Preparation process of salted cortex phellodendri standard decoction

Abstract

The invention discloses a preparation process of a salted cortex phellodendri standard decoction, and relates to the technical field of traditional Chinese medicine decoction preparation. The preparation method comprises the following steps: firstly, weighing a proper amount of salted cortex phellodendri decoction pieces, putting the salted cortex phellodendri decoction pieces into a marmite, decocting twice, adding 10 times of water for soaking for 30 minutes for the first time, boiling with strong fire, and then decocting with slow fire for 30 minutes; adding 8 times of water for the second time, boiling with strong fire, then decocting with slow fire for 20 minutes, filtering the liquid medicine with 200 meshes, rapidly cooling the filtrate to room temperature in a water bath, mixing the two filtrates, carrying out vacuum concentration at the temperature of 50 DEG C until the weight ratio of the medicinal material to the fluid extract is about 1: 1, collecting the concentrated solution, and freeze-drying to obtain a sample. According to the method, the salted cortex phellodendri decoction is taken as a standard, key quality indexes such as the main content, the characteristic spectrum and the extract of a single traditional Chinese medicine variety after the decoction is prepared are stipulated, the transfer rate is investigated, meanwhile, the transfer rate range of the main content of the salted cortex phellodendri medicinal material is stipulated, and the effectiveness of the salted cortex phellodendri decoction is ensured after the preparation is carried out according to the standard.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine decoction preparation technology, and in particular to the preparation process of standard decoction of salted Phellodendron bark. Background Technology

[0002] Salted Phellodendron bark is made by soaking Phellodendron bark filaments in salt water until thoroughly moistened, then stir-frying them over low heat until dry and cooled. Salted Phellodendron bark has a strong effect of nourishing yin and reducing fire, and clearing deficiency heat. It is often used for symptoms such as yin deficiency fever, night sweats, seminal emission, weakness of the legs and knees, cough with hemoptysis, etc. Traditional Chinese medicine decoctions are a traditional and widely used form of medication in clinical practice. Standardized decoctions are single-herb Chinese medicine decoctions prepared by standardized processes based on traditional Chinese medicine theory and clinical application, with reference to modern extraction methods. They are used for standardized clinical medication to ensure the accuracy of medication and the consistency of dosage.

[0003] Currently, there are no quality studies or standards for salt-processed Phellodendron bark decoction, so it is impossible to measure the quality and efficacy of the decoction after decoction, nor can it provide a basis for the formulation of quality standards for the final product of salt-processed Phellodendron bark decoction. Therefore, we propose a preparation process for a standard salt-processed Phellodendron bark decoction. Summary of the Invention

[0004] The purpose of this invention is to provide a preparation process for a standard decoction of salted Phellodendron bark, in order to solve the problems mentioned in the background art.

[0005] This invention is achieved through the following technical solution:

[0006] This invention relates to a preparation process for a standard decoction of salted Phellodendron bark, which includes two decoction processes. The preparation process includes the following steps:

[0007] S1: Place the salted Phellodendron bark slices in a clay pot, add 10 times the amount of water, and soak for 30 minutes. Bring to a boil over high heat, then reduce to low heat and simmer for 30 minutes to obtain a first decoction. Pour out the first decoction.

[0008] S2: Add 8 times the amount of water to the clay pot again, bring to a boil over high heat, then simmer over low heat for 20 minutes to obtain a second decoction. Pour out the second decoction.

[0009] S3: Filter the first and second medicinal solutions obtained in the above steps through a 200-mesh filter, cool the filtrate to room temperature in a cold water bath, and then combine the two filtrates to obtain the salt-treated Phellodendron bark medicinal solution;

[0010] S4: The obtained salt-treated Phellodendron amurense extract was concentrated under vacuum at a temperature of 50°C until the weight ratio of the medicinal material to the fluid extract was 1:1.

[0011] S5: Based on S4 above, the concentrated liquid is collected and freeze-dried to obtain the standard decoction of salted Phellodendron bark.

[0012] Among them, the maximum vacuum level that can be achieved by the oil-free variable frequency diaphragm vacuum pump is used as the vacuum environment, that is, the filtrate is concentrated under vacuum conditions of 50°C and absolute vacuum of 30-40 mbar.

[0013] Concentration and freeze-drying are used to measure the yield and extract indicators of salted Phellodendron bark in decoctions.

[0014] The present invention has the following beneficial effects:

[0015] The preparation process of the standard decoction of salted Phellodendron bark in this invention uses objective quality standards to measure the component transfer of salted Phellodendron bark slices into decoction, and ensures the quality and effectiveness of the salted Phellodendron bark decoction.

[0016] The present invention discloses the preparation process of the standard decoction of salted Phellodendron bark and specifies the quality standards of the decoction, including content determination, characteristic chromatogram, extract index, and content transfer rate of the decoction.

[0017] The "standard" in the salt-processed Phellodendron bark standard decoction of this invention mainly covers the representativeness of the raw materials, the consistency of the preparation process with the traditional method, and the rigor of quality control, which basically ensures the stability and uniformity of the efficacy and quality of the salt-processed Phellodendron bark formula. In addition, the salt-processed Phellodendron bark standard decoction has not undergone a drying process, thus maintaining the consistency with the traditional decoction in clinical practice to the greatest extent.

[0018] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a flowchart illustrating the preparation process of the standard decoction of salted Phellodendron bark according to the present invention.

[0021] Figure 2 This is a characteristic peak comparison spectrum diagram of the present invention;

[0022] Figure 3 This is a comparative characteristic chromatogram of the standard decoction of salted Phellodendron bark of the present invention. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] Please refer to Figure 1 As shown, this invention relates to a preparation process for a standard decoction of salted Phellodendron bark, the method comprising:

[0025] Weigh an appropriate amount of salt-processed Phellodendron bark slices, place them in a clay pot, and decoct twice. For the first decoction, add 10 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. For the second decoction, add 8 times the amount of water, bring to a boil over high heat, then simmer over low heat for 20 minutes. Filter the decoction through a 200-mesh sieve, and rapidly cool the filtrate to room temperature in a water bath. Mix the two filtrates and concentrate them under vacuum at 50°C until the weight ratio of the medicinal material to the fluid extract is approximately 1:1. Collect the concentrated liquid and freeze-dry it to obtain the sample.

[0026] Extract yield: After vacuum concentration of the aqueous extract of Phellodendron amurense, the concentrate is freeze-dried to dryness. The dried extract powder is collected and weighed, and the extract yield is calculated. The formula for extract yield is as follows:

[0027]

[0028] Ointment yield range: 16.8% to 24.8%.

[0029] Extractives: Determined by hot extraction method according to the method for determining alcohol-soluble extractives (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 2201) using ethanol as solvent. The extractives range of the standard decoction is 37.5%–60.1%.

[0030] Content determination: determined by high performance liquid chromatography (Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter 0512).

[0031] ---berberine hydrochloride

[0032] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase; acetonitrile-0.1% phosphoric acid solution (50:50) (with 0.1 g sodium dodecyl sulfonate per 100 ml) was used as the mobile phase; the flow rate was 1.0 ml / min; the column temperature was 30℃; and the detection wavelength was 265 nm. The theoretical plate number, calculated based on the berberine hydrochloride peak, should be no less than 4000.

[0033] Preparation of reference solution: Take an appropriate amount of berberine hydrochloride reference standard, accurately weigh it, and add methanol to prepare a solution containing 0.2 mg per ml.

[0034] Preparation of the test solution: Take an appropriate amount of this product, grind it into a fine powder, take about 0.1 g, weigh it accurately, place it in a stoppered conical flask, accurately add 100 ml of 50% methanol, weigh it, sonicate it (power 250W, frequency 40kHz) for 20 minutes, cool it, weigh it again, add 50% methanol to make up the weight loss, shake it well, filter it, and take the filtrate to obtain the test solution.

[0035] Assay: Accurately pipette 5 μl of the reference solution and the test solution into the liquid chromatograph and measure them to obtain the result.

[0036]

[0037] This product contains 95.7 mg to 149.4 mg of berberine hydrochloride per 1g.

[0038] The transfer rate of berberine hydrochloride content in the decoction of medicinal materials ranged from 23.3% to 43.2%.

[0039] ---Phellodendron hydrochloride

[0040] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase; acetonitrile-0.1% phosphoric acid solution (with 0.2 g sodium dodecyl sulfonate per 100 ml) (36:64) was used as the mobile phase; the flow rate was 1.0 ml / min; the column temperature was 30℃; and the detection wavelength was 284 nm. The theoretical plate number, calculated based on the berberine hydrochloride peak, should be no less than 6000.

[0041] Preparation of reference solution: Take an appropriate amount of berberine hydrochloride reference standard, accurately weigh it, and add methanol to prepare a solution containing 100 μg per ml.

[0042] Preparation of the test solution: Take an appropriate amount of this product, grind it into a fine powder, take about 0.1 g, weigh it accurately, place it in a stoppered conical flask, accurately add 25 ml of 50% methanol, weigh it, sonicate it (power 250W, frequency 40kHz) for 20 minutes, cool it, weigh it again, add 50% methanol to make up the weight loss, shake it well, filter it, and take the filtrate to obtain the test solution.

[0043] Assay: Accurately pipette 5 μl of the reference solution and the test solution into the liquid chromatograph and determine.

[0044] The content of berberine hydrochloride in each 1g of this product should be 10.5mg to 19.4mg; the transfer rate of berberine hydrochloride content in the decoction of the medicinal materials should be 34.5% to 64.1%.

[0045] Characteristic chromatogram: determined by high performance liquid chromatography (Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter 0512).

[0046] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the packing material (column length 250 mm, inner diameter 4.6 mm, particle size 5 μm); acetonitrile was used as mobile phase A, and 0.4 mol / L ammonium chloride solution was used as mobile phase B, with gradient elution performed according to the specifications in Table 1; the flow rate was 1.0 mL / min; the column temperature was 30 °C; and the detection wavelength was 210 nm. The theoretical plate number, calculated based on the berberine hydrochloride peak, should be no less than 5000.

[0047] Table 1 shows the gradient elution table for chromatographic conditions and system suitability testing:

[0048]

[0049] Preparation of reference solution: Take 0.2g of Phellodendron bark reference material, place it in a stoppered conical flask, add 50ml of 50% methanol, sonicate (power 250W, frequency 40kHz) for 30 minutes, cool, shake well, filter, and take the filtrate as the reference solution. Separately, take appropriate amounts of berberine hydrochloride reference standard and berberine hydrochloride reference standard, accurately weigh them, and add methanol to prepare a mixed solution containing 0.1mg of each per ml, as the reference solution.

[0050] Preparation of the test solution: Same as under the [Content Determination] section on berberine.

[0051] Determination method: Accurately pipette 5 μl of the reference solution and the test solution into the liquid chromatograph, measure and record the chromatogram to obtain the result.

[0052] like Figure 2 As shown (peak 2: 5-O feruloylquinic acid; peak 4 (S): berberine hydrochloride; peak 5: berberine hydrochloride; each milligram of test sample is approximately equivalent to 0.005 grams of medicinal slices), the chromatogram of the test sample should show 5 characteristic peaks, which should correspond to the retention times of the 5 characteristic peaks in the chromatogram of the reference medicinal material. Two of these peaks should correspond to the retention times of the corresponding reference material peaks. The peak corresponding to the berberine hydrochloride reference peak is peak S. Calculate the relative retention times of peaks 1, 2, and 3 with peak S. These relative retention times should be within ±7% of the specified values, which are: 0.63 (peak 1), 0.69 (peak 2), and 0.83 (peak 3). Calculate the relative peak areas of peaks 1, 2, and 3 with peak 5. These relative peak areas should be within the specified range: not less than 0.05 (peak 1), 0.10–0.61 (peak 2), and not less than 0.05 (peak 3).

[0053] Raw material selection: According to the "Technical Requirements for Quality Control and Standardization of Traditional Chinese Medicine Formula Granules," the samples used in the research should be representative, covering the main producing areas or authentic production areas of the medicinal materials to be harvested, with no fewer than three batches from each producing area. Salted Phellodendron bark is a processed form of Phellodendron bark, distributed throughout China. It is mainly produced in Guizhou, Hubei, and Sichuan provinces of my country, where its cultivation has reached a large scale and is also the main source of commercial salted Phellodendron bark. Based on a comprehensive evaluation of raw material quality, sustainable resource supply, and other factors, the preliminary producing areas for large-scale production were determined to be Bingchuan County in Shifang City, Sichuan Province; Kaili in Guizhou Province; Jianshi County in Enshi Prefecture, Hubei Province; and Wufeng County in Yichang City, Hubei Province. Ultimately, 15 qualified batches were selected for research on standard decoctions.

[0054] Research and standard setting on extract yield and transfer rate:

[0055] Table 2 shows the transfer rate (berberine hydrochloride) of 15 batches of standard decoction of Phellodendron amurense:

[0056]

[0057]

[0058] Based on data from 15 batches of salted Phellodendron bark slices containing berberine hydrochloride, standard decoction content, and extract yield, the average transfer rate of the standard decoction content (berberine hydrochloride) was calculated to be 33.2%. The range calculated using the mean plus or minus 3 times the SD is 25.2%–41.3%; the range calculated using the mean of 70%–130% is 23.3%–43.2%; considering the actual range of 28.6%–39.5%, it is recommended to take 23.3%–43.2% as the upper and lower limits of the standard decoction transfer rate.

[0059] Table 3 shows the transfer rate (berberine hydrochloride) of 15 batches of standard decoction of salted Phellodendron bark:

[0060]

[0061]

[0062] Based on data from 15 batches of salted Phellodendron bark slices (containing berberine hydrochloride), standard decoction content, and extract yield, the average transfer rate of the standard decoction content (berberine hydrochloride) was calculated to be 49.3%. The range calculated using the mean plus or minus 3 times the SD is 42.4%–56.2%; the range calculated using the mean of 70%–130% is 34.5%–64.1%; considering the actual range of 45.3%–53.9%, it is recommended to take 34.5%–64.1% as the upper and lower limits of the standard decoction transfer rate.

[0063] Content Research and Standard Formulation: Modern research shows that salted Phellodendron bark contains various components, such as alkaloids, terpenoids, phenylethanol glycosides, volatile oils, flavonoids, tannins, steroids, and organic acids. Phellodendron bark possesses various pharmacological activities, including hepatoprotective effects, cardiovascular benefits, anti-inflammatory effects, improved insulin sensitivity, enhanced immune function, analgesia, treatment of neuropsychiatric disorders, and therapeutic effects on gynecological diseases. The 2020 edition of the Chinese Pharmacopoeia lists berberine hydrochloride and berberine hydrochloride as quality control indicators for Phellodendron bark, and the national drug standard YBZ-PFKL-2021137 for "Salted Phellodendron Bark Formula Granules" also specifies berberine hydrochloride and berberine hydrochloride as content determination items. Therefore, this study selected berberine hydrochloride as the quality control indicator for the standard Phellodendron bark decoction.

[0064] ---berberine hydrochloride

[0065] Based on the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules", and combined with data from 15 batches of standard decoction of salted Phellodendron bark, the limits and upper and lower limits of the content (berberine hydrochloride) in the standard decoction were calculated.

[0066] The range calculated using the mean plus or minus 3 times the SD is 95.7mg to 149.4mg; the range calculated using 70% to 130% of the mean is 85.8mg to 159.3mg; considering the actual range of 110.3mg to 140.3mg, it is recommended to use the mean plus or minus 3 times the SD, i.e., 95.7mg to 149.4mg, as the upper and lower limits of the standard decoction content.

[0067] Based on data from 15 batches of salted Phellodendron bark slices containing berberine hydrochloride, standard decoction content, and extract yield, the average transfer rate of the standard decoction content (berberine hydrochloride) was calculated to be 33.2%. The range calculated using the mean plus or minus 3 times the SD is 25.2%–41.3%; the range calculated using the mean of 70%–130% is 23.3%–43.2%; considering the actual range of 28.6%–39.5%, it is recommended to take 23.3%–43.2% as the upper and lower limits of the standard decoction transfer rate.

[0068] ---Phellodendron hydrochloride

[0069] Based on the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules", and combined with data from 15 batches of standard decoction of salted Phellodendron bark, the limits and upper and lower limits of the content (Phellodendron hydrochloride) in the standard decoction were calculated.

[0070] The range calculated using the mean plus or minus 3 times the SD is 4.6mg to 25.3mg; the range calculated using 70% to 130% of the mean is 10.5mg to 19.4mg; considering the actual range of 10.8mg to 21.6mg, it is recommended to use the mean plus or minus 3 times the SD, i.e., 10.5mg to 19.4mg, as the upper and lower limits of the standard decoction content.

[0071] Based on the data of 15 batches of salted Phellodendron bark slices (phellodendron chinense hydrochloride), standard decoction content, and extract yield, the average transfer rate of standard decoction content (phellodendron chinense hydrochloride) was calculated to be 49.3%.

[0072] The range calculated using the mean plus or minus 3 times the SD is 42.4% to 56.2%; the range calculated using the mean of 70% to 130% is 34.5% to 64.1%; combined with the actual range of 45.3% to 53.9%, it is recommended to take 34.5% to 64.1% as the upper and lower limits of the standard decoction transfer rate.

[0073] Characteristic Spectrum Study and Standard Formulation: The spectral composition of the standard decoction of salted Phellodendron bark with experimental batch number BT(YHB)211101 was selected as the reference spectral composition. Based on the data analysis results, five common peaks were finally selected as characteristic peaks. The generated standard spectral composition is shown below. Figure 3 (Peak 2: 5-O feruloylquinic acid; Peak 4(S): berberine hydrochloride; Peak 5: berberine hydrochloride). Using berberine hydrochloride as the reference peak, the relative retention times of the characteristic peaks in the chromatogram were calculated. Comparison with the reference standard chromatogram revealed that among the five characteristic peaks in the standard decoction of *Phellodendron amurense*, peak 4(S) is berberine hydrochloride. According to the national drug standard YBZ-PFKL-2021137 for *Phellodendron amurense* formula granules, peak 2: 5-O feruloylquinic acid; peak 4(S): berberine hydrochloride; peak 5: berberine hydrochloride.

[0074] Table 4 shows a comparison of the retention times of 15 batches of standard decoctions containing salted Phellodendron bark.

[0075]

[0076] Table 5 shows the relative peak areas of 15 batches of standard decoctions containing salted Phellodendron bark.

[0077]

[0078] Table 6 shows the relative peak areas of 15 batches of standard decoctions containing salted Phellodendron bark.

[0079]

[0080]

[0081] The results showed that the characteristic chromatograms of the 15 batches of salt-processed Phellodendron bark standard decoction all showed chromatographic peaks corresponding to the retention times of the five main characteristic peaks in the control medicinal material. The relative retention time RSD of peaks 1-5 was less than 2%, indicating that the elution times of each peak were consistent among the batches.

[0082] The relative peak area RSDs of peaks 1, 2, and 3 are all less than 5%, indicating that there is almost no difference in the relative peak area between batches. Based on the detection limits of 15 batches of standard soup, the specified range is: the relative retention time should be within ±7% of the specified value, and the specified values ​​are: 0.63 (peak 1), 0.69 (peak 2), and 0.83 (peak 3). Peak 1 should not be lower than 0.05, peak 2 should be 0.10 to 0.61, and peak 3 should not be lower than 0.05.

[0083] The national standard YBZ-PFKL-202137, "Formula Granules of Salted Phellodendron Amurense," only specifies the retention times of peak 4 (berberine hydrochloride) and peak 5 (berberine hydrochloride), the relative retention times of peaks 1, 2, and 3 with peak 5 (S), and the relative peak areas of peaks 1, 2, and 3 with peak 5 (S). Combining the determination results of 15 Salted Phellodendron Amurense standard decoctions and the retention time data from the repeatability and precision tests in the methodology (see Tables 7 and 8 below), it can be seen that the retention times of peaks 4 and 5 are stable and correspond to the retention times of the corresponding reference standards. The relative peak drift of peaks 1, 2, and 3 is very small, basically within ±7%. The RSD of the relative peak areas of characteristic peaks 1, 2, and 3 is all less than 5%, indicating that the differences in the relative peak areas of peaks 7 and 8 between batches are small.

[0084] Therefore, the regulations stipulate that the chromatogram of the test sample should show 5 characteristic peaks, and the retention times should correspond to the 5 characteristic peaks in the chromatogram of the reference medicinal material. Two of these peaks should correspond to the retention times of the corresponding reference material peaks. The peak corresponding to the reference material peak of berberine hydrochloride is the S peak. The relative retention times of peaks 1, 2, and 3 with peak S should be calculated, and their relative retention times should be within ±7% of the specified values. The specified values ​​are: 0.63 (peak 1), 0.69 (peak 2), and 0.83 (peak 3). The relative peak areas of peaks 1, 2, and 3 with peak 5 should be calculated, and their relative peak areas should be within the specified range: not less than 0.05 (peak 1), 0.10–0.61 (peak 2), and not less than 0.05 (peak 3).

[0085] Table 7 is a comparison table of relative peak areas (relative retention times) for repeatability:

[0086]

[0087] Table 8 is a table comparing the relative peak area (relative retention time) for precision:

[0088]

[0089] Extractives study and standard setting: Extractives were determined using ethanol as the solvent, following the hot extraction method under the "Determination of Alcohol-Soluble Extractives" section of the Chinese Pharmacopoeia 2020, Part IV, General Chapter 2201. The test results for 15 batches of salt-processed Phellodendron amurense standard decoction are shown in Table 9.

[0090] Table 9 is a comparison table of the results of extract determination of 15 batches of salted Phellodendron bark:

[0091]

[0092]

[0093] The alcohol-soluble extract of 15 batches of standard decoction was determined, with an average value of 46.2%. The range calculated using the mean plus or minus 3 times the SD is 28.4% to 64.0%; the range calculated using the mean of 70% to 130% is 32.3% to 60.1%; combined with the actual range of 37.5% to 55.1%, it is recommended to take 37.5% to 60.1% as the upper and lower limits of the extract of standard decoction.

[0094] In this invention, standard decoctions serve as a "bridge" connecting traditional Chinese medicine decoction pieces and modern Chinese medicine preparations. They provide a reference for controlling the quality of Chinese medicine end products, a tool for standardizing different forms of Chinese medicine administration to ensure the uniformity of quality and the consistency of efficacy, and a reference for evaluating the consistency of product quality from different manufacturers. Therefore, the research on the quality standards of standard decoctions of Chinese medicine decoction pieces will provide a foundation for the formulation of quality standards for all end products derived from decoctions of Chinese medicine decoction pieces.

[0095] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0096] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to any specific implementation. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. The preparation process of standard decoction of salted Phellodendron bark, characterized in that, The preparation process includes two decoctions and includes the following steps: S1: Place the salted Phellodendron bark slices in a clay pot, add 10 times the amount of water, and soak for 30 minutes. Bring to a boil over high heat, then reduce to low heat and simmer for 30 minutes to obtain the first decoction. Pour out the first decoction. S2: Add 8 times the amount of water to the clay pot again, bring to a boil over high heat, then simmer over low heat for 20 minutes to obtain a second decoction. Pour out the second decoction. S3: Filter the first and second medicinal solutions obtained in the above steps through a 200-mesh filter, cool the filtrate to room temperature in a cold water bath, and then combine the two filtrates to obtain the salt-treated Phellodendron bark medicinal solution; S4: The obtained salt-treated Phellodendron amurense extract was concentrated under vacuum at a temperature of 50°C until the weight ratio of the medicinal material to the fluid extract was 1:

1. S5: Based on S4 above, the concentrated liquid is collected and freeze-dried to obtain the standard decoction of salted Phellodendron bark.

2. The preparation process of the standard decoction of salted Phellodendron bark according to claim 1, characterized in that, In step S4, the obtained salt-treated Phellodendron bark extract is concentrated under vacuum at a temperature of 50°C, with the absolute vacuum maintained at 30–40 mbar.

3. The preparation process of the standard decoction of salted Phellodendron bark according to claim 1, characterized in that, In S5, concentration and freeze-drying are used to measure the yield and extract index of salted Phellodendron bark in decoction.

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