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Quality detection method of Jindan pills

A quality detection method, the technology of Jindan, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the mutual interference between qualitative and quantitative, the quality control of Jindan pills, the difficulty of quality inspection, and the inability to meet the simultaneous qualitative determination of the chemical components of Jindan pills and quantitative problems, to achieve the effect of good repeatability and accurate quality detection methods

Pending Publication Date: 2020-09-11
GUANGZHOU BAIYUNSHAN QIXING PHARMA
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, since Jindan Pills contain many types of medicinal materials, each medicinal material contains a variety of chemical components, and these chemical components will interfere with each other in qualitative and quantitative processes, which will cause difficulties in the quality control and quality inspection of Jindan Pills.
Some current quality testing schemes for psoralen and / or isopsoralen in traditional Chinese medicine preparations, such as psoralen and isopsoralen in Yaotong pills with 12 medicinal materials using methanol-water (55:45) as the mobile phase Psoralen is carried out liquid chromatographic detection, or the test product (the Zhuangshen Pill containing psoralen and isopsoralen) is carried out ultrasonic extraction, then with acetonitrile-0.125% phosphoric acid (25:75) as Mobile phase is carried out liquid chromatographic detection, or carry out Soxhlet extraction up to 5 days to the test sample, then carry out thin-layer chromatography etc., all can't meet the simultaneous qualitative and qualitative analysis of multiple types of medicinal materials and multiple types of chemical components in Jindan Pills. Quantitative, not suitable for quality testing of Jindan Pills

Method used

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  • Quality detection method of Jindan pills
  • Quality detection method of Jindan pills
  • Quality detection method of Jindan pills

Examples

Experimental program
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Effect test

Embodiment 1

[0057] The present embodiment is the quality detection method of Jindan pill, and the steps are as follows:

[0058] (1) Chromatographic conditions and adaptability test: the chromatographic column is CAPCELL PAK C18 4.6*250mm 5μm, which uses octadecyl bonded silica gel as filler; methanol-water (volume ratio 32:68) as mobile phase; detection The wavelength is 246nm; the column temperature is 30°C; the flow rate is 1.0ml / min; the number of theoretical plates should not be less than 3000 based on the psoralen peak.

[0059] (2) Preparation of reference substance solution: Accurately weigh psoralen and isopsoralen reference substances, put them in a volumetric flask, add methanol to dilute to the mark, and make each 1mL containing 0.02mg of psoralen, isopsoralen Mixed solution of 0.02 mg of osteolipin, shake well, and obtain.

[0060] (3) Preparation of the test solution: get 14g of Jindan Pill sample (source Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd., batch number K8...

Embodiment 2

[0066] This embodiment is a condition investigation experiment of the quality detection method of Jindan pills described in Example 1.

[0067] 1. The influence of the detection wavelength on the detection results

[0068] Preparation of the test solution: take Jindan Pills for the test (sourced from Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd., batch number K8001A), grind, accurately weigh 1.5g, place in a stoppered Erlenmeyer flask, and accurately add Methanol 25mL, weighed, heated to reflux for extraction for 2 hours, allowed to cool, weighed again, made up for lost weight with methanol, shaken well, filtered, and obtained the filtrate.

[0069] Chromatographic conditions: chromatographic column is CAPCELL PAK C18 4.6*250mm 5μm, which uses octadecyl bonded silica gel as filler; methanol-water (volume ratio 32:68) as mobile phase; column temperature 30°C; flow rate 1.0ml / min. Precisely draw 10 μL of the Jindan Pill test solution for injection and detection. Absor...

Embodiment 3

[0118] This embodiment is a methodological investigation of the quality detection method of Jindan pills described in Example 1.

[0119] 1. Specific inspection

[0120] Prepare the negative reference substance not containing psoralen according to the same preparation process as Jindan Pills, and prepare the negative sample solution according to the same method of "preparation of the test solution" item in Example 1, and then take the blank Solvent (methanol), Jindan pill need testing solution, measure respectively by the same chromatographic condition of " chromatographic condition and adaptability test " item in embodiment 1, the results see Image 6 , Figure 7 with Figure 8 . It can be seen that the blank solvent and negative sample spectrum have the same retention time position as the psoralen and isopsoralen reference substances, and no peaks appear, indicating that the blank solvent and negative sample have no interference to the determination, and the method has st...

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Abstract

The invention relates to a quality detection method of Jindan pills, which comprises the following steps: preparation of a reference substance solution: precisely weighing a psoralen reference substance and an isopsoralen reference substance, and adding a solvent to dissolve to obtain the reference substance solution; preparing a test solution, namely grinding a to-be-detected Jindan pill sample,precisely weighing, adding monohydric alcohol, extracting, filtering an extracting solution, and taking subsequent filtrate, so as to obtain the test solution; detection: determining the reference substance solution and the test solution by using high performance liquid chromatography; wherein the high performance liquid chromatography adopts isogradient elution, and mobile phases are methanol andwater. The quality detection method can meet qualitative and quantitative analysis of psoralen and isopsoralen components in the Jindan pills, and is simple and convenient to operate, high in detection speed, high in specificity, high in precision, good in repeatability and high in accuracy.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine detection, in particular to a quality detection method of Jindan pills. Background technique [0002] Psoraleae is the dried and ripe fruit of leguminous plants. It has the functions of nourishing kidney and strengthening yang, strengthening essence and reducing urination, suffering from kidney deficiency, low back pain, frequent urination, enuresis in children, kidney leakage, warming spleen and stopping diarrhea, relieving qi and relieving asthma, etc. The chemical composition of psoraleae extract is very complex, including coumarins, flavonoids, monoterpene phenols, benzofurans and other compounds. The 2015 edition of "Chinese Pharmacopoeia" stipulates that the total amount of psoralen and isopsoralen in psoralen medicinal materials should not be less than 0.70%. It can be seen that psoralen and isopsoralen are very important index components . [0003] Jindan pills are c...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 冯倩玲赖远豪焦逸帆
Owner GUANGZHOU BAIYUNSHAN QIXING PHARMA
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