Detection method of Ruyi golden yellow powder

The determination of apigenin content in Ruyi Jinhuang San by ultraviolet-visible spectrophotometry solves the problem of the limitations of existing detection methods, realizes a comprehensive and accurate evaluation of the quality of Ruyi Jinhuang San, and ensures the efficacy and quality control of the product.

CN121324294APending Publication Date: 2026-01-13JIANGSU 707 NATURAL PHARMACEUTICAL CO LTD
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Patent Information

Application Number
CN202511816021.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-04
Publication Date
2026-01-13

AI Technical Summary

Technical Problem

The existing quality standard testing methods for Ruyi Jinhuang San are relatively limited, lacking quantitative testing related to the pharmacodynamic material basis, making it difficult to comprehensively and objectively reflect its intrinsic quality, thus affecting the precise control of the production process and the guarantee of product efficacy.

Method used

The content of apigenin in Ruyi Jinhuang San was determined by ultraviolet-visible spectrophotometry. By preparing a reference solution and a standard curve, a method for determining the total flavonoid content with apigenin as an indicator was established to ensure the accuracy and comprehensiveness of the detection.

Benefits of technology

This enabled an objective and comprehensive evaluation of the quality of Ruyi Jinhuang San, ensuring the efficacy and quality of the product and providing stable quantitative analysis indicators.

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Abstract

The invention provides a detection method of Ruyi golden yellow powder, and belongs to the technical field of quality control of traditional Chinese medicine preparations. According to the method, apigenin is used as a reference substance, the content of total flavonoids in Ruyi golden yellow powder in terms of apigenin is calculated by preparing a reference substance solution, establishing a standard curve and determining the absorbance of a sample to be detected by adopting ultraviolet-visible spectrophotometry, if the content of apigenin in Ruyi golden yellow powder to be detected is not lower than 20 micrograms / g, the detection is qualified, otherwise, the detection is qualified, and the content of total flavonoids in Ruyi golden yellow powder to be detected is not lower than 20 micrograms / g. Unqualified products are obtained. The method can be used for objectively, comprehensively and accurately evaluating the quality of the Ruyi golden yellow powder, and has important significance on guaranteeing the quality of the product while guaranteeing the curative effect of the product.
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Description

Technical Field

[0001] This invention belongs to the field of quality control technology for traditional Chinese medicine preparations, and specifically relates to a detection method for Ruyi Jinhuang San (a traditional Chinese medicine preparation). Background Technology

[0002] Ruyi Jinhuang San is a traditional Chinese medicine preparation made from ten herbs: turmeric, rhubarb, phellodendron bark, atractylodes rhizome, magnolia bark, tangerine peel, licorice root, raw arisaema rhizome, angelica root, and trichosanthes root. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain. It is suitable for boils and carbuncles caused by heat toxin stagnation in the skin, characterized by redness, swelling, heat, and pain. It can also be used for traumatic injuries. The preparation method is as follows: pulverize the above ten herbs into a fine powder, sift, and mix well.

[0003] Currently, the testing methods used in the quality standards of this product are relatively limited, lacking quantitative testing methods related to the pharmacodynamic material basis. This makes it difficult to comprehensively and objectively reflect its intrinsic quality, which is not conducive to precise control of the production process and guarantee of product efficacy.

[0004] Therefore, it is necessary to develop an analytical method that can accurately detect the active ingredients in Ruyi Jinhuang San in order to achieve systematic control over product quality.

[0005] Research has found that the Arisaema heterophyllum in Ruyi Jinhuang San contains apigenin (C... 15 H 10 The total flavonoid content, represented by apigenin (O5), is relatively high. Flavonoids generally possess anti-inflammatory and antioxidant activities, and are one of the important pharmacodynamic material bases related to the overall efficacy of the preparation. Moreover, apigenin has a stable structure and high detection sensitivity, making it very suitable as an indicator component for quantitative analysis. Therefore, establishing a method for determining the total flavonoid content using apigenin as a reference standard can provide a stable, reliable, and partially pharmacodynamic quantitative evaluation indicator for the quality control of Ruyi Jinhuang Powder. Summary of the Invention

[0006] Technical problem solved: The existing quality standards for Ruyi Jinhuang San preparations use limited testing methods, lacking quantitative detection methods related to the pharmacodynamic material basis. This makes it difficult to comprehensively and objectively reflect its intrinsic quality, hindering precise control of the production process and ensuring product efficacy. This invention proposes a testing method for Ruyi Jinhuang San that can objectively, comprehensively, and accurately evaluate its quality, significantly contributing to both product efficacy and quality assurance.

[0007] Technical solution: A method for detecting Ruyi Jinhuang San, the steps of which are as follows:

[0008] Step 1: Preparation of reference solution: Take an appropriate amount of apigenin reference standard, weigh it accurately, and add ethanol solution to prepare a solution containing 12 μg of apigenin per ml;

[0009] Step 2: Preparation of the standard curve: Accurately measure 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of the reference solution and place them in volumetric flasks respectively. Add ethanol solution to each flask to a final volume of 5 ml, then add 1% triethylamine solution to the mark and shake well. Using the corresponding reagents as blanks, measure the absorbance under ultraviolet light using ultraviolet-visible spectrophotometry. Plot the standard curve with absorbance as the ordinate and concentration as the abscissa.

[0010] Step 3, Determination: Accurately weigh 15 g of the powder to be tested (Ruyi Jinhuang San), place it in a stoppered conical flask, accurately add 50 ml of ethanol solution, seal tightly, weigh, sonicate, cool, weigh again, replenish the lost weight with 60% ethanol, shake well, and filter; accurately measure 5 ml of the filtrate, place it in a volumetric flask, and operate according to the method in Step 2 starting from "adding 1% triethylamine solution by volume", measure the absorbance, and read the content of apigenin in the test solution from the standard curve. If the total flavonoid content (calculated as apigenin) in the powder to be tested (Ruyi Jinhuang San) is not less than 20 μg / g, the test is qualified; otherwise, it is unqualified.

[0011] As a preferred embodiment, the Ruyi Jinhuang Powder includes turmeric, rhubarb, phellodendron bark, atractylodes rhizome, magnolia bark, tangerine peel, licorice root, raw arisaema rhizome, angelica root, and trichosanthes root.

[0012] Preferably, the ultrasonic treatment has a power of 250 W, a frequency of 40 kHz, and a treatment time of 45 min.

[0013] Preferably, the volumetric flask has a capacity of 10 ml.

[0014] Preferably, the volume fraction of the ethanol solution is 60%.

[0015] Preferably, the wavelength of the ultraviolet light is 400 nm.

[0016] Beneficial effects: The detection method provided by this invention uses apigenin contained in Arisaema heterophyllum in Ruyi Jinhuang Powder as an indicator component. By measuring its content, a systematic evaluation of product quality can be achieved. This method can objectively, comprehensively, and accurately evaluate the quality of Ruyi Jinhuang Powder, which is of great significance for ensuring product quality while ensuring product efficacy. Attached Figure Description

[0017] Figure 1 The standard curve obtained in the examples;

[0018] Figure 2 This is a graph showing the absorbance of Arisaema heterophyllum powder. Detailed Implementation

[0019] The present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0020] Unless otherwise specified, the raw materials used in the examples in this specification are all from commercially available products.

[0021] Example 1

[0022] A method for detecting Ruyi Jinhuang San (a traditional Chinese medicine formula) specifically includes the following steps:

[0023] Step 1. Preparation of the reference solution:

[0024] Take an appropriate amount of apigenin reference standard, weigh it accurately, and add 60% (volume fraction) ethanol solution to prepare a solution containing 12 μg of apigenin per ml.

[0025] Step 2. Preparation of the standard curve:

[0026] Accurately measure 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of the reference solution into separate 10 ml volumetric flasks. Add 60% ethanol to each flask to a final volume of 5 ml, then add 1% (v / v) triethylamine solution to the mark. Mix well. Using the corresponding reagents as blanks, measure the absorbance at 400 nm using UV-Vis spectrophotometry (General Rule 0401). Plot a standard curve with absorbance on the ordinate and concentration on the abscissa (see...). Figure 1 The test data is shown in Table 1 below.

[0027] Table 1 Standard Products

[0028]

[0029] Step 3. Measurement:

[0030] Accurately weigh approximately 15 g of the powder to be tested (passed through a No. 4 sieve), place it in a stoppered conical flask, accurately add 50 ml of 60% ethanol, seal tightly, weigh, sonicate (power 250W, frequency 40KHz) for 45 minutes, cool, weigh again, replenish the lost weight with 60% ethanol, shake well, and filter. Accurately measure 5 ml of the filtrate, place it in a 10 ml volumetric flask, and follow the procedure in step 2, starting from "adding 1% (volume fraction) triethylamine solution," and measure the absorbance. Read the weight of apigenin in the test solution from the standard curve. If the total flavonoid content (calculated as apigenin) in the powder to be tested is not less than 20 μg / g, the test is qualified; otherwise, it is unqualified.

[0031] Step 4. Verification and Conclusion:

[0032] To verify the feasibility of the above method, Arisaema heterophyllum powder (simulating the sample to be tested as Ruyi Jinhuang San) was processed according to the above steps, and the test results are shown in Table 2 below. Figure 2 The data show that the apigenin content in all samples was higher than 20 μg / g, which meets the detection standard, proving that the method is stable and reliable.

[0033] Table 2 Verification Sample

[0034]

[0035] Repeated measurements on Arisaema heterophyllum samples (see table above) showed high repeatability (relative standard deviation <1%), and the data agreed well with the standard curve. Figure 1 This indicates that the method can be used for the quality control of Ruyi Jinhuang San (a traditional Chinese medicine formula).

[0036] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for detecting Ruyi Jinhuang San, characterized in that, The steps are as follows: Step 1: Preparation of reference solution: Take an appropriate amount of apigenin reference standard, weigh it accurately, and add ethanol solution to prepare a solution containing 12 μg of apigenin per ml; Step 2: Preparation of the standard curve: Accurately measure 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml of the reference solution and place them in volumetric flasks respectively. Add ethanol solution to each flask to a final volume of 5 ml, then add 1% triethylamine solution to the mark and shake well. Using the corresponding reagents as blanks, measure the absorbance under ultraviolet light using ultraviolet-visible spectrophotometry. Plot the standard curve with absorbance as the ordinate and concentration as the abscissa. Step 3, Determination: Accurately weigh 15 g of the powder to be tested (Ruyi Jinhuang San), place it in a stoppered conical flask, accurately add 50 ml of ethanol solution, seal tightly, weigh, sonicate, cool, weigh again, replenish the lost weight with 60% ethanol, shake well, and filter; accurately measure 5 ml of the filtrate, place it in a volumetric flask, and operate according to the method in Step 2 starting from "adding 1% triethylamine solution by volume", measure the absorbance, and read the content of apigenin in the test solution from the standard curve. If the total flavonoid content (calculated as apigenin) in the powder to be tested (Ruyi Jinhuang San) is not less than 20 μg / g, the test is qualified; otherwise, it is unqualified.

2. The method for detecting Ruyi Jinhuang San according to claim 1, characterized in that, The Ruyi Jinhuang Powder includes turmeric, rhubarb, phellodendron bark, atractylodes rhizome, magnolia bark, tangerine peel, licorice root, raw arisaema rhizome, angelica root, and trichosanthes root.

3. The method for detecting Ruyi Jinhuang San according to claim 1, characterized in that, The ultrasonic treatment has a power of 250 W, a frequency of 40 kHz, and a treatment time of 45 min.

4. The method for detecting Ruyi Jinhuang San according to claim 1, characterized in that, The volumetric flask has a capacity of 10 ml.

5. The method for detecting Ruyi Jinhuang San according to claim 1, characterized in that, The volume fraction of the ethanol solution is 60%.

6. The method for detecting Ruyi Jinhuang San according to claim 1, characterized in that, The wavelength of the ultraviolet light is 400 nm.