High-temperature rapid processing technology of pinellia ternate rhizome slices

Abstract

The application belongs to the technical field of traditional Chinese medicine decoction piece processing, and particularly discloses a high-temperature rapid processing technology of ginger pinellia decoction pieces, which comprises the following steps: S1. soaking raw pinellia in clean water at room temperature for 72-120 hours, and then controlling the moisture content to obtain water-soaked pinellia; S2. taking a container, laying the water-soaked pinellia on the bottom of the container, and covering the ginger juice and alum processing liquid thereon; repeatedly laying the water-soaked pinellia and the ginger juice and alum processing liquid in a crosswise and layer-by-layer manner, and sealing the container after the container is fully laid; S3. placing the sealed container in a constant-temperature oven at 50-60 DEG C for heating and pickling for 18-22 hours, washing away the ginger juice and alum processing liquid residue with clean water after the water-soaked pinellia is soaked through, pouring clean water to immerse the medicine, heating and decocting, keeping the temperature slightly boiling, taking out the pinellia when the inside of the pinellia is free of white core, and drying, so the ginger pinellia decoction pieces can be processed within one week, the toxicity and efficacy of the decoction pieces are effectively verified, and the strong efficacy of raw pinellia and the safety and balance of processed products are successfully combined.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine processing technology. Specifically, it discloses a high-temperature and rapid processing technology for ginger-processed Pinellia ternata slices. Background Technology

[0002] Pinellia ternata is the dried tuber of Pinellia ternata (Thunb.) Breit., a plant in the Araceae family. It was first recorded in the Shennong's Classic of Materia Medica and was listed as an inferior herb. It is pungent and warm in nature, and is toxic. It enters the spleen, stomach, and lung meridians and has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and eliminating masses and nodules.

[0003] Raw Pinellia ternata has strong irritant toxicity. Ingestion can cause severe irritation to the lips, mouth, throat, and gastrointestinal tract, leading to needle-like pain and swelling. In severe cases, it can cause loss of voice, vomiting, and diarrhea. However, it has a wide range of clinical applications and very important medicinal value. Therefore, Pinellia ternata is usually used in medicine in its processed form. Ginger-processed Pinellia ternata is the most common processed form for reducing toxicity and is included in the 2025 edition of the Chinese Pharmacopoeia. At the same time, several traditional local processing schools also record the method of processing Pinellia ternata with ginger to reduce toxicity. Among them, ginger-pickled Pinellia ternata is a characteristic processing variety of the Beijing school, which is recorded in the book "Beijing School of Medicine". The book records that the processing of ginger-pickled Pinellia ternata takes more than 30 days and the processing is complicated.

[0004] The current 2025 edition of the Chinese Pharmacopoeia, Volume I, lists the following processing method for ginger-processed Pinellia ternata: Take clean Pinellia ternata, separate them by size, soak them in water until there is no dry core inside, then remove them; separately, take sliced ​​fresh ginger, decoct it in water, add alum and boil it together with the Pinellia ternata until thoroughly cooked, remove it, and air-dry it, or air-dry it until semi-dry, then dry it; or slice it thinly and dry it; for every 100 kg of clean Pinellia ternata, use 25 kg of fresh ginger and 12.5 kg of alum. This method is currently the most commonly used method, but the ginger-processed Pinellia ternata obtained by this method has a lower content of 6-gingerol, organic acids, etc.

[0005] Chinese Patent Application No. 201610108185.7 discloses a processing method for ginger-processed Pinellia ternata and ginger-infused Pinellia ternata. The method includes the following steps: (1) cleaning, (2) grading, (3) soaking, (4) drying, (5) decocting, (6) juice extraction, (7) steaming, (8) slicing, and drying. The method of this invention reduces the processing time of ginger-processed Pinellia ternata and ginger-infused Pinellia ternata to 8 days, increases the extract content from 11.0% to 25.0%, and increases the total organic acid content from 0.13% to 0.65%. However, it uses the conventional method of decocting sliced ​​old ginger, which limits the extraction efficiency of gingerol (such as 6-gingerol).

[0006] Chinese patent application number 201910301677.1 discloses a method for processing ginger-processed Pinellia ternata, comprising the following steps: 1) soaking 100 parts of cleaned Pinellia ternata in water until the core is dry; 2) decocting 30 parts of sliced ​​red ginger to obtain 30 parts of ginger broth; 3) boiling the soaked Pinellia ternata, ginger broth, and 15 parts of alum together for 4-5 hours, and then drying. Compared with the Pinellia ternata prepared by the pharmacopoeia method, the ginger-processed Pinellia ternata of this invention contains more 6-gingerol and organic acids, but it still uses the method of decocting sliced ​​ginger, which limits the extraction efficiency of the active ingredients. Furthermore, it also presents problems with uniformity and penetration efficiency in large-scale production.

[0007] Therefore, in order to address the problems of long processing time and low production efficiency of ginger-pickled Pinellia, it is necessary to develop a ginger-pickled Pinellia with short processing time and relatively high content of 6-gingerol and organic acids in the finished product. Summary of the Invention

[0008] (a) The technical problem to be solved:

[0009] To address the issues of long processing time for ginger-processed Pinellia ternata and the need to improve the content of 6-gingerol and organic acids in the finished product in existing technologies, a high-temperature rapid processing technology for ginger-processed Pinellia ternata slices is provided.

[0010] (II) Technical Solution:

[0011] A high-temperature rapid processing method for ginger-processed Pinellia ternata slices includes the following steps:

[0012] S1. Soak raw Pinellia ternata in clean water at room temperature for 72-120 hours, then drain the water to obtain water-soaked Pinellia ternata;

[0013] S2. Take a container, place the water-soaked Pinellia at the bottom of the container, and cover it with ginger juice and alum processing liquid; repeat the same method to layer the water-soaked Pinellia and ginger juice and alum processing liquid in a crisscross pattern, and seal the container after it is full.

[0014] S3. Place the sealed container from step S2 in a constant temperature oven at 50-60℃ and heat and marinate for 18-22 hours. After the water-soaked Pinellia ternata is thoroughly marinated, wash away the ginger juice, alum processing liquid, and dregs with clean water. Pour in clean water to submerge the surface of the herbs, heat and boil, keeping it at a gentle boil. When there is no white core inside the Pinellia ternata, remove it, dry it, and you will get the product.

[0015] The ginger-alum preparation liquid in step S2 is made by processing fresh ginger and alum. Expressed by weight, the weight ratio of raw Pinellia ternata, fresh ginger, and alum is 100:15-20:15-20. The ginger-alum preparation liquid is prepared using the following method:

[0016] T1. Select fresh ginger, wash it, and use ultra-fine grinding technology to grind the ginger with skin at <10℃ to ginger paste with a particle size of 50-100 microns.

[0017] T2. Add 4-5 times the weight of water to the ginger paste, stir well, add compound plant enzyme, and incubate at 40-45℃ for 30-60 minutes for enzymatic hydrolysis.

[0018] T3. Quickly transfer the enzymatically hydrolyzed ginger paste to a steam jet heater and maintain it at 125-135℃ for 5-15 seconds to achieve instant sterilization and cooking.

[0019] T4. Cool the cooked ginger paste to 50-55℃, add fine alum powder, and stir to fully disperse and dissolve the alum to obtain ginger juice alum preparation liquid.

[0020] The compound plant enzyme is pectinase and cellulase, wherein the enzyme activity of pectinase is not less than 5000 U / g and the enzyme activity of cellulase is not less than 1000 U / g.

[0021] In step S1, when the soaking temperature is less than 25°C, the water is changed every 24 hours; when the soaking temperature is ≥25°C, the water is changed every 12 hours.

[0022] (III) Beneficial Effects:

[0023] 1. Short cycle and high efficiency: High-temperature (50-60℃) pickling takes only 18-22 hours, and the total cycle is controlled within one week;

[0024] 2. Advanced ginger juice preparation technology: It combines ultra-micro pulverization and enzymatic hydrolysis, while using instant sterilization and ripening, which improves the cell wall breakage rate and enhances the extraction efficiency of gingerol; enzymatic hydrolysis releases more bound gingerol, and instant sterilization preserves heat-sensitive components;

[0025] 3. The water-soaked Pinellia ternata and the ginger juice and alum processing liquid are layered and alternately laid to improve the uniformity of component distribution.

[0026] 4. High temperatures of 50-60℃ promote the stable binding of alum and Pinellia ternata components, making free alum easier to wash away and significantly improving safety;

[0027] 5. The ginger-processed Pinellia ternata slices obtained through the processing method of this invention have had their toxicity and efficacy effectively verified. It successfully combines the "potency of raw Pinellia ternata" with the "safety and balance of processed products", and endows the product with the function of "bidirectional immune regulation" through process innovation. Attached Figure Description

[0028] Figure 1 The results of HE staining of lung tissue sections from rats in each group during the efficacy verification experiment;

[0029] Figure 2 This is a schematic diagram of the distribution of inflammatory cells in BALF detected by Wright-Gymza staining in a drug efficacy verification test. Detailed Implementation

[0030] To better explain and facilitate understanding of the present invention, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0031] The raw Pinellia ternata medicinal material described in this invention is sourced from commercially available sources.

[0032] In this invention, "high temperature" refers to 50-60℃, which is higher than room temperature and normal ambient temperature. Therefore, it is defined as "high temperature" in this case, which is the temperature selected by the constant temperature oven in step S2. A hot air circulating oven (model: 101-1A electric constant temperature blower drying oven, Shanghai Huyueming Technology Instrument Co., Ltd.) is used.

[0033] Unless otherwise specified, the ginger-processed Pinellia ternata slices described below are all obtained using the high-temperature processing technology of this invention.

[0034] Example 1

[0035] This invention discloses a high-temperature rapid processing method for ginger-processed Pinellia ternata slices, comprising the following steps:

[0036] S1. Soak raw Pinellia in clean water at room temperature for 96 hours, then drain the water. The room temperature should be 15-20℃. Change the water once every 24 hours to obtain soaked Pinellia.

[0037] S2. Take a container and place the water-soaked Pinellia ternata at the bottom of the container, then cover it with ginger juice and alum processing liquid; repeat the same method of layering the water-soaked Pinellia ternata and ginger juice and alum processing liquid in a crisscross pattern until the container is full, then seal the container; the ginger juice and alum processing liquid in this embodiment is prepared in a traditional way, by boiling ginger in water and adding alum to dissolve it, using 20 kg of ginger and 20 kg of alum for every 100 kg of raw Pinellia ternata.

[0038] S3. Place the sealed container from step S2 in a 50°C constant temperature oven and heat and marinate for 18 hours. After the medicine is thoroughly marinated, wash away the ginger juice, alum processing liquid, and medicine residue with clean water, add clean water to submerge the medicine, heat and decoct, keeping it at a gentle boil. When the inside of the Pinellia ternata is no longer white, remove it, dry it, and you will get ginger Pinellia ternata slices.

[0039] The key to using 50℃ high-temperature heating to pickle ginger and pinellia lies in utilizing the appropriate heat effect to significantly increase the penetration rate of key components (such as 6-gingerol and alum ions), thereby reducing the pickling time and shortening the entire processing cycle to within one week.

[0040] Example 2

[0041] This invention discloses a high-temperature rapid processing method for ginger-processed Pinellia ternata slices, comprising the following steps:

[0042] S1. Soak raw Pinellia in clean water at room temperature for 96 hours, then drain the water. The room temperature should be 15-20℃. Change the water once every 24 hours to obtain soaked Pinellia.

[0043] S2. Take a container and place the water-soaked Pinellia at the bottom of the container, then cover it with ginger juice and alum processing liquid; repeat the same method of layering the water-soaked Pinellia and ginger juice and alum processing liquid in a crisscross pattern until the container is full, then seal the container.

[0044] In this embodiment, the ginger-alum preparation liquid is made from fresh ginger and alum. For every 100 kg of fresh Pinellia ternata, 18 kg of fresh ginger and 18 kg of alum are used, and it is prepared using the following method:

[0045] T1. Select fresh ginger, wash it, and instead of using the traditional slicing or juicing method, use ultra-micro pulverization technology to pulverize the ginger with skin at 5℃ to a particle size of 50-100 microns into ginger paste.

[0046] T2. Add 4-5 times its weight of water to the ginger paste, stir well, add compound plant enzymes, the compound plant enzymes being pectinase and cellulase, wherein the enzyme activity of pectinase in the compound plant enzymes is not less than 5000 U / g, and the enzyme activity of cellulase is not less than 1000 U / g, the addition amount is 0.05%-0.1% of the weight of ginger paste, and incubate at 40-45℃ for 40 minutes for enzymatic hydrolysis;

[0047] Ultrafine grinding and enzymatic hydrolysis improve the utilization rate of ginger and increase the levels of 6-gingerol and total organic acids in the processing liquid.

[0048] T3. Quickly transfer the enzymatically hydrolyzed ginger paste to a steam jet heater and maintain it at 125-135℃ for 5-15 seconds to achieve instant sterilization and maturation. This step can sterilize the ginger paste and gelatinize it to a certain extent, increasing the adhesion and coating properties of the processing liquid, so that it can better adhere to the surface of Pinellia ternata and reduce loss.

[0049] T4. Quickly cool the cooked ginger paste to 50-55℃, which matches the subsequent pickling temperature. Add fine alum powder and stir to fully disperse and dissolve the alum to obtain ginger juice alum preparation liquid.

[0050] After the ginger juice and alum processing liquid is prepared, it can be applied layer by layer to the water-soaked Pinellia ternata by manual spreading or sprayed layer by layer.

[0051] S3. Place the soaked Pinellia ternata and ginger juice alum processing liquid after repeated layering in step S2 in a 50℃ constant temperature oven and heat and marinate for 18 hours. After the medicine is thoroughly marinated, wash off the ginger juice alum processing liquid residue with clean water, add clean water to submerge the medicine, heat and decoct, keep it at a gentle boil, and remove the Pinellia ternata when there is no white core inside. Dry it to obtain ginger Pinellia ternata slices.

[0052] Example 3

[0053] This invention discloses a high-temperature rapid processing method for ginger-processed Pinellia ternata slices, comprising the following steps:

[0054] S1. Soak raw Pinellia ternata in clean water at room temperature for 72 hours, then drain the water. The room temperature should be 30±2℃. Change the water once every 12 hours to obtain water-soaked Pinellia ternata.

[0055] S2. Take a container and place the water-soaked Pinellia at the bottom of the container, then cover it with ginger juice and alum processing liquid; repeat the same method to layer the water-soaked Pinellia and ginger juice and alum processing liquid in a crisscross pattern.

[0056] In this embodiment, the ginger juice and alum preparation solution is the same as in Example 2;

[0057] S3. Place the soaked Pinellia ternata and ginger juice alum processing liquid after repeated layering in step S2 in a 50℃ constant temperature oven and heat and marinate for 19 hours. After the medicine is thoroughly marinated, wash off the ginger juice alum processing liquid residue with clean water, add clean water to submerge the medicine, heat and decoct, keep it at a gentle boil, and remove the Pinellia ternata when there is no white core inside. Dry it to obtain ginger Pinellia ternata slices.

[0058] Example 4

[0059] This invention discloses a high-temperature rapid processing method for ginger-processed Pinellia ternata slices, comprising the following steps:

[0060] S1. Soak raw Pinellia in clean water at room temperature for 96 hours, then drain the water. The room temperature is 30±2℃. Change the water once every 12 hours to obtain water-soaked Pinellia.

[0061] S2. Take a container and place the water-soaked Pinellia at the bottom of the container, then cover it with ginger juice and alum processing liquid; repeat the same method to layer the water-soaked Pinellia and ginger juice and alum processing liquid in a crisscross pattern.

[0062] In this embodiment, the ginger juice and alum preparation solution is the same as in Example 2;

[0063] S3. Place the soaked Pinellia ternata and ginger juice alum processing liquid after repeated layering in step S2 in a constant temperature oven at 56℃ and heat and marinate for 17 hours. After the medicine is thoroughly marinated, wash off the ginger juice alum processing liquid residue with clean water, add clean water to submerge the medicine, heat and decoct, keep it at a gentle boil, and remove the Pinellia ternata when there is no white core inside. Dry it to obtain ginger Pinellia ternata slices.

[0064] Comparative Example 1

[0065] Room-temperature ginger-preserved Pinellia ternata slices: This comparative example uses the traditional Beijing-style room-temperature pickling process for ginger-preserved Pinellia ternata. The method is as follows: Place raw Pinellia ternata in a vat of appropriate volume, add water to submerge the herbs, and soak. Change the water once a day, or twice a day when the temperature is high (35℃). After the herbs have been soaked for 4-6 days, take an appropriate amount of ginger slices and fine alum powder (the mass ratio of raw Pinellia ternata, ginger, and alum is 100:18:18) and place them in another vat. Spread a layer of water-soaked herbs on top, and then sprinkle another layer of ginger and alum on the surface. Repeat this alternating process until all herbs are used. During the pickling process, the vat needs to be turned over every seven days. After the herbs have been pickled for 36 days, remove the soaking liquid and dregs, put them into a pot, add water to submerge the herbs, heat and boil, keeping it at a gentle boil. When the herbs no longer have a white core, remove them, dry them, and you will get room-temperature ginger-preserved Pinellia ternata slices.

[0066] Comparative Example 2

[0067] Pharmacopoeia-processed Ginger-processed Pinellia: This comparative example uses the processing method of Ginger-processed Pinellia according to the Chinese Pharmacopoeia. The processing method is as follows: Take raw Pinellia, separate by size, soak in water until there is no dry core inside, then remove; separately, take sliced ​​ginger, decoct in water, add alum and cook together with Pinellia until thoroughly cooked, remove, and air dry, or air dry until semi-dry, then dry; or slice thinly and dry. For every 100kg of raw Pinellia, use 25kg of ginger and 12.5kg of alum to obtain the Pharmacopoeia-processed Ginger-processed Pinellia.

[0068] The effective components of the above embodiments and comparative examples were detected, and the main indicators were 6-gingerol, organic acids, and extracts.

[0069] The concise descriptions of the commonly used determination methods for key indicators such as gingerol (6-gingerol), organic acids, extracts, and alum residues in various processing techniques of ginger and pinellia in the various embodiments and comparative examples are all based on traditional Chinese medicine industry standards (such as the Chinese Pharmacopoeia) and modern analytical techniques.

[0070] The ginger-processed Pinellia ternata slices, room-temperature ginger-processed Pinellia ternata slices, and pharmacopoeia-grade ginger-processed Pinellia ternata slices from each embodiment and comparative example were crushed and passed through a 65-mesh sieve as test samples.

[0071] I. Determination of 6-Gingerol (Gingerol-like Components)

[0072] Method: High performance liquid chromatography

[0073] 1. Sample preparation

[0074] (1) Preparation of reference solution: Accurately weigh 5 mg of 6-gingerol reference standard, place it in a 5 ml volumetric flask, and add methanol to make up to the mark.

[0075] (2) Preparation of test solution: Take 5g of sample powder, weigh it accurately, put it in a stoppered conical flask, add 50mL of methanol accurately, weigh it, and then extract it by ultrasonication for 40min (300W, 25KHz). After cooling, weigh it again, make up the weight loss with methanol, shake it well, and then filter it with a 0.45μm microporous membrane. Take the filtrate as the test solution.

[0076] 2. Chromatographic conditions:

[0077] Chromatographic column: SuperLu C18 (250×4.6mm, 5μm); mobile phase: acetonitrile-0.1% formic acid aqueous solution (45:55); detection wavelength: 282nm; column temperature: 30℃; injection volume: 10μL; flow rate: 0.8mL·min-1; theoretical plate number not less than 5000.

[0078] II. Determination of total organic acid content

[0079] Methods: Acid-base titration (using succinic acid as an indicator) was used to determine the content of organic acids in each test sample solution according to the method for determining the content of organic acids under the Pinellia ternata section of the Chinese Pharmacopoeia, with succinic acid as a reference standard.

[0080] 1. Preparation of standard titrant: Following the preparation method specified in the Chinese Pharmacopoeia (Part IV), prepare sodium hydroxide titrants (0.1 mol·L⁻¹). -1 ) and hydrochloric acid titrant (0.1 mol·L -1 ),spare.

[0081] 2. Preparation of reference solution: Weigh 102 mg of succinic acid reference standard accurately, place it in a 100 mL volumetric flask, add 95% ethanol to dissolve it, and then dilute to the mark to obtain a succinic acid reference solution containing 1.02 mg per mL.

[0082] 3. Preparation of the test solution: Weigh 5g of the sample powder and place it in a stoppered conical flask. Add 50mL of ethanol and reflux to extract three times, 1h each time. After cooling, filter, combine the filtrates, evaporate to dryness, and accurately add sodium hydroxide titrant (0.1mol·L⁻¹) to the residue. -1 Dissolve in 10 mL of water, sonicate (500 W, 40 kHz) for 30 min, then transfer to a 50 mL volumetric flask. Add freshly boiled and cooled water to the mark, shake well, and the test solution is obtained.

[0083] 4. Determination method: Determine the sample solution according to the potentiometric titration method in the Chinese Pharmacopoeia. Accurately measure 25 mL of the solution from section "3" and titrate with 0.1 mol·L⁻¹ hydrochloric acid solution. -1Titration. Plot the titration curve with the volume (V) of hydrochloric acid titrant consumed as the x-axis and ΔE / ΔV (the ratio of the potential difference between two consecutive titrations to the volume difference of titrant added) as the y-axis. The volume corresponding to the maximum value of ΔE / ΔV is the titration endpoint. The titration results are corrected using a blank test. Calculate the volume of each 1 mL of sodium hydroxide titrant (0.1 mol·L⁻¹). -1 This is equivalent to 5.904 mg of succinic acid (C4H6O4).

[0084] III. Determination of Alum Residue

[0085] According to the method for determining the limit of alum under the section on Pinellia ternata in the Chinese Pharmacopoeia, potassium aluminum sulfate [KAl(SO4)2·12H2O] was used as a reference standard to determine the alum residue in each sample.

[0086] 1. Preparation of indicators and titrants: Following the preparation methods specified in the Chinese Pharmacopoeia (Part IV), prepare methyl red and xylenol orange indicator solutions and zinc titrants (0.05 mol·L⁻¹) respectively. -1 ), disodium ethylenediaminetetraacetate (EDTA) titrant (0.05 mol·L⁻¹) -1 ),spare.

[0087] 2. Preparation of the test solution: Weigh 5g of sample powder, place it in a crucible, heat until completely carbonized, then transfer it to a box-type resistance furnace at 450℃ for 4 hours for ashing. After cooling, add 10mL of dilute hydrochloric acid to the crucible, cover the crucible with a watch glass, heat in a water bath for 10 minutes, then rinse the watch glass with 5mL of hot water. Add the washings to the crucible, filter, and wash the crucible and residue several times with 50mL of water. Combine the washings with the filtrate, add 1 drop of 0.025% methyl red ethanol solution, and add ammonia test solution until the solution turns slightly yellow. Add 20mL of acetate-ammonium acetate buffer (pH 6.0), and then accurately add 0.0523mol·L⁻¹ EDTA. -1 Boil 25 mL of xylenol orange indicator for 3-5 minutes, let cool, and add 1 mL of xylenol orange indicator to obtain the test solution.

[0088] 3. Determination method: Zinc titrant (0.0518 mol·L⁻¹) -1 The test solution under item "2" changed from yellow to red during titration, and the titration result was corrected using a blank test. The calculated titration value was: 1 mL of disodium ethylenediaminetetraacetate (EDTA) titrant (0.05 mol·L⁻¹). -1 This is equivalent to 23.72 mg of hydrated potassium aluminum sulfate (KA1(SO4)2·12H2O).

[0089] IV. Determination of Leachate

[0090] According to the cold maceration method for determining water-soluble extracts in the Chinese Pharmacopoeia: Take about 4g of sample powder, accurately weigh it, place it in a 250-300ml conical flask, add 100ml of water, seal tightly, and macerate. Shake for the first 6 hours, then let it stand for 18 hours. Filter quickly through a dry filter, accurately measure 20ml of the filtrate, place it in an evaporating dish that has been dried to constant weight, evaporate it to dryness on a water bath, dry it at 105℃ for 3 hours, cool it in a desiccator for 30 minutes, and quickly and accurately weigh it. Calculate the content (%) of water-soluble extracts in the sample based on the dried product.

[0091] The measurement results of the above embodiments and comparative examples are shown in Table 1:

[0092] Table 1: Detection results of the main effective components of Pinellia ternata in each example and comparative example:

[0093] ;

[0094] The test results showed that the ginger-processed Pinellia ternata slices obtained using Example 1 had higher levels of active ingredients such as 6-gingerol, organic acids, and extracts than those of Comparative Examples 1 and 2, with lower alum residue and a shorter processing time (less than one week). The ginger-processed Pinellia ternata slices obtained using Examples 2 to 4 showed significantly higher levels of active ingredients such as 6-gingerol, organic acids, and extracts compared to Example 1.

[0095] Test results verification: The ginger-processed Pinellia ternata slices mentioned in the following test results verification are the ginger-processed Pinellia ternata slices obtained in Example 2.

[0096] I. Toxicity verification of ginger-processed Pinellia ternata slices using rabbit eye irritation test:

[0097] (a) Test materials

[0098] 1. Experimental animals: 18 male white rabbits with large ears, weighing (2.5±0.5) kg, healthy, with no redness or swelling in their eyes, purchased from Henan Skbes Biotechnology Co., Ltd.

[0099] Eighty SPF-grade male SD rats, weighing (180±20) g, were housed in a controlled environment with a temperature of 25±2℃, relative humidity of 40%-60%, and natural light. They were purchased from Henan Skbes Biotechnology Co., Ltd.

[0100] 2. Statistical Analysis: All data were analyzed using SPSS statistical software. Quantitative data were expressed as mean ± standard deviation (mean ± standard deviation). () indicates that data that do not meet statistical requirements have been transformed, and one-way ANOVA was used for comparisons between groups. P<0.05 indicates a statistically significant difference, P<0.01 indicates a statistically significant difference, and P<0.001 indicates a statistically significant difference.

[0101] (II) Test method: Rabbit conjunctival irritation test

[0102] 1. Preparation of the drug solution:

[0103] Raw Pinellia ternata, prepared Pinellia ternata slices with ginger from the pharmacopoeia, prepared Pinellia ternata slices pickled with ginger at room temperature, and prepared Pinellia ternata slices with ginger were crushed and passed through a No. 4 sieve. 2g of each sample was weighed out and a suspension of 20% sodium carboxymethyl cellulose was prepared in 0.9% physiological saline to serve as the drug solution for each treatment group. A suspension of 20% sodium carboxymethyl cellulose was prepared in 0.9% physiological saline to serve as the drug solution for the blank control group.

[0104] 2. Test methods:

[0105] Fifteen randomly selected domestic rabbits were raised in a normal environment for 5 days. After that, they were given free access to food and water and were then randomly divided into five groups of three rabbits each. The groups were: blank control group, raw Pinellia ternata group, Pinellia ternata slices (from the pharmacopoeia of ginger Pinellia ternata slices obtained in Comparative Example 2), room temperature Pinellia ternata slices (from room temperature Pinellia ternata slices obtained in Comparative Example 1), and ginger Pinellia ternata slices (from ginger Pinellia ternata slices obtained in Example 2).

[0106] At the start of the experiment, rabbits were secured in their cages. During the experiment, the upper and lower eyelids were cupped together, and the medication was dripped into each of the rabbit's eyes. Six rabbit eyes were used in each sample group, with two drops administered to each eye. After administration, the upper and lower eyelids were passively closed for 5-10 seconds. Two minutes later, the eyes were rinsed with 40-50 ml of physiological saline. The condition of the rabbit eyes was observed at 1.5 hours and 3 hours after administration. The rabbits' eye irritation response was recorded by photograph and scored. The scoring criteria are shown in Table 2.

[0107] Table 2: Rabbit Eye Stimulation Scoring Criteria

[0108] ;

[0109] 3. Experimental Results:

[0110] Table 3: Results of rabbit eye stimulation test ( (n=6)

[0111] ;

[0112] After processing according to the present invention, the ginger and pinellia slices group showed less eye irritation to rabbits, indicating that the toxicity was greatly reduced after high-temperature processing.

[0113] II. Drug Efficacy Verification Test

[0114] 1. Preparation of medicinal solution: Take the ginger-Pinellia ternata slices from Example 2, add 10 times the amount of water and soak for 30 minutes, boil and filter for 30 minutes, add 8 times the amount of water to the residue and boil for 30 minutes, then filter, combine the filtrates and concentrate to 1.5 g / mL medicinal solution. This is the test medicinal solution of the ginger-Pinellia ternata slice group.

[0115] Take room temperature ginger and Pinellia ternata slices from Comparative Example 1 and prepare the medicinal liquid according to the above-mentioned medicinal liquid preparation steps. This is the comparative medicinal liquid of room temperature ginger and Pinellia ternata slices.

[0116] Take the prepared ginger-pillia slices from Comparative Example 2 and prepare the medicine solution according to the above medicine solution preparation steps. This is the comparative medicine solution of the ginger-pillia group in the pharmacopoeia.

[0117] Take raw Pinellia ternata slices and prepare the medicinal liquid according to the above-mentioned medicinal liquid preparation steps. This is the control medicinal liquid of the raw Pinellia ternata group.

[0118] Physiological saline: 0.9% sodium chloride aqueous solution.

[0119] Positive test result: Montelukast sodium, concentration 1.05 mg / ml.

[0120] 2. Grouping, modeling, and drug administration:

[0121] Grouping: Seventy male SD rats were selected and, after 7 days of acclimatization feeding, were randomly divided into 7 groups of 10 rats each: blank group (KB), model group (M), positive control group (Y), pharmacopoeia-prepared ginger and pinellia slices group (D) (ginger and pinellia slices obtained by pharmacopoeia method in Comparative Example 2), room temperature ginger and pinellia slices group (C) (room temperature ginger and pinellia slices obtained by Comparative Example 1), ginger and pinellia slices group (G), and raw pinellia group (S).

[0122] Allergic asthma model in rats: Except for the blank group, all other groups were drug treatment groups. On day 1 and day 7, rats in each drug treatment group were sensitized by intraperitoneal injection of 1 mL of freshly prepared OVA stimulation solution (1 mg OVA + 10 mg aluminum hydroxide + 1 mL 0.9% saline). On day 1 and day 7, rats in the blank group were injected intraperitoneally with 1 mL of saline.

[0123] Administration method:

[0124] Blank group (KB): From day 14 to day 21, the drug was administered orally via gavage with normal saline (0.1 ml / 100 g). One hour after administration, the drug was nebulized with normal saline solution using an ultrasonic nebulizer for 30 minutes, once a day.

[0125] Model group (M): From day 14 to day 21, the drug was administered orally via gavage with normal saline (0.1 ml / 100 g). One hour after administration, the drug was nebulized with 1% OVA normal saline solution using an ultrasonic nebulizer for 30 minutes, once a day.

[0126] Positive drug group (Y): Montelukast sodium solution (0.1 ml / 100 g) was administered orally by gavage from day 14 to day 21. One hour after administration, the drug was ultrasonically nebulized with 1% OVA saline solution for 30 minutes once a day.

[0127] Pharmacopoeia of Ginger and Pinellia ternata decoction (D): From day 14 to day 21, the medicine was administered orally by gavage (0.1 ml / 100 g) of Pharmacopoeia of Ginger and Pinellia ternata decoction. One hour after administration, the medicine was ultrasonically nebulized with 1% OVA saline solution for 30 minutes, once a day.

[0128] Group C: From day 14 to day 21, the medicine was administered orally via gavage (0.1 ml / 100 g) of room temperature ginger and pinellia decoction. One hour after administration, the medicine was ultrasonically nebulized for 30 minutes using an ultrasonic nebulizer with 1% OVA saline solution, once a day.

[0129] Ginger and Pinellia ternata decoction group (G): From day 14 to day 21, the medicine was administered orally by gavage (0.1 ml / 100 g) of ginger and Pinellia ternata decoction. One hour after administration, the medicine was ultrasonically nebulized for 30 minutes using an ultrasonic nebulizer with 1% OVA saline solution, once a day.

[0130] Raw Pinellia group (S): From day 14 to day 21, raw Pinellia liquid (0.1ml / 100g) was administered orally by gavage. One hour after administration, the drug was ultrasonically nebulized with 1% OVA saline solution for 30 minutes, once a day.

[0131] Twenty-four hours after the last administration, rats were sacrificed, and blood, bronchoalveolar lavage fluid (BALF), and lung tissue were collected and stored at −80°C for further analysis.

[0132] 2. Test Results

[0133] Figure 1 This is the result of HE staining of lung tissue sections from rats in each group during the efficacy verification experiment. HE staining results showed that the lung tissue structure of the control group was normal, with no inflammatory cell infiltration or obvious pathological changes. Compared with the control group, the model group showed alveolar wall thickening, damaged pathological structures, and extensive inflammatory cell infiltration. The severity of lesions in the ginger and Pinellia ternata decoction group was significantly reduced compared to the group treated with room-temperature ginger and Pinellia ternata decoction, the group treated with ginger and Pinellia ternata decoction from the pharmacopoeia, and the group treated with raw Pinellia ternata.

[0134] Figure 2 Table 4 below shows the results of Wright-Gymza staining for inflammatory cell classification and counting in BALF during the efficacy validation trial. (n=3).

[0135] Table 4: Results of Wright-Gymza staining for inflammatory cell classification and counting in BALF during efficacy validation trials:

[0136] ;

[0137] Table 4 shows that compared with the model group (M), the percentages of LYM, NE, and EOS cells in the BALF of rats in each group were significantly reduced, with statistically significant differences (P<0.001). The percentages of Mø cells in the BALF of rats in the ginger and Pinellia ternata decoction group (G), the pharmacopoeia ginger and Pinellia ternata decoction group (D), and the positive drug group (Y) were significantly reduced, with statistically significant differences (P<0.001). The percentages of Mø cells in the BALF of rats in the raw Pinellia ternata group (S) and the room temperature ginger and Pinellia ternata group (C) were significantly reduced, with statistically significant differences (P<0.01, P<0.05). Overall, the ginger and Pinellia ternata decoction group (G) showed a more significant reduction in inflammatory cells in the BALF than the other groups.

[0138] Table 5: Expression results of total IgE, IL-5 in rat serum and IL-4 and IFN-γ in BALF ( (n=6).

[0139] ;

[0140] As shown in Table 5, the ginger and pinellia decoction group (G) corrected immune disorders most closely to the normal state and most effectively bidirectionally regulated the abnormal Th2 immune hyperactivity (high IgE, IL-4, IL-5) and Th1 immune suppression (low IFN-γ) in allergic asthma model rats to a level close to the healthy level of the blank control group.

[0141] Group G achieved the best balance between the two key indicators of suppressing allergic mediators (IgE) and restoring protective immunity (IFN-γ), making its overall immune status closest to that of the blank group (KB).

[0142] The toxicity and efficacy of the ginger-processed Pinellia ternata slices obtained using the processing method of this invention have been effectively verified. The ginger-processed Pinellia ternata slice group (G) showed the best effect, successfully combining the "potency of raw Pinellia ternata" with the "safety and balance of processed products," and endowing the product with the function of "bidirectional immune regulation" through process innovation.

[0143] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions, or combinations of technical features in the above embodiments that do not conflict with each other, can be made in accordance with the manner described in the embodiments. These modifications, substitutions or combinations do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A high-temperature rapid processing method for ginger-processed Pinellia ternata slices, characterized in that, Includes the following steps: S1. Soak raw Pinellia ternata in clean water at room temperature for 72-120 hours, then drain the water to obtain water-soaked Pinellia ternata; S2. Take a container, place the water-soaked Pinellia at the bottom of the container, and cover it with ginger juice and alum processing liquid; repeat the same method to layer the water-soaked Pinellia and ginger juice and alum processing liquid in a crisscross pattern, and seal the container after it is full. S3. Place the sealed container from step S2 in a constant temperature oven at 50-60℃ and heat and marinate for 18-22 hours. After the water-soaked Pinellia ternata is thoroughly marinated, wash away the ginger juice, alum processing liquid, and dregs with clean water. Pour in clean water to submerge the surface of the herbs, heat and boil, keeping it at a gentle boil. When there is no white core inside the Pinellia ternata, remove it, dry it, and you will get the product. The ginger-alum preparation liquid in step S2 is made by processing fresh ginger and alum. Expressed by weight, the weight ratio of raw Pinellia ternata, fresh ginger, and alum is 100:15-20:15-20. The ginger-alum preparation liquid is prepared using the following method: T1. Select fresh ginger, wash it, and use ultra-fine grinding technology to grind the ginger with skin into ginger paste with a particle size of 50-100 microns at a temperature of <10℃. T2. Add 4-5 times the weight of water to the ginger paste, stir well, add compound plant enzyme, the amount of compound plant enzyme added is 0.05%-0.1% of the weight of ginger paste, and incubate at 40-45℃ for 30-60 minutes for enzymatic hydrolysis. T3. Transfer the enzymatically hydrolyzed ginger paste to a steam jet heater and sterilize and cook the ginger paste at 125-135℃ for 5-15 seconds. T4. Cool the cooked ginger paste to 50-55℃, add fine alum powder, and stir to fully disperse and dissolve the alum to obtain ginger juice alum preparation liquid.

2. The high-temperature rapid processing method for ginger-processed Pinellia ternata slices according to claim 1, characterized in that: The compound plant enzyme is pectinase and cellulase, wherein the enzyme activity of pectinase is not less than 5000 U / g and the enzyme activity of cellulase is not less than 1000 U / g.

3. The high-temperature rapid processing method for ginger-processed Pinellia ternata slices according to claim 1, characterized in that: In step S1, when the soaking temperature is less than 25°C, the water is changed every 24 hours; when the soaking temperature is ≥25°C, the water is changed every 12 hours.

Images