A Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, and its preparation method and application

Abstract

The present invention provides a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, which includes, in terms of raw materials, 1 to 5 parts by weight of yam; 1 to 5 parts by weight of polygonatum odoratum; 3 to 8 parts by weight of reed root; 1 to 5 parts by weight of mint; and 2 to 5 parts by weight of perilla. Compared with the prior art, the present invention has developed a Chinese medicine composition with the aroma of Chinese herbal medicine, a fresh and pleasant taste, and natural health, which has the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, based on a scientific formula, and the present invention highlights the characteristics of scientific formula, green herbs, natural health and zero addition, and its product preparation process has the advantages of simple and easy operation, low cost, and easy industrialization, and can provide a high-level product with guaranteed quality and safety for people who get angry (prone to get angry).

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, and a preparation method and application thereof. Background Art

[0002] With the continuous development of society, people's work and rest, diet, and life have become more and more irregular. As a result, "getting angry" has become a common phenomenon and has attracted public attention, seriously affecting people's physical and mental health. Modern medicine regards "getting angry" as "sub-health", believing that "getting angry" is inflammation and local infection when immune function decreases. According to traditional Chinese medicine theory, "getting angry" is caused by various reasons that cause the imbalance of qi, blood, yin and yang in the human body, including the invasion of the six evils, the seven emotions, improper diet, excessive work and rest, and innate endowment.

[0003] At present, the main treatment methods for "getting angry" are Western medicine intervention and Chinese medicine intervention. Western medicine intervention often treats from the perspective of anti-inflammatory and antibacterial treatment. Its treatment methods are relatively simple and have certain side effects. As a great treasure of the Chinese nation, Chinese medicine has the advantages and characteristics of overall regulation of treatment, and has outstanding advantages in regulating "pre-illness" and "sub-health". Therefore, combining the characteristics of my country's sub-healthy population and the characteristics of Chinese medicine, it is imperative to use Chinese medicine as the main means to improve the sub-healthy state of "getting angry". Summary of the invention

[0004] In view of this, the technical problem to be solved by the present invention is to provide a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, as well as a preparation method and application thereof.

[0005] The present invention provides a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, which comprises, in terms of raw materials:

[0006]

[0007] Preferably, the invention further comprises 6.6 to 40 parts by weight of concentrated sugarcane juice.

[0008] Preferably, the invention further comprises 6.6 to 13.4 parts by weight of concentrated sugarcane juice.

[0009] Preferably, the invention further comprises 20 to 40 parts by weight of concentrated sugarcane juice.

[0010] Preferably, based on the raw material, it includes:

[0011]

[0012] Preferably, 35 parts by weight of concentrated sugarcane juice is also included.

[0013] Preferably, the Chinese medicine composition has the effects of invigorating qi and nourishing yin, clearing away heat and purging fire by protecting the immune organs of the rat model of qi deficiency type internal heat, inhibiting inflammation, and regulating energy metabolism;

[0014] The Qi-deficiency type internal heat rat model was established according to the following method: rats were given free access to drinking water and adaptive feeding with standard feed, a Qi-deficiency model was established using a swimming exhaustion experiment, and the rats were given ginseng total extract by gavage once a day on time to obtain a Qi-deficiency type internal heat rat model.

[0015] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, comprising the following steps:

[0016] S1) soaking Chinese yam, polygonatum odoratum, reed root, mint and perilla in water, and then heating and boiling them with water as an extraction solvent to obtain a mixed extract;

[0017] S2) filtering the mixed extract to obtain a Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire.

[0018] Preferably, the soaking time is 30 to 90 minutes; the mass ratio of the total mass of the yam, polygonatum, reed root, mint and perilla to the extraction solvent is 1: (6 to 14); the number of heating and decocting is 1 to 3 times; and the time of each heating and decocting is 0.5 to 2 hours;

[0019] After heating and boiling, the mixture is concentrated under reduced pressure to 40% to 60% of the volume of the original mixed extract.

[0020] The present invention also provides a product with the functions of invigorating qi and nourishing yin, clearing away heat and purging fire, comprising the above-mentioned traditional Chinese medicine composition.

[0021] The present invention provides a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, which includes, in terms of raw materials, 1 to 5 parts by weight of yam; 1 to 5 parts by weight of polygonatum odoratum; 3 to 8 parts by weight of reed root; 1 to 5 parts by weight of mint; and 2 to 5 parts by weight of perilla. Compared with the prior art, the present invention has developed a Chinese medicine composition with the aroma of Chinese herbal medicine, a fresh and pleasant taste, and natural health, which has the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, based on a scientific formula, and the present invention highlights the characteristics of scientific formula, green herbs, natural health and zero addition, and its product preparation process has the advantages of simple and easy operation, low cost, and easy industrialization, and can provide a high-level product with guaranteed quality and safety for people who get angry (prone to get angry). BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A schematic diagram of the preparation process of the Chinese medicine composition provided by the present invention;

[0023] Figure 2A schematic diagram of the method for establishing a rat model of Qi deficiency type "heatiness" according to the present invention;

[0024] Figure 3 This is a diagram showing the changes in rectal temperature of rats caused by ginseng in the modeling example of the present invention;

[0025] Figure 4 This is a diagram showing changes in spleen index and thymus index of rats caused by ginseng in the modeling example of the present invention;

[0026] Figure 5 This is the interactive network diagram of biomarkers of "heatiness" caused by ginseng in the modeling example of the present invention;

[0027] Figure 6 The results of the effect of the Chinese medicine composition obtained in Examples 1 to 3 of the present invention on the spleen index and thymus index of rats are shown in the figure;

[0028] Figure 7 The results of the effect of the Chinese medicine composition obtained in Examples 1 to 3 of the present invention on the levels of TNF-α, IL-1β and IL-6 in rat serum are shown in the figure;

[0029] Figure 8 This is a graph showing the effect of the Chinese medicine composition obtained in Examples 1 to 3 of the present invention on the levels of LDH and ATPase in rat serum. DETAILED DESCRIPTION

[0030] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part 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.

[0031] The present invention provides a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, which comprises, in terms of raw materials:

[0032]

[0033]

[0034] According to the present invention, the content of the Chinese yam in the Chinese medicine composition is preferably 2 to 4 parts by weight, more preferably 2.5 to 3.5 parts by weight, and even more preferably 3 parts by weight. Chinese yam is the dried rhizome of the Dioscorea opposita Thunb. of the Dioscoreaceae family. It is sweet and flat in nature, enters the spleen, lung, and kidney meridians, can nourish the spleen and stomach, promote the production of body fluids and benefit the lungs, nourish the kidneys and astringe the essence, and the "Pharmaceutical Chemistry" says: Chinese yam, warm and nourishing but not sudden, slightly fragrant but not dry, has the function of regulating the lungs. In addition, its sweetness can nourish yang, so it can nourish the middle and replenish qi, warm and nourish muscles, and is an important medicine for the lungs and spleen. "Ben Cao Qiu Zhen" says: Chinese yam, originally a food, was used in decoctions by the ancients, saying that it nourishes the spleen, replenishes qi and removes heat. However, although the qi is warm, it is flat, which is to nourish the yin of the spleen and lungs, so it can moisten the skin and grow muscles, unlike the warm nature of Astragalus that can nourish the lung yang, and the bitter and dry white atractylodes that can nourish the spleen yang. The Classic of Materia Medica says: It can treat injuries, replenish deficiency, remove cold and heat evil spirits, replenish qi and strength, grow muscles, and make the ears and eyes smarter after long-term use. Modern pharmacological research shows that yam has pharmacological effects such as improving immune function, improving digestive function, lowering blood sugar, lowering blood lipids, anti-oxidation, delaying aging, anti-tumor, anti-mutation, promoting kidney regeneration and repair, and regulating acid-base balance.

[0035] According to the present invention, the content of Polygonatum odoratum in the Chinese medicine composition is preferably 1 to 4 parts by weight, more preferably 2 to 3 parts by weight, and more preferably 2 parts by weight. Polygonatum odoratum is the dry rhizome of Polygonatum odoratum (Mill.) Druce of the Liliaceae family. It is sweet and slightly cold in nature, belongs to the lung and stomach meridians, can nourish yin, moisten dryness, eliminate restlessness, and quench thirst. It is mainly used for yin damage in febrile diseases, cough and thirst, fever due to asthenia, etc. However, the medicine for nourishing yin is easy to hinder evil, but Polygonatum odoratum is sweet, flat and moisturizing, and it does not hinder evil although it nourishes. "Rihuazi Bencao" says: It eliminates boredom, quenches thirst, moisturizes the heart and lungs, replenishes five kinds of fatigue and seven kinds of injuries, deficiency, waist and leg pain, and natural heat madness. "Yaoxing Lun" says: It is mainly used for seasonal diseases, cold and heat, internal supplementation, removing asthenia and guest heat, and headache and restlessness. Modern pharmacological studies have shown that Polygonatum odoratum has the effects of lowering blood sugar, immunomodulation, anti-oxidation, anti-aging, and anti-tumor.

[0036] According to the present invention, the content of the reed root in the Chinese medicine composition is preferably 4 to 7 parts by weight, more preferably 4 to 6 parts by weight, and even more preferably 5 parts by weight. Reed root is the fresh or dried rhizome of Phragmites communis Trin., a grass plant. It is sweet and cold in nature, can clear away heat, promote the production of body fluid, relieve restlessness, and stop vomiting. It is used for fever and thirst, stomach heat and vomiting, lung heat and cough, and lung abscess and vomiting pus. "Ben Cao Jing Shu" says: Reed root, sweet and cold in taste and non-toxic. Sweetness can benefit the stomach and harmonize the middle, coldness can remove heat and reduce fire, heat can resolve the stomach and harmonize, then the body fluid will circulate and thirst will stop. Guest heat is pathogenic heat, and sweet and cold can remove pathogenic heat, then the guest heat will resolve itself. Modern pharmacological studies have shown that reed root has antioxidant, anti-tumor, lipid metabolism improvement, liver and kidney protection and other effects.

[0037] According to the present invention, the content of the mint in the Chinese medicine composition is preferably 2 to 4 parts by weight, more preferably 2.5 to 3.5 parts by weight, and more preferably 3 parts by weight. Mint is the dried aerial part of the mint plant Mentha haplocalyx Briq. of the Lamiaceae family, which is pungent and cool in nature, can dispel wind, dissipate heat, ward off filth, and detoxify. "Pharmaceutical Chemistry" says: Mint, pungent and dispersible, cool and clear in nature, can clear the meeting point of the six yangs, and remove the wind evil of various heats. It can reach the top of the head with Chuanxiong to guide the heat of stagnation. Take its fragrance and get the orifice, good at moving the muscle surface, use it to eliminate edema, disperse muscle heat, eliminate back pain, and lead the surface medicine into the Yingwei to slack the stagnant qi. "Medical Zhongzhong Canxi Lu" says: If it is used less, it is also good at reconciling internal injuries, treating liver qi and gallbladder fire stagnation and pain, and all diseases of wind, fire and heat stagnation can be cured. It is also suitable for patients with dysentery at the beginning with external infection. It can disperse the external pathogens and clear the heat in the intestines, so that the dysentery can be cured easily. Modern pharmacological research shows that mint has multiple pharmacological effects such as anti-inflammatory, antiviral, antioxidant, antibacterial, liver-protecting and gallbladder-promoting, and anti-tumor.

[0038] According to the present invention, the content of perilla in the Chinese medicine composition is preferably 2 to 4 parts by weight, more preferably 2 to 3 parts by weight, and even more preferably 2.5 parts by weight. Perilla is the tender leaves with branches of Perilla frutescens (L.) Britt. of the genus Perilla of the family Labiatae. It is pungent and warm in nature, can induce sweating and relieve the symptoms, and promote the flow of qi and relieve the middle. The prescription takes its effect of promoting the flow of qi and relieving the middle, and can relieve the symptoms of spleen and stomach qi stagnation, chest tightness, and nausea. Modern pharmacological studies have shown that perilla has a variety of pharmacological effects such as relieving cough and asthma, relieving fever, sedation, antibacterial, analgesia, anti-oxidation, anti-depression, lowering blood pressure, and regulating sugar and lipid metabolism.

[0039] According to the present invention, the Chinese medicine composition preferably further comprises 6.6 to 40 parts by weight of sugarcane concentrate, more preferably 6.6 to 13.4 parts by weight of sugarcane concentrate or 20 to 40 parts by weight of sugarcane concentrate, more preferably 10 to 12 parts by weight of sugarcane concentrate or 25 to 40 parts by weight of sugarcane concentrate, more preferably 11 to 12 parts by weight of sugarcane concentrate or 30 to 40 parts by weight of sugarcane concentrate, most preferably 11.6 to 11.7 parts by weight of sugarcane concentrate or 35 parts by weight of sugarcane concentrate. Sugarcane is the stalk of the grass plant sugarcane Sacharumsinense Roxb., which is sweet and flat in nature, can remove heat and quench thirst, harmonize the middle, widen the diaphragm, and promote water circulation. "Compendium of Materia Medica" says: Sugarcane is the fruit of the spleen, its juice is sweet and cold, and can purge fire and heat. "Da Ming" also says that it can eliminate phlegm and quench thirst, remove heart and chest heat, and detoxify alcohol. Nowadays, people use it to treat choking, nausea and vomiting, and constipation, all for its ability to remove heat, promote the production of body fluids, and moisten dryness. The "New Compendium of Materia Medica" says: It can harmonize the middle and clear away heat, soothe the liver and strengthen the spleen, promote the production of body fluids and quench thirst, treat vomiting, diarrhea, malaria, dysentery, and relieve sores and fire poisons. Modern pharmacological studies have shown that sugarcane has pharmacological effects such as antioxidant, liver protection, antibacterial, and anti-inflammatory.

[0040] According to the present invention, it is further preferred that the Chinese medicine composition, calculated as raw materials, comprises:

[0041]

[0042]

[0043] or include:

[0044]

[0045] According to the present invention, it is further preferred that the Chinese medicine composition, calculated as raw materials, comprises:

[0046]

[0047] According to the present invention, it is further preferred that the Chinese medicine composition, calculated as raw materials, comprises:

[0048]

[0049] The traditional Chinese medicine composition provided by the present invention plays the role of invigorating qi and nourishing yin, clearing away heat and purging fire by protecting immune organs, inhibiting inflammation and regulating energy metabolism.

[0050] The invention verifies that the traditional Chinese medicine composition has the effects of invigorating qi and nourishing yin, clearing away heat and purging fire through the protection of immune organs, the inhibition of inflammation and the regulation of energy metabolism in a rat model of qi deficiency type internal heat.

[0051] The Qi-deficiency type internal heat rat model is preferably established according to the following method: rats are allowed free access to drinking water and adaptively fed with standard feed, a Qi-deficiency model is established using a swimming exhaustion experiment, and rats are given ginseng total extract by gavage once a day on time to obtain a Qi-deficiency type internal heat rat model. The time for adaptive feeding of the standard feed is preferably 1 week; the total ginseng extract can be extracted according to a method well known to those skilled in the art, without special restrictions. In the present invention, it is preferably as follows: take an appropriate amount of ginseng slices, crush them appropriately, add 10 times the amount of water, soak for 30 minutes, heat and reflux for 1 hour, filter and collect the filtrate, add 8 times the amount of water to the residue and continue to reflux and extract twice, each time for 1 hour, combine the three filtrates, decompress and concentrate, and freeze-dry to obtain the total ginseng extract; the dose of the total ginseng extract for intragastric administration (in terms of crude drug amount) is preferably 0.45-1.8 g / kg, more preferably 0.6-1.2 g / kg, and more preferably 0.9 g / kg; the time for intragastric administration of the total ginseng extract is preferably 7-21 days, more preferably 10-16 days, and more preferably 14 days; the Qi-deficiency type internal heat rat model is confirmed to be successful by body characteristics, rectal temperature changes, organ index changes and metabolomics research.

[0052] Under the guidance of traditional Chinese medicine theory, the present invention combines Chinese yam, polygonatum, fresh reed root (or reed root), mint, perilla, and sugarcane (or concentrated sugarcane juice) to form a prescription. The Chinese yam is sweet and flat in nature, enters the spleen, lung, and kidney meridians, can nourish the spleen and stomach, promote the production of body fluid and benefit the lungs, nourish the kidneys and astringe the essence. The "Pharmaceuticals" says: Chinese yam is warm and nourishing without being sudden, slightly fragrant without being dry, and has the function of regulating the lungs. In addition, its sweetness can nourish yang, so it can nourish the middle and replenish qi, warm and nourish muscles, and is an important medicine for the lungs and spleen. The "Ben Jing" says: It is mainly used for injuring the middle, replenishing deficiency, removing cold and heat evil spirits, replenishing the middle and replenishing qi, growing muscles, and taking it for a long time can make the ears and eyes smart. In the prescription, it performs the functions of clearing and replenishing at the same time; polygonatum is sweet and slightly cold in nature, enters the lung and stomach meridians, can nourish yin, moisturize dryness, eliminate restlessness, and quench thirst. It is mainly used for yin injury in febrile diseases, cough and thirst, and fever due to asthenia. The medicine for nourishing yin is easy to hinder evil, but polygonatum is sweet and flat and moisturizing, and it can replenish but not hinder evil. Reed root clears away heat, promotes the production of body fluid, relieves restlessness, and stops vomiting. It is used for fever, thirst, stomach heat, vomiting, lung heat, cough, and lung abscess. "Ben Cao Jing Shu" says: Reed root is sweet, cold, and non-toxic. Sweetness can benefit the stomach and harmonize the middle, and coldness can remove heat and reduce fire. When heat is relieved and the stomach is in harmony, body fluids will circulate and thirst will stop. Guest heat is pathogenic heat. Sweetness and coldness can remove pathogenic heat, and guest heat will be relieved. Mint is pungent and cool. It can dissipate wind, dissipate heat, ward off filth, and detoxify. "Yao Yao Hua Yi" says: Mint is pungent and can disperse, cool and clear in nature, and can clear the meeting point of the six yangs and remove the wind evil of various heats. It can reach the top of the head with Chuanxiong to guide the stagnant heat. It is taken from its fragrant smell and has a good sense, and is good at moving on the surface of the muscles. It can be used to eliminate edema, disperse muscle heat, eliminate back pain, and lead the surface medicine into the Yingwei to relieve the stagnant qi. "Medical Records of Chinese and Western Medicine" says: If used in small amounts, it can also be good at harmonizing internal injuries, treating liver qi and gallbladder fire stagnation and pain, and all diseases caused by wind, fire and heat stagnation. It is also suitable for those with dysentery at the beginning with external infection. It can disperse the external evil and clear the heat in the intestines, so that the dysentery can be easily cured. Perilla can induce sweating and relieve the exterior, promote qi and relieve the middle. The prescription takes its role of promoting qi and relieving the middle, which can relieve the symptoms of spleen and stomach qi stagnation, chest tightness, and nausea. Sugarcane is sweet and flat. It can remove heat and quench thirst, harmonize the middle, relieve diaphragm, and promote water. "Compendium of Materia Medica" says: Sugarcane is the fruit of the spleen, and its juice is sweet and cold, which can purge fire and heat. "Da Ming" also says that it can eliminate phlegm and quench thirst, eliminate heart and chest irritability, and relieve alcohol poisoning. Nowadays, people use it to treat choking, nausea and vomiting, and dry stools, all of which are based on its functions of removing heat, promoting body fluid, and moistening dryness. The combination of various medicines can clear and nourish the body, harmonize the stomach, clear without cold, and nourish without stagnation, and play the role of nourishing qi and yin, clearing away heat and purging fire, and promoting body fluid and quenching thirst. In addition, based on the scientific formulation of the present invention, a product with the effects of nourishing qi and yin, clearing away heat and purging fire, which contains the fragrance of Chinese herbal medicine, has a fresh and pleasant taste, and is natural and healthy, has been developed. The formulation and application of the present invention highlight the characteristics of scientific formulation, green herbs, natural health and zero addition. The product preparation process has the advantages of simple and easy operation, low cost, and easy industrialization, and can provide a high-level product with guaranteed quality and safety for people who get angry (prone to get angry).

[0053] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, comprising the following steps: S1) soaking yam, polygonatum, reed root, mint and perilla in water, and then heating and decocting them with water as an extraction solvent to obtain a mixed extract; S2) filtering the mixed extract to obtain the Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire.

[0054] See also Figure 1 , Figure 1 The present invention provides a schematic flow chart of the method for preparing the Chinese medicine composition.

[0055] The present invention has no particular limitation on the sources of all raw materials, and any raw materials available on the market can be used.

[0056] Chinese yam, polygonatum, reed root, mint and perilla are soaked in water, and then heated and boiled with water as extraction solvent to obtain a mixed extract; in the present invention, Chinese yam, polygonatum, perilla and mint are dry raw materials, and reed root can be a dry raw material or a fresh reed root; the soaking time is preferably 30 to 90 minutes; the mass ratio of the total mass of the Chinese yam, polygonatum, reed root, mint and perilla to the extraction solvent is preferably 1: (6 to 14); the number of heating and boiling is preferably 1 to 3 times; the time of each heating and boiling is 0.5 to 2 hours; after heating and boiling, it is preferably filtered and then concentrated under reduced pressure; the reduced pressure concentration is preferably to 40% to 60% of the original mixed extract volume to obtain a mixed extract.

[0057] After filtering the mixed extract, a Chinese medicine composition with the effects of invigorating qi and nourishing yin, clearing away heat and purging fire is obtained; in the present invention, the mixed extract is preferably mixed with concentrated sugarcane juice before filtering; the filtering method is preferably a method well known to those skilled in the art, and there is no special limitation. The present invention preferably adopts ceramic membrane filtration treatment; the specification of the filter membrane used for the filtration is preferably 500nm.

[0058] The present invention also provides an application of the above-mentioned traditional Chinese medicine composition in preparing a health product having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire.

[0059] To further illustrate the present invention, the following describes in detail the Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, as well as the preparation method and application thereof, in combination with the embodiments.

[0060] The reagents used in the following examples are all commercially available.

[0061] Ginseng was purchased from Fusong, Jilin; acetonitrile and methanol were purchased from Fisher (chromatographic grade); formic acid was purchased from Tedia (chromatographic grade); physiological saline was purchased from Jilin Cornell Pharmaceutical Co., Ltd., and water was homemade deionized water; ACQUITY UPLC liquid chromatography system and SYNAPT G2 quadrupole-time-of-flight mass spectrometer (Waters, USA); Allegra X-30R desktop high-speed centrifuge (Beckman, USA); DZF-6020 vacuum drying oven (Shanghai Yarong Biochemical Instrument Factory, China), KDM temperature-controlled electric heating mantle (Zhencheng Hualu Electric Heating Instrument Co., Ltd., China); analytical balance (Sanorius BS110S and SQP, Beijing Sartorius Co., Ltd.); Milli-Q Plus water purification system (Millipore Corporation, USA); Chinese yam, polygonatum, reed root, mint, and perilla were purchased from Jilin Hongjian Pharmacy Co., Ltd., and sugarcane concentrated juice was purchased from Xi'an Green Peptide Biotechnology Co., Ltd.; TNF-α, IL-1β, and IL-6 kits were purchased from ELISA Biotechnology Co., Ltd.; LDH and ATP kits were purchased from Wuhan Youersheng Trading Co., Ltd.; physiological saline was purchased from Jilin Cornell Pharmaceutical Co., Ltd.; water was homemade deionized water; BONA-GM-22 ceramic membrane filtration test machine (Shandong Bona Biotechnology Group Co., Ltd., China); HYDJ20L decoction machine (Tianjin Huayanyuan Machinery Co., Ltd., China); Milli-Q Plus water purification system (Millipore Corporation, USA).

[0062] Modeling Example

[0063] 1.1 Exploratory study on the rat model of Qi deficiency type "heatiness"

[0064] In order to better study the effect of the present invention, the present invention conducted an exploratory study on a rat model of "getting angry" due to qi deficiency, wherein the total extract of ginseng (the specific preparation method is: take an appropriate amount of ginseng slices, crush them appropriately, add 10 times the amount of water, soak for 30 minutes, heat and reflux for 1 hour, filter and collect the filtrate, add 8 times the amount of water to the residue and continue to reflux and extract twice, each time for 1 hour, combine the three filtrates, decompress and concentrate, and freeze-dry to obtain the total extract of ginseng.) is used as a modeling drug, and the drug is continuously administered for 7, 14 and 21 days respectively to establish a rat model of "getting angry" due to qi deficiency, and the administration time and dosage of the total extract of ginseng to cause "getting angry" in rats with qi deficiency are evaluated. Figure 2 shown.

[0065] 1.2 Animal grouping and model design

[0066] Sprague-Dawley (SD) rats were purchased from Liaoning Changsheng Biotechnology Co., Ltd., license number SCXK (Liao) 2020-0001, male, weighing 200-220 g. After free drinking water and adaptive feeding of standard feed for 1 week, they were randomly divided into a normal group (NG), a Qi deficiency model group (QG), a 7-day Qi deficiency + low, medium, and high total extract administration group (WGQ1-1, 2, 3), a 14-day Qi deficiency + low, medium, and high total extract administration group (WGQ2-1, 2, 3), and a 21-day Qi deficiency + low, medium, and high total extract administration group (WGQ3-1, 2, 3). Except for the normal group, the rest of the rats were used to establish a Qi deficiency model using the swimming exhaustion test, and the rats were given ginseng total extract by gavage once a day on time (dosage see Table 1), and the administration was continued for 7, 14, and 21 days, respectively. The dosage of this experiment was calculated based on the raw drug amount: low dose 0.45g / kg, medium dose 0.9g / kg, high dose 1.8g / kg. The specific animal groups and dosages are shown in Table 1.

[0067] Table 1 Experimental groups and dosages

[0068]

[0069] 1.3 Animal model evaluation and mechanism investigation

[0070] (1) Physical characteristics of rats

[0071] In the experiment, through the observation of the physical signs and status of the rats, it was found that the NG group rats had moist fur, docile temperament, and moist stool; the QG group rats had dark fur, liked to gather together, were lethargic and sleepy, had slightly loose stools, and decreased appetite; the fur of the rats in the low-dose administration group recovered on days 7, 14, and 21, and the condition recovered, the stool was normal, the appetite improved, and they recovered health; the medium-dose and high-dose administration groups on days 7 had mild symptoms of internal heat; the medium-dose and high-dose administration groups on days 14 and 21 had dull fur, easy hair loss, dry stool, dark yellow urine, irritability, and obvious symptoms of internal heat, and the high-dose administration groups on days 14 and 21 had deaths. The results are shown in Table 2.

[0072] Table 2 Changes of physical signs in experimental rats

[0073]

[0074]

[0075] (2) Changes in rectal temperature of rats

[0076] The rectal temperature of rats in each group was measured every 7 days. The results are shown in Figure 3 The results showed that the rectal temperature of rats in the medium and high dose groups increased significantly after 14 days of treatment.

[0077] (3) Changes in organ index

[0078] After the experimental animals in each group were sacrificed, the spleen and thymus were collected and weighed respectively, and the spleen index and thymus index were calculated. The results are shown in Figure 4 The results showed that ginseng total extract at different concentrations and times had a certain effect on the immune function of rats, especially the thymus index, and showed a bidirectional regulatory effect with the dose.

[0079] (4) Metabolomics study on ginseng-induced heatiness in rats with qi deficiency

[0080] Through metabolomics research, we can obtain the interaction network diagram of relevant biomarkers, such as Figure 5 As shown. Figure 5 It can be seen that the mechanism by which ginseng induces "heat" in rats with qi deficiency is closely related to glycolysis, tricarboxylic acid cycle, ketone body synthesis and degradation, unsaturated fatty acid metabolism, tryptophan metabolism and bile acid metabolism pathways.

[0081] 1.4 Summary

[0082] In summary, the above studies show that medium and high doses of the drug for 14 and 21 days can cause rats to have "heaty" symptoms, and high doses of the drug for 14 and 21 days caused rats to die. Therefore, the dosage for establishing the rat "heaty" model is 0.9g / kg (in terms of raw drug amount) and the administration time is 14 days. In addition, through the study of the "heaty" mechanism, it was found that ginseng-induced "heaty" in rats with qi deficiency is mainly closely related to energy metabolism and inflammation.

[0083] Example 1

[0084] 1.1 Weigh 9 parts by weight of yam, 6 parts by weight of polygonatum, 15 parts by weight of reed root, 9 parts by weight of mint, and 7.5 parts by weight of perilla.

[0085] 1.2 The above Chinese medicine was soaked for 60 minutes, and the mixture was heated and decocted twice with 10 times the amount of water as the extraction solvent, each time for 1 hour, and the filtrate was concentrated under reduced pressure to 50% of the original extract volume to obtain mixed extract A.

[0086] 1.3 Weigh 35 parts by weight of concentrated sugarcane juice, add it to the mixed extract A, mix well, and obtain mixed solution B.

[0087] 1.4 Filter the mixed solution B through a 500 nm ceramic membrane to obtain a Chinese medicine composition.

[0088] Example 2

[0089] 2.1 Weigh 3 parts by weight of yam, 2 parts by weight of polygonatum, 5 parts by weight of reed root, 3 parts by weight of mint, and 2.5 parts by weight of perilla.

[0090] 2.2 The above Chinese medicine was soaked for 60 minutes, and the mixture was heated and decocted twice with 10 times the amount of water as the extraction solvent, each time for 1 hour, and the filtrate was concentrated under reduced pressure to 50% of the original extract volume to obtain mixed extract A.

[0091] 2.3 Filter the mixed solution A through a 500 nm ceramic membrane to obtain a Chinese medicine composition.

[0092] Example 3

[0093] 3.1 Weigh 3 parts by weight of yam, 2 parts by weight of polygonatum, 5 parts by weight of reed root, 3 parts by weight of mint, and 2.5 parts by weight of perilla.

[0094] 3.2 The above Chinese medicine was soaked for 60 minutes, and the mixture was heated and decocted twice with 10 times the amount of water as the extraction solvent, each time for 1 hour, and the filtrate was concentrated under reduced pressure to 50% of the original extract volume to obtain mixed extract A.

[0095] 3.3 Weigh 35 parts by weight of concentrated sugarcane juice, add it to the mixed extract A, mix well, and obtain mixed solution B.

[0096] 3.4 Filter the mixed solution B through a 500 nm ceramic membrane to obtain a Chinese medicine composition.

[0097] Evaluation of the efficacy of the samples in the embodiment on rats with "heatiness" caused by qi deficiency

[0098] Experimental methods

[0099] (1) Animal grouping and dosing regimen

[0100] Sprague-Dawley (SD) rats were purchased from Liaoning Changsheng Biotechnology Co., Ltd., license number SCXK (Liao) 2020-0001, male, weighing 200-220g. Free drinking water, adaptive feeding for 1 week, and then randomly divided into a control group, a model group, an embodiment 1 group, an embodiment 2 group, and an embodiment 3 group. Except for the control group, the remaining rats were modeled according to the exploratory research results of the above-mentioned Qi deficiency type "getting angry" rat model (0.9g / kg (in terms of crude drug amount), administration time was 14 days), and each administration group was given the corresponding embodiment sample after modeling. The specific method is: the embodiment sample is further concentrated to a relative density of 1.20-1.22 (measured at 50-55°C), and 1ml / rat is administered by gavage, and the test period is 30 days.

[0101] (2) Determination of organ index and serum inflammatory factors

[0102] After the experimental animals in each group were killed, the spleen and thymus were collected and weighed respectively, and the spleen index and thymus index were calculated according to the formula organ index = organ weight (mg) / rat body weight (g). Take appropriate amount of serum and measure the serum TNF-α, IL-1β, and IL-6 levels of rats in each group according to the instructions of the ELISA kit.

[0103] (3) Serum LDH and ATPase determination

[0104] Take an appropriate amount of serum and determine the levels of rat serum LDH and ATPase according to the instructions of the ELISA kit.

[0105] Experimental Results

[0106] (1) Effects of the samples in each example group on the organ indexes of rats with "heatiness"

[0107] After the experiment, the spleen and thymus of each group of rats were collected and weighed respectively, and the spleen index and thymus index were calculated. The results are shown in Figure 6 (Note: compared with the model group, *p<0.05, **p<0.01), where A is the spleen index and B is the thymus index. The results showed that compared with the control group, the spleen index and thymus index of the model group decreased (p<0.05), indicating that the immune organs of the rats in the model group were damaged and the immune function was decreased. After administration, the spleen index and thymus index of the rats were adjusted back in each of the example drug-dosing groups. Compared with the model group, there were significant differences between Example 1 and Example 3 (p<0.05), and the adjustment effect of Example 1 was better, indicating that the samples of Example 1 and Example 3 have a protective effect on the immune organs of rats with "heat".

[0108] (2) Effects of samples from each example group on inflammatory factors in rats with "heatiness"

[0109] After the experiment, the serum of rats in each group was collected, and the levels of TNF-α, IL-1β, and IL-6 in the serum of rats in each group were determined according to the instructions of the ELISA kit. The results are shown in Figure 7 (Note: Compared with the model group, *p<0.05, **p<0.01), where A is TNF-α, B is IL-1β, and C is IL-6. The results showed that compared with the control group, the levels of TNF-α, IL-1β, and IL-6 in the serum of the rats in the model group increased. After administration to the drug-treated groups in each embodiment, the levels of inflammatory factors in the serum of the rats were adjusted, among which the adjustment effect on the level of IL-1β was the most obvious, showing a significant difference (p<0.05), indicating that the samples in each embodiment have the effect of inhibiting inflammation.

[0110] 3) Effects of samples from each example group on energy metabolism in rats with "heatiness"

[0111] After the experiment, the serum of rats in each group was collected and the levels of LDH and ATPase in rat serum were determined according to the instructions of the ELISA kit. The results are shown in Figure 8 , where A is rat serum LDH and B is ATPase. The results showed that compared with the control group, the levels of LDH and ATPase in the serum of the rats in the model group were significantly reduced, showing a significant difference (p<0.05), indicating that the rats in the model group had energy metabolism disorders. After administration to the drug-dosing groups in each embodiment, the level of LDH in the rat serum was significantly adjusted, among which the adjustment effect of the embodiment 1 group was the most obvious, while the regulatory effect on the ATPase in the rat serum was not obvious. The above results show that the samples in the drug-dosing groups in each embodiment can regulate the energy metabolism disorders of rats with "heat", but the targets and strengths of the action are different.

[0112] In summary, the study shows that the immune organs of rats with qi deficiency type "getting angry" are damaged, the immune function is reduced, and inflammatory reaction and energy metabolism disorder occur at the same time. After administration of each embodiment, the immune organs of rats with qi deficiency type "getting angry" are greatly improved, the inflammatory reaction of rats with qi deficiency type "getting angry" is suppressed, and the energy metabolism disorder of rats with qi deficiency type "getting angry" is regulated. It shows that the samples of each embodiment have good functions of invigorating qi and nourishing yin, clearing heat and purging fire.

Claims

1. A Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire, characterized in that: In terms of API, it includes:

2. The Chinese medicine composition according to claim 1, characterized in that: The invention also comprises 35 parts by weight of concentrated sugar cane juice.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition has the effects of invigorating qi and nourishing yin, clearing away heat and purging fire by protecting the immune organs of the rat model of qi deficiency type internal heat, inhibiting inflammation and regulating energy metabolism; The Qi-deficiency type internal heat rat model was established according to the following method: rats were given free access to drinking water and adaptive feeding with standard feed, a Qi-deficiency model was established using a swimming exhaustion experiment, and the rats were given ginseng total extract by gavage once a day on time to obtain a Qi-deficiency type internal heat rat model.

4. A method for preparing the Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire as claimed in claim 1, characterized in that: The following steps are involved: S1) soaking Chinese yam, polygonatum odoratum, reed root, mint and perilla in water, and then heating and boiling them with water as an extraction solvent to obtain a mixed extract; S2) filtering the mixed extract to obtain a Chinese medicine composition having the effects of invigorating qi and nourishing yin, clearing away heat and purging fire.

5. The preparation method according to claim 4, characterized in that: The soaking time is 30 to 90 minutes; the mass ratio of the total mass of the Chinese yam, polygonatum, reed root, mint and perilla to the extraction solvent is 1: (6 to 14); the number of heating and decocting is 1 to 3 times; and the time of each heating and decocting is 0.5 to 2 hours; After heating and boiling, the mixture is concentrated under reduced pressure to 40% to 60% of the volume of the original mixed extract.

6. A product with the functions of invigorating qi and nourishing yin, clearing away heat and purging fire, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to claim 4 or 5.

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