Low-potassium and low-phosphorus protein assembly for special medical purpose and preparation method of low-potassium and low-phosphorus protein assembly

Abstract

The invention belongs to the technical field of formula foods for special medical purposes, and particularly relates to a low-potassium low-phosphorus protein component for special medical purposes and a preparation method thereof. The protein component is of a liquid ready-to-use type, and comprises the following components on the basis of 100 mL of total volume: 10.0-12.0 g of separated whey protein powder; and 0.05 to 0.15 g of stevioside. 0.20 to 0.30 g of a compound stabilizer; and the balance of water. The compound stabilizer is prepared from phospholipid and xanthan gum. The separated whey protein powder with low phosphorus and potassium content and specific calcium content is selected as a core protein source, so that the final product has extremely low phosphorus-protein ratio and potassium content. The phosphorus intake brought by the product is obviously lower than that of commercially available like products, and the kidney metabolism burden and the hyperphosphatemia risk of patients are greatly relieved. The phospholipid and the xanthan gum in a specific mass ratio are used as a compound stabilizer, and the phospholipid is used as an emulsifier, so that protein particles can be effectively wrapped, and aggregation is prevented.

Description

Technical Field

[0001] This invention belongs to the field of special medical purpose formula food technology, and particularly relates to a low-potassium, low-phosphorus special medical purpose protein component and its preparation method. Background Technology

[0002] Patients with chronic kidney disease (CKD) commonly experience protein-energy wastage (PEW), requiring adequate intake of high-quality protein to maintain positive nitrogen balance and slow disease progression. However, impaired kidney function leads to reduced excretion of electrolytes such as phosphorus and potassium, easily causing hyperphosphatemia and hyperkalemia, the latter being independent risk factors for increased cardiovascular events and mortality. Therefore, nutritional support for CKD patients faces a core contradiction: balancing adequate protein intake with strict restriction of phosphorus and potassium intake. Currently available general-purpose protein supplements and some kidney-specific nutritional products, while optimized for protein sources, still have the following shortcomings: 1) The phosphoprotein ratio (i.e., the number of milligrams of phosphorus per gram of protein) is generally high, meaning patients still ingest a considerable amount of "accompanying phosphorus" to meet their protein needs, hindering blood phosphorus control; 2) Potassium content is not strictly controlled or clearly labeled, posing potential risks; 3) The dosage form (especially liquid) is unstable, prone to protein precipitation, fat floating, or taste separation, affecting patient compliance. Whey protein isolate is considered a high-quality protein source due to its complete amino acid profile, high bioavailability, and rapid gastric emptying. However, regular whey protein isolate still contains a certain amount of phosphorus and potassium.

[0003] How to reduce the phosphorus and potassium content of the final product to extremely low levels while ensuring protein supply efficiency and product physical stability through in-depth design of the formulation system has become an urgent problem to be solved. Summary of the Invention

[0004] The main objective of this invention is to provide a low-potassium, low-phosphorus protein component for special medical applications and its preparation method, in order to overcome the shortcomings of the prior art.

[0005] To achieve the aforementioned objectives, the technical solution adopted by this invention includes: According to a first aspect of the present invention, a low-potassium, low-phosphorus protein component for special medical use is provided. The protein component is a ready-to-use liquid. Based on a total volume of 100 mL, the raw materials for preparing the protein component include: 10.0-12.0 g of isolated whey protein powder; 0.05-0.15 g of steviol glycosides; 0.20-0.30 g of composite stabilizer; and the balance being water. The composite stabilizer is composed of phospholipids and xanthan gum, with a mass ratio of phospholipids to xanthan gum of 1.2-1.8:1.

[0006] Furthermore, the phosphoprotein ratio of the protein component is 1.8-2.2 mg phosphorus / g protein.

[0007] Furthermore, the potassium content in the protein component is 0.15-0.25 mg / g.

[0008] Furthermore, the isolated whey protein powder has a protein content of not less than 90 wt% and a calcium content of 300-500 mg / 100g.

[0009] Furthermore, the osmotic pressure of the protein assembly is 25-40 mOsmol / kg.

[0010] Furthermore, the pH value of the protein component is 6.8-7.2.

[0011] Furthermore, the raw materials for preparing the protein assembly also include nicotinamide, and based on a total volume of 100 mL, the amount of nicotinamide is 0.05-0.20 g.

[0012] According to a second aspect of the present invention, a method for preparing a protein component is provided, comprising the following steps: S1. Heat 60%-70% of the water in the formula to 65-75℃, add the composite stabilizer, and shear and disperse at a high speed of 1000-2000 rpm for 5-10 minutes to obtain the stabilizer solution. S2. Add the steviol glycosides to the stabilizer solution and disperse them at a high speed of 1000-2000 rpm for 5-10 minutes. S3. Slowly add the separated whey protein powder to S2, and shear and dissolve it at 55-65°C and 1000-1500 rpm for 10-15 minutes to obtain a mixture; S4. Homogenize the mixture obtained in S3, adjust the volume, sterilize, aseptically homogenize, and aseptically fill. Furthermore, the homogenization pressure in step S4 is 18-30 MPa; the sterilization is carried out by steam immersion sterilization at a temperature of 140-150℃ for 4-6 seconds; and the aseptic filling volume is 100 mL / bottle.

[0013] Furthermore, step S2 includes dissolving the steviol glycoside and nicotinamide together in an aqueous phase at 65-75°C, then adding them to the stabilizer solution and dispersing them at a high speed of 1000-2000 rpm for 5-10 minutes to form a premixed solution.

[0014] According to a second aspect of the present invention, a method for preparing the above-described protein component is provided, comprising the following steps: S1. Heat 60%-70% of the water in the formula to 65-75℃, add the composite stabilizer, and shear and disperse at a high speed of 1000-2000 rpm for 5-10 minutes. S2. Add the steviol glycosides to S1 and disperse them at a high speed of 1000-2000 rpm for 5-10 minutes.

[0015] S3. Slowly add the isolated whey protein powder to S2, and dissolve it by shearing at 1000-1500 rpm for 10-15 minutes at 55-65℃.

[0016] S4. Homogenize the mixture from S3, adjust the volume, sterilize, aseptically homogenize, and aseptically fill.

[0017] Furthermore, the homogenization pressure in step S4 is 18-30 MPa; the sterilization is carried out by steam immersion sterilization at a temperature of 140-150℃ for 4-6 seconds; and the aseptic filling volume is 100 mL / bottle.

[0018] According to a third aspect of the present invention, the above-described protein component is provided for use in the preparation of special medical purpose foods for improving the nutritional status of patients with chronic kidney disease and assisting in the control of blood phosphorus and potassium levels.

[0019] Furthermore, the special medical purpose formula food is suitable for CKD stage 3-5 non-dialysis and maintenance dialysis patients.

[0020] Compared with the prior art, the advantages of the present invention include: This invention provides a low-potassium, low-phosphorus protein component for special medical applications and its preparation method. By selecting whey protein powder with low phosphorus and potassium content and specific calcium content as the core protein source and optimizing the formulation, the final product has an extremely low phosphorus-to-protein ratio and potassium content. This results in significantly lower phosphorus intake compared to similar commercially available products, greatly reducing the metabolic burden on the kidneys and the risk of hyperphosphatemia in patients. This invention uses a specific mass ratio of phospholipids and xanthan gum as a composite stabilizer. Phospholipids, as an emulsifier, effectively encapsulate protein particles and prevent aggregation; xanthan gum provides steric hindrance and viscosity support. The two components, at this ratio, produce a synergistic effect, ensuring that the liquid product does not precipitate or float to the surface during long-term storage, has a uniform and smooth taste, and good patient compliance. Detailed Implementation

[0021] In view of the shortcomings of the prior art, the inventors of this invention, through long-term research and extensive practice, have proposed the technical solution of this invention. The following will further explain and illustrate the technical solution, its implementation process, and its principles.

[0022] The present invention will now be described in further detail with reference to specific embodiments. The given embodiments are merely illustrative of the invention and not intended to limit its scope. The embodiments provided below can serve as a guide for further improvements by those skilled in the art and do not constitute a limitation on the invention in any way.

[0023] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials used in the following embodiments are commercially available.

[0024] This invention provides a low-potassium, low-phosphorus protein component for special medical applications. The protein component is a ready-to-use liquid. Based on a total volume of 100 mL, the raw materials for preparing the protein component include: 10.0-12.0 g of isolated whey protein powder; 0.05-0.15 g of steviol glycosides; 0.20-0.30 g of a composite stabilizer; and the balance being water. The composite stabilizer consists of phospholipids and xanthan gum, with a mass ratio of phospholipids to xanthan gum of 1.2-1.8:1. The phosphoprotein ratio of the protein component is 1.8-2.2 mg phosphorus / g protein. The potassium content of the protein component is 0.15-0.25 mg / g. The protein content of the isolated whey protein powder is not less than 90 wt%, and its calcium content is 300-500 mg / 100g. The osmotic pressure of the protein component is 25-40 mOsmol / kg. The pH value of the protein component is 6.8-7.2. In some embodiments, the raw materials for preparing the protein assembly also include nicotinamide, and the amount of nicotinamide is 0.05-0.20 g per 100 mL total volume.

[0025] Based on the above technical solution, a method for preparing a protein component is provided, comprising the following steps: S1. Heat 60%-70% of the water in the formula to 65-75℃, add the composite stabilizer, and shear and disperse at a high speed of 1000-2000 rpm for 5-10 minutes to obtain the stabilizer solution. S2. Add the steviol glycosides to the stabilizer solution and disperse them at a high speed of 1000-2000 rpm for 5-10 minutes. S3. Slowly add the separated whey protein powder to S2, and shear and dissolve it at 55-65°C and 1000-1500 rpm for 10-15 minutes to obtain a mixture; S4. Homogenize the mixture obtained in S3, adjust the volume, sterilize, aseptically homogenize, and aseptically fill. Furthermore, the homogenization pressure in step S4 is 18-30 MPa; the sterilization is carried out by steam immersion sterilization at a temperature of 140-150℃ for 4-6 seconds; and the aseptic filling volume is 100 mL / bottle.

[0026] In some embodiments, step S2 includes co-dissolving the steviol glycosides and nicotinamide in an aqueous phase at 65-75°C, then adding them to the stabilizer solution and dispersing them at a high-speed shearing speed of 1000-2000 rpm for 5-10 minutes to form a premixed solution. By co-dissolving the steviol glycosides and nicotinamide in an aqueous phase at 65-75°C in step S2 to form a homogeneous premixed solution, the pH environment (6.8-7.2) of this premixed solution effectively maintains the chemical stability of nicotinamide when subsequently mixed with whey protein isolate powder, preventing observable hydrolysis under acidic or high-temperature sterilization conditions. This technique enables the final product to provide low-phosphorus protein nutritional support while providing a synergistic, endogenous auxiliary phosphorus-lowering mechanism for patients through the specific inhibition of the intestinal sodium-phosphorus cotransporter (NaPi-IIb) by nicotinamide.

[0027] This invention also provides the application of a protein component in the preparation of a special medical purpose food for improving the nutritional status of patients with chronic kidney disease and assisting in the control of blood phosphorus and potassium levels. The special medical purpose food is suitable for CKD stage 3-5 patients undergoing non-dialysis and maintenance dialysis.

[0028] The protein components prepared by this invention achieve extremely low phosphorus and potassium levels while ensuring a sufficient supply of high-quality protein (10-12 g / 100 mL). The product's osmotic pressure and pH are regulated within a physiologically suitable range, reducing the risk of gastrointestinal discomfort. The specific range of calcium content in the raw materials is designed to balance safety with potential benefits for phosphorus control. The provided preparation method has clear steps, and the process parameters (temperature, shear rate, homogenization pressure, sterilization conditions) are highly compatible with the formulation characteristics, enabling stable and efficient production of products that meet quality standards with good reproducibility.

[0029] To better understand the technical solution of the present invention, the following detailed discussion is provided in conjunction with specific embodiments.

[0030] Example 1 Formula: 214 kg of whey protein isolate (protein content 92wt%, calcium content 380mg / 100g), 2 kg of steviol glycosides, 5 kg of compound stabilizer (phospholipids: xanthan gum = 1.5:1), and water to 2000 kg.

[0031] Preparation method: S1. Measure 1400 kg of water, heat it to 75°C, add the composite stabilizer, and disperse it at high speed by shearing at 1500 rpm for 8 minutes.

[0032] S2. Add steviol glycosides to S1, maintain the temperature at 60-70℃, and disperse at high speed by shearing at 1500 rpm for 5 minutes.

[0033] S3. Add the whey protein isolate to S2 and shear disperse at 1500 rpm for 10 minutes.

[0034] S4. Homogenize the material from S3 under a pressure of 25 MPa and bring the volume to 2000 kg.

[0035] S5. The protein assembly is obtained by steam immersion sterilization at 143°C for 5 seconds, followed by aseptic homogenization at 25 MPa pressure, and finally aseptic filling.

[0036] Example 2: Formula: 234 kg of whey protein isolate (protein content 91wt%, calcium content 450mg / 100g), 3 kg of steviol glycosides, 6 kg of compound stabilizer (phospholipids: xanthan gum = 1.8:1), and water to 2000 kg.

[0037] The preparation method is the same as in Example 1, except that the high-speed shearing speed is 3000 rpm and the homogenization pressure is 30 MPa.

[0038] Example 3: Formula: 194 kg of whey protein isolate (protein content 90wt%, calcium content 320mg / 100g), 1 kg of steviol glycosides, 4 kg of compound stabilizer (phospholipids: xanthan gum = 1.2:1), and water to 2000 kg.

[0039] The preparation method is the same as in Example 1, except that the high-speed shearing speed is 2000 rpm and the homogenization pressure is 20 MPa.

[0040] Comparative Example 1: The formulation is basically the same as in Example 1, except that the ratio of phospholipid to xanthan gum in the composite stabilizer is changed to 2.5:1. The preparation method is the same.

[0041] Comparative Example 2: The formulation is basically the same as in Example 1, except that the composite stabilizer (5 kg) is replaced with an equal amount of xanthan gum (5 kg). The preparation method is the same.

[0042] Product performance testing The following tests were performed on the products obtained in Examples 1-3 and Comparative Examples 1-2: Stability test: The product was sealed and stored at 4℃ and 25℃ for 30 days, and the sedimentation and stratification were observed and recorded.

[0043] Key indicator determination: The protein, phosphorus, and potassium content of the product were determined using national standard methods, and the phosphoprotein ratio was calculated. Osmotic pressure was measured using a freezing point osmometer, and pH value was measured using a pH meter.

[0044] Sensory evaluation: Ten trained evaluators will assess the product’s color, aroma, smoothness of texture, and presence of graininess.

[0045] The test results are shown in Table 1.

[0046] Table 1

[0047] The test results show that: The products in Examples 1-3 all met the core indicators of low phosphorus-to-protein ratio and low potassium content set by this invention, and the osmotic pressure and pH value were all within the appropriate range.

[0048] In terms of stability, the products of Examples 1-3 performed excellently under both storage conditions, demonstrating the effectiveness of the composite stabilizer of the present invention (phospholipid to xanthan gum ratio 1.2-1.8:1).

[0049] Comparative Example 1 (with a stabilizer ratio exceeding the scope of this invention) showed slight fat floating and stratification, and had a greasy feel, indicating that the imbalance in the ratio affected the emulsion stability.

[0050] Comparative Example 2 (using only xanthan gum) produced severe precipitation and had a poor taste, proving that a single colloidal stabilizer cannot effectively stabilize the protein system of this invention. The emulsifying effect of phospholipids is indispensable, and the two need to work synergistically in a specific ratio.

[0051] In summary, the protein components and their preparation methods provided by this invention can effectively solve the problem of balancing high protein and low phosphorus and potassium in nutritional support for CKD patients. The products have good stability and significant clinical application value.

[0052] Experiment 1 Experimental group (this invention): Formula: 11.0 g of whey protein isolate (92% protein, 380 mg / 100 g calcium), 0.10 g of steviol glycosides, 0.25 g of compound stabilizer (phospholipids: xanthan gum = 1.5:1), 0.10 g of nicotinamide, and water to 100 mL.

[0053] Preparation method: S1. Heat 65% of the water in the formula to 70°C, add the composite stabilizer, and shear and disperse at 1500 rpm for 8 minutes to obtain the stabilizer solution. S2. The steviol glycosides and nicotinamide are dissolved together in an aqueous phase at 70°C, and then added to the stabilizer solution. The mixture is then sheared and dispersed at 1500 rpm for 8 minutes to form a premixed solution. S3. Slowly add the separated whey protein powder to S2, and shear dissolve it at 1300 rpm for 13 minutes at 60°C to obtain a mixture; S4. The mixture obtained in S3 is homogenized, brought to a constant volume, sterilized, aseptically homogenized, and aseptically filled. The homogenization pressure is 24 MPa. The sterilization is carried out by steam immersion sterilization at a temperature of 145°C for 5 seconds. The aseptic filling volume is 100 mL / bottle.

[0054] Control group 1 (non-nicotinamide group): Formulation and preparation: exactly the same as the experimental group, but without the addition of nicotinamide. Only steviol glycosides were added in step S2.

[0055] Control group 2 (routinely supplemented with nicotinamide): Formula: exactly the same as the experimental group.

[0056] Preparation method: The conventional mixing sequence for preparing protein components in this art was adopted. Nicotinamide and whey protein isolate powder were dry-mixed and then slowly added to the aqueous phase (temperature 60°C) for dissolution. Other steps (such as stabilizer treatment, homogenization, and sterilization) were consistent with those of the experimental group. This method simulates a simple addition method that does not consider interactions between components.

[0057] Control group 3 (commercially available reference group): A certain brand of protein drink specifically for kidney disease does not contain nicotinamide or other active ingredients that claim to have phosphorus-lowering functions.

[0058] Test 1: Chemical stability of nicotinamide and physical stability of the product Methods: The products of the experimental group and control group 2 were stored under accelerated stability test conditions (40°C ± 2°C, relative humidity 75% ± 5%), and samples were taken at 0, 1, 3 and 6 months.

[0059] Chemical stability: The retention rate of nicotinamide in the sample was determined by high performance liquid chromatography (HPLC), and the amount of its main hydrolysis product, nicotinic acid, was detected simultaneously.

[0060] Physical stability: Observe whether the sample has precipitation, layering, or discoloration; measure pH value and viscosity.

[0061] result: Table 2

[0062] The steviol glycoside-nicotinamide co-dissolution technology (experimental group) used in this invention can significantly maintain the chemical stability of nicotinamide, effectively inhibit its hydrolysis, and keep the product's physical state stable. In contrast, conventional mixing methods (control group 2) lead to severe degradation of nicotinamide, resulting in poor product color and uniformity, demonstrating the non-obviousness and necessity of the specific technical means described above.

[0063] The above descriptions are merely some embodiments of the present invention. It should be noted that those skilled in the art can make other modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A low-potassium, low-phosphorus protein component for special medical applications, characterized in that, The protein component is a ready-to-use liquid. Based on a total volume of 100 mL, the raw materials for preparing the protein component include: 10.0-12.0 g of isolated whey protein powder; 0.05-0.15 g of steviol glycosides; 0.20-0.30 g of composite stabilizer; and the balance being water. The composite stabilizer is composed of phospholipids and xanthan gum, with a mass ratio of phospholipids to xanthan gum of 1.2-1.8:

1.

2. The protein assembly according to claim 1, characterized in that, The phosphoprotein ratio of the protein component is 1.8-2.2 mg phosphorus / g protein.

3. The protein assembly according to claim 1, characterized in that, The potassium content in the protein component is 0.15-0.25 mg / g.

4. The protein assembly according to claim 1, characterized in that, The isolated whey protein powder has a protein content of not less than 90 wt% and a calcium content of 300-500 mg / 100g.

5. The protein assembly according to claim 1, characterized in that, The osmotic pressure of the protein assembly is 25-40 mOsmol / kg.

6. The protein assembly according to claim 1, characterized in that, The protein component has a pH value of 6.8-7.

2.

7. The protein assembly according to claim 1, characterized in that, The raw materials for preparing the protein assembly also include nicotinamide, and based on a total volume of 100 mL, the amount of nicotinamide is 0.05-0.20 g.

8. A method for preparing a protein assembly according to any one of claims 1 to 7, characterized in that, Includes the following steps: S1. Heat 60%-70% of the water in the formula to 65-75℃, add the composite stabilizer, and shear and disperse at a high speed of 1000-2000 rpm for 5-10 minutes to obtain the stabilizer solution. S2. Add the steviol glycosides to the stabilizer solution and disperse them at a high speed of 1000-2000 rpm for 5-10 minutes. S3. Slowly add the separated whey protein powder to S2, and shear and dissolve it at 55-65°C and 1000-1500 rpm for 10-15 minutes to obtain a mixture; S4. Homogenize the mixture obtained in S3, adjust the volume, sterilize, aseptically homogenize, and aseptically fill. In step S4, the homogenization pressure is 18-30 MPa; the sterilization is carried out by steam immersion sterilization at a temperature of 140-150℃ for 4-6 seconds; and the aseptic filling volume is 100 mL / bottle.

9. The method for preparing the protein assembly according to claim 8, characterized in that, Step S2 includes dissolving the steviol glycosides and nicotinamide together in an aqueous phase at 65-75°C, then adding them to the stabilizer solution and dispersing them at a high speed of 1000-2000 rpm for 5-10 minutes to form a premixed solution.

10. The use of a protein component as described in any one of claims 1-7 in the preparation of a special medical purpose food for improving the nutritional status of patients with chronic kidney disease and assisting in the control of blood phosphorus and potassium levels; the special medical purpose food is suitable for non-dialysis and maintenance dialysis patients in CKD stages 3-5.

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