CN217067794U - Device for removing organic solvent in fragile medicinal particles - Google Patents
Device for removing organic solvent in fragile medicinal particles Download PDFInfo
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- CN217067794U CN217067794U CN202220233616.3U CN202220233616U CN217067794U CN 217067794 U CN217067794 U CN 217067794U CN 202220233616 U CN202220233616 U CN 202220233616U CN 217067794 U CN217067794 U CN 217067794U
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Abstract
The utility model discloses a device for getting rid of organic solvent in breakable medicinal granule, its characterized in that: the device comprises at least one flow channel (1) for flowing a liquid mixed with fragile medicinal particles containing an organic solvent, the flow channel (1) at least comprising an inlet (2) and an outlet (3) for allowing the liquid to spontaneously flow under the action of gravity, and the roughness range of the surface directly contacted with the liquid in the flow channel (1) is as follows: ra is more than 0.8 mu m and less than 25 mu m. The device of the utility model can make the breakable medicinal particles and the liquid generate different movement speeds only by relying on the gravity and the action of the friction force between the breakable medicinal particles and the flow channel under the condition of not using a moving part, thereby accelerating the removal process of the organic solvent under the condition of not damaging the breakable medicinal particles; the device has high production efficiency, high speed and low cost, and can realize the amplification of the yield and reduce the amplification effect by connecting a plurality of devices in parallel on occasions needing amplification production.
Description
Technical Field
The utility model belongs to the technical field of the pharmaceutical production technique and specifically relates to a device for getting rid of organic solvent in breakable medicinal granule.
Background
The pharmaceutical production process inevitably involves the use of large amounts of organic solvents, many of which are harmful to humans and need to be removed in the final formulation. For ordinary medicinal granules, reduced pressure drying, freeze drying, oven heating and the like can be adopted to remove the organic solvent, however, in special cases, particularly when the solid granules are unstable and cannot tolerate the processes, the removal work of the organic solvent needs to be carried out under relatively mild conditions, and the liquid-in-liquid drying method is a suitable process.
The liquid-in-liquid drying method is a process for removing organic solvent in liquid, and usually involves suspending or emulsifying medicinal granules in water (or aqueous solution, the same applies hereinafter) by buoyancy, and simultaneously extracting organic solvent from the granules, which is usually carried out in a stirred tank. For fragile medicinal particles, the structure of the particles can be damaged by the stirring paddle when high-speed shearing is used, so that only low-shearing stirring paddles such as frame type stirring paddles and anchor type stirring paddles can be used for stirring at a relatively low rotating speed. Under the working condition, suspension or emulsion particles in the stirring kettle are mainly laminar flow, which means that the particles are nearly static relative to surrounding liquid, and organic solvent passively diffused into water from the particles cannot be rapidly dispersed, so that the concentration difference of the organic solvent between the water and the particles is reduced, and the further diffusion of the organic solvent in the particles is inhibited.
Therefore, under the laminar flow condition with weak external force, the problem how to continuously renew the liquid around the particles so as to accelerate the mass transfer process of the organic solvent while making the particles and the water generate relative motion is urgently needed to be solved in the field.
At present, the removal process and related equipment of the organic solvent are mostly seen in the sewage treatment or chemical production industry, and most of the devices are aeration tanks or stripping towers, and both the aeration tanks and the stripping towers can not be used for removing the organic solvent of the fragile medicinal particles due to the existence of strong shearing action.
SUMMERY OF THE UTILITY MODEL
The utility model aims at solving the problems in the prior art and providing a device for removing organic solvent in fragile medicinal granules.
The utility model aims at solving through the following technical scheme:
an apparatus for removing organic solvent from friable pharmaceutical granules, comprising: the device comprises at least one flow channel for flowing liquid mixed with fragile medicinal particles containing organic solvent, at least one flow channel comprising an inlet and an outlet for spontaneous flow of the liquid under the action of gravity, and the roughness range of the surface in the flow channel, which is directly contacted with the liquid, is as follows: 0.8 mu m < Ra < 25 mu m, so that the particles can form a certain friction force with the fragile medicinal particles and the structure of the medicinal particles is not broken enough.
The roughness Ra of the surface which is not contacted with the fluid in the flow channel is less than 0.4 mu m.
The material of the runner is 316 stainless steel.
The whole structure of the flow channel is S-shaped, so that the total flow strokes of the liquid in the flow channel are consistent, the consistency of the removal speed of the organic solvent in the fragile medicinal particles is further realized, and the stability of the product is favorably improved; the concrete conditions are as follows: the length of the curve through which the mass point at any position starts from the inlet, advances along the direction of the flow channel for the liquid to flow and finally reaches the outlet is the same, and the S-shaped flow channel is one way to ensure the characteristic.
The inlet is positioned at the uppermost end of the flow channel, and the opening direction of the inlet is vertical to the extending direction of the flow channel at the inlet so as to reduce the initial flow rate of the suspension or emulsion containing the fragile medicinal particles after entering the flow channel.
The outlet is positioned at the lowest end of the flow passage and is opened downwards, so that no residue exists in the fragile medicinal particles at the outlet.
The runner include the direct section, turn to the section, export link up section and export section, through turning to the section intercommunication between a plurality of direct sections, the top of first direct section sets up the entry, the afterbody of last direct section passes through export link up section and connects the export section, the bottom of the export section of toper design sets up the export.
The bottom of the channel of the straight section is of a plane structure, the height of the straight section in the direction perpendicular to the liquid flow is not less than 20mm, and the orientation of the straight section forms an included angle of 1-30 degrees with the horizontal plane.
The orientation of the straight section and the horizontal plane form an included angle of 1-10 degrees.
The outlet section is of a vertically arranged inverted cone structure, and by the design, when the flow at the inlet is large, suspension or emulsion at the outlet cannot be discharged in time and accumulation occurs, the narrow part can trigger a siphon effect, so that the suspension or emulsion accumulated at the outlet can be discharged in time.
One preferred scheme is as follows: the minimum height of the outlet section in the direction perpendicular to the liquid flow is not more than 10 mm.
The breakable medicinal particles can be formed by polymer materials, medicines and (or) other additional components, or can be formed by only the medicines and (or) other additional components without the polymer materials, or can be formed by only the polymer materials and (or) other additional components without the medicines, or can be emulsion drops formed by the medicines, emulsifying agents, grease and the like, or can be liposomes formed by the medicines, phospholipids and other materials; the shape of the fragile medicinal granules can be regular round spheres, irregular blocks or strips and the like; the particle size of the friable medicinal granules is within the range of 1000-0.1 μm; the friable medicinal granules may be generally organic solvent-containing or after removal of the organic solvent, but the friable medicinal granules mentioned in the present invention must be organic solvent-containing.
Compared with the prior art, the utility model has the following advantages:
the device of the utility model can make the breakable medicinal particles and the liquid generate different movement speeds only by relying on the gravity and the action of the friction force between the breakable medicinal particles and the flow channel under the condition of not using a moving part, thereby accelerating the removal process of the organic solvent under the condition of not damaging the breakable medicinal particles; meanwhile, the fragile medicinal particles continuously roll in the movement process, so that the uniform degree of removing the organic solvent in all directions of the fragile medicinal particles is ensured; the strokes of the fragile medicinal particles in the flow channel are consistent, so that the production consistency of the fragile medicinal particles is ensured; the design of the inverted cone-shaped outlet section enables the flow range applicable to the device to be wider; the whole device is composed of continuous pipelines, the production efficiency is high, the speed is high, the cost is low, and in the occasion of production amplification, the amplification of yield is realized and the amplification effect is reduced by connecting a plurality of devices in parallel.
Drawings
FIG. 1 is a schematic structural diagram of an apparatus for removing organic solvent from fragile pharmaceutical particles according to the present invention.
Wherein: 1, a flow channel; 10-a straight section; 11-a turning section; 12-an outlet connection section; 13-an outlet section; 2-an inlet; and 3, an outlet.
Detailed Description
The following detailed description of embodiments of the present invention is provided in connection with the accompanying drawings and examples. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
As shown in fig. 1, an apparatus for removing an organic solvent from friable medicinal granules comprises at least one flow channel 1 for flowing a liquid mixed with friable medicinal granules containing an organic solvent, the flow channel comprising at least one inlet 2 and one outlet 3 for allowing the liquid to spontaneously flow by gravity; the inlet 2 is positioned at the uppermost end of the flow channel 1, and the opening direction of the inlet 2 is vertical to the extending direction of the flow channel 1 at the inlet 2 so as to reduce the initial flow rate of the suspension or emulsion containing the fragile medicinal particles after entering the flow channel 1; the outlet 3 is positioned at the lowest end of the flow channel 1 and is opened downwards, so that no residue exists at the outlet 3 of the fragile medicinal particles; the material of runner 1 is 316 stainless steel, and the roughness scope of the direct liquid contact's surface in runner 1 is: ra is more than 0.8 mu m and less than 25 mu m, so that a certain friction force can be formed between the particles and the fragile medicinal particles, and the structure of the medicinal particles is not broken enough; the roughness Ra of the surface of the flow channel 1 which is not in contact with the fluid is less than 0.4 mu m. The whole structure of the flow channel 1 is S-shaped, so that the total flow stroke of the liquid in the flow channel 1 is consistent, the consistency of the removal speed of the organic solvent in the fragile medicinal particles is further realized, and the stability of the product is favorably improved; the concrete conditions are as follows: the lengths of the curves through which the particles at any position start from the inlet 2, advance in the direction of the flow channel 1 for the liquid to flow and finally reach the outlet 3 are the same, and the S-shaped flow channel 1 is one way to ensure this characteristic.
The utility model discloses a device for getting rid of organic solvent in breakable medicinal granule is when using, with breakable medicinal granule suspensoid in liquid, liquid via entry 2 add the device in runner 1, the effect of gravity is lower the tiling in runner 1's lower surface, forms the grained layer on 1 ~ 5 layers, along runner 1's extending direction slow rolling flow direction relief low place, collect in 3 departments of export at last and obtain the breakable medicinal granule suspensoid or the emulsion that organic solvent content is showing and descends. In the moving process of the fragile medicinal particles in the flow channel 1, the internal organic solvent is gradually transferred into the liquid, so that the aim of reducing the content of the organic solvent in the fragile medicinal particles or removing the organic solvent is fulfilled; the suspension or emulsion collected from outlet 3 may be subjected to further agitation to evaporate or solution replace the water containing the organic solvent (e.g., by solvent replacement through a tangential flow filter to remove a substantial amount of the organic solvent from the liquid or by evaporation with prolonged agitation).
The liquid can be pure water or a solution formed by water and an emulsion stabilizer, and the emulsion stabilizer is added to prevent the aggregation of the fragile medicinal particles; the emulsion stabilizer comprises one or more of polyvinyl alcohol, polyethylene glycol, polyvidone, sodium carboxymethylcellulose, tween, span, and poloxamer. In addition, it should be noted that: the liquid hardly contacts the top of the flow channel 1 when flowing in the flow channel 1; the liquid will have a waterfall-like fall-off in the diverting section 11 to make the total stroke uniform.
Example one
Fig. 1 is a schematic structural diagram of an apparatus for removing an organic solvent from a friable medicinal granule according to a first embodiment of the present application. The device comprises a flow channel 1 for liquid flowing, wherein the flow channel 1 comprises a plurality of straight sections 10, a plurality of turning sections 11 serving as turning angles, an outlet connection section 12 and an outlet section 13, the included angle of the straight sections 10 and the horizontal plane is 8 degrees, the height of the straight sections 10 in the direction perpendicular to the liquid flowing direction is 30mm, the straight sections and the outlet connection section are arranged in a staggered mode, the turning sections 11 are fan-shaped, the outlet connection section 12 is fan-shaped and is used for gently bearing fluid in the straight sections 10 to flow into the outlet section 13, the flowing direction of the liquid in the outlet section 13 in a conical design is perpendicular to the horizontal plane, and the height of the outlet section 13 in the direction perpendicular to the liquid flowing direction is initial 30mm to 10mm transition. The flow channel 1 is subjected to grinding and polishing treatment, wherein the roughness Ra of the surface in the flow channel 1, which is directly contacted with liquid, is 6.3 mu m, and the rest surfaces are polished to Ra of less than 0.4 mu m. The device also comprises an inlet 2 connected with the flow channel 1, wherein the inlet 2 is positioned at the upper part of the flow channel 1, and suspension or emulsion enters the flow channel 1; the apparatus further comprises an outlet 3 at the end of the outlet section 13 from which the friable pharmaceutical particles that have performed the removal of the organic solvent are discharged along with the liquid.
The following description specifically describes an example of the use of the above-mentioned apparatus for removing organic solvent from fragile medicinal particles provided in the present invention for preparing fragile medicinal particles.
Use example one
Dissolving 9910mg of phospholipid, 5790mg of cholesterol and 2538mg of tricaprylin in 500mL of chloroform to obtain an organic phase; dissolving 30g of bupivacaine phosphate in 500mL of water to obtain an internal water phase; mixing the internal water phase with the organic phase, and performing probe ultrasonic treatment for 10min under the stirring action of 200rpm to obtain W/O type emulsion; the W/O type emulsion was mixed with a 0.1% aqueous lysine solution at a ratio of 1: 9 and emulsified by a static mixer at a total flow rate of 8L/min to obtain a W/O/W type emulsion. The W/O/W type emulsion was fed into the flow channel 1 from the inlet 2 at a rate of 1L/min, and the effluent emulsion was collected from the outlet 3. After the emulsion addition was complete, 10L of purified water was added at a rate of 10L/min from inlet 2, all the liquid collected from outlet 3 was combined, the liquid was concentrated to about 3L using a tangential flow filter, and the aqueous phase component of the concentrate was replaced with a volume of 90L of 0.9% NaCl solution using a tangential flow filter. Finally, bupivacaine liposome with particle size (d 50) of 50 μm and 1% organic solvent residue is obtained.
Use example two
Dissolving 4g of risperidone and 6g of polylactic-co-glycolic acid (PLGA) in 60mL of dichloromethane to obtain an organic phase; the organic phase was mixed with 6L of a 1% polyvinyl alcohol (PVA) solution, and then passed through a static mixer at a speed of 8L/min to form an O/W type emulsion. The emulsion was fed into the flow channel 1 from the inlet 2 at a rate of 1L/min, and the effluent emulsion was collected from the outlet 3. After the emulsion was added, 10L/min of purified water was continuously added from inlet 2, and all the liquids collected from outlet 3 were combined and transferred to a 30L reactor, and then stirred at 50rpm while air was introduced at 5L/min after sterilization filtration. After 5 hours, the in-pot emulsion was filtered using a 20 μm sieve, and then the particles on the sieve were washed with purified water to obtain risperidone sustained-release particles having a particle size (d 50) of 70 μm and 3% of organic solvent remaining.
The device of the utility model can make the breakable medicinal particles and the liquid generate different movement speeds only by relying on the gravity and the friction force between the breakable medicinal particles and the flow channel 1 under the condition of not using a moving part, thereby accelerating the removal process of the organic solvent under the condition of not damaging the breakable medicinal particles; meanwhile, the fragile medicinal particles continuously roll in the movement process, so that the uniform degree of removing the organic solvent in all directions of the fragile medicinal particles is ensured; the strokes of the fragile medicinal particles in the flow channel 1 are consistent, so that the production consistency of the fragile medicinal particles is ensured; the inverted cone-shaped outlet section 13 is designed to enable the device to be applicable to a wider flow range; the whole device is composed of continuous pipelines, the production efficiency is high, the speed is high, the cost is low, and in the occasion of production amplification, the amplification of yield is realized and the amplification effect is reduced by connecting a plurality of devices in parallel.
The above embodiments are only for explaining the technical idea of the present invention, and the protection scope of the present invention cannot be limited thereby, and any modification made on the basis of the technical scheme according to the technical idea provided by the present invention all fall within the protection scope of the present invention; the technology not related to the utility model can be realized by the prior art.
Claims (9)
1. An apparatus for removing organic solvent from friable pharmaceutical granules, comprising: the device comprises at least one flow channel (1) for flowing a liquid mixed with fragile medicinal particles containing an organic solvent, the flow channel (1) at least comprising an inlet (2) and an outlet (3) for allowing the liquid to spontaneously flow under the action of gravity, and the roughness range of the surface directly contacted with the liquid in the flow channel (1) is as follows: ra is more than 0.8 mu m and less than 25 mu m.
2. The apparatus according to claim 1, wherein the apparatus further comprises: the roughness Ra of the surface which is not contacted with the fluid in the flow channel (1) is less than 0.4 mu m.
3. The apparatus according to claim 1, wherein the apparatus further comprises: the integral structure of the flow channel (1) is S-shaped, so that the total flowing stroke of the liquid in the flow channel (1) is consistent.
4. The apparatus according to claim 1, wherein the apparatus further comprises: the inlet (2) is positioned at the uppermost end of the flow channel (1), and the opening direction of the inlet (2) is vertical to the extending direction of the flow channel (1) at the inlet (2) so as to reduce the initial flow rate of the suspension or emulsion containing the fragile medicinal particles after entering the flow channel (1).
5. The apparatus according to claim 1, wherein the apparatus further comprises: the outlet (3) is positioned at the lowest end of the flow passage (1) and is opened downwards, so that no residue exists in the outlet (3) of the fragile medicinal particles.
6. The apparatus for removing organic solvent from friable pharmaceutical granules according to any one of claims 1-5, wherein: the runner (1) include straight section (10), turn to section (11), export linking section (12) and export section (13), be linked together through turning to section (11) between a plurality of straight sections (10), the top of first straight section (10) sets up entry (2), the afterbody of last straight section (10) links up section (12) through the export and connects export section (13), the bottom of the export section (13) of toper design sets up export (3).
7. The apparatus according to claim 6, wherein the apparatus further comprises: the bottom of the channel of the straight section (10) is of a plane structure, the height of the straight section (10) in the direction perpendicular to the liquid flow is not less than 20mm, and the orientation of the straight section (10) forms an included angle of 1-30 degrees with the horizontal plane.
8. The apparatus according to claim 7, wherein the apparatus further comprises: the orientation of the straight section (10) forms an included angle of 1-10 degrees with the horizontal plane.
9. The apparatus according to claim 6, wherein the apparatus further comprises: the outlet section (13) is of a vertically arranged inverted cone structure; the minimum height of the outlet section (13) in the direction perpendicular to the liquid flow is not greater than 10 mm.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202220233616.3U CN217067794U (en) | 2022-01-28 | 2022-01-28 | Device for removing organic solvent in fragile medicinal particles |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202220233616.3U CN217067794U (en) | 2022-01-28 | 2022-01-28 | Device for removing organic solvent in fragile medicinal particles |
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| CN217067794U true CN217067794U (en) | 2022-07-29 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114669085A (en) * | 2022-01-28 | 2022-06-28 | 南京宁源科生物技术有限公司 | Organic solvent removing device for medicinal particles |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114669085A (en) * | 2022-01-28 | 2022-06-28 | 南京宁源科生物技术有限公司 | Organic solvent removing device for medicinal particles |
| CN114669085B (en) * | 2022-01-28 | 2024-05-31 | 南京宁源科生物技术有限公司 | Organic solvent removing device for medicinal particles |
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