Method for detecting content of five components in traditional Chinese medicine preparation children oral liquid capable of clearing heat and benefiting lung

Abstract

The invention belongs to the technical field of detection, and discloses a method for detecting the content of five components in a traditional Chinese medicine preparation child heat-clearing and lung-benefiting oral liquid. According to the method, the contents of five active ingredients, namely ephedrine hydrochloride, pseudoephedrine hydrochloride, tectoridin, forsythin and arctiin, in the oral liquid for clearing heat and benefiting lung for children are simultaneously detected by adopting a multi-wavelength switching method through a specific solvent and chromatographic conditions. Compared with the prior art, the method has the advantages that the problems of single component, long detection period, high labor and reagent cost and the like in content determination of the oral liquid for clearing heat and benefiting lung for children are solved, the method is simple, convenient, high in specificity, good in repeatability and accurate in result, and reference can be provided for process research, quality guarantee and quality standard improvement of the oral liquid for clearing heat and benefiting lung for children.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of detection, and particularly relates to a method for detecting the contents of five components in a traditional Chinese medicine preparation pediatric heat-clearing and lung-nourishing oral liquid. BACKGROUND

[0002] The pediatric heat-clearing and lung-nourishing oral liquid is a commonly used traditional Chinese medicine preparation in clinical practice. The prescription is derived from the Yinqiao Powder in the Treatise on Febrile Diseases and the Maxing Shigan Decoction in the Treatise on Cold Pathogenic Diseases. The prescription is composed of 11 medicinal materials. Ephedra is the monarch drug, which plays the roles of inducing perspiration to dispel cold, relieving asthma, and promoting water excretion to relieve edema. Fried Arctium seeds, Belamcanda chinensis, and Forsythia suspensa are the ministerial drugs, which respectively have the effects of dispelling wind-heat, promoting lung and rash, relieving throat, clearing heat and resolving toxins, relieving throat, clearing heat and resolving toxins, relieving edema and resolving phlegm, and dispelling wind-heat. The three ministerial drugs together enhance the efficacy of the monarch drug. The oral liquid is used for treating pediatric cough caused by wind-heat invading the lung, with symptoms of fever, cough or expectoration, runny nose or nasal obstruction, sore throat, thirst, red tongue, and yellowish tongue fur, and pediatric acute bronchitis with the above symptoms.

[0003] The current quality standard for the pediatric heat-clearing and lung-nourishing oral liquid is WS3-599 (Z-119)-2012 (Z)-2022. The standard performs thin-layer identification on the medicinal materials of ephedra, fried Arctium seeds, and Belamcanda chinensis, and determines the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the preparation by high performance liquid chromatography, as the control standard for content detection. However, the standard does not set content detection items for the 10 medicinal materials in the prescription, such as fried Arctium seeds (ministerial drug), Belamcanda chinensis (ministerial drug), and Forsythia suspensa (ministerial drug). Since the efficacy of traditional Chinese medicine compound preparations depends on the synergistic effect of multiple components, using a single medicinal material component (ephedrine hydrochloride and pseudoephedrine hydrochloride) as the quality control indicator cannot comprehensively and effectively reflect the actual quality of the medicine.

[0004] At present, the quality evaluation methods for the pediatric heat-clearing and lung-nourishing oral liquid mainly focus on single components, such as ephedrine hydrochloride and pseudoephedrine hydrochloride in ephedra and belamcanda chinensis glycoside in Belamcanda chinensis, and lack comprehensive detection methods for various components in the pediatric heat-clearing and lung-nourishing oral liquid. Moreover, the existing detection methods require multiple independent analysis means to determine different components, which is complicated and inefficient. Therefore, it is necessary to establish an analysis method that is efficient, accurate, and can simultaneously determine multiple active components, in order to solve the problems of single quality control indicator and low detection efficiency, and to improve the quality controllability and detection efficiency of the preparation. SUMMARY

[0005] The present application aims to at least solve one of the technical problems existing in the prior art. A detection method for quality evaluation of the traditional Chinese medicine preparation pediatric heat-clearing and lung-nourishing oral liquid is provided, which has good stability, good repeatability, simple operation, accuracy, and reliability.

[0006] The application aims to provide a detection method for the content of ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcandin, forsythoside and arctiin in the traditional Chinese medicine preparation Xiaoer Qingre Lixu Oral Liquid.

[0007] The application aims to provide an application of the detection method of the first aspect of the application in the quality evaluation of Xiaoer Qingre Lixu Oral Liquid.

[0008] To achieve the above-mentioned purposes, the application adopts the following technical solutions: The first aspect of the application provides a detection method for the content of ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcandin, forsythoside and arctiin in the traditional Chinese medicine preparation Xiaoer Qingre Lixu Oral Liquid, which comprises the following steps: preparing a test sample solution and a control solution, and detecting the test sample solution and the control solution by high performance liquid chromatography; the solvent of the test sample solution and the control solution is methanol.

[0009] In some embodiments of the application, the elution in the chromatography adopts gradient elution, and the mobile phase A is acetonitrile and the mobile phase B is 0.2%-0.6% phosphoric acid solution.

[0010] In some preferred embodiments of the application, the mobile phase in the chromatography is acetonitrile for the mobile phase A and 0.4% phosphoric acid solution for the mobile phase B.

[0011] In some embodiments of the application, the gradient elution program is as follows: 0-15 min, 3%-8% A; 15-20 min, 6%-15% B; 20-35 min, 15% A-25% A; 35-45 min, 25% A-28% A; 45-60 min, 28% A-60% A; 60-70 min, 60% A-6% A.

[0012] In some embodiments of the application, the column temperature in the chromatography is 20-30℃, and the flow rate is 0.5-2.0 mL•min -1 .

[0013] In some preferred embodiments of the application, the column temperature in the chromatography is 20-25℃, and the flow rate is 1-2.0 mL•min -1 , and the injection volume is 3-6 μL.

[0014] In some embodiments of the application, the detection wavelength in the chromatography is 200-270 nm.

[0015] In some preferred embodiments of the present invention, the detection wavelength in the chromatogram is 207 nm during 0-20 min and 40-46 min; the detection wavelength in the chromatogram is 260 nm during 20-40 min; and the detection wavelength in the chromatogram is 230 nm during 46-70 min.

[0016] In some embodiments of the present invention, the chromatographic column in the chromatogram is an Agilent 5-IC C18 column (4.6 mm × 250 mm, 5 µm).

[0017] In some embodiments of the present invention, the detector in the chromatography is a DAD detector.

[0018] In some preferred embodiments of the present invention, the injection volume in the chromatogram is 3 to 6 µL.

[0019] In some embodiments of the present invention, the preparation method of the reference solution is as follows: a standard solution containing ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcanda chinensis glycoside, forsythoside, and arctiin is prepared with methanol, and the solutions are mixed to obtain a reference solution containing ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcanda chinensis glycoside, forsythoside, and arctiin.

[0020] In some preferred embodiments of the present invention, the test solution is prepared by mixing pediatric heat-clearing and lung-benefiting oral liquid with methanol to obtain the test solution.

[0021] In some embodiments of the present invention, the volume ratio of the pediatric heat-clearing and lung-benefiting oral liquid to methanol is 1:(8-10).

[0022] Based on the quality control requirements for Belamcanda chinensis, Forsythia suspensa, and Arctium lappa (fried) in the 2020 edition of the Chinese Pharmacopoeia, this invention adds the content determination indicators for Belamcanda chinensis glycoside (Belamcanda chinensis), Forsythoside (Forsythia suspensa), and Arctin (fried Arctium lappa). First, utilizing the high-efficiency separation characteristics of HPLC, by optimizing the chromatographic column, mobile phase composition, and gradient elution program, the five target components in the preparation are well separated on the chromatographic column, ensuring that the chromatographic peaks of each component do not interfere with each other. Second, during chromatographic operation, the detector dynamically switches according to the maximum absorption wavelength of each component, ensuring that each component is detected at its optimal wavelength, thereby improving the sensitivity and accuracy of detection. Compared with traditional methods, this method avoids the cumbersome operations of multiple injections and changes in detection conditions, significantly improving testing efficiency and reducing time, manpower, and reagent costs. As an important means of quality control for pediatric heat-clearing and lung-benefiting oral liquid, the detection method provided by this invention not only improves the quality standards of the drug but also provides strong protection for the safety of clinical medication.

[0023] In a second aspect, the invention provides the application of the detection method of the first aspect of the invention in the quality evaluation of pediatric heat-clearing and lung-tonifying oral liquid.

[0024] The beneficial effects of the present application are: The present application adopts high performance liquid chromatography to simultaneously determine the contents of 5 active ingredients (ephedrine hydrochloride and pseudoephedrine hydrochloride in ephedra, belamcandin in belamcanda, forsythoside in forsythia, and thistle seed in fried thistle seed) in pediatric heat-clearing and lung-qi-boosting oral liquid, realizing the quality control of pediatric heat-clearing and lung-qi-boosting oral liquid. Compared with the prior art, the present application solves the problems of single content determination, long detection period, high labor and reagent costs, and the like of pediatric heat-clearing and lung-qi-boosting oral liquid. The method is simple, specific, reproducible, and accurate, and can provide a reference for process research, quality assurance, and quality standard improvement of pediatric heat-clearing and lung-qi-boosting oral liquid.

[0025] Specifically: Overall improvement of quality control: By establishing a multi-component method for simultaneously determining ephedrine hydrochloride and pseudoephedrine hydrochloride in ephedra, belamcandin in belamcanda, forsythoside in forsythia, and thistle seed in fried thistle seed, the limitations of the original standard of detecting only a single component are broken through, the simultaneous monitoring of active ingredients of monarch drug and key minister drug is realized, a more scientific and perfect quality evaluation system is constructed, and the comprehensiveness and accuracy of product quality control are significantly improved, providing a more reliable guarantee for clinical medication safety.

[0026] Significant improvement of detection efficiency: During the chromatographic operation, the detector dynamically switches according to the maximum absorption wavelength of each component, so that each component is detected at its optimal wavelength, thereby improving the sensitivity and accuracy of detection. Compared with the traditional method, this method avoids the tedious operation of multiple injections and changing detection conditions, greatly improves the testing efficiency, and reduces the time, labor, and reagent costs.

[0027] Reducing impurity interference: By optimizing the chromatographic column, mobile phase composition, and gradient elution program, the 5 target components in the preparation are well separated on the chromatographic column, ensuring that the chromatographic peaks of each component do not interfere with each other, reducing the interference of coexisting impurities and excipient signals, and making the detection results more accurate.

[0028] Stable and reliable method: The HPLC method established in the present application has good precision, stability, and reproducibility, which can meet the quality control requirements of industrial production, and provides technical support for the standardization and normalization of drug production.

[0029] Promotion and application value: The method is not only suitable for the quality control of pediatric heat-clearing and lung-qi-boosting oral liquid, but also can be applied to the simultaneous detection of multiple components of other traditional Chinese medicine compound preparations, and has wide application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0030] The present application will be further described below in conjunction with the drawings and examples, wherein: Figure 1 Chromatograms of each target compound for different mobile phases, wherein A is the chromatogram of each target compound when the mobile phase is acetonitrile-0.2% phosphoric acid solution, and B is the chromatogram of each target compound when the mobile phase is acetonitrile-0.4% phosphoric acid solution.

[0031] Figure 2 Chromatograms of five target components at 207 nm.

[0032] Figure 3 Chromatograms of blank solvent (A), mixed control (B), test sample (C), and ephedra negative sample (D), wherein 1 is ephedrine hydrochloride, 2 is pseudoephedrine hydrochloride, 3 is belamcandin, 4 is forsythoside, and 5 is arctiin.

[0033] Figure 4 Chromatograms of belamcandae negative sample (A), forsythiae negative sample (B), stir-baked arctii negative sample (C), and negative control sample lacking ephedra, belamcandae, forsythiae, and stir-baked arctii (D), wherein 1 is ephedrine hydrochloride, 2 is pseudoephedrine hydrochloride, 3 is belamcandin, 4 is forsythoside, and 5 is arctiin. DETAILED DESCRIPTION

[0034] The concept and technical effects of the present application will be described below in combination with examples for a clear and complete understanding of the purpose, features and effects of the present application. Obviously, the described examples are only a part of the examples of the present application, but not all the examples. Based on the examples of the present application, other examples obtained by those skilled in the art without creative labor are within the protection scope of the present application.

[0035] The specific conditions not mentioned in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments not mentioned by the manufacturer are all conventional products that can be obtained by market purchase.

[0036] The features and properties of the present application will be further described in combination with examples below.

[0037] Example 1: A content detection method for five components in a traditional Chinese medicine preparation, pediatric heat-clearing and lung-protecting oral liquid 1. Instruments and reagents 1.1 Instruments Electronic analytical balance (precision: 0.001 mg, Mettler Corporation); Agilent 1100 type high performance liquid chromatograph (Agilent Corporation).

[0038] 1.2 Reagents The manufacturer of Xiaoer Qingre Lifen Oral Liquid is Guangzhou Baiyunshan Panguoshou Pharmaceutical Co., Ltd. (2302003C, 2301003A, 2301002A, 2305006A); water is purified water, acetonitrile is chromatographically pure, and phosphoric acid is analytically pure. The information of each reference substance is shown in Table 1.

[0039] Table 1: Table of relevant information of 5 reference substances

[0040] 2 Experimental methods and results 2.1 Chromatographic conditions and system suitability test The chromatographic column is Agilent 5-IC C18 (4.6 mm x 250 mm, 5 µm); the DAD detector, the detection wavelength is 207 nm (0-20 min, 40-46 min), 260 nm (20-40 min), 230 nm (46-70 min); the flow rate is 1.0 mL•min -1 ; the mobile phase is acetonitrile (A)-0.4% phosphoric acid aqueous solution (B), gradient elution (0-15 min, 6% A; 15-20 min, 6% A-15% A; 20-35 min, 15% A-25% A; 35-45 min, 25% A-28% A; 45-60 min, 28% A-60% A; 60-70 min, 60% A-6% A); the column temperature is 25°C; the injection volume is 5 µL; the theoretical plate number calculated by pseudoephedrine hydrochloride peak should not be less than 10,000.

[0041] 2.2 Preparation of reference solution Take ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcandin, forsythoside and arctoside reference substances, accurately weigh and place in the same volumetric flask, add methanol to prepare a mixed reference substance stock solution, the concentrations of each reference substance are ephedrine hydrochloride 0.4128 mg·mL -1 , pseudoephedrine hydrochloride 0.3123 mg·mL -1 , belamcandin 0.1905 mg·mL -1 , forsythoside 0.09748 mg·mL -1 , arctoside 1.4535 mg·mL -1 (the concentration has been converted to reference substance purity).

[0042] 2.3 Preparation of test solution Accurately take 1 mL of Xiaoer Qingre Lifen Oral Liquid, place it in a 10 mL volumetric flask, add methanol to the mark, shake well, and it is obtained.

[0043] 2.4 Preparation of negative sample solution Take ephedra, belamcanda, forsythia, fried burdock and at the same time do not contain ephedra, belamcanda, forsythia, fried burdock four ingredients of negative control sample, according to the preparation method of 2.3 test solution, ephedra negative control sample solution, belamcanda negative control sample solution, forsythia negative control sample solution, fried burdock negative control sample solution and at the same time do not contain four ingredients of negative control sample solution were prepared respectively.

[0044] 2.5 quantitative determination The different concentration gradient of target substance control was analyzed by high performance liquid chromatography, and the standard curve was obtained by regression analysis of the chromatographic peak area and its corresponding concentration. Under the same conditions, the test solution was determined by high performance liquid chromatography, and the chromatographic peak area of each target substance in the sample solution was measured, which was substituted into the standard curve for quantitative analysis.

[0045] Example 2 This example investigates the influence of different mobile phases on the detection results (other conditions are the same as in example 1), and selects acetonitrile-0.2% phosphoric acid solution, acetonitrile-0.4% phosphoric acid solution as the mobile phase according to the current version of Xiaoer Qingre Lungs oral liquid standard and the content determination chromatographic conditions of belamcanda and other medicinal materials.

[0046] The results are shown in Figure 1 , acetonitrile-0.2% phosphoric acid solution is not conducive to the separation of acid substances, especially the separation degree of benzoic acid and belamcanda glycoside is poor; while acetonitrile-0.4% phosphoric acid solution as the mobile phase, the separation degree of each test component and the adjacent chromatographic peak is greater than 2.21, and the chromatographic peak shape is symmetrical. Therefore, acetonitrile-0.4% phosphoric acid solution is finally selected as the mobile phase.

[0047] Example 3 The maximum absorption wavelength of the five target components was detected by DAD detector, and the results showed that the five components had larger terminal absorption at 207 nm, among which belamcanda glycoside had maximum absorption at 260 nm, and arctiin had maximum absorption at 230 nm Figure 2 ). Considering that the peak area of arctiin is 14 times that of forsythoside, the overall spectrum looks not beautiful, and the belamcanda negative sample has interference at 207 nm wavelength, so 207 nm wavelength is used to detect ephedrine hydrochloride, pseudoephedrine hydrochloride and forsythoside, 230 nm to detect arctiin and 260 nm to detect belamcanda glycoside.

[0048] Example 4 This example investigates the influence of solvents in the preparation method of sample solution such as control solution and test solution on the detection results, and different solvents such as water, methanol, 50% methanol, 50% ethanol, 70% ethanol and ethanol are selected for sample solution preparation.

[0049] The results show that the impurities are less when methanol is used to dilute the sample solution, and each component can be better extracted, while other components cannot extract each component, so methanol is selected to prepare the sample solution.

[0050] Example 5 The pediatric heat-clearing and lung-qi-boosting oral liquid has 11 medicinal materials and many content indicators. In this embodiment, the selection of effective components in the pediatric heat-clearing and lung-qi-boosting oral liquid is investigated, so that the pediatric heat-clearing and lung-qi-boosting oral liquid can be effectively quality controlled.

[0051] The results show that the content indicators include ephedrine hydrochloride, pseudoephedrine hydrochloride, geniposidic acid, chlorogenic acid, belamcandin, forsythoside, arctiin, second iridin, forsythoside A, naringin, etc. However, considering that the specificity of chlorogenic acid is not strong, the peak area of geniposidic acid, second iridin and forsythoside A is small, and it is not linear, ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcandin, forsythoside and arctiin are selected as content indicators.

[0052] Further effect detection is made on Example 1 1. Specificity test The blank solvent (methanol), the mixed control solution, the test sample solution and each negative control sample solution are respectively taken, the detection method of Example 1 is used for sample determination, and the results are shown in Figures 3-4 . The sample peak and impurity peak in the test sample chromatogram are well separated, and the negative control has no interference.

[0053] 2. Linear relationship investigation 5 mL, 1 mL, 1 mL, 1 mL and 1 mL of the mixed control stock solution under item 2.2 in Example 1 are precisely taken and placed in 10 mL, 5 mL, 10 mL, 25 mL and 50 mL volumetric flasks respectively. Methanol is added to the mark, the chromatographic conditions of Example 1 are used for determination, and the peak area is calculated. The mass concentration (μg·mL -1 ) of each control solution is taken as the abscissa (x), and the peak area is taken as the ordinate (y), the regression equation is calculated, and the results are shown in Table 2.

[0054] Table 2: Linear relationship investigation table of each component

[0055] 3. Precision test 5 μL of the test sample solution under item 2.3 in Example 1 is precisely taken, the chromatographic conditions of Example 1 are used for determination, and the sample determination is repeated for 6 times continuously, the chromatographic peak area is calculated, and the RSD is calculated.

[0056] The results show that the RSD of the chromatographic peak area of each substance is 0.12%, 0.75%, 1.33%, 1.35% and 0.16% respectively, which indicates that the instrument precision is good. The specific results are shown in Table 3.

[0057] Table 3: Precision test results table of 5 components (n=6)

[0058] 4. Stability test The same test sample solution under item 2.3 in Example 1 was precisely taken, and the chromatographic conditions of Example 1 were used for sample injection determination at 0, 4, 8, 12, 16, 24 and 36 h, and the chromatographic peak areas of jiedan saponin, forsythoside, ephedrine hydrochloride, pseudoephedrine hydrochloride and arctiin were recorded.

[0059] The results show that the RSD of the chromatographic peak area of each substance is 0.42%, 0.61%, 1.11%, 1.23% and 0.43% respectively, which indicates that the test sample solution is stable within 36 h after preparation. The specific results are shown in Table 4.

[0060] Table 4: Stability test results table of 5 components

[0061] 5. Reproducibility test The sample with batch number 2302003C was taken, and the test sample solution was prepared in parallel according to the method of item 2.3 in Example 1, the chromatographic conditions of Example 1 were used for sample injection determination, and the standard curve was constructed using the control sample solution of each target substance, and the content of each substance was calculated.

[0062] The results show that the average content of ephedrine hydrochloride, pseudoephedrine hydrochloride, jiedan saponin, forsythoside and arctiin in the test sample solution is 0.4070, 0.2983, 0.1852, 0.0900 and 1.5135 mg•ml -1 respectively, and the RSD is 0.55%, 0.53%, 1.34%, 1.36% and 0.56% respectively (Table 5), which indicates that the reproducibility of the method of Example 1 is good.

[0063] Table 5: Reproducibility test results table of 5 components

[0064] 6. Sample addition recovery test Take the known content of the sample with the same batch of sample 0.5 mL, a total of 6, respectively, in 10 mL brown volumetric flask, respectively, precision 0.5 mL of mixed control stock solution prepared in item 2.2 of example 1, then according to the sample treatment method under item 2.3 is handled, finally according to the chromatographic conditions in example 1 is determined, the recovery of each component is calculated.

[0065] The results are shown in Table 6, the average recovery of the target is between 97.32% and 99.74%, the relative standard deviation is 0.26% to 0.98%, indicating that the method of example 1 has good accuracy.

[0066] Table 6: the results of the recovery test of 5 components (n=6)

[0067] 7. Detection of actual sample The method of example 1 is used to detect 3 batches of pediatric heat and lung oral liquid, the test sample solution is prepared according to the test sample solution preparation method, and the content of each component is calculated according to the chromatographic conditions.

[0068] The results are shown in Table 7.

[0069] Table 7: the content of 5 components in 3 batches of pediatric heat and lung oral liquid (mg·mL -1 , n=2)

[0070] The embodiments of the application are described in detail above in combination with the drawings, but the application is not limited to the above embodiments, and various changes can be made within the knowledge of those skilled in the art without departing from the purpose of the application. In addition, the embodiments of the application and the features in the embodiments can be combined with each other without conflict.

Claims

1. A method for detecting the content of ephedrine hydrochloride, pseudoephedrine hydrochloride, belamcanda chinensis glycoside, forsythoside, and arctiin in a traditional Chinese medicine preparation, Xiaor Qingre Lifeng Oral Liquid, the method comprising the following steps: Prepare test solution and reference solution, and use high performance liquid chromatography to detect the test solution and reference solution respectively; The solvent for both the test solution and the reference solution is methanol.

2. The detection method according to claim 1, characterized in that, The elution in the chromatogram was performed using a gradient elution method, with mobile phase A being acetonitrile and mobile phase B being a 0.2%–0.6% phosphoric acid solution.

3. The detection method according to claim 2, characterized in that, The gradient elution program is as follows: 0–15 min, 3%–8% A; 15–20 min, 6%–15% B; 20–35 min, 15% A–25% A; 35–45 min, 25% A–28% A; 45–60 min, 28% A–60% A; 60–70 min, 60% A–6% A.

4. The detection method according to any one of claims 1 to 3, characterized in that, The column temperature in the chromatogram was 20–30 °C, and the flow rate was 0.5–2.0 mL / min. -1 The injection volume is 3–6 μL.

5. The detection method according to any one of claims 1 to 3, characterized in that, The detection wavelength in the chromatogram is 200–270 nm.

6. The detection method according to any one of claims 1 to 3, characterized in that, The chromatographic column used in the chromatography was an Agilent 5-IC C18 column.

7. The detection method according to claim 6, characterized in that, The detector used in the chromatography is a DAD detector.

8. The detection method according to any one of claims 1 to 3, characterized in that, The preparation method of the reference solution is as follows: prepare a standard solution containing ephedrine hydrochloride, pseudoephedrine hydrochloride, iridoside, forsythoside, and arctiin with methanol, mix them, and obtain a reference solution containing ephedrine hydrochloride, pseudoephedrine hydrochloride, iridoside, forsythoside, and arctiin.

9. The detection method according to claim 8, characterized in that, The test solution is prepared by mixing pediatric heat-clearing and lung-benefiting oral liquid with methanol to obtain the test solution.

10. The application of the detection method according to any one of claims 1 to 9 in the quality evaluation of Xiaor Qingre Lifeng Oral Liquid.

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