Quality control method of Baihuanning cough syrup

Abstract

The application discloses a quality control method of Baihuanning cough syrup and belongs to the technical field of medicine detection. The quality control method of the Baihuanning cough syrup comprises the following steps: (1) preparation of a control solution; (2) preparation of a test solution; and (3) high performance liquid chromatography determination. The Baihuanning cough syrup is determined on the content of ephedrine hydrochloride and pseudoephedrine hydrochloride by the high performance liquid chromatography method, and the content information characteristics of the components in the medicine can be better reflected. The method has strong specificity, good reproducibility, high accuracy and good stability, can better control the quality of the Baihuanning cough syrup product, makes up for the shortcomings of the existing method, so that the medicine reaches the stable, controllable, efficient and safe standard, provides a scientific and reasonable basis for quality control and standard improvement of the Baihuanning cough syrup, and provides a reliable guarantee for the stability of the curative effect of the product.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical detection, and in particular relates to a quality control method for Baihua Ningsou Dew. Background Art

[0002] Baihua Ningsou Lu (Baihua Ningsou Lu) is a medicine developed by the Wuzhou Hospital of Traditional Chinese Medicine in Guangxi. Its formula consists of Chinese herbs such as ephedra, stemona, bitter almond, asarum, plantain, cyperus, and liquorice. It has the functions of dispelling wind and clearing heat, relieving cough and reducing phlegm, and relieving asthma. It is used for wind-heat cough and wheezing caused by excessive phlegm. Baihua Ningsou Lu has demonstrated clinical efficacy and positive patient feedback. The main ingredient in this medicine is ephedra, which has the functions of inducing diaphoresis and dispelling cold, promoting lung function and relieving asthma, and promoting diuresis and reducing swelling. It is used for colds caused by wind and cold, chest tightness, cough and wheezing, and edema caused by wind and water. Ephedra mainly contains the active ingredients ephedrine hydrochloride and pseudoephedrine hydrochloride. Currently, quality control for Baihua Ningsou Lu mostly relies on thin-layer chromatography identification studies of the ingredients in the formula, such as ephedra, bitter almond, and platycodon grandiflorum, but lacks the ability to determine the content of the ingredients. Therefore, to ensure the safety, efficacy, and stability of clinical use, it is necessary to develop a method that can accurately and efficiently determine the content of the active ingredients in Baihua Ningsou Lu.

[0003] High-performance liquid chromatography (HPLC) offers high separation efficiency, rapid analysis, high quantitative precision, and excellent stability. Furthermore, the method is not limited by sample volatility or thermal stability, allowing for the analysis and detection of most components in the sample. To effectively control the quality of the pharmaceutical, the present invention employs HPLC to determine the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the pharmaceutical. This method is simple, rapid, accurate, and efficient, effectively controlling the quality of Baihua Ningsou Lu. Summary of the Invention

[0004] In response to the above problems, the present invention provides a quality control method for Baihua Ningsou Lu, which can better control the quality of the medicine by measuring the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in Baihua Ningsou Lu using high performance liquid chromatography.

[0005] The present invention is achieved through the following technical solutions:

[0006] A quality control method for Baihua Ningsou Lu comprises the following steps:

[0007] (1) Preparation of reference solution: Accurately weigh appropriate amounts of ephedrine hydrochloride reference substance and pseudoephedrine hydrochloride reference substance, dissolve them in methanol and dilute to volume to obtain reference solution;

[0008] (2) Preparation of the test solution: accurately measure an appropriate amount of Baihua Ningsou Lu, add 68-70% methanol and perform ultrasonic treatment, centrifuge and collect the supernatant, evaporate to dryness and dissolve in water, then extract using a macroporous adsorption resin, evaporate the resulting eluate to dryness, add 0.08-0.1 mol / L hydrochloric acid methanol to make up the volume, filter, and collect the filtrate to obtain the test solution;

[0009] (3) High performance liquid chromatography determination: using octadecylsilane bonded silica gel as filler, acetonitrile as mobile phase A, and 0.2% phosphoric acid solution as mobile phase B, gradient elution was performed, column temperature was 30-35°C, detection wavelength was 209-212 nm, flow rate was 0.8-1.0 mL / min, the theoretical plate number was not less than 3000 calculated based on the ephedrine hydrochloride peak, 5-6 μL of the reference solution and the test solution were respectively transferred into the high performance liquid chromatograph for determination, and the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the test solution were obtained.

[0010] Furthermore, in step (3), the gradient elution procedure is: 0-20 min, 3% A; 20-21 min, 3-90% A; 21-31 min, 90% A; 31-32 min, 90-3% A; 32-42 min, 3% A.

[0011] Furthermore, in step (3), the column temperature is 35° C., the detection wavelength is 210 nm, and the flow rate is 1.0 mL / min.

[0012] Furthermore, in step (3), the dosage of the reference solution and the test solution is 5 μL.

[0013] Furthermore, in step (2), the ultrasonic treatment is carried out at a power of 160 to 180 W and a frequency of 40 to 45 Hz for 28 to 30 minutes.

[0014] Furthermore, in step (2), the macroporous adsorption resin is of type D101, with an inner diameter of 1.3 to 1.5 cm and a column height of 12 to 14 cm.

[0015] Furthermore, in step (1), the concentration of ephedrine hydrochloride in the reference solution is 1.02-1.03 mg / mL, and the concentration of pseudoephedrine hydrochloride is 1.05-1.06 mg / mL.

[0016] Compared with the prior art, the advantages and beneficial effects of the present invention are:

[0017] 1. Compared with the existing standards that do not measure the content of Baihua Ningsou Lu, the present invention uses high-performance liquid chromatography to measure the content of ephedrine hydrochloride and pseudoephedrine hydrochloride in Baihua Ningsou Lu, which can better reflect the content information characteristics of the ingredients in the medicine. This method has strong specificity, good reproducibility, high accuracy and good stability, can better control the quality of Baihua Ningsou Lu products, and make up for the shortcomings of existing methods, so that the medicine can reach the standards of stability, controllability, efficiency and safety, provide a scientific and reasonable basis for the quality control and standard improvement of Baihua Ningsou Lu, and provide a practical and reliable guarantee for the stability of the efficacy of the medicine.

[0018] 2. The present invention establishes chromatographic conditions and uses liquid chromatography to detect the content of ephedrine hydrochloride and pseudoephedrine hydrochloride in Baihua Ningsou Lu, which can quickly detect the content of active ingredients in the medicine to better control the quality of Baihua Ningsou Lu products. In addition, the detection method is quick to operate, low in cost, and has high detection efficiency.

[0019] 3. When preparing the test solution, the present invention first uses 68-70% methanol and then performs ultrasonic treatment, and then uses a D101 macroporous adsorption resin column for extraction. The extraction is clean and complete, the sample reproducibility is good, there is less impurity interference, and the extraction process is safe, which is beneficial to improving the accuracy and stability of drug detection and improving detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is the UV scanning diagram of the ephedrine hydrochloride reference substance in Example 1.

[0021] Figure 2 This is the UV scan of the pseudoephedrine hydrochloride reference substance in Example 1.

[0022] Figure 3 HPLC diagram of the ephedrine hydrochloride and pseudoephedrine hydrochloride reference substances in Example 1.

[0023] Figure 4 This is the HPLC chart of the Baihua Ningsou Lu sample in Example 1.

[0024] Figure 5 HPLC chart of the negative control in Example 1.

[0025] Figure 6 HPLC chart of blank solvent in Example 1. DETAILED DESCRIPTION

[0026] The present invention is further described in detail below through examples. These examples are only used to illustrate the present invention and do not limit the scope of protection of the present invention.

[0027] The preparation method of Baihua Ningsou Decoction of the present invention is as follows:

[0028] Prescription: Ephedra 25g, Stemona 60g, Bitter Apricot 50g, Asarum 15g, Plantago 50g, Ardisia 100g, Licorice 25g, Platycodon 60g, Cicada Periostracum 40g, Fritillaria 15g, Houttuynia Cordata 75g, Paris polyphylla 75g; Excipients: Sucrose 300g, Benzoic Acid 2g, Ethylparaben 0.5g.

[0029] Preparation process: Crush the granules of Fritillaria cirrhosa, add water to the remaining raw materials except Houttuynia cordata, boil for 1.5 hours, filter, take the filtrate, add water to the residue and continue to boil for 1 hour, take the filtrate and combine it with the previous filtrate, mix it, concentrate it to a certain amount, add Houttuynia cordata and boil for 20 minutes, filter, take the filtrate, then add sugar, stir to dissolve, boil, filter, add benzoic acid and ethylparaben, stir well, adjust the total amount to 1000mL, and package it into sterilized oral liquid medicinal high-density polyethylene bottles, with 100mL in each bottle.

[0030] Example 1

[0031] 1 Experimental instruments, materials and reagents

[0032] 1.1 Instrument

[0033] Ultimate 3000DGLC high-performance liquid chromatograph; Agilent 1260 high-performance liquid chromatograph (UV detector); XS205DU electronic analytical balance (Mettler-Toledo, weighing range: 81 / 220 g; precision: 0.01 / 0.1 mg); UV spectrophotometer (Shimadzu UV-2450); B5200S ultrasonic cleaner (Branson Ultrasonics (Shanghai) Co., Ltd.); HH-S digital constant temperature water bath (Jintan Medical Instrument Factory, Jiangsu Province).

[0034] 1.2 Chromatographic column

[0035] The chromatographic columns were filled with octadecylsilane bonded silica gel (YMC Hydrosphere 4.5*250 mm, 5 μm; Agilent InfinityLab Poroshell 120SB-C18, 3*150 mm, 2.7 μm).

[0036] 1.3 Reagents

[0037] Acetonitrile (chromatographic grade, OMNI CHEM); methanol (analytical grade, Sinopharm Chemical Reagent Co., Ltd.); ammonia (analytical grade, Guangdong Guanghua Technology Co., Ltd.); hydrochloric acid and phosphoric acid (analytical grade, Chengdu Kelong Chemical Co., Ltd.); acetonitrile was chromatographic grade, and all other reagents were analytical grade; water was purified. D101 macroporous adsorption resin (Tianjin Guangfu Fine Chemical Research Institute)

[0038] 1.4 Sample

[0039] Baihua Ningsou Decoction (batch numbers: 210707, 210726, 210816, 211011, 211020, 211207, 211221, 220105, 220124) and negative control sample lacking ephedra (all provided by the preparation room of Wuzhou Traditional Chinese Medicine Hospital).

[0040] 1.5 Reference substances

[0041] Ephedrine hydrochloride reference substance (China Food and Drug Inspection Institute, batch number 171241-201809); pseudoephedrine hydrochloride reference substance (China Food and Drug Inspection Institute, batch number 171237-201510).

[0042] 2 Experimental methods and results

[0043] 2.1 Selection of experimental conditions

[0044] 2.1.1 Chromatographic conditions

[0045] Octadecylsilane bonded silica gel was used as the filler; acetonitrile-0.2% phosphoric acid water was used as the mobile phase, wherein acetonitrile was used as mobile phase A and 0.2% phosphoric acid solution was used as mobile phase B, and gradient elution was performed according to the provisions in the following table; injection volume was 5 μL; column temperature was 35°C; flow rate was 1.0 mL / min; the number of theoretical plates calculated based on the ephedrine hydrochloride peak should be no less than 3000; detection wavelength was 210 nm, and scanning was performed at 200-400 nm using a UV-visible spectrophotometer; ephedrine hydrochloride and pseudoephedrine hydrochloride reference substances had maximum absorption near a wavelength of 210 nm, as shown in the table below. Figure 1 and Figure 2 , determine the detection wavelength to be 210nm.

[0046] Table 1 Elution program

[0047]

[0048] 2.1.2 Investigation of extraction methods

[0049] An investigation of ultrasonic treatment with 70% methanol directly into HPLC analysis revealed a high concentration of impurities, severe interference, and a high baseline. An investigation of using 70% methanol ultrasonic treatment followed by cleanup on a neutral alumina column or a D101 macroporous adsorption resin column to remove impurities revealed that the sample was viscous and difficult to pass through the neutral alumina column. Cleanup on the D101 macroporous adsorption resin column resulted in good reproducibility, complete extraction, and less impurity interference than before cleanup, achieving baseline separation. Distillation extraction under alkaline conditions and ether extraction were also investigated. Distillation extraction resulted in cleaner extraction without impurity interference, but extraction was incomplete and the sample content was low. Ether extraction also resulted in cleaner extraction without impurity interference. However, ether is a precursor reagent and its use in large quantities poses a health risk. Therefore, the 70% methanol ultrasonic treatment followed by cleanup on a D101 macroporous adsorption resin column was selected as the extraction method.

[0050] Table 2 Results of the extraction method investigation

[0051]

[0052]

[0053] 2.2 Preparation of test sample solution

[0054] 2.2.1 Preparation of reference solution

[0055] Accurately weigh 10.27 mg of ephedrine hydrochloride reference substance and 10.61 mg of pseudoephedrine hydrochloride reference substance, dilute to 10 mL with methanol, and prepare stock solutions of ephedrine hydrochloride and pseudoephedrine hydrochloride with concentrations of 1.0270 mg / mL and 1.0589 mg / mL, respectively.

[0056] 2.2.2 Preparation of test solution

[0057] Accurately measure 10mL of Baihuaning cough syrup in a volumetric flask, add 10mL of 70% methanol, ultrasonically treat (power 180W, frequency 42Hz) for 30min, let cool, dilute to 25mL, shake well, and centrifuge. Accurately transfer 15mL of the supernatant, evaporate to near dryness, dissolve with 20mL of water, and pass all through D101 macroporous adsorption resin (inner diameter 1.5cm, column height 13cm). Wash and transfer through the macroporous resin in an evaporating dish with 20mL of water in small amounts multiple times. First elute with 100mL of water, discard the eluate, then elute with 100mL of 50% ethanol, collect the eluate, evaporate to dryness, add 0.1mol / L hydrochloric acid methanol to the residue and dilute to 20mL, shake well, filter, and take the filtrate to obtain.

[0058] 2.2.3 Preparation of negative control solution

[0059] Take 10 mL of the negative sample lacking ephedra and extract it according to the method of preparing the test solution in 2.2.2.

[0060] 2.3 Methodological validation

[0061] 2.3.1 Specificity test

[0062] Take the prescription except ephedra, and make a negative control without ephedra according to the same process as this product. Then, perform the content determination according to the high performance liquid chromatography method. Accurately aspirate 5μL of the reference solution and the test solution respectively, and inject them into the liquid chromatograph for determination. The results show that there is no absorption peak at the same position as ephedrine hydrochloride and pseudoephedrine hydrochloride in the negative control, indicating that the other ingredients in the prescription have no negative interference with the content determination of this product. See the chromatogram. Figure 3-6 .

[0063] 2.3.2 Linear relationship test

[0064] Accurately measure 1 mL of the ephedrine hydrochloride reference stock solution and 1 mL of the pseudoephedrine hydrochloride reference stock solution under 2.2.1, add methanol to make the volume to 5 mL, and prepare ephedrine hydrochloride and pseudoephedrine hydrochloride stock solutions with concentrations of 205.4000 μg / mL and 211.7800 μg / mL, respectively. Accurately pipette 2 mL of the above ephedrine hydrochloride stock solution and 1.5 mL of the pseudoephedrine hydrochloride stock solution into the same volumetric flask. Add methanol to the volume to 10 mL to prepare mixed solutions with concentrations of 41.0800 μg / mL for ephedrine hydrochloride and 31.7670 μg / mL for pseudoephedrine hydrochloride, respectively. Dilute this mixture with methanol to prepare a series of mixed control solutions with concentrations of 1.3693, 6.8467, 13.6933, 20.5400, and 27.3867 μg / mL; and 1.0587, 5.2933, 10.5867, 15.8800, and 21.1733 μg / mL for ephedrine hydrochloride and pseudoephedrine hydrochloride, respectively. Accurately pipette 5 μL of each of these mixed control solutions and inject them for determination according to the chromatographic conditions in Section 2.1.1.

[0065] Standard curves were drawn using peak area (Y) as the ordinate and concentration (X) as the abscissa. The results showed good linearity over the concentration ranges of 1.3693 to 27.3867 μg / mL for ephedrine hydrochloride and 1.0587 to 21.1733 μg / mL for pseudoephedrine hydrochloride. The linear equations for ephedrine hydrochloride were: Y = 0.1534X + 0.0098 (r = 0.999, n = 5); and for pseudoephedrine hydrochloride, Y = 0.1408X + 0.0047 (r = 0.999, n = 5).

[0066] 2.3.3 Precision test

[0067] Select the mixed reference solution from "2.3.2" and inject 5 μL of the sample five times. Measure the peak area. The RSD for the peak area of ​​ephedrine hydrochloride is 0.3%, and the RSD for the peak area of ​​pseudoephedrine hydrochloride is 0.5%, indicating good instrument precision. The results are shown in Table 3.

[0068] Table 3 Precision test results

[0069]

[0070] 2.3.4 Stability test

[0071] A solution of the test sample (Batch No. 210726) was injected with 5 μL of sample at 0, 2, 4, 6, 8, 10, and 12 h, and the peak area was determined. The RSD of the peak area for ephedrine hydrochloride was calculated to be 0.9%, and the RSD of the peak area for pseudoephedrine hydrochloride was 1.0%. The test showed that the tested solution was stable within 12 h. The results are shown in Table 4.

[0072] Table 4 Stability test results

[0073]

[0074] 2.3.5 Repeatability test

[0075] Six samples of the same batch of Baihua Ningsou Lu (lot number 210726) were taken and assayed according to the method outlined in the text. The results showed that the average ephedrine hydrochloride and pseudoephedrine hydrochloride contents were 37.08 μg / mL and 27.50 μg / mL, respectively, with RSDs of 1.2% and 0.9%, respectively (n=6), indicating good reproducibility. The results are shown in Table 5.

[0076] Table 5 Repeatability test results

[0077]

[0078]

[0079] 2.3.6 Recovery test

[0080] Accurately measure 5 mL of Baihua Ningsou Dew (batch number 210726) of known concentration from the same batch (ephedrine hydrochloride content is 37.08 μg / mL, pseudoephedrine hydrochloride content is 27.50 μg / mL) and place it in a 25 mL volumetric flask. Then accurately draw an appropriate amount of the control stock solution, and then measure solutions of three different concentrations, low, medium and high, and calculate the sample recovery rate. The results are shown in Table 6. It can be seen that the method has good accuracy.

[0081] Table 6 Sample recovery determination results (n=9)

[0082]

[0083] 2.3.7 Durability test

[0084] 2.3.7.1 Examination of chromatographic columns

[0085] The total amount of ephedrine hydrochloride and pseudoephedrine hydrochloride in a sample (210726) was determined using two chromatographic columns of different brands (YMC Hydrosphere 4.5*250mm, 5μm; Agilent ZORBAX SB-Aq, 4.6×150mm, 3.5μm). The average value of the results from the two columns was 62.00μg / mL, with an RAD of 2.6% (n=2). The experiment showed that the use of columns of different manufacturers and models had little effect on the results, with no interference from other peaks and good reproducibility.

[0086] 2.3.7.2 Inspection of chromatograph

[0087] The total amount of ephedrine hydrochloride and pseudoephedrine hydrochloride in a sample (210726) was determined using two different brands of chromatographs (Agilent 1260 and Ultimate 3000 DGLC). The average value of the two chromatographs was 65.74, with an RAD of 3.3% (n=2). The experiment showed that the different manufacturers and different models of instruments had little effect on the results, no interference from other peaks, and good reproducibility.

[0088] 2.3.7.3 Changes in mobile phase ratio

[0089] Based on the selected chromatographic conditions of 4:96, we examined varying the ratio within the specified range, injecting 5 μL of sample each time. The average total concentration of ephedrine hydrochloride and pseudoephedrine hydrochloride was 62.96 μg / mL, with an RSD of 3.3%. This experiment demonstrated that varying the mobile phase ratio within the specified range, while ensuring that the required resolution was met, had little effect on the ratio. The experimental results are shown in Table 7.

[0090] Table 7 Mobile phase ratio investigation table (210721:ADD2-1)

[0091]

[0092] 2.3.7.4 Wavelength variation

[0093] On the basis of the selected detection wavelength of 210nm, the same test solution was varied within its specified range (i.e., 210±2nm), and 5μL was injected each time. The average total amount of ephedrine hydrochloride and pseudoephedrine hydrochloride in the test solution was 63.48μg / mL, and the RSD was 0.4%, indicating that the wavelength variation within the specified range has little effect on it. The experimental results are shown in Table 8.

[0094] Table 8 Effect of wavelength variation (sample batch number: 210726)

[0095]

[0096] 2.3.7.5 Effect of different column temperatures

[0097] At room temperature, the same reference and test sample were injected at different column temperatures, with 5 μL injected each time. The results showed that the higher the temperature, the faster the peak elution time. At a column temperature of 40°C, the ephedrine hydrochloride and pseudoephedrine hydrochloride peaks were completely enveloped by impurity peaks, resulting in increased concentrations. At 30-35°C, the RAD was 0.5%, which had little impact on the results. There was no interference from impurity peaks, and reproducibility was excellent. The results are shown in Table 9.

[0098] Table 9 Column temperature inspection table (210721:ADD2-1)

[0099]

[0100] 2.4 Sample determination

[0101] Nine batches of preparations were sampled and the ephedrine hydrochloride and pseudoephedrine hydrochloride content of this product was determined. Among the nine batches, the total ephedrine hydrochloride and pseudoephedrine hydrochloride content was highest at 72.31 μg / mL and lowest at 49.03 μg / mL, with an average content of 60.91 μg / mL. The results are shown in Table 10.

[0102] Table 10 Content determination results of 9 batches of preparations

[0103]

[0104] Based on the content determination data of ephedrine hydrochloride and pseudoephedrine hydrochloride in 9 batches of Baihua Ningsou Lu, the average content of the total amount (60.91 μg / mL) is reduced by 20% to 48.73 μg / mL. Taking into account the differences in the sources of medicinal materials, the tentative limit is not less than 45.00 μg / mL.

[0105] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A quality control method for Baihua Ningsou Dew, characterized in that: The following steps are involved: (1) Preparation of reference solution: Accurately weigh appropriate amounts of ephedrine hydrochloride reference substance and pseudoephedrine hydrochloride reference substance, dissolve them in methanol and make up to volume to obtain reference solution; (2) Preparation of the test solution: accurately measure an appropriate amount of Baihua Ningsou Lu, add 68-70% methanol and perform ultrasonic treatment. After centrifugation, collect the supernatant, evaporate to dryness, dissolve in water, and then extract using a macroporous adsorption resin. After evaporating the eluate to dryness, add 0.08-0.1 mol / L hydrochloric acid methanol to make up the volume, filter, and collect the filtrate to obtain the test solution. The macroporous adsorption resin is of model D101, with an inner diameter of 1.3 to 1.5 cm and a column height of 12 to 14 cm; the eluent of the macroporous adsorption resin is 50% ethanol; (3) High performance liquid chromatography determination: octadecylsilane bonded silica gel was used as the filler, acetonitrile was used as the mobile phase A, and 0.2% phosphoric acid solution was used as the mobile phase B. Gradient elution was performed, the column temperature was 30-35°C, the detection wavelength was 209-212 nm, the flow rate was 0.8-1.0 mL / min, and the theoretical plate number was not less than 3000 based on the ephedrine hydrochloride peak. 5-6 μL of the reference solution and the test solution were respectively transferred into the high performance liquid chromatograph for determination, and the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the test solution were obtained; The gradient elution program is: 0-20 min, 3% A; 20-21 min, 3-90% A; 21-31 min, 90% A; 31-32 min, 90-3% A; 32-42 min, 3% A.

2. The quality control method of Baihua Ningsou Dew according to claim 1, characterized in that: In step (3), the column temperature is 35°C, the detection wavelength is 210 nm, and the flow rate is 1.0 mL / min.

3. The quality control method of Baihua Ningsou Dew according to claim 1, characterized in that: In step (3), the amount of the reference solution and the test solution is 5 μL.

4. The quality control method of Baihua Ningsou Dew according to claim 1, characterized in that: In step (2), the ultrasonic treatment is carried out at a power of 160 to 180 W and a frequency of 40 to 45 Hz for 28 to 30 minutes.

5. The quality control method of Baihua Ningsou Dew according to claim 1, characterized in that: In step (1), the concentration of ephedrine hydrochloride in the reference solution is 1.02-1.03 mg / mL, and the concentration of pseudoephedrine hydrochloride is 1.05-1.06 mg / mL.

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