Automatic dissolving medium blending system

Abstract

The utility model discloses an automatic blending system for a dissolution medium. The device comprises a solvent transport vehicle, and a pH regulator bottle is arranged at the top of the solvent transport vehicle; the solvent barrel is arranged in the solvent transport vehicle, the solvent barrel is communicated with the pH regulator bottle, a water inlet is formed in the upper part of the solvent barrel, a water outlet is formed in the lower part of the solvent barrel, a stirring motor is arranged at the top of the solvent barrel, a stirring paddle is arranged at the bottom of the stirring motor, and the stirring paddle extends downwards into the solvent barrel; the heating and degassing device is arranged in the solvent transport vehicle, the heating and degassing device comprises a direct-current pump, a heating wire and a ventilation membrane, the solvent barrel is sequentially communicated with the direct-current pump, the heating wire and the ventilation membrane through a pipeline, and a flow meter is arranged on the pipeline. According to the utility model, the pH regulator bottle and the stirring paddle are arranged to carry out pH regulation on the mother liquor, and cyclic heating and degassing treatment are completed through the heating and degassing device, so that a preset temperature and an ideal degassing state are achieved.

Description

Technical Field

[0001] The utility model relates to the technical field of in vitro drug dissolution testing, and more specifically to an automatic dissolution medium preparation system. Background Art

[0002] In vitro dissolution testing is to examine the dissolution or release of the main ingredients (API) of the drug in the formulation by placing the drug under various conditions that simulate the human body environment, and to use this as a basis for the development of drug formulations, and to evaluate the quality consistency of the formulation within batches, between batches, and before and after changes in the drug formulation process. When conducting an in vitro dissolution test of a drug, the medium used is called a dissolution medium (solvent). In order to simulate the actual dissolution environment of the drug in the body, people generally select and prepare a variety of pH conditions for key parts of the body (such as stomach pH = 1.2, intestinal pH = 6.8, body fluid pH = 7.4, etc.) Solvents for in vitro drug release. And in order to prevent the oxygen in the dissolution medium from affecting the drug dissolution process and causing deviations in the measurement results, the solvent needs to be degassed before entering the dissolution instrument.

[0003] However, at present, major pharmaceutical factories, pharmaceutical companies, CRO companies and other departments that have the need for in vitro drug dissolution experiments have the following problems and pain points in the process of solvent preparation and degassing:

[0004] Dissolution experiments usually need to be repeated several times a day, using about 8-12L of solvent each time. Repeated tests are performed several times a day, and a large amount of solvent needs to be prepared.

[0005] It is necessary to prepare a variety of solvents with different pH values. In the process of adjusting the pH of the solvent, it is usually manually stirred and mixed in an open environment using a glass rod. During the repeated stirring process, oxygen is reintroduced into the solvent, resulting in a high dissolved oxygen content, which may cause deviations in the measurement results.

[0006] Multiple dissolution testers are usually placed in different areas of the laboratory, and transporting solvents is time-consuming and laborious.

[0007] A series of processes, including solvent degassing, pH adjustment, solvent transportation, solvent packaging and solvent heating (simulating human body temperature), are completed step by step, which is time-consuming, increases time costs but has low experimental efficiency.

[0008] At present, relevant experimental personnel usually use ① ultrasound / boiling; ② fixed solvent degasser; ③ online solvent degasser to degas the solvent. However, the above treatment methods still have the following problems: ① There are noise problems when large volumes of solvent are treated by ultrasound, and there are safety hazards such as scalding when boiling. In addition, due to the specifications of the ultrasound / boiling equipment, the above three methods often require repeated operations, which is time-consuming and labor-intensive; ② The fixed solvent degasser is difficult to move. When the experimenter transports the degassed solvent in batches to the pH adjustment area and different dissolution apparatuses for manual distribution, there are problems such as heavy solvent weight, difficulty in manual transportation, and large manual distribution errors; ③ Although the commercially available online solvent degasser is more convenient to move than the fixed solvent degasser, the early pH adjustment process still needs to be carried out manually, which increases time costs.

[0009] Therefore, how to provide an automatic dissolution medium preparation system that adds an online solvent pH adjustment function and meets the customer's solvent (mother liquor) transportation, automatic pH adjustment, heating, and degassing requirements is a problem that technical personnel in this field urgently need to solve. Utility Model Content

[0010] In view of this, the utility model provides an automatic dissolution medium preparation system, which adds a solvent pH online adjustment function and meets the customer's solvent (mother liquor) transportation, automatic pH adjustment, heating and degassing needs.

[0011] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0012] An automatic dissolution medium preparation system, comprising:

[0013] A solvent transport vehicle, wherein a pH regulator bottle is arranged on the top of the solvent transport vehicle;

[0014] A solvent barrel, wherein the solvent barrel is arranged in the solvent transport vehicle, the solvent barrel is connected to the pH regulator bottle, a water inlet is arranged above the solvent barrel, a water outlet is arranged below the solvent barrel, a stirring motor is arranged at the top of the solvent barrel, a stirring paddle is arranged at the bottom of the stirring motor, and the stirring paddle extends downward into the solvent barrel;

[0015] A heating and degassing device is arranged in the solvent transport vehicle, and the heating and degassing device includes a DC pump, a heating wire and a ventilation membrane. The solvent barrel is connected with the DC pump, the heating wire and the ventilation membrane in sequence through pipelines. A flow meter is provided on the pipeline. The heating and degassing device is used to complete the cyclic heating and degassing treatment to achieve a preset temperature and an ideal degassing state.

[0016] Furthermore, it also includes an oxygen processing device, which is arranged in the solvent transport vehicle. The oxygen processing device includes a primary filter bottle and a water vapor separator. One end of the primary filter bottle is connected to the ventilation membrane through a three-way valve, and the other end of the primary filter bottle is connected to the water vapor separator.

[0017] Furthermore, it also includes a solvent output handle, which is arranged on the solvent transport vehicle, and the solvent output handle is connected to the ventilation membrane through the third end of the three-way valve.

[0018] Furthermore, a pH electrode is provided in the solvent barrel.

[0019] Furthermore, a peristaltic pump is provided in the pH regulator bottle.

[0020] Furthermore, the control component is arranged on the solvent transport vehicle, and the control component includes an operation screen, a retractable power cord and a switch power supply.

[0021] Through the above technical scheme, it can be known that compared with the prior art, the utility model discloses a dissolution medium automatic preparation system. The device introduces a mother liquor pH adjustment function based on the technology of the original commercially available online solvent degasser, which can make full use of the time in the transportation process of the solvent, and synchronously complete a series of operations such as solvent pH adjustment, heating and degassing, so that the user can automatically complete the heating, degassing, pH adjustment, quantitative distribution and other operations required in the solvent preparation process without adding additional pH adjustment time. The time utilization efficiency of manual transportation of solvents is improved, the operation process of manual pH adjustment, waiting time and the risk of reintroduction of air during the adjustment process are reduced, so that the solvent preparation personnel can complete the original transportation of solvents and pH adjustment in the same time period, shortening the total time of solvent preparation, reducing the human labor intensity in the transportation process of large-volume solvents, and the closed pH automatic adjustment system avoids the problem of poor degassing effect caused by oxygen re-immersion caused by manual pH adjustment after solvent degassing. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0023] Figure 1 A schematic diagram of the internal structure of the automatic dissolution medium preparation system provided by the utility model;

[0024] Figure 2 A schematic diagram of the structure of the automatic dissolution medium preparation system provided by the utility model;

[0025] Figure 3 This is a structural schematic diagram from another perspective of the automatic dissolution medium preparation system provided by the utility model.

[0026] Among them: 1 is a solvent transport vehicle; 2 is a pH regulator bottle; 3 is a solvent barrel; 4 is a water inlet; 5 is a water outlet; 6 is a stirring motor; 7 is a stirring paddle; 8 is a DC pump; 9 is a heating wire; 10 is a ventilation membrane; 11 is a flow meter; 12 is a primary filter bottle; 13 is a water-gas separator; 14 is a three-way valve; 15 is a solvent output handle; 16 is a pH electrode; 17 is a peristaltic pump; 18 is an operating screen; 19 is a retractable power cord; 20 is a switching power supply. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0028] See also Figure 1-3 The present utility model discloses an automatic dissolution medium preparation system, comprising:

[0029] A solvent transport vehicle 1, a pH adjusting agent bottle 2 is arranged on the top of the solvent transport vehicle 1; the solvent transport vehicle 1 is arranged for transportation, and the pH adjusting agent bottle 2 is arranged for storage of the pH adjusting agent;

[0030] A solvent barrel 3 is provided in the solvent transport vehicle 1, the solvent barrel 3 is connected with the pH regulator bottle 2, a water inlet 4 is provided above the solvent barrel 3, a water outlet 5 is provided below the solvent barrel 3, a stirring motor 6 is provided at the top of the solvent barrel 3, a stirring paddle 7 is provided at the bottom of the stirring motor 6, and the stirring paddle 7 extends downward into the solvent barrel 3; by providing the stirring paddle 7, the mother liquor and the regulator are quickly and fully mixed under the drive of the stirring motor 6; by injecting the mother liquor into the solvent barrel 3 from the water inlet 4; the solvent barrel 3 is automatically cleaned, and the cleaning liquid is discharged through the water outlet 5;

[0031] The heating and degassing device is arranged in the solvent transport vehicle 1. The heating and degassing device includes a DC pump 8, a heating wire 9 and a ventilation membrane 10. The solvent barrel 3 is connected with the DC pump 8, the heating wire 9 and the ventilation membrane 10 in sequence through pipelines. A flow meter 11 is provided on the pipeline. The heating and degassing device completes the cyclic heating and degassing treatment to achieve a preset temperature and an ideal degassing state.

[0032] In this embodiment, an oxygen processing device is also included. The oxygen processing device is arranged in the solvent transport vehicle 1. The oxygen processing device includes a primary filter bottle 12 and a water vapor separator 13. One end of the primary filter bottle 12 is connected to the ventilation membrane 10 through a three-way valve 14, and the other end of the primary filter bottle 12 is connected to the water vapor separator 13. The oxygen in the solvent will be discharged out of the equipment along with water vapor through the primary filter bottle 12 and the water vapor separator 13.

[0033] In this embodiment, a solvent output handle 15 is also included. The solvent output handle 15 is arranged on the solvent transport vehicle 1. The solvent output handle 15 is connected to the ventilation membrane 10 through the third end of the three-way valve 14; the solvent is injected into the target container through the solvent output handle 15.

[0034] In this embodiment, a pH electrode 16 is provided in the solvent barrel 3; the pH is assisted by the pH electrode 16 to adjust the pH.

[0035] In this embodiment, a peristaltic pump 17 is provided in the pH adjusting agent bottle 2 .

[0036] In this embodiment, the control component is arranged on the solvent transport vehicle 1 , and the control component includes an operation screen 18 , a retractable power cord 19 and a switch power supply 20 .

[0037] Specific use process:

[0038] A preparation plan is established through the operation screen 18, and the equipment injects the mother liquid into the solvent barrel 3 from the water inlet 4 according to the plan, and simultaneously injects the pH adjuster from the pH adjuster bottle 2 into the solvent barrel 3 through the peristaltic pump 17;

[0039] While the mother liquid and the pH adjusting agent are being injected, the stirring paddle 7 is driven by the stirring motor 6 to quickly and fully mix the mother liquid and the adjusting agent;

[0040] While the pH value of the mother solution is being adjusted, the solvent in the solvent barrel 3 will pass through the DC pump 8, the heating wire 9, the ventilation membrane 10, the flow meter 11, and the three-way valve 14 in sequence, completing the cyclic heating and degassing treatment in the pipeline to reach the preset temperature and the ideal degassing state;

[0041] The oxygen in the solvent will be discharged out of the equipment along with the water vapor through the primary filter bottle 12 and the water vapor separator 13;

[0042] The successfully prepared and degassed solvent will be transported to the target location by the solvent transport vehicle 1 and injected into the target container through the solvent output handle 15;

[0043] When the device is used, it can be automatically cleaned and the cleaning liquid is discharged through the water outlet 5.

[0044] Technical effect:

[0045] This equipment comes with a solvent barrel 3 with a volume of >13L, which can support the successful completion of 1-2 dissolution experiments in one preparation (based on the reference of using 500-1000ml solvent in a single dissolution cup and testing 12 cups at a time);

[0046] This equipment comes with an integrated cart design, which makes solvent transportation easy and fast, without the need for manual batch transportation;

[0047] The device has a built-in pH adjustment function (with a pH adjustment agent bottle 2, a peristaltic pump 17, and a stirring paddle 7), which can automatically complete the pH adjustment work according to the pH adjustment method established in advance during the process of injecting the mother liquid (solvent that has not been pH adjusted) into the solvent barrel 3, without the need for intermediate manual operation steps, thus reducing time costs;

[0048] This equipment retains the characteristic functions of the online solvent degasser, adopts a sealed design as a whole, and is equipped with a vacuum pump, a water-gas separator 13 and other devices. It can automatically complete the solvent heating and degassing actions during the process of solvent pH adjustment and transportation, and can perform the final precise quantitative distribution of the solvent.

[0049] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referred to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part.

[0050] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A dissolution medium automatic preparation system, characterized in that: include: A solvent transport vehicle, wherein a pH regulator bottle is arranged on the top of the solvent transport vehicle; A solvent barrel, wherein the solvent barrel is arranged in the solvent transport vehicle, the solvent barrel is connected to the pH regulator bottle, a water inlet is arranged above the solvent barrel, a water outlet is arranged below the solvent barrel, a stirring motor is arranged at the top of the solvent barrel, a stirring paddle is arranged at the bottom of the stirring motor, and the stirring paddle extends downward into the solvent barrel; A heating and degassing device is arranged in the solvent transport vehicle, and the heating and degassing device includes a DC pump, a heating wire and a ventilation membrane. The solvent barrel is connected with the DC pump, the heating wire and the ventilation membrane in sequence through pipelines. A flow meter is provided on the pipeline. The heating and degassing device is used to complete the cyclic heating and degassing treatment to achieve a preset temperature and an ideal degassing state.

2. The automatic dissolution medium preparation system according to claim 1, characterized in that: It also includes an oxygen processing device, which is arranged in the solvent transport vehicle. The oxygen processing device includes a primary filter bottle and a water vapor separator. One end of the primary filter bottle is connected to the ventilation membrane through a three-way valve, and the other end of the primary filter bottle is connected to the water vapor separator.

3. The automatic dissolution medium preparation system according to claim 2, characterized in that: It also includes a solvent output handle, which is arranged on the solvent transport vehicle, and the solvent output handle is connected to the ventilation membrane through the third end of the three-way valve.

4. The automatic dissolution medium preparation system according to claim 1, characterized in that: A pH electrode is arranged in the solvent barrel.

5. The automatic dissolution medium preparation system according to claim 1, characterized in that: A peristaltic pump is arranged in the pH regulator bottle.

6. The automatic dissolution medium preparation system according to claim 1, characterized in that: It also includes a control component, which is arranged on the solvent transport vehicle and includes an operation screen, a retractable power cord and a switch power supply.

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