Manual capsule filling assembly for lab-scale test stage

Abstract

The utility model discloses a manual capsule filling component for lab-scale test stage, which comprises a syringe, an injection push rod, a pressure gauge and a baffle plate, the bottom of the injection push rod is provided with a push rod bottom sheet, the push rod bottom sheet is matched with the inner diameter of the syringe, the injection push rod is pushed to connect powder between the push rod bottom sheet and the baffle plate for extrusion, and the baffle plate opens the syringe. And the materials enter the capsule body. The manual capsule filling assembly is simple in structure, easy to assemble and disassemble, high in filling efficiency, suitable for capsules of various sizes in the prior art and capsules of customized sizes, high in practicability and capable of easily obtaining data such as extrusion height and powder stress in the filling process so as to facilitate later reference, and therefore the manual capsule filling assembly can be used for filling capsules of various sizes and capsules of customized sizes. The manual capsule filling assembly provided by the utility model is particularly suitable for a small-scale test stage.

Description

Technical Field

[0001] The utility model relates to the technical field of pharmaceutical equipment, in particular to a manual capsule filling assembly for small-scale trials. Background Art

[0002] Oral solid preparations are still the most commonly used drug dosage forms due to their advantages such as good chemical stability, convenient transportation, mature production process, and low production cost. Common solid preparation forms mainly include tablets, capsules, granules, etc., among which capsules are widely used due to their relatively short R & D cycle. Many drugs need to be prepared into capsules for improvement and protection due to some characteristics such as irritating odor, poor taste, volatility, light sensitivity, and easy decomposition by saliva or gastric juice. In addition, some drugs need to be released at specific sites, such as sustained-release drugs and controlled-release drugs, and can also be formulated by selecting capsule shells of specific materials.

[0003] Hollow capsule shells generally present an elliptical barrel shape, formed by combining a capsule cap and a capsule body. Common materials are gelatin and HPMC (hydroxypropyl methylcellulose). Common models include 000, 00, 0, 0el, 1, 1el, 2, 2el, 3, 4, 5, and the most suitable capsule shell can also be customized according to the desired effect and target volume. Existing capsule filling equipment for R & D and production stages mainly includes micro-capsule filling machines, semi-automatic capsule filling machines, and fully automatic capsule filling machines. Micro-capsule filling machines are mainly suitable for filling low-content substances. Limited by the volume of the substances, and due to micro-filling, the equipment needs precise measurement, and the time and cost required are relatively high. The principle of semi-automatic capsule filling machines is through manual scraping and filling, material compaction / vibration compaction, and capsule locking. It is suitable for filling materials equal to or slightly larger than the capsule body. Generally, dozens to hundreds of capsules can be produced at a time, depending on the specific model of the instrument spare parts. Semi-automatic capsule filling machines are the most commonly used capsule filling equipment in the R & D stage. However, due to the limited filling volume range and manual scraping filling, it has high requirements for the operator's technique and is prone to the risk of uneven content in different parts; for materials with high viscosity and poor fluidity, it will also cause weight differences and reduce the yield. Fully automatic capsule filling machines are mainly suitable for process scale-up and production stages, generally after the prescription process is basically determined. Its advantages are relatively stable filling volume, fast speed, and large output; but its disadvantages are complex installation, long cleaning time, large dead volume of the machine, etc. Therefore, the required material batch is large and the loss is more, which is not suitable for small-scale R & D trials and brings many troubles to R & D workers in pharmaceutical enterprises. Summary of the Utility Model

[0004] The technical problem to be solved by the utility model is to provide a manual capsule filling assembly for small-scale trials, which is suitable for application in the small-scale R & D trial stage.

[0005] To solve the above technical problems, the manual capsule filling assembly for the pilot test stage provided by the present utility model includes:

[0006] An injection cylinder, the outer diameter of which is smaller than the inner diameter of the capsule body;

[0007] An injection push rod, at the bottom end of which a push rod bottom plate is installed, and the push rod bottom plate is matched with the injection cylinder;

[0008] A pressure gauge, which is installed on the injection push rod for testing the pressure of the injection push rod to extrude the material;

[0009] A baffle, which is installed on the injection cylinder for opening or closing the injection cylinder along the radial direction of the injection cylinder.

[0010] Preferably, the injection cylinder is provided with scales along its height direction.

[0011] Preferably, a funnel is provided at the top of the injection cylinder.

[0012] Preferably, the manual capsule filling assembly further includes a bracket, the bracket is installed with a snap ring, and the inner diameter of the snap ring is smaller than the outer diameter of the funnel mouth of the funnel;

[0013] The funnel is placed in the snap ring to install the injection cylinder on the bracket.

[0014] Preferably, the bracket is installed with a clamping portion for fixing the injection cylinder.

[0015] Preferably, the capsule body to be filled is placed below the injection cylinder through a capsule body base.

[0016] Preferably, the size of the baffle is greater than or equal to the inner diameter of the injection cylinder.

[0017] Preferably, the push rod bottom plate is threadedly connected to the injection push rod.

[0018] The present utility model provides a manual capsule filling assembly, which has a simple structure, is easy to assemble and disassemble, has high filling efficiency, can be suitable for capsules of various sizes in the prior art, and is applicable to capsules of customized sizes, has strong practicability, and can easily obtain data such as extrusion height and powder force during the filling process for later reference. Therefore, the manual capsule filling assembly provided by the present utility model is particularly suitable for the pilot test stage. Description of the Drawings

[0019] To more clearly illustrate the technical solution of the present utility model, the following briefly introduces the drawings required for the present utility model. Obviously, the drawings in the following description are only some embodiments of the present utility model. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0020] Figure 1 It is a schematic diagram of an embodiment of the manual capsule filling assembly of the present utility model;

[0021] Figure 2 It is a schematic diagram of a semi-circular groove opened circumferentially on the barrel wall of the syringe of an embodiment of the manual capsule filling assembly of the present utility model;

[0022] Figure 3 is the same as Figure 2 The schematic diagram of the shape of the baffle matching the semi-circular groove;

[0023] Figure 4 It is a schematic diagram of a circular groove opened circumferentially on the barrel wall of the syringe of an embodiment of the manual capsule filling assembly of the present utility model;

[0024] Figure 5 is the same as Figure 4 The schematic diagram of the shape of the baffle matching the circular groove;

[0025] In the figure, 1 - syringe; 11 - funnel; 12 - baffle slide; 2 - injection push rod; 21 - push rod bottom plate; 3 - pressure gauge; 4 - baffle; 41 - round hole; 5 - bracket; 51 - snap ring; 52 - clamping part; 6 - capsule body; 7 - capsule body base. Detailed implementation manners

[0026] The following will clearly and completely describe the technical solutions in the present utility model in conjunction with the drawings. Obviously, the described embodiments are part of the embodiments of the present utility model, rather than all embodiments. Based on the embodiments in the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present utility model.

[0027] Refer to Figure 1 , which shows a manual capsule filling assembly for the pilot scale stage of the present utility model, including:

[0028] A syringe, the outer diameter of which is smaller than the inner diameter of the capsule body;

[0029] An injection push rod, a push rod bottom plate is installed at the bottom end thereof, and the push rod bottom plate is matched with the syringe;

[0030] A pressure gauge, which is installed on the injection push rod for testing the pressure of the injection push rod to extrude the material;

[0031] A baffle plate, which is installed on the syringe barrel for opening or closing the syringe barrel in the radial direction of the syringe barrel.

[0032] In the present utility model, the outer diameter of the syringe barrel is smaller than (generally slightly smaller is sufficient) the inner diameter of the capsule body so that when the powder material is injected into the capsule body, the syringe barrel is located inside the capsule body, effectively preventing the powder material from scattering outside the capsule body, resulting in material waste and insufficient material in the capsule body. The diameter or size of the injection push rod is smaller than the inner diameter of the syringe barrel so that the injection push rod can move freely inside the syringe barrel. It pushes the bottom plate of the push rod to move along the axial direction of the syringe barrel. The matching of the bottom plate of the push rod and the syringe barrel means that the outer diameter of the bottom plate of the push rod matches the inner diameter of the syringe barrel, for example, they are equal or the diameter of the bottom plate of the push rod is slightly larger than the inner diameter of the syringe barrel, so that when the bottom plate of the push rod moves along the axial direction of the syringe barrel, the edge of the bottom plate of the push rod and the inner wall of the syringe barrel are always in a sealed state, preventing the powder material below the bottom plate of the push rod from overflowing; the function of the baffle plate is to open or close the syringe barrel to control the powder material from entering the capsule body, and also plays a role in squeezing the powder material together with the injection push rod and the bottom plate of the push rod. Generally speaking, when adding powder material into the syringe barrel, the baffle plate closes (seals) the syringe barrel. After adding, the installed injection push rod and the bottom plate of the push rod enter the syringe barrel from the top of the syringe barrel, push the injection push rod, and squeeze the powder material located between the baffle plate and the bottom plate of the push rod, while paying attention to the pressure value of the pressure gauge; after extrusion, move the baffle plate to make the syringe barrel in an open state, and the powder column formed by the extruded powder material falls into the capsule body. It should be noted that the pressure gauge is used to detect the force on the extruded powder, for example, it can be composed of a pressure sensor and a display screen signal-connected thereto. The pressure sensor can be installed on the syringe barrel wall or on the side where the bottom plate of the push rod contacts the powder, etc. Testing the force on the powder by using the pressure gauge can be achieved through the prior art, so it will not be elaborated here.

[0033] In a specific embodiment, the syringe barrel is provided with scales along its height direction. Understandably, the scale lines can display the height of the extruded powder in real time, make records, and combined with the real-time pressure value displayed (and recorded) in real time, these data will be of great help for the later process of scale-up production.

[0034] In a specific embodiment, a funnel is provided at the top of the syringe barrel. Understandably, due to the limited inner diameter of the syringe barrel, when adding powder material into it, there may be a risk of scattering outside the syringe barrel. Therefore, setting a funnel at its top or setting its top in the shape of a funnel can effectively avoid the scattering of the powder material and affect the accuracy of the added material (generally added after weighing. After scattering outside, the added amount will be less than the target amount).

[0035] In a specific embodiment, the manual capsule filling assembly further comprises a bracket, the bracket is provided with a snap ring, the inner diameter of the snap ring is smaller than the outer diameter of the funnel mouth of the funnel; the funnel is placed on the snap ring to install the syringe on the bracket. Understandably, in order to facilitate operation, a bracket and a snap ring are added, the height of the bracket is usually higher than the length of the syringe, and when the syringe is installed (suspended) on the bracket, it is convenient to place the capsule base and the capsule body at the bottom of the syringe; it should be noted that the snap ring can be moved along the height direction of the bracket to adjust the height relationship between the syringe and the capsule body, and the preferred height relationship is the distance from the bottom end of the syringe to the capsule body (the capsule body is fixed by the capsule body base) located below it, so that there is a better sealing between the two to prevent leakage of materials; the snap ring is usually in a horizontal direction, and the distance between it and the bracket is preferably adjustable. The bracket and the snap ring can generally adopt general chemical experimental instruments in the prior art, so they will not be repeated here.

[0036] In a specific embodiment, the bracket is equipped with a clamping part for fixing the syringe. Understandably, since the syringe is preferably in a fixed state during the extrusion of the powder, and it is difficult to fix the syringe by a clamping ring, it is preferred to add a clamping part, which fixes and clamps the syringe to ensure that the syringe is in a stable state during the extrusion of the powder material; the position where the clamping part clamps the syringe can preferably be made of hard rubber or silicone to prevent damage to the syringe, and the clamping part can be fixed to the bracket by means of threaded fastening.

[0037] In a specific embodiment, the syringe is provided with a baffle slide between its outlet and the scale line or at the beginning of the scale line (e.g., the 0 scale line) so that the baffle slides in the baffle slide to open or close the syringe. The baffle slide can be, for example, a semicircular groove opened in the circumferential direction of the syringe wall, such as Figure 2 As shown, a groove is opened along half of the circumference of the syringe barrel wall (that is, half of the circumference of the syringe barrel is in a truncated state, and the truncation height is equal to or slightly higher than the thickness of the baffle), and the baffle enters the inside of the syringe barrel from the outside at the groove. In this case, the baffle (such as Figure 3 The portion of the syringe that enters the syringe is matched with the inner wall of the syringe, and the edge of the baffle contacts the inner wall of the syringe to close the syringe. Preferably, a shallow groove is provided on the inner wall of the syringe at the contact position between the baffle and the inner part to cooperate with the baffle, thereby increasing the sealing performance between the baffle and the inner wall of the syringe; the baffle sliding mouth can also, for example, open a circular groove along the circumference of the syringe, such as Figure 4 and Figure 5As shown, that is, the syringe barrel is integrally cut off circumferentially, and the height of the cut-off is equal to or slightly higher than the thickness of the baffle. However, the outer walls at both ends in a diameter direction are in an uncut connection state so that the upper and lower parts of the syringe barrel located above and below the groove are connected. Preferably, the outer wall at the connection part bulges outwards to make the connection firmer. In this case, the baffle can be of any shape (preferably a rectangle as shown in Figure 5 ), and the width is equal to or slightly smaller than the distance between the connection parts of the outer wall of the syringe barrel). Moving the baffle, the perforated part is used to open the syringe barrel, and the unperforated part is used to close the syringe barrel. Without wishing to be bound by this, any method in the prior art that can radially open or close the syringe barrel can be applied to the present invention.

[0038] In a specific embodiment, the bottom plate of the push rod is threadedly connected to the injection push rod.

[0039] The filling process of the manual capsule filling assembly of the present invention is generally as follows: According to the model of the target capsule, select a suitable syringe barrel, bottom plate of the push rod, baffle and capsule body base and assemble them. At this time, the baffle blocks the syringe barrel, that is, the syringe barrel is in a closed state, and is placed (or fixed) on the bracket. Place the capsule body base with the capsule body on the lower part of the syringe barrel, and insert the bottom end of the syringe barrel into the capsule body for a short distance (such as 1mm, 2mm, 3mm, 4mm, etc.); after accurately weighing the powder material, take out the injection push rod and the bottom plate of the push rod, pour the powder material into the syringe barrel, then put in the injection push rod and the bottom plate of the push rod, push the injection push rod, and the bottom plate of the push rod and the baffle squeeze the powder material, record the pressure value and the height value. After the extrusion is completed, slide the baffle to open the syringe barrel, push the injection push rod, and the bottom plate of the push rod pushes the powder column into the capsule body. After removing the syringe barrel from the capsule body, put on the capsule cap and manually lock the capsule.

[0040] By providing a manual capsule filling assembly, the present invention has a simple structure, is easy to assemble and disassemble, has high filling efficiency, can be suitable for capsules of various sizes in the prior art, and is applicable to customized-sized capsules, has strong practicability, and can easily obtain data such as extrusion height and powder force during the filling process for later reference. Therefore, the manual capsule filling assembly provided by the present invention is particularly suitable for the small-scale test stage.

[0041] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A manual capsule filling assembly for a pilot test, characterized in that: include: The syringe barrel has an outer diameter smaller than the inner diameter of the capsule body; An injection push rod, a push rod bottom plate is installed at the bottom end of which, and the push rod bottom plate matches the injection barrel; A pressure gauge, which is installed on the injection push rod and is used to test the pressure of the material extruded by the injection push rod; A baffle is mounted on the injection cylinder to open or close the injection cylinder in a radial direction of the injection cylinder.

2. The manual capsule filling assembly for the pilot stage as claimed in claim 1, characterized in that: The injection cylinder is provided with scales along its height direction.

3. The manual capsule filling assembly for the pilot stage as claimed in claim 1, characterized in that: A funnel is arranged on the top of the syringe.

4. The manual capsule filling assembly for the pilot stage as claimed in claim 3, characterized in that: The manual capsule filling assembly further comprises a bracket, the bracket is provided with a clamping ring, the inner diameter of the clamping ring is smaller than the outer diameter of the funnel opening of the funnel; The funnel is placed on the retaining ring to mount the syringe to the bracket.

5. The manual capsule filling assembly for the pilot stage as claimed in claim 4, characterized in that: The bracket is equipped with a clamping portion for fixing the syringe.

6. The manual capsule filling assembly for pilot stage according to claim 1, characterized in that: The capsule body to be filled is placed at a lower position of the injection cylinder through the capsule body base.

7. The manual capsule filling assembly for the pilot stage as claimed in claim 2, characterized in that: The injection cylinder is provided with a baffle sliding opening between its outlet and the scale line or at the beginning of the scale line so that the baffle can slide in the baffle sliding opening to open or close the injection cylinder.

8. The manual capsule filling assembly for pilot testing as claimed in claim 1, characterized in that: The push rod bottom plate is threadedly connected to the injection push rod.

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