Dampness-clearing paste and preparation method thereof

Abstract

A preparation method of the dampness-clearing paste comprises an ultra-high pressure step and a fermentation step, raw materials used in the ultra-high pressure step comprise an effective dose of dampness-clearing medicinal materials, and the dampness-clearing medicinal materials comprise one or more of poria cocos, coix seeds and radix fici simplicissimae; the effective dose of the liver-calming yin-nourishing / bowel-relaxing medicinal material comprises one or more of fructus cannabis, folium mori and lotus leaf. The invention also discloses a preparation method of the liver-calming yin-nourishing / bowel-relaxing medicinal material with the effective dose of liver-calming yin-nourishing / bowel-relaxing medicinal material. The compound zymophyte used in the fermentation step comprises saccharomyces cerevisiae, lactobacillus plantarum and bifidobacterium breve. The invention aims to solve the technical problems of low extraction efficiency and the like in the preparation process of the traditional dampness-clearing cream formula, the extraction rate of active ingredients of the cream formula is improved by introducing ultrahigh pressure and fermentation technologies, the cream formula has a very obvious intervention effect on damp-heat constitution, can obviously improve the symptoms of heavy body, weakness and the like of the damp-heat constitution, and is very safe and free of toxic and side effects. Long-term taking can be realized.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceuticals, and in particular relates to a dehumidifying ointment. Background Art

[0002] Damp-heat constitution is one of the most common biased constitution types in today's society, which has a great impact on people's physical and mental health. Intervention of the constitution of people with damp-heat constitution to make them tend to be balanced is both a current clinical problem and a current social demand. As a traditional Chinese medicine preparation, ointment has unique therapeutic effect and application value, but the low extraction efficiency of the traditional ointment process leads to low clinical effect. Summary of the invention

[0003] In order to solve the above technical problems, the present invention provides a dehumidifying paste having a very obvious intervention effect on damp-heat constitution.

[0004] The present invention relates to a dehumidifying paste. The preparation method of the dehumidifying paste comprises an ultra-high pressure step and a fermentation step. The raw materials used in the ultra-high pressure step comprise: an effective dose of dehumidifying medicinal materials, the medicinal materials comprising one or more of Poria cocos, Coix seeds and Eleutherodactyl quinquefolius; an effective dose of liver-nourishing yin / intestine-moistening and laxative medicinal materials, the medicinal materials comprising one or more of hemp seeds, mulberry leaves and lotus leaves; the composition of the composite fermentation bacteria used in the fermentation step comprises: saccharomyces cerevisiae, Lactobacillus plantarum and Bifidobacterium breve in a weight ratio of 0.2-20:0.2-20:0.1-10, preferably: the weight ratio is 2:2:1.

[0005] The present invention further relates to a dehumidifying paste, wherein the raw materials used in the ultra-high pressure step also include: an effective dose of adjuvant medicinal materials, the adjuvant medicinal materials include one or more of an effective dose of digestive and stomachic medicinal materials, an effective dose of qi-invigorating and dehumidifying medicinal materials, an effective dose of qi-invigorating and dehumidifying medicinal materials, an effective dose of qi-invigorating and yin-nourishing medicinal materials, and an effective dose of blood-invigorating and yin-nourishing medicinal materials; preferably, the digestive and stomachic medicinal materials include hawthorn, the qi-invigorating and dehumidifying medicinal materials include cassia seed and peach kernel, the qi-invigorating and yin-nourishing medicinal materials include polygonatum, and the blood-invigorating and yin-nourishing medicinal materials include yak glue.

[0006] The present invention further relates to a dehumidifying paste, wherein the raw materials used in the ultra-high pressure step include: 1 to 10 parts by weight of Poria cocos, 1 to 10 parts by weight of Coix seeds, 1 to 10 parts by weight of Eleutherodactyl schizonepeta, 1 to 10 parts by weight of Hemp seeds, 1 to 10 parts by weight of Cassia seeds, 6 to 20 parts by weight of Hawthorn, 1 to 10 parts by weight of Mulberry leaves, 1 to 10 parts by weight of Lotus leaves, 2 to 12 parts by weight of Polygonatum sibiricum, 1 to 10 parts by weight of Peach kernel, and 0.1 to 1 part by weight of yak glue; preferably: 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Eleutherodactyl schizonepeta, 4.1 parts by weight of Hemp seeds, 4.1 parts by weight of Cassia seeds, 13 parts by weight of Hawthorn, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Peach kernel, and 0.3 part by weight of yak glue.

[0007] The present invention further relates to a dehumidifying paste, wherein the ultra-high pressure conditions of the ultra-high pressure step are: pressure 50MPa-850MPa; holding time 25 to 40 minutes; preferably, any one of the following groups is included: the ultra-high pressure condition of the Poria cocos is 350MPa and holding time 25 minutes; the ultra-high pressure condition of the Coix seeds is 400MPa and holding time 25 minutes; the ultra-high pressure condition of the five-fingered ginseng is 450MPa and holding time 25 minutes; the ultra-high pressure condition of the hemp seed is 400MPa and holding time 25 minutes; the ultra-high pressure condition of the Cassia seed is The ultra-high pressure conditions are a pressure of 350MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the hawthorn are a pressure of 300MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the mulberry leaf are a pressure of 400MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the lotus leaf are a pressure of 350MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the polygonatum are a pressure of 400MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the peach kernel are a pressure of 450MPa and a holding time of 25 minutes; the ultra-high pressure conditions of the yak glue are a pressure of 400MPa and a holding time of 25 minutes.

[0008] The present invention further relates to a dehumidifying paste, which further includes one or more of a crushing step and a mixing step after the ultra-high pressure step; wherein the crushing step obtains a single medicinal powder including any one of the raw materials; and the mixing step obtains a compound medicinal powder including a plurality of the raw materials; preferably, the compound medicinal powder includes single medicinal powder of Poria cocos, single medicinal powder of Coix seeds, single medicinal powder of Cannabis sativa seeds, single medicinal powder of Cassia seeds, single medicinal powder of Hawthorn, single medicinal powder of Mulberry leaves, single medicinal powder of Lotus leaves, single medicinal powder of Polygonatum sibiricum and single medicinal powder of Peach kernel.

[0009] The present invention further relates to a dehumidifying paste, which comprises 25% to 65% by weight of the compound powder, 1% to 5% by weight of the single powder of Eleutherodactyl schizonepeta, 0.4% to 0.8% by weight of the single powder of yak glue, 20% to 60% by weight of fructose-glucose syrup, and the remainder of distilled water; preferably, 45% by weight of the compound powder, 2% by weight of the single powder of Eleutherodactyl schizonepeta, 0.6% by weight of the single powder of yak glue, 40% by weight of fructose-glucose syrup, and the remainder of distilled water.

[0010] The present invention further relates to a dehumidifying paste, wherein the fermentation step comprises: inoculating the culture medium with a dosage of 0.3-10% of the composite fermentation bacteria, shaking the culture medium at a constant temperature in an incubator, and fermenting at 28-38°C for 12-72 hours; preferably, inoculating the culture medium with a dosage of 3% of the composite fermentation bacteria, shaking the culture medium at a constant temperature in an incubator, and fermenting at 33°C for 48 hours.

[0011] The present invention further relates to the dehumidifying paste, wherein the fermentation step further comprises one or more of a filtration step or a centrifugation step.

[0012] The present invention also provides a traditional craft dehumidifying paste, which is mainly prepared from 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Prunus quinquefolia, 4.1 parts by weight of Cannabis sativa seeds, 4.1 parts by weight of Cassia seed, 13 parts by weight of Crataegus pinnatifida, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Peach kernel, and 0.3 parts by weight of yak glue. The traditional craft dehumidifying paste includes a decoction (paste), a fluid extract or an extract.

[0013] The present invention also relates to the use of any of the aforementioned dehumidifying pastes in the preparation of dehumidifying medicines, wherein the dehumidifying medicines include pharmaceutical compositions having very obvious intervention effects on damp-heat constitutions.

[0014] The present invention aims to solve the technical problems such as low extraction efficiency existing in the preparation process of traditional dehumidifying paste prescriptions. By introducing ultra-high pressure and fermentation technology, the extraction rate of active ingredients in the paste prescription is improved, which has a very obvious intervention effect on damp-heat constitution and can significantly improve the symptoms of damp-heat constitution such as body heaviness and fatigue. Moreover, the paste prescription is very safe and can be taken for a long time. DETAILED DESCRIPTION

[0015] The following examples further illustrate the content of the present invention, but should not be construed as limiting the present invention. Without departing from the spirit and substance of the present invention, modifications or substitutions made to the methods, steps or conditions of the present invention all fall within the scope of the present invention.

[0016] Dampness, clearing dampness, damp-heat constitution, clearing dampness paste

[0017] Dampness is one of the six evil spirits in traditional Chinese medicine. The symptoms vary depending on the location of the disease. It is mainly divided into internal dampness and external dampness. The formation of internal dampness is mainly related to physical constitution and eating habits. It is generally seen in people with spleen deficiency. Due to the poor function of spleen and stomach transportation, the spleen fails to transport and transform, thus accumulating dampness, which is manifested as thick and greasy tongue coating, obesity, stuffiness, poor appetite, and sticky stools. External dampness is caused by external factors, mainly related to the living environment or climate, and its manifestations are mainly body aches and pains, and joint pains.

[0018] Clear dampness, cold and dampness are pathogenic evils. "Lingshu·The Beginning of All Diseases" says: "When clear dampness attacks the weak, the disease starts from the lower part." Attacking the weak means taking advantage of the weak to invade. "Lingshu·The Beginning of All Diseases" says: "The beginning of all diseases is caused by wind, rain, cold, heat, clear dampness, joy and anger. Uncontrolled joy and anger will damage the internal organs, wind and rain will damage the upper part, and clear dampness will damage the lower part. The three parts of qi are injured in different ways. Uncontrolled joy and anger will damage the internal organs, and when the internal organs are injured, the disease starts from the yin; when clear dampness attacks the weak, the disease starts from the lower part; when wind and rain attack the weak, the disease starts from the upper part, which is called the three parts." It emphasizes that diseases are always caused by evil qi imposed on the human body, not changes that the human body itself should have. Wind, rain, clear dampness, belong to external factors; uncontrolled joy and anger, belong to internal factors. Different origins, different natures, so the injuries are different.

[0019] Damp-heat constitution is a disease name in traditional Chinese medicine, and the common site of disease is the spleen. Common causes include congenital disease, addiction to tobacco and alcohol, frequent late nights, improper nourishment, liver depression and qi stagnation, and long-term living in a damp and hot environment. Common symptoms include heavy limbs, yellow and greasy tongue coating, rapid pulse, acne, dry and bitter mouth, red eyes, restlessness and laziness, short and dark urine, and dry or sticky stools.

[0020] Qingshi paste prescription refers to a paste prescription (ointment) that has the function of clearing away the aforementioned dampness-related pathogenic factors and has a very obvious intervention effect on damp-heat constitution.

[0021] Ultra-high pressure technology

[0022] The principle of extracting effective ingredients from traditional Chinese medicine by ultra-high pressure technology (UHP) is: first mix the crushed medicinal materials with the extraction medium and put them into a closed container, quickly increase the pressure (above 100MPa), then maintain the pressure for a period of time, and finally quickly release the pressure. During the process of increasing and maintaining the pressure, the concentration of the solution inside the pores of the medicinal materials and the concentration of the medium outside can reach equilibrium in a short time, and the cells are in a medium with high osmotic pressure. During the pressure release process, the medium pressure drops rapidly, and the osmotic pressure difference between the inside and outside of the cells increases rapidly, which leads to cell fragmentation, and the effective ingredients in the cells are fully in contact with the extraction solvent, thus shortening the extraction time and improving the extraction efficiency. Please refer to "Application of Ultra-High Pressure Technology in Extracting Effective Ingredients from Traditional Chinese Medicine" (He Shuai, "Chinese Medicinal Materials" Vol. 32 No. 3, March 2009), "Application of Ultra-High Pressure Extraction Technology in Extraction of Traditional Chinese Medicine" (Zhao Peng, "Chinese Pharmaceutical Biotechnology" Vol. 3 No. 4, August 2008). CN101485876A discloses that ultra-high pressure technology can improve the total effective rate of the prescription of raw Chuanwu, raw Caowu, ephedra, atractylodes, angelica, angelica dahurica, dried ginger, galangal, star anise and chrysanthemum, CN101954003A discloses that ultra-high pressure technology can improve the total effective rate of bupleurum, siler, kudzu root, platycodon, bitter almond, angelica dahurica, bitter herb, and reed root, CN101933967A discloses that ultra-high pressure technology can improve the total organic acid content in honeysuckle, CN107929512A discloses that ultra-high pressure technology can improve the astragaloside content of the prescription of codonopsis, astragalus, ophiopogon, tortoise shell, atractylodes, yam, schisandra, dragon bone, oyster, tuckahoe, jujube, liquorice, and chicken gizzard, CN 114762703 A discloses that ultra-high pressure technology can improve the content and clinical effect of danshensu, reduced catechin aldehyde, vanillic acid, rosmarinic acid, salvianolic acid A, salvianolic acid E, salvianolic acid B, and salvianolic acid D in the formula of white flower danshen and astragalus. CN105079135A discloses that ultra-high pressure technology can improve the paste yield and paeoniflorin content of honeysuckle, red peony root, and mianma guanzhong, and CN107412712A discloses that ultra-high pressure technology can improve the effective ingredient extraction rate of ginger magnolia bark, perilla leaf; Angelica dahurica, Poria; bran fried atractylodes, tangerine peel; patchouli, ginger pinellia. However, due to the complexity of Chinese medicine ingredients and the diversity of ultra-high pressure technology parameters, when the existing ultra-high pressure technology is applied to the new Chinese medicine extraction process, it is necessary to readjust the ultra-high pressure technology parameters to optimize the extraction efficiency and clinical effect, and even if the ultra-high pressure technology parameters are adjusted, more Chinese medicines still cannot improve the extraction efficiency and clinical effect through ultra-high pressure technology.

[0023] Traditional Chinese Medicine Fermentation Technology

[0024] Fermentation is one of the methods of preparing traditional Chinese medicine. The fermentation technology of traditional Chinese medicine uses traditional Chinese medicine as a matrix. Under the action of microorganisms and enzymes, it improves the release rate of active substances in traditional Chinese medicine, transforms and produces new bioactive substances, and degrades toxic macromolecules. Please refer to "Progress in Research on Fermentation of Traditional Chinese Medicine" (He Shuai, "Chinese Medicinal Materials", Vol. 12, No. 3, 2010) and "Progress in Research on Fermentation of Tonic Traditional Chinese Medicine" (Zhao Peng, "Chinese Patent Medicine", 2023-09-27). The use of fermentation technology for Chinese medicine in Chinese medicine processing is well known to pharmacists. However, there are few reports on the application of combining ultra-high pressure technology with fermentation technology in the field of Chinese medicine. It is known that CN105380964A discloses the use of pile fermentation and ultra-high pressure technology to treat pine tips and pine wood chips, CN106511419A discloses the use of container fermentation and ultra-high pressure technology to treat ginseng, CN111821233A discloses the use of shaking table fermentation and ultra-high pressure technology to treat mulberry bark, raspberry, and Centella asiatica, and CN115068512A discloses the use of solid-state fermentation and ultra-high pressure technology to treat Baixue tea.

[0025] The properties, flavors and meridians of 11 Chinese medicinal materials

[0026] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It tastes sweet and light, and is neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and dispelling dampness, strengthening the spleen, and calming the mind. The active ingredients include polysaccharides, triterpenoid compounds, etc.

[0027] Job's tears, also known as coix seed (Semen Coicis), is the dried mature seed kernel of the grass plant Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf. It is sweet, light and cool. It enters the spleen, stomach and lung meridians. It can strengthen the spleen and eliminate dampness, eliminate numbness and stop diarrhea, clear away heat and expel pus. It is used for edema, beriberi, urinary difficulty, dampness and numbness cramps, spleen deficiency diarrhea, lung abscess, intestinal abscess; flat warts. The active ingredients include polysaccharides, oils, polyphenols and triterpenoid compounds.

[0028] Five-fingered ginseng is the root of Ficus simplicissima Lour., a plant of the Moraceae family. It is sweet in taste and neutral in nature. It enters the spleen, lung and liver meridians. It strengthens the spleen and lungs, promotes qi and eliminates dampness, relaxes tendons and activates collaterals. It is used to treat edema due to spleen deficiency, loss of appetite and weakness, cough due to tuberculosis, night sweats, leucorrhea, postpartum agalactia, rheumatic pain, edema, ascites due to liver cirrhosis, hepatitis and traumatic injuries. The active ingredients include psoralen, flavonoids, coumarins, terpenoids, steroids and volatile oils.

[0029] Hemp seed is the dried mature fruit of Cannabis sativa L., a plant of the Moraceae family. It is sweet and neutral in nature. It enters the spleen, stomach, and large intestine meridians. It moisturizes the intestines and promotes bowel movements. It is used for blood deficiency, fluid deficiency, and constipation caused by dry intestines. The active ingredients include unsaturated fatty acids (such as oleic acid, linoleic acid, linolenic acid, etc.), phytosterols, proteins, volatile oils, and vitamin E.

[0030] Cassia seeds are the dried mature seeds of Senna obtusifolia (L.) HSIrwin & Barneby or Senna tora (L.) Roxb., a plant of the Leguminosae family. They taste sweet, bitter, and salty, and are slightly cold in nature. They enter the liver, gallbladder, kidney, and large intestine meridians. They have the functions of clearing away heat, improving eyesight, and moistening the intestines and relieving constipation. They are mainly used to treat eye diseases, constipation, hypertension, hyperlipidemia, and diabetes. The active ingredients include anthraquinones, fatty acids, polysaccharides, etc.

[0031] Hawthorn is the dried mature fruit of Crataegus pinnatifida Bge.var.major NEBr. or Crataegus pinnatifida Bge. of the Rosaceae family. It is sour, sweet and slightly warm. It enters the spleen, stomach and liver meridians. It helps digestion and invigorates the stomach, promotes qi and dissipates blood stasis, removes turbidity and reduces fat. It is used for meat stagnation, fullness in the stomach, abdominal pain due to diarrhea, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain and hyperlipidemia. The effect of charred hawthorn on digestion and relieving stagnation is enhanced. It is used for meat stagnation and diarrhea. The active ingredients include flavonoids and triterpenoids.

[0032] Mulberry leaf is the dried leaf of Morus alba L., a plant of the Moraceae family. It is sweet, bitter and cold. It enters the lung and liver meridians. It can dispel wind-heat, clear the lungs and moisten dryness, clear the liver and improve eyesight. It is used for wind-heat cold, lung heat and dry cough, dizziness and headache, red and blurred eyes. The active ingredients include flavonoids, alkaloids, polysaccharides, organic acids and their analogs, coumarins, Diels-Alder type adducts, stilbene compounds, amino acids, vitamins and mineral elements.

[0033] Lotus leaf is the leaf of Nelumbo nucifera Gaertn, a plant of the Nymphaeaceae family. It is bitter and neutral. It enters the liver, spleen and stomach meridians. It clears away heat and dampness, promotes the flow of clear yang, cools blood and stops bleeding. It is used for thirst due to summer heat, diarrhea due to summer dampness, diarrhea due to spleen deficiency, vomiting and bleeding due to blood heat, and metrorrhagia due to blood in stool. Lotus leaf charcoal is astringent, removes blood stasis and stops bleeding. It is used for hemorrhagic diseases and postpartum blood fainting. The active ingredients include flavonoids, alkaloids, volatile oils, organic acids and polysaccharides.

[0034] Polygonatum sibiricum is the dried rhizome of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua, all of the Liliaceae family. It is sweet and neutral in taste. It enters the spleen, lung and kidney meridians. It replenishes qi and nourishes yin, strengthens the spleen, moistens the lungs and benefits the kidneys. It is used for spleen and stomach qi deficiency, fatigue, insufficient stomach yin, dry mouth and poor appetite, dry cough due to lung deficiency, hemoptysis due to overwork, insufficient essence and blood, soreness of waist and knees, premature graying of hair and beard, and internal heat and thirst. The effective ingredients include Polygonatum sibiricum polysaccharide, steroidal saponin, flavonoids, lignans, nitrogen-containing compounds, cardiac glycosides, volatile oils, etc.

[0035] Peach kernel is the dried mature seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. of the Rosaceae family. It tastes bitter, sweet and neutral. It enters the heart, liver and large intestine meridians. It can promote blood circulation and remove blood stasis, moisten the intestines and promote bowel movements. It is used for amenorrhea, dysmenorrhea, abdominal masses, injuries from falls, and constipation due to dry intestines. The active ingredients include amygdalin, fatty acids, proteins, sterols and their glycosides, flavonoids, phenolic acids, etc.

[0036] Yak glue, also known as yak rhino glue, is made from fresh yak skin, frozen yak skin (unwashed or washed, pre-treated) or dried yak skin as the main raw materials, which are thawed or not thawed, washed or not washed, peeled, filtered, concentrated, added with rice wine, crystal sugar, soybean oil, and then mixed, boiled, condensed, packaged [or cut into pieces (diced), air-dried or dried or roasted, crushed or not crushed, packaged] to make yak glue. Sweet, flat. Enter the lung, liver, and kidney meridians. It nourishes blood and yin, moisturizes dryness, and stops bleeding. It is used for blood deficiency and sallow complexion, dizziness and palpitations, muscle weakness, restlessness and insomnia, internal wind movement, dry cough due to lung dryness, hemoptysis due to fatigue, hematuria due to vomiting blood, hematochezia and metrorrhagia, and pregnancy and fetal bleeding. The active ingredients include collagen, and collagen includes acid-soluble collagen (ASC), enzyme-soluble collagen (PSC) and water-soluble collagen (HWSC).

[0037] Fructose corn syrup

[0038] High fructose syrup is a starch crystal made by hydrolysis and isomerization of plant starch. It is mainly composed of glucose and fructose. According to the fructose content, high fructose syrup is divided into three categories: the first generation of high fructose syrup (F42 type) contains 42% fructose; the second generation of high fructose syrup (F55 type) contains 55% fructose; the third generation of high fructose syrup (F90 type) contains 90% fructose. The second generation of high fructose syrup (F55 type) used in the embodiment of the present invention contains 55% fructose.

[0039] Dehumidifying paste

[0040] The dehumidifying paste of the present invention is composed of Poria, Coix seeds, Prunus mume, Hemp seeds, Cassia seeds, Hawthorn, Mulberry leaves, Lotus leaves, Polygonatum, Peach kernel, and Yak glue, and belongs to the invention of the prescription formed by directly dispatching drugs according to the theory of traditional Chinese medicine and the experience of using medicine, or changing the main medicinal flavor of the known prescription. The dehumidifying paste is good at clearing away heat and dampness, and is mainly used to treat damp-heat syndrome. Poria strengthens the spleen, dries dampness and resolves phlegm, clears the Yangming meridian, drives away invisible evil, and guides it to pass through the urine; Coix seeds and Prunus mume strengthen the spleen and remove dampness, promote qi and eliminate dampness; Hawthorn strengthens the stomach and helps digestion, Hemp seeds, Mulberry leaves, Lotus leaves soothe the liver and nourish yin, moisten the intestines and relieve constipation; Polygonatum nourishes the kidney and replenishes essence, Cassia seeds and Peach kernel replenish qi and remove dampness, and Yak glue nourishes yin and moistens dryness, so as to restore the clear and turbid. Poria, Coix seeds, Prunus mume have the effect of penetrating dampness and removing dampness, and are the main drugs. Hemp seed, mulberry leaf, and lotus leaf have the effects of calming the liver and nourishing yin / moistening the intestines and relieving constipation, and assist in removing dampness, and are the assistant drugs. Hawthorn can help digestion and invigorate the stomach, cassia seed and peach kernel can replenish qi and remove dampness, polygonatum can replenish qi and nourish yin, and yak glue can replenish blood and nourish yin, and are the assistant drugs.

[0041] CN107927699A discloses a dehumidifying and spleen-strengthening edible spice and its preparation method. The spice of the invention is mainly used for soup broth, and can achieve the effect of dehumidifying and spleen-strengthening by adding a variety of dehumidifying herbs such as Atractylodes, Prunus mume, Ginger, Poria, Acanthopanax, Hawthorn, Artemisia capillaris, Coix seeds, Euryale ferox and Adzuki bean. CN 113476567 A discloses an anti-epidemic and clearing tonic bone tea, which is made of dried tangerine peel, Adenophora radix, Atractylodes, Polygonatum odoratum, Momordica grosvenori, Coix seeds, Prunus mume, Astragalus, Patchouli, Firewood, Licorice, Poria and the like. CN115634270A discloses a spleen nourishing Chinese herbal medicine preparation formula and process, which is composed of the following components: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice, Ginseng, Euryale ferox, Coix seeds, Amomum villosum, Cloves, Cinnamon bark, Dendrobium candidum, Anoectochilus roxburghii, Pig's stomach powder, 20-year-old dried orange peel, Ganoderma lucidum, Kumquat, Hawthorn, Shenqu, Lotus seeds, Chinese yam, Malt, Chicken's gizzard lining, Five-fingered ginseng, Red bean, Hericium erinaceus, Ziziphus jujuba seeds, Platycodon grandiflorus, Citron, Pueraria root, Seabuckthorn, Anoectochilus roxburghii, White lentil, Astragalus, Red dates. Although the above prior art uses Poria cocos, Coix seeds, and Five-fingered ginseng, all do not further disclose the composition principle of the dampness-clearing paste of the present invention.

[0042] Traditional craft moisturizing cream

[0043] On the basis of the dehumidifying paste of the present invention, the present invention provides a traditional dehumidifying paste based on traditional processes such as solvent extraction technology and vacuum drying technology, which is mainly composed of 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Prunus mume, 4.1 parts by weight of Cannabis sativa seeds, 4.1 parts by weight of Cassia seeds, 13 parts by weight of Crataegus pinnatifida, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Prunus persica, and 0.3 parts by weight of Yak glue to prepare an oral paste (decoction (paste), fluid extract or extract, etc.). Among them, the solvent extraction technology includes any one of water extraction, ethanol extraction, water extraction and alcohol precipitation. In some specific embodiments of the traditional process of extracting water from decoction of moist paste, the steps include material selection, cleaning, soaking, first water boiling and filtrate collection, second water boiling and filtrate collection, third water boiling and filtrate collection, sugar addition (optional depending on the type of paste), liquid concentrating step, filtration (adjustable according to the process sequence and can be repeated multiple times), packaging, sterilization and packaging.

[0044] The difference between Example 1 of the traditional process dehumidifying paste and the aforementioned process is that the water addition ratio and decoction time of the three decoctions and filtrations are 1:7, 3 hours, 1:5, 2 hours, and 1:3, 1 hour, respectively.

[0045] Moisturizing cream

[0046] Traditional dehumidifying pastes have the technical problem of low extraction efficiency. The following examples provide a method for preparing dehumidifying paste using ultra-high pressure and fermentation technology. In order to distinguish it from the dehumidifying paste using the traditional process, unless otherwise specified in the following examples, the dehumidifying paste refers to the dehumidifying paste prepared using ultra-high pressure and fermentation technology.

[0047] In some embodiments of the present invention, the preparation method of the dehumidifying paste includes an ultra-high pressure step and a fermentation step, and the raw materials used in the ultra-high pressure step include: an effective dose of dehumidifying medicinal materials, the dehumidifying medicinal materials include one or more of Poria cocos, Coix seeds, and Eleutherodactylus chinensis; an effective dose of dehumidifying medicinal materials for soothing the liver and nourishing yin / moistening the intestines and relieving constipation, the dehumidifying medicinal materials for soothing the liver and nourishing yin / moistening the intestines and relieving constipation include one or more of Hemp seeds, mulberry leaves, and lotus leaves; in these embodiments, Poria cocos, Coix seeds, and Eleutherodactylus chinensis have the effect of dehumidifying and removing dampness, and are monarch drugs. Hemp seeds, mulberry leaves, and lotus leaves have the effect of soothing the liver and nourishing yin / moistening the intestines and relieving constipation to assist in dehumidifying, and are minister drugs. The composition of the composite fermentation bacteria used in the fermentation step includes: Saccharomyces cerevisiae, Lactobacillus plantarum, and Bifidobacterium breve in a weight ratio of 0.2-20:0.2-20:0.1-10, preferably: the weight ratio is 2:2:1. In these embodiments, the ultra-high pressure step is combined with the fermentation step to prepare the moistening paste. The ultra-high pressure step is to use ultra-high pressure equipment to treat the medicinal materials, destroy the cell structure, and promote the release of effective ingredients, wherein the ultra-high pressure equipment uses known equipment. The fermentation step refers to the interaction of the medicinal materials treated by the ultra-high pressure step to control the fermentation conditions and promote the transformation and improvement of the active ingredients in the medicinal materials. In a further embodiment, before the ultra-high pressure step, the medicinal materials can be cleaned, impurities removed, and sliced ​​to increase the surface area, all using known Chinese medicine processing technology.

[0048] In the dehumidifying paste of other embodiments of the present invention, the raw materials used in the ultra-high pressure step also include: an effective dose of adjuvant medicinal materials, the adjuvant medicinal materials include one or more of the following: an effective dose of digestive and stomachic medicinal materials, an effective dose of invigorating qi and dehumidifying medicinal materials, an effective dose of invigorating qi and dehumidifying medicinal materials, an effective dose of invigorating qi and nourishing yin medicinal materials, an effective dose of invigorating qi and nourishing yin medicinal materials, and an effective dose of invigorating blood and nourishing yin medicinal materials; preferably, the digestive and stomachic medicinal materials include hawthorn, the invigorating qi and dehumidifying medicinal materials include cassia seed and peach kernel, the invigorating qi and nourishing yin medicinal materials include polygonatum, and the invigorating blood and nourishing yin medicinal materials include yak glue. In these embodiments, Poria, coix seed, and five-fingered hair peach have the effect of infiltrating dampness and removing dampness, and are the main medicines. Hemp seed, mulberry leaf, and lotus leaf have the effect of calming the liver and nourishing yin / moistening the intestines and relieving constipation, and assist in infiltration of dampness, and are the ministerial medicines. Hawthorn digests food and invigorates the stomach, cassia seed and peach kernel invigorate qi and remove dampness, polygonatum invigorates qi and nourishes yin, and yak glue invigorates blood and nourishes yin, and are adjuvant medicines. In more embodiments, the present invention does not limit the types of adjuvant medicinal materials. For example, Codonopsis pilosula (codonosinolate saponin), Rubia cordifolia (rubia pigment), American cockroach (amino acids, oligopeptides), Chrysanthemum (chrysanthemum total flavonoids), Cinnamomum camphora (camphora anthocyanins), Peony (gallic acid, cosmosin, etc.), Ganoderma lucidum (Ganoderma lucidum triterpenoids), Cordyceps sinensis (Cordyceps sinensis polysaccharides), Lacquercetin (total flavonoids), Mustard oil (benzyl glucosinolate), Maca (total flavonoids, total saponins), Ligusticum chuanxiong (ligustilide, ferulic acid), Cyperus oleifera (cyperus oleifera total flavonoids), Dioscorea zingiberensis (Dioscorea zingiberensis saponins), Persimmon (persimmon polyphenols), Propolis (propolis total flavonoid extract), Ginseng (ginsenosides), Deer antler (insulin-like growth factor IGF-1), Bletilla striata (Bletilla striata polysaccharides), Snow chrysanthemum (proanthocyanidins), Longan (longan proteoglycans), Artemisia argyi (polysaccharides and flavonoids). The ingredients in the above brackets are the active ingredients of the medicinal materials. For example, raw Chuanwu, raw Caowu, ephedra, atractylodes, angelica, white angelica, dried ginger, galangal, star anise, chrysanthemum, bupleurum, saposhnikovia, kudzu root, platycodon, bitter almond, bitter herb, reed root, honeysuckle, astragalus, ophiopogon, tortoise shell, white atractylodes, yam, schisandra, dragon bone, oyster, poria, jujube, licorice, chicken gizzard lining, white flower, salvia miltiorrhiza, red peony root, Corydalis cyrtomium, ginger magnolia bark, perilla leaf, tangerine peel, patchouli, ginger pinellia, etc.

[0049] The term "effective dose" refers to the dosage of the medicinal material when it exerts the corresponding efficacy (function and indications) as reported in the known technology and recorded in the present invention, or the prescription amount converted based on the dosage. Taking Poria as an example, refer to the "Chinese Pharmacopoeia" (2020 edition, Part I), [Functions and Indications] Diuresis and Dampness Removal, Spleen Invigoration, and Heart Tranquility. It is used for edema, oliguria, phlegm and fluid, dizziness and palpitations, spleen deficiency and poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia. [Usage and Dosage] 10-15g; Therefore, in the present invention, Poria can be called a dampness-removing medicinal material, and the effective dose for dampness-removing is the prescription amount converted based on the dosage of 10-15g. If a 1000-fold prescription is prepared, the "effective dose" is 10-15kg.

[0050] In some other embodiments of the dehumidifying paste of the present invention, the raw materials used in the ultra-high pressure step include: 1-10 parts by weight of Poria cocos, 1-10 parts by weight of Coix seeds, 1-10 parts by weight of Eleutherodactyl quinquefolius, 1-10 parts by weight of Hemp seeds, 1-10 parts by weight of Cassia seeds, 6-20 parts by weight of Hawthorn, 1-10 parts by weight of Mulberry leaves, 1-10 parts by weight of Lotus leaves, 2-12 parts by weight of Polygonatum sibiricum, 1-10 parts by weight of Peach kernel, and 0.1-1 parts by weight of yak glue; preferably: 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Eleutherodactyl quinquefolius, 4.1 parts by weight of Hemp seeds, 4.1 parts by weight of Cassia seeds, 13 parts by weight of Hawthorn, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Peach kernel, and 0.3 parts by weight of yak glue.

[0051] In some other embodiments of the dehumidifying paste of the present invention, the ultra-high pressure conditions of the ultra-high pressure step are: pressure 50MPa-850MPa; holding time 25 to 40 minutes; preferably include any one of the following groups: the ultra-high pressure condition of the Poria cocos is 350MPa and holding time 25 minutes; the ultra-high pressure condition of the Coix seeds is 400MPa and holding time 25 minutes; the ultra-high pressure condition of the five-fingered peach is 450MPa and holding time 25 minutes; the ultra-high pressure condition of the hemp seed is 400MPa and holding time 25 minutes; the ultra-high pressure condition of the Cassia seed is The ultra-high pressure conditions are 350MPa and 25 minutes; the ultra-high pressure conditions of hawthorn are 300MPa and 25 minutes; the ultra-high pressure conditions of mulberry leaf are 400MPa and 25 minutes; the ultra-high pressure conditions of lotus leaf are 350MPa and 25 minutes; the ultra-high pressure conditions of polygonatum are 400MPa and 25 minutes; the ultra-high pressure conditions of peach kernel are 450MPa and 25 minutes; the ultra-high pressure conditions of yak glue are 400MPa and 25 minutes. It should be pointed out that based on the concept of the present invention, the different ultra-high pressure treatment parameters explored to achieve the technical solutions applied to different types of paste prescriptions are within the protection scope of the present invention.

[0052] In the dehumidifying paste of other embodiments of the present invention, the ultra-high pressure step further includes one or more of a crushing step and a mixing step; wherein the crushing step obtains a single-prescription powder comprising any one of the raw materials; the mixing step obtains a compound powder comprising a plurality of the raw materials; preferably, the compound powder includes a single-prescription powder of Poria cocos, a single-prescription powder of Coix seeds, a single-prescription powder of Cannabis sativa seeds, a single-prescription powder of Cassia seeds, a single-prescription powder of Hawthorn, a single-prescription powder of Mulberry leaves, a single-prescription powder of Lotus leaves, a single-prescription powder of Polygonatum sibiricum, and a single-prescription powder of Peach kernel. In these embodiments, the structure of the medicinal materials has become relatively loose after ultra-high pressure treatment, and crushing is performed at this time to further increase the release of the active ingredients.

[0053] The dehumidifying paste of other embodiments of the present invention comprises 25% to 65% of the compound medicinal powder by weight, 1% to 5% of the single medicinal powder of Eleutherodendron chinense by weight, 0.4% to 0.8% of the single medicinal powder of yak glue by weight, 20% to 60% of fructose-glucose syrup by weight, and the remainder is distilled water; preferably, the compound medicinal powder by weight is 45%, the single medicinal powder of Eleutherodendron chinense by weight is 2%, the single medicinal powder of yak glue by weight is 0.6%, the single medicinal powder of yak glue by weight is 40%, and the remainder is distilled water.

[0054] In some other embodiments of the dehumidifying cream of the present invention, the fermentation step includes: inoculating the culture medium with the composite fermentation bacteria at a dosage of 0.3-10%, shaking at a constant temperature in an incubator, and fermenting at 28-38°C for 12-72 hours; preferably: inoculating the culture medium with the composite fermentation bacteria at a dosage of 3%, shaking at a constant temperature in an incubator, and fermenting at 33°C for 48 hours. Other fermentation conditions of the present invention adopt well-known technologies, such as fermentation temperature. In the embodiments of the present invention, the preferred fermentation process conditions are a fermentation temperature of 38-42°C.

[0055] In some other embodiments of the dehumidifying paste of the present invention, the fermentation step further includes one or more of a filtration step and a centrifugation step, and the filtration and centrifugation methods of the present invention adopt well-known technologies.

[0056] Dehumidifying cream embodiments 1 to 9

[0057] (1) A total of 11 medicinal materials, including Poria cocos, Coix seeds, Prunus mume, Cannabis sativa seeds, Cassia seeds, Hawthorn fruit, Mulberry leaves, Lotus leaves, Polygonatum sibiricum, Peach kernel, and Yak glue, were subjected to ultrahigh pressure treatment;

[0058] (2) Nine kinds of medicinal materials, including Poria cocos, Coix seeds, hemp seeds, Cassia seeds, Hawthorn fruit, mulberry leaves, lotus leaves, Polygonatum sibiricum, and peach kernel, which have been treated with ultrahigh pressure, are crushed into single-ingredient powders, and then the single-ingredient powders are mixed into compound powders.

[0059] (3) Adding the compound medicinal powder with the five-fingered peach and yak glue treated with ultrahigh pressure, fructose syrup, and distilled water to prepare a traditional Chinese medicine culture medium, adjusting the pH value to 6.5, and sterilizing to obtain a sterilized traditional Chinese medicine culture medium.

[0060] (4) A composite fermentation bacteria consisting of saccharomyces cerevisiae, Lactobacillus plantarum and Bifidobacterium breve is inoculated into a traditional Chinese medicine culture medium, and the culture medium is placed in a constant temperature incubator for constant shaking, fermentation and centrifugal filtration to obtain a dehumidifying paste.

[0061] The process parameters of Examples 1 to 9 of the dehumidifying paste are shown in Tables 1 to 5, and the other steps are basically the same as the preparation method of the aforementioned dehumidifying paste examples.

[0062] Table 1 Raw materials used in the ultra-high pressure step

[0063]

[0064] Note: The data in the table are “parts by weight” converted based on weight.

[0065] Table 2 Ultrahigh pressure conditions of the ultrahigh pressure step

[0066]

[0067]

[0068] Note: "min" in the table refers to the holding time, in minutes.

[0069] Table 3 Composition of the composite fermentation bacteria used in the fermentation step

[0070]

[0071] Note: The data in the table are “parts by weight” converted based on weight.

[0072] Table 4 Composition of the culture medium used in the fermentation step

[0073]

[0074] Note: "Remainder" in the table means the weight percentage remaining after deducting the remaining components from 100%. Taking Example 1 as an example, the residue is 14.1%.

[0075] Table 5 Process conditions of fermentation step

[0076]

[0077] Note: The "shaking culture" in the table is carried out in a constant temperature incubator, and the specific temperature is set according to the fermentation temperature.

[0078] Dehumidifying cream comparison examples 1 to 5

[0079] The dehumidifying paste control examples 1 to 5 are basically the same as the dehumidifying paste embodiment 4, and the differences are shown in Table 6.

[0080] Table 6 Process conditions of the control example of dehumidifying paste

[0081]

[0082] Note: The "ultra-high pressure conditions" in the table are the conditions used for Poria cocos, Coix seeds, Eleutherodactyla quinquefolia, hemp seeds, Cassia seeds, hawthorn, mulberry leaves, lotus leaves, Polygonatum sibiricum, peach kernels, and yak glue.

[0083] Test Example 1 Detection of active ingredients of medicinal materials

[0084] The detection method of the active ingredient of the present invention basically adopts the content determination detection method of the "Chinese Pharmacopoeia". If the "Chinese Pharmacopoeia" does not specify, the method recorded in the known literature is adopted, as shown in Table 7. The sources of the medicinal materials used in the present invention are all authentic medicinal materials, and the relevant detection results (weight percentage) are shown in Table 7.

[0085] Table 7. Detection methods and results of active ingredients in medicinal materials

[0086]

[0087]

[0088] Test Example 2: Selection test of extraction efficiency of single medicinal material under ultrahigh pressure conditions

[0089] Purpose of the experiment: To obtain the ultra-high pressure conditions for the best extraction efficiency of single medicinal materials.

[0090] Experimental medicinal materials: Poria cocos, coix seed, quinoa ternata, hemp seed, cassia seed, hawthorn, mulberry leaf, lotus leaf, polygonatum, peach kernel, and yak glue.

[0091] Test method: Each medicinal material is divided into 9 cases, each of which includes a comparative example and an exemplary example. The comparative example adopts ultra-high pressure treatment with water as the medium, and the exemplary example adopts ultra-high pressure treatment without a medium. The ultra-high pressure treatment method is to apply high pressure to the same medicinal material within the pressure range of 50MPa to 850MPa, and the high pressure holding time can be adjusted within the range of 25 to 40 minutes.

[0092] Calculation method of extraction efficiency: Extraction efficiency refers to the weight percentage (%) of the measured amount of active ingredients in the extract (based on medicinal materials) to the measured amount of active ingredients in the medicinal materials, that is, the transfer rate of the active ingredients. "Based on medicinal materials" means converting the measured amount of active ingredients in the extract to the equivalent content of active ingredients in the medicinal materials. Calculation example:

[0093] The measured amount of component B in 1 kg of medicinal material A is 2.20%, so the amount of component B contained in 1 kg of medicinal material before extraction is 22.0 g.

[0094] After ultra-high pressure treatment of 1 kg of medicinal material A, 30.4 g of C extract is obtained. The measured amount of component B in the C extract is 63.44%. Therefore, the component B in 30.4 g of C extract after extraction is 19.3 g, which is equivalent to 19.3 g of component B in 1 kg of medicinal material A after extraction.

[0095] The extraction efficiency of the C extract obtained after the ultrahigh pressure treatment is 19.3 / 22.0*100%=87.73%, indicating that the extraction process transfers 87.73% of the B component from the A medicinal material to the C extract.

[0096] Test method: As shown in Table 7, for the medicinal materials containing multiple active ingredients in Table 7, the extraction efficiency is calculated according to the average value.

[0097] Test results: See Tables 8 to 9.

[0098] Table 8 Poria cocos ultra-high pressure condition selection test

[0099]

[0100] Table 9 Optimal ultrahigh pressure conditions for other medicinal materials

[0101]

[0102]

[0103] Results and discussion: According to Tables 8 and 9, the extraction effect of ultrahigh pressure treatment without medium is higher than that of ultrahigh pressure treatment with water as medium. The ultrahigh pressure conditions at 150MPa-450MPa and 25 minutes can improve the extraction efficiency of the target components of each medicinal material. Among them, the extraction efficiency of Prunus mume and yak glue treated alone is higher.

[0104] Test Example 3. Comparison of extraction efficiency between ultra-high pressure and traditional processes

[0105] Purpose of the experiment: To compare the extraction efficiency using the ultra-high pressure step with that using the traditional process.

[0106] Test samples: 1. Referring to the preparation method of the sterilized Chinese medicine culture medium obtained in Examples 1 to 9, the five-fingered hair peach and yak glue were treated with ultra-high pressure separately, and the difference was that Poria cocos, coix seeds, hemp seeds, cassia seeds, hawthorn, mulberry leaves, lotus leaves, polygonatum, and peach kernel were treated with ultra-high pressure (350MPa, 25 minutes) to obtain the compound powder and then prepare it into the Chinese medicine culture medium. 2. According to the traditional process dehumidification paste Example 1, the sterilized traditional process dehumidification paste was obtained. Test method: See Table 7.

[0107] Test results: as shown in Tables 10 to 12.

[0108] Table 10. Extraction efficiency of the main drug in different extraction processes

[0109]

[0110] Table 11. Extraction efficiency of different extraction processes

[0111]

[0112]

[0113] Table 12. Extraction efficiency of adjuvant drugs in different extraction processes

[0114]

[0115] Results and discussion: (1) The extraction efficiency of the dehumidifying paste of Examples 1 to 9 is higher than that of the dehumidifying paste of the traditional process, indicating that the ultrahigh pressure step has a higher extraction efficiency than the traditional process and has a higher transfer rate of effective ingredients. (2) The extraction efficiency of most medicinal materials is lower than that of the ultrahigh pressure treatment alone, suggesting that ultrahigh pressure treatment of medicinal materials alone is more conducive to improving the transfer rate of effective ingredients. (3) There is still a difference in the extraction efficiency of the Chinese medicine culture medium of Examples 1 to 4 and the Chinese medicine culture medium of Examples 5 to 9, indicating that the ultrahigh pressure conditions and the proportion of medicinal materials have a certain influence on the extraction efficiency of the effective ingredients of some medicinal materials (the total amount of pachymic acid and dehydropachymic acid, nuciferine, amygdalin, etc.), and these effective ingredients cannot be stably transferred to the extract simply by adjusting the ultrahigh pressure conditions.

[0116] Test Example 4 Fermentation Condition Selection Test

[0117] Purpose of the experiment: To obtain the fermentation conditions with the best extraction efficiency.

[0118] Test samples: the dehumidifying pastes of Examples 1 to 4 and the dehumidifying pastes of Control Examples 1 to 4.

[0119] Test method: As shown in Table 7, the extraction efficiency of "Pachycoric acid and total amount of dehydrogenated Pachycory (FLZL)", nuciferine and amygdalin was tested.

[0120] Test results: as shown in Table 13.

[0121] Table 13 Extraction efficiency of Examples 1 to 4 and Comparative Examples 1 to 4

[0122]

[0123]

[0124] Results and discussion: The extraction efficiency of "Total amount of pachymic acid and dehydrogenated pachymargine (FLZL)", nuciferine, and amygdalin of the dehumidifying paste of Examples 1 to 4 is further improved compared with that of Examples 1 to 4, indicating that at least the extraction efficiency of the main drug pachymargine, the ministerial drug lotus leaf, and the adjuvant drug peach kernel has been improved. The extraction efficiency of "Total amount of pachymargine and dehydrogenated pachymargine (FLZL)", nuciferine, and amygdalin of the dehumidifying paste of Examples 1 to 4 is better than that of Control Examples 1 to 4, indicating that the fermentation conditions have a great influence on the extraction efficiency of the main drug pachymargine, the ministerial drug lotus leaf, and the adjuvant drug peach kernel.

[0125] Test Example 6 Clinical Trial

[0126] From July 2017 to June 2018, 90 patients with damp-heat constitution were admitted and diagnosed by TCM differentiation of syndromes. They were randomly divided into three groups, 30 cases in each group. There were 14 females and 16 males in the low-dose group of Qingshi Paste, aged 28 to 50 years old, with an average age of (38.53±8.29) years old. There were 15 females and 15 males in the medium-dose group, aged 25 to 49 years old, with an average age of (36.33±6.26) years old. There were 16 females and 14 males in the high-dose group, aged 30 to 50 years old, with an average age of (39.25±6.96) years old. There was no significant difference in the general data among the three groups (P>0.05), and they were comparable.

[0127] Diagnostic criteria: TCM constitution assessment criteria. Experienced TCM physicians will make a double-blind assessment of the TCM constitution of the subjects, based on the calculation method of the TCM weight scale compiled by Professor Wang Qi and others (Classification and Determination of TCM Constitution is a book published by China Traditional Chinese Medicine Press in 2009, written by the Chinese Association of Traditional Chinese Medicine). The TCM meridian detector will analyze and determine whether the constitution is damp-heat.

[0128] Treatment method: ① Patients who meet the inclusion criteria are randomly divided into low, medium and high dose groups of Qingshi paste according to the inclusion time, and the drugs are administered in a ratio of 1:2:4. ② The Qingshi paste of Example 4, the prescription composition: Poria, coix seed, five-fingered peach, hemp seed, cassia seed, hawthorn, mulberry leaf, lotus leaf, polygonatum, peach kernel, yak glue. ③ Usage: 1 tablespoon (15-20g) each time, 2 times / d, 12 weeks as a course of treatment.

[0129] Observation indicators: ⑴ Background data observation (before the test): ① Demographic data: date of birth, gender, ethnicity, marital status, height, weight, smoking history, etc.; ② General clinical data: medical history, past medical history and medication history. ⑵ Safety observation indicators: General physical examination items: body temperature, blood pressure, resting heart rate, respiration, blood routine, urine routine, stool routine, liver function, kidney function, electrocardiogram, etc. The examination was recorded once before and after treatment. ⑶ Efficacy observation indicators: ① Symptoms: chest fullness, heaviness and drowsiness, lingering fever, short and dark urine, etc.; ② Physical signs: tongue and pulse; ③ Constitution identification results of TCM meridian detector; ④ TCM syndrome score.

[0130] TCM syndrome scoring standard: refer to the 2002 edition of "Guidelines for Clinical Research of New Chinese Medicines" for evaluation:

[0131] ⑴ Scoring method for main symptoms of traditional Chinese medicine: ① Scoring of body heaviness: 0 points - normal: none; 3 points - mild: occasional feeling of body heaviness; 6 points - moderate: obvious heaviness in the head and body; 9 points - severe: heaviness in the head, heaviness in the body and drowsiness.

[0132] ⑵ Scoring method for minor symptoms in traditional Chinese medicine: ① Fatigue scoring: 0 points - normal: none; 1 point - mild: slight fatigue; 2 points - moderate: obvious fatigue; 3 points - severe: severe fatigue. ② Chest tightness scoring: 0 points - normal: none; 1 point - mild: slight chest tightness; 2 points - moderate: obvious chest tightness, sighing from time to time; 3 points - severe chest tightness as if suffocating. ③ Bitter mouth scoring: 0 points - normal: none; 1 point - mild: occasional bitter mouth; 2 points - moderate: more severe bitter mouth in the morning; 3 points - severe: bitter mouth all the time. ④ Loose stool scoring: 0 points - normal: none; 1 point - mild: mild; 2 points - moderate: obvious; 3 points - severe: severe (Note: specific description of tongue and pulse will not be scored).

[0133] Efficacy evaluation criteria:

[0134] ⑴ TCM syndrome efficacy evaluation criteria (using nimodipine method), efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. ① Clinical cure: clinical symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; ② Marked effect: clinical symptoms and signs are significantly improved, efficacy index ≥ 70% and < 95%; ③ Effective: clinical symptoms and signs are improved, efficacy index ≥ 30% and < 70%; ④ Ineffective: clinical symptoms and signs are not significantly improved, or even aggravated, efficacy index < 30%.

[0135] ⑵ Criteria for judging the efficacy of a single symptom: ① Clinical control: symptoms basically disappear; ② Marked effect: symptoms are significantly improved; ③ Effective: symptoms are improved, and some symptoms are alleviated; ④ Ineffective: symptoms do not change, or the alleviation is not obvious, and symptoms worsen.

[0136] Statistical methods: The data were analyzed using SPSS17.0 software; the count data were expressed as [n(%)] and the chi-square test was used; the measurement data were expressed as (x±s) and the t-test was used; P<0.05 was considered statistically significant.

[0137] result

[0138] Comparison of TCM syndrome efficacy evaluation before and after treatment among the three groups of patients: The patients with damp-heat constitution showed significant efficacy after taking Qingshi Paste, with a total effective rate of over 90%; and the middle and high dose groups were better than the low dose group, with a statistically significant difference (P < 0.05); there was no statistically significant difference in efficacy between the middle and high dose groups (P > 0.05). See Table 14.

[0139] Table 14 Comparison of TCM syndrome efficacy evaluation before and after treatment among the three groups of patients (n)

[0140]

[0141]

[0142] Comparison of the efficacy of body weight in the three groups of patients before and after treatment: the symptoms of body weight in patients with damp-heat constitution were significantly improved after taking Qingshi Paste, and the total effective rate was above 93.3%; the middle and high dose groups were better than the low dose group, and the difference was statistically significant (P < 0.05); the comparison of the efficacy between the middle and high dose groups showed no statistically significant difference (P > 0.05). See Table 15.

[0143] Table 15 Comparison of body weight effects before and after treatment in three groups of patients (cases)

[0144]

[0145] Comparison of fatigue efficacy before and after treatment among the three groups of patients: After taking Qingshi Paste, fatigue symptoms of patients with damp-heat constitution were significantly improved, with a total effective rate of more than 93.3%; the middle and high dose groups were better than the low dose group, with a statistically significant difference (P < 0.05); There was no statistically significant difference in efficacy between the middle and high dose groups (P > 0.05). See Table 16.

[0146] Table 16 Comparison of fatigue efficacy among three groups of patients before and after treatment (cases)

[0147]

[0148] Result discussion: The clinical trial results show that the dehumidifying paste of the present invention has a very obvious intervention effect on damp-heat constitution, and can significantly improve the symptoms of body heaviness, fatigue, etc. of damp-heat constitution, and the paste is very safe and can be taken for a long time.

[0149] Although the present invention has been described in detail above by general description, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. A dehumidifying cream, characterized in that: The preparation method of the dehumidifying paste includes an ultra-high pressure step and a fermentation step. The raw materials used in the ultra-high pressure step include: an effective dose of dehumidifying medicinal materials, the dehumidifying medicinal materials include one or more of Poria cocos, Coix seeds, and Eleutherodactyl quinquefolius; an effective dose of liver-nourishing yin / intestine-moistening and laxative medicinal materials, the liver-nourishing yin / intestine-moistening and laxative medicinal materials include one or more of hemp seeds, mulberry leaves, and lotus leaves; the composition of the composite fermentation bacteria used in the fermentation step includes: brewer's yeast, plant lactobacillus, and bifidobacterium breve in a weight ratio of 0.2-20:0.2-20:0.1-10, preferably: the weight ratio is 2:2:

1.

2. The dehumidifying paste according to claim 1, characterized in that: The raw materials used in the ultra-high pressure step also include: an effective dose of adjuvant medicinal materials, the adjuvant medicinal materials include one or more of an effective dose of digestive and stomachic medicinal materials, an effective dose of qi-invigorating and dehumidifying medicinal materials, an effective dose of qi-invigorating and dehumidifying medicinal materials, an effective dose of qi-invigorating and yin-nourishing medicinal materials, and an effective dose of blood-nourishing and yin-nourishing medicinal materials; preferably, the digestive and stomachic medicinal materials include hawthorn, the qi-invigorating and dehumidifying medicinal materials include cassia seed and peach kernel, the qi-invigorating and yin-nourishing medicinal materials include polygonatum, and the blood-invigorating and yin-nourishing medicinal materials include yak glue.

3. The dehumidifying paste according to any one of claims 1 to 2, characterized in that: The raw materials used in the ultra-high pressure step include: 1-10 parts by weight of Poria cocos, 1-10 parts by weight of Coix seeds, 1-10 parts by weight of Prunus mume, 1-10 parts by weight of Hemp seeds, 1-10 parts by weight of Cassia seeds, 6-20 parts by weight of Hawthorn, 1-10 parts by weight of Mulberry leaves, 1-10 parts by weight of Lotus leaves, 2-12 parts by weight of Polygonatum sibiricum, 1-10 parts by weight of Peach kernel, and 0.1-1 parts by weight of yak glue; preferably: 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Prunus mume, 4.1 parts by weight of Hemp seeds, 4.1 parts by weight of Cassia seeds, 13 parts by weight of Hawthorn, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Peach kernel, and 0.3 parts by weight of yak glue.

4. The dehumidifying paste according to any one of claims 1 to 3, characterized in that: The ultra-high pressure conditions of the ultra-high pressure step are: pressure 50MPa-850MPa; holding time 25 to 40 minutes; preferably include any one of the following groups: the ultra-high pressure conditions of the Poria cocos are pressure 350MPa and holding time 25 minutes; the ultra-high pressure conditions of the Coix seeds are pressure 400MPa and holding time 25 minutes; the ultra-high pressure conditions of the five-fingered peach are pressure 450MPa and holding time 25 minutes; the ultra-high pressure conditions of the hemp seeds are pressure 400MPa and holding time 25 minutes; the ultra-high pressure conditions of the Cassia seeds are pressure 3 The ultra-high pressure condition of the hawthorn is 300MPa and 25 minutes; the ultra-high pressure condition of the mulberry leaf is 400MPa and 25 minutes; the ultra-high pressure condition of the lotus leaf is 350MPa and 25 minutes; the ultra-high pressure condition of the polygonatum is 400MPa and 25 minutes; the ultra-high pressure condition of the peach kernel is 450MPa and 25 minutes; the ultra-high pressure condition of the yak glue is 400MPa and 25 minutes.

5. The dehumidifying paste according to any one of claims 1 to 4, characterized in that: The ultra-high pressure step further includes one or more of a crushing step and a mixing step; wherein the crushing step obtains a single medicinal powder comprising any one of the raw materials; and the mixing step obtains a compound medicinal powder comprising a plurality of the raw materials; preferably, the compound medicinal powder includes single medicinal powder of Poria cocos, single medicinal powder of Coix seeds, single medicinal powder of Cannabis sativa seeds, single medicinal powder of Cassia seeds, single medicinal powder of Hawthorn, single medicinal powder of Mulberry leaves, single medicinal powder of Lotus leaves, single medicinal powder of Polygonatum sibiricum and single medicinal powder of Peach kernel.

6. The dehumidifying paste according to any one of claims 1 to 5, characterized in that: The culture medium used in the fermentation step includes: the compound medicinal powder with a weight ratio of 25% to 65%, the single medicinal powder of quinquefolius with a weight ratio of 1% to 5%, the single medicinal powder of yak glue with a weight ratio of 0.4% to 0.8%, the weight ratio of high fructose corn syrup of 20% to 60%, and the balance of distilled water; preferably: the compound medicinal powder with a weight ratio of 45%, the single medicinal powder of quinquefolius with a weight ratio of 2%, the single medicinal powder of yak glue with a weight ratio of 0.6%, the weight ratio of high fructose corn syrup of 40%, and the balance of distilled water.

7. The dehumidifying paste according to any one of claims 1 to 6, characterized in that: The fermentation step comprises: inoculating the culture medium with the composite fermentation bacteria at a dosage of 0.3-10%, shaking the culture medium at a constant temperature in an incubator, and fermenting at 28-38°C for 12-72 hours; preferably, inoculating the culture medium with the composite fermentation bacteria at a dosage of 3%, shaking the culture medium at a constant temperature in an incubator, and fermenting at 33°C for 48 hours.

8. The dehumidifying paste according to any one of claims 1 to 7, characterized in that: The fermentation step may be followed by one or more of a filtration step or a centrifugation step.

9. A traditional dehumidifying paste, characterized in that: The traditional dehumidifying paste is mainly prepared from 4.1 parts by weight of Poria cocos, 4.1 parts by weight of Coix seeds, 1 part by weight of Prunus quinquefolia, 4.1 parts by weight of Cannabis sativa seeds, 4.1 parts by weight of Cassia seeds, 13 parts by weight of Crataegus pinnatifida, 4.1 parts by weight of Mulberry leaves, 4.1 parts by weight of Lotus leaves, 5.3 parts by weight of Polygonatum sibiricum, 4.1 parts by weight of Peach kernels, and 0.3 parts by weight of yak glue. The traditional dehumidifying paste includes a decoction (paste), a fluid extract, or an extract.

10. Use of the dehumidifying paste according to any one of claims 1 to 8 in the preparation of dehumidifying medicines, wherein the dehumidifying medicines include a pharmaceutical composition having a very obvious intervention effect on damp-heat constitution.

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