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Quality control method for rhizoma dioscoreae nipponicae-acanthopanax root collateral-dredging capsules

A quality control method, the technology of Longjia Tongluo, applied in the field of medicine, can solve the problems of unstable yield, cumbersome operation, occurrence of side reactions, etc., and achieve the effects of good reproducibility, convenient operation and accurate results.

Inactive Publication Date: 2016-11-23
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since diosgenin is a raw material in the pharmaceutical industry, most of the quality control of the plant involves only one component of diosgenin, but obtaining diosgenin requires steps such as acid hydrolysis, extraction, and pH adjustment of the medicinal material. The operation is cumbersome and often has side effects. occurs, the yield is unstable

Method used

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  • Quality control method for rhizoma dioscoreae nipponicae-acanthopanax root collateral-dredging capsules
  • Quality control method for rhizoma dioscoreae nipponicae-acanthopanax root collateral-dredging capsules
  • Quality control method for rhizoma dioscoreae nipponicae-acanthopanax root collateral-dredging capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Chromatographic conditions and system suitability test: use C18 silica gel as filler; mobile phase is acetonitrile-water for gradient elution as shown in Table 14:

[0100] Table 14 gradient elution conditions

[0101]

[0102] Need testing solution preparation: get the contents of Longjiatongluo capsules, grind finely, get 2g, accurately weigh, put in a stoppered Erlenmeyer flask, add 50ml 95% ethanol, ultrasonic treatment (power 180W, frequency 40kHz) 30min, Allow to cool, weigh to make up for weight loss, filter, and take the subsequent filtrate to pass through a 0.45 μm microporous membrane as the test solution.

[0103]Preparation of reference substance solution: Accurately weigh the appropriate amount of dioscin reference substance and syringin reference substance, add methanol to make a mixed solution containing 0.6 mg of diosgenin reference substance and 10 μg of syringin per 1 ml, as a mixed reference substance solution.

[0104] Determination: Accurately d...

Embodiment 2

[0106] Chromatographic conditions and system suitability test: use C8 silica gel as filler; mobile phase is acetonitrile-water-formic acid for gradient elution as shown in Table 15:

[0107] Table 15 gradient elution conditions

[0108]

[0109] Preparation of the test solution: take the content of Longjiatongluo capsule, grind it finely, take 2g, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 50ml of 95% ethanol, soak in cold for 120min, let it cool, and weigh to make up for the weight loss , Filtration, take the continued filtrate through 0.45μm microporous membrane, as the test solution.

[0110] Preparation of reference substance solution: Accurately weigh the appropriate amount of dioscin reference substance and syringin reference substance, add methanol to make a mixed solution containing 0.6 mg of diosgenin reference substance and 10 μg of syringin per 1 ml, as a mixed reference substance solution.

[0111] Determination: Accurately draw 10 μl of t...

Embodiment 3

[0113] Chromatographic conditions and system suitability test: use C4 silica gel as filler; mobile phase is acetonitrile-water-formic acid for gradient elution as shown in Table 16:

[0114] Table 16 gradient elution conditions

[0115]

[0116] Preparation of the test solution: take the content of Longjiatongluo capsule, grind it finely, take 2g, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 20ml of 75% methanol, reflux in a water bath for 90min, weigh it to make up for weight loss, and let it cool Filtrate, and take the continued filtrate to pass through a 0.45 μm microporous membrane as the test solution.

[0117] Preparation of reference substance solution: Accurately weigh the appropriate amount of dioscin reference substance and syringin reference substance, add methanol to make a mixed solution containing 0.6 mg of diosgenin reference substance and 10 μg of syringin per 1 ml, as a mixed reference substance solution.

[0118] Determination: Accurat...

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Abstract

The invention discloses a quality control method for rhizoma dioscoreae nipponicae-acanthopanax root collateral-dredging capsules; the method includes determination of the content of rhizoma dioscoreae nipponicae and acanthopanax root, and adopts high performance liquid chromatography for simultaneously or separately determining the content of one or more components. C4, C8 and C18 are used as fillers; an acetonitrile or methanol-water-formic acid or acetic acid or phosphoric acid solution with the ratio of (0-50):(100-50):(0-2) is used as a mobile phase, and the flow rate is 0.5-1.5 ml / min; the detection wavelength is 203-320 nm; the column temperature is 20-40 DEG C. The content of the two medicinal materials in the prescription is controlled, and the preparation quality control is more comprehensive, accurate and effective, so that drug safety and effectiveness are facilitated to be ensured; and moreover, the determination method is simple to operate, accurate in result, good in precision, stability and reproducibility, and convenient for drug standardized production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a quality control method of a traditional Chinese medicine compound. Specifically, the invention relates to a quality control method of Longjiatongluo Capsules, especially the formulation of Longjiatongluo Capsules formulations of Chuanshanlong and Acanthopanax. One or more components are subjected to high performance liquid chromatography content determination method simultaneously or separately. Background technique [0002] Stroke is a general term for acute cerebrovascular diseases in traditional Chinese medicine. It is a kind of disease whose main symptoms are hemiplegia, which is caused by sudden fainting and unconsciousness, accompanied by crooked mouth corners and poor speech. Due to the high morbidity rate, high mortality rate, high disability rate, high recurrence rate and many complications of this disease, the medical community listed it as one of the three major dise...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 郑雅楠孙卫廖茂梁
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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