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Quality analysis method for loins-strengthening and kidney-invigorating oral liquid

A kidney oral liquid, quality analysis technology, applied in the analysis of materials, material separation, pharmaceutical formulations, etc., can solve the problems of large interference, many impurities, interference of medicinal ingredients, etc., to achieve the effect of quality control, strong specificity, and high sensitivity

Active Publication Date: 2011-02-16
GUANGZHOU XIANGXUE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Zhuangyaojianshen Oral Liquid was extracted by using the extraction method reported in the literature, and the results showed that there were many impurities in the sample, and the interference was large, and formononetin could not be detected, and the chromatographic peaks could not reach the baseline separation
This is due to the fact that different products contain different medicinal materials, and the components of medicinal materials interfere with each other. The method reported in the literature is used for preparation and determination, and the ideal separation effect cannot be obtained.

Method used

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  • Quality analysis method for loins-strengthening and kidney-invigorating oral liquid
  • Quality analysis method for loins-strengthening and kidney-invigorating oral liquid
  • Quality analysis method for loins-strengthening and kidney-invigorating oral liquid

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Experimental program
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Effect test

Embodiment 1

[0019] Example 1 A quality analysis method of Zhuangyao Jianshen Oral Liquid

[0020] The determination of formononetin content by HPLC includes the following steps:

[0021] a. Prepare the test solution

[0022] Take 40ml of Zhuangyaojianshen oral liquid, add petroleum ether for extraction 2 to 3 times, 60ml each time, discard the petroleum ether; add chloroform for extraction 2 to 3 times, 60ml each time, combine the extracts, evaporate to dryness, and residue Add methanol to the volume to 10ml, shake well, filter, and use as the test solution;

[0023] b. Prepare the reference solution

[0024] Take formononetin reference substance, add methanol to make 1ml solution containing 20μg formononetin to obtain the reference substance solution;

[0025] c. Determination

[0026] Chromatographic conditions: octadecylsilane-bonded silica gel is used as filler, and acetonitrile-1% formic acid solution with volume ratio of 38~42:58~62 is used as mobile phase; detection wavelength is 290nm; the n...

Embodiment 2

[0031] Example 2 Conditional screening and methodological verification of a quality analysis method for Zhuangyao Jianshen Oral Liquid

[0032] 1. HPLC chromatographic conditions screening

[0033] The existing literature reports that there is absorption at 249nm and 254nm. The spectrum measured by the diode array detector shows that there is absorption at 249nm, 254nm, 290nm, 327nm, and the maximum absorption is 290nm. The sensitivity is high at this wavelength and the peak shape is sharp. , The resolution is greater than 1.5, and the peak time is within 10 minutes, which saves the detection time. Therefore, the chromatographic conditions are determined as follows: octadecyl silane bonded silica gel is used as a filler, and acetonitrile at 38~42:58~62 is -1% The formic acid solution is the mobile phase; the detection wavelength is 290nm. The number of theoretical plates should not be less than 4000 based on formononetin peak.

[0034] 2. Preparation of the test article

[0035] Ref...

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Abstract

The invention discloses a quality analysis method for loins-strengthening and kidney-invigorating oral liquid. The content of formononetin is measured by high performance liquid chromatography (HPLC), and the method comprises the steps of: preparing test solution, preparing reference solution and measuring. The method controls quality of the loins-strengthening and kidney-invigorating oral liquid by measuring the content of formononetin in the loins-strengthening and kidney-invigorating oral liquid through the HPLC, has high sensitivity, high specificity, no interference on negative control, has the accuracy, repeatability, linear relation and stability which can meet the requirements of scientific research and production, can more effectively control the product quality, and ensures the curative effect of medicaments.

Description

Technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine preparations, and particularly relates to a quality analysis method of Zhuangyao Jianshen oral liquid. Background technique [0002] At present, the oral liquid for strengthening waist and kidney on the market is generally processed from Caulis spatholobi, dog ridge, mulberry parasitic, golden cherry seed, ligustrum lucidum and other medicinal flavors. It has the effects of strengthening waist and kidney, dispelling wind and activating collaterals. , Used for kidney deficiency, low back pain, rheumatic bone pain, knee weakness, frequent urination. Clinical verification shows that this product has an effective rate of 95.0% for patients with kidney deficiency and low back pain, and a significant rate of 58.3%; for patients with lumbar hyperostosis, it has an effective rate of 94.8%, and it can treat clinical symptoms such as waist pain, limb pain, and knee weakness. Both h...

Claims

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Application Information

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IPC IPC(8): A61P19/08A61K9/00A61P13/12A61P29/00G01N30/02A61K36/738
Inventor 连林生李小妹康志英朱小燕蔡春玲
Owner GUANGZHOU XIANGXUE PHARMA CO LTD
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