Microcapsule for promoting peristalsis and repairing intestinal wall cells and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a microcapsule for promoting peristalsis and repairing intestinal wall cells and a preparation method thereof.A natural raw material double-layer microcapsule embedding technology is adopted, rubber tree seed oil, a pseudo-ginseng extract and a prune extract are reasonably combined, intestinal peristalsis is promoted, intestinal wall cells are repaired, intestinal health is improved, and the effects of promoting intestinal peristalsis and repairing intestinal wall cells are achieved. Carnosic acid is selected to be introduced into a capsule core system, so that the stability of the capsule core system is improved, and the solubility of the microcapsule in warm water is also improved; inulin is selected to be introduced into a capsule material system, intestinal tract movement is promoted, proliferation of probiotics is facilitated, and the actual effect and bioavailability of the microcapsule are improved; a vitamin E membrane is formed outside the condensation nucleus, so that the composite wall material plays a better role in protecting the activity of the core material and remarkably improving the stability of the core material, the prepared microcapsule has no side effect, a safer therapeutic drug is provided for treatment and rehabilitation of people with various chronic diseases caused by dysbacteriosis of intestinal flora, and the compliance of patients is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a microcapsule for promoting intestinal peristalsis and repairing intestinal wall cells and a preparation method thereof. Background Art

[0002] The intestine is the largest digestive and detoxifying organ in the human body, and the state of the intestine determines a person's appearance and beauty. The unfolded area of the human digestive tract is equivalent to that of a tennis court. The small intestine is about 46 meters long and the large intestine is about 1.5 meters long. The intestine is also the largest immune organ in the human body, with the largest microecological environment in the human body, generating about 80% of the resistance. Among them, the weight of normal flora is about 1.5 kg, the number reaches 100 trillion, and the types of flora are 500 - 1000. The human intestine is actually an organic combination of its own organs and symbiotic resident microbiota. Among them, the beneficial and harmful intestinal flora maintain a dynamic balance, which can help digest food, produce immune components, enhance the body's own immunity, promote the synthesis of certain vitamins, improve the absorption of lactose, protect the human body from pathogenic bacteria, promote intestinal peristalsis, and inhibit intestinal putrefaction. The intestinal barrier is an important biological barrier in the human body. The imbalance of the intestinal flora will cause the intestinal barrier to be damaged, and harmful bacteria or endotoxins enter the body, leading to inflammatory reactions and various discomforts. Modern medical evidence tells us that "aging starts from the intestine", and "important adult diseases such as colorectal cancer, breast cancer, heart disease, hypertension, and Alzheimer's disease are all closely related to intestinal health".

[0003] The seed oil of Hevea brasiliensis is a kind of woody vegetable oil with a very high degree of unsaturation and rich in essential fatty acids for the human body. The content of unsaturated fatty acids in the oil is about 84%. Especially α-linolenic acid, which is essential for the human body but cannot be synthesized by itself, can be converted into EPA and DHA after being ingested by the human body and play a role, having high value in health care. Traditional Chinese medicine is rich in polysaccharides, oligosaccharides and glycoside components. After ingestion, polysaccharides can reach the distal intestine and ferment through the action of the intestinal microbiota.

[0004] Microencapsulation technology is one of the high-techs that have developed rapidly and are widely used today. It is a technology that uses natural or synthetic polymer materials to wrap dispersed solid, liquid, or even gaseous substances to form tiny particles with semi-permeable or sealed capsule membranes. This technology can protect substances from the influence of the environment, improve the stability of substances, and can shield the taste and smell of the embedded substances, isolate and protect active ingredients, and change the form of substances for easy storage, transportation, etc. Summary of the Invention

[0005] In order to overcome the above technical defects, the present invention provides a microcapsule for promoting intestinal peristalsis and repairing intestinal wall cells and a preparation method thereof. By using microencapsulation technology, it isolates and protects active ingredients, improves quality and efficacy, and avoids poor solubility and resulting taste discomfort during taking.

[0006] One of the objectives of the present invention is to provide a microcapsule that promotes intestinal peristalsis and repairs intestinal wall cells, comprising a core and a first coating material and a second coating material sequentially wrapped around the core;

[0007] The core comprises hevea seed oil, carnosic acid, prune extract, and notoginseng extract;

[0008] The first coating material comprises a colloid and a protein;

[0009] The second coating material comprises a colloid and vitamin E.

[0010] Further, the core comprises 1-100 parts by weight of hevea seed oil; for example, 5-90 parts by weight, or 10-80 parts by weight, or 15-70 parts by weight, or 20-60 parts by weight, or 25-55 parts by weight; and

[0011] 1-10 parts by weight of carnosic acid, for example, 1-8 parts by weight, or 1-6 parts by weight, or 3-5 parts by weight; and 1-50 parts by weight of prune extract, for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight;

[0012] 0.1-20 parts by weight of notoginseng extract, for example, 0.5-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight.

[0013] In this specification, the "parts by weight" of each traditional Chinese medicine ingredient represents the dosage ratio relationship between each traditional Chinese medicine ingredient, rather than an actual mass unit. According to the actual situation, the unit parts by weight can be any mass, such as 1 part by weight can be 1 g, 500 g, or 1 kg, and even can be 15 g, 30 g, etc.

[0014] Those skilled in the art can understand that the notoginseng extract is obtained by extracting notoginseng with an extraction solvent; the extraction solvent is selected from one or more of water, methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, methyl formate, ethyl formate, methyl acetate, ethyl acetate, dichloromethane, chloroform, carbon tetrachloride, dichloroethane, acetone, butanone, and pentanone.

[0015] Further, the notoginseng extract is a water extract of notoginseng or an alcohol extract of notoginseng.

[0016] The prune extract is obtained by extracting prunes with an extraction solvent; the extraction solvent is selected from one or more of water, methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, methyl formate, ethyl formate, methyl acetate, ethyl acetate, dichloromethane, chloroform, carbon tetrachloride, dichloroethane, acetone, butanone, and pentanone.

[0017] Furthermore, the prune extract is a water extract or an alcohol extract of prunes.

[0018] Furthermore, the colloid is selected from natural and / or synthetic polymer materials;

[0019] Furthermore, the colloid is selected from one or more of gelatin, gum arabic, alginate, soy protein, starches and maltodextrin, inulin, fructooligosaccharide, xylooligosaccharide, polycarbonate, polyamino acid, polylactic acid, polyvinyl alcohol, methylcellulose, ethylcellulose or hydroxypropyl methylcellulose;

[0020] Furthermore, the colloid is selected from one of inulin and fructooligosaccharide.

[0021] Furthermore, the protein is selected from one or more of casein, whey protein, milk fat globule membrane protein, and hydrolyzed protein;

[0022] Furthermore, the protein is selected from casein.

[0023] Furthermore, the addition amount of vitamin E is 0.01-10% of the total mass of the microcapsules; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

[0024] Furthermore, the addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%.

[0025] Furthermore, the addition amount of the protein is 0.1-10% of the total mass of the microcapsules; for example, 0.5-8%, or 1-5%, or 1-3%.

[0026] Furthermore, the first coating material and / or the second coating material further includes other pharmaceutical excipients.

[0027] Furthermore, the pharmaceutical excipients include any one or more of fillers, binders, wetting agents, disintegrants, solubilizers, solubilizing agents, osmotic pressure regulators, surfactants, pH regulators, antioxidants, bacteriostatic agents or buffers.

[0028] In addition, if necessary, coloring agents, preservatives, fragrances, flavoring agents, sweetening agents or other materials can also be added.

[0029] The second object of the present invention is to provide a method for preparing microcapsules, which comprises mixing rubber tree seed oil, carnosic acid, prune extract, and Panax notoginseng extract to obtain a core material; mixing the core material with a first coating material and then spray-drying to form condensation nuclei; and mixing the condensation nuclei with a second coating material and then spray-drying to obtain the microcapsules.

[0030] Further, the first coating material includes colloid, protein and pharmaceutically acceptable excipients in the art. The addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%.

[0031] Further, the addition amount of the protein is 0.1-10% of the total mass of the microcapsules; for example, 0.5-8%, or 1-5%, or 1-3%.

[0032] Further, the second coating material includes colloid, vitamin E and pharmaceutically acceptable excipients in the art.

[0033] The addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%.

[0034] The addition amount of the vitamin E is 0.01-10% of the total mass of the microcapsules; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] The present invention first rationally combines rubber tree seed oil, Panax notoginseng extract and Prunus domestica extract to promote intestinal peristalsis and repair intestinal wall cells, improve intestinal health and reduce disease risks.

[0037] The present invention adopts a double-layer microcapsule embedding process with natural raw materials, selects carnosic acid to introduce into the core system, which not only improves the stability of the core system, but also improves the solubility of the microcapsules in warm water; selects inulin to introduce into the coating material system. After inulin enters the human body, it is not absorbed by the stomach and small intestine and directly enters the large intestine, promoting intestinal peristalsis and being preferentially utilized by probiotics such as Bifidobacterium and Lactobacillus, which is beneficial to the proliferation of probiotics and greatly improves the actual effect and bioavailability of the above microcapsules; forms a vitamin E film outside the coagulation nucleus to further improve the antioxidant property, thereby improving the performance of the composite wall material as a whole, enabling the composite wall material to better protect the activity of the core material and significantly improve the stability of the core material, making the prepared microcapsules have strong acid resistance, so that they can withstand the test of gastric acid and release and proliferate at a fixed point in the intestine, improving the bioavailability.

[0038] The microcapsules of the present invention have no side effects and can be used by people with various chronic diseases caused by intestinal flora imbalance for a long time, providing a safer therapeutic drug for the treatment and rehabilitation of people with various chronic diseases caused by intestinal flora imbalance and improving patient compliance. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a solubility result diagram of the present invention;

[0040] Among them, 1A is the dissolution result of Comparative Example 1; 1B is the dissolution result of Example 1. Detailed implementation manners

[0041] To enable those skilled in the art to better understand the technical solutions of the present invention, the present invention will be described in detail below in conjunction with specific implementation manners. For the experimental methods without specific conditions noted in the following examples, they are generally carried out under conventional conditions or according to the conditions recommended by the manufacturer. Unless otherwise stated, percentages and parts are calculated by weight. Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the described content can be applied to the present invention. The preferred implementation methods and materials described herein are for illustrative purposes only.

[0042] In the ranges disclosed herein, the endpoints and any values are not limited to the exact ranges or values. These ranges or values should be understood to include values close to these ranges or values. For numerical ranges, the endpoint values of each range, between the endpoint values of each range, between the endpoint values of each range and individual point values, and between individual point values can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed herein.

[0043] According to the present invention, on the one hand, a microcapsule for promoting intestinal peristalsis and repairing intestinal wall cells is provided, which includes a core and a first capsule material and a second capsule material sequentially wrapped on the core;

[0044] The core includes rubber tree seed oil, carnosic acid, prune extract, and notoginseng extract;

[0045] The first capsule material includes colloid and protein;

[0046] The second capsule material includes colloid and vitamin E.

[0047] Based on the present invention, using rubber tree seed oil, carnosic acid, prune extract, and notoginseng extract as the core, it contains both ingredients for treating intestinal inflammation and ingredients for maintaining intestinal health. The two ingredients interact with each other, making the effect of repairing the intestinal wall remarkable.

[0048] Based on traditional Chinese medicine theory, rubber tree seed oil contains essential fatty acids linoleic acid and linolenic acid for the human body. And the content of ω-3 fatty acid (linolenic acid) in rubber tree seed oil is 18% - 20%, the content of ω-6 fatty acid (linoleic acid) is 34% - 38%, and the ratio of ω-3 fatty acid (linolenic acid) to ω-6 fatty acid (linoleic acid) is nearly 1:2. ω-3 fatty acid (linolenic acid) has good anti-inflammatory effects, while ω-6 fatty acid (linoleic acid) can help regulate the body's metabolic function and promote immune responses.

[0049] Notoginseng is warm in nature, sweet and slightly bitter in taste, and belongs to the liver meridian and stomach meridian. It can disperse stasis and stop bleeding, reduce swelling and relieve pain. It has the effects of promoting blood circulation to remove blood stasis and stopping bleeding, and activating blood circulation to relieve pain. It is mainly used to treat various bleeding syndromes, swelling and pain due to blood stasis, traumatic injuries, etc. caused by blood stasis blockage; Ginseng is sweet and slightly bitter in taste, slightly warm in nature, and belongs to the lung meridian and heart meridian. It has the effects of invigorating the spleen and benefiting the lung, promoting the production of body fluid, and calming the mind and improving intelligence. It is mainly used to treat qi deficiency on the verge of collapse, weak pulse, deficiency of the spleen qi, sinking of the middle qi, cough and asthma due to lung deficiency, shortness of breath and fatigue, thirst due to fluid injury, consumptive thirst with deficiency heat, insomnia and forgetfulness, palpitation and anxiety, sallow complexion due to blood deficiency, impotence and cold uterus, etc.

[0050] Prunes are rich in insoluble and soluble fibers, which help promote digestive health. They contain sorbitol, which has a mild laxative effect and can help relieve constipation. They also contain antioxidants such as catechins and quercetin, which can help fight free radicals.

[0051] Carnosic acid is a diterpenoid compound isolated from the plant Rosmarinus officinalis of the Lamiaceae family, and has a variety of biological activities and pharmacological effects. Carnosic acid remains stable at 200 °C and has antioxidant properties to scavenge free radicals and reduce the damage of oxidative stress to cells. It can inhibit inflammatory reactions and help alleviate inflammatory diseases.

[0052] In some specific embodiments, the core of the capsule comprises 1-100 parts by weight of rubber tree seed oil; for example, 5-90 parts by weight, or 10-80 parts by weight, or 15-70 parts by weight, or 20-60 parts by weight, or 25-55 parts by weight; and 1-10 parts by weight of carnosic acid, for example, 1-8 parts by weight, or 1-6 parts by weight, or 3-5 parts by weight; and 1-50 parts by weight of prune extract, for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight;

[0053] 0.1-20 parts by weight of notoginseng extract, for example, 0.5-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight.

[0054] In some specific embodiments, the notoginseng extract is obtained by extracting notoginseng with an extraction solvent; the extraction solvent is selected from one or more of water, methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, methyl formate, ethyl formate, methyl acetate, ethyl acetate, dichloromethane, chloroform, carbon tetrachloride, dichloroethane, acetone, butanone, pentanone.

[0055] In some specific embodiments, the notoginseng extract is notoginseng water extract or notoginseng alcohol extract.

[0056] The prune extract is obtained by extracting prunes with an extraction solvent; the extraction solvent is selected from one or more of water, methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, methyl formate, ethyl formate, methyl acetate, ethyl acetate, dichloromethane, chloroform, carbon tetrachloride, dichloroethane, acetone, butanone, and pentanone.

[0057] In some specific embodiments, the prune extract is a prune water extract or a prune alcohol extract.

[0058] In some specific embodiments, the colloid is selected from natural and / or synthetic polymer materials;

[0059] In some specific embodiments, the colloid is selected from one or more of gelatin, gum arabic, alginate, soy protein, starches and maltodextrin, inulin, fructooligosaccharide, xylooligosaccharide, polycarbonate, polyamino acid, polylactic acid, polyvinyl alcohol, methylcellulose, ethylcellulose, or hydroxypropyl methylcellulose;

[0060] In some specific embodiments, the colloid is selected from one of inulin and fructooligosaccharide.

[0061] In some specific embodiments, the protein is selected from one or more of casein, whey protein, milk fat globule membrane protein, and hydrolyzed protein;

[0062] In some specific embodiments, the protein is selected from casein.

[0063] In some specific embodiments, the addition amount of vitamin E is 0.01-10% of the total mass of the microcapsules; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

[0064] In some specific embodiments, the addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%.

[0065] In some specific embodiments, the addition amount of the protein is 0.1-10% of the total mass of the microcapsules; for example, 0.5-8%, or 1-5%, or 1-3%.

[0066] In some specific embodiments, the first capsule material and / or the second capsule material further comprises other pharmaceutical excipients.

[0067] In some specific embodiments, the pharmaceutical excipients include any one or more of fillers, binders, wetting agents, disintegrants, cosolvents, solubilizers, osmotic pressure regulators, surfactants, pH regulators, antioxidants, bacteriostatic agents, or buffers.

[0068] In addition, if necessary, coloring agents, preservatives, flavors, flavor correctives, sweeteners or other materials can also be added.

[0069] In a second aspect, the present invention provides a method for preparing microcapsules, which comprises mixing rubber tree seed oil, carnosic acid, prune extract and notoginseng extract to obtain a core material; spray-drying the core material after mixing it with a first capsule material to prepare a condensation nucleus; and spray-drying the condensation nucleus after mixing it with a second capsule material to obtain the microcapsules.

[0070] The main absorption sites of notoginseng extract and prune extract are both the intestine. Total saponins of notoginseng have significant anti-inflammatory effects on various experimental animal inflammation models, can improve the phagocytic ability of macrophages, increase the total number of blood leukocytes and the percentage of lymphocytes, and the absorption mode of notoginseng extract is passive diffusion. Through the method of this patent, it can effectively protect notoginseng from being decomposed by gastric acid, maintain a high concentration in the intestine, and is more conducive to the absorption and utilization of notoginseng, playing a better therapeutic effect on the repair of intestinal inflammation; prunes contain a large amount of fiber, especially dietary fiber, which can promote intestinal peristalsis, relieve constipation, effectively remove harmful substances in the intestine, maintain intestinal health, and prevent intestinal diseases such as colon cancer. The present invention targets and transports prune extract, notoginseng extract and rubber tree seed oil to the intestine through a double-layer microcapsule embedding process, avoiding the destruction of the above substances by gastric acid.

[0071] Further, the first capsule material includes a colloid, a protein and pharmaceutically acceptable excipients in the art. The addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%;

[0072] Further, the addition amount of the protein is 0.1-10% of the total mass of the microcapsules; for example, 0.5-8%, or 1-5%, or 1-3%.

[0073] Further, the second capsule material includes a colloid, vitamin E and pharmaceutically acceptable excipients in the art. The addition amount of the colloid is 10-50% of the total mass of the microcapsules; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%;

[0074] The addition amount of vitamin E is 0.01-10% of the total mass of the microcapsules; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

[0075] Those skilled in the art can understand that the "parts by weight" of each Chinese medicinal material represent the dosage ratio relationship between each Chinese medicinal material, rather than an actual mass unit. According to the actual situation, the unit parts by weight can be any mass, such as 1 part by weight can be 1 g, 500 g or 1 kg, and even can be 15 g, 30 g, etc.

[0076] Those skilled in the art can understand that the dosage of the pharmaceutical composition of the present invention depends on many factors, such as the gender, age, weight and individual response of the patient or animal, the administration route and the number of administrations, etc. The above dosage can be administered in a single dosage form or divided into several, for example, two, three or four dosage forms. The dosage level must be selected according to the specific administration route, the severity of the condition to be treated and the condition and past medical history of the patient to be treated, etc. However, the practice in the art is that the dosage starts from a level lower than that required to obtain the desired therapeutic effect and gradually increases the dosage until the desired effect is obtained.

[0077] The dosage of the composition and drug of the present invention can be 10 mg - 10 g of active ingredient / kg body weight. For example, 200 mg of active ingredient / kg body weight, 3 g of active ingredient / kg body weight, 4 g of active ingredient / kg body weight, or 10 mg of active ingredient / kg body weight.

[0078] The embodiments of the present invention will be described in detail below in conjunction with examples. However, those skilled in the art will understand that the following examples are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention. For those not specified in the examples, they are carried out under conventional conditions or conditions recommended by the manufacturer. For reagents or instruments not specified by the manufacturer, they are all conventional products that can be obtained through commercial purchase.

[0079] Example 1 Microcapsule

[0080] The microcapsule includes a core, a first coating material coated outside the core material, and a second coating material coated outside the first coating material; the core includes the following components: 48 parts of rubber tree seed oil, 1 part of carnosic acid, 2 parts of plum extract, and 0.1 part of Panax notoginseng extract; the first coating material includes the following components: 25 parts of inulin, 4 parts of sodium caseinate, 3 parts of casein, 1 part of sodium stearoyl lactate, 1 part of mono- and diglycerol fatty acid esters, and 0.3 part of silica; the second coating material includes the following components: 14.5 parts of inulin and 0.1 part of natural vitamin E.

[0081] Preparation method: Mix the rubber tree seed oil, carnosic acid, plum extract, and Panax notoginseng extract in parts by mass to obtain a core material; mix the core material with inulin, sodium caseinate, casein, sodium stearoyl lactate, mono- and diglycerol fatty acid esters, and silica in parts by mass, and then spray-dry to form a nuclei coated with the first coating material; mix the nuclei with inulin and natural vitamin in parts by mass and then spray-dry to obtain the microcapsule coated with the second coating material.

[0082] Example 2

[0083] The microcapsules comprise a core, a first shell material coated outside the core material, and a second shell material coated outside the first shell material; the core comprises the following components: 55 parts of rubber tree seed oil, 3 parts of carnosic acid, 2 parts of prune extract, and 5 parts of notoginseng extract; the first shell material comprises the following components: 20 parts of inulin, 0.55 part of sodium caseinate, 1.65 parts of casein, 0.5 part of sodium stearoyl lactylate, 1 part of mono- and diglycerol fatty acid esters, and 0.03 part of silicon dioxide; the second shell material comprises the following components: 12.24 parts of inulin and 0.03 part of natural vitamin E.

[0084] Example 3

[0085] The microcapsules comprise a core, a first shell material coated outside the core material, and a second shell material coated outside the first shell material; the core comprises the following components: 25 parts of rubber tree seed oil, 5 parts of carnosic acid, 20 parts of prune extract, and 10 parts of notoginseng extract; the first shell material comprises the following components: 20 parts of inulin, 0.55 part of sodium caseinate, 1.65 parts of casein, 0.5 part of sodium stearoyl lactylate, 1 part of mono- and diglycerol fatty acid esters, and 0.03 part of silicon dioxide; the second shell material comprises the following components: 12.24 parts of inulin and 0.03 part of natural vitamin E.

[0086] Example 4

[0087] The microcapsules comprise a core, a first shell material coated outside the core material, and a second shell material coated outside the first shell material; the core comprises the following components: 35 parts of rubber tree seed oil, 8 parts of carnosic acid, 3 parts of prune extract, and 11.6 parts of notoginseng extract; the first shell material comprises the following components: 20 parts of inulin, 4 parts of sodium caseinate, 5 parts of casein, 1 part of sodium stearoyl lactylate, 1 part of mono- and diglycerol fatty acid esters, and 0.4 part of silicon dioxide; the second shell material comprises the following components: 14.5 parts of inulin and 1 part of natural vitamin E.

[0088] Example 5

[0089] The microcapsules comprise a core, a first shell material coated outside the core material, and a second shell material coated outside the first shell material; the core comprises the following components: 29 parts of rubber tree seed oil, 10 parts of carnosic acid, 7.3 parts of prune extract, and 0.5 part of notoginseng extract; the first shell material comprises the following components: 30 parts of inulin, 2 parts of sodium caseinate, 8 parts of casein, 1 part of sodium stearoyl lactylate, 1 part of mono- and diglycerol fatty acid esters, and 0.2 part of silicon dioxide; the second shell material comprises the following components: 8 parts of inulin and 3 parts of natural vitamin E.

[0090] Example 6

[0091] The microcapsules comprise a core, a first coating material wrapped around the core material, and a second coating material wrapped around the first coating material; the core comprises the following components: 35 parts of rubber tree seed oil, 5 parts of carnosic acid, 10 parts of prune extract, and 4 parts of notoginseng extract; the first coating material comprises the following components: 27.2 parts of inulin, 3 parts of sodium caseinate, 1 part of casein, 1 part of sodium stearoyl lactate, 1 part of mono- and diglycerol fatty acid esters, and 0.3 part of silicon dioxide; the second coating material comprises the following components: 12 parts of inulin and 0.5 part of natural vitamin E.

[0092] Comparative example

[0093] Same as Example 1, except that carnosic acid is not added.

[0094] Example 7 examines the solubility of the microcapsules of the present invention

[0095] From Figure 1 It can be seen that the microcapsules prepared by the present invention have better dispersibility in water and can be completely dissolved by simply stirring appropriately in warm water at 40°C. In contrast, the microcapsules prepared in the comparative example have poor solubility. Similarly, in warm water at 40°C, there are still some insoluble lumps after stirring for a long time. It can be seen that adding carnosic acid helps to enhance the dispersibility of the microcapsules in water, enables them to dissolve better in water, is convenient for use, and greatly improves the taste.

[0096] Example 8 examines the clinical effect of the microcapsules of the present invention

[0097] Research subjects: 50 patients who met the diagnostic criteria and inclusion criteria of this study, including 28 males and 24 females, aged 36 - 50 years old, with an average age of (49.12 ± 12.34) years.

[0098] Diagnostic criteria: Excluding constipation caused by intestinal or systemic organic causes and drug factors and meeting the Rome III criteria: At least 12 weeks of continuous or intermittent occurrence of more than 2 of the following symptoms in at least 6 months before diagnosis: 1. At least 25% of defecations involve straining; 2. At least 25% of defecations are hard stools; 3. At least 25% of defecations have a feeling of incomplete evacuation; 4. At least 25% of defecations have a feeling of anorectal obstruction; 5. At least 25% of defecations require manual assistance for defecation (such as finger defecation, supporting the pelvic floor); 6. Have fewer than 3 bowel movements per week.

[0099] Treatment plan: 50 patients take the microcapsules prepared in Example 3 every day, 2 times a day, 15 grams each time, taken after breakfast and before going to bed. The efficacy judgment criteria are formulated according to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Diseases" of the State Administration of Traditional Chinese Medicine. Cure: Have a bowel movement once within 2 days, the stool quality becomes moist, and it is smooth during defecation, with no recurrence in the short term; Improvement: Have a bowel movement within 3 days, the stool quality becomes moist, and the defecation is not smooth enough; Not cured: The symptoms have not improved. The treatment effects are shown in Table 1 below:

[0100] Table 1

[0101]

[0102] After treatment, it was found that the effective rate of the clinical efficacy of the microcapsules of the present invention reached 84%, and no adverse reactions such as abdominal cramps, abdominal borborygmus, diarrhea and other symptoms occurred, indicating that the microcapsules provided by the present invention have high safety, are suitable for use by all groups, have the effects of promoting intestinal peristalsis and repairing intestinal wall cells, and can effectively treat functional constipation.

[0103] Finally, it should be noted that the above description is only the preferred embodiment of the present invention. Under the inspiration of the present invention and without violating the purpose and claims of the present invention, those skilled in the art can make various similar representations, and such transformations all fall within the protection scope of the present invention.

Claims

1. A microcapsule for promoting intestinal peristalsis and repairing intestinal wall cells, characterized in that: It comprises a capsule core and a first capsule material and a second capsule material sequentially wrapped on the capsule core; The capsule core comprises rubber tree seed oil, carnosic acid, prune extract and Panax notoginseng extract; The first capsule material includes colloid and protein; The second capsule material includes colloid and vitamin E.

2. The microcapsule according to claim 1, characterized in that The capsule core comprises 1-100 parts by weight of rubber tree seed oil; for example, 5-90 parts by weight, or 10-80 parts by weight, or 15-70 parts by weight, or 20-60 parts by weight, or 25-55 parts by weight; as well as 1-10 parts by weight of carnosic acid, for example 1-8 parts by weight, or 1-6 parts by weight, or 3-5 parts by weight; and 1-50 parts by weight of prune extract, for example 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight; The notoginseng extract is 0.1-20 parts by weight, for example 0.5-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight.

3. The microcapsule according to claim 1, characterized in that The colloid is selected from natural and / or synthetic polymer materials; further, selected from one or more of gelatin, gum arabic, alginate, soy protein, starch and maltodextrin, inulin, oligofructose, oligoxylose, polycarbonate, polyamino acid, polylactic acid, polyvinyl alcohol, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose; further, selected from one of inulin, oligofructose and oligoxylose.

4. The microcapsule according to claim 1, characterized in that The protein is selected from one or more of casein, whey protein, milk fat globule membrane protein, and hydrolyzed protein; further, selected from casein.

5. The microcapsule according to claim 1, characterized in that The added amount of vitamin E is 0.01-10% of the total mass of the microcapsule; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

6. The microcapsule according to claim 1, characterized in that The amount of the colloid added is 10-50% of the total mass of the microcapsule; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%.

7. The microcapsule according to claim 1, characterized in that The added amount of the protein is 0.1-10% of the total mass of the microcapsule; for example, 0.5-8%, or 1-5%, or 1-3%.

8. A method for preparing microcapsules, characterized in that: The rubber tree seed oil, carnosic acid, prune extract and Panax notoginseng extract are mixed to obtain a capsule core; the capsule core is mixed with a first capsule material and then spray-dried to obtain a condensation nucleus; the condensation nucleus is mixed with a second capsule material and then spray-dried to obtain the product.

9. The preparation method according to claim 8, characterized in that: The first capsule material includes colloid, protein and pharmaceutical excipients acceptable in the art, wherein the colloid is added in an amount of 10-50% of the total mass of the microcapsule; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%; the protein is added in an amount of 0.1-10% of the total mass of the microcapsule; for example, 0.5-8%, or 1-5%, or 1-3%.

10. The preparation method according to claim 8, characterized in that: The second capsule material includes a colloid, vitamin E and pharmaceutical excipients acceptable in the art. The amount of the colloid added is 10-50% of the total mass of the microcapsule; for example, 15-50%, or 20-45%, or 25-45%, or 30-40%; the amount of vitamin E added is 0.01-10% of the total mass of the microcapsule; for example, 0.01-8%, or 0.05-5%, or 0.1-3%, or 0.1-1%.

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