Device for efficiently preparing icodextrin

Abstract

The utility model relates to a device for efficiently preparing icodextrin, which comprises a slurry mixing reaction kettle, a liquefaction ejector, a decomposition reaction kettle, a filter pressing tank, a fine filtering tank, a first circulating temporary storage tank, an ultrafiltration tank, a second circulating temporary storage tank, a spray dryer and an automatic subpackaging device which are sequentially communicated through a pipeline, the liquefaction ejector is provided with a discharging end, a liquid feeding end and a steam feeding end, the discharging end is communicated with the decomposition reaction kettle through a pipeline, the liquid feeding end is communicated with the slurry mixing reaction kettle through a pipeline, the steam feeding end is communicated with a steam supply pipeline provided with an adjusting valve, and the first circulating temporary storage tank is communicated with the second circulating temporary storage tank through a backflow pipeline. The device disclosed by the utility model has the advantages that by virtue of the liquefying ejector connected with the steam pipeline provided with the adjusting valve, the slurry-mixed feed liquid is more uniformly heated and is conveyed to the decomposition reaction kettle at a more controllable temperature, so that icodextrin which is more concentrated in component distribution, relatively controllable in branching degree and higher in quality is efficiently prepared.

Description

Technical Field

[0001] This utility model belongs to the field of pharmaceutical and chemical engineering, and specifically relates to an apparatus for the efficient preparation of icodextrin. Background Technology

[0002] Icodextrin, as the main component of icodextrin peritoneal dialysis fluid, is used for the treatment of end-stage renal disease.

[0003] Currently, the price of icodextrin dialysis solution in China is still relatively high, which is related to certain defects in the production equipment and processes of icodextrin. Existing equipment cannot avoid issues with the uniformity of heating and reaction during starch gelatinization and hydrolysis, leading to problems such as uneven molecular weight distribution and uncontrollable branching during the reaction. This affects the yield and quality of the final product, thus increasing the production cost of icodextrin. Utility Model Content

[0004] This invention provides an apparatus for the efficient preparation of icodextrin, aiming to overcome the aforementioned shortcomings in the prior art.

[0005] The technical solution of this utility model to solve the above-mentioned technical problems is as follows: An apparatus for efficiently preparing icodextrin includes a mixing reactor, a liquefaction ejector, a decomposition reactor, a filter press, a fine filter, a first circulation storage tank, an ultrafiltration tank, a second circulation storage tank, a spray dryer, and an automatic dispenser, which are connected in sequence by pipelines. The liquefaction ejector has a discharge end, a liquid inlet end, and a steam inlet end. The discharge end is connected to the decomposition reactor through a pipeline. The liquid inlet end is connected to the mixing reactor through a pipeline. The steam inlet end is connected to a steam supply pipeline equipped with a regulating valve. The mixing reactor is also connected to a first metering feeding mechanism for feeding a set amount of purified water, starch, and decomposition liquid into it. The first circulation storage tank and the second circulation storage tank are connected by a return pipeline to return the material in the second circulation storage tank to the first circulation storage tank.

[0006] Based on the above technical solution, the present invention can be further improved as follows.

[0007] Furthermore, the decomposition reactor is also connected to a second metering and feeding mechanism for feeding quenching liquid and decolorizing agent into it.

[0008] Furthermore, the first metering and feeding mechanism includes a purified water metering and feeding tank, a starch metering and feeding tank, and a decomposition liquid metering and feeding tank, while the second metering and feeding mechanism includes a quenching liquid metering and feeding tank and a decolorizing agent metering and feeding tank.

[0009] Furthermore, each of the following is provided with a delivery pump: between the mixing reactor and the liquefaction ejector, between the filter press and the fine filter, between the fine filter and the first circulating storage tank, between the first circulating storage tank and the ultrafiltration tank, between the ultrafiltration tank and the second circulating storage tank, and between the second circulating storage tank and the spray dryer.

[0010] Furthermore, the return pipe is equipped with a shut-off valve and a circulation pump.

[0011] Furthermore, the top of the filter press is connected to a pressurized gas source via a pressurized pipe, and the pressurized gas source is air or nitrogen.

[0012] Furthermore, a sampling tube is connected to the bottom of the second circulating temporary storage tank, and a sampling valve is provided on the sampling tube.

[0013] Furthermore, a sampling valve is provided on the connecting pipe between the second circulating storage tank and the spray dryer.

[0014] Compared with the prior art, the beneficial effects of this utility model are:

[0015] The device for efficiently preparing icodextrin provided by this utility model uses a liquefied ejector connected to a steam pipe equipped with a regulating valve to ensure more uniform heating and more controllable temperature control of the mixed slurry before it is delivered to the decomposition reactor. This allows the starch to be gelatinized in a more uniform and controllable temperature manner, resulting in icodextrin with a more concentrated weight distribution, relatively controllable branching, and higher quality. The material obtained after the decomposition reaction is sequentially decolorized, pressure filtered, fine filtered, ultrafiltered, spray dried, and automatically packaged to obtain the target product. The device features a high degree of automation and good product quality. If the product temporarily stored in the second circulation storage tank after ultrafiltration fails the test, it can be directly returned to the first circulation storage tank via the return pipe, and then subjected to ultrafiltration again until the product passes the inspection. This device is suitable for industrial automated production and can prepare icodextrin relatively efficiently with high yield and good quality. Attached Figure Description

[0016] Figure 1 This utility model provides an efficient apparatus for preparing icodextrin;

[0017] The attached diagram lists the components represented by each number as follows:

[0018] 1. Mixing reactor; 2. Liquefaction ejector; 3. Decomposition reactor; 4. Filter press; 5. Fine filter; 6. First circulation storage tank; 7. Ultrafiltration tank; 8. Second circulation storage tank; 9. Spray dryer; 10. Automatic dispenser; 11. Reflux pipeline; 12. Purified water metering feeder; 13. Starch metering feeder; 14. Decomposition liquid metering feeder; 15. Quenching liquid metering feeder; 16. Decolorizing agent metering feeder. Detailed Implementation

[0019] The principles and features of this utility model are described below with reference to the accompanying drawings. The examples given are only for explaining this utility model and are not intended to limit the scope of this utility model.

[0020] In the description of this utility model, if terms such as "upper", "lower", "left", "right", "top", "bottom", "inner", and "outer" are used to indicate the orientation or positional relationship, the orientation or positional relationship indicated is based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0021] like Figure 1 As shown, this utility model provides an efficient apparatus for preparing icodextrin, which includes a mixing reactor 1, a liquefaction ejector 2, a decomposition reactor 3, a filter press 4, a fine filter 5, a first circulation storage tank 6, an ultrafiltration tank 7, a second circulation storage tank 8, a spray dryer 9, and an automatic dispenser 10, all connected in sequence by pipes. The liquefaction ejector 2 has a discharge end, a liquid inlet end, and a steam inlet end. The discharge end is connected to the decomposition reactor 3 by a pipe, the liquid inlet end is connected to the mixing reactor 1 by a pipe, and the steam inlet end is connected to a steam supply pipe equipped with a regulating valve. The mixing reactor 1 is also connected to a first metering feeding mechanism for feeding a set amount of purified water, starch, and decomposition liquid into it. The first circulation storage tank 6 and the second circulation storage tank 8 are connected by a return pipe 11 to return the material in the second circulation storage tank 8 to the first circulation storage tank 6.

[0022] It should be noted that in the above-mentioned device provided by this utility model, high-temperature and high-pressure steam is introduced into the liquefaction ejector. The regulating valve can adjust the steam flow rate to control the temperature. The high-temperature and high-pressure steam impacts and disperses the starch slurry liquid pumped into the liquefaction ejector by the pressure pump (transfer pump) from the mixing reactor and transfers heat. Finally, it is injected into the decomposition reactor to carry out the decomposition reaction. The strong impact and rapid heat transfer of the steam on the starch slurry can ensure that the starch float quickly reaches the preheating temperature and enters the decomposition reactor for reaction. The heating is uniform, which is conducive to a more concentrated molecular weight distribution of the decomposition products.

[0023] In one embodiment of this utility model, the decomposition reactor 3 is further connected to a second metering and feeding mechanism for feeding quenching liquid and decolorizing agent into it; the first metering and feeding mechanism includes a purified water metering and feeding tank 12, a starch metering and feeding tank 13 and a decomposition liquid metering and feeding tank 14, and the second metering and feeding mechanism includes a quenching liquid metering and feeding tank 15 and a decolorizing agent metering and feeding tank 16.

[0024] It should be noted that the mixing reactor is equipped with a purified water metering tank, a starch metering tank, and an enzymatic hydrolysate (or acid) metering tank. The enzymatic hydrolysate (or acid) metering tank is also the decomposition solution metering tank. The mixing reactor is sequentially connected to a liquefaction ejector, a decomposition reactor, a filter press, a fine filter, a first circulation storage tank, an ultrafiltration tank, a second circulation storage tank, a spray dryer, and an automatic dispenser. The decomposition reactor is also known as an enzymatic hydrolysis (hydrolysis) reactor. The enzymatic hydrolysis (hydrolysis) reactor is equipped with a quenching solution metering tank and an activated carbon metering tank (decolorizing agent metering tank). Starch, water, and amylase are added to the mixing reactor from their respective feed tanks and stirred evenly to form a starch slurry. The evenly mixed starch slurry is pumped into a liquefaction ejector by a pressure pump. Steam is introduced into the other end of the liquefaction ejector, and the temperature is adjusted by a valve. After the preheating temperature is reached, the liquid is injected into the preheated enzymatic hydrolysis (hydrolysis) reactor and stirred for reaction. After the reaction is completed, the temperature is lowered and acid is added to adjust the pH and inactivate the amylase. After the reaction temperature drops to a certain level, activated carbon is added and stirred for decolorization and impurity removal.

[0025] In one embodiment of this utility model, a delivery pump is provided between the mixing reactor 1 and the liquefaction ejector 2, between the filter press 4 and the fine filter tank 5, between the fine filter tank 5 and the first circulating storage tank 6, between the first circulating storage tank 6 and the ultrafiltration tank 7, between the ultrafiltration tank 7 and the second circulating storage tank 8, and between the second circulating storage tank 8 and the spray dryer 9.

[0026] In one embodiment of this utility model, the return pipe 11 is provided with a shut-off valve and a circulation pump.

[0027] In one embodiment of this utility model, the top of the filter press 4 is connected to a pressurized gas source via a pressurized pipe, and the pressurized gas source is air or nitrogen.

[0028] It should be noted that after decolorization is completed in the decomposition reactor, the liquid is introduced into the filter press. The other end of the filter press is connected to a pressurization pipe. The filter is pressurized by air or nitrogen and then pressed into the fine filter tank. After fine filtration, the liquid enters the first circulation temporary storage tank.

[0029] In one embodiment of the present invention, the bottom of the second circulating temporary storage tank 8 is connected to a sampling tube, and the sampling tube is provided with a sampling valve.

[0030] In one embodiment of this utility model, a sampling valve is provided on the connecting pipe between the second circulating temporary storage tank 8 and the spray dryer 9.

[0031] It should be noted that the first circulation storage tank is connected to the ultrafiltration tank and the second circulation storage tank in sequence. The ultrafiltration process is repeated continuously through the selected ultrafiltration membrane pack. The qualified product enters the spray dryer for drying and is finally collected in the automatic dispenser. Whether the product is qualified can be determined by sampling through the sampling valve mentioned above.

[0032] This invention also provides an example of actual production using this device for the preparation of icodextrin:

[0033] A certain amount of corn starch, high-temperature amylase, and water are mixed in the mixing reactor via purified water metering tanks, starch metering tanks, and enzymatic hydrolysate metering tanks connected to the mixing reactor. This prepares a starch slurry with a starch concentration of 25% and a high-temperature amylase concentration of 7 U / g. The slurry is then stirred and mixed to form a starch slurry. The pre-set temperature of the enzymatic hydrolysis reactor is 90-100℃. The air flow rate of the liquefaction ejector and the feeding speed of the starch slurry are adjusted so that the pre-prepared starch slurry is liquefied and sprayed into the preheated enzymatic hydrolysis reactor at a temperature of 90-100℃. The reaction temperature is maintained for 0.5 hours, and then the temperature is lowered to 60℃ to obtain the enzymatic hydrolysate. Hydrochloric acid was added via a quenching solution metering tank to adjust the pH to 3, and the mixture was stirred for 30 minutes to inactivate the enzyme. Then, activated carbon (5% of the starch weight) was added via an activated carbon metering tank for decolorization for 1 hour. The solution was then added in batches to a filter press, pressurized, and filtered to obtain the filtrate. The filtrate was then subjected to a 0.45 μm fine filtration tank, followed by ultrafiltration using a 5000 Da ultrafiltration membrane. Ultrafiltration was stopped after the molecular weight was determined to be within acceptable limits, yielding the ultrafiltrate. The ultrafiltrate was then spray-dried in a spray dryer, with the inlet air temperature controlled at 180-190℃ and the outlet air temperature at 100-110℃, to obtain the icodextrin raw material.

[0034] The molecular weight and its distribution were determined according to size exclusion chromatography (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0514). The drug quality standard requires that the weight-average molecular weight of icodextrin be 13,000-19,000, the number-average molecular weight be 5,000-6,500 Da, and the molecular weight distribution be: less than 1638 Da not exceeding 6%, and 1638-5000 Da not exceeding 12%-26%.

[0035] The weight-average molecular weight of the icodextrin raw material obtained in this embodiment was 17653 Da, ranging from 13000 to 19000 Da, and the number-average molecular weight was 5866 Da, ranging from 5000 to 6500 Da. The portion of molecular weight less than 1638 accounted for 2%. The yield was 81.3% (based on dry starch).

[0036] This invention relates to an icodextrin processing device that ensures uniform heating during starch gelatinization and controllable branching. The entire production system is simple and well-suited for automated industrial production, yielding high-yield and high-quality icodextrin. This invention solves the problem of uneven reaction during starch hydrolysis and heating, enabling continuous and efficient production of high-quality icodextrin. It also addresses the limitations of the industrial application of high-temperature amylases.

[0037] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A device for efficiently producing isomaltulose, characterized by comprising: The system includes a mixing reactor (1), a liquefaction ejector (2), a decomposition reactor (3), a filter press (4), a fine filter (5), a first circulation storage tank (6), an ultrafiltration tank (7), a second circulation storage tank (8), a spray dryer (9), and an automatic dispenser (10), all connected in sequence by pipes. The liquefaction ejector (2) has a discharge end, a liquid inlet end, and a steam inlet end. The discharge end is connected to the decomposition reactor (3) through a pipe. The liquid inlet end is connected to the mixing reactor (1) through a pipe. The steam inlet end is connected to a steam supply pipe equipped with a regulating valve. The mixing reactor (1) is also connected to a first metering feeding mechanism for feeding a set amount of purified water, starch, and decomposition liquid into it. The first circulation storage tank (6) and the second circulation storage tank (8) are connected by a return pipe (11) to return the material in the second circulation storage tank (8) to the first circulation storage tank (6).

2. The device for efficiently preparing isomaltulose according to claim 1, wherein The decomposition reactor (3) is also connected to a second metering and feeding mechanism for feeding quenching liquid and decolorizing agent into it.

3. The device for efficiently preparing isomaltulose according to claim 2, wherein The first metering and feeding mechanism includes a purified water metering and feeding tank (12), a starch metering and feeding tank (13), and a decomposition liquid metering and feeding tank (14). The second metering and feeding mechanism includes a quenching liquid metering and feeding tank (15) and a decolorizing agent metering and feeding tank (16).

4. The device for efficiently preparing isomaltulose according to claim 1, wherein A delivery pump is provided between the mixing reactor (1) and the liquefaction ejector (2), between the filter press (4) and the fine filter tank (5), between the fine filter tank (5) and the first circulating storage tank (6), between the first circulating storage tank (6) and the ultrafiltration tank (7), between the ultrafiltration tank (7) and the second circulating storage tank (8), and between the second circulating storage tank (8) and the spray dryer (9).

5. The device for efficiently preparing isomaltulose according to claim 1, wherein The return pipe (11) is equipped with a shut-off valve and a circulation pump.

6. The apparatus for efficiently preparing isomaltulose according to any one of claims 1 to 5, wherein The top of the filter press (4) is connected to a pressurized gas source via a pressurized pipe. The pressurized gas source is air or nitrogen.

7. The apparatus for efficiently preparing isomaltulose according to claim 6, wherein The bottom of the second circulating storage tank (8) is connected to a sampling tube, and the sampling tube is equipped with a sampling valve.

8. The device for efficiently preparing isomaltulose according to claim 6, wherein A sampling valve is provided on the connecting pipe between the second circulating storage tank (8) and the spray dryer (9).

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