Clindamycin phosphate vaginal gel preparation device and method

Abstract

The invention discloses a clindamycin phosphate vaginal gel preparation device and method, and belongs to the technical field of pharmacy. The method comprises the steps that after clindamycin phosphate vaginal gel is prepared by a preparation tank, the clindamycin phosphate vaginal gel is filled into a vacuum defoaming tank through a feeding opening in the bottom of the vacuum defoaming tank, and a packaging tank is conveyed to a rotary positioning mechanism through a conveying mechanism; and the filling mechanism is used for filling the clindamycin phosphate vaginal gel stored in the vacuum defoaming tank into the packaging tank on the rotary positioning mechanism. The invention aims to solve the problems that the existing clindamycin phosphate vaginal gel is complex in preparation process and difficult to carry out constant temperature control, the preparation and filling process needs to be transferred for multiple times, the viscosity of the gel can change along with time, temperature or storage conditions, the uniformity of the gel and the use experience of a patient are influenced, and the gel is difficult to be used. And the filled finished product gel is very easy to have a large number of bubbles, so that a more transparent and uniform gel product can be obtained, and the physical property and the use comfort of the gel are improved.

Description

Technical Field

[0001] The invention relates to a device and a method for preparing clindamycin phosphate vaginal gel, and belongs to the technical field of pharmaceuticals. Background Art

[0002] Clindamycin phosphate vaginal gel is a topical antibiotic used to treat vaginal infections such as bacterial vaginosis (BV). Clindamycin phosphate is easily hydrolyzed and degraded in aqueous solution, which will lead to reduced activity of the drug and affect the efficacy. Therefore, the pH value and other conditions need to be strictly controlled during the preparation process to maintain the stability of the drug. Existing preparation methods usually involve multi-step mixing, heating, cooling, pH adjustment and other processes, which are complicated and difficult to control at a constant temperature. This may lead to large differences between batches and make it difficult to achieve stable quality control. At the same time, the existing technology equipment is complicated, and the preparation and filling process requires multiple transfers. The viscosity of the gel may change with time, temperature or storage conditions, which affects the uniformity of the gel and the patient's experience. In addition, the finished gel after filling is prone to a large number of bubbles, which affects the product quality, output quality and filling weight.

[0003] Therefore, it is urgent to propose a novel clindamycin phosphate vaginal gel preparation device and method to solve the above technical problems. Summary of the invention

[0004] The purpose of the present invention is to solve the problems that the existing clindamycin phosphate vaginal gel preparation process is complicated and difficult to be thermostatically controlled, the preparation and filling process requires multiple transfers, the viscosity of the gel may change with time, temperature or storage conditions, resulting in the gel's uniformity and patient experience being affected, and the finished gel after filling is very likely to have a large number of bubbles. A brief overview of the present invention is given below to provide a basic understanding of certain aspects of the present invention. It should be understood that this overview is not an exhaustive overview of the present invention. It is not intended to determine the key or important parts of the present invention, nor is it intended to limit the scope of the present invention.

[0005] The technical solution of the present invention:

[0006] Solution 1: A clindamycin phosphate vaginal gel preparation device comprises a preparation tank, a vacuum defoaming tank, a filling mechanism, a conveying mechanism, a rotating positioning mechanism and a frame. The preparation tank is connected with a feed port at the bottom of the vacuum defoaming tank through a valve pipeline. A vacuum defoaming tank is installed on the top of the frame. A filling mechanism is installed at the bottom of the vacuum defoaming tank. The filling mechanism is connected with the inside of the vacuum defoaming tank through a valve pipeline. A rotating positioning mechanism is arranged directly below the filling mechanism. The rotating positioning mechanism is connected with the conveying mechanism. After the preparation tank prepares the clindamycin phosphate vaginal gel, the preparation tank fills the clindamycin phosphate vaginal gel into the inside of the vacuum defoaming tank through the feed port at the bottom of the vacuum defoaming tank. The packaging tank is conveyed to the rotating positioning mechanism by the conveying mechanism. The filling mechanism fills the clindamycin phosphate vaginal gel stored in the vacuum defoaming tank into the packaging tank on the rotating positioning mechanism, and then the filling mechanism transports the clindamycin phosphate vaginal gel to the next process through the conveying mechanism.

[0007] Preferably: the preparation tank comprises a sealed tank body, a stirring blade and a stirring motor, the sealed tank body has a temperature-adjusting interlayer chamber, the temperature-adjusting interlayer chamber is injected with constant temperature circulating water through the water inlet and outlet pipes, the top cover of the sealed tank body is fixedly installed with a stirring motor, the output end of the stirring motor is connected to the stirring blade, the stirring blade is placed inside the sealed tank body, the bottom of the sealed tank body is provided with a discharge port, and the discharge port is connected to the feed port at the bottom of the vacuum defoaming tank through a valve pipeline.

[0008] Preferably: the filling mechanism comprises a lifting cylinder assembly and a filling needle assembly, the filling needle assembly is installed at the bottom of the vacuum defoaming tank through the lifting cylinder assembly, and the filling needle assembly is connected to the bottom outlet of the vacuum defoaming tank through a valve pipeline.

[0009] Preferably, the vacuum defoaming tank is a sealed tank, and the top of the sealed tank is connected to the vacuum pumping mechanism through a valve pipeline.

[0010] Preferably: the rotation positioning mechanism includes a support frame, a slide, a rotating disk frame, a rotating motor and a limiting arc plate, a slide is fixedly installed on the top of the support frame, the rotating motor is fixedly installed on the support frame, and the output end of the rotating motor is fixedly connected to the center of the rotating disk frame through a connecting shaft, a plurality of arc positioning grooves are processed on the outer side wall of the rotating disk frame, and the plurality of arc positioning grooves are arranged in a uniform circular array with the center of the rotating disk frame as the center of the circle, the rotating disk frame is located above the slide, the limiting arc plate is fixedly installed on one side of the slide, and the limiting arc plate and the center of the circle of the rotating disk frame are coaxially arranged.

[0011] Preferably: the conveying mechanism includes a base bracket, a conveyor belt mechanism and a limit baffle, the conveyor belt mechanism is fixedly mounted on the base bracket, the conveyor belt mechanism is arranged at the left and right end portions of the limit arc plate in the rotation positioning mechanism, and limit baffles are installed on both sides of the top of the conveyor belt mechanism.

[0012] Scheme 2: A method for preparing clindamycin phosphate vaginal gel, which is realized by relying on the clindamycin phosphate vaginal gel preparation device described in Scheme 1, comprising:

[0013] Step 1, inject a certain amount of distilled water into a preparation tank, then weigh hydroxypropyl methylcellulose and gelatin and place them in the preparation tank overnight until the solution is free of particles;

[0014] Step 2, dissolving sorbic acid in hot distilled water, adding clindamycin phosphate to dissolve when the solution temperature is lower than 40° C., and then injecting into the preparation tank after overnight storage in step 1;

[0015] Step 3, starting the stirring motor, the stirring blades in the preparation tank rotate, and the liquid in the preparation tank is mixed and stirred;

[0016] Step 4, adding glycerol and triethanolamine into the preparation tank, stirring with a stirring blade, and then adding water and continuing to mix and stir to prepare the clindamycin phosphate vaginal gel;

[0017] Step 5, filling the clindamycin phosphate vaginal gel prepared in the preparation tank into the vacuum defoaming tank through the feed port at the bottom of the vacuum defoaming tank;

[0018] Step 6, vacuumizing the internal gas of the vacuum defoaming tank from the top through a vacuum pumping mechanism, and then letting the tank stand to achieve the clindamycin phosphate vaginal gel defoaming step;

[0019] Step 7, start the conveying mechanism and the rotating positioning mechanism, and convey the packaging cans in batches to the rotating positioning mechanism through the conveying mechanism. The rotating disk rack of the rotating positioning mechanism rotates, and each packaging can is respectively clamped in each arc-shaped positioning groove, and the packaging can is brought to the bottom of each filling needle assembly;

[0020] Step 8, start the filling mechanism, the conveying mechanism and the rotating positioning mechanism are suspended, the lifting cylinder assembly drives the filling needle assembly to move downward, so that the bottom of the filling needle assembly is inserted into the bottom side of the corresponding packaging can, and then the lifting cylinder assembly drives the filling needle assembly to rise, and the filling needle assembly evenly draws the clindamycin phosphate vaginal gel in the vacuum defoaming tank into the packaging can;

[0021] Step 9, starting the conveying mechanism and the rotating positioning mechanism, the rotating positioning mechanism rotates, and the packaging can filled with clindamycin phosphate vaginal gel is transported from the conveying mechanism to the next process.

[0022] The present invention has the following beneficial effects:

[0023] 1. The preparation tank of the present invention can always maintain a constant temperature during the preparation, mixing and stirring, which can avoid the damage to the molecular structure of the drug caused by a sudden rise or fall in temperature, thereby extending the shelf life and stability of the drug, helping to prevent the degradation or failure of these ingredients, and ensuring that the drug maintains its activity throughout the production and storage cycle. At the same time, temperature changes will cause changes in the solubility of thickeners such as hydroxypropyl methylcellulose and carbomer in the gel matrix, thereby affecting the viscosity and rheology of the gel. Maintaining a constant temperature can ensure that the thickener is evenly dissolved and dispersed, so that the gel maintains a consistent texture and appearance, and enhances the user experience and quality of the product;

[0024] 2. The constant temperature of the preparation tank of the present invention avoids the formation of bubbles caused by temperature fluctuations, improves the appearance, physical properties and drug release characteristics of the gel, and the generation of bubbles will be significantly reduced under a constant temperature environment, which helps to obtain a more transparent and uniform gel product and improves the physical properties and comfort of the gel;

[0025] 3. The present invention makes the dissolution and mixing of drugs and excipients more stable and uniform, preventing the crystallization or precipitation of clindamycin phosphate during the preparation process. This ensures that the drug is evenly dispersed in the gel matrix, helps to achieve consistent drug concentration and release performance, and thus ensures consistent therapeutic effects for each dose of the product;

[0026] 4. The preparation method of the present invention is simple, which helps to simplify the production process, reduce the frequency of equipment and process parameter adjustments, and improve production efficiency;

[0027] 5. The vacuum defoaming tank of the present invention can expand bubbles and float to the surface through the vacuum environment without affecting the molecular components of the drug, thereby breaking and releasing the bubbles, making the appearance more uniform and transparent, and improving the overall sensory quality of the product. At the same time, the defoaming process can ensure the uniformity of the gel matrix, thereby ensuring the dosage consistency of the drug in each package, improving the reliability and effectiveness of the treatment, and ensuring that the drug has a consistent concentration and lasting therapeutic effect in the local environment of the vagina. Defoaming can also reduce the contact surface of oxygen and other possible degradation factors, extend the storage period and validity period of the gel, and ensure the sterility and safety of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a stereoscopic view of a device for preparing a clindamycin phosphate vaginal gel;

[0029] Figure 2 It is a diagram of the coordination and installation of a device for preparing a clindamycin phosphate vaginal gel;

[0030] Figure 3 is a perspective view of the conveying mechanism of the present invention;

[0031] Figure 4 It is a structural schematic diagram of the preparation tank of the present invention;

[0032] Figure 5 It is a structural schematic diagram of the rotary positioning mechanism of the present invention;

[0033] In the figure, 1-preparation tank, 2-vacuum defoaming tank, 3-filling mechanism, 4-conveying mechanism, 5-rotation positioning mechanism, 6-frame, 7-packaging tank, 11-sealed tank body, 12-stirring blade, 13-stirring motor, 14-temperature regulating interlayer chamber, 15-water inlet and outlet pipelines, 16-constant temperature circulating water, 17-discharge port, 21-feed port, 22-bottom outlet, 31-lifting cylinder assembly, 32-filling needle assembly, 41-base bracket, 42-conveyor belt mechanism, 43-limit baffle, 51-support frame, 52-slide, 53-rotating disc frame, 54-rotating motor, 55-limiting arc plate, 56-arc positioning groove. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention is described below by the specific embodiments shown in the accompanying drawings. However, it should be understood that these descriptions are only exemplary and are not intended to limit the scope of the present invention. In addition, in the following description, the description of well-known structures and technologies is omitted to avoid unnecessary confusion of the concept of the present invention.

[0035] The connection mentioned in the present invention is divided into fixed connection and detachable connection. The fixed connection is a non-detachable connection including but not limited to conventional fixed connection methods such as folding connection, rivet connection, bonding connection and welding connection. The detachable connection includes but not limited to conventional detachable methods such as threaded connection, snap connection, pin connection and hinge connection. When the specific connection method is not clearly defined, it is assumed that at least one connection method can always be found in the existing connection methods to achieve the function. Those skilled in the art can choose according to their needs. For example: a fixed connection is selected as a welding connection, and a detachable connection is selected as a hinge connection.

[0036] Specific implementation method 1: Combination Figure 1-Figure 5The present embodiment is described. The clindamycin phosphate vaginal gel preparation device of the present embodiment comprises a preparation tank 1, a vacuum defoaming tank 2, a filling mechanism 3, a conveying mechanism 4, a rotation positioning mechanism 5 and a frame 6. The preparation tank 1 is connected with a feed port 21 at the bottom of the vacuum defoaming tank 2 through a valve pipeline. The vacuum defoaming tank 2 is installed on the top of the frame 6. The filling mechanism 3 is installed at the bottom of the vacuum defoaming tank 2. The filling mechanism 3 is connected with the inside of the vacuum defoaming tank 2 through a valve pipeline. A rotation positioning mechanism 5 is arranged just below the filling mechanism 3. The rotation positioning mechanism 5 is connected with the conveying mechanism 4. After the preparation tank 1 prepares the clindamycin phosphate vaginal gel, it is filled into the inside of the vacuum defoaming tank 2 through the feed port 21 at the bottom of the vacuum defoaming tank 2. The packaging tank 7 is conveyed to the rotation positioning mechanism 5 through the conveying mechanism 4. The filling mechanism 3 fills the clindamycin phosphate vaginal gel stored in the vacuum defoaming tank 2 into the packaging tank 7 on the rotation positioning mechanism 5, and then transports it to the next process through the conveying mechanism 4.

[0037] The preparation tank 1 realizes the stirring preparation of the early stage of clindamycin phosphate vaginal gel. The entire batching process is carried out in the same preparation tank 1 to avoid product contamination caused by multiple mechanism transfers. The preparation tank 1 includes a sealed tank body 11, a stirring blade 12 and a stirring motor 13. The top of the sealed tank body 11 is provided with a sealed upper cover, and the upper cover is provided with a material injection port so as to batch the materials in batches. The material injection port is provided with a sealing cover to ensure that the environment inside the sealed tank body 11 is sealed during standing and stirring to reduce pollution. The sealed tank body 11 has a temperature-adjusting interlayer chamber 14, and the temperature-adjusting interlayer chamber 14 is connected to the temperature-adjusting interlayer chamber 14 by water inlet and outlet. The pipeline 15 is injected with constant temperature circulating water 16, and the constant temperature circulating water 16 is contained in a constant temperature heating pool. The constant temperature heating pool is provided with an adjustable temperature heating device to ensure that the constant temperature circulating water 16 always maintains the target temperature. The inner wall of the temperature regulating interlayer chamber 14 is made of heat conductive material, and the outer wall of the temperature regulating interlayer chamber 14 is made of heat insulating material, in order to transfer the temperature and heat to the inside of the sealed tank body 11 as much as possible, so that the inside of the sealed tank body 11 maintains a constant temperature processing environment, and avoids the problem of uneven local temperature distribution caused by heating components such as heating wires and heating rods, which affects the medicinal properties of the ingredients;

[0038] A stirring motor 13 is fixedly installed on the top cover of the sealed tank body 11, and a stirring blade 12 is connected to the output end of the stirring motor 13. The stirring blade 12 is placed inside the sealed tank body 11, and the stirring motor 13 drives the stirring blade 12 to rotate to achieve a stirring function. The sealed tank body 11 has a discharge port 17 at the bottom, and the discharge port 17 is connected to a feed port 21 at the bottom of the vacuum defoaming tank 2 through a valve pipeline. The purpose of arranging the feed port 21 at the bottom of the vacuum defoaming tank 2 is to infiltrate the vacuum defoaming tank 2 from the bottom of the tank body, thereby avoiding the generation of a large number of bubbles that are inevitably caused by the vertical descent and injection of the liquid, and realizing the defoaming processing to the maximum extent from each process.

[0039] The filling mechanism 3 includes a lifting cylinder assembly 31 and a filling needle assembly 32. The filling needle assembly 32 is installed at the bottom of the vacuum defoaming tank 2 through the lifting cylinder assembly 31. The filling needle assembly 32 is connected to the bottom outlet 22 of the vacuum defoaming tank 2 through a valve pipeline. The lifting cylinder assembly 31 is a conventional telescopic cylinder assembly, which can drive the filling needle assembly 32 to achieve lifting movement. The filling needle assembly 32 is a conventional filling assembly, which has an extraction pump and a filling needle. The clindamycin phosphate vaginal gel inside the vacuum defoaming tank 2 is extracted to the filling needle by the extraction pump, and the filling needle injects the clindamycin phosphate vaginal gel into the packaging tank 7.

[0040] The vacuum defoaming tank 2 is a sealed tank, and the top of the sealed tank is connected to a vacuum pump through a valve pipeline. The vacuum pump can be a vacuum pump, etc. The vacuum defoaming tank 2 is allowed to stand and evacuate. Under the premise of not affecting the molecular components of the drug, the vacuum environment allows the bubbles remaining in the clindamycin phosphate vaginal gel to expand and float to the surface, thereby rupturing and releasing.

[0041] The rotary positioning mechanism 5 comprises a support frame 51, a slide 52, a rotating disk frame 53, a rotating motor 54 and a limiting arc plate 55. The slide 52 is fixedly mounted on the top of the support frame 51. The rotating motor 54 is fixedly mounted on the support frame 51, and the output end of the rotating motor 54 is fixedly connected to the center of the rotating disk frame 53 through a connecting shaft. A plurality of arc positioning grooves 56 are processed on the outer wall of the rotating disk frame 53. The plurality of arc positioning grooves 56 are arranged in a uniform circumferential array with the center of the rotating disk frame 53 as the center of the circle. The rotating disk frame 53 is located above the slide 52. The limiting arc plate 55 is fixedly mounted on the top of the support frame 51. It is fixedly installed on one side of the slide 52, and the limiting arc plate 55 and the center of the rotating disc frame 53 are coaxially arranged. The output end of the rotating motor 54 is vertically upward. The rotating motor 54 is started to drive the rotating disc frame 53 to rotate. The arc-shaped positioning groove 56 on the rotating disc frame 53 can be separately clamped on the side wall of each packaging can 7. When the rotating disc frame 53 rotates, the bottom of the packaging can 7 slides on the top of the slide 52. When passing directly under the filling mechanism 3, the rotating disc frame 53 stops rotating, so that the packaging can 7 is clamped between the limiting arc plate 55 and the arc-shaped positioning groove 56, so as to avoid the packaging can 7 from shaking during filling.

[0042] The conveying mechanism 4 includes a base bracket 41, a conveying belt mechanism 42 and a limit baffle 43. The conveying belt mechanism 42 is fixedly installed on the base bracket 41. The conveying belt mechanism 42 is arranged at the left and right end portions of the limit arc plate 55 in the rotation positioning mechanism 5. The limit baffles 43 are installed on both sides of the top of the conveying belt mechanism 42.

[0043] The conveyor belt mechanism 42 is a conventional belt conveyor, and the limit baffles 43 are arranged on the left and right sides of the top of the conveyor belt in the conveyor belt mechanism 42 through brackets, and do not contact it, in order to play a role in limiting and supporting the packaging can 7.

[0044] Specific implementation method 2: Combination Figure 1-Figure 5 The present embodiment is described. The method for preparing the clindamycin phosphate vaginal gel of the present embodiment is implemented by relying on the clindamycin phosphate vaginal gel preparation device described in the first embodiment, and comprises:

[0045] Step 1, inject a certain amount of distilled water into the preparation tank 1, and then weigh the prescribed amount of hydroxypropyl methylcellulose and gelatin and place them together in the preparation tank 1, and leave overnight until the solution is free of particles;

[0046] Step 2, dissolving the prescribed amount of sorbic acid in hot distilled water, adding clindamycin phosphate to dissolve when the solution temperature is lower than 40° C., and then injecting into the preparation tank 1 after overnight storage in step 1;

[0047] Step 3, starting the stirring motor 13, the stirring blade 12 in the preparation tank 1 rotates, and the liquid in the preparation tank 1 is mixed and stirred;

[0048] Step 4, adding glycerol and triethanolamine into the preparation tank 1, stirring the stirring blade 12 to continue mixing and stirring, adjusting the pH value to about 6.0, and then adding water to continue mixing and stirring to prepare the clindamycin phosphate vaginal gel;

[0049] Step 5, filling the clindamycin phosphate vaginal gel prepared in the preparation tank 1 into the vacuum defoaming tank 2 through the feed port 21 at the bottom of the vacuum defoaming tank 2;

[0050] Step 6, vacuumizing the internal gas of the vacuum defoaming tank 2 from the top thereof by a vacuuming mechanism, and then letting it stand, thereby achieving the defoaming step of the clindamycin phosphate vaginal gel;

[0051] Step 7, start the conveying mechanism 4 and the rotating positioning mechanism 5, and convey the packaging cans 7 in batches to the rotating positioning mechanism 5 through the conveying mechanism 4, and the rotating disk rack 53 of the rotating positioning mechanism 5 rotates, and each packaging can 7 is respectively clamped in each arc-shaped positioning groove 56, and the packaging can 7 is brought to the bottom of each filling needle assembly 32;

[0052] Step 8, start the filling mechanism 3, the conveying mechanism 4 and the rotating positioning mechanism 5 are suspended, the lifting cylinder assembly 31 drives the filling needle assembly 32 to move downward, so that the bottom of the filling needle assembly 32 is inserted into the bottom side of the corresponding packaging can 7, and then the lifting cylinder assembly 31 drives the filling needle assembly 32 to rise, and the filling needle assembly 32 evenly draws the clindamycin phosphate vaginal gel in the vacuum defoaming tank 2 into the packaging can 7;

[0053] Step 9, starting the conveying mechanism 4 and the rotating positioning mechanism 5, the rotating positioning mechanism 5 rotates, and the packaging can 7 filled with clindamycin phosphate vaginal gel is transported from the conveying mechanism 4 to the next process.

[0054] The clindamycin phosphate vaginal gel prepared by the preparation method of the clindamycin phosphate vaginal gel of this embodiment is tested for its product quality, and the key indicator inspection item "related substances" accounts for a lower proportion and is better. Through stability test observation, i.e., accelerated test for 6 months and long-term test for 12 months, the test results show that the product properties are better than other comparative prescriptions, the increase in the inspection item indicator "related substances" is lower than that of other prescriptions, and the decrease in the content of the main drug component is lower than that of other ingredient prescriptions.

[0055] Step 10, extracting the clindamycin phosphate vaginal gel in any packaging can 7 as a measurement sample, performing a linear test of clindamycin phosphate, and determining the clindamycin phosphate content by reverse phase high performance liquid chromatography, comprising:

[0056] Potassium dihydrogen phosphate and acetonitrile were selected as the mobile phase, and the composition ratio of potassium dihydrogen phosphate and acetonitrile was 86:36

[0057] The content of clindamycin phosphate in the sample was determined.

[0058] Set the following chromatographic conditions:

[0059] A Shimadzu 10AVP high-performance liquid chromatograph was used, in which the range value of the Alltech Apollo C18 column was set to 150 mm × 4·6 mm, 6 μm;

[0060] Add water to dissolve potassium dihydrogen phosphate, then use 85% phosphoric acid solution to adjust the pH value to 2.5 to make potassium dihydrogen phosphate solution, and then use this solution and acetonitrile as the mobile phase with a composition ratio of 745:265; the detection wavelength is 223nm; the flow rate is 1.2mL / min; the column temperature is 33°C.

[0061] Weigh clindamycin phosphate as a reference substance, add a certain amount into two different cups, dissolve it in water, dilute it, and shake it well.

[0062] Take 8 portions and inject them into the liquid chromatograph, and record the chromatogram and peak area;

[0063] A standard curve was made with peak area A versus concentration C, and the regression equation was obtained:

[0064] A=2121378·2C+491·1343r=0·9999The linear range is 0·058~0·39g / L.

[0065] By comparing the regression equation with the standard curve of clindamycin phosphate, it is determined whether the clindamycin phosphate content meets the standard value, thereby completing the preparation of clindamycin phosphate vaginal gel that meets the production standards.

[0066] It should be noted that in the above embodiments, as long as the technical solutions are not contradictory, they can be arranged and combined, and those skilled in the art can exhaust all possibilities based on the mathematical knowledge of arrangement and combination. Therefore, the present invention will no longer describe the technical solutions after arrangement and combination one by one, but it should be understood that the technical solutions after arrangement and combination have been disclosed by the present invention.

[0067] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A device for preparing clindamycin phosphate vaginal gel, characterized in that: The invention comprises a preparation tank (1), a vacuum defoaming tank (2), a filling mechanism (3), a conveying mechanism (4), a rotating positioning mechanism (5) and a frame (6); the preparation tank (1) is connected to a feed port (21) at the bottom of the vacuum defoaming tank (2) through a valve pipeline; the vacuum defoaming tank (2) is installed on the top of the frame (6); the filling mechanism (3) is installed at the bottom of the vacuum defoaming tank (2); the filling mechanism (3) is connected to the inside of the vacuum defoaming tank (2) through a valve pipeline; a rotating positioning mechanism (5) is arranged directly below the filling mechanism (3); The positioning mechanism (5) is connected to the conveying mechanism (4). After the preparation tank (1) has prepared the clindamycin phosphate vaginal gel, the preparation tank (1) is filled into the vacuum defoaming tank (2) through a feed port (21) at the bottom of the vacuum defoaming tank (2). The packaging tank (7) is transported to the rotating positioning mechanism (5) through the conveying mechanism (4). The filling mechanism (3) fills the clindamycin phosphate vaginal gel stored in the vacuum defoaming tank (2) into the packaging tank (7) on the rotating positioning mechanism (5), and then the clindamycin phosphate vaginal gel is transported to the next process through the conveying mechanism (4).

2. The clindamycin phosphate vaginal gel preparation device according to claim 1, characterized in that: The preparation tank (1) comprises a sealed tank body (11), a stirring blade (12) and a stirring motor (13); the sealed tank body (11) has a temperature-adjusting interlayer chamber (14); constant temperature circulating water (16) is injected into the temperature-adjusting interlayer chamber (14) through an inlet and outlet water pipeline (15); a stirring motor (13) is fixedly mounted on the top cover of the sealed tank body (11); the output end of the stirring motor (13) is connected to the stirring blade (12); the stirring blade (12) is placed inside the sealed tank body (11); a discharge port (17) is provided at the bottom of the sealed tank body (11); the discharge port (17) is communicated with a feed port (21) at the bottom of a vacuum defoaming tank (2) through a valve pipeline.

3. The clindamycin phosphate vaginal gel preparation device according to claim 2, characterized in that: The filling mechanism (3) comprises a lifting cylinder assembly (31) and a filling needle assembly (32); the filling needle assembly (32) is installed at the bottom of the vacuum defoaming tank (2) via the lifting cylinder assembly (31); and the filling needle assembly (32) is connected to the bottom outlet (22) of the vacuum defoaming tank (2) via a valve pipeline.

4. The device for preparing clindamycin phosphate vaginal gel according to claim 3, characterized in that: The vacuum defoaming tank (2) is a sealed tank, and the top of the sealed tank is connected to the vacuum pumping mechanism through a valve pipeline.

5. The device for preparing clindamycin phosphate vaginal gel according to claim 4, characterized in that: The rotary positioning mechanism (5) comprises a support frame (51), a slide table (52), a rotating disk frame (53), a rotating motor (54) and a limiting arc plate (55); the slide table (52) is fixedly mounted on the top of the support frame (51); the rotating motor (54) is fixedly mounted on the support frame (51); and the output end of the rotating motor (54) is fixedly connected to the center of the rotating disk frame (53) via a connecting shaft; a plurality of arc-shaped positioning grooves (56) are processed on the outer wall of the rotating disk frame (53); the plurality of arc-shaped positioning grooves (56) are arranged in a uniform circular array with the center of the rotating disk frame (53) as the center of the circle; the rotating disk frame (53) is located above the slide table (52); the limiting arc plate (55) is fixedly mounted on one side of the slide table (52); and the centers of the limiting arc plate (55) and the rotating disk frame (53) are coaxially arranged.

6. The device for preparing clindamycin phosphate vaginal gel according to claim 5, characterized in that: The conveying mechanism (4) comprises a base support (41), a conveying belt mechanism (42) and a limit baffle (43); the conveying belt mechanism (42) is fixedly mounted on the base support (41); the conveying belt mechanism (42) is arranged at the left and right end portions of a limit arc plate (55) in the rotation positioning mechanism (5); and the limit baffles (43) are mounted on both sides of the top of the conveying belt mechanism (42).

7. A method for preparing a clindamycin phosphate vaginal gel, which is realized by using the clindamycin phosphate vaginal gel preparation device according to claim 6, characterized in that: include: Step 1, inject a certain amount of distilled water into a preparation tank (1), then weigh hydroxypropyl methylcellulose and gelatin and place them together in the preparation tank (1) overnight until the solution is free of particles; Step 2, dissolving sorbic acid in hot distilled water, adding clindamycin phosphate to dissolve when the solution temperature is lower than 40° C., and then injecting into the preparation tank (1) after overnight storage in step 1; Step 3, starting the stirring motor (13), the stirring blade (12) in the preparation tank (1) rotates, and the liquid in the preparation tank (1) is mixed and stirred; Step 4, adding glycerol and triethanolamine into the preparation tank (1), stirring the mixture with the stirring blade (12) and then adding water to the mixture to prepare the clindamycin phosphate vaginal gel; Step 5, filling the clindamycin phosphate vaginal gel prepared in the preparation tank (1) into the vacuum defoaming tank (2) through the feed port (21) at the bottom of the vacuum defoaming tank (2); Step 6, vacuumizing the internal gas of the vacuum defoaming tank (2) from the top thereof by a vacuuming mechanism, and then letting the tank stand to achieve the defoaming step of the clindamycin phosphate vaginal gel; Step 7, start the conveying mechanism (4) and the rotating positioning mechanism (5), and convey the packaging cans (7) in batches to the rotating positioning mechanism (5) through the conveying mechanism (4), and the rotating disk rack (53) of the rotating positioning mechanism (5) rotates, and each packaging can (7) is respectively clamped in each arc-shaped positioning groove (56), and the packaging can (7) is brought to the bottom of each filling needle tube assembly (32); Step 8, the filling mechanism (3) is started, the conveying mechanism (4) and the rotation positioning mechanism (5) are suspended, the lifting cylinder assembly (31) drives the filling needle assembly (32) to move downward, so that the bottom of the filling needle assembly (32) is inserted into the bottom side of the corresponding packaging can (7), and then the lifting cylinder assembly (31) drives the filling needle assembly (32) to rise, and the filling needle assembly (32) evenly draws the clindamycin phosphate vaginal gel in the vacuum defoaming tank (2) into the packaging can (7); Step 9, starting the conveying mechanism (4) and the rotating positioning mechanism (5), the rotating positioning mechanism (5) rotates, and the packaging can (7) filled with clindamycin phosphate vaginal gel is transported from the conveying mechanism (4) to the next process.

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