Composition for preventing and treating complications of nephrotic dialysis patients as well as preparation method, preparation and application of composition

Abstract

The invention belongs to the technical field of biological medicines, and particularly relates to a composition for preventing and treating complications of nephrotic dialysis patients, and a preparation method, a preparation and application thereof. The composition is composed of the following components: whey protein isolate, calcium caseinate and sucralose, and the preparation method of the whey protein isolate comprises the following steps: mixing whey protein concentrate with an ionic liquid, adding an enzyme for hydrolysis, and performing enzyme deactivation to obtain an enzymatic hydrolysate; the enzymatic hydrolysate is sequentially subjected to ultrafiltration and nanofiltration and dried, and the enzyme is a mixture of trypsin and cysteine protease. The concentrated whey protein is subjected to enzymolysis by selecting a specific enzymolysis process to obtain the separated whey protein, and the separated whey protein, the calcium caseinate and the sucralose jointly form the composition for preventing and treating the complications of the nephropathy dialysis patients, so that the composition for preventing and treating the complications of the nephropathy dialysis patients can comprehensively improve the complications of protein malnutrition, hyperphosphatemia, hyperkalemia and the like which are easy to occur in the nephropathy dialysis patients, and has a good clinical application prospect. The occurrence rate of complications of nephropathy dialysis patients is obviously reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedicine, and specifically relates to a composition for preventing and treating complications of dialysis patients with kidney disease, and a preparation method, a preparation and application thereof. Background Art

[0002] Dialysis therapy is to remove the components of the body fluids of the dialysis patient (such as solutes or water, etc.) through a semipermeable membrane through hemodialysis or peritoneal dialysis. Hemodialysis uses the principle of a semipermeable membrane to remove various harmful metabolites and excess electrolytes from the body through diffusion, purify the patient's blood, and correct the water electrolyte and acid-base balance. Peritoneal dialysis uses the peritoneum as a semipermeable membrane and uses gravity to infuse the prepared dialysis fluid into the patient's peritoneal cavity through a catheter. Then, by continuously replacing the peritoneal dialysis fluid, the body's metabolic products and toxic substances are removed, and the patient's water and electrolyte imbalance is corrected.

[0003] Long-term dialysis causes patients to suffer from malnutrition-induced protein and energy imbalance, hyperphosphatemia, hyperkalemia, renal hypertension, post-dialysis hypotension, anemia and other complications, which reduce the quality of life of dialysis patients, increase the patient's hospitalization rate, shorten the patient's life span, and even increase the patient's risk of death.

[0004] Chinese invention patent application CN108651988A discloses a clinical nutritional formula specifically for kidney disease dialysis and a preparation method thereof, comprising the following components and their weight proportions: 15-25 parts of protein, 8-12 parts of fat, 50-54 parts of carbohydrates, 3-5 parts of dietary fiber, 0.3-0.6 parts of macroelements, 0.01-0.05 parts of trace elements, 0.005-0.02 parts of fat-soluble vitamins, 0.01-0.2 parts of water-soluble vitamins, 0.05-1 parts of dietary essences, 0.05-2 parts of medicinal and edible ingredients, 0.1-3 parts of natural plant compounds and 0.005-2 parts of new resource foods. This formula provides nutritional needs of protein, fat, carbohydrates, etc. required by kidney dialysis patients, but the invention is not designed according to the metabolic characteristics of kidney dialysis patients, and cannot meet the nutritional needs of kidney dialysis patients, especially the situation that protein energy malnutrition is prone to occur.

[0005] Another Chinese invention patent application CN110897153A discloses a nutritional preparation suitable for kidney disease dialysis patients, including protein, lipid, carbohydrate and dietary fiber; wherein the energy supply proportions of protein, lipid, carbohydrate and dietary fiber are 12-16%, 25-30%, 52-58% and 1-5% respectively; the energy supply proportion of saturated fatty acids in the lipids is less than 10%, the energy supply proportion of monounsaturated fatty acids is 8-22%, and the energy supply ratio of polyunsaturated fatty acids to saturated fatty acids is greater than 2; the mass ratio of L-carnitine and L-glutamine in the protein is 1:1-1.5, but the nutritional preparation of the invention has complex ingredients, which increases the complexity of the preparation process and the production cost, and is not suitable for industrial production.

[0006] In view of this, there is an urgent need in the art to develop a composition that meets the nutritional needs of renal dialysis patients, especially protein, can improve calcium and phosphorus metabolism disorders and hyperkalemia, and has a simple raw material composition for preventing and treating complications in renal dialysis patients. Summary of the invention

[0007] In view of the problems existing in the prior art, the present invention provides a composition for preventing and treating complications of dialysis patients with kidney disease, and a preparation method, a preparation and application thereof.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] A composition for preventing and treating complications in patients with renal dialysis, the composition comprising the following components: isolated whey protein, calcium caseinate and sucralose,

[0010] The preparation method of the isolated whey protein comprises the following steps:

[0011] (1) mixing concentrated whey protein with an ionic liquid, and then hydrolyzing with an enzyme to inactivate the enzyme to obtain an enzymatic solution;

[0012] (2) The enzymatic hydrolysate is subjected to ultrafiltration and nanofiltration in sequence, and dried to obtain:

[0013] Wherein, the enzyme in step (1) is a mixture of trypsin and cysteine ​​protease.

[0014] Preferably, the enzyme is a mixture of trypsin and cysteine ​​protease in a mass ratio of 2-3:1.

[0015] Preferably, the mass concentration of the concentrated whey protein in step (1) is 8-10%.

[0016] Preferably, the ionic liquid in step (1) is triethylammonium trifluoromethanesulfonate or tributylammonium tetrafluoroborate.

[0017] Preferably, the volume ratio of the concentrated whey protein to the ionic liquid is 5-10:1-2.

[0018] Preferably, the mixing temperature in step (1) is 30-40° C., and the mixing time is 20-30 min.

[0019] Preferably, the mass of the enzyme added in step (1) is 0.5-2% of the mass of concentrated whey protein.

[0020] Preferably, the hydrolysis temperature in step (1) is 30-40° C., the hydrolysis time is 120-150 min, and the hydrolysis pH is 7-9.

[0021] Preferably, the hydrolysis requires ultrasound, the power of the ultrasound is 300-400W, and the time of the ultrasound is 10-20min.

[0022] Preferably, the temperature for inactivating the enzyme in step (1) is 70-90°C, the time for inactivating the enzyme is 30-40 minutes, and after the inactivation of the enzyme, the mixture is centrifuged to collect the supernatant.

[0023] Preferably, the ultrafiltration in step (2) comprises using a filter membrane with a molecular weight cutoff of 10-30 kDa and an ultrafiltration pressure of 0.1-0.2 MPa.

[0024] Preferably, the nanofiltration in step (2) comprises a filter membrane with a molecular weight cutoff of 100-200 Da, a nanofiltration pressure of 0.2-0.3 MPa, and after the nanofiltration is completed, a concentrate with a solid content of 20-30% is collected.

[0025] Preferably, the drying in step (2) is spray drying or freeze drying.

[0026] Preferably, the composition consists of the following components in parts by weight: 15-20 parts of isolated whey protein, 12-18 parts of calcium caseinate and 1-2 parts of sucralose.

[0027] The present invention also provides a method for preparing the composition, which comprises uniformly mixing isolated whey protein, calcium caseinate and sucralose to obtain the composition.

[0028] The present invention also provides a nutritional preparation, comprising the above composition or the composition prepared by the above preparation method.

[0029] The present invention also provides the use of the above composition or the above preparation in preparing nutritional products for treating complications of renal dialysis patients.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] (1) The present invention selects triethylmethylammonium trifluoromethanesulfonate or tributylmethylammonium tetrafluoroborate and mixes it with concentrated whey protein, and then enzymatically hydrolyzes the concentrated whey protein through the synergistic effect of trypsin and cysteine ​​protease to obtain isolated whey protein, which is then combined with calcium caseinate and sucralose to obtain a composition for preventing and treating complications in patients with renal disease undergoing dialysis.

[0032] (2) The composition provided by the present invention can provide sufficient protein for dialysis patients to meet the patients' low phosphorus and low potassium needs, comprehensively improve complications such as protein malnutrition, hyperphosphatemia, hyperkalemia, hypertension and anemia that are prone to occur in renal dialysis patients, and significantly reduce the incidence of complications in renal dialysis patients.

[0033] (3) The preparation method of the composition of the present invention is simple and convenient, is conducive to large-scale industrial production, has significant cost-effectiveness, and has good application prospects. DETAILED DESCRIPTION

[0034] It is worth noting that the raw materials used in the present invention are all common commercially available products: concentrated whey protein powder, with a content of 99%, was purchased from Hebei Runbu Biotechnology Co., Ltd.; calcium caseinate, item number 6309-500-1, was purchased from Beijing Yinhe Road Trading Co., Ltd.

[0035] Example 1

[0036] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0037] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0038] (1) Dissolve concentrated whey protein powder in deionized water, mix well, configure to a concentrated whey protein with a mass concentration of 8%, then mix with triethylmethylammonium trifluoromethanesulfonate at a volume ratio of 5:1 at 35°C for 25min, then add a mixed enzyme (the mixed enzyme consists of trypsin and cysteine ​​protease in a mass ratio of 2:1) with a mass of 1% of the concentrated whey protein mass to perform ultrasonic hydrolysis, wherein the hydrolysis temperature is 35°C, the hydrolysis time is 120min, the hydrolysis pH is 7, the ultrasonic power is 300W, and the ultrasonic time is 15min. After the hydrolysis is completed, the enzyme is deactivated at 80°C for 40min, centrifuged at 3000rpm for 20min, and the supernatant is finally collected to obtain an enzymolyzate.

[0039] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 20 kDa, and nanofiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 200 Da. After the nanofiltration, a concentrate with a solid content of 25% is collected and freeze-dried to obtain isolated whey protein.

[0040] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0041] Example 2

[0042] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 15 parts of isolated whey protein, 18 parts of calcium caseinate and 1 part of sucralose.

[0043] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0044] (1) Dissolve concentrated whey protein powder in deionized water, mix well, and prepare concentrated whey protein with a mass concentration of 9%, then mix with tributyl methyl ammonium tetrafluoroborate at a volume ratio of 5:2 at 30°C for 30 minutes, then add a mixed enzyme (the mixed enzyme consists of trypsin and cysteine ​​protease at a mass ratio of 3:1) with a mass of 0.5% of the mass of concentrated whey protein to perform ultrasonic hydrolysis, wherein the hydrolysis temperature is 30°C, the hydrolysis time is 150 minutes, the hydrolysis pH is 8, the ultrasonic power is 400W, and the ultrasonic time is 10 minutes. After the hydrolysis is completed, the enzyme is inactivated at 70°C for 35 minutes, centrifuged at 3000rpm for 20 minutes, and the supernatant is finally collected to obtain an enzymolyzate.

[0045] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 10 kDa, and nanofiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 100 Da. After the nanofiltration, a concentrate with a solid content of 20% is collected and freeze-dried to obtain isolated whey protein.

[0046] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0047] Example 3

[0048] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 20 parts of isolated whey protein, 12 parts of calcium caseinate and 2 parts of sucralose.

[0049] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0050] (1) Dissolve concentrated whey protein powder in deionized water, mix well, configure to a concentrated whey protein with a mass concentration of 10%, then mix with triethyl methyl ammonium trifluoromethane sulfonate at a volume ratio of 10:1 at 40°C for 20min, then add a mixed enzyme (the mixed enzyme consists of trypsin and cysteine ​​protease in a mass ratio of 2:1) with a mass of 2% of the concentrated whey protein mass to perform ultrasonic hydrolysis, wherein the hydrolysis temperature is 40°C, the hydrolysis time is 120min, the hydrolysis pH is 9, the ultrasonic power is 300W, and the ultrasonic time is 20min. After the hydrolysis is completed, the enzyme is deactivated at 90°C for 30min, centrifuged at 3000rpm for 20min, and the supernatant is finally collected to obtain an enzymolyzate.

[0051] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 30 kDa, and nanofiltration at 0.3 MPa through a filter membrane with a molecular weight cutoff of 100 Da. After the nanofiltration, a concentrate with a solid content of 30% is collected and freeze-dried to obtain isolated whey protein.

[0052] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0053] Comparative Example 1

[0054] The same as Example 1, the only difference is that in the preparation method of isolated whey protein, triethylmethylammonium trifluoromethanesulfonate is replaced by N-ethylpyridinium trifluoromethanesulfonate.

[0055] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0056] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0057] (1) Dissolve concentrated whey protein powder in deionized water, mix well, configure to a concentrated whey protein with a mass concentration of 8%, then mix with N-ethylpyridinium trifluoromethanesulfonate at a volume ratio of 5:1 at 35°C for 25min, then add a mixed enzyme (the mixed enzyme consists of trypsin and cysteine ​​protease in a mass ratio of 2:1) with a mass of 1% of the concentrated whey protein mass to perform ultrasonic hydrolysis, wherein the hydrolysis temperature is 35°C, the hydrolysis time is 120min, the hydrolysis pH is 7, the ultrasonic power is 300W, and the ultrasonic time is 15min. After the hydrolysis is completed, deactivate the enzyme at 80°C for 40min, centrifuge at 3000rpm for 20min, and finally collect the supernatant to obtain an enzymolyzate.

[0058] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 20 kDa, and nanofiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 200 Da. After the nanofiltration, a concentrate with a solid content of 25% is collected and freeze-dried to obtain isolated whey protein.

[0059] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0060] Comparative Example 2

[0061] The same as Example 1, the only difference is that the mixed enzyme is replaced by trypsin in the preparation method of isolated whey protein, and a composition for preventing and treating complications of kidney disease dialysis patients is prepared.

[0062] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0063] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0064] (1) Dissolve concentrated whey protein powder in deionized water, mix well, and prepare concentrated whey protein with a mass concentration of 8%, then mix with triethylmethylammonium trifluoromethanesulfonate at a volume ratio of 5:1 at 35°C for 25 minutes, then add trypsin with a mass of 1% of the mass of concentrated whey protein for ultrasonic hydrolysis, wherein the hydrolysis temperature is 35°C, the hydrolysis time is 120 minutes, the hydrolysis pH is 7, the ultrasonic power is 300W, and the ultrasonic time is 15 minutes. After the hydrolysis is completed, the enzyme is inactivated at 80°C for 40 minutes, centrifuged at 3000rpm for 20 minutes, and finally the supernatant is collected to obtain an enzymolyzate.

[0065] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 20 kDa, and nanofiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 200 Da. After the nanofiltration, a concentrate with a solid content of 25% is collected and freeze-dried to obtain isolated whey protein.

[0066] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0067] Comparative Example 3

[0068] The same as Example 1, the only difference is that the mixed enzyme is replaced by cysteine ​​protease in the preparation method of isolated whey protein, and a composition for preventing and treating complications of kidney disease dialysis patients is prepared.

[0069] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0070] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0071] (1) Dissolve concentrated whey protein powder in deionized water, mix well, and prepare concentrated whey protein with a mass concentration of 8%, then mix with triethylmethylammonium trifluoromethanesulfonate at a volume ratio of 5:1 at 35°C for 25 minutes, then add cysteine ​​protease with a mass of 1% of the mass of concentrated whey protein for ultrasonic hydrolysis, wherein the hydrolysis temperature is 35°C, the hydrolysis time is 120 minutes, the hydrolysis pH is 7, the ultrasonic power is 300W, and the ultrasonic time is 15 minutes. After the hydrolysis is completed, the enzyme is inactivated at 80°C for 40 minutes, centrifuged at 3000rpm for 20 minutes, and finally the supernatant is collected to obtain an enzymolyzate.

[0072] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 20 kDa, and nanofiltration at 0.2 MPa through a filter membrane with a molecular weight cutoff of 200 Da. After the nanofiltration, a concentrate with a solid content of 25% is collected and freeze-dried to obtain isolated whey protein.

[0073] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0074] Comparative Example 4

[0075] The same as Example 1, except that nanofiltration is not performed in the preparation method of isolated whey protein, and a composition for preventing and treating complications of kidney disease dialysis patients is prepared.

[0076] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0077] The preparation method of the above-mentioned isolated whey protein comprises the following steps:

[0078] (1) Dissolve concentrated whey protein powder in deionized water, mix well, configure to a concentrated whey protein with a mass concentration of 8%, then mix with triethylmethylammonium trifluoromethanesulfonate at a volume ratio of 5:1 at 35°C for 25min, then add a mixed enzyme (the mixed enzyme consists of trypsin and cysteine ​​protease in a mass ratio of 2:1) with a mass of 1% of the concentrated whey protein mass to perform ultrasonic hydrolysis, wherein the hydrolysis temperature is 35°C, the hydrolysis time is 120min, the hydrolysis pH is 7, the ultrasonic power is 300W, and the ultrasonic time is 15min. After the hydrolysis is completed, the enzyme is deactivated at 80°C for 40min, centrifuged at 3000rpm for 20min, and the supernatant is finally collected to obtain an enzymolyzate.

[0079] (2) The obtained enzymatic hydrolysate is then subjected to ultrafiltration at 0.1 MPa through a filter membrane with a molecular weight cutoff of 20 kDa. After the ultrafiltration, a concentrate with a solid content of 25% is collected and freeze-dried to obtain isolated whey protein.

[0080] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0081] Comparative Example 5

[0082] The same as Example 1, except that the isolated whey protein is commercially available (purchased from Shanghai Prochin International Trading Co., Ltd.), and a composition for preventing and treating complications in patients with kidney disease undergoing dialysis is prepared.

[0083] A composition for preventing and treating complications of dialysis patients with kidney disease consists of the following components by weight: 18 parts of isolated whey protein, 16 parts of calcium caseinate and 1.5 parts of sucralose.

[0084] A preparation method of a composition for preventing and treating complications of dialysis patients with kidney disease comprises the following steps: mixing isolated whey protein, calcium caseinate and sucralose in a high-speed stirring device to obtain the composition.

[0085] Test Example 1

[0086] The protein content and nutritional component (sodium, potassium and phosphorus) content of the isolated whey protein in Examples 1-3 and Comparative Examples 1-5 were measured respectively, wherein the protein content was measured according to the Kjeldahl method; the sodium and potassium contents were measured according to ISO 8070:2007; and the phosphorus content was measured according to BS ISO 9874:2006. The test results are shown in Table 1.

[0087] Table 1 Content determination data

[0088] serial number Protein content (%) Sodium (mg / 100g) Potassium (mg / 100g) Phosphorus (mg / 100g) Example 1 98.8 60.4±25 90.4±2.4 90.7±2.2 Example 2 98.4 65.2±2.7 92.6±2.1 96.5±3.1 Example 3 98.1 62.6±2.5 95.1±1.8 92.7±3.0 Comparative Example 1 92.5 81.1±3.2 117.2±3.2 125.7±3.5 Comparative Example 2 93.6 80.8±3.5 111.3±3.5 118.4±3.4 Comparative Example 3 91.7 82.6±3.1 120.7±2.6 115.6±3.8 Comparative Example 4 92.9 83.5±2.7 122.3±3.3 125.7±2.2 Comparative Example 5 91.3 83.3±3.6 134.1±2.4 132.5±4.1

[0089] Test Example 2

[0090] 1. Experimental Animals

[0091] 100 SD rats, 2 months old, half male and half female, weighing 270-300 g, were purchased from Chengdu Dashuo Experimental Animal Co., Ltd., animal license: SYXK(Chuan)014-189, and were raised in an SPF-grade experimental animal environment with an optimal temperature of 20-24°C and an ambient relative humidity of 55±5%. The rats had free access to drinking water and ordinary feed.

[0092] 2. Experimental Methods

[0093] 2.1 Grouping: 100 SD rats were weighed and randomly divided into 10 groups: a sham operation group, a model control group and an experimental group (Examples 1-3 and Comparative Examples 1-5).

[0094] 2.2 Animal modeling: After 1 week of adaptive feeding, 100 SD rats were gavaged with 250 mg / (kg·dw) of adenine once a day for 2 consecutive weeks except for the rats in the sham operation group. The rats were fasted for 12 hours that night after the 2-week gavage. 0.5 ml of blood was collected the next morning to measure the levels of blood creatinine and urea nitrogen. The modeling was successful when the blood creatinine and urea nitrogen values ​​were more than twice the normal values, i.e., the standard of chronic renal failure was met.

[0095] The rats with successful modeling were anesthetized with 2% sodium pentobarbital, and a longitudinal incision was made 1.5 cm below the xiphoid process of the rats to insert a peritoneal dialysis tube. The end of the tube was placed on the left posterior wall, and a purse-string suture was made along the abdominal wall around the dialysis tube to fix the dialysis tube. The rats were injected with 4.25% glucose dialysate for peritoneal dialysis once a week. After 4 weeks of dialysis treatment, the peritoneal dialysis tube was placed and flushed with heparin. If the peritoneal dialysis tube was smooth, the chronic renal failure dialysis rat model was successfully established.

[0096] 2.3 Administration method: Based on the conversion of human and rat body surface areas, the oral administration dose of the experimental group (Examples 1-3 and Comparative Examples 1-5) was calculated to be 2.0 g / kg. The compositions prepared in Examples 1-3 and Comparative Examples 1-5 for preventing and treating complications in patients with renal dialysis were dissolved in normal saline at a concentration of 0.2 g / ml. The sham operation group and the model control group were gavaged with an equal volume of normal saline. Once a day, the experimental period was 12 weeks. The rats were weighed weekly and the oral administration dose was adjusted. During the experimental period, all rats had free access to the same basic feed and water.

[0097] 2.4 Experimental index detection: After 12 weeks of intragastric administration, blood was collected from the rat tails to measure the changes in serum albumin, blood potassium, blood calcium, blood phosphorus and blood sodium in the plasma.

[0098] 3. Experimental results

[0099] The test results are shown in Table 2.

[0100] Table 2 Changes of plasma biochemical indicators

[0101]

[0102]

[0103] Note: Compared with the sham operation group, ** indicates P < 0.01, * Indicates P < 0.05; compared with the model group, ## indicates P < 0.01,

[0104] # P<0.05.

[0105] As shown in Table 2, compared with the sham operation group, the serum albumin content of the model group was significantly reduced, and the serum potassium, blood calcium, blood phosphorus and blood sodium contents were significantly increased, indicating that the modeling was successful. Compared with the model group, the serum albumin content of Examples 1-3 was significantly increased, and the serum potassium, blood calcium, blood phosphorus and blood sodium contents were significantly reduced, indicating that the composition provided by the present invention can provide sufficient protein for dialysis patients, meeting the patient's low phosphorus, low potassium and low sodium requirements. Example 1 Compared with Comparative Examples 1-5, the composition prepared in Example 1 for preventing and treating complications of dialysis patients with renal disease can increase the serum albumin content, reduce the serum potassium, blood calcium, blood phosphorus and blood sodium contents, indicating that the present invention is obtained by a specific enzymolysis process. The isolated whey protein, which acts together with calcium caseinate and sucralose, can comprehensively improve the calcium and phosphorus metabolism disorder of dialysis in renal disease, and is suitable for use in dialysis patients with renal disease.

[0106] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for preventing and treating complications in patients with renal dialysis, characterized in that: The composition consists of the following components: isolated whey protein, calcium caseinate and sucralose. The preparation method of the isolated whey protein comprises the following steps: (1) mixing concentrated whey protein with an ionic liquid, and then adding an enzyme to hydrolyze and inactivate the enzyme to obtain an enzymatic hydrolyzate; (2) The enzymatic hydrolysate is subjected to ultrafiltration and nanofiltration in sequence, and dried to obtain: Wherein, the enzyme in step (1) is a mixture of trypsin and cysteine ​​protease.

2. The composition according to claim 1, characterized in that The enzyme is a mixture of trypsin and cysteine ​​protease in a mass ratio of 2-3:

1.

3. The composition according to claim 1, characterized in that The ionic liquid in step (1) is triethylammonium trifluoromethanesulfonate or tributylammonium tetrafluoroborate.

4. The composition according to claim 3, characterized in that The mass concentration of the concentrated whey protein in step (1) is 8-10%, the volume ratio of the concentrated whey protein to the ionic liquid is 5-10:1-2, the mixing temperature is 30-40° C., and the mixing time is 20-30 min.

5. The composition according to claim 1, characterized in that The mass of the added enzyme in step (1) is 0.5-2% of the mass of concentrated whey protein, the hydrolysis temperature is 30-40°C, the hydrolysis time is 120-150min, the hydrolysis pH is 7-9, the hydrolysis requires ultrasound, the ultrasound power is 300-400W, the ultrasound time is 10-20min, the enzyme inactivation temperature is 70-90°C, the enzyme inactivation time is 30-40min, and the enzyme inactivation is centrifuged after completion to collect the supernatant.

6. The composition according to claim 1, characterized in that The ultrafiltration in step (2) includes using a filter membrane with a molecular weight cutoff of 10-30 kDa and an ultrafiltration pressure of 0.1-0.2 MPa, and the nanofiltration includes using a filter membrane with a molecular weight cutoff of 100-200 Da and a nanofiltration pressure of 0.2-0.3 MPa. After the nanofiltration is completed, a concentrate with a solid content of 20-30% is collected, and the drying is spray drying or freeze drying.

7. The composition according to claim 1, characterized in that The composition consists of the following components by weight: 15-20 parts of isolated whey protein, 12-18 parts of calcium caseinate and 1-2 parts of sucralose.

8. A method for preparing the composition according to any one of claims 1 to 7, characterized in that: The invention comprises mixing isolated whey protein, calcium caseinate and sucralose.

9. A nutritional preparation, characterized in that The invention comprises the composition according to any one of claims 1 to 7 or the composition prepared by the preparation method according to claim 8.

10. Use of the composition according to any one of claims 1 to 7 or the nutritional preparation according to claim 9 in the preparation of nutritional products for complications of renal dialysis patients.

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