CN102860505A - Korean medicinal healthcare food composition with effect of assisting in protecting gastric mucosa, and preparation method and use thereof - Google Patents

Abstract

The invention provides a Korean medical health food composition with the function of assisting in protecting the gastric mucosa, which is a preparation prepared from coix seed, dried chestnut, radish seed, schisandra, Ophiopogon japonicus and platycodon grandiflorum as raw materials. The invention also provides the preparation method and application of the composition. The composition of the invention is based on the theory of health preservation of Chinese Korean medicine, based on the clinical prescriptions of Korean medicine for preventing and treating stomach diseases, and screens out the formula that meets the raw material requirements of health food. For "Taiyin people" who are prone to respiratory and digestive system diseases caused by weak lungs and excessive liver, the purpose of preventing gastric mucosal damage is achieved by nourishing the lungs and regulating the stomach, exorcising evil and eliminating food, and adjusting the function balance between the lungs, stomach and liver. A new option is provided for the development of health food.

Description

A Chaoyue health food composition with the function of assisting in the protection of gastric mucosa, its preparation method and application

technical field

The invention relates to a health food composition, in particular to a Korean medical health food composition with the function of assisting in protecting the gastric mucosa, its preparation method and application, and belongs to the field of research, production and use of health food. the

Background technique

The present invention is based on the health preservation theory of Chinese Korean medicine and according to the provisions of the "Health Food Registration Management Measures", develops a health food composition with the function of assisting in protecting gastric mucosa and a preparation method thereof. The formula of the composition is mainly based on the proven prescription for preventing and treating stomach diseases in Korean medicine, and the specific ingredients are derived from commonly used medicinal and edible plants. the

The incidence of gastrointestinal diseases in my country accounts for about 10% to 12% of the population, about 130 million to 160 million people. About 40% of them suffer from gastrointestinal diseases for a long time. As the age increases, the condition continues to deteriorate, and some patients may also develop cancer. the

Gastric mucosal damage is often caused by chemical factors (smoking, drinking, strong tea, coffee, and drugs that irritate the gastric mucosa such as aspirin, indomethacin, etc.), physical factors (too cold, too hot, too rough food or overeating) etc.), bacteria or their toxin stimulation and other factors. No matter what kind of invasive factors, the gastric mucosal injury caused by it shows a programmed injury response: first, the superficial mucosal injury is caused by the shedding of the superficial epithelium; further development of the injury, the injury of microvascular endothelial cells will lead to mucosal ischemia, Oxygen, tissue necrosis, resulting in deep mucosal damage (erosion or ulceration). The damage of the defense function of the gastric mucosa is an important factor in the formation of ulcers. Strengthening the defense ability of the mucosa and promoting the repair of the mucosa are one of the important links in the treatment of peptic ulcer. Colloidal bismuth, prostaglandins, epidermal growth factor, sucralfate, levodopa and other drugs are often used in Western medicine to treat gastric mucosal injury, all of which have certain curative effects, but at the same time there are problems such as easy recurrence and relatively large side effects. the

The understanding of gastric mucosal injury in traditional Chinese medicine is mainly based on the theory of spleen and stomach in traditional Chinese medicine. Domestic research results on the theory of spleen and stomach have proved that the spleen and stomach in traditional Chinese medicine are closely related to the digestive system and immune function of the human body. The spleen and stomach are closely related to the local defense function of the digestive system, especially the anti-injury ability of the gastric mucosa. Protection has a role. the

Chinese Korean medicine is gradually formed and developed on the basis of the inherent cultural foundation of the Korean nationality and Eastern medicine, absorbing the theory of traditional Chinese medicine, and combining the experience of the nation's disease prevention and treatment. Korean medicine is guided by the theory of "heaven, man, world, and earth" as a whole, with the structure of "four-dimensional four images" as the main form, and a diagnosis and treatment science that combines image discrimination (physical constitution, disease) and dialectics. The theory of Korean medicine believes that "Taiyin people" account for more than 50% of Sixiang people. Taiyin people have large livers and small lungs. The formula of this product is mainly based on the proven prescription "Taiyin Tiaowei Decoction" for the prevention and treatment of gastrointestinal diseases in Taiyin people. Disease curative effect is remarkable. Korean medicine believes that the protection of gastric mucosa lies in "nourishing" rather than "curing". Appropriate dietary content and good eating habits are important measures to prevent gastric mucosal damage. The diet that strongly stimulates the gastric mucosa should be limited, and the diet should be used to reduce or increase the secretion of gastric acid to regulate gastric function. the

The formula of this product is mainly based on "Taiyin Tiaowei Decoction", a proven prescription of Korean medicine for preventing and treating gastrointestinal diseases in Taiyin people, with appropriate additions and subtractions. Dual-purpose plants are used as raw materials. the

In the formula, dried chestnut is a common food, coix seed, radish seed, platycodon grandiflorum are both food and medicine items, Schisandra chinensis and Ophiopogon japonicus are items that can be used as health food. The composition of all medicinal flavors in the formula meets the requirements of health food on the source of raw materials. the

Coix seed is the dried and mature seed kernel of Coix lacryma-jobi L.var.ma-yuan (Roman) Stapf, a plant of Gramineae. Properties: sweet, light, cool. Return spleen, stomach, lung meridian. It has the effects of diuresis and swelling, expelling dampness, invigorating the spleen and eliminating numbness, clearing away heat and expulsing pus, and is a good product for body tonic. Li Shizhen recorded in "Compendium of Materia Medica": "Coix seed, a yangming medicine, can strengthen the spleen and nourish the stomach. If it is deficient, it can nourish its mother, so it is used for lung impotence and lung abscess." Chinese medicine believes that coix seed has diuresis, dampness, and health. Spleen antidiarrheal, eliminating numbness and detumescence, clearing away heat and expulsion of pus and other effects. Traditionally used to treat short red urine, edema and beriberi; fever, lung abscess, intestinal abscess; spleen deficiency and dampness, diarrhea; rheumatic arthralgia, tendon spasm and other diseases. Korean doctors believe that coix seed is an important medicine for Taiyin people, and it has the effect of opening the stomach qi in the lungs and promoting digestion. It is mainly used to treat Taiyin people with cold syndrome, that is, typhoid fever, headache, body pain, anhidrosis, and nausea due to food stagnation. "Taiyin Tiaowei Decoction" is used to dispel cold and relieve the exterior, invigorate the spleen and eliminate food, and treat the syndrome of coldness in the exterior of the Taiyin. Modern research shows that coix seed contains amino acids, coixin, coixin, triterpenoids, protein, fat, carbohydrates, and various vitamins and minerals. Coix seed diet therapy has the effect of promoting metabolism and reducing gastrointestinal burden, and can be used as a tonic food for weak patients during or after illness. Consuming raw barley soup is good for dehumidification and wind removal. It is used to strengthen the spleen and stomach, and to treat diarrhea due to spleen deficiency. It must be fried and eaten. the

Dried chestnut is the dried kernel of Castanea mollissima BL. Commonly known as chestnuts, it is a special product in my country and has the reputation of "the king of dried fruits". It is also called "ginseng fruit" abroad. "Famous Doctors" records that chestnuts: "mainly benefit qi, thicken stomach, nourish kidney qi, and make people endure hunger." "Food Materia Medica" records: "mainly replenish qi, thicken intestines and stomach, nourish kidney qi, and make people endure hunger." Dried chestnut is a kind of dried fruit with high carbohydrate content. It contains unsaturated fatty acids and multivitamins, which have the effect of fighting hypertension, coronary heart disease, arteriosclerosis and other diseases. From the medicinal point of view, chestnut fruit is a good product for invigorating the kidney, and has the functions of invigorating the spleen and replenishing qi, clearing heat and detoxifying, relieving diarrhea and treating cough. Korean doctors believe that dried chestnut is a commonly used medicine for Taiyin people. It has the stomach qi of opening the lungs and helps digestion, nourishing the spleen and stomach. The effect of hemostasis. It is mainly used for Taiyin people with stagnation of food, fullness, heel weakness, indigestion, lack of appetite and dysentery; it is also used for abdominal distension and edema caused by spleen deficiency. "Eastern Medicine Sixiang New Edition" records: "Huang Lichun Genpi Decoction" has the effects of nourishing the spleen and stomach, clearing away heat and detoxifying. Dried chestnut diet therapy can provide more heat energy to the human body and help fat metabolism. Guarantee the supply of basic nutrients for the body. It is known as "hardcore crops" and "woody grains". Modern studies have shown that dried chestnuts contain a large amount of starch, rich in protein, fat, B vitamins, calcium, phosphorus, iron, potassium and other inorganic salts, unsaturated fatty acids and other ingredients. the

Raphanus sarivus L is the mature seed of cruciferous plant radish Raphanus sarivus L. Properties of medicine: pungent, sweet, flat. Return lung, spleen, stomach warp. It has the effect of eliminating indigestion and swelling, reducing qi and reducing phlegm. Traditional Chinese medicine is often used for food stagnation, abdominal distension and pain, constipation, stagnant diarrhea, phlegm congestion, wheezing and coughing and other diseases. Li Shizhen recorded in "Compendium of Materia Medica": "Exerting Qi to calm asthma, cure phlegm, eliminate food, eliminate swelling, facilitate defecation, stop gas pain, severe diarrhea after diarrhea, and sore rash." The doctor of the dynasty believes that radish has the stomach to open the lungs The effect of eating and digesting with qi can help coix seed enhance the power of digestion. It is mainly used for cough, wheezing, and chest and abdominal pain in Taiyin people. It is also used for qi headache, no sweat, and feeling full after eating during typhoid fever. Modern studies have shown that radish seeds contain fatty oil, volatile oil, fatty oil, radish and other components, which can promote the emptying of the gastrointestinal tract. the

Schisandra chinensis is the mature fruit of Schisandra chinesis (Turcz.) Bail or Schisandra sphenanthera Rehd.et Wils. Properties: acid, sweet, warm. Return lung, heart, kidney channel. It has the effects of astringent and astringent, nourishing qi and promoting body fluid, invigorating the kidney and calming the heart. It is used to treat diseases such as chronic cough, dyspnea due to deficiency, lack of fluid, dry mouth, spermatorrhea and diarrhea, forgetfulness and insomnia. According to modern medicine, schisandra can regulate the excitation and inhibition process of the central nervous system, promote body metabolism, regulate gastric juice and bile secretion, and reduce transaminase levels in convalescent hepatitis patients. It can regulate the secretion of gastric juice, excite the uterus, improve vision and hearing, and improve the discrimination ability of skin receptors. According to the doctor of the dynasty, schisandra is used by Taiyin people, and it has the effect of invigorating the lungs. It is mainly used for Taiyin people with cough, thirst, hyperhidrosis, heart palpitations, insomnia, and dreaminess. This product has the function of strengthening the lungs, and it is often used with Ophiopogon japonicus, Platycodon grandiflorum, etc. Modern research shows that schisandra is rich in organic acids, vitamins, flavonoids, phytosterols and lignans with strong restoration effects (such as schisandrin A, schisandrin B or schisandrin). It is one of the few medicinal materials for the three major benefits of qi and spirit. It can nourish qi and strengthen the liver, improve the efficiency of cells to eliminate waste, supply more oxygen, create and use energy, and improve memory and sexual endurance. the

Ophiopogon japonicus (Thumb.) Ker-Gawl. is the root tuber of Ophiopogon japonicus (Thumb.) Ker-Gawl. Properties of medicine: sweet, slightly bitter, slightly cold. Return stomach, lung, heart channel. It has the effects of nourishing yin and promoting body fluid, moistening the lungs and clearing the heart. It can be used for dry cough due to dryness of the lung, lung abscess, cough due to yin deficiency, thirst for fluid wounds, diabetes, vexation and insomnia, sore throat, dryness of the intestine, constipation, blood heat and vomiting of nosebleeds. "Materia Medica Huiyan" records: "The medicine for clearing the heart and nourishing the lungs. It is mainly used for lack of heart energy, palpitations, forgetfulness, trance, mental loss; or lung heat and dryness, continuous coughing; or dryness of the spleen and stomach, constipation and difficulty in defecation." "New Compendium of Materia Medica" records: Ophiopogon japonicus, relieves volts in the lungs, clears heat evils in the stomach, nourishes heart qi for strained injuries, stops vomiting in the home, improves essence and strengthens yin, relieves annoyance and quenches thirst, beautifies color, Pleasant skin, relieves deficiency and heat, relieves dryness of the lungs, calms coughs, it can really be used as a king and can be used as an envoy. According to the traditional Chinese medical science, Ophiopogon japonicus is a medicine used by Taiyin people, and it has the effects of nourishing the lungs and lungs, clearing away heat and moistening dryness. It is mainly used as a conditioning agent for Taiyin people after illness, as well as heat stroke, polydipsia, and summer sickness. the

Campanulaceae is the root of Campanulaceae Platycodon grandiflorum (Jacq.) A.DC. Properties of medicine: bitter, pungent, flat. Return lung meridian. It has the effects of promoting the lung, eliminating phlegm, relieving the throat and draining pus. "Shen Nong's Materia Medica" records: "Pain in the chest and hypochondrium is like a stabbing knife, abdominal fullness and bowel sounds are faint, and panic and palpitations." Modern medicine believes that bellflower contains a variety of saponins, inulin, and phytosterols. The crude platycodon saponins have sedative, analgesic, antipyretic and other central inhibitory effects, and have anti-inflammatory, antitussive and expectorant effects, dilating blood vessels, lowering blood pressure, and anti-ulcer effects. According to the doctor of the imperial court, platycodon grandiflorum is a medicine used by Taiyin people. It has the power to strengthen the lungs and fight against the outside world. It can disperse external evils and benefit the throat. Campanulaceae can also be made into delicious dishes, and it is very common as edible vegetables in North Korea, South Korea, Japan and Northeast my country. the

At present, there is no health food with a formula based on the Chinese Korean medical health preservation theory listed on the market, and no health food patents and research reports similar to the formula of the composition of the present invention have been found in the search of Chinese patents and literature databases. The design theory and thinking of the composition of the present invention are innovative. Based on the invention, the health food with the function of assisting in protecting the gastric mucosa is developed, and the market demand prospect is broad. the

Contents of the invention

The technical solution of the present invention provides a health food composition with the function of assisting in protecting the gastric mucosa based on the health preservation theory of Chinese Korean medicine. become. The invention also provides the preparation method and application of the compound health food composition. the

The present invention provides a kind of medical health food composition with auxiliary protection gastric mucosa, it is the preparation that is made of the raw material of following weight ratio:

Coix seed 3-45 parts, dried chestnut 3-45 parts, radish seed 2-30 parts, schisandra 1-15 parts, Ophiopogon japonicus 1-15 parts, bellflower 1-15 parts. the

Further preferably, it is a preparation made of the raw materials of the following weight ratio:

Coix seed 15 parts, dried chestnut 15 parts, radish seed 10 parts, schisandra 5 parts, Ophiopogon japonicus 5 parts, bellflower 5 parts. the

The health food composition of the present invention is composed of coix seed, radish seed, schisandra, Ophiopogon japonicus, platycodon grandiflorum extract and dried chestnut or dried chestnut extract as active ingredients, plus acceptable auxiliary materials or auxiliary ingredients for health food. Preparations made from ingredients. the

Wherein, the preparation is: powder, granule, tablet, chewable tablet, capsule, oral liquid, paste, concentrated liquid, ointment, soup, cake. the

The present invention also provides the preparation method of this health food composition, it comprises the steps:

(1) Weigh the raw materials in proportion by weight: Coix seed 3-45 parts, dried chestnut 3-45 parts, radish seed 2-30 parts, Schisandra 1-15 parts, Ophiopogon japonicus 1-15 parts, bellflower 1-15 parts share;

(2) Take coix seed, radish seed, Schisandra chinensis, Ophiopogon japonicus, Platycodon grandiflorum and extract with water or organic solvent to obtain extract 1, take dried chestnut, grind it into fine powder, and pass through a 100-mesh sieve to obtain dried chestnut powder, or take coix coix seed Kernel, dried chestnut, radish seed, schisandra, Ophiopogon japonicus, platycodon grandiflorum are extracted with water or organic solvent to obtain extract 2;

(3) Take extract 1 and dry chestnut powder and mix, add acceptable auxiliary materials or auxiliary ingredients in health food, and make preparations respectively according to the corresponding molding process, or take extract 2 and add acceptable auxiliary materials or auxiliary ingredients in health food Auxiliary components are made into preparations according to the corresponding molding process. the

The health food composition of the present invention is based on the health preservation theory of Chinese Korean medicine, based on the clinical prescriptions of Korean medicine for preventing and treating stomach diseases, and screens out the formula that meets the raw material requirements of health food. The specific ingredients are derived from commonly used medicinal and edible plants. For "Taiyin people" who are prone to respiratory and digestive system diseases caused by weak lungs and excessive liver, the purpose of preventing gastric mucosal damage is achieved by nourishing the lungs and regulating the stomach, exorcising evil and eliminating food, and adjusting the function balance between the lungs, stomach and liver. A new option is provided for the development of health food. the

Detailed ways

The present invention will be described in more detail below in conjunction with experimental examples and examples. the

Example 1

The health food of the present invention is made from the raw materials of the following weights: Coix seed 300g, dried chestnut 300g, radish seed 200g, Schisandra chinensis, Ophiopogon japonicus and Platycodon grandiflorum each 100g. the

And, the health food of the present invention is prepared through the following stages:

(1) Take the coix seed, radish seed, schisandra, Ophiopogon japonicus, and Platycodon grandiflorum of the above weight, add water to decoct and extract twice, filter, and combine the filtrate to obtain the extract, which is obtained after being refined by adsorption clarification or ultracentrifugation Refined liquid, refined liquid concentrated under reduced pressure and vacuum-dried at 80°C to obtain dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder, and set aside;

(2) Process dried chestnuts into powder, pass through a 100-mesh sieve to obtain dried chestnut powder, and set aside;

(3) Mix 300 g of dried chestnut powder with the above-mentioned extract powder, add an appropriate amount of lactose as a filler, mix evenly, use 50% ethanol as a wetting agent to make a soft material, pass through a 18-mesh sieve to granulate by extrusion, and dry. Sieve through a 16-mesh sieve to obtain granules. the

Implementation example 2

The health food of the present invention is made of the following raw materials: 300g of coix seed, 200g of dried chestnut, 150g of radish seed, 100g of Schisandra chinensis, Ophiopogon japonicus and Platycodon grandiflorum. the

And, the health food of the present invention is prepared through the following stages:

(1) Take the coix seed, radish seed, schisandra, Ophiopogon japonicus, and Platycodon grandiflorum of the above weight, add water to decoct and extract twice, filter, and combine the filtrate to obtain the extract, which is obtained after being refined by adsorption clarification or ultracentrifugation Refined liquid, refined liquid concentrated under reduced pressure and vacuum-dried at 80°C to obtain dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder, and set aside;

(2) Process dried chestnuts into powder, pass through a 100-mesh sieve to obtain dried chestnut powder, and set aside;

(3) Take 200g of dried chestnut powder and mix with the above-mentioned extract powder, add an appropriate amount of lactose as a filler, mix well, use 2.5% starch slurry as a wetting agent to make a soft material, pass through a 18-mesh sieve to granulate by extrusion, and dry , passed through a 16-mesh sieve for granulation to obtain dry granules, and the dry granules were compressed with a tablet machine to obtain chewable tablets. the

Implementation example 3

The health food of the present invention is made of the following raw materials: 300g of coix seed, 100g of dried chestnut, 100g of radish seed, 100g of Schisandra chinensis, Ophiopogon japonicus and Platycodon grandiflorum. the

And, the health food of the present invention is prepared through the following stages:

(1) Take the coix seed, radish seed, schisandra, Ophiopogon japonicus, and Platycodon grandiflorum of the above weight, add water to decoct and extract twice, filter, and combine the filtrate to obtain the extract, which is obtained after being refined by adsorption clarification or ultracentrifugation Refined solution, refined solution concentrated under reduced pressure to obtain concentrated solution, for subsequent use;

(2) Process dried chestnuts into powder, pass through a 100-mesh sieve to obtain dried chestnut powder, and set aside;

(3) Put 50g of agar into 20 times concentrated solution, soak for 10 hours, heat until dissolved, add cyclamate and natural preservatives, stir well, heat to 80°C, add 100g of dried chestnut powder, stir evenly, and press Sterilize, cool to 80°C and inject into molds to obtain soup. the

Implementation example 4

The health food of the present invention is made of the following raw materials: 200g of coix seed, 250g of dried chestnut, 150g of radish seed, 100g of Schisandra chinensis, Ophiopogon japonicus and Platycodon grandiflorum. the

And, the health food of the present invention is prepared through the following stages:

(1) Take coix seed, radish seed, Schisandra chinensis, Ophiopogon japonicus, Platycodon grandiflorum, and dried chestnut, decoct and extract twice, filter, and combine the filtrate to obtain the extract. The extract is clarified by adsorption or ultracentrifugation After refining, the refined liquid is obtained, and the refined liquid is vacuum-dried at 80°C after being concentrated under reduced pressure to obtain a dry extract, which is pulverized and passed through a 100-mesh sieve to obtain an extract powder, which is set aside;

(2) Take the above-mentioned extract powder and add appropriate amount of dextrin as a filler, mix well, use 60% ethanol as a wetting agent, and adopt a one-step granulation method to obtain dry granules, which are filled into capsules to obtain capsules. the

Experimental example 1 Identification of Chinese herbal medicines in chewable tablets

(1) Thin-layer identification of Schisandra chinensis Take 10g of the powder of this product, add 80mL of chloroform, heat to reflux for 30 minutes, filter, evaporate the filtrate to dryness, add 1mL of chloroform to dissolve the residue, and use it as the test solution. Take 2 g of Schisandra chinensis reference medicinal material, and make a reference medicinal material solution in the same way. Then take Schizandrin A reference substance, add chloroform to make a solution containing 1mg per 1mL, as the reference substance solution. Take 2 g of the preparation lacking Schisandra chinensis, and make a negative control solution in the same way. According to the thin-layer chromatography (Appendix VIB of the 10th edition of the Chinese Pharmacopoeia), the above-mentioned four kinds of solutions were drawn, and they were respectively spotted on the same silica gel GF ₂₅₄ thin-layer plate. : 5: 1) The upper layer solution is the developer, developed, taken out, dried in the air, and inspected under ultraviolet light (254nm). Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots.

(2) Ophiopogon japonicus thin-layer identification Take 4g of this product powder, add chloroform-methane (7:3) mixed solution 40mL, soak for 3 hours, ultrasonicate for 30 minutes, let cool, filter, the filtrate is evaporated to dryness, and the residue is added Dissolve 0.5mL of chloroform as the test solution. Take 2 g of Ophiopogon japonicus as reference medicinal material, and prepare the reference medicinal material solution in the same way. Take 2 g of the preparation lacking Ophiopogon japonicus, and make a negative control solution in the same way. According to the thin-layer chromatography test, draw the above three solutions, respectively point on the same silica gel G thin-layer plate, use toluene-methanol-glacial acetic acid (80:5:0.1) as the developer, develop, take out, dry in the air, spray Develop color with 10% H ₂ SO ₄ solution, and inspect under fluorescent light. Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots.

(3) Platycodon grandiflora thin-layer identification Take 4g of this product powder, add 7% sulfuric acid ethanol-water (7:3) mixed solution 50mL, reflux for 3 hours, let cool, shake and extract twice with chloroform, 30mL each time, Discard the lotion, dehydrate the chloroform solution with anhydrous sodium sulfate, filter, evaporate the filtrate to dryness, add methanol 1mL to dissolve the residue, and use it as the test solution. Take 2 g of Platycodon grandiflorum as the reference medicinal material, and prepare the reference medicinal material solution in the same way. Another 2 g of the preparation lacking Platycodon grandiflorum was taken, and the negative control solution was prepared in the same way. According to the thin-layer chromatography test, draw the above three solutions, respectively point on the same silica gel G thin-layer plate, use chloroform-ether (2:1) as the developer, develop, take out, dry in the air, and spray with 10% Sulfuric acid ethanol solution, heated at 105°C until the spots are clearly colored. Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots. the

(4) Thin-layer identification of radish seeds Take 10g of the powder of this product, add 100mL of ether, heat and reflux for 1 hour, discard the ether solution, evaporate the medicine residue to dryness, add 100mL of methanol, heat and reflux for 1 hour, filter, and the filtrate is evaporated to dryness. Add methanol 2mL to dissolve, as the test solution. Take radish seed reference medicinal material 1g, and prepare the reference medicinal material solution in the same way. Take 2 g of the radish seed-deficient preparation, and make a negative control solution in the same way. Then take the sinapine cyanate reference substance, add methanol to make a solution containing 1mg per 1mL, as the reference substance solution. According to the thin-layer chromatography test, draw 3-5 μl of each of the above four solutions, and spot them on the same silica gel G thin-layer plate respectively, and use the upper layer solution of ethyl acetate-formic acid-water (10:2:3) as the developer. Unfold it, take it out, dry it, and inspect it under a UV lamp (365nm). In the chromatogram of the test product, at the position corresponding to the chromatogram of the control medicinal material, there are fluorescent spots of the same color. Spray 10% ethanol sulfuric acid solution with 1% vanillin, and heat until the spots develop clear color. Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots. the

(5) Coix Seed Take 10g of the powder of this product, add petroleum ether (60-90℃) 50mL, ultrasonically extract for 30min, filter, evaporate the filtrate to dryness, add petroleum ether (60-90℃) 1mL to dissolve the residue, and use it as the test product solution. Take 2 g of coix seed as the reference medicinal material, and make the same method as the reference medicinal material. Take 2 g of "Taiyin Tiaowei Decoction" granules without coix seed, and make a negative control solution in the same way. According to the thin-layer chromatography test, draw 10 μl of each of the above three solutions, spot them on the same silica gel G thin-layer plate, use petroleum ether-ethyl acetate-acetic acid (10:3:0.1) as the developer, develop, take out, Allow to dry and inspect under UV light (365nm). Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots. the

(6) Dry chestnut Take 4g of the powder of this product, add 40mL of chloroform, heat to reflux for 30min, filter, evaporate the filtrate to dryness, add 1mL of chloroform to the residue to dissolve, and use it as the test solution. Take 2 g of dried chestnut as reference medicinal material, and prepare the reference medicinal material solution in the same way. Take 2 g of "Taiyin Tiaowei Granules" of Wuganli, and make a negative control solution in the same way. Draw the above three solutions, respectively spot on the same silica gel G thin-layer plate, use the upper layer solution of petroleum ether (30-60°C)-ethyl acetate-formic acid (15:5:1) as the developer, develop, take out, Dry it in the air, spray it with 10% sulfuric acid solution, and heat it at 105°C until the color of the spots is clear. Results At the corresponding position of the chromatogram of the control medicinal material, the chromatogram of the test product showed spots of the same color, while the negative control product had no corresponding spots. the

Experimental Example 2 Determination of Total Flavonoids in Chewable Tablets

The content of total flavonoids in chewable tablets was determined by ultraviolet spectrophotometry. the

1 Preparation of solution

1.1 Sample solution

Grind this product finely, accurately weigh 0.5g, add ethanol to dilute to 25mL, shake well, sonicate for 20min, let stand, and filter through a microporous membrane to obtain a sample solution. the

1.2 The test solution

Precisely measure 1mL of the sample solution in an evaporating dish, add 1g of polyamide powder for adsorption, evaporate ethanol in a water bath or incubator, then transfer to a chromatography column, first elute with 20mL of petroleum ether, discard the petroleum ether solution, and then Elute with methanol, collect the methanol solution, evaporate to dryness under reduced pressure, dissolve in methanol and dilute to 25 mL. the

1.3 Reference substance solution

Accurately weigh 5 mg of rutin reference substance, dissolve it with methanol ultrasonically, and dilute to 100 mL to obtain a 0.05 mg·mL ^-1 reference substance solution.

2. Linear relationship investigation Measure the reference solution 1, 2, 3, 4, 5, 6, 7mL respectively in a 10mL volumetric flask, add methanol to the mark, shake well, and measure the absorbance at 256nm. Linear regression was performed with reference substance solution concentration (X) and absorbance value (Y), and the regression equation was Y=0.013X-0.0171, r=0.9996 (n=7). The results showed that within the range of 0.05-0.35 mg·mL ^-1 the concentration of the reference substance had a good linear relationship with the absorbance value.

3 Precision inspection The reference substance solution was accurately measured, and the measurement was repeated 5 times. The results are shown in Table 1, indicating that the precision of the instrument is good. the

Table 1 Precision inspection results

4. Stability investigation Accurately measure the solution of the test product, and measure the absorbance at 0, 2, 4, 6, 8, 10, and 12 hours respectively. The results are shown in Table 2. The results showed that the test solution was stable within 12h. the

Table 2 Stability investigation results

5 Repeatability investigation Accurately weigh the same batch of samples, prepare 5 test samples according to the item of the test sample solution, and measure the absorbance. The results are shown in Table 3. The results show that the method has good repeatability. the

Table 3 Repeatability inspection results

6. Sample recovery investigation Accurately measure 6 parts of the sample solution with known content, respectively accurately add the appropriate amount of reference substance, prepare according to the item of the test solution, calculate the recovery rate, and the results are shown in Table 4. Results The average recovery rate of this method was 99.67%, RSD=1.27%, which indicated that the method had good accuracy and was feasible. the

7 Determination of sample content According to the above-mentioned determination method, 3 batches of samples were determined, and the content was calculated. The results are shown in Table 5. the

According to the content determination results of 3 batches of samples, it is tentatively determined that each 1g of this product contains no less than 84.56mg (93.95mg×90%) of total flavonoids, and the weight of each tablet is 2g, so it is tentatively determined that each piece of this product contains no less total flavonoids At 169.12mg. the

Table 4 The results of the sample recovery investigation

Table 5 Determination results of sample content

Experimental Example 3 Determination of Sinapine Thiocyanate in Chewable Tablets

The content of sinapine thiocyanate in the preparation was determined by high performance liquid chromatography. the

1 Chromatographic conditions The chromatographic column is Kromasil 100-5PHENYL (4.6mm×250mm, 5μm), the mobile phase is acetonitrile-water (60:40), the flow rate is 1mL·min ^-1 ; the detection wavelength is 326nm, and the column temperature is 30°C.

2 Preparation of solution

Reference substance solution: Accurately weigh an appropriate amount of sinapine thiocyanate reference substance, place it in a brown volumetric flask, and prepare a solution with a concentration of 40 μg·mL ^-1 with methanol to obtain the solution.

Test solution: take the chewable tablet and grind it into powder (through No. 3 sieve), accurately weigh 0.5g and place it in a brown measuring bottle, add 70% methanol, ultrasonicate (power 250W, frequency 50kHz) for 30min, and dilute to 50mL. Shake well, filter, take the continued filtrate, put it in a brown bottle, and get it. the

Negative control solution: take 0.5 g of chewable tablet not containing radish seed, and prepare it with the method for preparing the test sample, to obtain final product. the

3 System Suitability Test Take 10 μL each of the reference solution, the test solution and the negative sample solution respectively, and inject them into the chromatograph for measurement, see Figures 1, 2 and 3. The number of theoretical plates is calculated according to the sinapine thiocyanate peak. Below 5000. Under this chromatographic condition, the components to be tested can be separated better, and the test product has the same chromatographic peak at the corresponding chromatographic retention time of the reference product, while the negative control has no interference. the

4. Investigation of linear relationship Precisely measure 2, 6, 10, 16, and 20 μL of the reference solution, inject it into the chromatograph, measure the peak area, and use the peak area (Y) to regress the injection volume (X), and the regression equation is Y =372054X-11685, r=0.9995, the results showed that within the range of 0.08-0.72 μg, there was a good linear relationship between the amount of sinapine thiocyanate injected and the peak area. The results are shown in Figure 4. the

5 Precision inspection Precisely measure the above-mentioned reference substance solution, inject 10 μL each time, repeat the injection 5 times, and the measured RSD is 0.72%, indicating that the precision of the instrument is good. the

Table 5 Precision inspection results

6. Stability investigation Precisely measure the same test solution, inject 10 μL of sample at 0, 2, 4, 6, and 8 hours respectively, and measure it. The RSD is 0.86%, indicating that the test solution is stable within 8 hours. the

Table 6 Stability investigation results

7 Reproducibility investigation Accurately weigh 5 samples of the same batch, prepare according to the item of the test solution, inject 10 μL of the sample, measure, and calculate the RSD to be 1.57%, indicating that the reproducibility of this method is good. the

Table 7 Repeatability inspection results

8 Sample recovery investigation Accurately measure a total of 6 parts of the sample solution with known content, add an appropriate amount of reference substance accurately respectively, prepare according to the item of the test solution, inject 10 μ L of sample, measure, and calculate the recovery rate. The results are shown in Table 8. It shows that the average recovery rate of this method is 99.56%, and RSD=0.70%, which shows that this method has good accuracy and is feasible. the

Table 8 The results of the sample recovery investigation

9 Determination of the content of the sample Three batches of samples were measured according to the above-mentioned determination method, calculated by the external standard method, the results are shown in Table 9, showing that the content of sinapine thiocyanate in the chewable tablet is 130.60 μg/g. 

According to the content determination results of 3 batches of samples, it is tentatively determined that every 1g of this product contains no less than 117.54μg (130.60μg×90%) of sinapine thiocyanate, and the weight of each tablet is 2g, so it is tentatively determined that each tablet of this product contains Sinapine thiocyanate shall not be less than 235.08μg. the

Determination results of sinapine thiocyanate content in the batch samples of table 9

Experimental Example 4 Functional Evaluation and Toxicological Study of Preparations

1 Function evaluation experiment with auxiliary protection of gastric mucosa

1.1 Sample The sample is the chewable tablet of this product, and this experiment uses 2, 5, and 10 times the dosage as the test substance. the

1.2 Experimental animals Healthy Wistar rats were selected. the

1.3 Dosage grouping and test sample administration time The experiment consisted of 3 dosage groups and 1 negative control group. 2 times, 5 times, and 10 times the recommended dose for the human body are three dosage groups. The chronic ulcer model was built first, and then grouped the next day after surgery. The test sample was administered for 9 days. the

1.4 Acute Gastric Mucosa Injury Model Female Wistar rats were randomly divided into 5 groups, 5 rats in each of the model group and negative control group, and 6 rats in each of the high, medium and low dose groups. The model group and the negative control group were infused with 1 mL of normal saline per day, and the experiment set up 3 dose groups of 160, 320, and 640 mg/kg. , middle dose group, high dose group). Gavage once a day for 10 consecutive days. Before dissection, animals were fasted for 24 hours without water. On the 10th day of the experiment, animals were gavaged with the test substance for 1 hour and then 1.01 mL of absolute ethanol was gavaged (except for the negative control group). , resulting in an acute alcohol injury model. One hour later, the animals were killed after ether anesthesia, and the whole stomach was fixed in 10% methanol solution for 20 minutes. The fixed stomach was cut along the greater curvature of the stomach, and the contents of the stomach were washed. Strip hyperemia or diffuse hemorrhage of the gastric mucosa, the area of the hyperemia or diffuse hemorrhage strip (accurate to 0.01mm) was measured with a vernier caliper, and the total area of the hyperemia band and diffuse hemorrhage was used as the evaluation index of the degree of injury. the

1.5 Data processing and result judgment

1.5.1 Statistical processing The significance test of the data difference between groups was processed by one-way analysis of variance using SPSS16.0 statistical software, and the difference was considered significant when P<0.05. the

1.5.2 Results A single large dose of absolute ethanol to rats caused significant damage to the gastric mucosa, which may show striped hyperemia or diffuse bleeding, which can be observed with the naked eye. Compared with the absolute ethanol control group, each dose group in the experimental group Taiyin Tiaowei Chewable Tablets can significantly reduce the damage of absolute ethanol to the gastric mucosa, and alleviate the symptoms of bleeding. the

The hemorrhage area in the gastric mucosa of rats in the anhydrous ethanol model control group was higher than that in the negative control group. The difference was statistically significant (P<0.05) by one-way analysis of variance, indicating that the model was successful and the experimental system was reliable. The areas of bleeding in the high, middle and low dose groups set in the experiment were all lower than those in the control group, and with the increase of the dose, the ulcer area tended to decrease, and the difference was statistically significant. the

2 Toxicology research

2.1 Sample The sample is the chewable tablet of this product, and this experiment uses 5, 10, and 20 times the dosage as the test substance. the

2.2 Experimental animals Kunming mice were selected. the

2.3 Acute Toxicology Experiment The experimental method adopts Horn's method. 40 mice, 10 in each group, half female and half male, 4 dosage groups were set up in the experiment, with 21.5, 10.0, 4.64, 2.15g/kg BW as the 4 dosage groups. The test substance was given by oral gavage, 2 times a day, for 10 consecutive days, and the animals were fasted for 24 hours before dissection. On the 14th day of the experiment, the central nervous system and body movement of the mice were mainly observed to change their posture. , abnormal cry, movement disorders, etc.; whether the autonomic nerves have dilated or narrowed pupils, tears, etc.; whether the respiratory system has runny nose, tide breathing, etc.; whether the gastrointestinal system has flatulence, diarrhea or constipation, etc., and records the occurrence of poisoning time of symptoms. If the animal died, record the number of deaths and the time of death, perform a gross dissection on the dead animal, weigh the body on the 14th day, and calculate the weight gain. the

2.4 Micronucleus test Select 25 female and 25 male mice according to body weight requirements, weigh and dye and randomly divide them into 3 dosage groups and negative and positive control groups, 10 mice in each group, half male and half female, based on the recommended amount of human body 10.0, 5, 2.5g/kg BW are 3 dose groups, the negative control group is given the same amount of distilled water, and the positive control group is given the same amount of cyclophosphamide. Six hours after the second gavage, the mice were sacrificed by cervical dislocation, the femurs were diluted with calf serum for smears, fixed in methanol, and stained with Giemsa. Under the light microscope, count 1000 polychromatic erythrocytes (PCE) per animal, and count 200 polychromatic erythrocytes per animal. (PCE), the ratio of polychromatic erythrocytes (PCE) to mature erythrocytes (RBC) was calculated and statistically analyzed. the

2.5 Sperm deformity experiment 50 mice, 10 in each group, half female and half male, 3 dosage groups and negative and positive control groups were set up in the experiment, with 10.0, 5, 2.5g/kg BW as the 3 dosage groups, negative The control group was given the same amount of distilled water, and the positive control group was given the same amount of cyclophosphamide (take 200 mg of cyclophosphamide and add it to 10 mL of normal saline, mix well, and dilute it 10 times, which is the 40 mg/kg BW dose group). The test substance was given by oral gavage twice a day for 10 consecutive days. Before dissection, the animals were fasted for 24 hours. On the 14th day of the experiment, the mice were killed 30 hours after the last gavage, and the epididymis was taken. For eosin staining, 1000 spermatozoa with complete structure were counted from 5 animals in each group, and the incidence of aberrant spermatozoa was calculated and statistically analyzed. the

2.6 Experimental results The oral acute toxicity test LD ₅₀ of mice taking this product is greater than 15.0g/kg BW, which belongs to the non-toxic level according to the toxicity classification. Mouse micronucleus and mouse sperm abnormality tests were negative. The 30-day feeding experiment had no adverse effects on blood routine, blood biochemical indicators, organ coefficients, body weight, weight gain, food intake, food utilization and other indicators. Histopathological observation showed no meaningful pathological changes in liver, spleen, kidney, stomach, duodenum, testis, and ovary.

Experimental Example 5 Human Food Trial Experiment

Select 30 subjects (20 males and 10 females) who have been diagnosed with chronic superficial gastritis by gastroscopy and have qualified experience. a month. The results of the food trial showed that after taking the health food of the present invention, the patients with chronic gastritis who tried the food had improved pain, loss of appetite, acid reflux, heartburn, abdominal distension and belching. The health food of the present invention can quickly neutralize gastric acid, prevent gastric acid from eroding and digesting the gastric mucosa and the injured surface of the gastric body, relieve pain quickly, and have a long effective time for neutralizing gastric acid, which is beneficial to the self-healing and regeneration of gastric mucosa. There is an obvious sense of comfort, and it can obviously delay the recurrence cycle of various stomach diseases. the

The above function evaluation experiments and human food trial experiments show that the health food of the present invention has the function of assisting in protecting the gastric mucosa, and has no toxic or side effects. the

The scope of protection of the present invention should not be regarded as limited to the above-mentioned specific implementation methods and specific examples. For those of ordinary skill in the art, without departing from the basic premise of the present invention, some simple deduction or equivalent replacements can be made, and these equivalent replacements will still be considered within the protection scope of the present invention . the

Claims (6)

1. A medical health food composition with an auxiliary function of protecting the gastric mucosa, characterized in that: it is a preparation made of the raw materials of the following weight ratio: Coix seed 3-45 parts, dried chestnut 3-45 parts, radish seed 2-30 parts, schisandra 1-15 parts, Ophiopogon japonicus 1-15 parts, bellflower 1-15 parts. 2. The medical health food composition according to claim 1, characterized in that: it is a preparation made from the following raw materials with preferred weight ratio: Coix seed 15 parts, dried chestnut 15 parts, radish seed 10 parts, schisandra 5 parts, Ophiopogon japonicus 5 parts, bellflower 5 parts. 3. The medical health food composition according to any one of claims 1-2, which has the function of assisting the protection of gastric mucosa, and is characterized in that: it is extracted from coix seed, radish seed, schisandra, Ophiopogon japonicus, and Platycodon grandiflorum. It is a preparation prepared by adding dried chestnut or dry chestnut extract as active ingredients, plus acceptable auxiliary materials or auxiliary ingredients for health food. 4. The medical health food composition according to claim 3, which has the function of assisting the protection of gastric mucosa, wherein the preparation is: powder, granule, tablet, chewable tablet, capsule, oral liquid, Pastes, concentrates, ointments, soups, cakes. 5. A preparation of the medical health food composition according to claim 1, characterized in that it comprises the steps of: (1) Weigh the raw materials in proportion by weight: 3-45 parts of coix seed, 3-45 parts of dried chestnut, 2-30 parts of radish seed, 1-15 parts of Schisandra chinensis, 1-15 parts of Ophiopogon japonicus, 1-15 parts of bellflower share; (2) Take coix seed, radish seed, Schisandra chinensis, Ophiopogon japonicus, Platycodon grandiflorum and extract with water or organic solvent to obtain extract 1, take dried chestnut, grind it into fine powder, and pass through a 100-mesh sieve to obtain dried chestnut powder, or take coix coix seed Kernel, dried chestnut, radish seed, schisandra, Ophiopogon japonicus, platycodon grandiflorum are extracted with water or organic solvent to obtain extract 2; (3) Take extract 1 and dry chestnut powder and mix, add acceptable auxiliary materials or auxiliary ingredients in health food, and make preparations respectively according to the corresponding molding process, or take extract 2 and add acceptable auxiliary materials or auxiliary ingredients in health food Auxiliary components are made into preparations according to the corresponding molding process. 6. Use of the composition according to any one of claims 1-5 in the preparation of health food with the function of assisting the protection of gastric mucosa.

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