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Detection method of pharmaceutical composition Zuozhudaxi

A technology of sitting pearl Darcy and detection method, applied in the field of medicine, can solve the problems of no measurement index, inaccuracy, increase detection of toxic medicinal material strychnine, etc., and achieve the effect of improving thin-layer chromatography identification

Active Publication Date: 2014-09-03
JINKE TIBETAN MEDICINE QINGHAI PROV
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0003] For the detection method of Zhuzhu Daxi, the current legal standard "Standards promulgated by the Ministry of Tibetan Medicine" only has two chemical reaction identification items and Aconitum aconitum TLC identification item, without any quantitative measurement indicators, which cannot effectively detect the quality of the preparation ; published in "Chinese Modern Applied Pharmacy", Volume 29, Issue 3, 2012, "Research on Improving the Quality Standards of Zhazhu Darcy" (referred to as "literature"), carried out TLC detection of bear bile, bezoar, woody fragrance and clove , the toxic medicinal material Nuxe officinale was identified by liquid chromatography, and the content of crocin Ⅰ in saffron was determined by high performance liquid chromatography, and the mobile phase used was methanol-water (45:55); The mobile phase condition for the liquid chromatography identification of Stony Chin is a mixture of acetonitrile-0.01mol / L sodium heptanesulfonate and 0.02mol / L potassium dihydrogen phosphate (10% phosphoric acid to adjust the pH to 2.8), the ratio is 20:80
[0004] Due to the extremely complex composition of Zuzhu Daxi, there are technical problems in the comprehensive detection of Zuzhu Daxi, such as which detection indicators to choose, how to exclude the interference of other components, etc., and the current legal standard "Standard issued by the Ministry of Tibetan Medicine The inspection items in "are too simple to accurately and exclusively control the quality of Zuzu Darcy
Although the literature has been improved, the content determination of saffron has been added, the detection of the toxic medicinal material Nuxychia chinensis has been added, and the TLC identification of four medicinal materials such as bear bile and bezoar has been added, but the content of saffron The determination is not comprehensive, and the detection of crocin II is not carried out; the strychnine in the toxic medicinal material Nuxychnium is only qualitatively detected, and there is no quantitative detection. The operation is complicated and time-consuming

Method used

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  • Detection method of pharmaceutical composition Zuozhudaxi
  • Detection method of pharmaceutical composition Zuozhudaxi
  • Detection method of pharmaceutical composition Zuozhudaxi

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0040] Experimental example 1: Determination of saffron in Zuozhu Daxi

[0041] 1. Instruments, reagents and test samples

[0042] Instrument: High performance liquid chromatography: Hitachi L-7110 pump, Hitachi-7420 detector; Shimadzu AUW220D electronic balance

[0043] Reference substance: Crocin-I reference substance (batch number: 111588-200501), crocin-II reference substance (batch number: 100001-200504)

[0044]Sample: Zuozhu Daxi (Qinghai Jinhe Tibetan Medicine Pharmaceutical Co., Ltd.) Lot number: 20090501, 20090502, 20090503

[0045] 2. Mobile phase selection

[0046] The study found that the medicinal components of Zuozhu Daxi are complex, which interferes with the determination of saffron. Methanol-water and ethanol-water systems alone cannot achieve good chromatographic separation, and the use of methanol-acetonitrile-water system basically completes the chromatographic separation. Separation, after adjusting water to be 0.05mol / L ammonium acetate, chromatograph...

experiment example 2

[0066] Experimental Example 2: Determination of Nuxe Chin in Zuozhu Daxi

[0067] 1. Instruments, reagents and test samples

[0068] Instrument: High performance liquid chromatography: Hitachi L-7110 pump, Hitachi-7420 detector; Shimadzu AUW220D electronic balance

[0069] Reference substance: strychnine reference substance (batch number: 110705-200306)

[0070] Sample: Zuozhu Daxi (Qinghai Jinhe Tibetan Medicine Pharmaceutical Co., Ltd.) Lot number: 20090501, 20090502, 20090503

[0071] 2. Selection of chromatographic conditions

[0072] Strychnine is also a toxic component as the main component in Nuxychonnia, and the prior art mainly uses C18 columns, and ion-pair reagents are used to carry out chromatographic separation, such as using acetonitrile-0.01mol / L sodium heptanesulfonate and 0.02mol / L in the literature Potassium dihydrogen phosphate mixture (adjusted pH to 2.8 with 10% phosphoric acid) is used as the mobile phase. The experiment time is too long, the separatio...

experiment example 3

[0091] Experimental example 3: TLC identification of bezoar

[0092] The experiment found that the identification method provided by the literature "Research on Improving the Quality Standard of Zuzu Darcy", that is, after dissolving the sample with ethanol ultrasonic treatment, add 10% sodium hydroxide water bath to reflux for 6 hours, add hydrochloric acid to adjust the pH to 2-3, and then Extract with ethyl acetate, evaporate the extract to dryness and dissolve it in ethanol as the test solution; developing solvent is isooctane-=petroleum ether (60-90°C)-n-butanol-glacial acetic acid-age (10:5: 3:5:1) of the supernatant (prepared for use now), the identification effect obtained is not ideal, the resolution is poor and the configuration of the developer is complicated, and the experiment takes too long. The present invention improves on it.

[0093]Take 3g of the medicinal composition Zuzudaxi, add 30ml of ethyl acetate, ultrasonicate for 30min, filter, evaporate the filtra...

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Abstract

The invention relates to a detection method of a pharmaceutical composition Zuzudaxi. The detection method of the present invention can comprehensively and accurately measure the content of saffron, and can detect the content of the toxic medicinal material Nuxe chinensis; the present invention also conducts thin-layer chromatography identification on longan longan, bezoar and gallic acid, and can more comprehensively and accurately The pharmaceutical composition Zuzudaxi was detected.

Description

technical field [0001] The invention relates to a detection method of a pharmaceutical composition, in particular to a detection method of a pharmaceutical composition Zuzudaxi, which belongs to the technical field of medicine. Background technique [0002] Zuozhu Daxi, recorded in "Drug Standards of the Ministry of Health of the People's Republic of China. Tibetan Medicine" (hereinafter referred to as "Standards issued by the Ministry of Tibetan Medicine"), standard number: WS3-BC-0315-95, is composed of Hanshuishi, Muxiang , cloves, boat-shaped aconitum, saffron, nutmeg, grass fruit, bear bile, bezoar, nuxonum, musk and other 35 herbs. The prescription has remarkable curative effect and is widely used in clinical practice. [0003] For the detection method of Zhuzhu Daxi, the current legal standard "Standards promulgated by the Ministry of Tibetan Medicine" only has two chemical reaction identification items and Aconitum aconitum TLC identification item, without any quant...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/90
Inventor 孙绪丁任松鹏赵延霞李怀平姬涛
Owner JINKE TIBETAN MEDICINE QINGHAI PROV