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Construction method of HPLC characteristic chromatogram of Jingyaokang capsules

A construction method and a technology of characteristic maps, applied in the field of construction of HPLC characteristic maps, can solve problems such as controlling product quality, no relevant reports on construction methods, and difficulty in reflecting products as a whole, so as to ensure controllability, avoid singleness and One-sidedness, the effect of reducing the possibility of product quality compliance

Active Publication Date: 2018-06-15
吉林修正药业新药开发有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its quality standards only control the content determination of one component of the blind medicine and the qualitative identification of a single component, and it is difficult to reflect the quality of the product as a whole or to control the quality of the product as a whole
At present, there is no relevant report on the construction method of the HPLC characteristic map of Jingyaokang Capsules

Method used

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  • Construction method of HPLC characteristic chromatogram of Jingyaokang capsules
  • Construction method of HPLC characteristic chromatogram of Jingyaokang capsules
  • Construction method of HPLC characteristic chromatogram of Jingyaokang capsules

Examples

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preparation example Construction

[0059] (1) Preparation of the test solution: take 2-5g of the content of this product, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 20-50mL of 2%-10% methanolic hydrochloric acid solution precisely, weigh it, and heat Reflux extraction for 1 to 2 hours, or ultrasonic treatment for 20 to 40 minutes, let cool, weigh again, make up the lost weight with methanolic hydrochloric acid solution, shake well, filter, accurately measure 5 to 10 mL of the filtrate, and evaporate to dryness Add an appropriate amount of methanol to the residue to dissolve, add 2g of neutral alumina, mix well, evaporate to dryness, add to a neutral alumina column, 100-200 mesh, 6g, inner diameter 1.2cm, wash with 50mL of chloroform-methanol mixed solution The volume ratio of chloroform in the mixed solution is 50% to 90%. Collect the eluate, evaporate to dryness, add an appropriate amount of methanol to the residue to dissolve it, transfer it to a 10mL measuring bottle, add methanol to the...

Embodiment 1

[0072] Example 1: Quality control method for Jingyaokang capsules based on characteristic maps

[0073] Instrument: Agilent1200 high performance liquid chromatograph, MS205DU analytical balance.

[0074] Reagents and reagents: strychnine reference substance (110705-201307), acetonitrile for liquid chromatography analysis is chromatographically pure, other reagents are analytically pure, water is ultrapure water, and Jingyaokang capsules are purchased from Jilin Changbaishan Pharmaceutical Group Co., Ltd. supply.

[0075] Preparation of the test solution: take about 5g of the content of this product, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 50mL of 2% hydrochloric acid methanol accurately, weigh it, extract it under reflux for 1 hour, let it cool, and weigh it again Use hydrochloric acid methanol to make up for the lost weight, shake well, filter, accurately measure 10mL of the subsequent filtrate, evaporate to dryness, add appropriate amount of methano...

Embodiment 2

[0087] Example 2: Quality control method for Jingyaokang capsules based on characteristic maps

[0088] Instrument: Agilent1200 high performance liquid chromatograph, MS205DU analytical balance.

[0089] Reagents and reagents: strychnine reference substance (110705-201307), acetonitrile for liquid chromatography analysis is chromatographically pure, other reagents are analytically pure, water is ultrapure water, and Jingyaokang capsules are purchased from Jilin Changbaishan Pharmaceutical Group Co., Ltd. supply.

[0090] Preparation of the test solution: take about 5 g of the product, 6 parts, accurately weighed, respectively put in a stoppered Erlenmeyer flask, accurately add 50 mL of 2% hydrochloric acid methanol, weigh the weight, reflux extraction for 1 hour, let cool , weigh again, make up the lost weight with methanol hydrochloride, shake well, filter, accurately measure 10mL of the subsequent filtrate, evaporate to dryness, add appropriate amount of methanol to the res...

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Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a construction method of an HPLC characteristic chromatogram of Jingyaokang capsules. The construction method comprises the steps that a test solution is prepared, wherein the content of the Jingyaokang capsules is extracted with a methanolic hydrochloride solution, and a neutral alumina column is addedto obtain the test solution; strychnine serves as a reference substance; the test solution and a reference substance solution are detected by adopting high performance liquid chromatography separately to obtain the HPLC characteristic chromatogram of the Jingyaokang capsules, wherein according to conditions of high performance liquid chromatography, a C18 column serves as a chromatographic column, a mobile phase A is acetonitrile, a mobile phase B is a mixed solution of water, acetic acid and triethylamine, and gradient elution is carried out. The similarity between the HPLC characteristic chromatogram, constructed through the method, of the Jingyaokang capsules and a reference chromatogram is greater than 0.90, the quality of the Jingyaokang capsules can be effectively represented, and the product quality can be comprehensively monitored. The method has the advantages of being convenient to use, quick, high in precision, good in reproducibility and the like.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a method for constructing an HPLC characteristic map of Jingyaokang capsules. Background technique [0002] The Chinese patent medicine Jingyaokang Capsule is composed of ten herbs such as Nuxebra chinensis, Shenjincao, Xiangjiapi, frankincense, myrrh, and safflower; Fracture congestion, swelling and pain, fracture recovery period, arthralgia caused by kidney deficiency and dampness, hyperplastic spondylitis, lumbar disc prolapse, etc. The drug has definite curative effect and is widely used clinically. However, due to the scattered production areas of traditional Chinese medicines, constant similar products and substitutes, coupled with factors such as growth environment, harvest period, different processing methods and preparation production techniques, the same variety of traditional Chinese medicine products produced by different manufacturers and diffe...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 赵源慧徐建白冰张显涛展月李亚东郑广晶崔宪利
Owner 吉林修正药业新药开发有限公司
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