Method for efficiently preparing hemodialysis liquid by utilizing enzymatic dissolution technology

Abstract

The invention relates to the technical field of hemodialysis liquid preparation, in particular to a method for efficiently preparing hemodialysis liquid by utilizing an enzymatic dissolution technology, which comprises the following steps: selecting a specific enzyme to promote dissolution of dialysis powder, and combining multi-step filtration, degassing and quality control measures to prepare the hemodialysis liquid. The problems of low dissolving efficiency, high energy consumption, unstable dialysate quality and the like in a traditional method are effectively solved, and the method has the advantages of improving the dissolving efficiency, reducing the energy consumption, improving the dialysate quality and enhancing the safety and the reliability.

Description

Technical Field

[0001] The present invention relates to the technical field of hemodialysis fluid preparation, and in particular to a method for efficiently preparing hemodialysis fluid by using an enzymatic dissolution technology. Background Art

[0002] At present, hemodialysis is an important means of treating chronic renal failure, and high-quality dialysate is the key factor to ensure the effectiveness of hemodialysis. The traditional method of preparing hemodialysis fluid mainly relies on physical stirring and heating, which has problems such as long dissolution time, high energy consumption, and insufficient dissolution. Especially when using medical-grade dialysis powder, some components have poor solubility and require a long time of stirring to completely dissolve. This is not only time-consuming and energy-consuming, but may also affect the uniformity and stability of the solution. It is difficult to achieve rapid and sufficient dissolution by relying solely on physical methods.

[0003] In the prior art, the preparation process of dialysate usually requires long-term stirring and heating, which not only increases energy consumption but also prolongs the production cycle. At the same time, due to insufficient dissolution, undissolved particles may exist in the dialysate, affecting the dialysis effect and patient safety. In addition, traditional methods make it difficult to accurately control key parameters of the dialysate, such as pH, conductivity, and osmotic pressure, which are crucial to ensuring the physiological compatibility of the dialysate.

[0004] In terms of filtration and purification, existing technologies often use a single filtration method, which is difficult to effectively remove impurities of various sizes and properties. This may lead to residual enzymes, microorganisms or other harmful substances in the dialysate, increasing the risk of use. At the same time, due to the lack of effective degassing treatment, the dialysate may produce bubbles during use, affecting the dialysis effect.

[0005] In terms of filling and storage of dialysate, the existing technology lacks strict aseptic operation and precise environmental control, which may cause the dialysate to deteriorate or be contaminated during storage. In addition, the existing technology also has deficiencies in the quality control of dialysate, lacks comprehensive quality testing methods, and is difficult to ensure the stability and safety of the dialysate.

[0006] In this regard, the present application specifically proposes a method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology to solve the above technical problems. Summary of the invention

[0007] The present invention provides a method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology. By selecting a specific enzyme to promote the dissolution of dialysis powder and combining multi-step filtration, degassing and quality control measures, the problems of low dissolution efficiency, high energy consumption, unstable dialysate quality, etc. in traditional methods are effectively solved. The method has the advantages of improving dissolution efficiency, reducing energy consumption, improving dialysate quality, and enhancing safety and reliability.

[0008] The technical solution adopted by the present invention to solve the above technical problems is: a method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology, comprising the following steps:

[0009] Step 1: Select medical grade dialysis powder, which includes glucose, sodium chloride, sodium bicarbonate, potassium chloride and sodium lactate. Use deionized water or distilled water as solvent. Prepare phosphate buffer with a pH value of 7.2-7.4 to adjust the pH value of the dialysate.

[0010] Step 2: According to the components in the dialysis powder, select corresponding enzymes to accelerate the dissolution process, the enzymes include cellulase, amylase, protease, pectinase and lipase; dissolve the cellulase, amylase, protease, pectinase and lipase in the solvent respectively to form an enzyme solution, and the concentration of each enzyme is 1mg-5mg / mL; according to the ratio of 0.1% to 0.5% of the total weight of the dialysis powder, mix the above enzyme solutions evenly and add them to the solvent, and add phosphate buffer;

[0011] Step 3: preliminarily mix the dialysis powder and the solvent containing the enzyme at room temperature for 10 to 15 minutes to promote full contact between the enzyme and the dialysis powder to obtain a dialysis powder solution; transfer the premixed dialysis powder solution to a dissolving tank for stirring and heating to accelerate dissolution;

[0012] Step 4: Use a 100-mesh screen to preliminarily filter the dialysis powder solution to remove large particle impurities and undissolved solids; then use a 0.22μm microporous filter membrane to finely filter the dialysis powder solution to completely remove enzyme residues and tiny impurities; use a nanofiltration membrane to further purify the dialysate to remove impurities with a molecular weight greater than 1000Da to obtain a pure dialysate;

[0013] Step 5: Degas the obtained dialysate to remove the gas dissolved in the liquid and prevent the generation of bubbles during use;

[0014] Step 6: Aseptically fill the dialysate, seal it in a dialysis bag, and store it in a cool and dry place, avoiding direct sunlight. The storage environment temperature should be controlled at 15℃-25℃.

[0015] Furthermore, after the enzymes are dissolved in the solvents in step 2, the enzyme solutions are precooled: the enzyme solutions are precooled at 4° C. for 30 minutes to maintain the activity of the enzymes and ensure the efficiency and stability of the enzymes in the subsequent dissolution process.

[0016] Furthermore, in step 3, during the dissolution of the dialysis powder solution in the dissolution tank, an ultrasonic generator is used to perform ultrasonic treatment on the dialysis powder solution in the dissolution tank, the frequency is 20kHz-40kHz, the power of the ultrasonic generator is 100W-300W, and the treatment time is 10 minutes-20 minutes.

[0017] Furthermore, after the ultrasonic treatment is completed, the dialysis powder solution is subjected to microwave heating treatment using a microwave oven, the microwave oven power is 500W-800W, and the heating treatment time is 5 minutes-10 minutes.

[0018] Furthermore, in step 3, the temperature in the dissolving tank is 35° C.-45° C., the dialysis powder solution is continuously stirred for 30 minutes-60 minutes, and the stirring speed is controlled at 100 rpm-200 rpm.

[0019] Furthermore, after the dialysate is degassed in step 5, a pH meter is used to measure the pH value of the dialysate to ensure that it is between 7.2 and 7.4, which is consistent with the physiological environment of the human body; a conductivity meter is used to measure the conductivity of the dialysate to ensure that it is within 12.0 mS / cm to 16.0 mS / cm; the dialysate is sampled and microbial culture is performed to ensure that the dialysate is sterile; an osmometer is used to measure the osmotic pressure of the dialysate to ensure that it is between 280 mOsm and 320 mOsm / kg·H2O, which meets clinical requirements.

[0020] The advantages of the present invention are as follows: the present invention provides a method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology, which effectively solves the problems of low dissolution efficiency, high energy consumption, unstable dialysate quality, etc. in traditional methods by selecting specific enzymes to promote the dissolution of dialysis powder and combining multi-step filtration, degassing and quality control measures, and has the advantages of improving dissolution efficiency, reducing energy consumption, improving dialysate quality, and enhancing safety and reliability. DETAILED DESCRIPTION

[0021] The technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] Embodiment 1:

[0023] The present application proposes a method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology, comprising the following steps: selecting medical-grade dialysis powder, the ingredients of which include glucose, sodium chloride, sodium bicarbonate, potassium chloride and sodium lactate, and using deionized water or distilled water as a solvent; preparing a phosphate buffer with a pH value of 7.2-7.4 to adjust the pH value of the dialysis fluid. According to the ingredients in the dialysis powder, select the corresponding enzyme to accelerate the dissolution process, the enzymes include cellulase, amylase, protease, pectinase and lipase; dissolve the cellulase, amylase, protease, pectinase and lipase in the solvent respectively to form an enzyme solution, and the concentration of each enzyme is 1mg-5mg / mL; according to the ratio of 0.1% to 0.5% of the total weight of the dialysis powder, mix the above enzyme solution evenly and add it to the solvent, and add the phosphate buffer. The dialysis powder and the solvent containing the enzyme are preliminarily mixed at room temperature for 10 minutes to 15 minutes to promote full contact between the enzyme and the dialysis powder to obtain a dialysis powder solution; the premixed dialysis powder solution is transferred to a dissolution tank for stirring and heating to accelerate dissolution. The dialysis powder solution is preliminarily filtered using a 100-mesh screen to remove large particle impurities and undissolved solids; then the dialysis powder solution is finely filtered using a 0.22 μm microporous filter membrane to thoroughly remove enzyme residues and tiny impurities; the dialysate is further purified using a nanofiltration membrane to remove impurities with a molecular weight greater than 1000 Da to obtain a pure dialysate. The obtained dialysate is degassed to remove the gas dissolved in the liquid and prevent bubbles from being generated during use. The dialysis solution is sterile filled, sealed in a dedicated dialysis bag, and stored in a cool and dry place, avoiding direct sunlight, and the storage environment temperature is controlled at 15°C-25°C.

[0024] Among them, enzyme selection and concentration control is one of the key steps. The concentration range of cellulase, amylase, protease, pectinase and lipase is 1mg-5mg / mL, which ensures the activity of the enzyme while avoiding the cost increase caused by overuse. The mixing ratio of the enzyme solution is 0.1% to 0.5% of the total weight of the dialysis powder. This ratio has been optimized to effectively accelerate the dissolution process without negatively affecting the quality of the final product.

[0025] Furthermore, the initial mixing of the dialysis powder and the enzyme solution is carried out at room temperature, and the stirring time is 10 minutes to 15 minutes. This step ensures sufficient contact between the enzyme and the dialysis powder, thereby improving the dissolution efficiency. The stirring and heating process in the dissolution tank helps to further accelerate the dissolution. Specifically, the temperature in the dissolution tank is controlled at 35°C to 45°C, and the stirring speed is 100 to 200 rpm. This combination of temperature and stirring speed can effectively promote the dissolution of the dialysis powder.

[0026] Thus, the purity of the dialysate is ensured through multiple filtration and purification steps, including the use of 100 mesh screens, 0.22μm microporous membranes and nanofiltration membranes. Degassing further improves the stability of the dialysate and prevents the generation of bubbles during use.

[0027] As a preferred embodiment, the dialysate is aseptically filled and sealed and stored in a dedicated dialysis bag, and the storage environment temperature is controlled at 15°C-25°C. This measure ensures the safety of the dialysate during storage and transportation.

[0028] The technical solution of the present application solves the problems of low efficiency and insufficient purity of dialysate preparation in the prior art by optimizing the selection and use of enzymes, multiple filtration and purification steps, and aseptic filling and storage measures. Compared with the prior art, the method of the present application not only improves the preparation efficiency, but also significantly improves the purity and stability of the dialysate, meeting clinical requirements.

[0029] Furthermore, the present application also proposes that after the enzymes are dissolved in the solvent, the enzyme solution is precooled. Specifically, the enzyme solution is precooled at 4°C for 30 minutes to maintain the activity of the enzyme and ensure the efficiency and stability of the enzyme in the subsequent dissolution process.

[0030] Among them, the precooling process can be carried out by placing the enzyme solution in a refrigerated environment at 4°C to ensure that the enzyme solution maintains its biological activity at low temperatures. Further, the precooling time can be controlled between 25 minutes and 35 minutes to ensure that the activity of the enzyme is fully maintained. In addition, the precooling process can also be carried out by using a special precooling device that can accurately control the temperature and time, thereby improving the precooling effect.

[0031] Thus, by precooling treatment, the activity of the enzyme can be effectively maintained, and the efficiency and stability of the enzyme during the dissolution process can be improved. Specifically, precooling treatment can prevent the enzyme from being inactivated at high temperatures, ensuring that the enzyme can fully exert its catalytic effect during the subsequent dissolution process, thereby improving the preparation efficiency and quality of the dialysate. Compared with the prior art, the present application not only improves the enzyme activity retention rate through precooling treatment, but also reduces the risk of enzyme inactivation, thereby improving the preparation efficiency and stability of the dialysate.

[0032] Furthermore, the present application also proposes that, during the dissolution process of the dialysis powder solution in the dissolution tank, an ultrasonic generator is used to perform ultrasonic treatment on the dialysis powder solution in the dissolution tank. Specifically, the frequency of the ultrasonic treatment is 20kHz-40kHz, the power of the ultrasonic generator is 100W-300W, and the treatment time is 10 minutes-20 minutes. As a preferred embodiment, ultrasonic treatment can optimize the dissolution effect of the dialysis powder solution by adjusting the frequency and power. For example, higher frequency and power can more effectively destroy the particle structure in the dialysis powder, thereby accelerating the dissolution process. In addition, ultrasonic treatment can also increase the mixing efficiency of the solution by generating tiny bubbles, further promoting the full contact between the enzyme and the dialysis powder.

[0033] Therefore, this technical solution significantly improves the dissolution efficiency of the dialysis powder solution through ultrasonic treatment. Specifically, ultrasonic treatment can effectively destroy the particle structure in the dialysis powder and accelerate the dissolution process. At the same time, it increases the mixing efficiency of the solution by generating tiny bubbles and promotes full contact between the enzyme and the dialysis powder. Compared with the prior art, this technical solution not only improves the dissolution efficiency, but also ensures the quality and stability of the dialysate, and solves the problems of insufficient dissolution and residual impurities in traditional methods.

[0034] Furthermore, the present application also proposes that after the ultrasonic treatment is completed, the dialysis powder solution is subjected to microwave heating treatment using a microwave oven. Specifically, the power of the microwave oven is 500W-800W, and the heating treatment time is 5 minutes-10 minutes. As a preferred embodiment, the microwave heating treatment can optimize the dissolution effect of the dialysis powder solution by adjusting the power and heating time of the microwave oven. For example, by increasing the power of the microwave oven or extending the heating time, the dissolution of undissolved particles in the dialysis powder solution can be more effectively promoted.

[0035] Thus, microwave heating can further improve the dissolution efficiency of the dialysis powder solution and ensure the purity and stability of the dialysis fluid. Compared with the prior art, the technical solution of the present application significantly improves the preparation efficiency and quality of the dialysis fluid by combining ultrasonic treatment and microwave heating.

[0036] Furthermore, the present application also proposes that during the dissolution of the dialysis powder solution in the dissolution tank, the temperature in the dissolution tank is 35°C-45°C, the dialysis powder solution is continuously stirred for 30 minutes-60 minutes, and the stirring speed is controlled at 100 rpm-200 rpm.

[0037] Specifically, the temperature control in the dissolution tank is to ensure that the dialysis powder solution is dissolved at an appropriate temperature to improve the dissolution efficiency and the quality of the dialysate. The temperature is controlled between 35℃-45℃, which can effectively promote the activity of the enzyme and accelerate the dissolution process of the dialysis powder. Continuous stirring for 30 minutes to 60 minutes can ensure that the dialysis powder solution is fully in contact with the enzyme and improve the uniformity of dissolution. The stirring speed is controlled at 100-200 rpm, which helps to maintain the uniformity and stability of the solution and prevent local overheating or overcooling.

[0038] As a preferred embodiment, the temperature in the dissolving tank can be monitored in real time by a temperature sensor, and the heating device can be adjusted by an automatic control system to maintain a constant temperature range. The stirring device can use a variable frequency motor to adjust the stirring speed according to actual needs to ensure the best stirring effect.

[0039] Therefore, by controlling the temperature and stirring conditions in the dissolution tank, the dissolution efficiency of the dialysis powder solution can be significantly improved, ensuring that the quality of the dialysis fluid meets clinical requirements. Compared with the prior art, the technical solution of the present application can more effectively control the temperature and stirring conditions during the dissolution process, thereby improving the preparation efficiency and quality of the dialysis fluid.

[0040] Furthermore, the present application also proposes that after the dialysate is degassed, a pH meter is used to measure the pH value of the dialysate to ensure that it is between 7.2-7.4, which is consistent with the physiological environment of the human body; a conductivity meter is used to measure the conductivity of the dialysate to ensure that it is within 12.0mS / cm to 16.0mS / cm; the dialysate is sampled and microbial culture is performed to ensure that the dialysate is sterile; an osmometer is used to measure the osmotic pressure of the dialysate to ensure that it is between 280mOsm-320mOsm / kg·H2O, which meets clinical requirements.

[0041] Specifically, pH meters are used to accurately measure the pH of dialysate to ensure it is within the normal pH range of human blood. Conductivity meters are used to detect the conductivity of dialysate to ensure it meets medical standards. Microbial culture is used to verify the sterility of dialysate to prevent infection risks. Osmometers are used to measure the osmotic pressure of dialysate to ensure it matches the osmotic pressure of human blood to avoid cell damage.

[0042] As a preferred embodiment, the pH meter can be a portable device for rapid on-site detection. Microbial culture can be automated to improve detection efficiency and accuracy. The osmometer can be a digital display model for intuitive reading of data.

[0043] Therefore, the present application ensures the quality and safety of the dialysate through the above technical means, and solves the problems of unstable dialysate quality, microbial contamination and osmotic pressure mismatch that may exist in the prior art. Compared with the prior art, the technical solution of the present application has higher accuracy and reliability, and can better meet clinical needs.

[0044] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments can still be modified, or some or all of the technical features therein can be replaced by equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology, characterized in that: The steps include: Step 1: Select medical grade dialysis powder, which includes glucose, sodium chloride, sodium bicarbonate, potassium chloride and sodium lactate. Use deionized water or distilled water as solvent. Prepare phosphate buffer with a pH value of 7.2-7.4 to adjust the pH value of the dialysate. Step 2: According to the components in the dialysis powder, select corresponding enzymes to accelerate the dissolution process, the enzymes include cellulase, amylase, protease, pectinase and lipase; dissolve the cellulase, amylase, protease, pectinase and lipase in the solvent to form an enzyme solution, and the concentration of each enzyme is 1mg-5mg / mL; according to the ratio of 0.1% to 0.5% of the total weight of the dialysis powder, mix the above enzyme solutions evenly and add them to the solvent, and add phosphate buffer; Step 3: preliminarily mix the dialysis powder and the solvent containing the enzyme at room temperature for 10 to 15 minutes to promote full contact between the enzyme and the dialysis powder to obtain a dialysis powder solution; transfer the premixed dialysis powder solution to a dissolving tank for stirring and heating to accelerate dissolution; Step 4: Use a 100-mesh screen to preliminarily filter the dialysis powder solution to remove large particle impurities and undissolved solids; then use a 0.22μm microporous filter membrane to finely filter the dialysis powder solution to completely remove enzyme residues and tiny impurities; use a nanofiltration membrane to further purify the dialysate to remove impurities with a molecular weight greater than 1000Da to obtain a pure dialysate; Step 5: Degas the obtained dialysate to remove the gas dissolved in the liquid and prevent the generation of bubbles during use; Step 6: Aseptically fill the dialysate, seal it in a dialysis bag, and store it in a cool and dry place, avoiding direct sunlight. The storage environment temperature should be controlled at 15℃-25℃.

2. The method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology according to claim 1, characterized in that: After the enzymes are dissolved in the solvents in step 2, the enzyme solutions are precooled: the enzyme solutions are precooled at 4° C. for 30 minutes to maintain the activity of the enzymes and ensure the efficiency and stability of the enzymes in the subsequent dissolution process.

3. The method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology according to claim 1, characterized in that: In step 3, while the dialysis powder solution is being dissolved in the dissolving tank, an ultrasonic generator is used to perform ultrasonic treatment on the dialysis powder solution in the dissolving tank, the frequency is 20kHz-40kHz, the power of the ultrasonic generator is 100W-300W, and the treatment time is 10 minutes-20 minutes.

4. The method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology according to claim 3, characterized in that: After the ultrasonic treatment is completed, the dialysis powder solution is subjected to microwave heating treatment using a microwave oven, the microwave oven power is 500W-800W, and the heating treatment time is 5 minutes-10 minutes.

5. The method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology according to claim 1, characterized in that: In step 3, the temperature in the dissolving tank is 35° C.-45° C., the dialysis powder solution is stirred continuously for 30 minutes-60 minutes, and the stirring speed is controlled at 100 rpm-200 rpm.

6. The method for efficiently preparing hemodialysis fluid using enzymatic dissolution technology according to claim 1, characterized in that: After the dialysate is degassed in step 5, the pH value of the dialysate is measured using a pH meter to ensure that it is between 7.2 and 7.4, which is consistent with the physiological environment of the human body; the conductivity of the dialysate is measured using a conductivity meter to ensure that it is within a range of 12.0 mS / cm to 16.0 mS / cm; the dialysate is sampled and microbial culture is performed to ensure that the dialysate is sterile; the osmotic pressure of the dialysate is measured using an osmometer to ensure that it is between 280 mOsm and 320 mOsm / kg·H2O, which meets clinical requirements.