Preparation method of soft capsule of rana rugosa and sacha inchi oil red koji powder

Abstract

The application provides a preparation method of a soft capsule of Rana spinosa Mato Grosso oil red yeast powder, and belongs to the technical field of health food preparation. Specific weight parts of Rana spinosa freeze-dried powder 50 parts, red yeast powder 20-30 parts, Mato Grosso oil 100 parts and beta-cyclodextrin 10-20 parts are used as raw materials, the Rana spinosa freeze-dried powder is prepared through an optimized freeze-drying process, and the soft capsule is prepared after being mixed uniformly. The application realizes synergistic effect through scientific compounding of raw materials, can comprehensively regulate four indexes of blood lipids, and protects liver function at the same time. The beta-cyclodextrin embedding and soft capsule sealing double protection technology are adopted, so that the shelf life of the product is prolonged to 24 months. The prepared soft capsule has a remarkable effect of reducing blood lipids, is safe and has no side effects, is convenient to take, and is suitable for large-scale industrial production.

Description

Technical Field

[0001] This invention relates to the field of health food preparation technology, and in particular to a method for preparing soft capsules of red yeast rice powder from the spiny-breasted frog (Sinocyclocheilus spinosa) fruit oil. Background Technology

[0002] Hyperlipidemia is a global chronic metabolic disease characterized by elevated levels of serum total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C), and decreased levels of high-density lipoprotein cholesterol (HDL-C). Long-term hyperlipidemia can lead to cardiovascular and cerebrovascular diseases such as atherosclerosis, coronary heart disease, and stroke, seriously threatening human health. With improved living standards and changes in dietary structure, the incidence of hyperlipidemia is increasing year by year, and the age of onset is gradually becoming younger. Currently, statins and fibrates are mainly used clinically to treat hyperlipidemia, but long-term use may cause side effects such as liver damage and muscle pain. Therefore, developing natural, safe, and effective lipid-lowering health foods is of significant practical importance.

[0003] The spiny-breasted frog, also known as the stone chicken, stone scale frog, or stone frog, is a large wild frog endemic to China, mainly distributed in mountain streams in the southern mountains. Its meat is tender and rich in high-quality protein, various amino acids, minerals, and trace elements, earning it the title of "King of Frogs." In traditional Chinese medicine, the spiny-breasted frog is believed to have nourishing, strengthening, lung-clearing, spleen-strengthening, and stomach-nourishing effects. However, most spiny-breasted frog products on the market are either fresh and cooked or simply dried. Its proteins are mostly large molecules with low digestibility and absorption rates, and its active ingredients are easily destroyed during processing, resulting in its nutritional value and health benefits not being fully realized.

[0004] Red yeast rice is a traditional fermented food made by inoculating japonica rice with Monascus purpureus and fermenting it. It has been used for food and medicine in my country for thousands of years. Modern research shows that Monacolin K, contained in red yeast rice, can specifically inhibit the activity of HMG-CoA reductase, thereby blocking the synthesis of endogenous cholesterol and significantly reducing serum total cholesterol and low-density lipoprotein cholesterol levels. However, using red yeast rice alone has the following drawbacks: first, its effect on regulating triglycerides is limited; second, some red yeast rice products may contain harmful substances such as citrinin; and third, long-term, high-dose use may still pose a certain risk of liver damage.

[0005] Sacha inchi oil is a natural plant oil extracted from sacha inchi seeds through cold pressing. It is rich in unsaturated fatty acids, with α-linolenic acid content ≥43% and linoleic acid content ≥36%. α-linolenic acid and linoleic acid are essential polyunsaturated fatty acids that can promote cholesterol metabolism, lower serum triglyceride levels, and raise high-density lipoprotein cholesterol. However, sacha inchi oil contains a large number of unsaturated double bonds, making it highly susceptible to oxidation and rancidity. Furthermore, its bioavailability is low when taken alone, limiting its widespread application in health supplements.

[0006] Currently, most lipid-lowering health supplements on the market use single ingredients or simple combinations of two ingredients, and have the following common technical problems: single efficacy, unable to simultaneously and comprehensively regulate the four blood lipid indicators of TC, TG, LDL-C and HDL-C; poor stability of active ingredients, short shelf life, usually only 12-18 months; failure to consider the synergistic effect between ingredients, simple superposition leads to large dosage, increasing the risk of side effects; lack of liver protection, long-term use may still increase the burden on the liver.

[0007] Therefore, developing a soft capsule made from red yeast rice powder from the spiny-breasted frog with significant lipid-lowering effects, high retention rate of active ingredients, good product stability, and no side effects has important application value. Summary of the Invention

[0008] This invention provides a method for preparing soft capsules of Sagittaria sagittifolia fruit oil and red yeast rice powder, in order to overcome the defects in the prior art.

[0009] This invention provides a method for preparing soft capsules of Sagittaria sagittifolia fruit oil and red yeast rice powder, comprising the following steps: Step 1: Disinfect and kill the spiny-breasted frog, remove its internal organs and clean it thoroughly, and dissect it to obtain spiny-breasted frog meat; Step 2: Prepare the spiny-breasted frog meat obtained in Step 1 into spiny-breasted frog freeze-dried powder; Step 3: Weigh out the freeze-dried powder of spiny-breasted frog, red yeast rice powder, sacha inchi oil and β-cyclodextrin according to the weight parts, put them into a mixer and mix them evenly to obtain the contents; Step four: Transfer the contents into a soft capsule press and press them into soft capsules containing spiny-breasted frog red yeast rice powder.

[0010] According to the present invention, the preparation method of the spiny-breasted frog Sacha involucrata oil and red yeast rice powder soft capsules, the weight parts of each raw material in step three are: 50 parts of spiny-breasted frog freeze-dried powder, 20-30 parts of red yeast rice powder, 100 parts of Sacha involucrata oil, and 10-20 parts of β-cyclodextrin.

[0011] According to the present invention, a method for preparing spiny-breasted frog (Sapindus mukorossi) oil and red yeast rice powder soft capsules is provided. The preparation method of the spiny-breasted frog freeze-dried powder in step two specifically includes the following steps: (1) Remove impurities from the spiny frog meat, add 20-30% of deionized water equivalent to the weight of the spiny frog meat, heat to 80-90℃ and then blend into a slurry, and freeze the slurry at -20℃ for more than 36 hours. (2) After disinfecting the freeze-drying tray with 75% alcohol, fill it with the above slurry. Spread the slurry evenly with a thickness of 1.5cm. Then place the freeze-drying tray in a -70℃ environment and evacuate it to 10Pa. (3) Maintain the vacuum degree between 10-15 Pa, raise the temperature to 60 °C at a rate of 10 °C / h, and hold at this temperature for 5 h; (4) Stop heating, cool to room temperature and then crush to obtain freeze-dried powder of spiny-breasted frog.

[0012] According to the present invention, a method for preparing a soft capsule of spiny frog sago palm oil and red yeast rice powder is provided, wherein the deionized water added in step (1) is 25% of the weight of spiny frog meat, the heating temperature is 85°C, and the freezing time is 48h.

[0013] According to the preparation method of the spiny-breasted frog Sacha involucrata oil and red yeast rice powder soft capsules provided by the present invention, in step (2), the vacuum is drawn to an absolute pressure of 10 Pa.

[0014] According to the preparation method of the red yeast rice powder soft capsule of the spiny-breasted frog Sacha in the present invention, in step (3), the vacuum degree is maintained at 12 Pa and the temperature is raised to 60°C and then maintained for 5 h.

[0015] According to the present invention, a method for preparing red yeast rice powder soft capsules of Saxifraga spinosa oil is provided, wherein the content of Monacoline K in the red yeast rice powder in step three is 0.2-0.8 wt%.

[0016] According to the present invention, a method for preparing Sacha indica oil and red yeast rice powder soft capsules is provided, wherein the Sacha indica oil in step three is low-temperature cold-pressed Sacha indica oil, wherein the content of linolenic acid is ≥43wt% and the content of linoleic acid is ≥36wt%.

[0017] According to the preparation method of the spiny-breasted frog Sacha Inonotus spp. oil and red yeast rice powder soft capsules provided by the present invention, the mixing conditions in step three are: mixing at a speed of 30-50 r / min for 15-30 min.

[0018] According to the present invention, a method for preparing soft capsules of spiny-breasted frog oil and red yeast rice powder is provided. In step four, the weight of each soft capsule is 0.5g, and the soft capsule shell is composed of gelatin, glycerin and purified water in a mass ratio of 1:0.4:1.

[0019] The present invention provides a method for preparing soft capsules of Sagittaria sagittifolia fruit oil and red yeast rice powder, which has the following beneficial effects: (1) The lyophilized powder of spiny-breasted frog, red yeast rice powder, Sacha inchi oil and β-cyclodextrin were compounded in a specific ratio, and the components played a synergistic role. Monacolin K (0.2-0.8wt%) in red yeast rice powder reduced the synthesis of endogenous cholesterol from the source by inhibiting HMG-CoA reductase activity, and significantly reduced serum TC and LDL-C levels. The high content of α-linolenic acid and linoleic acid in Sacha inchi oil can promote cholesterol decomposition and metabolism, reduce serum TG levels and increase HDL-C levels, making up for the deficiency of red yeast rice in regulating triglycerides. The small molecule active peptides, amino acids and minerals in the lyophilized powder of spiny-breasted frog can enhance the body's immunity, protect liver function, reduce the risk of liver damage that may be caused by long-term use of red yeast rice, and at the same time assist in regulating lipid metabolism. β-cyclodextrin, as an encapsulating agent, can encapsulate hydrophobic monacolin K and unsaturated fatty acids in its hollow structure, thereby improving the water solubility and bioavailability of active ingredients.

[0020] (2) The present invention uses a specific freeze-drying process to prepare freeze-dried powder of spiny-breasted frog: First, spiny-breasted frog meat is added to 20-30% deionized water and heated to 80-90℃ to make a pulp, so that the macromolecular proteins undergo moderate denaturation, destroy their spatial structure, and improve the digestibility and absorption rate of the human body; it is pre-frozen at -20℃ for more than 36 hours, so that the water in the pulp forms uniform and fine ice crystals, avoiding the destruction of cell structure by excessively large ice crystals; it is sublimated and dried at -70℃ and 10Pa high vacuum, and slowly heated to 60℃ at a rate of 10℃ / h and held for 5 hours, which not only ensures the complete removal of water, but also avoids the destruction of heat-sensitive active ingredients by high temperature.

[0021] (3) This invention uses a soft capsule dosage form, sealing the contents in a capsule composed of gelatin, glycerin, and purified water. This effectively isolates the contents from air, light, and moisture, preventing the unsaturated fatty acids in Sacha inchi oil from oxidizing and becoming rancid, while also avoiding the degradation of monacolin K in red yeast rice. Accelerated stability test results show that the soft capsules prepared in this invention, after being placed at 40℃ and 75% relative humidity for 6 months, retain ≥88% monacolin K, have a peroxide value ≤0.15g / 100g, and exhibit stable product quality with a shelf life of up to 24 months.

[0022] (4) The soft capsules prepared by this invention contain 0.5g of contents per capsule, which is accurate in dosage, convenient to take, and can effectively mask the unpleasant odors of spiny-breasted frog powder and red yeast rice powder, thereby improving consumer compliance. The preparation process does not require complex equipment or harsh reaction conditions, the parameters of each step are controllable, the product quality is stable, and it is suitable for large-scale industrial production. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0024] Therefore, the detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0025] Example 1

[0026] This embodiment provides a method for preparing soft capsules of red yeast rice powder from the spiny-breasted frog, the specific steps of which are as follows: Raw material pretreatment: Select healthy and live spiny-breasted frogs, disinfect the body surface with 75% alcohol, slaughter them, remove the internal organs, head and limb skin, rinse them repeatedly with purified water, and dissect them to obtain the clean spiny-breasted frog meat.

[0027] Preparation of freeze-dried spiny frog powder: (1) Remove impurities such as fascia from the spiny frog meat, weigh 1000g of spiny frog meat, add 250g of deionized water (accounting for 25% of the weight of spiny frog meat), heat to 85℃ and grind into a uniform slurry using a colloid mill, divide the slurry into sealed containers and freeze in a -20℃ refrigerator for 48h; (2) Wipe the freeze-drying tray with 75% alcohol for disinfection, spread the thawed slurry evenly on the tray, and control the thickness to 1.5cm; then place the freeze-drying tray in a vacuum freeze dryer, pre-cool to -70℃, and evacuate to an absolute pressure of 10Pa; (3) Maintain the vacuum degree at 12Pa, slowly raise the temperature to 60℃ at a rate of 10℃ / h, and keep it at this temperature for 5h; (4) Stop heating, wait for the material to cool to room temperature, take it out, crush it to 80 mesh with a pulverizer, and obtain the freeze-dried spiny frog powder.

[0028] Mixing: Weigh out 50 parts by weight of the above-mentioned freeze-dried spiny-breasted frog powder, 25 parts by weight of red yeast rice powder (monacolin K content 0.5wt%), 100 parts by weight of cold-pressed sacha inchi oil (α-linolenic acid content 45wt%, linoleic acid content 38wt%), and 15 parts by weight of β-cyclodextrin. Put them into a three-dimensional motion mixer and mix for 20 minutes at a speed of 40 r / min to obtain a uniform mixture.

[0029] Saccharification: The contents are transferred to a soft capsule saccharification machine and saccharification is performed using a gelatin-glycerin-purified water (mass ratio 1:0.4:1). Each soft capsule contains 0.5g of contents. After shaping, drying, washing, and sorting, the spiny-breasted frog red yeast rice powder soft capsules are obtained.

[0030] Example 2

[0031] This embodiment provides a method for preparing soft capsules of red yeast rice powder from the spiny-breasted frog, which differs from Example 1 only in that: The raw materials in step 3 are as follows by weight: 50 parts of freeze-dried spiny-breasted frog powder, 20 parts of red yeast rice powder (monacolin K content 0.2wt%), 100 parts of cold-pressed sacha inchi oil (α-linolenic acid content 43wt%, linoleic acid content 36wt%), and 10 parts of β-cyclodextrin. In step 2 (1), the mass of deionized water added is 20% of the mass of the spiny-breasted frog meat, the heating temperature is 80℃, and the freezing time is 36h; In step 2 (3), the vacuum level is maintained at 10 Pa; The mixing conditions in step 3 are: mixing at a speed of 30 r / min for 30 min.

[0032] Example 3

[0033] This embodiment provides a method for preparing soft capsules of red yeast rice powder from the spiny-breasted frog, which differs from Example 1 only in that: The raw materials in step 3 are as follows by weight: 50 parts of freeze-dried spiny-breasted frog powder, 30 parts of red yeast rice powder (monacolin K content 0.8wt%), 100 parts of cold-pressed sacha inchi oil (α-linolenic acid content 46wt%, linoleic acid content 37wt%), and 20 parts of β-cyclodextrin. In step 2 (1), the mass of deionized water added is 30% of the mass of the spiny-breasted frog meat, the heating temperature is 90℃, and the freezing time is 48h; In step 2 (3), the vacuum level is maintained at 15 Pa; The mixing conditions in step 3 are: mixing at a speed of 50 r / min for 15 min.

[0034] Comparative Example 1 This comparative example provides a method for preparing red yeast rice and sago palm oil soft capsules. The only difference from Example 1 is that no lyophilized spiny-breasted frog powder is added in step 3. All other raw materials and process parameters are exactly the same as in Example 1.

[0035] Comparative Example 2 This comparative example provides a method for preparing Saxifraga spinosa oil soft capsules. The only difference from Example 1 is that red yeast rice powder is not added in step 3, while the other raw materials and process parameters are exactly the same as in Example 1.

[0036] Comparative Example 3 This comparative example provides a method for preparing spiny-breasted frog red yeast rice powder soft capsules. The only difference from Example 1 is that the spiny-breasted frog powder is prepared by hot air drying in step 2. Specifically, the spiny-breasted frog meat is ground into a slurry and then placed in a 60°C hot air drying oven for 24 hours to dry. The slurry is then crushed to 80 mesh to obtain spiny-breasted frog powder. The remaining raw materials and process parameters are exactly the same as in Example 1.

[0037] Comparative Example 4 This comparative example provides a preparation method of Rana spinosa red yeast rice powder soft capsule, which is only different from Example 1 in that: β-cyclodextrin is not added in step 3, and the remaining raw materials and process parameters are exactly the same as those in Example 1.

[0038] Comparative Example 5 This comparative example provides a preparation method of Rana spinosa red yeast rice powder soft capsule, which is only different from Example 1 in that: the raw materials in parts by weight in step 3 are: 50 parts of Rana spinosa freeze-dried powder, 10 parts of red yeast rice powder, 100 parts of sacha inchi oil, and 5 parts of β-cyclodextrin, and the remaining process parameters are exactly the same as those in Example 1.

[0039] Experiment 1 Verification of hypolipidemic effect: Fifty SPF male SD rats, with a body weight of 180-220 g, were provided by Hebei Provincial Laboratory Animal Center, with the animal license number: SCXK(Hebei)2025-0003. The rats were fed adaptively for 1 week, with free access to food and water. The feeding environment temperature was 22±2°C, the relative humidity was 50±5%, and a 12 h light / 12 h dark cycle was maintained.

[0040] Experimental grouping and modeling: The rats were randomly divided into 10 groups, with 5 rats in each group: Blank control group: fed with ordinary diet; Model control group: fed with high-fat diet (78.8% of basic diet + 1% of cholesterol + 0.2% of bile salt + 10% of lard + 10% of egg yolk powder); Groups of Examples 1-3: after successful modeling, the contents of the soft capsules prepared in Examples 1-3 were respectively administered by intragastric gavage at a dose of 0.5 g / kg body weight; Groups of Comparative Examples 1-5: after successful modeling, the contents of the soft capsules prepared in Comparative Examples 1-5 were respectively administered by intragastric gavage at a dose of 0.5 g / kg body weight.

[0041] Except for the blank control group, all other groups were fed with high-fat diet for 4 weeks. Blood was collected from the orbital vein to determine serum lipid indexes, and the successful establishment of the hyperlipidemia model was confirmed. After successful modeling, each group continued to be fed with high-fat diet and administered by gavage at the above dose, while the blank control group and the model control group were given an equal volume of normal saline, once a day, for 4 consecutive weeks.

[0042] Detection indicators: after the last administration, the animals were fasted for 12 h, then blood was collected from the orbital vein, centrifuged at 3000 r / min for 10 min to separate serum. A full-automatic biochemical analyzer was used to determine the contents of serum total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C).

[0043] The experimental results are shown in Table 1.

[0044] Table 1 Comparison of serum lipid levels in rats of different groups ( (n=5) Note: Compared with the model control group, *P<0.05; compared with comparative groups 1-5, #P<0.05.

[0045] Table 1 shows that compared with the model control group, the serum TC, TG, and LDL-C levels of rats in all treatment groups were significantly reduced, while the HDL-C level was significantly increased (P<0.05), indicating that each formulation has a certain lipid-lowering effect. The lipid-lowering effect of the Example 1-3 groups was significantly better than that of all comparative groups (P<0.05), with the Example 1 group showing the best effect: TC decreased by 42.5%, TG decreased by 45.3%, LDL-C decreased by 43.8%, and HDL-C increased by 29.4%. The lipid-lowering effects of Comparative Examples 1 and 2 were significantly weaker than those of the Example Group, demonstrating that the freeze-dried powder of the spiny-breasted frog, red yeast rice powder, and Sacha indica oil have a significant synergistic lipid-lowering effect; the effect of Comparative Example 3 was lower than that of the Example Group, demonstrating that the freeze-drying process of the present invention can better preserve the active ingredients of the spiny-breasted frog; the effect of Comparative Example 4 decreased, demonstrating that β-cyclodextrin can improve the bioavailability of the active ingredients; the effect of Comparative Example 5 was significantly reduced, demonstrating that the raw material ratio specified in the present invention is the key to achieving the optimal lipid-lowering effect.

[0046] Experiment 2: Verification of the retention rate of active ingredients in the spiny-breasted frog: Spiny-breasted frog powder was prepared using the freeze-drying process of Example 1 and the hot-air drying process of Comparative Example 3, respectively. The contents of protein, small molecule peptides and total amino acids were determined, and the retention rate was calculated (with the contents of the corresponding components in fresh spiny-breasted frog meat as 100%). The results are shown in Table 2.

[0047] Table 2. Effects of different drying processes on the retention rate of active ingredients in the spiny-breasted frog (%) The results show that the freeze-drying process of the present invention can significantly improve the retention rate of active ingredients in spiny-breasted frogs, especially the retention rate of small molecule peptides, which is 5 times that of the traditional hot air drying process. This is an important basis for the good health benefits of the product of the present invention.

[0048] Experiment 3: Product stability verification The soft capsules prepared in Example 1 were subjected to accelerated stability testing at a temperature of 40℃±2℃ and a relative humidity of 75%±5%. Samples were taken at 0, 1, 2, 3 and 6 months to determine the monacolin K content and peroxide value. The results are shown in Table 3.

[0049] Table 3. Results of accelerated stability test of Spiny-breasted Frog Red Yeast Rice Powder Soft Capsules The results showed that the soft capsules prepared by this invention, after being placed under accelerated testing conditions for 6 months, still had a Monacoline K retention rate as high as 88.8% and a peroxide value of 0.14 g / 100 g, which is far below the limit of 0.25 g / 100 g specified in the national standard, proving that the product has good stability and a shelf life of up to 24 months.

[0050] This invention provides a method for preparing soft capsules of spiny-breasted frog, Sacha indica oil, and red yeast rice powder. The method involves compounding spiny-breasted frog freeze-dried powder, red yeast rice powder, Sacha indica oil, and β-cyclodextrin in a specific ratio. The components work synergistically. Monacolin K (0.2-0.8 wt%) in the red yeast rice powder inhibits HMG-CoA reductase activity, reducing endogenous cholesterol synthesis at its source and significantly lowering serum TC and LDL-C levels. The high content of α-linolenic acid and linoleic acid in Sacha indica oil promotes cholesterol metabolism, lowers serum TG levels, and increases HDL-C levels, compensating for the insufficient triglyceride regulation effect of red yeast rice. The small molecule active peptides, amino acids, and minerals abundant in the spiny-breasted frog freeze-dried powder enhance immunity, protect liver function, reduce the risk of liver damage from long-term red yeast rice consumption, and assist in regulating lipid metabolism. β-cyclodextrin, as an encapsulating agent, can encapsulate hydrophobic monacolin K and unsaturated fatty acids in its hollow structure, improving the water solubility and bioavailability of the active ingredients. Animal experiments showed that, compared with the model control group, the spiny-breasted frog red yeast rice powder soft capsules prepared in this invention could reduce serum TC by 38.2%-42.5%, TG by 41.6%-45.3%, LDL-C by 40.1%-43.7%, and increase HDL-C by 26.8%-29.4% in hyperlipidemic rats. Compared with the red yeast rice powder alone group, the TC reduction rate increased by 12.3%-15.6%, and the TG reduction rate increased by 21.5%-24.8%. Compared with the sacha inchi oil alone group, the TG reduction rate increased by 9.7%-12.2%, and the TC reduction rate increased by 18.4%-21.1%, demonstrating that the raw material combination of this invention has a significant synergistic lipid-lowering effect.

[0051] A specific freeze-drying process was used to prepare freeze-dried powder of *Rana spinosa* (spiny-breasted frog): First, spiny-breasted frog meat was added to 20-30% deionized water and heated to 80-90℃ to slurry, causing moderate denaturation of large protein molecules, disrupting their spatial structure, and improving human digestibility and absorption. Then, it was pre-frozen at -20℃ for more than 36 hours, allowing the water in the slurry to form uniform and fine ice crystals, preventing excessively large ice crystals from damaging cell structure. Sublimation drying was then carried out at -70℃ and a high vacuum of 10 Pa, followed by a slow heating to 60℃ at a rate of 10℃ / h and holding for 5 hours. This ensured complete removal of moisture while avoiding damage to heat-sensitive active ingredients from high temperatures. Testing showed that the freeze-dried powder of *Rana spinosa* prepared using this process had a protein retention rate ≥92%, a small molecule peptide content ≥35%, and an amino acid retention rate ≥90%, significantly higher than that of the traditional hot air drying process (protein retention rate approximately 65%, small molecule peptide content approximately 18%).

[0052] The soft capsule formulation seals the contents within a gelatinous membrane composed of gelatin, glycerin, and purified water. This effectively isolates the contents from air, light, and moisture, preventing the oxidative rancidity of unsaturated fatty acids in Sacha Inchi oil and avoiding the degradation of monacolin K in red yeast rice. Accelerated stability testing results show that the soft capsules prepared according to this invention, after being stored at 40°C and 75% relative humidity for 6 months, exhibit a monacolin K retention rate ≥88%, a peroxide value ≤0.15g / 100g, stable product quality, and a shelf life of up to 24 months.

[0053] The prepared soft capsules contain 0.5g of contents per capsule, ensuring accurate dosage and convenient administration. They also effectively mask the unpleasant odors of spiny-breasted frog powder and red yeast rice powder, improving consumer compliance. The preparation process requires no complex equipment or stringent reaction conditions; parameters at each step are controllable, resulting in stable product quality and suitability for large-scale industrial production.

[0054] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing soft capsules of spiny-breasted frog (Saxifraga stolonifera) oil and red yeast rice powder, characterized in that, Includes the following steps: Step 1: Disinfect and kill the spiny-breasted frog, remove its internal organs and clean it thoroughly, and dissect it to obtain spiny-breasted frog meat; Step 2: Prepare the spiny-breasted frog meat obtained in Step 1 into spiny-breasted frog freeze-dried powder; Step 3: Weigh out the freeze-dried powder of spiny-breasted frog, red yeast rice powder, sacha inchi oil and β-cyclodextrin according to the weight parts, put them into a mixer and mix them evenly to obtain the contents; Step four: Transfer the contents into a soft capsule press and press them into soft capsules containing spiny-breasted frog red yeast rice powder.

2. The preparation method of the spiny-breasted frog, Sacha indica fruit oil, and red yeast rice powder soft capsules according to claim 1, characterized in that, The weight parts of each raw material in step three are: 50 parts of freeze-dried spiny-breasted frog powder, 20-30 parts of red yeast rice powder, 100 parts of Sacha indica oil, and 10-20 parts of β-cyclodextrin.

3. The preparation method of the spiny-breasted frog, Sacha indica fruit oil, and red yeast rice powder soft capsules according to claim 1, characterized in that, The preparation method of the spiny-breasted frog freeze-dried powder in step two specifically includes the following steps: (1) Remove impurities from the spiny frog meat, add 20-30% of deionized water equivalent to the weight of the spiny frog meat, heat to 80-90℃ and then blend into a slurry, and freeze the slurry at -20℃ for more than 36 hours. (2) After disinfecting the freeze-drying tray with 75% alcohol, fill it with the above slurry. Spread the slurry evenly with a thickness of 1.5cm. Then place the freeze-drying tray in a -70℃ environment and evacuate it to 10Pa. (3) Maintain the vacuum degree between 10-15 Pa, raise the temperature to 60 °C at a rate of 10 °C / h, and hold at this temperature for 5 h; (4) Stop heating, cool to room temperature and then crush to obtain freeze-dried powder of spiny-breasted frog.

4. The preparation method of the spiny-breasted frog, Sacha indica fruit oil, and red yeast rice powder soft capsules according to claim 3, characterized in that, The deionized water added in step (1) is 25% of the weight of the spiny frog meat, the heating temperature is 85℃, and the freezing time is 48h.

5. The preparation method of the spiny-breasted frog (Rosa rugosa) oil and red yeast rice powder soft capsules according to claim 3, characterized in that, In step (2), the vacuum is evacuated to an absolute pressure of 10 Pa.

6. The preparation method of the spiny-breasted frog, Sacha indica oil, and red yeast rice powder soft capsules according to claim 3, characterized in that, In step (3), the vacuum degree is maintained at 12 Pa, and the temperature is raised to 60°C and maintained for 5 hours.

7. The preparation method of the spiny-breasted frog, Sacha indica fruit oil, and red yeast rice powder soft capsules according to claim 1, characterized in that, The content of Monacoline K in the red yeast rice powder mentioned in step three is 0.2-0.8 wt%.

8. The method for preparing a soft capsule of spiny-breasted frog (Sapindus mukorossi) oil and red yeast rice powder according to claim 1, characterized in that, The sacha in step three is cold-pressed sacha in a low temperature, with an alpha-linolenic acid content of ≥43wt% and an oleic acid content of ≥36wt%.

9. The method for preparing a soft capsule of spiny-breasted frog (Sapindus mukorossi) oil and red yeast rice powder according to claim 1, characterized in that, The conditions for achieving uniform mixing in step three are: mixing at a speed of 30-50 r / min for 15-30 min.

10. The method for preparing a soft capsule of spiny-breasted frog (Sapindus mukorossi) oil and red yeast rice powder according to claim 1, characterized in that, The contents of each soft capsule described in step four weigh 0.5g, and the soft capsule shell is composed of gelatin, glycerin and purified water in a mass ratio of 1:0.4:1.

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