for children, which is provided by the invention, is stable, reliable and good in repeatability, achieves the purpose of controlling the quality by virtue of fingerprint chromatogram detection, and meanwhile is significant for ensuring the consistency of quality of each batch of products.

Description

technical field [0001] The invention relates to the field of detection of traditional Chinese medicine preparations, in particular to a quality detection method for children's cough syrup. Background technique [0002] The fingerprint of traditional Chinese medicine is established to comprehensively reflect the types and quantities of internal chemical components contained in traditional Chinese medicine, and then reflect the quality of traditional Chinese medicine. To characterize the quality of traditional Chinese medicine. Fingerprint as a method of quality control has become a consensus in the industry, and fingerprints are often used internationally for quality control of herbal medicines. [0003] The main ingredients of children's cough syrup include 150ml of liquid extract of licorice, 30ml of liquid extract of bellflower, 10g of ammonium chloride and 20ml of tincture of orange peel; for the above four flavors, dissolve ammonium chloride in appropriate amount of wat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈海刚刘春方符国成龚小兵
Owner 华润三九(郴州)制药有限公司
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