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Quality inspection method of anti-hysteritis soft capsules

A quality inspection method and soft capsule technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of incomplete quality control indicators and inability to control product quality, so as to achieve simple and easy quality inspection methods and ensure clinical efficacy , high precision effect

Inactive Publication Date: 2015-04-01
GUIZHOU HUIZHENG PHARMA CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The national standard implemented by this product is YBZ09182006-2011Z. In this standard, only the identification of Guangdong Zizhu dry extract and Wuyao dry extract is made, and there is no quantitative index; Qualitative indicators, quality control indicators are not perfect, and can not fully control the quality of products more effectively

Method used

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  • Quality inspection method of anti-hysteritis soft capsules
  • Quality inspection method of anti-hysteritis soft capsules
  • Quality inspection method of anti-hysteritis soft capsules

Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0025] Experimental example: Determination of the content of hiraegina lactone

[0026] (1) Selection of mobile phase:

[0027] Mobile phase 1: methanol-acetonitrile-water (35:25:40);

[0028] Mobile phase 2: methanol-acetonitrile-water (355:255:40);

[0029] Mobile phase 3: methanol-water (60:40);

[0030] Mobile phase 4: methanol-water (40:60);

[0031] Mobile phase 5: acetonitrile-water (60:40);

[0032] Mobile phase 6: acetonitrile-water (56:44);

[0033] Through the analysis of the above comparative test results, mobile phase 6 has the characteristics of appropriate retention time, good sample separation effect, negative and no interference, etc. At the same time, according to the analysis and conclusion of follow-up experiments, when the number of theoretical plates of huigui lactone reaches 3000, the separation is greater than 1.5, so the number of theoretical plates based on the peak of huigui lactone should not be less than 3000.

[0034] (2) Screening of ...

Embodiment

[0061] A quality detection method for Kanggongyan Soft Capsules, comprising the following steps:

[0062] (1) Identification of Guangdong Zizhu:

[0063] Take 2 g of the content of this product, add 50ml of 60% ethanol, 1ml of hydrochloric acid, heat and reflux on a water bath for 4 hours, filter, steam the filtrate on a water bath to 15ml, add 20ml of water, shake well, filter, and shake the filtrate with ether Extract 3 times, 15ml each time, combine the ether solution, put it on a water bath and evaporate to dryness, add 1ml methanol to the residue to dissolve, and use it as the test solution. Another 5 g of Guangdong Zizhu reference medicinal material was taken, and the reference medicinal material solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia 2010 Edition), draw 5 μl of each of the above two solutions, spot them on the same silica gel G thin-layer plate, and mix with toluene-ethyl formate...

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Abstract

The invention discloses a quality inspection method of anti-hysteritis soft capsules. The quality inspection method comprises the following steps: determining the content of linderane and stachydrine hydrochloride in the anti-hysteritis soft capsules by a high performance liquid chromatography, wherein the content of radix lindera in each capsule is not less than 0.23mg according to the weight of linderane; carrying out thin-layer chromatography on leonurus, and authenticating Guangdong callicarpa bodinieri and radix lindera simultaneously. The quality inspection method disclosed by the invention is high in determination efficiency, high in accuracy, accurate in determination content, and capable of effectively detecting and controlling product quality.

Description

technical field [0001] The invention belongs to the field of quality detection of traditional Chinese medicine preparations, in particular to a quality detection method of Kanggongyan Soft Capsules. Background technique [0002] Kanggongyan Soft Capsule is composed of Guangdong Zizhu Dry Extract, Leonurus Dry Extract, and Wuyao Dry Extract. , Cervical erosion, bleeding embolism. Guangdong Zizhu Dry Extract is the main drug in the prescription. It has the functions of astringent and hemostasis, dissipating blood stasis, clearing away heat and detoxification, and is used for epistaxis, hemoptysis, hematemesis, blood in the stool, metrorrhagia, traumatic bleeding, cough due to lung heat, sore throat, and heat ulcer Sores, water and fire burns embolism. Motherwort dry extract is a common gynecological drug, which has the functions of promoting blood circulation, regulating menstruation, diuresis and swelling, clearing heat and detoxifying. It is used for irregular menstruatio...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/90
Inventor 罗伟
Owner GUIZHOU HUIZHENG PHARMA CO
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