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CN-122005627-A - Gastric acid-resistant composite prebiotics and probiotics co-carried soft capsule and preparation method and application thereof

CN122005627ACN 122005627 ACN122005627 ACN 122005627ACN-122005627-A

Abstract

The invention relates to the technical field of probiotics, in particular to a gastric acid-resistant composite prebiotics and probiotic co-carried soft capsule, and a preparation method and application thereof. The gastric acid-resistant composite prebiotics and probiotics co-carried soft capsule comprises a capsule shell material and a content emulsion, wherein the content emulsion comprises an oil phase and a water phase, the oil phase comprises sunflower seed oil, beeswax, lecithin and vitamin E, the water phase comprises bifidobacterium bifidum, lactobacillus rhamnosus and other composite probiotics and various composite prebiotics such as galactooligosaccharides, beta-glucan and the like, and the capsule shell material is gelatin-chitosan glue solution. The co-carried soft capsule is prepared by compounding composite prebiotics and probiotics, performing antioxidant and intestinal tract regulating synergistic effects, improving vascular function and metabolic homeostasis together, and matching with a low-temperature film forming technology to form a compact and stable gelatin-chitosan composite capsule shell, wherein the stability of active ingredients and gastric acid tolerance are greatly improved, so that the comprehensive protection effect of delaying senile cardiovascular aging is realized.

Inventors

  • WANG YING
  • ZHOU YANAN
  • WANG YONGPING
  • WANG YONGCUN
  • JI CHAO

Assignees

  • 威凯海思(山东)生物工程有限公司

Dates

Publication Date
20260512
Application Date
20260410

Claims (10)

  1. 1. The gastric acid-resistant composite prebiotics and probiotics co-carried soft capsule is characterized by comprising a capsule shell material and a content emulsion, wherein the content emulsion comprises an oil phase and a water phase, the water phase comprises composite probiotics and composite prebiotics, the composite prebiotics comprises galactooligosaccharides, beta-glucan and inulin, the composite probiotics comprise cheese bacillus (Lacticaseibacillus case), bifidobacterium bifidum (Bifidobacterium bifidum), rhamnose cheese bacillus (Lacticaseibacillus rhamnosus), streptococcus thermophilus (Streptococcus thermophilus) and lactobacillus reuteri (Limosilactobacillus reuteri), and the weight ratio of the composite probiotics to the composite prebiotics is 1:10-20.
  2. 2. The gastric acid resistant composite prebiotic and probiotic co-carried soft capsule according to claim 1, wherein the weight ratio of galactooligosaccharide, beta-glucan and inulin is 1-3:1-2:1-2, the ratio of viable count of cheese bacillus, bifidobacterium bifidum, rhamnose cheese bacillus, streptococcus thermophilus and lactobacillus reuteri is 1-2:2-3:2-3:1-2:1-2, and the total viable count of the composite probiotics is more than or equal to 1 multiplied by 10 10 CFU/g.
  3. 3. The gastric acid resistant composite prebiotic and probiotic co-carried soft capsule of claim 1, wherein the cheese bacillus is cheese bacillus HC1378, and the strain is preserved in 2023, 2 months and 20 days to China general microbiological culture Collection center with the preservation address of North Star west way No.1, 3 in the korean region of beijing and the preservation number of CGMCC No.26585; the bifidobacterium bifidum is bifidobacterium bifidum HC2273, the strain is preserved to the China general microbiological culture Collection center (China Committee for culture Collection of microorganisms) in the 12 th month of 2022, the preservation address is the number 3 of the West-road No. 1 of the Korean area North Star of Beijing, and the preservation number is CGMCC No.26328; the streptococcus thermophilus is streptococcus thermophilus FP13-03, the strain is preserved to the common microorganism center of China Committee for culture Collection of microorganisms in the 7 th month of 2022, the preservation address is number 3 of West Leu 1 of North Star in the Korean area of Beijing city, and the preservation number is CGMCC No.25311; The lactobacillus rhamnosus is lactobacillus rhamnosus HC1509, the strain is preserved to the common microorganism center of China Committee for culture Collection of microorganisms in the 12 th month of 2022, the preservation address is the number 3 of the West road 1 of the Korean area North Star of Beijing, and the preservation number is CGMCC No.26327; the lactobacillus reuteri is lactobacillus reuteri HC1602, and the strain is preserved in 2023, 3 and 23 days to China general microbiological culture Collection center with the preservation address of North Star Xili No.1, 3 in the Korean region of Beijing city and the preservation number of CGMCC No.26890.
  4. 4. The gastric acid-resistant composite prebiotic and probiotic co-carried soft capsule according to claim 1, wherein the oil phase comprises, by mass, 20-40 parts of sunflower seed oil, 1-4 parts of beeswax, 1-5 parts of DHA algae oil, 0.1-0.5 part of vitamin E and 1-3 parts of lecithin, and the capsule shell material is gelatin-chitosan glue solution.
  5. 5. A method for preparing the gastric acid resistant composite prebiotic and probiotic co-carried soft capsule according to claim 4, comprising the following steps: (1) Filling and forming, namely injecting gelatin-chitosan glue solution into a cavity of a soft capsule die in an environment of 20-25 ℃, and then injecting content emulsion into the gelatin-chitosan glue solution, closing an upper die and a lower die, and keeping for 10-15 minutes under the pressure of 0.2MPa, and performing preliminary forming; (2) And (3) curing and drying, namely demolding the preliminarily molded soft capsule, standing for 12-24 hours at the temperature of 4 ℃ to finish low-temperature curing, transferring into a vacuum drying oven, and performing vacuum drying treatment under the conditions that the temperature is lower than 30 ℃ and the vacuum degree is not lower than-0.08 MPa, wherein the drying time is controlled to be 24-48 hours, and the water content of the capsule is reduced to be lower than 10%.
  6. 6. The preparation method of claim 5, wherein the preparation method of the gelatin-chitosan gelatin solution comprises the following steps: Adding gelatin into water with the mass volume ratio of 8% -12% and the temperature of 40-45 ℃ for stirring for 15-20 minutes until the gelatin is completely dissolved, adding chitosan into acetic acid solution with the mass volume ratio of 1% -2%, adjusting the pH of the solution to 4.8-5.2, stirring for 4-6 hours until the gelatin is transparent and clear, adding glycerol into the chitosan solution according to 15% -25% of the total gelatin solution mass, slowly pouring the prepared chitosan solution into the gelatin solution, stirring while chamfering to form uniform compound gelatin solution, and defoaming the compound gelatin solution through vacuum treatment.
  7. 7. The method according to claim 6, wherein the stirring speed is 200 to 300rpm for 15 minutes, the vacuum degree of the vacuum treatment is-0.08 MPa, and the defoaming time is 10 to 15 minutes.
  8. 8. The preparation method of the content emulsion according to claim 5, wherein the preparation method comprises the steps of heating sunflower seed oil and beeswax in a water bath at 65 ℃ and continuously stirring, cooling to 40 ℃ after the beeswax is completely dissolved, sequentially adding DHA algae oil, vitamin E and lecithin, fully and uniformly mixing to form an oil phase, adding galactooligosaccharide, beta-glucan and inulin into pure water, magnetically stirring to fully dissolve the galactooligosaccharide, beta-glucan and inulin, adding composite probiotics, continuously stirring to be completely uniform to obtain a water phase, slowly dripping the oil phase into the water phase, forming a stable water-in-oil emulsion through high-speed homogenization, and removing bubbles through vacuum treatment to obtain the content emulsion.
  9. 9. The method according to claim 8, wherein the high-speed homogenization is carried out at 5000rpm for 2min.
  10. 10. Use of a gastric acid resistant composite prebiotic and probiotic co-carried soft capsule according to any one of claims 1-4 for the preparation of a product for improving vascular function and metabolic homeostasis.

Description

Gastric acid-resistant composite prebiotics and probiotics co-carried soft capsule and preparation method and application thereof Technical Field The invention relates to the technical field of probiotics, in particular to a gastric acid-resistant composite prebiotics and probiotic co-carried soft capsule, and a preparation method and application thereof. Background Cardiovascular system is subject to structural and functional deterioration with age, and cardiovascular aging has become an important pathological basis for central hypofunction and high incidence of cardiovascular diseases in the elderly, and its typical characteristics include reduced vascular elasticity, endothelial dysfunction, increased level of oxidative stress, and reduced mitochondrial function. These changes can lead to decreased myocardial energy efficiency, increased vascular stiffness, and sustained presence of chronic inflammatory responses, which in turn can induce a variety of chronic diseases such as atherosclerosis, hypertension, and heart failure. In recent years, the theory of 'intestine-mandrel' has been paid attention to, and related researches indicate that intestinal microecology plays an important role in cardiovascular function regulation. Probiotics can indirectly affect cardiovascular-related physiological functions by improving intestinal barrier function, inhibiting systemic inflammatory response, regulating lipid metabolism and other ways. However, the effect of probiotics is mainly reflected in the aspect of intestinal microecology regulation, which is helpful for improving the whole metabolic state by improving the flora structure, promoting the generation of short-chain fatty acids and regulating and controlling cholesterol metabolism, but the direct support capability on the energy metabolism of myocardial cells and vascular endothelial functions is still limited. In this context, prebiotics gradually show potential value in cardiovascular function regulation as functional dietary ingredients that can be selectively utilized by intestinal beneficial bacteria. Typical prebiotics such as galactooligosaccharides, beta-glucan and inulin promote the proliferation of beneficial bacteria such as bifidobacteria and lactobacillus, enhance intestinal barrier integrity, reduce endotoxin translocation levels, and help maintain cardiovascular-related physiological function homeostasis by modulating short chain fatty acid production, improving lipid metabolism and inhibiting chronic low-grade inflammatory response. Compared with single-dependent probiotics, the prebiotic-probiotic synergistic system has obvious advantages in improving the stability of intestinal microecology, prolonging the duration of the function of the probiotics and delaying senile cardiovascular aging. However, in practical applications, the prebiotic and probiotic composite formulation still faces various technical challenges. The prebiotics are mostly hydrophilic carbohydrates, are easy to swell or partially degrade in the stomach section, and are easy to inactivate in a large amount in an acidic stomach environment as active microorganisms which are highly sensitive to the environment, so that when the prebiotics are compounded in the same preparation, the structural stability of the prebiotics and the selective promotion effect on the probiotics are required to be ensured, the activity of the probiotics in the preparation, storage and in-vivo delivery processes is required to be maintained, and the existing embedding system is difficult to simultaneously meet the requirements. At present, soft capsules have been widely studied and used as important dosage forms for active bacteria protection and intestinal delivery. For example, chinese patent CN111000241a adopts probiotic lyophilized powder, cod liver oil, vitamin E, glycerin, gelatin, and other raw materials, and prepares a soft capsule by a high-temperature sol method. The process is simple and convenient to operate, the film forming temperature is high, the activity loss of probiotics is easy to cause, the capsule shell mainly takes single gelatin as a base material, the capsule shell lacks good gastric acid resistance and pH response characteristics, and is easy to quickly swell or dissolve in a gastric acid environment, so that the probiotics are exposed to strong acid conditions and are inactivated in a large amount, and the delivery efficiency is limited. Therefore, a composite delivery system with low-temperature preparation conditions, good gastric acid resistance and structural stability is developed, so that prebiotics and probiotics are effectively protected in the stomach section, and synergistic release and function exertion are realized in the intestinal tract environment, and the key technical problem to be solved in the development of the probiotic composite preparation is still urgent. The method also provides an important research direction for the application of the gastric acid