A manufacturing device for pharmaceutical excipients

Abstract

The invention discloses a manufacturing equipment for pharmaceutical excipients, which is mainly used for preparing pharmaceutical excipients stearic acid and cetostearyl alcohol; it includes a raw material tank, a delivery pump, a cooling tower, a separator, a fan and a cooler; the air outlet at the top of the cooling tower is connected to the fan through a separator, and the fan is connected to the lower air inlet of the cooling tower through a cooler to form an air circulation; a discharge port is provided at the bottom of the cooling tower; a nozzle is installed inside the cooling tower through a pipeline, and the nozzle is connected to the raw material tank through a delivery pump. The material formula of the manufacturing process of the equipment product of the invention is continuously adjustable, and no pre-batch is required; the production process is highly safe, and there is basically no fine powder in the separator before the fan.

Description

Technical Field

[0001] The invention relates to a manufacturing device for pharmaceutical excipients, and is particularly suitable for the preparation of small granular stearic acid and cetostearyl alcohol. Background Art

[0002] Small-granular medicinal cetostearyl alcohol has a large specific surface area and is easy to mix evenly with other materials, so it is widely used in the pharmaceutical industry. At present, the production process of medicinal-grade cetostearyl alcohol is mainly to melt and mix cetostearyl alcohol in a certain proportion according to the formula, and then cool it through a granulator to make products in the shape of small beads, hemispherical balls or sheets. This process has four major disadvantages. First, the mixing of two different materials will lower the solidification point, causing the products to easily stick together in summer, especially for small granular products. Second, in order to prevent the materials from sticking together, the particle size can be increased, but large particles are not easy to solidify, or the particle cooling effect is poor and the product temperature is high, and additional equipment is required for deep cooling, and large particles affect the use effect. Third, the material ratio mixing operation is complicated; Fourth, the product size distribution is uneven, and it is easy to cause safety problems and agglomeration problems if there are more fine powder products.

[0003] There are three types of medicinal stearic acid products, namely stearic acid 50 (stearic acid content of 40-60%), stearic acid 70 (stearic acid content of 60-80%) and stearic acid 95. Currently, they need to be mixed evenly before production. There are also various disadvantages. First, the solidification point is lowered; second, the pre-batch operation and product switching are easy to mix; third, the fine powder of the product has many particles and unevenly adheres to the tower wall, which has high maintenance costs and is very likely to cause dust explosions and other safety issues. Summary of the invention

[0004] The purpose of the present invention is to address the defects of current manufacturing processes and manufacturing equipment, and to propose a manufacturing equipment for pharmaceutical excipients, which is particularly suitable for the preparation of small granular stearic acid and cetostearyl alcohol, to obtain small granular products with high true sphericity, with a product diameter of 0.05-0.3mm, and the product is not easy to melt and clump in summer. The material ratio is automatic and can be operated continuously.

[0005] The technical solution adopted by the present invention is:

[0006] A manufacturing device for pharmaceutical excipients comprises a raw material tank, a delivery pump, a cooling tower, a separator, a fan and a cooler; the air outlet at the top of the cooling tower is connected to the fan through a separator, and the fan is connected to the lower air inlet of the cooling tower through the cooler to form an air circulation; a discharge port is provided at the bottom of the cooling tower; a nozzle is installed inside the cooling tower through a pipeline, and the nozzle is connected to the raw material tank through a delivery pump.

[0007] The raw material tank, the delivery pump and the nozzle constitute a set of feeding and granulation systems, and the manufacturing equipment comprises at least two sets of feeding and granulation systems. For example, when producing cetostearyl alcohol, one set quantitatively delivers cetostearyl alcohol for cetostearyl alcohol granulation, and the other set quantitatively delivers octadecanol for octadecanol granulation. By changing the flow rates of cetostearyl alcohol and octadecanol, compounding in different proportions can be performed.

[0008] The nozzle structure comprises an upper cavity and a lower cavity, wherein the upper cavity and the lower cavity are connected by screws; a feed hole is arranged on the upper cavity; and a filter screen, a filler, a distribution orifice plate and a discharge orifice plate are sequentially stacked in the lower cavity.

[0009] The discharge orifice plate is provided with many small holes with a hole diameter of 0.05-0.2 mm; the distribution orifice plate is also provided with many small holes with a hole diameter of 0.3-1.0 mm; the filter screen is a wire screen with a mesh size of 100-500.

[0010] During the operation of the manufacturing equipment of the present invention, the temperature of the circulating air is maintained at 5-40°.

[0011] After adopting the above technical solution, the beneficial effects of the present invention are:

[0012] 1. The product is a single-component solid mixture with high sphericity and uniform distribution of small particles. The diameter is 0.05-0.3mm. The product does not clump and stick together, and the small particle material can be homogenized quickly.

[0013] 2. Due to the extremely fast cooling speed, the product particles have a better crystal structure and the product has a white crystal structure.

[0014] 3. The material formula of the product manufacturing process is continuously adjustable and does not require pre-batch; the production process is highly safe and there is basically no fine powder in the separator before the fan. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a connection diagram of the device in Example 2 of the present invention;

[0016] Figure 2 It is a structural schematic diagram of the nozzle of the present invention.

[0017] In the figure: 1. Hexadecanol raw material tank; 2. Delivery pump 1; 3. Nozzle 1; 4. Octadecanol raw material tank; 5. Delivery pump 2; 6. Nozzle 2; 7. Cooling tower; 8. Discharge port; 9. Cooler; 10. Fan; 11. Separator; 31. Feed hole; 32. Discharge orifice plate; 33. Upper cavity; 34. Lower cavity; 35. Screws; 36. Filter screen; 37. Filler; 38. Distribution orifice plate; 39. Sealing gasket. DETAILED DESCRIPTION

[0018] The present invention will be further described below in conjunction with the accompanying drawings.

[0019] Example 1

[0020] A pharmaceutical excipient manufacturing device is mainly used for preparing pharmaceutical excipients stearic acid and cetostearyl alcohol; it comprises a raw material tank, a delivery pump, a cooling tower 7, a separator 11, a fan 10 and a cooler 9; the air outlet at the top of the cooling tower 7 is connected to the fan 10 through the separator 11, and the fan 10 is connected to the lower air inlet of the cooling tower 7 through the cooler 9 to form an air circulation; a discharge port 8 is provided at the bottom of the cooling tower; a nozzle is installed inside the cooling tower 7 through a pipeline, and the nozzle is connected to the raw material tank through the delivery pump.

[0021] The raw materials in the raw material tank are transported to the cooling tower 7 through the nozzle, dispersed into droplets and fall down; the cooling air is introduced from the lower air inlet of the cooling tower 7, discharged from the top air outlet, and then passes through the separator 11 to the fan 10, forming a cycle. The falling raw material droplets immediately solidify into solid particles when they come into countercurrent contact with the cold air, and fall down. They continue to cool during the falling process. The small particle products are sieved and packaged at the bottom discharge port 8 of the cooling tower 7, while a very small amount of fine powder is brought to the separator 11 by the cold air for separation.

[0022] The nozzle structure in the manufacturing equipment of the present invention includes an upper cavity 33 and a lower cavity 34, which are connected by screws 35; a feed hole 31 is provided on the upper cavity 33; a filter screen 36, a filler 37, a distribution orifice plate 38 and a discharge orifice plate 32 are stacked in sequence in the lower cavity 34. The discharge orifice plate 32 is provided with many small holes with a hole diameter of 0.05-0.2mm; the distribution orifice plate 38 is also provided with many small holes with a hole diameter of 0.3-1.0mm; the filter screen 36 is a wire mesh of 100-500 meshes.

[0023] Example 2

[0024] The equipment described in Example 1 was used to prepare small particles of cetostearyl alcohol, a pharmaceutical excipient. The details are shown in Table 1 below:

[0025] Table 1

[0026]

[0027] Example 3

[0028] The equipment described in Example 1 was used to prepare small stearic acid particles. The details are shown in Table 1 below:

[0029] Table 2

[0030]

Claims

1. A manufacturing device for pharmaceutical excipients, characterized in that: It includes a raw material tank, a conveying pump, a cooling tower, a separator, a fan and a cooler; the air outlet at the top of the cooling tower is connected to the fan through a separator, and the fan is connected to the lower air inlet of the cooling tower through a cooler to form an air circulation; a discharge port is provided at the bottom of the cooling tower; a nozzle is installed inside the cooling tower through a pipeline, and the nozzle is connected to the raw material tank through a conveying pump; the raw material tank, the conveying pump and the nozzle constitute a group of feed particle spraying systems, and the manufacturing equipment includes at least two sets of feed particle spraying systems; the nozzle structure includes an upper cavity and a lower cavity, and the upper cavity and the lower cavity are connected by screws; a feed hole is provided on the upper cavity; a filter screen, a filler, a distribution orifice plate and a discharge orifice plate are stacked in sequence in the lower cavity.

2. The manufacturing equipment of a pharmaceutical excipient according to claim 1, characterized in that: The discharge orifice plate is provided with many small holes with a hole diameter of 0.05-0.2 mm; the distribution orifice plate is also provided with many small holes with a hole diameter of 0.3-1.0 mm; the filter screen is a wire screen with a mesh size of 100-500.

3. The manufacturing equipment of a pharmaceutical excipient according to claim 1, characterized in that: The circulating air temperature is maintained at 5-40℃.

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