Gorgon fruit capsule with function of bidirectionally regulating constipation and diarrhea and processing method of gorgon fruit capsule

Abstract

The invention discloses a gordon euryale seed capsule with a function of bidirectionally regulating constipation and diarrhea and a processing method of the gordon euryale seed capsule. Mixing powder containing active ingredients of gordon euryale seed, Chinese yam, rheum officinale and plantain herb with an embedding liquid formed by dissolving a polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin, and performing spray drying to form an inner layer microcapsule; mixing medlar, honeysuckle, scutellaria baicalensis, lotus leaf, liquorice and bighead atractylodes rhizome, and adding water for dissolving to obtain an outer-layer medicine mixed solution; gelatin, sodium alginate and HPMC are dispersed in water and heated to be fully dissolved to obtain capsule liquid, and the capsule liquid is mixed with the outer-layer medicine mixed liquid to obtain outer-layer capsule liquid; adding the inner-layer microcapsule into the outer-layer capsule liquid, adding a calcium gluconate aqueous solution, continuously stirring to carry out a cross-linking reaction for 10-20 minutes, and carrying out a freeze-drying method to obtain the gordon euryale seed capsule with the function of bidirectionally regulating constipation and diarrhea. The double-release microcapsule design is adopted, the release mechanism of gordon euryale seeds and other functional components is accurately controlled, and bidirectional regulation of constipation and diarrhea is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of functional product processing, and particularly relates to a gorgon fruit capsule with bidirectional regulating functions of constipation and diarrhea and a processing method thereof. Background Art

[0002] As modern people's lifestyles change, intestinal health problems such as constipation and diarrhea have gradually become important health issues that plague consumers around the world. According to relevant statistics, the incidence of constipation is on the rise worldwide, especially among the elderly and sedentary people. In addition, due to factors such as unbalanced diet and excessive stress, diarrhea is also a common problem. Constipation and diarrhea not only affect the quality of life, but are also closely related to a variety of diseases such as intestinal inflammation and metabolic disorders.

[0003] The intestinal regulation products on the current market are mainly concentrated in two types of functions: one is to relieve constipation, such as promoting intestinal peristalsis and increasing stool volume through ingredients such as dietary fiber, prebiotics, and laxatives; the other is to relieve diarrhea, such as reducing excessive intestinal water excretion through water-absorbing ingredients, antibacterial agents, etc. However, most existing products can only regulate one symptom of constipation or diarrhea, and there is a lack of products that can regulate constipation and diarrhea in both directions. This means that when consumers encounter alternating constipation and diarrhea, they often need to switch to different products, which is inconvenient to use and has limited effects.

[0004] Euryale Fox, as a traditional Chinese medicinal material, has gradually attracted attention in the field of functional foods and health products in recent years. Euryale Fox is rich in polysaccharides, dietary fiber, saponins, amino acids and other ingredients, which have certain positive effects on intestinal health. For example, Euryale Fox polysaccharides have potential in regulating intestinal hydration, promoting intestinal peristalsis, and maintaining intestinal microecological balance. However, the use of Euryale Fox in the existing technology is mainly focused on the research and development of a single function. There is no comprehensive product that can achieve the bidirectional regulation function of constipation and diarrhea, and there is a lack of innovative designs that accurately control its release mechanism.

[0005] Patent CN 105726680A discloses a drug that can bidirectionally regulate multiple diseases and the preparation and application of its hard capsule preparation. The drug ingredients are coptis root and cinnamon bark, the capsule shell is a hard capsule, and the release mechanism is single. It is difficult to play the same role when diarrhea or constipation occurs.

[0006] Therefore, there is an urgent need for a new type of product that can achieve bidirectional regulation of constipation and diarrhea under different intestinal conditions through precise technical means. The use of the natural ingredients of Gorgon fruit combined with novel microencapsulation technology can provide a more efficient, convenient and comprehensive solution for intestinal health. Summary of the invention

[0007] In view of the lack of products that can bidirectionally regulate constipation and diarrhea in the prior art and the problem of single development of the function of Gorgon fruit, the present invention provides a Gorgon fruit capsule with bidirectional regulating function of constipation and diarrhea and a processing method thereof, adopts a double-release microcapsule design, and realizes bidirectional regulation of constipation and diarrhea by precisely controlling the release mechanism of Gorgon fruit and other functional ingredients.

[0008] The present invention is achieved through the following technical solutions: A method for processing Euryale ferox capsules with bidirectional regulating functions of constipation and diarrhea comprises the following steps: (1) Preparation of inner layer microcapsules: powders containing active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain are mixed with an embedding solution formed by dissolving polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin, and the mixture is embedded in microcapsules by spray drying technology to form inner layer microcapsules; (2) Mix the wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract, and atractylodes macrocephala extract, and add water to dissolve them to obtain an outer layer drug mixture; (3) Dispersing gelatin, sodium alginate and HPMC in water, heating them to fully dissolve them to obtain capsule liquid, and mixing them with the outer layer drug mixture in step (2) to obtain an outer layer capsule liquid; (4) adding the inner layer microcapsules prepared in step (1) to the outer layer capsule solution prepared in step (3), stirring the mixture thoroughly, adding a calcium gluconate aqueous solution, stirring the mixture continuously for 10 to 20 minutes to carry out a cross-linking reaction, and drying the reaction solution by freeze drying to obtain a Gorgon fruit capsule having the function of bidirectionally regulating constipation and diarrhea.

[0009] Furthermore, the preparation method of the powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain in step (1) is: mixing Euryale ferox, Chinese yam, rhubarb and plantain, extracting the active ingredients therein by water-alcohol extraction, concentrating the extract to 10-20% of its volume to obtain a concentrated solution, adding 2-5% inulin by mass of the concentrated solution, mixing evenly, spray drying, and obtaining the powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain.

[0010] Furthermore, in step (1), the mass ratio of Euryale ferox, Chinese yam, rhubarb and plantain is 18-22:13-16:4-6:4-6; extraction is performed using an ethanol-water solution with a volume ratio of 1:1-3, the temperature is controlled at 50-60°C, the extraction time is 1-2h, and the total mass ratio of the extract to Euryale ferox, Chinese yam, rhubarb and plantain is 10-20:1; and the spray drying temperature is 130-150°C.

[0011] Furthermore, in step (1), the mass ratio of polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin is 2-4:2-4:3-5; preferably 3:3:4; polylactic acid-glycolic acid copolymer is dissolved in dichloromethane to obtain an organic phase, sodium polyacrylate is dissolved in water to obtain an aqueous phase, the organic phase is slowly added to the aqueous phase and mixed, fully emulsified, heated to 50-60° C., gelatin is added and stirred to dissolve to obtain an embedding solution, and the volume ratio of the organic phase to the aqueous phase is 1:3-5; the mass ratio of the active ingredient powder containing Euryale ferox, yam, rhubarb and plantain to the embedding solution in step (1) is 1:6-10, and the spray drying condition is 130-150° C.

[0012] Furthermore, the wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract and atractylodes macrocephala extract are powders after water extracts are dried, the mass ratio of wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract and atractylodes macrocephala extract is 3:2:2:1:1:2, and the mass percentage concentration of the outer layer drug mixture is 15-20%.

[0013] Furthermore, in step (3), the mass ratio of gelatin, sodium alginate and HPMC is 8-12:4-7:2-4, and the mixture is dissolved by heating to 50-60°C, and the mass percentage concentration of the aqueous solution is 10-20%; the volume ratio of the capsule liquid to the outer layer drug mixture is 3-5:1.

[0014] Furthermore, in step (4), the mass percentage concentration of the calcium gluconate aqueous solution is 5-10%, the amount of calcium gluconate added is 5-10% of the total mass of gelatin, sodium alginate and HPMC; and the mass volume ratio of the inner layer microcapsule to the outer layer capsule liquid is 1:3-4.

[0015] Furthermore, the stirring speed in step (4) is 150-200 rpm; and the cold trap temperature of the freeze-drying method is -40±5°C.

[0016] In the present invention, the gorgon fruit capsules processed by the processing method have the function of bidirectionally regulating constipation and diarrhea.

[0017] Furthermore, the Euryale gorgonii capsule with the function of bidirectionally regulating constipation and diarrhea is characterized in that the particle size of the Euryale gorgonii capsule with the function of bidirectionally regulating constipation and diarrhea is 40~80 meshes.

[0018] Beneficial Effects (1) The Euryale ferox capsule with bidirectional regulation function of constipation and diarrhea prepared by the present invention can flexibly regulate between constipation and diarrhea through the creative bidirectional regulation function, which can not only relieve constipation but also control diarrhea. This dual effect provides consumers with a highly targeted and effective intestinal health management solution; (2) The inner and outer microencapsulation design of the present invention ensures that the product ingredients are released in different areas of the intestine, which can achieve timed release and targeted effects, making the product effect more precise and lasting, and enhancing the therapeutic effect of the product; (3) The present invention uses natural microcapsule materials instead of synthetic materials, which not only improves the safety and environmental protection of the product, but also reduces potential side effects, which is in line with modern consumers' health concept of natural and additive-free. DETAILED DESCRIPTION

[0019] The above contents of the present invention are further described in detail below through examples, but this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples, and all technologies implemented based on the above contents of the present invention belong to the scope of the present invention.

[0020] The preparation method of the powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain in the following examples and comparative examples is as follows: Euryale ferox, Chinese yam, rhubarb and plantain in a mass ratio of 4:3:1:1 are mixed, 75% ethanol aqueous solution with a mass of 20 times of the mass of the traditional Chinese medicine is added for extraction, the extraction temperature is 55±5°C, the extraction time is 2h, the obtained extract is concentrated to 10% of its volume to obtain a concentrated solution, 3% inulin by mass of the concentrated solution is added, the mixture is mixed evenly, and the mixture is spray-dried (140±5°C) to obtain a powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain.

[0021] The preparation of the following examples and comparative examples of wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract, and atractylodes macrocephala extract are all water extraction methods. The specific extraction method is to grind wolfberry, honeysuckle, scutellaria baicalensis, lotus leaf, licorice and atractylodes macrocephala, add 5 times the weight of water, heat to 55±5°C, extract for 1.5h, repeat the extraction 3 times, combine the extracts, and spray dry to obtain the corresponding extract powder.

[0022] Example 1 (1) Preparation of inner layer microcapsules: polylactic acid-glycolic acid copolymer is dissolved in dichloromethane to obtain an organic phase, sodium polyacrylate is dissolved in water to obtain an aqueous phase, the organic phase is slowly added to the aqueous phase and mixed, fully emulsified, heated to 55±5°C, gelatin is added and stirred to dissolve to obtain an embedding solution, the volume ratio of the organic phase to the aqueous phase is 1:3-5, and the mass ratio of polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin is 3:3:4; the powder containing the active ingredients of gorgon fruit, yam, rhubarb and plantain is mixed with the embedding solution, the mass ratio of the powder containing the active ingredients of gorgon fruit, yam, rhubarb and plantain to the embedding solution is 1:8, and it is embedded in the microcapsules by spray drying (140±5°C) technology to form inner layer microcapsules; (2) Mix wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract, and atractylodes macrocephala extract in a mass ratio of 3:2:2:1:1:2, add water to dissolve, and obtain an outer layer drug mixture with a mass percentage concentration of 15%; (3) Dispersing gelatin, sodium alginate and HPMC in a mass ratio of 10:5:3 into water, heating to 55±5°C to fully dissolve them, obtaining an aqueous solution with a mass percentage concentration of 15%, and mixing it with the outer layer drug mixture in step (2) to obtain an outer layer capsule solution, wherein the volume ratio of the aqueous solution to the outer layer drug mixture is 4:1; (4) The inner layer microcapsules prepared in step (1) are added to the outer layer capsule liquid prepared in step (3) in a mass volume ratio of 1:4. The mixture is stirred thoroughly, and a calcium gluconate aqueous solution having a mass concentration of 10% (the amount of calcium gluconate added is 8% of the total mass of gelatin, sodium alginate and HPMC) is added. The mixture is stirred continuously (180 rpm) for a cross-linking reaction for 20 min. The reaction liquid is dried by freeze drying (cold trap temperature -40±5°C) to obtain a Gorgon fruit capsule having a bidirectional function of regulating constipation and diarrhea. The particle size of the Gorgon fruit capsule having a bidirectional function of regulating constipation and diarrhea is 40-80 mesh.

[0023] Example 2 (1) Preparation of inner layer microcapsules: polylactic acid-glycolic acid copolymer is dissolved in dichloromethane to obtain an organic phase, sodium polyacrylate is dissolved in water to obtain an aqueous phase, the organic phase is slowly added to the aqueous phase and mixed, fully emulsified, heated to 55±5°C, gelatin is added and stirred to dissolve to obtain an embedding solution, the volume ratio of the organic phase to the aqueous phase is 1:3-5, and the mass ratio of polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin is 3:3:4; the powder containing the active ingredients of gorgon fruit, yam, rhubarb and plantain is mixed with the embedding solution, the mass ratio of the powder containing the active ingredients of gorgon fruit, yam, rhubarb and plantain to the embedding solution is 1:8, and it is embedded in the microcapsules by spray drying (140±5°C) technology to form inner layer microcapsules; (2) Mix wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract, and atractylodes macrocephala extract in a mass ratio of 3:2:2:1:1:2, add water to dissolve, and obtain an outer layer drug mixture with a mass percentage concentration of 15-20%; (3) Dispersing gelatin, sodium alginate and HPMC in a mass ratio of 10:5:3 into water, heating to 55±5°C to fully dissolve them, obtaining an aqueous solution with a mass percentage concentration of 20%, and mixing it with the outer layer drug mixture in step (2) to obtain an outer layer capsule solution, wherein the volume ratio of the aqueous solution to the outer layer drug mixture is 3:1; (4) The inner layer microcapsules prepared in step (1) are added to the outer layer capsule liquid prepared in step (3) in a mass volume ratio of 1:3. The mixture is stirred thoroughly, and a 5% calcium gluconate aqueous solution (the amount of calcium gluconate added is 5% of the total mass of gelatin, sodium alginate and HPMC) is added. The mixture is stirred continuously (180 rpm) for a cross-linking reaction for 15 min. The reaction liquid is dried by freeze drying (cold trap temperature -40±5°C) to obtain a Gorgon fruit capsule having a bidirectional function of regulating constipation and diarrhea. The particle size of the Gorgon fruit capsule having a bidirectional function of regulating constipation and diarrhea is 40-80 mesh.

[0024] Comparative Example 1 (1) Dissolve polylactic acid-glycolic acid copolymer in dichloromethane to obtain an organic phase, dissolve sodium polyacrylate in water to obtain an aqueous phase, slowly add the organic phase to the aqueous phase and mix, fully emulsify, heat to 55±5°C, add gelatin and stir to dissolve to obtain an embedding solution, the volume ratio of the organic phase to the aqueous phase is 1:3-5, and the mass ratio of polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin is 3:3:4; (2) The powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain in the same amount as in Example 1, wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, liquorice extract and Atractylodes macrocephala extract in a mass ratio of 3:2:2:1:1:2 were mixed with the embedding solution in a mass ratio of 1:8, and embedded in microcapsules by spray drying (140±5°C) technology to obtain microcapsule particles.

[0025] Application testing: (1) 60 patients with chronic diarrhea (aged 25-60 years old, 32 males and 28 females) were divided into two groups (Example 1 group and Comparative Example 1 group). The Euryale capsules and microcapsule particles with bidirectional regulating constipation and diarrhea prepared in Example 1 and Comparative Example 1 were administered, respectively, with a dosage of 0.8 g / time, twice a day (once in the morning and once in the evening), for 3 consecutive months. The treatment status was recorded. The results showed that 21 patients in Example 1 group were cured after taking the medicine for 1 month, and were completely cured after 2 months. 8 patients were significantly improved after taking the medicine for 2 months and were cured after 3 months. 1 patient was slightly improved. All 30 patients had no other side effects. In Comparative Example 1 group, 12 patients were significantly improved after taking the medicine for 1 month and were cured after 2 months. 6 patients were significantly improved after taking the medicine for 2 months and were cured after 3 months. 6 patients were significantly improved after taking the medicine for 3 months. 6 patients were not significantly improved after taking the medicine for 3 months. Among the 30 patients, 5 had mild constipation.

[0026] (2) 60 constipation patients (aged 25-60 years old, 31 males and 29 females) were divided into two groups (Example 1 group and Comparative Example 1 group). They were administered with the Euryale ferox capsules and microcapsule particles with bidirectional regulating constipation and diarrhea functions prepared in Example 1 and Comparative Example 1, respectively. The dosage was 0.8 g / time, 3 times a day, for 7 consecutive days. The treatment status was recorded. The results showed that 18 patients in Example 1 group were cured with significantly improved symptoms after 3 days of medication and completely cured after 5 days. 10 patients were significantly improved after 5 days of medication and cured after 7 days. 2 patients had no significant improvement. All 30 patients had no other side effects. In Comparative Example 1 group, 14 patients had significantly improved symptoms after 3 days of medication and were cured after 5 days. 5 patients were significantly improved after 5 days of medication and were cured after 7 days. 6 patients were significantly improved after 7 days of medication. 5 patients had no significant improvement after one week of medication. 7 out of 30 patients had mild diarrhea.

Claims

1. A method for processing Euryale ferox capsules having the function of bidirectionally regulating constipation and diarrhea, characterized in that: The following steps are involved: (1) Preparation of inner layer microcapsules: powders containing active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain are mixed with an embedding solution formed by dissolving polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin, and the mixture is embedded in microcapsules by spray drying technology to form inner layer microcapsules; (2) Mix the wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract, and atractylodes macrocephala extract, and add water to dissolve them to obtain an outer layer drug mixture; (3) Dispersing gelatin, sodium alginate and HPMC in water, heating them to fully dissolve them to obtain capsule liquid, and mixing them with the outer layer drug mixture in step (2) to obtain an outer layer capsule liquid; (4) adding the inner layer microcapsules prepared in step (1) to the outer layer capsule solution prepared in step (3), stirring the mixture thoroughly, adding a calcium gluconate aqueous solution, stirring the mixture continuously for 10 to 20 minutes to carry out a cross-linking reaction, and drying the reaction solution by freeze drying to obtain a Gorgon fruit capsule having the function of bidirectionally regulating constipation and diarrhea.

2. The processing method of the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: The preparation method of the powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain in step (1) is as follows: Euryale ferox, Chinese yam, rhubarb and plantain are mixed, the active ingredients are extracted by water-alcohol extraction, the extract is concentrated to 10-20% of its volume to obtain a concentrated solution, 2-5% of the mass of inulin is added to the concentrated solution, the mixture is mixed evenly, and the mixture is spray-dried to obtain the powder containing the active ingredients of Euryale ferox, Chinese yam, rhubarb and plantain.

3. The processing method of the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 2, characterized in that: In step (1), the mass ratio of Euryale ferox, Chinese yam, rhubarb and plantain is 18-22:13-16:4-6:4-6; extraction is performed using an ethanol-water solution with a volume ratio of 1:1-3, the temperature is controlled at 50-60°C, the extraction time is 1-2h, and the total mass ratio of the extract to Euryale ferox, Chinese yam, rhubarb and plantain is 10-20:1; and the spray drying temperature is 130-150°C.

4. The processing method of the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: The mass ratio of polylactic acid-glycolic acid copolymer, sodium polyacrylate and gelatin in step (1) is 2-4:2-4:3-5; preferably 3:3:4; polylactic acid-glycolic acid copolymer is dissolved in dichloromethane to obtain an organic phase, sodium polyacrylate is dissolved in water to obtain an aqueous phase, the organic phase is slowly added to the aqueous phase and mixed, fully emulsified, heated to 50-60° C., gelatin is added and stirred to dissolve to obtain an embedding solution, and the volume ratio of the organic phase to the aqueous phase is 1:3-5; the mass ratio of the active ingredient powder containing Euryale ferox, yam, rhubarb and plantain to the embedding solution in step (1) is 1:6-10, and the spray drying condition is 130-150° C.

5. The method for processing the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: The wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract and atractylodes macrocephala extract are powders after water extracts are dried, and the mass ratio of the wolfberry extract, honeysuckle extract, scutellaria baicalensis extract, lotus leaf extract, licorice extract and atractylodes macrocephala extract is 3:2:2:1:1:2, and the mass percentage concentration of the outer layer drug mixture is 15-20%.

6. The method for processing the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: In step (3), the mass ratio of gelatin, sodium alginate and HPMC is 8-12:4-7:2-4, which are dissolved by heating to 50-60°C. The mass percentage concentration of the aqueous solution is 10-20%; the volume ratio of the capsule liquid to the outer layer drug mixture is 3-5:

1.

7. The method for processing the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: The mass percentage concentration of the calcium gluconate aqueous solution in step (4) is 5-10%, and the amount of calcium gluconate added is 5-10% of the total mass of gelatin, sodium alginate and HPMC; the mass volume ratio of the inner layer microcapsule to the outer layer capsule liquid is 1:3-4.

8. The method for processing the Euryale ferox capsule having the function of bidirectionally regulating constipation and diarrhea according to claim 1, characterized in that: The stirring speed in step (4) is 150-200 rpm; the cold trap temperature of the freeze-drying method is -40±5°C.

9. A Gorgon fruit capsule having the function of bidirectionally regulating constipation and diarrhea obtained by the processing method according to any one of claims 1 to 8.

10. The Euryale ferox capsule with the function of bidirectionally regulating constipation and diarrhea according to claim 9, characterized in that: The particle size of the Euryale ferox capsule with the function of bidirectionally regulating constipation and diarrhea is 40-80 meshes.