A method for constructing a fingerprint spectrum of gastrodia rhizome decoction pieces, the fingerprint spectrum and application thereof

Abstract

The application discloses a kind of ginseng root decoction pieces fingerprint construction method and fingerprint and application, including the ginseng root decoction pieces fingerprint construction that meets the quality requirement of ginseng root dispensing granule, the fingerprint includes ginseng root factor, p-hydroxybenzyl alcohol, ballysen glycoside, ballysen glycoside B, ballysen glycoside C and ballysen glycoside E six Mark peaks, the control fingerprint generated by common peak mode can be used as comparison, whether the ginseng root decoction pieces fingerprint meets the requirement is judged, when ginseng root decoction pieces fingerprint similarity is not less than 0.76, the ginseng root dispensing granule fingerprint prepared similarity is not less than 0.90.The application solves the unstable problem of ginseng root decoction pieces quality that meets the quality requirement of ginseng root dispensing granule.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine formula granules, specifically relating to a method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules, the construction of fingerprint spectrum and its application. Background Technology

[0002] The national drug standard for Gastrodia elata granules YBZ-PFKL-2021122 has been promulgated and implemented. This standard uses water as a solvent, with a formulation and production ratio of 4:1. It stipulates that the content of the finished product, using the peak area of ​​gastrodin as a reference, is multiplied by a correction factor to calculate the content of gastrodin, p-hydroxybenzyl alcohol, bacilin E, bacilin B, bacilin C, and bacilin, which should be 43.0-80.0 mg / g. The fingerprint chromatogram specifies that the finished product fingerprint chromatogram should show chromatographic peaks with the same retention time as the reference peak, using Mark peak matching. According to the similarity evaluation system for chromatographic fingerprint chromatograms of traditional Chinese medicine, the similarity between the test sample fingerprint chromatogram and the reference fingerprint chromatogram should not be less than 0.90.

[0003] Gastrodia elata is the dried tuber of the perennial orchid Gastrodia elata Bl., and is a species included in the Chinese Pharmacopoeia. The Pharmacopoeia specifies characteristic chromatogram requirements for the raw material of Gastrodia elata, stipulating that the chromatogram of the test sample should show six characteristic peaks, corresponding to the six characteristic peaks in the chromatogram of the reference material. Peaks 1 and 2 should have retention times consistent with the reference peaks of gastrodin and p-hydroxybenzyl alcohol. Peaks 3, 4, 5, and 6 correspond to barisonoside E, barisonoside B, barisonoside C, and barisonoside, respectively, with the content requirement being the total amount of gastrodin and p-hydroxybenzyl alcohol. There are no characteristic chromatogram requirements for processed Gastrodia elata, but the content limits for processed slices are consistent with those for the raw material.

[0004] Gastrodia elata is a commonly used bulk Chinese medicinal herb, widely distributed in Anhui, Hubei, Shaanxi, Sichuan, Yunnan, Guizhou, and other regions. It has been included in the fresh-processing product catalogs by the drug regulatory authorities of these provinces. However, the processing of Gastrodia elata slices is quite meticulous, with the ancient saying "nine steamings and nine sun-dryings." The Chinese Pharmacopoeia has relatively simple requirements for the processing of Gastrodia elata slices: the raw material is washed, thoroughly moistened or steamed until soft, sliced ​​thinly, and dried. Modern research shows that barisonin-like chemical substances have unstable structures and can interconvert with gastrodin under different temperature conditions. Different processing methods, temperatures, and times all affect the quality of Gastrodia elata slices. As a product processed fresh in its place of origin, the quality of processed Gastrodia elata slices fluctuates greatly due to differences in processing methods and processes, thus affecting the quality of prepared Gastrodia elata granule products. In particular, the fingerprint similarity of Gastrodia elata granule products fluctuates significantly, resulting in many substandard products.

[0005] In view of this, the present invention is hereby proposed. Summary of the Invention

[0006] The purpose of this invention is to provide a method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules, and to construct a fingerprint spectrum of Gastrodia elata slices. This processing method can produce Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules. The constructed fingerprint spectrum and detection method can determine the similarity of the fingerprint spectrum of Gastrodia elata slices. When the similarity meets the requirements, the fingerprint spectrum of the prepared Gastrodia elata formula granules meets the national standard requirements, achieving accurate, objective, and effective control of the quality of Gastrodia elata slices and ensuring that the fingerprint spectrum of the prepared Gastrodia elata formula granules meets the requirements.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] A method for constructing a fingerprint spectrum of Gastrodia elata slices includes the following steps:

[0009] Step 1: Take the raw Gastrodia elata, wash it, place it in a steamer and steam for 5 to 10 hours. Then cut it into thin slices, let it cool at room temperature, and dry it at a low temperature of 50℃ to 60℃. Sift out the fine powder to obtain the Gastrodia elata slices.

[0010] Step 2: Place the prepared Gastrodia elata slices in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extraction filtrates, concentrate under reduced pressure at 60℃ to a material-to-liquid ratio of 1:1, with a relative density of 1.05-1.10 at 60℃, spray dry, add excipients, mix well, and granulate to obtain the finished Gastrodia elata formula granules, with each 1g of formula granules equivalent to 4g of slices;

[0011] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, and thin-layer identification index of the Gastrodia elata formula granules in accordance with the requirements of the national drug standard YBZ-PFKL-2021122.

[0012] Step 4: Following the processing techniques for Gastrodia elata decoction pieces corresponding to the Gastrodia elata formula granules that have passed all tests in Step 3, process 15 different batches of Gastrodia elata decoction pieces and execute Step 2 and Step 3 respectively.

[0013] Step 5: Take the Gastrodia elata slices corresponding to the Gastrodia elata formula granules from Step 4 that have passed all the tests as samples, and perform the following steps:

[0014] A) Take Gastrodia elata slices, crush them, pass them through a No. 4 pharmacopoeia sieve, and take the sieve residue as the test sample.

[0015] B) Dissolve and extract the test sample using a solvent to obtain the test solution;

[0016] C) The test solution was analyzed by ultra-high performance liquid chromatography to obtain the UPLC characteristic chromatograms of each batch of Gastrodia elata slices;

[0017] D) Import the UPLC characteristic chromatograms of each batch of medicinal materials into the similarity evaluation system of chromatographic fingerprint chromatograms of traditional Chinese medicine, use Mark peak matching to generate common peak pattern chromatograms, and construct a reference fingerprint chromatogram of Gastrodia elata slices.

[0018] Step 6: Perform feature map detection on Gastrodia elata slices with different steaming times according to the method described in Step 5, and perform Mark peak matching with the constructed fingerprint map of Gastrodia elata slices to calculate the similarity between the fingerprint map and the control fingerprint map.

[0019] Step 7: Using the similarity of the fingerprint spectra of Gastrodia elata slices with different steaming times in Step 6 as the x-axis and the similarity of the fingerprint spectra of the corresponding Gastrodia elata formula granules as the y-axis, perform a linear regression equation fitting. According to the fitted linear regression equation, if the similarity of the fingerprint spectra of Gastrodia elata formula granules is not lower than 0.90, the similarity of the fingerprint spectra of the corresponding Gastrodia elata slices should not be lower than 0.76.

[0020] In this invention, the steaming time in step one is 5h, 6h, 7h, 8h, 9h, or 10h, and the low-temperature drying temperature is 55℃.

[0021] In this invention, the steaming time range for the 15 different batches of Gastrodia elata slices processed in step four is 5h-10h.

[0022] In this invention, the sample weight of the pulverized Gastrodia elata slices sieved in step five is 1.0g.

[0023] In this invention, the method for preparing the test solution in step five is specifically as follows:

[0024] Accurately weigh 1.0g of Gastrodia elata powder and place it in a stoppered conical flask. Accurately add 50ml of water, heat under reflux for 1 hour, cool, filter, accurately measure 10ml of the filtrate, evaporate to dryness, add 30% methanol to dissolve and make up to 5ml, sonicate (power 250W, frequency 40kHz) for 30 minutes, cool, and filter with a 0.22μm syringe filter to obtain the final product.

[0025] The chromatographic conditions for ultra-high performance liquid chromatography (UHPLC) described in step five are as follows: octadecyl-bonded silica gel as the packing material; column length 150 mm; column inner diameter 2.1 mm; particle size 1.6 μm; column temperature 30 °C; flow rate 0.30 mL / min; detection wavelength 220 nm; injection volume 1 μL; theoretical plate number calculated based on gastrodin should be no less than 3000; acetonitrile as mobile phase A; 0.05% phosphoric acid solution as mobile phase B; and elution according to the following gradient elution program:

[0026]

[0027] In this invention, the C18 column has dimensions of 2.1×150mm and 1.6μm, and the column temperature is 30℃.

[0028] In this invention, the flow rate is 0.30 mL per minute, the detection wavelength is 220 nm, the injection volume is 1 μL, and the theoretical plate number calculated based on gastrodin should be no less than 3000.

[0029] In this invention, the 0.05% phosphoric acid solution is mobile phase B, which is a volume fraction.

[0030] In this invention, the preparation of reference solutions is also included, specifically as follows: accurately weigh gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E reference standards, place them in volumetric flasks, dissolve them in methanol and mix well to prepare solutions containing 200 μg, 5 μg, 200 μg, 150 μg, 50 μg, and 200 μg per 1 mL, respectively, as reference solutions.

[0031] The Mark peak matching described in this invention refers to the six characteristic peaks of gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E. These peaks are injected under the same chromatographic conditions, and reference standards of gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E are used for chromatographic peak localization and identification.

[0032] In step six, for comparison, in addition to the steaming time mentioned in step one, gastrodia slices steamed for 2h, 3h, and 4h were also included to comprehensively study the influence of different steaming times on the characteristic spectrum of gastrodia slices. These gastrodia slices were also prepared into gastrodia formula granules and the various indicators of the formula granules were tested according to the methods described in steps two, three, and five.

[0033] In step seven, a linear regression equation is fitted using the similarity of the fingerprint spectrum of Gastrodia elata slices as the x-axis (X) and the similarity of the fingerprint spectrum of the corresponding Gastrodia elata formula granules as the y-axis (Y). The fitted linear regression equation is as follows:

[0034] Y = 0.4714X + 0.5544, correlation coefficient R 2 =0.9768.

[0035] In this invention, based on the fitted linear regression equation, if the similarity of the fingerprint spectrum of Gastrodia elata formula granules is not less than 0.90, the similarity of the corresponding fingerprint spectrum of Gastrodia elata slices should not be less than 0.733. Considering the errors in the detection and processing, and combining data from multiple batches, the similarity of the fingerprint spectrum of Gastrodia elata slices is revised to not less than 0.76.

[0036] Gastrodia elata is a fresh-processed variety, and different processing methods and techniques result in significant differences in the quality of Gastrodia elata slices. To meet the specific requirements of the national standard for Gastrodia elata formula granules, it is necessary to establish quality judgment standards for Gastrodia elata slices, especially fingerprint spectrum similarity requirements. If purchasing raw Gastrodia elata and processing it in-house, it is necessary to clearly define the specific processing techniques and the quality requirements for the processed slices. Based on this, the technical solution of this invention has the following advantages:

[0037] 1. This invention combines the preparation process of Gastrodia elata formula granules and conducts in-depth research on the key process of Gastrodia elata decoction piece processing, namely the steaming process in step one. With the result of ensuring that the content, characteristic spectrum and other indicators of the prepared Gastrodia elata formula granules meet the standard requirements, an industrial processing method for Gastrodia elata decoction pieces that meets the quality requirements of Gastrodia elata formula granules has been established.

[0038] 2. This invention establishes for the first time a fingerprint spectrum detection method for Gastrodia elata slices. Using this method, a reference fingerprint spectrum of Gastrodia elata slices was constructed using 15 batches of Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules. A linear regression equation was also established between the similarity of the fingerprint spectrum of Gastrodia elata slices and the similarity of the fingerprint spectrum of Gastrodia elata formula granules. Through this detection method, the constructed fingerprint spectrum, and the linear regression equation, the fingerprint spectrum of Gastrodia elata slices can be determined, thereby controlling the quality of Gastrodia elata slices and improving the product qualification rate of Gastrodia elata formula granules. Attached Figure Description

[0039] Figure 1 This is the chromatogram of the gastrodin reference solution;

[0040] Figure 2 This is the chromatogram of the p-hydroxybenzyl alcohol reference solution;

[0041] Figure 3 Chromatogram of baicalin E reference solution;

[0042] Figure 4 Chromatogram of baicalin B reference solution;

[0043] Figure 5 Chromatogram of baicalin C reference solution;

[0044] Figure 6 Chromatogram of baicalin reference solution;

[0045] Figure 7 Chromatograms of 15 batches of Gastrodia elata slices;

[0046] Figure 8 Fingerprint spectrum of Gastrodia elata slices (as a reference);

[0047] Figure 9 A linear relationship graph showing the similarity between the fingerprint spectra of Gastrodia elata slices and the fingerprint spectra of Gastrodia elata granules.

[0048] Figure 10 To investigate the precision of fingerprint spectroscopy of Gastrodia elata slices;

[0049] Figure 11 To investigate the stability of the fingerprint spectrum of Gastrodia elata slices;

[0050] Figure 12 To investigate the repeatability of fingerprint chromatograms of Gastrodia elata slices. Detailed Implementation

[0051] The present application will be further explained below with reference to specific embodiments, but the embodiments do not limit the present application in any way.

[0052] instrument

[0053] Agilent 1290 series ultra-high performance liquid chromatograph (Agilent Technologies), column: CORTEC ST3 C18 column (2.1×150mm, 1.6μm); SQP electronic analytical balance (Sartorius GmbH, Germany); CNC ultrasonic cleaner (Shanghai Kedao Ultrasonic Instrument Co., Ltd.); PURELAB classic UV ultrapure water system (ELGA, UK); digital display constant temperature water bath (Changzhou Guohua Electric Appliance Co., Ltd.); HYDJ20 micro-pressure circulating decoction machine (Tianjin Huayanyuan Machinery Co., Ltd.); R-1020 rotary evaporator (Zhengzhou Changcheng Science & Industry Trade Co., Ltd.); OPD-8 spray dryer (Wuxi Heming Drying Equipment Co., Ltd.); PSJ-1000 jet cleaning machine (Jiangsu Baowei Machinery Technology Co., Ltd.); CT-C-II hot air circulating oven (Hubei Hengfeng Medical Pharmaceutical Equipment Co., Ltd.); QWZL-300D linear reciprocating medicine cutting machine (Taizhou Boda Pharmaceutical Machinery Technology Co., Ltd.); LG100 dry granulation machine (Nanjing Canaan Pharmaceutical Equipment Co., Ltd.).

[0054] Drug testing

[0055] Gastrodin reference standard (batch number: 110807-202010, purity 95.5%, China National Institutes for Food and Drug Control).

[0056] p-Hydroxybenzyl alcohol reference standard (batch number: 111970-201702, purity 99.4%, China National Institutes for Food and Drug Control).

[0057] Barisonoside (batch number: 020141-202208, purity 98.0%, Shanghai Hongyong Biotechnology Co., Ltd.).

[0058] Barisonoside B (batch number: 020144-202205, purity 98.0%, Shanghai Hongyong Biotechnology Co., Ltd.). Barisonoside C (batch number: 020154-202211, purity 98.0%, Shanghai Hongyong Biotechnology Co., Ltd.).

[0059] Barisonoside E (batch number: 020162-202112, purity 98.0%, Shanghai Hongyong Biotechnology Co., Ltd.).

[0060] Acetonitrile was of chromatographic grade, Fisher Scientific, USA.

[0061] Phosphoric acid was of chromatographic grade and was obtained from Sinopharm Chemical Reagent Co., Ltd.

[0062] The water used was ultrapure water, and all other reagents were of analytical grade.

[0063] Table 1 Information on 15 batches of Gastrodia elata medicinal materials and formula granules

[0064]

[0065]

[0066] Example 1

[0067] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0068] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 5 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then dry it at a low temperature of 50°C in a hot air circulating oven. Sift out the fine powder to obtain the prepared Gastrodia elata slices.

[0069] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0070] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0071] Example 2

[0072] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0073] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 6 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then place it in a hot air circulating oven at 55°C to dry at a low temperature. Sift out the fine powder to obtain the Gastrodia elata slices.

[0074] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.09 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0075] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0076] Example 3

[0077] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0078] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 7 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then dry it at a low temperature of 60°C in a hot air circulating oven. Sift out the fine powder to obtain the prepared Gastrodia elata slices.

[0079] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.05 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0080] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0081] Example 4

[0082] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0083] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 8 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then dry it at a low temperature of 50°C in a hot air circulating oven. Sift out the fine powder to obtain the Gastrodia elata slices.

[0084] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.05 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0085] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0086] Example 5

[0087] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0088] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 9 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then dry it at a low temperature of 55℃ in a hot air circulating oven. Sift out the fine powder to obtain the Gastrodia elata slices.

[0089] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0090] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0091] Example 6

[0092] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0093] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 10 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then place it in a hot air circulating oven at 60℃ to dry at a low temperature. Sift out the fine powder to obtain the Gastrodia elata slices.

[0094] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.10 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0095] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0096] Comparative Example 1

[0097] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0098] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 2 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then dry it at a low temperature of 50°C in a hot air circulating oven. Sift out the fine powder to obtain the prepared Gastrodia elata slices.

[0099] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0100] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0101] Comparative Example 2

[0102] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0103] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 3 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then place it in a hot air circulating oven at 55°C to dry at a low temperature. Sift out the fine powder to obtain the Gastrodia elata slices.

[0104] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0105] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0106] Comparative Example 3

[0107] A method for processing Gastrodia elata slices that meet the quality requirements of Gastrodia elata formula granules includes the following steps:

[0108] Step 1: Take the raw Gastrodia elata (medicinal material number T1), wash it, place it in a steamer and steam for 4 hours, cut it into thin slices using a linear reciprocating herb cutter, spread it out to cool at room temperature, and then place it in a hot air circulating oven at 60℃ to dry at a low temperature. Sift out the fine powder to obtain the Gastrodia elata slices.

[0109] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.07 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0110] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0111] Table 2 Comparison of processing techniques between each embodiment and the comparative example.

[0112]

[0113] As can be seen from Table 2, all indicators of the Gastrodia elata formula granules prepared in Examples 1, 2, 3, 4, 5, and 6 meet the requirements of the national standards. The content, extract, properties, thin-layer identification, and extract yield of the Gastrodia elata formula granules in Comparative Examples 1, 2, and 3 all meet the requirements of the national standards, but the fingerprint spectrum similarity is all below 0.90, which does not meet the requirements of the national standards for Gastrodia elata formula granules.

[0114] The similarity of the fingerprint spectrum of the formulation particles in each embodiment was greater than 0.90. As the steaming time of the medicinal slices increased, the similarity of the fingerprint spectrum of the prepared Gastrodia elata formulation particles showed an upward trend. However, the content of the formulation particles showed a downward trend as the steaming time of the medicinal slices increased. This may be related to the interconversion of gastrodin with other components under high temperature conditions.

[0115] Based on the test results of various indicators, the processing technology of Gastrodia elata slices was determined as follows: Take the raw Gastrodia elata material, wash it, place it in a steamer and steam it for 5 to 10 hours, cut it into thin slices, spread it out to cool at room temperature, and then place it in a hot air circulating oven to dry at a low temperature of 50℃ to 60℃. Sift out the fine powder to obtain Gastrodia elata slices.

[0116] Example 7

[0117] The construction of a fingerprint spectrum for Gastrodia elata decoction pieces that meets the quality requirements of Gastrodia elata formula granules includes using 15 batches of Gastrodia elata raw materials (medicinal material numbers T1-T15) from different batches and origins as raw materials, processing them into Gastrodia elata decoction pieces according to the above-mentioned processing technology, selecting Gastrodia elata decoction pieces whose indicators of the prepared Gastrodia elata formula granules all passed the tests as test samples and preparing test sample solutions, obtaining the characteristic spectra of each test sample solution using ultra-high performance liquid chromatography, and then importing each characteristic spectra into a traditional Chinese medicine chromatographic fingerprint spectrum similarity evaluation system, using Mark peak matching to generate common peak mode spectra, and constructing the fingerprint spectrum of Gastrodia elata decoction pieces.

[0118] Specifically, in this embodiment, 15 batches of Gastrodia elata raw materials numbered T1-T15 were processed according to the processing technology determined above. The processed slices were then used to prepare Gastrodia elata formula granules according to the aforementioned method. The various indicators of the formula granules were tested according to the quality standard requirements of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0119] Table 3. Test results of various indicators of Gastrodia elata formula granules prepared from 15 batches of Gastrodia elata slices.

[0120]

[0121] As can be seen from Table 3, 15 batches of raw Gastrodia elata from different batches and origins were processed into Gastrodia elata decoction pieces according to the processing technology determined above. The content, fingerprint spectrum, extract, properties, thin-layer identification, and extract yield of the prepared Gastrodia elata formula granules all met the national standard requirements. All 15 batches of Gastrodia elata decoction pieces can meet the quality requirements of formula granules and can be used as test samples for constructing fingerprint spectrum of Gastrodia elata decoction pieces.

[0122] Specifically, the chromatographic conditions for this ultra-high performance liquid chromatography (UHPLC) in this embodiment are as follows: octadecyl bonded silica gel is used as the packing material; the column length is 150 mm, the column inner diameter is 2.1 mm, the particle size is 1.6 μm, and the column temperature is 30 °C; the flow rate is 0.30 mL per minute, the detection wavelength is 220 nm, the injection volume is 1 μL, and the theoretical plate number calculated based on gastrodin should be no less than 3000; acetonitrile is used as mobile phase A, and 0.05% phosphoric acid solution is used as mobile phase B, eluted according to the following gradient elution program:

[0123]

[0124] Preparation of reference solutions: Accurately weigh appropriate amounts of gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E reference standards, place them in volumetric flasks, dissolve and mix with methanol to prepare solutions containing 200 μg, 5 μg, 200 μg, 150 μg, 50 μg, and 200 μg per mL, respectively, as reference solutions.

[0125] Preparation of the test solution: Weigh 1g of Gastrodia elata powder accurately, place it in a stoppered conical flask, add 50ml of water accurately, heat under reflux for 1 hour, cool, filter, accurately measure 10ml of the filtrate, evaporate to dryness, add 30% methanol to dissolve and make up to 5ml, sonicate (power 250W, frequency 40kHz) for 30 minutes, cool and filter with a 0.22μm needle filter to obtain the test solution.

[0126] Determination method: Accurately pipette 1 μL of the reference solution and the test solution into the liquid chromatograph and determine the result.

[0127] Specifically, in this embodiment, the characteristic chromatograms of 15 batches of Gastrodia elata slices showed 6 characteristic peaks, which were located using 6 reference standards. The peaks, in chronological order of elution, were gastrodin, p-hydroxybenzyl alcohol, balisenoside E, balisenoside B, balisenoside C, and balisenoside. The chromatograms of each reference standard solution are shown below. Figure 1-6 .

[0128] In this embodiment, to construct a reference fingerprint chromatogram for Gastrodia elata slices, chromatograms of characteristic chromatograms from 15 batches of Gastrodia elata slices from different batches and origins were imported into a similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine (version 2012.130723) to evaluate the similarity of the 15 batches of Gastrodia elata slices. The evaluation results showed that the similarity between each batch of slices was above 0.95. (See [link to relevant documentation]). Figure 7 As shown in Table 4.

[0129] Six characteristic peaks—gastrodin, p-hydroxybenzyl alcohol, balithenoside E, balithenoside B, balithenoside C, and balithenoside—were selected as Mark peaks. Mark peak matching was used to generate a common peak pattern spectrum, resulting in a reference fingerprint spectrum for Gastrodia elata slices. Figure 8 As shown.

[0130]

[0131] Example 8

[0132] An application of fingerprint spectrum analysis of Gastrodia elata slices that meets the quality requirements of Gastrodia elata formula granules includes using an established fingerprint spectrum analysis method for Gastrodia elata slices and a constructed reference fingerprint spectrum analysis method to determine the fingerprint spectrum analysis of Gastrodia elata slices processed at different steaming times, establishing a linear relationship between the similarity of the fingerprint spectrum analysis of Gastrodia elata slices and the similarity of the fingerprint spectrum analysis of Gastrodia elata formula granules, in order to evaluate whether the quality of Gastrodia elata slices meets the requirements of Gastrodia elata formula granules.

[0133] Specifically, in this embodiment, the Gastrodia elata slices prepared with different steaming times (2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h) were subjected to fingerprint spectral determination according to the above fingerprint spectral detection method. Mark peak matching was used, and the results were imported into the Chinese herbal chromatographic fingerprint spectral similarity evaluation system to detect the similarity between each slice and the control fingerprint spectral.

[0134] Specifically, in this embodiment, the similarity of the fingerprint spectra of Gastrodia elata slices with different steaming times is used as the abscissa (X), and the similarity of the fingerprint spectra of the corresponding Gastrodia elata formula granules is used as the ordinate (Y) to establish a linear relationship between the two. The results show that the similarity of the fingerprint spectra of Gastrodia elata slices and the similarity of the fingerprint spectra of Gastrodia elata formula granules exhibit a typical positive correlation. The linear regression equation is: Y = 0.4714X + 0.5544, and the correlation coefficient R is 1 / 2. 2 =0.9768, such as Figure 9 As shown.

[0135] According to the linear regression equation, when the similarity of the fingerprint spectrum of Gastrodia elata formula granules is not lower than 0.90, the similarity of Gastrodia elata slices should not be lower than 0.733. Considering the errors in the testing and processing, and based on data from multiple batches, the similarity of the fingerprint spectrum of Gastrodia elata slices is revised to not lower than 0.76.

[0136] Table 5. Similarity detection results of fingerprint spectra between Gastrodia elata slices and Gastrodia elata granules processed at different steaming times.

[0137]

[0138] In particular, to examine the rationality of the application of the constructed fingerprint spectrum, the following three comparative examples were conducted.

[0139] Comparative Example 4

[0140] An application of fingerprint spectroscopy for Gastrodia elata slices that meets the quality requirements of Gastrodia elata formula granules includes the following steps:

[0141] Step 1: Take the raw Gastrodia elata (No. T7), wash it, steam it in a steamer for 1.5 hours, cut it into thin slices using a linear reciprocating herb cutter, let it cool at room temperature, and then dry it at a low temperature of 55°C in a hot air circulating oven. Sift out the fine powder to obtain the prepared Gastrodia elata slices.

[0142] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.09 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0143] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0144] Comparative Example 5

[0145] An application of fingerprint spectroscopy for Gastrodia elata slices that meets the quality requirements of Gastrodia elata formula granules includes the following steps:

[0146] Step 1: Take the Gastrodia elata slices that have been steamed for 1.5 hours in Example 1, place them in a steamer and steam for another 5 hours. After steaming, let them cool at room temperature, place them in a hot air circulating oven and dry at a low temperature of 55°C, and sift out the fine powder to obtain the Gastrodia elata slices.

[0147] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0148] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0149] Comparative Example 6

[0150] An application of fingerprint spectroscopy for Gastrodia elata slices that meets the quality requirements of Gastrodia elata formula granules includes the following steps:

[0151] Step 1: Take the raw Gastrodia elata (No. T7), wash it, place it in a water tank, add an appropriate amount of water (completely submerging the herb) and moisten it for 10 hours. Take it out, filter out the water, cut it into thin slices using a linear reciprocating herb cutter, and then place it in a hot air circulating oven at 55℃ to dry at a low temperature. Sift out the fine powder to obtain the Gastrodia elata slices.

[0152] Step 2: Take the Gastrodia elata slices obtained in Step 1, place them in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extracts, concentrate under reduced pressure at 60℃ to a relative density of 1.08 (60℃), spray dry, add an appropriate amount of dextrin, mix well, and granulate to obtain the Gastrodia elata formula granules (each 1g of formula granules is equivalent to 4g of slices).

[0153] Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, thin-layer identification and other indicators of the formula granules according to the method under the content determination and fingerprint spectrum of Gastrodia elata formula granules YBZ-PFKL-2021122.

[0154] Table 6 shows the experimental results of comparative examples 4, 5, and 6.

[0155]

[0156] The comparative experimental results show that when the steaming time of the Gastrodia elata slices did not meet the processing requirements, the fingerprint similarity of the processed Gastrodia elata slices was only 0.514, and the fingerprint similarity of the prepared formula granules was 0.793, which is lower than the national standard requirement (Comparative Example 4). When the steaming time of the slices was extended to meet the processing requirements, the fingerprint similarity of the Gastrodia elata slices increased from 0.514 to 0.783, and the fingerprint similarity of the formula granules also increased from 0.793 to 0.934, which meets the national standard requirement (Comparative Example 5). When the soaking process was used, the fingerprint similarity of the processed Gastrodia elata slices was 0.503, and the fingerprint similarity of the prepared formula granules was 0.772, which does not meet the national standard requirement (Comparative Example 6). This indicates that the processing technology and the constructed fingerprint of the present invention have good applicability.

[0157] Example 9

[0158] This embodiment conducts a methodological evaluation of the fingerprint detection method in Example 7, including chromatographic peak identification, precision testing, stability testing, and repeatability testing, as detailed below:

[0159] 1. Chromatographic peak identification

[0160] Preparation of reference solutions: Accurately weigh appropriate amounts of gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E reference standards, place them in volumetric flasks, dissolve and mix with methanol to prepare solutions containing 200 μg, 5 μg, 200 μg, 150 μg, 50 μg, and 200 μg per mL, respectively, as reference solutions.

[0161] Preparation of the test solution: Weigh 1g of Gastrodia elata powder accurately, place it in a stoppered conical flask, add 50ml of water accurately, heat under reflux for 1 hour, cool, filter, accurately measure 10ml of the filtrate, evaporate to dryness, add 30% methanol to dissolve and make up to 5ml, sonicate (power 250W, frequency 40kHz) for 30 minutes, cool and filter with a 0.22μm needle filter to obtain the test solution.

[0162] Based on the retention time and full-wavelength absorption curves of each reference standard, the characteristic spectral peaks of Gastrodia elata slices were identified. Peak 1 was identified as gastrodin, peak 2 as p-hydroxybenzyl alcohol, peak 3 as barisonoside E, peak 4 as barisonoside B, peak 5 as barisonoside C, and peak 6 as barisonoside.

[0163] 2. Precision test

[0164] One sample solution was prepared from the same batch of Gastrodia elata slices according to the preparation method in Example 7. The solution was injected six times consecutively under the described chromatographic conditions. The results showed that the similarity among the six injections was greater than 0.9. Using gastrodin as the reference peak, the RSD of the relative retention time of each common peak was 0.19%, and the RSD of the relative peak area was 0.16%, indicating good instrument precision. Related detection results can be found in [reference needed]. Figure 10 .

[0165] Table 7. Results of similarity determination in precision tests.

[0166]

[0167] Table 8. Relative retention time and relative peak area of ​​gastrodin

[0168]

[0169] 3. Stability test

[0170] One sample solution was prepared from the same batch of Gastrodia elata slices according to the preparation method described in Example 7. The solution was injected and analyzed at 0, 2, 4, 6, 8, and 12 hours under the described chromatographic conditions. The results showed that the similarity among the six injections was greater than 0.9. Using gastrodin as the reference peak, the RSD of the relative retention time of each common peak was 0.85%, and the RSD of the relative peak area was 0.31%, indicating that the sample solution had good stability within 12 hours. Related detection results can be found in [link to relevant test results]. Figure 11 .

[0171] Table 9. Results of Stability Test Similarity Measurement

[0172]

[0173]

[0174] Table 10. Relative retention time and relative peak area of ​​gastrodin

[0175]

[0176] 4. Repeatability test

[0177] Six test solutions were prepared from the same batch of Gastrodia elata slices according to the preparation method described in Example 7. Chromatographic analysis was performed under the described conditions, and the results showed that the similarity among the six test solutions was greater than 0.9. Using gastrodin as a reference peak, the RSD of the relative retention time of each common peak was 0.30%, indicating good repeatability of the method. Related detection results can be found in [reference needed]. Figure 12 .

[0178] Table 11 Results of Repeatability Test Similarity Measurement

[0179]

[0180] Table 12 Relative retention time of gastrodin

[0181]

[0182] The above description is merely a preferred embodiment of the present invention and is not intended to limit the implementation. Those skilled in the art will recognize that numerous variations or modifications can be made based on the above description; it is neither necessary nor possible to describe all embodiments here, and these variations or modifications remain within the scope of protection of this invention.

Claims

1. A method for constructing and detecting fingerprint spectra of Gastrodia elata slices, characterized in that, Includes the following steps: Step 1: Take the raw Gastrodia elata, wash it, place it in a steamer and steam for 5 to 10 hours. Then cut it into thin slices, let it cool at room temperature, and dry it at a low temperature of 50℃ to 60℃. Sift out the fine powder to obtain the Gastrodia elata slices. Step 2: Place the prepared Gastrodia elata slices in a decoction machine, add 8 times the amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 60 minutes, filter while hot and set aside; add 6 times the amount of water, bring to a boil over high heat, then simmer over low heat for 40 minutes, filter while hot and set aside; combine the two extraction filtrates, concentrate under reduced pressure at 60℃ to a material-to-liquid ratio of 1:1, with a relative density of 1.05-1.10 at 60℃, spray dry, add excipients, mix well, and granulate to obtain the finished Gastrodia elata formula granules, with each 1g of formula granules equivalent to 4g of slices; Step 3: Take the Gastrodia elata formula granules prepared in Step 2 and test the content, fingerprint spectrum, extract, properties, and thin-layer identification index of the Gastrodia elata formula granules in accordance with the requirements of the national drug standard YBZ-PFKL-2021122. Step 4: Following the processing techniques for Gastrodia elata decoction pieces corresponding to the Gastrodia elata formula granules that have passed all tests in Step 3, process 15 different batches of Gastrodia elata decoction pieces and execute Step 2 and Step 3 respectively. Step 5: Take the Gastrodia elata slices corresponding to the Gastrodia elata formula granules from Step 4 that have passed all the tests as samples, and perform the following steps: A) Take Gastrodia elata slices, crush them, pass them through a No. 4 pharmacopoeia sieve, and take the sieve residue as the test sample; B) Dissolve and extract the test sample using a solvent to obtain the test solution; C) The test solution was analyzed by ultra-high performance liquid chromatography to obtain the UPLC characteristic chromatograms of each batch of Gastrodia elata slices; D) Import the UPLC characteristic chromatograms of each batch of medicinal materials into the similarity evaluation system of chromatographic fingerprint chromatograms of traditional Chinese medicine, use Mark peak matching to generate common peak pattern chromatograms, and construct a reference fingerprint chromatogram of Gastrodia elata slices. Step 6: Perform feature map detection on Gastrodia elata slices with different steaming times according to the method described in Step 5, and perform Mark peak matching with the constructed fingerprint map of Gastrodia elata slices to calculate the similarity between the fingerprint map and the control fingerprint map. Step 7: Using the similarity of the fingerprint spectrum of Gastrodia elata slices with different steaming times in Step 6 as the x-axis and the similarity of the fingerprint spectrum of the corresponding Gastrodia elata formula granules as the y-axis, perform a linear regression equation fitting. According to the fitted linear regression equation, if the similarity of the fingerprint spectrum of Gastrodia elata formula granules is not lower than 0.90, the similarity of the fingerprint spectrum of the corresponding Gastrodia elata slices should not be lower than 0.

76. The chromatographic conditions for obtaining the fingerprint chromatogram of Gastrodia elata slices are as follows: Chromatographic conditions: Octadecyl-bonded silica gel was used as the packing material; the column length was 150 mm, the inner diameter was 2.1 mm, the particle size was 1.6 µm, and the column temperature was 30 °C; the flow rate was 0.30 mL / min, the detection wavelength was 220 nm, the injection volume was 1 μL, and the theoretical plate number calculated based on gastrodin should not be less than 3000; acetonitrile was used as mobile phase A, and 0.05% phosphoric acid solution was used as mobile phase B, eluting according to the following gradient elution program: ； It also includes the preparation of reference solutions, specifically: accurately weigh the reference standards of gastrodin, p-hydroxybenzyl alcohol, balithinoside, balithinoside B, balithinoside C, and balithinoside E, place them in a volumetric flask, dissolve and mix them with methanol to prepare solutions containing 200 μg, 5 μg, 200 μg, 150 μg, 50 μg, and 200 μg per 1 mL, respectively, as reference solutions; Mark peaks refer to the six characteristic peaks of gastrodin, p-hydroxybenzyl alcohol, balithin, balithin B, balithin C, and balithin E. These peaks were injected under the same chromatographic conditions, and reference standards of gastrodin, p-hydroxybenzyl alcohol, balithin, balithin B, balithin C, and balithin E were used for chromatographic peak localization and identification. In step seven, a linear regression equation is fitted using the similarity of the fingerprint spectrum of Gastrodia elata slices as the x-axis (X) and the similarity of the fingerprint spectrum of the corresponding Gastrodia elata formula granules as the y-axis (Y). The fitted linear regression equation is as follows: Y = 0.4714X + 0.5544, correlation coefficient R 2 =0.9768.

2. The method according to claim 1, characterized in that, In step one, the steaming time is 5h, 6h, 7h, 8h, 9h, and 10h, and the low-temperature drying temperature is 55℃.

3. The method according to claim 1, characterized in that, The steaming time range for the 15 different batches of Gastrodia elata slices mentioned in step four is 5h-10h.

4. The method according to claim 1, characterized in that, The specific method for preparing the test solution described in step five is as follows: Accurately weigh 1.0g of Gastrodia elata powder and place it in a stoppered conical flask. Accurately add 50ml of water, heat under reflux for 1 hour, cool, filter, accurately measure 10ml of the filtrate, evaporate to dryness, add 30% methanol to dissolve and dilute to 5ml, sonicate for 30 minutes at a power of 250W and a frequency of 40kHz; after cooling, filter with a 0.22μm needle filter to obtain the final product.

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