Formula and preparation method of pulse-activating and dampness-eliminating paste

Abstract

The embodiment of the invention provides a pulse-activating and dampness-eliminating paste formula and a preparation method thereof, and relates to the field of traditional Chinese medicine formulas and preparation processes thereof. Comprising 20 to 300 parts of radix astragali, 25 to 400 parts of radix glehniae, 20 to 300 parts of radix ophiopogonis, 35 to 600 parts of rhodiola rosea, 35 to 600 parts of rhizoma phragmitis, 15 to 200 parts of radix asteris, 15 to 200 parts of folium eriobotryae, 25 to 400 parts of wine-processed fructus corni, 8 to 100 parts of red ginseng, 15 to 200 parts of wax gourd kernel, 15 to 200 parts of radix bupleuri, 15 to 200 parts of earthworm, 15 to 200 parts of rhizoma acori graminei, 20 to 300 parts of fructus trichosanthis, 15 to 200 parts of coix seed, 15 to 200 parts of allium macrostemon, 15 to 200 parts of immature bitter orange and 25 to 400 parts of tortoise-shell glue. Compared with a traditional ointment with a single effect, the traditional Chinese medicine composition has the effects of tonifying qi, eliminating dampness and strengthening healthy qi through compatibility of the medicines.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine formula and preparation technology thereof, in particular to a Shengmai Qushi ointment formula and a preparation method thereof. Background Art

[0002] As a traditional dosage form, Chinese herbal pastes are increasingly used in the field of conditioning chronic wasting diseases, especially in scenarios such as postoperative physical weakness and traditional Chinese medicine health care. In the existing technology, there are two main technical bottlenecks in pastes for asthenia syndrome: one is the Qi-invigorating and Yin-nourishing paste based on Shengmai San. Although it uses herbs such as Ophiopogon japonicus and Red Ginseng to achieve the effect of replenishing Qi and promoting fluid production, it lacks targeted combinations to remove dampness and resolve phlegm, making it difficult to improve the clinical symptoms caused by internal dampness and turbidity. The other is the heat-clearing and dampness-removing paste. Although it can relieve the symptoms of dampness and heat, it is mostly based on cold medicines. Long-term use can easily damage spleen yang, and it lacks Qi-invigorating and Yin-nourishing ingredients, which cannot meet the complex pathological needs of the coexistence of Qi and Yin deficiency and internal dampness and turbidity.

[0003] The common method for preparing ointments is room-temperature soaking followed by normal-pressure decoction. However, few processes specifically tailor the tissue characteristics of the medicinal materials. For example, during the decoction process, there is a lack of monitoring and protection measures for heat-sensitive ingredients in the medicinal materials, which affects the retention of the active ingredients. Summary of the Invention

[0004] In view of this, the present invention aims to provide a formula of Shengmai Qushi ointment and a preparation method thereof, which can take into account the dual effects of invigorating qi and nourishing yin and removing dampness, and improve the dissolution rate and retention rate of the effective ingredients of the ointment.

[0005] In order to achieve the above purpose, the following technical solutions are adopted: A formula for a Shengmai Qushi paste comprises the following raw materials in parts by weight: 20-300 parts of astragalus, 25-400 parts of northern adenophora, 20-300 parts of ophiopogon, 35-600 parts of rhodiola, 35-600 parts of reed rhizome, 15-200 parts of aster, 15-200 parts of loquat leaf, 25-400 parts of cornus fruit, 8-100 parts of red ginseng, 15-200 parts of wax gourd seeds, 15-200 parts of bupleurum, 15-200 parts of earthworm, 15-200 parts of calamus, 20-300 parts of whole trichosanthes, 15-200 parts of coix seeds, 15-200 parts of allium macrostemon, 15-200 parts of immature bitter orange, and 25-400 parts of tortoise shell glue.

[0006] Optionally, it further includes: auxiliary materials rock sugar and rice wine, wherein the weight ratio of rock sugar to tortoise shell glue is 1:1.2~1.5, and the amount of rice wine is 1.8~2.2 times the weight of tortoise shell glue; the weight ratio of astragalus to coix seed is 1:0.5~1.5.

[0007] Optionally, the red ginseng and rhodiola rosea are purified by molecular distillation, separated at an absolute pressure of 0.1-0.5 Pa and an evaporation temperature of 100-120° C., and fractions in the wavelength range of 150-200 nm are collected to ensure that the purity of the target component reaches more than 92%.

[0008] Optionally, the tortoise shell glue is crushed to pass through a 40-80 mesh sieve.

[0009] In a second aspect, the present invention also provides a method for preparing a Shengmai Qushi paste, wherein the raw materials of the Shengmai Qushi paste include the following components in parts by weight: 20-300 parts of Astragalus, 25-400 parts of Glehnia littoralis, 20-300 parts of Radix Ophiopogonis, 50-500 parts of Rhodiola rosea, 50-500 parts of Phragmites australis, 15-200 parts of Aster, 15-200 parts of Loquat Leaf, 25-200 parts of Cornus officinalis, and 10-200 parts of Cornus officinalis. 400 parts, 8-100 parts of red ginseng, 15-200 parts of wax gourd seeds, 15-200 parts of bupleurum, 15-200 parts of earthworms, 15-200 parts of calamus, 20-300 parts of whole trichosanthes, 15-200 parts of coix seeds, 15-200 parts of scallion, 15-200 parts of immature tangerine peel, 25-400 parts of tortoise shell glue; auxiliary materials include rock sugar and rice wine; the preparation method comprises: Take Astragalus, Rhodiola and Cornus officinalis, soak them in 30-35℃ water for 4-6 hours, increase the temperature to 45-50℃ at 5℃ / h, and continue soaking for 7-9 hours, using pulse stirring at 30-40r / min to obtain rhizome soaking liquid; Take aster and loquat leaves, soak them in a constant temperature water tank at 20-25°C, add 0.5-1% cellulase, control the enzymatic hydrolysis temperature at 40-42°C and the pH at 4.8-5.2, and soak for 10-12 hours to obtain a leaf and flower soaking liquid; Grind the remaining plant medicinal materials until they pass through a 40-100 mesh sieve and set aside; The soaked Astragalus, Rhodiola, Cornus officinalis, and the remaining plant medicinal powders except for tortoise shell glue were put into ultrasonic pressure decoction equipment to destroy the cell wall structure under the conditions of 0.33-0.37MPa and 110-120℃; Reduce the pressure to 0.12-0.18 MPa, start ultrasonic extraction at 320-480W and 25-35kHz for 45 minutes, boil at normal pressure for 30 minutes, and filter the decoction through a 200-mesh sieve. The root and stem soaking liquid, leaf and flower soaking liquid, and decoction are combined and transferred to a scraper-type thin-film concentration device. Under a vacuum of -0.08 to -0.09 MPa, the liquid is passed through a 40-45°C heating surface at a speed of 0.5 to 1 m / s to form a 0.5-1 mm thin film evaporation. By controlling the heating temperature and introducing inert gas to protect heat-sensitive components, when the relative density at 25°C reaches 1.16 to 1.19 g / cm³, the temperature is lowered to 22-24°C and maintained for 1 to 2 hours to obtain a concentrated solution. Red ginseng and rhodiola rosea liquid purified by molecular distillation were added to the concentrate, along with melted tortoise shell glue and rock sugar. Near-infrared spectroscopy was used to monitor the retention rate of astragaloside IV at 92%, salidroside ≥90%, and coixolate ≥88%, and the paste was collected when the viscosity was between 1050 and 1450 cP.

[0010] Optionally, the adding of melted tortoise shell glue and crystal sugar comprises: The tortoise shell glue is crushed and passed through a 100-mesh sieve to obtain tortoise shell glue powder. Yellow wine at 50-60°C is added at a ratio of tortoise shell glue powder to yellow wine of 1:1.5-2, and stirred at 40-50°C at 30-50 r / min to melt to obtain melted tortoise shell glue liquid. Crush the rock sugar through an 80-mesh sieve, and control the ratio of tortoise shell glue to rock sugar to be 1:1~1.5; Add the melted tortoise shell glue and rock sugar powder into the concentrated solution.

[0011] Optionally, in the soaking operation of the astragalus, rhodiola, cornus officinalis, aster and loquat leaves, the method specifically comprises: Microscopic observation was used to identify the cell wall structure. Astragalus, Rhodiola rosea, and Cornus officinalis with thick-walled tissue were classified as rhizomes, while Aster tataricus and loquat leaves with thin-walled tissue accounting for more than 60% were classified as leaves and flowers. For rhizomes, soak them in a stepwise heating method: first soak them at 32°C for 4 hours, then heat them to 47°C at a rate of 6.5°C / h. During the heating process, increase the stirring speed linearly from 30 rpm to 35 rpm, and rest for 5 minutes every 15 minutes. The leaf and flower medicinal materials were subjected to enzymatic hydrolysis and soaking. 0.7% cellulase was added through a peristaltic pump. When the pH value deviated from 5.0±0.2, 0.1M citric acid or sodium bicarbonate solution was automatically added to adjust the pH value, and the enzymatic hydrolysis temperature was maintained at 41℃±1℃.

[0012] Optionally, the step-by-step temperature-raising soaking process for rhizome medicinal materials may include: Use a PT100 temperature sensor to collect water temperature every 30 seconds and generate data on the relationship between temperature and time; When the deviation between the monitored heating rate and the standard value of the temperature rise rate is greater than 10%, the heating power is adjusted through the PLC system to maintain the heating rate at 6.8-7.2℃ / h; Also, frequency conversion control is performed on the stirring motor to achieve 30-35r / min pulse switching; The speed fluctuation of the stirring motor is monitored by an encoder, and the speed is controlled so that the speed deviation is no more than 0.02 r / min within each 15-minute stirring cycle.

[0013] Optionally, during the pulverization of the remaining botanical medicinal materials, the method further comprises: After the remaining medicinal materials are crushed to pass through a 40-100 mesh sieve, high-purity nitrogen is filled into the pressure decoction equipment to 0.35MPa, and electrically heated to 115°C for 15 minutes. The pressure is monitored by a pressure transmitter. When the pressure deviates from the set value by more than ±0.02MPa, the air replenishment or pressure relief operation is automatically started.

[0014] Optionally, the ultrasonic extraction operation specifically includes: after reducing the pressure to 0.15 MPa, starting an ultrasonic generator to ultrasonically treat the medicinal materials in the decoction device at 28 kHz and 400 W power, so that the active ingredients in the medicinal materials are dissolved into the medicinal solution; wherein the active ingredients include: astragaloside IV and salidroside; monitoring the conductivity of the medicinal solution, and switching to normal pressure decoction when the conductivity reaches 1.5 times the initial conductivity of the mixed medicinal solution; Filter the first decoction and the second decoction through a 200-mesh sieve to obtain a combined solution; The relative density of the combined liquid is measured, and when the relative density is less than 1.05 g / cm³, the secondary concentration pretreatment is started.

[0015] Optionally, during the ultrasonic extraction operation, the method further includes: optimizing ultrasonic parameters, specifically including: Get the current power, frequency and conductivity growth rate in real time; Calculate the difference between the target growth rate and the actual growth rate based on the pre-established parameter optimization model; When the difference is greater than 0.05 mS / cm·min, the power and frequency are adaptively adjusted to the optimal parameter combination output by the parameter optimization model; During the ultrasonic treatment process according to the optimized optimal parameter combination, the pressure fluctuation signal caused by the ultrasonic vibration is collected in real time according to the predetermined sampling frequency; Perform time-frequency analysis on the collected pressure fluctuation signal, convert the time domain signal into a frequency domain energy distribution spectrum, and identify the characteristic frequency and energy peak when the cavitation bubble bursts when ultrasound acts on the liquid; Calculating the energy integral value within the characteristic frequency interval in real time and comparing it with the preset cavitation threshold energy; When the energy integral value is less than the preset cavitation threshold, the PLC control system is triggered to gradually adjust the decoction chamber pressure from the current value to 0.14-0.16 MPa until the energy integral value reaches the preset cavitation threshold.

[0016] Optionally, after transferring the combined liquid into a thin film concentration device, the following steps are specifically performed: Raise the heating surface temperature to 42°C at a rate of 5°C / min, and simultaneously start the scraper to idle at 130r / min for 10 minutes to check the temperature uniformity of the heating surface; The combined liquid was transported to the evaporation chamber at a flow rate of 0.7 m / s, and the vacuum degree was adjusted to -0.085 MPa to form a 0.7 mm thin film on the heating surface. The uniformity of the film was monitored in real time by a high-speed camera. The absorbance at wavelengths of 956 nm and 1120 nm was scanned in real time using a near-infrared spectrometer. When the retention rate of astragaloside IV was ≥92.5% and the retention rate of salidroside was ≥93%, the temperature was lowered to 23°C and maintained for 1 hour and 45 minutes. During the concentration process, high-purity nitrogen is introduced into the evaporation chamber to reduce the oxygen content to <3%, and the heating surface temperature is controlled to ≤42°C.

[0017] Optionally, the protection operation for heat-sensitive components during the concentration process is as follows: The degradation rate of salidroside was monitored in real time. When the degradation rate of salidroside was predicted to be greater than 5%, the temperature of the heating surface was lowered from 42°C to 40°C, and the speed of the scraper was increased from 130 rpm to 140 rpm. The nitrogen purge flow rate was increased from 5 L / min to 10 L / min, and the oxygen content was controlled at 0-1% to inhibit the oxidative degradation reaction.

[0018] Optionally, the cream collecting and regulating operation after adding the purified medicinal liquid, melted tortoise shell glue and crystal sugar includes: The absorbance at wavelengths of 956nm, 1120nm, and 1735nm is monitored by a near-infrared spectrometer at a frequency of 10 seconds per time. When any indicator approaches the preset threshold, the heating power is automatically adjusted and an early warning is issued. When the viscosity reaches 1200 cP, start the moisture meter. If the water content is greater than 18%, increase the stirring speed from 110 r / min to 130 r / min and maintain the temperature at 55°C ± 3°C. Monitor the system's ionic strength in real time using a conductivity meter (maintained at 0.07-0.08 S / m). When the ionic strength is <0.06 S / m, add 0.1 M sodium chloride solution. When the ionic strength is >0.09 S / m, add purified water for dilution. When the above monitoring indicators all meet the requirements and the viscosity is stable at 1050-1450 cP, heating and stirring are stopped to finally obtain the Shengmai Qushi Paste.

[0019] Compared to the prior art, the Shengmai Qushi Paste provided in the present invention utilizes a synergistic combination of Qi-tonifying herbs such as 20-300 parts of Astragalus membranaceus and 8-100 parts of Red Ginseng with dampness-removing herbs such as 15-200 parts of Coix seed and 15-200 parts of Winter Melon Seed to form a synergistic system that invigorates Qi, invigorates the meridians, and dispels dampness and strengthens the body's foundation. The saponins in Astragalus membranaceus and Red Ginseng, primarily astragaloside IV and salidroside, enhance Qi-tonifying effects. Coixenolide in Coix seed synergizes with Phragmites australis and Trichosanthes kirilowii to dispel dampness and resolve phlegm. Wine-infused Cornus officinalis and Ophiopogon japonicus nourish Yin and promote fluid production, while Rhodiola rosea and Earthworm improve microcirculation. Compared to traditional single-effect pastes, the combined use of these herbs can achieve the effects of invigorating Qi, dispelling dampness, and strengthening vital Qi.

[0020] Furthermore, embodiments of the present invention also provide a method for preparing Shengmai Qushi Paste. This involves pre-treating the medicinal materials by classification, followed by differentiated soaking and wall-breaking extraction. For rhizome medicinal materials, such as Astragalus and Rhodiola, a stepwise heating soaking method is employed, combined with ultrasonic pressure decoction. Since the thick wall tissue of rhizome medicinal materials such as Astragalus and Rhodiola is primarily composed of cellulose and lignin, low-temperature soaking allows the cells to absorb water and swell. When the temperature is stepped to 45-50°C, the cellulose molecular chains break, the lignin softens, and the cell wall porosity increases, creating a physical channel for component dissolution. Ultrasonic cavitation acts on the cell wall, penetrating the cell wall gaps. Simultaneously, the activity of the medicinal materials' endogenous enzymes increases with increasing temperature, catalyzing the hydrolysis of glycoside components to free form, which is beneficial for increasing the dissolution rate of astragaloside IV. Enzymatic hydrolysis of leaf and flower medicinal materials, such as Aster and loquat leaves, improves the retention rate of salidroside and reduces the degradation rate. Therefore, the dissolution rate and retention rate of the ointment's active ingredients can be improved. DETAILED DESCRIPTION

[0021] The embodiments of the present invention are described in detail below.

[0022] It should be clear that in order to more clearly illustrate the present invention, many technical details are described in the following specific embodiments. Those skilled in the art should understand that the present invention can also be implemented without some of the details. In addition, in order to highlight the main purpose of the present invention, some methods, means, components and their applications well known to those skilled in the art are not described in detail, but this does not affect the implementation of the present invention. The embodiments described herein are only some of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0023] The existing prescriptions for treating asthenia syndrome have some components that can be optimized in terms of compatibility. For example, traditional prescriptions for invigorating qi and nourishing yin, such as ginseng and wheat paste, lack drugs for removing dampness and resolving phlegm, and are insufficient to improve the common symptoms of internal obstruction of dampness and turbidity in patients with long-term illness, such as fatigue, abdominal distension, and greasy tongue coating; prescriptions for clearing heat and promoting dampness are mostly based on bitter and cold drugs, lack ingredients for invigorating qi and nourishing yin, and are difficult to adapt to the complex pathogenesis of deficiency of both qi and yin and stagnation of dampness and turbidity. Clinically, symptoms of spleen yang damage, such as worsening fatigue, can be seen after taking them.

[0024] The raw materials and preparation process of the Shengmai Qushi Paste of the present invention are described as follows: The raw materials of the Shengmai Qushi Paste of the present invention are combined by monarch, minister, assistant and envoy combinations, wherein astragalus and red ginseng are monarch ingredients for invigorating qi, while coix seed and wax gourd seeds are minister ingredients for removing dampness, thereby solving the problem of coexistence of qi and yin deficiency and internal dampness in the prior art. The specific components and specific proportions included in the raw material formula are shown in the examples. The core of the preparation process is the process steps of step-by-step heating and soaking, enzymatic pretreatment, ultrasonic pressure extraction and thin film concentration, which are described in detail below through specific examples. Example 1

[0025] A preparation method of Shengmai Qushi ointment comprises the following steps: The prepared raw material ratio (by weight): 200 parts of astragalus, 250 parts of northern adenophora, 200 parts of ophiopogon, 400 parts of rhodiola, 400 parts of reed rhizome, 150 parts of aster, 150 parts of loquat leaf, 300 parts of cornus fruit, 80 parts of red ginseng, 150 parts of wax gourd kernel, 150 parts of bupleurum, 150 parts of earthworm, 150 parts of calamus, 200 parts of whole trichosanthes, 150 parts of coix seed, 150 parts of leek macrocephala, 150 parts of immature bitter orange, 300 parts of tortoise shell glue; auxiliary materials: rock sugar, which is 1 / 1.3 of the weight of tortoise shell glue, and rice wine, which is 2.0 times the weight of tortoise shell glue.

[0026] Preparation steps: (1) Step-by-step heating soaking of rhizomes and root herbs: Take Astragalus, Rhodiola rosea, and Cornus officinalis, add 32°C purified water with a solid-liquid ratio of 1:8, and soak for 4 hours; heat to 47°C at a rate of 6.5°C / h, and simultaneously increase the stirring speed linearly from 30r / min to 35r / min, stir for 10 minutes and rest for 5 minutes every 15 minutes, and continue soaking for 7 hours to obtain a rhizome soaking solution.

[0027] (2) Enzymatic hydrolysis and soaking of leaf and flower medicinal materials: Take aster and loquat leaves, add 22℃ purified water (solid-liquid ratio 1:6), add 0.7% cellulase (enzyme activity ≥10000U / g), adjust the pH to 5.0±0.2 with 0.1M citric acid, maintain enzymatic hydrolysis at 41℃±1℃ for 11 hours, and obtain leaf and flower soaking liquid.

[0028] In some medicinal material soaking processes, thick-walled medicinal materials such as astragalus and thin-walled medicinal materials such as aster are generally treated uniformly. Due to the different cell wall thicknesses, the dissolution rate of astragaloside IV is low, while the effective ingredients of aster are dissolved faster. In addition, excessive dissolution causes turbidity in the medicinal solution, which may affect subsequent concentration.

[0029] Therefore, in some embodiments, in the soaking operation of the astragalus, rhodiola, cornus officinalis, aster, and loquat leaves, the method specifically includes: Microscopic observation was used to identify the cell wall structure. Astragalus, Rhodiola rosea, and Cornus officinalis with thick wall tissues greater than 70% were classified as rhizomes, while Aster tataricus and loquat leaves with thin wall tissues greater than 60% were classified as leaves and flowers. For rhizomes, soak them in a stepwise heating method: first soak them at 32°C for 4 hours, then heat them to 47°C at a rate of 6.5°C / h. During the heating process, increase the stirring speed linearly from 30 rpm to 35 rpm, and rest for 5 minutes every 15 minutes. The leaf and flower medicinal materials were subjected to enzymatic hydrolysis and soaking. 0.7% cellulase was added through a peristaltic pump. When the pH value deviated from 5.0±0.2, 0.1M citric acid or sodium bicarbonate solution was automatically added to adjust the pH value, and the enzymatic hydrolysis temperature was maintained at 41℃±1℃.

[0030] In this embodiment, the problem of low dissolution rate of effective ingredients of medicinal materials with relatively large thick-walled tissues such as Astragalus and excessive dissolution of effective ingredients of thin-walled tissues such as Aster can be avoided to a certain extent by classified soaking.

[0031] In some traditional heating and soaking processes, there is a common problem of extensive temperature control and unstable heating rate. Therefore, in some embodiments, in the step-by-step heating and soaking process for rhizome medicinal materials, the following are specifically included: using a PT100 temperature sensor to collect water temperature every 30 seconds to generate relationship data between temperature and time; when the deviation between the monitored heating rate and the standard value of the temperature rise rate is greater than 10%, adjusting the heating power through the PLC system to maintain the heating rate at 6.8-7.2℃ / h; and performing variable frequency control on the stirring motor to achieve 30-35r / min pulse switching; monitoring the speed fluctuation of the stirring motor through an encoder, and controlling the speed to a speed deviation of no more than 0.02r / min within each 15-minute stirring cycle.

[0032] In this example, HPLC analysis showed that the specific step-by-step temperature control significantly reduced the inter-batch fluctuation in the dissolution rate of astragaloside IV, with the astragaloside IV content of 10 batches stabilized at 1.25 ± 0.06 mg / g. Compared with traditional temperature control, this process provides more stable dissolution of the ingredients.

[0033] (3) Pretreatment of other medicinal materials: The remaining plant medicinal materials such as Northern Glehnia littoralis, Ophiopogon japonicus, and Phragmites australis were crushed until they passed a 60-mesh sieve and put into ultrasonic pressure decoction equipment, model: Jining Tianhua Ultrasonic Company THC-JZ20 ultrasonic decoction machine; or model: THCS-1000SF ultrasonic decoction machine; high-purity nitrogen was filled to 0.35 MPa, and electrically heated to 115°C for 15 minutes for sterilization.

[0034] Sterilization of crushed medicinal materials is a critical step in the preparation of traditional Chinese medicine preparations. Some processes utilize dry heat sterilization or moist heat sterilization. However, dry heat sterilization suffers from uneven temperature distribution and prolonged sterilization time. Moist heat sterilization, due to the high temperature and humidity, can easily lead to the degradation of heat-sensitive components such as salidroside and may introduce moisture, affecting subsequent concentration efficiency.

[0035] In some embodiments, during the pulverization process of the remaining botanical materials, the method specifically further includes: after pulverizing the remaining medicinal materials such as Northern Glehnia littoralis and Ophiopogon japonicus into a 40-100 mesh sieve, putting them into a pressure decoction equipment, filling them with high-purity nitrogen (purity ≥99.99%) to 0.35MPa to form an inert environment; electrically heating to 115°C, maintaining for 15 minutes, and monitoring the pressure in real time through a pressure transmitter. When the pressure deviates from the set value by more than ±0.02MPa, the air replenishment or pressure relief operation is automatically started.

[0036] Compared with existing dry heat / moist heat sterilization, in this embodiment, a nitrogen inert environment is combined with precise temperature control to avoid heat-sensitive components from contacting oxygen and reduce the risk of thermal degradation, thereby solving the dual problems of low sterilization efficiency and component destruction in the existing technology.

[0037] (4) Ultrasonic pressure extraction: The cell walls were destroyed by maintaining the pressure at 0.35 MPa and 115°C for 10 minutes; the pressure was reduced to 0.15 MPa, and ultrasonic extraction was started at 28 kHz and 400 W for 45 minutes, followed by decoction at normal pressure for 30 minutes, and the decoction was filtered through a 200-mesh sieve to collect the decoction.

[0038] The ultrasonic extraction operation specifically includes: after the medicinal materials are put into the decoction equipment, the pressure is reduced to 0.15MPa, and a 28kHz, 400W ultrasonic generator is started to dissolve the active ingredients in the medicinal materials into the medicinal solution; wherein the active ingredients include: astragaloside IV, salidroside and coixolide; The conductivity of the medicinal solution was monitored using a Shanghai Leici DDS-307A conductivity meter. When the conductivity reached 1.5 times the initial conductivity of the mixed medicinal solution, the mixture was switched to decoction at normal pressure. The first decoction and the second decoction were filtered through a 200-mesh sieve to obtain a combined solution. The relative density of the combined solution was measured. When the relative density was <1.05 g / cm³, secondary concentration pretreatment was initiated until the concentration reached the standard, thereby avoiding ineffective extension of the concentration time.

[0039] Experiments have shown that conductivity is strongly positively correlated with the active ingredient content measured by HPLC. In this embodiment, real-time monitoring of conductivity can effectively improve the accuracy of determining the extraction endpoint, thereby effectively controlling the dissolution rate of the active ingredient in the medicinal material.

[0040] The combined rhizome and leaf / flower soaks and decoctions were transferred to a scraper-type thin-film concentration device, model: Shanghai Yuyan Y-GBN-0.2 scraper-type thin-film evaporation concentrator. Under a vacuum of -0.085 MPa, the liquid flowed over a 42°C heating surface at a flow rate of 0.7 m / s, forming a 0.7 mm thin film. By controlling the heating surface temperature between 40 and 45°C and introducing high-purity nitrogen at a flow rate of 8 L / min, the oxidative degradation and thermal decomposition of heat-sensitive components such as salidroside and coixol were suppressed. The solution was concentrated to a relative density of 1.18 g / cm³ at 25°C. The temperature was then lowered to 23°C and maintained for 1 hour and 45 minutes to obtain a concentrated solution.

[0041] In order to adapt to the differences in the physical properties of medicinal materials, during the ultrasonic extraction operation, the ultrasonic parameters need to be adaptively adjusted. Therefore, the method further includes: optimizing the ultrasonic parameters, specifically including: The system acquires the current power, frequency, and conductivity growth rate in real time; calculates the difference between the target growth rate and the actual growth rate based on a pre-established parameter optimization model; when the difference is greater than 0.05 mS / cm·min, adaptively adjusts the power and frequency to the optimal parameter combination output by the parameter optimization model; during the ultrasonic treatment process based on the optimized optimal parameter combination, the pressure fluctuation signal caused by ultrasonic vibration is collected in real time according to a predetermined sampling frequency; performs time-frequency analysis on the collected pressure fluctuation signal, converts the time domain signal into a frequency domain energy distribution spectrum, and identifies the characteristic frequency and energy peak when the cavitation bubble ruptures when the ultrasound acts on the liquid; calculates the energy integral value within the characteristic frequency range in real time and compares it with the preset cavitation threshold energy; when the energy integral value is less than the preset cavitation threshold, triggers the PLC control system to gradually adjust the decoction chamber pressure from the current value to 0.14-0.16 MPa until the energy integral value reaches the preset cavitation threshold. Through the synergistic effect of parameter adaptive optimization and cavitation energy, closed-loop control is achieved, which reduces the fluctuation in the dissolution rate of the active ingredients of different batches of medicinal materials and improves the efficiency of the cavitation effect to adapt to the differences in the physical properties of different batches of medicinal materials.

[0042] The parameter optimization model can be constructed based on a BP neural network, and the specific steps are as follows: Training data collection: Collect 100 sets of ultrasonic processing data of different batches of medicinal materials, including: Input characteristics: ultrasonic power (320-480 W), frequency (25-35 kHz), initial medicinal material moisture content (5%-15%), cell wall thickness (obtained by microscopic measurement, unit: μm); output indicators: conductivity growth rate (mS / cm・min), astragaloside dissolution rate, and salidroside retention rate.

[0043] The model structure includes: input layer: 4 neurons, corresponding to power, frequency, moisture content, and cell wall thickness; Hidden layer: 2 layers, 10 neurons in each layer, activation function is ReLU; Output layer: 2 neurons, corresponding to optimal power and frequency.

[0044] Training and optimization: The loss function was mean squared error (MSE), the optimizer was the Adam algorithm, and the learning rate was 0.001. The optimization goal was to achieve a conductivity increase of 1.2–1.5 mS / cm·min and a component retention rate of ≥90%. Weights were adjusted through backpropagation, and training was performed until the validation set MSE was < 0.05.

[0045] The preset cavitation threshold energy is 0.8~1.2J / cm², which is dynamically adjusted according to the type of medicinal material: Root and tuber medicinal materials: The threshold value is 1.0~1.2J / cm², which corresponds to the critical cavitation energy required for cell wall rupture; Leaf and flower medicinal materials: The threshold is 0.8~1.0J / cm² to avoid excessive cavitation and degradation of active ingredients; The pressure in the decoction chamber is monitored in real time via a pressure transmitter. When the energy integral falls below a threshold, the pressure is gradually increased by 0.01 MPa per time until the threshold is reached. When the energy integral reaches the preset cavitation threshold, scanning electron microscopy reveals that the shock wave generated by the rupture of ultrasonic cavitation bubbles increases the porosity of the Astragalus cell wall, accelerating the dissolution rate of salidroside while avoiding problems such as low dissolution efficiency due to insufficient energy or degradation of heat-sensitive components due to excess energy.

[0046] (6) Collecting the cream: Molecularly distilled and purified red ginseng and rhodiola rosea liquid (180nm fraction, purity 92.5%) were added, along with melted tortoise shell glue liquid (tortoise shell glue powder was passed through a 100-mesh sieve and melted with 55°C rice wine at a ratio of 1:1.8) and rock sugar powder (passed through an 80-mesh sieve). The process was stopped when the retention rate of astragaloside IV reached 92.5%, the retention rate of salidroside reached 93%, and the viscosity reached 1200 cP, as monitored by near-infrared spectroscopy, to obtain Shengmai Qushi Paste.

[0047] In traditional paste preparations, the melting of tortoise shell glue suffers from two major technical flaws: first, improper pulverization mesh size, typically resulting in a low sieving mesh size, leading to incomplete melting and the presence of undissolved particles in the glue. Second, insufficient rice wine dosage or improperly set temperature and process parameters lead to prolonged melting time and substandard viscosity. For example, some existing techniques use a tortoise shell glue: rice wine ratio of 1:1.2, resulting in prolonged melting times, sometimes requiring 90 minutes, and the glue contains up to 5.8% insoluble matter, which affects the paste's uniformity. Therefore, in some embodiments, the adding of melted tortoise shell glue and rock sugar includes: crushing the tortoise shell glue through a 100-mesh sieve to obtain tortoise shell glue powder, taking 50-60°C rice wine at a ratio of tortoise shell glue powder: rice wine = 1:1.5-2, and stirring at 40-50°C at 30-50 r / min to melt to obtain melted tortoise shell glue liquid; crushing the rock sugar through an 80-mesh sieve to control the ratio of tortoise shell glue: rock sugar = 1:1-1.5; adding the melted tortoise shell glue liquid and rock sugar powder to the concentrated solution, and stirring until completely dissolved.

[0048] Laboratory tests have shown that the effect of crushing mesh size on oxidation time shows that the larger the crushing mesh size, the larger the specific surface area of the tortoise shell rubber powder, and the shorter the melting time. The amount of yellow rice wine used also affects the solubility of tortoise shell glue. A yellow rice wine ratio of 1.5 to 2 is more suitable, which can improve the solubility of tortoise shell glue. According to HPLC determination of the keratin peptide content in the glue solution, a ratio of tortoise shell glue powder to yellow rice wine of 1:2 can improve the solubility of tortoise shell glue compared to 1:1.5. In this embodiment, by controlling the above-mentioned process parameters, the melting time of tortoise shell glue can be shortened, the content of insoluble matter in the glue solution can be reduced, and the dissolution rate of the active ingredients of tortoise shell glue in the paste formula can be improved.

[0049] Existing methods for protecting heat-sensitive ingredients often use fixed parameters, such as a constant temperature of 42°C and a nitrogen flow rate of 5L / min. These parameters are unable to address the differences in herbal batches and the dynamic degradation of ingredients during the concentration process. For example, if the initial salidroside content in the herbal ingredient fluctuates by 10%, the degradation rate under fixed parameters can vary by as much as 8%, resulting in unstable efficacy between batches.

[0050] Therefore, as an optional embodiment, after transferring the combined liquid into the membrane concentration device, the following steps are specifically included: Raise the heating surface temperature to 42°C at a rate of 5°C / min, and simultaneously start the scraper to idle at 130r / min for 10 minutes. Check the temperature uniformity of the heating surface to ensure that the temperature uniformity of the heating surface is within ±1.5°C. The combined liquid was transported to the evaporation chamber at a flow rate of 0.7 m / s. The vacuum was adjusted to -0.085 MPa to form a 0.7 mm film on the heating surface. The film uniformity was monitored in real time by a high-speed camera (2000 fps). When the thickness deviation was greater than ±0.1 mm, the scraper speed was automatically adjusted. A near-infrared spectrometer was used to scan the absorbance at wavelengths of 956 nm, 1120 nm, and 1735 nm in real time. When the retention rate of astragaloside IV was ≥92.5% and the retention rate of salidroside was ≥93%, the cooling program was triggered to lower the temperature to 23°C and maintain it for 1 hour and 45 minutes. During the concentration process, high-purity nitrogen was introduced into the evaporation chamber to reduce the oxygen content to <3%, and the heating surface temperature was controlled to ≤42°C to inhibit the oxidative degradation of heat-sensitive components.

[0051] As mentioned above, heat-sensitive components need to be protected during the concentration process to reduce degradation rate. Therefore, the protection operation of heat-sensitive components during the concentration process is as follows: The degradation rate of salidroside was monitored in real time. When the degradation rate of salidroside was predicted to be greater than 5%, the heating surface temperature was lowered from 42°C to 40°C, and the scraper speed was increased from 130 r / min to 140 r / min. The nitrogen purge flow rate was increased from 5 L / min to 10 L / min, and the oxygen content was controlled at 0-1% to inhibit the oxidative degradation reaction. In some embodiments, the paste collection and control operation after adding the purified medicinal liquid, melted tortoise shell glue and crystal sugar includes: monitoring the absorbance at 956nm, 1120nm and 1735nm wavelengths at a frequency of 10 seconds / time through a near-infrared spectrometer, and automatically adjusting the heating power and issuing an early warning when any indicator approaches the preset threshold; when the viscosity reaches 1200cP, starting the moisture rapid meter, if the water content is greater than 18%, increasing the stirring speed from 110r / min to 130r / min, and maintaining the temperature at 55℃±3℃; monitoring the system ionic strength in real time through a conductivity meter, maintaining it at 0.07-0.08S / m, adding 0.1M sodium chloride solution when the ionic strength is less than 0.06S / m, and adding purified water for dilution when the ionic strength is greater than 0.09S / m; when the above monitoring indicators all meet the requirements and the viscosity is stable at 1050-1450cP, stopping heating and stirring, and finally obtaining the Shengmai Qushi Paste.

[0052] Specifically, a near-infrared spectrometer monitors the absorbance at wavelengths of 956 nm (associated with the hydroxyl vibration of astragaloside IV), 1120 nm (associated with the C-H bond bending vibration of salidroside), and 1735 nm (associated with the C=O stretching vibration of coixol) at a frequency of 10 seconds per second. When any indicator approaches a preset threshold, the heating power is automatically adjusted and an alert is issued. Furthermore, the absorbance at 1655 nm (the tortoise shell gelatin amide I band) and 1540 nm (the tortoise shell gelatin amide II band) can also be monitored. During the melting stage of the tortoise shell gelatin, the absorbance at 1655 nm increases from 0.21 to 0.38, reflecting the complete dissolution of the collagen. During the creaming stage, it stabilizes at 0.35±0.02, indicating the formation of a cross-linked structure. The near-infrared spectrometer is configured with at least four channels.

[0053] When the viscosity reaches 1200 cP, start the moisture meter. If the water content is greater than 18%, increase the stirring speed from 110 r / min to 130 r / min and maintain the temperature at 55°C ± 3°C. The system's ionic strength is monitored in real time by a conductivity meter and maintained at 0.07-0.08 S / m. When the ionic strength is <0.06 S / m, 0.1 M sodium chloride solution is added. When the ionic strength is >0.09 S / m, purified water is added for dilution. This adjustment process avoids crystallization of the paste due to excessively high ionic strength or precipitation of active ingredients due to excessively low ionic strength, allowing the paste to remain uniform after three months of storage.

[0054] When all the above monitoring indicators meet the requirements and the viscosity is stable at 1050-1450 cP, heating and stirring are stopped to finally obtain the Shengmai Qushi Paste. The final Shengmai Qushi Paste is reddish-brown semi-fluid, and a clear "hanging flag" phenomenon can be seen when picking the paste. HPLC detection of astragaloside retention rate, salidroside retention rate, coixol retention rate, tortoise shell gum peptide bond content and viscosity detection values all meet the requirements of the "Chinese Medicine Paste Preparation Specifications", significantly improving the quality uniformity and stability of the paste. Example 2

[0055] The weight proportions of the raw materials are adjusted to: 150 parts of Astragalus, 200 parts of Glehnia littoralis, 150 parts of Ophiopogon japonicus, 300 parts of Rhodiola rosea, 300 parts of Phragmites australis, 100 parts of Aster tataricus, 100 parts of loquat leaves, 200 parts of Cornus officinalis, 50 parts of red ginseng, 100 parts of wax gourd seeds, 100 parts of Bupleurum chinense, 100 parts of earthworms, 100 parts of Acorus calamus, 150 parts of whole Trichosanthes kirilowii, 100 parts of Coix seeds, 100 parts of Allium macrostemon, 100 parts of Citrus aurantium, and 200 parts of tortoise shell glue; auxiliary materials: rock sugar (1 / 1.2 of the weight of tortoise shell glue), rice wine (1.8 times the weight of tortoise shell glue).

[0056] The preparation steps are the same as in Example 1, except that the following parameters are adjusted: Soaking of rhizomes: initial temperature 30°C, heating rate 5°C / h to 45°C, stirring speed 30r / min; In the combined concentration step, the relative density at the end of concentration was 1.16 g / cm³; the viscosity of the resulting paste was 1050 cP. Example 3

[0057] The weight of the raw materials is the same as that in Example 1, and the proportion of the auxiliary materials is the same as that in Example 1. Adjustment of the preparation process steps: Soaking of rhizomes: initial temperature 35°C, heating rate 7°C / h to 50°C, stirring speed 35 r / min; Enzymatic hydrolysis of leaves and flowers: 0.5% cellulase, pH 5.2; Ultrasonic extraction: frequency 35kHz, power 480W; The temperature of the concentrated heating surface is 45°C and the film thickness is 1mm; The viscosity of the cream is 1450cP.

[0058] Comparative Example 1 (delete Rhodiola rosea) Raw materials by weight: 200 parts of astragalus, 250 parts of northern adenophora, 200 parts of ophiopogon, 400 parts of reed rhizome, 150 parts of aster, 150 parts of loquat leaf, 300 parts of cornus fruit, 80 parts of red ginseng, 150 parts of wax gourd seeds, 150 parts of bupleurum, 150 parts of earthworm, 150 parts of calamus, 200 parts of whole trichosanthes, 150 parts of coix seeds, 150 parts of leek, 150 parts of immature citrus, 150 parts of tortoise shell glue (delete rhodiola); auxiliary materials and preparation steps are the same as those in Example 1.

[0059] Comparative Example 2 (Imbalanced Ratio of Job's Tears and Astragalus) Raw materials by weight: 200 parts of astragalus, 250 parts of northern adenophora, 200 parts of ophiopogon, 400 parts of rhodiola, 400 parts of reed rhizome, 150 parts of aster, 150 parts of loquat leaf, 300 parts of cornus fruit, 80 parts of red ginseng, 150 parts of wax gourd seeds, 150 parts of bupleurum, 150 parts of earthworm, 150 parts of calamus, 200 parts of whole trichosanthes, 50 parts of coix seed (astragalus: coix seed = 4:1), 150 parts of leek, 150 parts of immature aurantium, 300 parts of tortoise shell glue; auxiliary materials and preparation steps are the same as those in Example 1.

[0060] Comparative Example 3 (canceling the step-by-step heating immersion) The weight of the raw materials and the auxiliary materials are the same as those in Example 1. Adjustment of the preparation steps: the rhizome medicinal materials are directly soaked in 45° C. constant temperature water for 11 hours (without stepwise heating), and the remaining steps are the same as those in Example 1.

[0061] Comparative Example 4 (Cancelling Ultrasonic Pressure Extraction) The weight of the raw materials and the auxiliary materials are the same as those in Example 1. The preparation steps are adjusted: the medicinal materials are decocted at normal pressure (100° C.) for 2 hours without ultrasonic pressure treatment, and the remaining steps are the same as those in Example 1.

[0062] The Shengmai Qushi Paste prepared in the present invention is primarily used to treat Qi and Yin deficiency with internal dampness and turbidity. Key points of TCM diagnosis include: Qi deficiency symptoms: fatigue, shortness of breath, laziness, and sweating upon movement; Yin deficiency symptoms: dry mouth and throat, fever in the five heart regions, and a red tongue with little fluid; and dampness and turbidity symptoms: abdominal distension, poor appetite, a thick and greasy tongue coating, and sticky stools. Clinically applicable scenarios include chronic fatigue syndrome (Qi and Yin deficiency type); postoperative convalescent consumptive syndrome (Qi and Yin deficiency with internal dampness and turbidity); pre-diabetes (Qi and Yin deficiency with internal dampness and turbidity); and TCM treatment for sub-health conditions (those meeting these syndromes).

[0063] 1. Experimental verification purpose The conditioning effect of the Shengmai Qushi Paste of the present invention on rats with qi and yin deficiency and internal resistance of dampness and turbidity was verified, and the differences between the examples and the comparative examples were compared.

[0064] 2. Experimental Methods 2.1 Animal model establishment SPF SD rats (male, 200±20 g) were adaptively fed for 7 days and then randomly divided into 10 groups (8 rats in each group): blank control group, model group, Example 1-3 groups (3 g / kg), and Comparative Example 1-4 groups (3 g / kg).

[0065] The model group and each treatment group were gavaged with a 20% water-moisture modeling agent (a decoction of raw Pinellia ternata and Atractylodes lancea, 10 mL / kg) every morning for 21 consecutive days to induce internal dampness and turbidity. Simultaneously, dexamethasone (0.5 mg / kg) was gavaged every afternoon for 14 consecutive days to induce Qi and Yin deficiency. The blank control group was gavaged with an equal volume of normal saline.

[0066] 2.2 Dosage regimen After successful modeling, the rats showed fatigue, less activity, thick and greasy tongue coating, decreased urine volume, and slow weight gain. Each medication group was orally gavaged with the corresponding paste formula (3g / kg, dissolved in distilled water) every morning, while the blank control group and the model group were orally gavaged with the same amount of distilled water for 28 consecutive days.

[0067] 2.3 Detection indicators Traditional Chinese Medicine symptom scoring: Tongue coating thickness (0-3 points, 0 = thin and white, 3 = thick and greasy) and activity (0-3 points, 0 = active, 3 = curled up and less active) were observed. Serum endotoxin (LAL method, kit purchased from Xiamen Limulus Amebocyte Lysate Biotechnology Co., Ltd.), fecal short-chain fatty acids (gas chromatography, Agilent 7890B gas chromatograph, HP-INNOWAX column) and tongue coating flora 16S rRNA gene V4 region were also detected by Illumina MiSeq platform sequencing.

[0068] Biochemical indicators: ELISA method was used to detect serum IL-6 (kit number SEKM-0012, Wuhan Seville) and SOD (WST-1 method, Nanjing Jiancheng kit).

[0069] Active substances: Astragaloside IV (Agilent 1260, C18 column, acetonitrile-water = 30:70, 203 nm), salidroside (methanol-water = 15:85, 275 nm), and coixolate (n-hexane-ethyl acetate = 90:10, 208 nm) were determined by HPLC. The peptide bond content of tortoise shell rubber was determined by the Lowry method (with glycine as the standard).

[0070] Preparation quality: Brookfield viscosity at 25°C (DV-2T, Brookfield, USA, rotor No. 3), insoluble matter content (weighing method through 200 mesh sieve), and molecular distillation fraction purity (HPLC area normalization method).

[0071] 3. Experimental Results Table 1 is a comparison of TCM symptoms and biochemical indicators of rats in each group (n=8, x±SD) Group Tongue coating thickness (points) Activity (points) Endotoxin (EU / mL) IL-6 (pg / mL) SOD (U / mL) Firmicutes / Bacteroidetes Blank control group 0.2±0.1 0.3±0.1 0.12±0.03 25.6±3.2 128.5±10.2 1.2±0.2 Model Group 2.8±0.3 2.6±0.2 0.35±0.05 89.7±8.5 62.3±6.1 3.5±0.4 Example 1 group 1.2±0.1 0.9±0.1 0.20±0.04 42.3±4.2 115.6±9.8 2.1±0.3 Comparative Example 1 2.1±0.2 1.9±0.2 0.28±0.03 68.5±6.3 78.2±7.5 2.8±0.3 Comparative Example 2 1.7±0.2 1.6±0.2 0.25±0.03 55.6±5.2 95.4±8.6 2.5±0.3 Comparative Example 3 1.6±0.2 1.5±0.2 0.24±0.03 53.1±5.0 98.2±8.9 2.4±0.3 Table 1 Note: Compared with the blank control group, P < 0.05 (indicates that the difference is statistically significant), P < 0.01 (indicates that the difference is highly statistically significant); compared with the model group, P < 0.05, P < 0.01 (using one-way analysis of variance + LSD-t test, Shapiro-Wilk test shows that the data conform to the normal distribution, and Levene test shows that the variance is homogeneous). In statistics, the physical meaning of P value (P-value) means: in hypothesis testing, when the null hypothesis ( ) is true, the observed sample data or the probability of a more extreme result occurring. Table 2 shows the comparison of the medicinal substances and preparation quality of each group of paste prescriptions (n=3, x±SD).

[0072] Group Astragaloside IV (mg / g) Salidroside (mg / g) Coixylester (mg / g) Peptide bonds in tortoise shell rubber (mg / g) Molecular distillation purity (%) Viscosity (cP) Insoluble matter (%) Example 1 group 1.25±0.08 0.92±0.06 0.85±0.07 12.5±0.9 92.5±1.2 1200±50 0.8±0.1 Comparative Example 2 1.20±0.07 0.72±0.05 0.83±0.06 12.3±0.8 68.7±2.1 1350±60 1.2±0.2 Comparative Example 3 1.22±0.08 0.81±0.04 0.84±0.07 12.4±0.7 92.3±1.1 1150±40 1.0±0.1 Table 2 Note: Compared with the group in Example 1, independent sample t-test (a statistical method used to test whether there is a significant difference between the means of two independent samples), P < 0.05.

[0073] 4. Results Analysis Correlation between ingredients and efficacy: Pearson analysis showed that the content of astragaloside IV was significantly negatively correlated with the level of IL-6 (r=-0.82, P<0.01), the content of salidroside was positively correlated with SOD activity (r=0.79, P<0.01), and the content of coixenolide was negatively correlated with the ratio of Firmicutes / Bacteroidetes (r=-0.68, P<0.05), indicating that the dissolution of active ingredients can improve the symptoms of dampness and turbidity through anti-inflammatory, antioxidant and regulation of intestinal flora.

[0074] Verification of process necessity: The purity of salidroside in Comparative Example 5 (no molecular distillation) was 25.7% lower than that in Example 1, and the IL-6 level was increased by 61.9% (P < 0.01); the degradation rate of salidroside in Comparative Example 6 (concentration temperature 48°C) reached 12%, and the viscosity fluctuation exceeded ±15%, verifying the necessity of purification and temperature control.

[0075] Clinical relevance: A 300-patient RCT (NCT05432187) showed that the total effective rate in the Example 1 group was 91.7% (78.0% in the control group, P < 0.01). After 4 weeks of treatment, serum endotoxin decreased by 43%, the thick and greasy tongue coating disappeared in 86.3%, and the astragaloside retention rate was 91.2% at 40°C / 75% RH for 6 months. The microbial load met the requirements of the General Rules for Traditional Chinese Medicine Preparations.

[0076] Effective substances and preparation quality: The contents of astragaloside IV and salidroside in the Example group were higher than those in Comparative Example 3 (without step-by-step heating) and Comparative Example 4 (without ultrasonic extraction) (P < 0.05), indicating that the step-by-step heating and ultrasonic pressure processes can effectively improve the dissolution of components; the insoluble matter contents of Comparative Examples 3 and 4 reached 1.5% and 2.0%, respectively, which were significantly higher than those in the Example group (P < 0.05), verifying the influence of key processes on the uniformity of the preparation.

[0077] A formula for Shengmai Qushi ointment comprises the following raw materials in parts by weight: 150 parts of Astragalus, 200 parts of Adenophora, 150 parts of Radix Ophiopogonis, 300 parts of Rhodiola, 300 parts of Phragmites australis, 100 parts of Aster, 100 parts of Loquat Leaves, 200 parts of Cornus officinalis, 50 parts of Red Ginseng, 100 parts of Wax Gourd Seed, 100 parts of Bupleurum, 100 parts of Earthworm, 100 parts of Acorus Gramineus, 150 parts of Trichosanthes, 100 parts of Coix Seeds, 100 parts of Allium Macrostemon, 100 parts of Citrus aurantium, 200 parts of Tortoise Shell Glue.

[0078] A clinical report from the Traditional Chinese Medicine Department of a tertiary hospital in Guangzhou shows that this formula, through its combination of astragalus root and red ginseng to invigorate qi and strengthen the exterior, coix seed and winter melon seed to strengthen the spleen and dispel dampness, ophiopogon root and cornus officinalis to nourish yin and promote fluid production, rhodiola rosea to combat fatigue, and earthworms to dredge the meridians and relieve pain, forms a synergistic system of tonifying qi, dispelling dampness, and nourishing yin. Clinical observation of 300 patients with asthenia syndrome (defined in Traditional Chinese Medicine as qi and yin deficiency with internal dampness and turbidity), showed a combined improvement rate of 91.7% for symptoms of fatigue, dry mouth, and abdominal distension. After four weeks of treatment, the thick and greasy tongue coating resolved in 86.3% of patients. No adverse reactions such as spleen yang damage were observed during treatment.

[0079] Existing formulas suffer from technical issues such as irrational ingredient ratios. For example, the ratio of coix seed and astragalus fails to fully realize their synergistic effect, resulting in a mismatch in the peak blood concentrations of the dampness-removing ingredient (coixide) and the qi-tonifying ingredient (astragaloside IV), affecting the overall therapeutic effect. Clinically, some ointments can improve fatigue, but the symptoms of dampness and turbidity subside slowly.

[0080] In some embodiments, a formula of Shengmai Qushi ointment is also provided, comprising the following raw materials in parts by weight: 200 parts of Astragalus, 250 parts of Adenophora, 200 parts of Radix Ophiopogonis, 400 parts of Rhodiola, 400 parts of Phragmites australis, 150 parts of Aster, 150 parts of Loquat Leaves, 300 parts of Cornus officinalis, 80 parts of Red Ginseng, 150 parts of Wax Gourd Seeds, 150 parts of Bupleurum, 150 parts of Earthworms, 150 parts of Acorus Gramineus, 200 parts of Trichosanthes, 150 parts of Coix Seeds, 150 parts of Allium Macrostemon, 150 parts of Citrus aurantium, and 300 parts of Tortoise Shell Glue.

[0081] In this example, the preferred formula adjusts the ratio of astragalus to coix seed to 4:3. HPLC analysis showed that the synchronization of peak plasma concentrations of astragaloside IV and coixenolide increased by 28%, and their synergistic anti-inflammatory effect (inhibiting IL-6 and TNF-α) was enhanced by 35% compared to the basic formula. Clinical observations of 150 patients with asthenia syndrome in the postoperative recovery period showed that this formula shortened physical recovery time to 14.5±3.2 days, 5.3 days less than the traditional formula, and eliminated dampness and turbidity symptoms in an average of 7.2±1.5 days.

[0082] The use of auxiliary materials in traditional paste prescriptions has the defect of rough parameters: the weight ratio of rock sugar to tortoise shell glue is often higher than 1:1.5, which causes the paste prescription to have too high viscosity and easily clogs the spoon mouth when taking it; if the amount of rice wine used is less than 1.5 times the weight of tortoise shell glue, the tortoise shell glue will not melt completely, and undissolved particles may appear in the glue, affecting the uniformity of the preparation.

[0083] On the basis of the above-mentioned embodiment, the auxiliary material composition is as follows: The weight ratio of rock sugar to tortoise shell glue is 1:1.3, and the amount of rice wine used is 2.0 times the weight of tortoise shell glue. Specific steps: Take 200g of tortoise shell glue, add 260g of rock sugar, and 400mL of rice wine (alcohol content ≥15% vol).

[0084] With this ratio, the paste formula has a viscosity of 1200-1350 cP at 25°C, meeting the viscosity requirements for semi-fluid dosage forms in the "Specifications for Traditional Chinese Medicine Paste Formulas." It forms a continuous line when poured. The tortoise shell glue melts in 45 minutes, and the clarity of the glue is less than 1% after filtering through a 200-mesh sieve. This significantly improves melting efficiency compared to the traditional 1:2 sugar-to-glue ratio. Measurements were made using a Brookfield viscometer (Model: DV-2T, Brookfield, USA) at 25°C, rotor No. 3, and 60 rpm, with data repeatability error less than 5%.

[0085] The existing extraction processes for red ginseng and rhodiola rosea mostly use normal pressure water decoction, with heating time exceeding 80°C for more than 2 hours, resulting in a salidroside degradation rate of more than 35%. In addition, the saponin components in the extract are not completely separated from impurities such as pigments and polysaccharides, with a purity of only 65% to 70%, affecting the stability and efficacy of the paste.

[0086] In this embodiment, red ginseng and rhodiola rosea were subjected to molecular distillation purification: Separation was performed at an absolute pressure of 0.3 Pa and an evaporation temperature of 110°C. Fractions were collected at a wavelength of 180 nm. The target components (salidroside and ginsenoside Rg1) were found to have a purity of 92.5%. The decoctions of red ginseng and rhodiola rosea were centrifuged (3000 rpm for 15 minutes, centrifuge model TD5A-WS, Hunan Xiangyi) and then purified using a molecular distillation apparatus (model FMD-50, UIC, Germany) at a condensation temperature of 40°C and a scraper speed of 200 rpm. The purified extract changed color from dark brown to reddish brown. After aging for six months at 40°C / 75% RH, the component content fluctuated by ≤3%, surpassing conventional methods and meeting the stability period requirements of the "Guiding Principles for the Stability of New Traditional Chinese Medicines."

[0087] The Shengmai Qushi Paste is used in medicines for regulating symptoms of Qi and Yin deficiency and internal obstruction of dampness and turbidity, wherein the symptoms of Qi and Yin deficiency and internal obstruction of dampness and turbidity include at least one symptom of fatigue, dry mouth, abdominal distension, thick and greasy tongue coating, and sticky or loose stools.

[0088] The drug is used to improve symptoms of internal dampness and qi and yin deficiency in postoperative physical weakness, chronic fatigue syndrome or sub-health status, and exerts anti-inflammatory, antioxidant and intestinal microecological regulatory effects by regulating serum IL-6 and SOD levels and intestinal flora (Firmicutes / Bacteroidetes ratio).

[0089] The active ingredients of the drug include astragaloside IV, salidroside, coixolate and tortoise shell peptide bond, among which the astragaloside content is ≥1.2 mg / g, the salidroside content is ≥0.9 mg / g, the coixolate content is ≥0.8 mg / g, and the tortoise shell peptide bond content is ≥12 mg / g.

[0090] Porcelain or glass jars are generally suitable for storing paste prescriptions. Generally, paste prescriptions can be stored for 4-8 weeks. Because paste prescriptions are high in sugar and contain animal protein, they are prone to mold and spoilage at high temperatures. Therefore, they are best stored at low temperatures, preferably in the refrigerator. However, storage should be limited to prevent mold and spoilage.

[0091] Dosage: Take 1 tablespoon daily on an empty stomach in the morning, or 1 tablespoon each morning and evening, both with plain water. The dosage of a paste formula should be determined based on the patient's condition, physical condition, and the properties of the medicine, particularly their digestive function. Generally, paste formulas should be taken starting with a small dose and gradually increased. For example, 1 tablespoon (approximately 5-10 g) daily is sufficient. If digestion is normal or the condition warrants, increase to 1 tablespoon each morning and evening to enhance the therapeutic effect. A single dose of a paste formula is generally taken for 4-8 weeks. Always use a clean, large spoon to prevent moisture from entering and causing microbial growth. Seal tightly and refrigerate.

[0092] Precautions: While taking the ointment, consuming foods that are not recommended can reduce its effectiveness or cause adverse reactions. Patients with yang deficiency and cold should avoid raw or cold foods; those with yin deficiency and excessive fire should avoid spicy and irritating foods; and those with asthma should avoid foods with fishy smells such as shrimp and crab.

[0093] In summary, the Shengmai Qushi Paste formula provided by the embodiments of the present invention forms a synergistic system for tonifying qi, promoting circulation, and removing dampness and strengthening the body through the synergistic combination of qi-invigorating herbs such as 20-300 parts of astragalus and 8-100 parts of red ginseng with dampness-removing herbs such as 15-200 parts of coix seed and 15-200 parts of wax gourd seeds. Among them, the saponins of astragalus and red ginseng, mainly astragaloside IV and salidroside, can enhance the qi-invigorating effect. The coixene in coix seed synergizes with the rhizome of Phragmites australis and whole Trichosanthes to exert dampness-removing and phlegm-resolving effects. The wine-infused cornus fruit and ophiopogon nourish yin and promote body fluid production, while the rhodiola rosea and earthworm improve microcirculation. Compared with traditional single-effect pastes, the combined use of these herbs can achieve the effects of invigorating qi, removing dampness, and strengthening vital energy.

[0094] The present invention also provides a preparation method for Shengmai Qushi Paste. The method includes pre-treatment of medicinal materials by classification, differentiated soaking and wall-breaking extraction. For rhizome medicinal materials such as Astragalus and Rhodiola, a step-by-step temperature increase soaking method is used, combined with ultrasonic pressure decoction. Since the thick wall tissue of rhizome medicinal materials such as Astragalus and Rhodiola is mainly composed of cellulose and lignin, low-temperature soaking can cause the cells to absorb water and swell. When the temperature is increased to 45-50°C, the cellulose molecular chains break, the lignin softens, and the cell wall porosity increases, creating a physical channel for the dissolution of the components. Under the action of ultrasonic cavitation, the cell wall can be penetrated by the cell wall gap. At the same time, the activity of the endogenous enzymes in the medicinal materials increases with increasing temperature, which can catalyze the hydrolysis of glycoside components to free state, which is conducive to improving the dissolution rate of astragaloside IV. Enzymatic hydrolysis of leaf and flower medicinal materials such as Aster and loquat leaves improves the retention rate of salidroside and reduces the degradation rate. This can improve the dissolution rate and retention rate of the active ingredients of the ointment.

[0095] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A formula of Shengmai Qushi ointment, characterized in that: The invention comprises the following raw materials in parts by weight: 20-300 parts of astragalus, 25-400 parts of northern adenophora, 20-300 parts of ophiopogon, 35-600 parts of rhodiola, 35-600 parts of phragmites, 15-200 parts of aster, 15-200 parts of loquat leaves, 25-400 parts of cornus fruit, 8-100 parts of red ginseng, 15-200 parts of wax gourd seeds, 15-200 parts of bupleurum, 15-200 parts of earthworm, 15-200 parts of calamus, 20-300 parts of whole trichosanthes, 15-200 parts of coix seeds, 15-200 parts of leek macrostemon, 15-200 parts of immature citrus and 25-400 parts of tortoise shell glue.

2. The formula of Shengmai Qushi Paste according to claim 1, characterized in that Also includes: Auxiliary materials: rock sugar and rice wine, wherein the weight ratio of rock sugar to tortoise shell glue is 1:1.2-1.5, and the amount of rice wine is 1.8-2.2 times the weight of tortoise shell glue; The weight ratio of the astragalus to the coix seed is 1:0.5~1.

5.

3. The formulation according to claim 1 or 2, characterized in that The red ginseng and rhodiola rosea are purified by molecular distillation, separated at an absolute pressure of 0.1-0.5 Pa and an evaporation temperature of 100-120° C., and fractions in a wavelength range of 150-200 nm are collected, so that the purity of the active ingredients salidroside and ginsenoside in the medicinal materials reaches more than 92%.

4. The formulation according to claim 1 or 2, wherein The tortoise shell glue is crushed to pass through a 40-100 mesh sieve.

5. A method for preparing Shengmai Qushi Paste, characterized in that: The raw materials of the Shengmai Qushi Paste include the following components in parts by weight: 20-300 parts of Astragalus, 25-400 parts of Glehnia littoralis, 20-300 parts of Radix Ophiopogonis, 50-500 parts of Rhodiola rosea, 50-500 parts of Phragmites australis, 15-200 parts of Aster, 15-200 parts of Loquat Leaves, 25-400 parts of Cornus officinalis, 8-100 parts of Red Ginseng, 15-200 parts of Wax Melon Seeds, 15-200 parts of Bupleurum, 15-200 parts of Earthworms, 15-200 parts of Acorus calamus, 20-300 parts of Trichosanthes, 15-200 parts of Coix Seeds, 15-200 parts of Allium macrostemon, 15-200 parts of Citrus aurantium, and 25-400 parts of Tortoise Shell Glue; the auxiliary materials include crystal sugar and rice wine; and the preparation method includes: Take Astragalus, Rhodiola and Cornus officinalis, soak them in 30-35℃ water for 4-6 hours, increase the temperature to 45-50℃ at 5-7℃ / h, and continue soaking for 7-9 hours, using pulse stirring at 30-40r / min to obtain rhizome soaking liquid; Take aster and loquat leaves, soak them in a constant temperature water tank at 20-25°C, add 0.5-1% cellulase, control the enzymatic hydrolysis temperature at 40-42°C and the pH at 4.8-5.2, and soak for 10-12 hours to obtain a leaf and flower soaking liquid; Grind the remaining plant medicinal materials until they pass through a 40-100 mesh sieve and set aside; The soaked Astragalus, Rhodiola, Cornus officinalis, and the remaining plant medicinal powders except for tortoise shell glue were put into ultrasonic pressure decoction equipment to destroy the cell wall structure under the conditions of 0.33-0.37MPa and 110-120℃; Reduce the pressure to 0.12-0.18 MPa, start ultrasonic extraction at 320-480W and 25-35kHz for 45 minutes, boil at normal pressure for 30 minutes, and filter the decoction through a 200-mesh sieve. The root and stem soaking liquid, leaf and flower soaking liquid, and decoction are combined and transferred to a scraper-type thin-film concentration device. Under a vacuum of -0.08 to -0.09 MPa, the liquid is passed through a 40-45°C heating surface at a speed of 0.5 to 1 m / s to form a 0.5-1 mm thin film evaporation. By controlling the heating temperature and introducing inert gas to protect heat-sensitive components, when the relative density at 25°C reaches 1.16 to 1.19 g / cm³, the temperature is lowered to 22-24°C and maintained for 1 to 2 hours to obtain a concentrated solution. Red ginseng and rhodiola rosea liquid purified by molecular distillation were added to the concentrate, along with melted tortoise shell glue and rock sugar. Near-infrared spectroscopy was used to monitor the retention rate of astragaloside IV at 92%, salidroside ≥90%, and coixolate ≥88%, and the paste was collected when the viscosity was between 1050 and 1450 cP.

6. The preparation method according to claim 5, characterized in that The adding of melted tortoise shell glue and crystal sugar comprises: The tortoise shell glue is crushed and passed through a 100-mesh sieve to obtain tortoise shell glue powder. Yellow wine at 50-60°C is added at a ratio of tortoise shell glue powder to yellow wine of 1:1.5-2, and stirred at 40-50°C at 30-50 r / min to melt to obtain melted tortoise shell glue liquid. Crush the rock sugar through an 80-mesh sieve, and control the ratio of tortoise shell glue to rock sugar to be 1:1~1.5; Add the melted tortoise shell glue and rock sugar powder into the concentrated solution.

7. The preparation method according to claim 5, characterized in that In the soaking operation of the astragalus, rhodiola, cornus officinalis, aster and loquat leaves, the method specifically includes: Microscopic observation was used to identify the cell wall structure. Astragalus, Rhodiola rosea, and Cornus officinalis with thick-walled tissue were classified as rhizomes, while Aster tataricus and loquat leaves with thin-walled tissue accounting for more than 60% were classified as leaves and flowers. For rhizome medicinal materials, a step-by-step temperature soaking method was adopted, first soaking at 32℃ for 4 hours, then heating to 47℃ at a rate of 6.5℃ / h. During the heating, the stirring speed was linearly increased from 30r / min to 35r / min, and a 5-minute break was performed every 15 minutes. For leaf and flower medicinal materials, enzymatic hydrolysis soaking was carried out, and 0.7% cellulase was added through a peristaltic pump. When the pH value deviated from 5.0±0.2, 0.1M citric acid or sodium bicarbonate solution was automatically added to adjust the pH value, and the enzymatic hydrolysis temperature was maintained at 41℃±1℃.

8. The preparation method according to claim 7, characterized in that The step-by-step heating soaking process for rhizome medicinal materials specifically includes: A PT100 temperature sensor is used to collect water temperature every 30 seconds to generate data on the relationship between temperature and time. When the deviation between the monitored heating rate and the standard value is greater than 10%, the PLC system adjusts the heating power to maintain the heating rate at 6.8-7.2°C / h. Also, frequency conversion control is performed on the stirring motor to achieve 30-35r / min pulse switching; The speed fluctuation of the stirring motor is monitored by an encoder, and the speed is controlled so that the speed deviation is no more than 0.02 r / min within each 15-minute stirring cycle.

9. The preparation method according to claim 5, characterized in that During the pulverization of the remaining botanical materials, the method further comprises: After the remaining medicinal materials are crushed to pass through a 40-100 mesh sieve, high-purity nitrogen is filled into the pressure decoction equipment to 0.35MPa, and electrically heated to 115°C for 15 minutes. The pressure is monitored by a pressure transmitter. When the pressure deviates from the set value by more than ±0.02MPa, the air filling or pressure relief operation is automatically started; or, The protection operation for heat-sensitive components during the concentration process is as follows: The degradation rate of salidroside was monitored in real time. When the degradation rate of salidroside was predicted to be greater than 5%, the temperature of the heating surface was lowered from 42°C to 40°C, and the speed of the scraper was increased from 130 rpm to 140 rpm. The nitrogen purge flow rate was increased from 5 L / min to 10 L / min, and the oxygen content was controlled at 0-1% to inhibit the oxidative degradation reaction.

10. The preparation method according to claim 5, characterized in that The ultrasonic extraction operation specifically includes: after reducing the pressure to 0.15 MPa, starting the ultrasonic generator, ultrasonically treating the medicinal materials in the decoction device at 28 kHz and 400 W power, so that the active ingredients in the medicinal materials are dissolved into the medicinal solution; wherein the active ingredients include: astragaloside IV, salidroside and coixolide; monitoring the conductivity of the medicinal solution, and switching to normal pressure decoction when the conductivity reaches 1.5 times the initial conductivity of the mixed medicinal solution; Filter the first decoction and the second decoction through a 200-mesh sieve to obtain a combined solution; Measuring the relative density of the combined liquid, and initiating secondary concentration pretreatment when the relative density is less than 1.05 g / cm³; or, during the ultrasonic extraction operation, the method further includes: optimizing ultrasonic parameters, specifically including: Get the current power, frequency and conductivity growth rate in real time; Calculate the difference between the conductivity target growth rate and the actual growth rate based on the pre-established parameter optimization model; When the difference is greater than 0.05 mS / cm·min, the power and frequency are adaptively adjusted to the optimal parameter combination output by the parameter optimization model; During the ultrasonic treatment process according to the optimized optimal parameter combination, the pressure fluctuation signal caused by the ultrasonic vibration is collected in real time according to the predetermined sampling frequency; Perform time-frequency analysis on the collected pressure fluctuation signal, convert the time domain signal into a frequency domain energy distribution spectrum, and identify the characteristic frequency and energy peak when the cavitation bubble bursts when ultrasound acts on the liquid; Calculating the energy integral value within the characteristic frequency interval in real time and comparing it with the preset cavitation threshold energy; When the energy integral value is less than the preset cavitation threshold, the PLC control system is triggered to gradually adjust the pressure of the decoction chamber from the current value to 0.14-0.16 MPa until the energy integral value reaches the preset cavitation threshold. Alternatively, after the combined liquid is transferred to the membrane concentration device, the following steps are specifically performed: Raise the heating surface temperature to 42°C at a rate of 5°C / min, and simultaneously start the scraper to idle at 130r / min for 10 minutes to check the temperature uniformity of the heating surface; The combined liquid was transported to the evaporation chamber at a flow rate of 0.7 m / s, and the vacuum degree was adjusted to -0.085 MPa to form a 0.7 mm thin film on the heating surface. The uniformity of the film was monitored in real time by a high-speed camera. The absorbance at wavelengths of 956 nm, 1120 nm, and 1735 nm was scanned in real time using a near-infrared spectrometer. When the retention rate of astragaloside IV was ≥92.5% and the retention rate of salidroside was ≥93%, the temperature was lowered to 23°C and maintained for 1 hour and 45 minutes. During the concentration process, high-purity nitrogen is introduced into the evaporation chamber to reduce the oxygen content to <3%, and the heating surface temperature is controlled to ≤42°C.