Settling basket

Abstract

The utility model belongs to the technical field of dissolution test articles, and provides a settling basket which comprises a top end, a bottom end and side reinforcing ribs for connecting the top end and the bottom end, the side reinforcing ribs are arc-shaped; the arc-shaped protruding parts of the side reinforcing ribs form the cross section of the middle end. The cross section of the top end and the cross section of the bottom end are smaller than the cross section of the middle end. The settling basket provided by the utility model can overcome the defect of viscous pharmaceutical preparations, solves the problem of large variation of dissolution results of the viscous pharmaceutical preparations, and solves the problem of large variation of the dissolution results caused by non-uniform flushing force of the paddles among preparation units due to the rotation of the pharmaceutical preparations along with the paddles.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the technical field of dissolution test supplies, and the utility model provides a sedimentation basket. BACKGROUND

[0002] At present, in vitro dissolution experiment is considered to be able to estimate in vivo dissolution behavior and absorption, but the human body environment is complex, and similar in vitro dissolution behavior between preparations can easily cause in vivo BE non-equivalence, which hinders enterprise research and development progress and also brings economic burden. The conventional dissolution mode has a basket method or a slurry method, and dissolution inspection as a quality means for drug in vitro control, the accuracy of the detection process is particularly important for drug preparation quality control.

[0003] The basket method in Chinese Pharmacopoeia and US Pharmacopoeia is a commonly used method for detecting the dissolution rate of drug preparations. For such large variation drug preparations as enteric-coated tablets and coated tablets, due to the difference in drug administration position during in vitro dissolution process, it leads to large dissolution deviation, and the coating on the outer layer of coated tablets and enteric-coated tablets becomes sticky during the dissolution process, which is easy to adhere to a certain part of the rotating basket, resulting in large changes in dissolution results, and the relative standard deviation cannot meet the requirements of sample tablet dissolution test, thereby making it difficult to develop a dissolution method.

[0004] The prior art CN213121860 U uses a built-in sedimentation basket combined with a rotating basket to significantly reduce the problems of uneven dissolution and poor dissolution parallelism of sticky capsules and other solid preparations during the dissolution process. The use of the patented device can realize the quality detection and control of sticky solid preparations (especially capsules), and is suitable for capsule preparations that are easy to stick during the dissolution process, especially for the dissolution rate detection of pellet capsule preparations, and particularly for the dissolution rate detection of Pamiparib pellet capsule preparations. However, the device has certain limitations in actual application due to the excessively dense structure design, which is not conducive to the development of in vitro dissolution method of coated tablets and enteric-coated tablets. UTILITY MODEL CONTENT

[0005] In order to solve the defects in the prior art, the utility model provides a sedimentation basket, which reduces the side reinforcing ribs and changes the shape of the reinforcing ribs to accurately position the drug during the dissolution process and stabilize the water flow dynamics, thereby reducing the influence of dissolution variation of anisotropic tablets (such as coated tablets or enteric-coated tablets) and solid dosage forms with high stickiness during the dissolution process, and ensuring the stability of the flushing force of the tablets during the dissolution process.

[0006] Specifically, the utility model is realized through the following technical solutions:

[0007] In one aspect, the utility model provides a sedimentation basket, which comprises a top end, a bottom end and a side reinforcing rib connecting the two.

[0008] The side reinforcing ribs are arc-shaped; the arc-shaped convex part of the side reinforcing ribs forms the cross section of the middle end;

[0009] The cross sections of the top end and the bottom end are both smaller than the cross section of the middle end.

[0010] Further, the angle of the arc shape of the side reinforcing ribs is 1-180°, preferably 5-90°.

[0011] Further, the ratio of the cross sectional areas of the top end and the bottom end is 1:0.5-1.5, preferably 1:1.

[0012] Further, the cross sectional area of the middle end is 1.1-2 times, preferably 1.1-1.5 times, the cross sectional area of the top end or the bottom end. The size of the cross sectional area of the top end or the bottom end is determined.

[0013] Further, the side reinforcing ribs are 3-6, preferably 3-4, in order to sufficiently reduce the influence on the dynamics of the water flow.

[0014] Further, the side reinforcing ribs are uniformly arranged.

[0015] Further, the cross sectional shapes of the top end, the middle end and the bottom end are both circular or elliptical. Further, the diameter of the cross section of the top end is 5-15 mm; the diameter of the cross section of the middle end is 10-20 mm. Further, the distance between the top end and the bottom end is 5-25 mm.

[0016] Further, a middle reinforcing rib is arranged at the middle end for supporting the side reinforcing ribs.

[0017] Further, all the structures of the settling basket are made of metal or non-metal materials, preferably made of stainless steel materials, for example made of stainless steel nickel-plated materials.

[0018] Further, each part of the settling basket is made of corrosion-resistant materials, and each part is made after welding.

[0019] Further, a first cross-linking structure is arranged in the cross section of the bottom end, for example a "*", "#", "+" "U", "^", "\", "~" "-", "=" and the like structure.

[0020] Further, the middle reinforcing rib is selectively absent or arc-shaped, circular or elliptical.

[0021] Further, the top end is provided with a second cross-linking structure in the cross section, such as "*", "#", "+" "U", "^", "\", "~" "-", "=" and the like; and when the middle reinforcing rib is arc-shaped, the middle end is further provided with a buckle structure fixed by a hinge.

[0022] Further, the buckle structure comprises a ring-shaped component sleeved on the first side reinforcing rib, an arc-shaped component connected with the ring-shaped component, a line segment component connected with the arc-shaped component, and an arc-shaped buckle connected by the line segment component. Figure 1-2 In particular, the ring-shaped component of the buckle structure is arranged at the middle of the two middle reinforcing ribs connected with the first side reinforcing rib, and the arc-shaped buckle is just buckled with the second side reinforcing rib, so as to facilitate closing and locking the sedimentation basket by the buckle mode, and facilitating drug delivery. When the middle reinforcing rib is arc-shaped, the angle of the arc-shaped middle reinforcing rib can be determined according to the number of the side reinforcing ribs, and when the side reinforcing rib is four, the angle of the arc-shaped middle reinforcing rib is 270°; the angle of the arc-shaped component of the buckle structure is 90°, and so on.

[0023] Further, when the middle reinforcing rib is absent or circular or elliptical, the top end is provided with a buckle structure fixed by a hinge.

[0024] Further, the buckle structure comprises a ring-shaped component sleeved on the top end, an arc-shaped component connected with the ring-shaped component, a line segment component connected with the arc-shaped component, and an arc-shaped buckle connected by the line segment component. Figure 3-5 In particular, the ring-shaped component of the buckle structure is arranged at the middle of the two side reinforcing ribs connected with the top end, and the arc-shaped buckle is just buckled with the cross-sectional shape of the top end, so as to facilitate closing and locking the sedimentation basket by the buckle mode, and facilitating drug delivery.

[0025] Compared with the prior art, the utility model has the following beneficial effects:

[0026] (1) The sedimentation basket can overcome the problem of large variation of dissolution results of viscous drug preparations, and can make the relative standard deviation of dissolution results meet the requirements of sample dissolution test.

[0027] (2) The sedimentation basket has simple structure and appropriate size, can ensure accurate drug delivery position each time, balance the scouring force in the dissolution process, reduce the influence of dissolution caused by uneven force on tablets, and solve the problem of large variation of dissolution results caused by uneven scouring force of paddle on each unit of drug preparation.

[0028] (3) The sedimentation basket has simple structure, can ensure the stability of water flow dynamics in the dissolution process, and has small variation of dissolution results. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 The structure diagram of the settling basket opening in the product embodiment 1 is shown.

[0030] Figure 2 The structure diagram of the settling basket closing in the product embodiment 1 is shown.

[0031] Figure 3 The structure diagram of the settling basket closing in the product embodiment 2 is shown.

[0032] Figure 4 The structure diagram of the settling basket closing in the product embodiment 2 is shown.

[0033] Figure 5 The structure diagram of the settling basket closing in the product embodiment 3 is shown.

[0034] Figure 6 The dissolution result diagram of application example 2. DETAILED DESCRIPTION

[0035] The utility model will be further explained below by referring to specific examples. It should be understood that the specific examples described herein are only used to explain the utility model, and are not used to limit the scope of the utility model.

[0036] The specific technology or condition is not marked in the examples, and is carried out according to the technology or condition described in the literature in the field, or according to the product manual. The reagent or instrument used is not marked by the manufacturer, and is a conventional product that can be purchased through a regular channel.

[0037] The experimental method in the following examples is a conventional method, unless otherwise specified. The test materials used in the following examples are commercially available products, unless otherwise specified.

[0038] Product Example 1

[0039] For example, Figure 1-2As shown, this utility model provides a settling basket, including a top end 1, a bottom end 3, and side reinforcing ribs 5 connecting the two; the side reinforcing ribs 5 are arc-shaped; the arc-shaped protruding portion of the side reinforcing ribs 5 forms the cross-section of the middle end; the cross-sections of the top end 1 and the bottom end 3 are both smaller than the cross-section of the middle end; the cross-sectional areas of the top end 1 and the bottom end 3 are both smaller than the cross-sectional area of ​​the middle end; the ratio of the cross-sectional areas of the top end 1 and the bottom end 3 is 1:1; the cross-sectional area of ​​the middle end is 1.1 to 1.5 times that of the cross-sectional area of ​​the top end 1 or the bottom end 3. Specifically, it depends on the size of the cross-sectional area of ​​the top end 1 or the bottom end 3. In some embodiments, the diameter of the cross-sections of the top end 1 and the bottom end 3 is 10 mm; the diameter of the cross-section of the middle end is 15 mm. Further, the distance between the top end 1 and the bottom end 3 is 20 mm. As shown in the figure, the settling basket provided by this utility model is irregularly shaped, divided by the middle end, with both the upper and lower parts being frustum structures.

[0040] The side reinforcing rib 5 is arc-shaped, and the arc angle can be from 5 to 75°, which can be adjusted freely; there are 3 to 6 side reinforcing ribs 5, preferably 3 to 4, in order to fully reduce the dynamic impact on the water flow; the side reinforcing ribs 5 are evenly distributed.

[0041] A first cross-linked structure 6 is provided in the cross-section of the top end 1, and a second cross-linked structure 11 is provided in the cross-section of the bottom end 3, such as structures resembling "*", "#", "+", "U", "^", "\", "~", "-", "=", etc. Figure 1-2 In the middle, all are “=" shaped structures, striving for simplicity at the top 1 and bottom 3, so as to ensure accurate drug dosing while reducing the impact of the structure on water flow.

[0042] The top, middle, and bottom ends 1 and 3 are all circular or elliptical in cross-sectional shape. A central reinforcing rib 10 is provided at the middle end to support the side reinforcing ribs 5.

[0043] exist Figure 1-2 In the middle section, the central reinforcing rib 10 is arc-shaped, and the middle end is also provided with a hinged fastening structure; the fastening structure includes an annular component 9 sleeved on the first side reinforcing rib 12, an arc-shaped component 4 connecting the annular component 9, a line segment component 8 connected to the arc-shaped component 4, and an arc-shaped clip 7 connected through the line segment component 8. Figure 1-2 In this design, the annular component 9 of the snap-fit ​​structure is positioned between the two central reinforcing ribs 10 and the first side reinforcing rib 12, and the arc-shaped snap-fit ​​component 7 engages precisely with the second side reinforcing rib 2, facilitating the closure and locking of the settling basket via a snap-fit ​​mechanism, which is beneficial for drug delivery. When the central reinforcing rib 10 is arc-shaped, the angle of the arc can be determined based on the number of side reinforcing ribs 5. When there are four side reinforcing ribs 5, the angle of the arc of the central reinforcing rib 10 is 270°; the arc-shaped component 4 of the snap-fit ​​structure is 90°, and so on.

[0044] The structure of the sink basket is made of metal or non-metal material, preferably stainless steel material, such as stainless steel nickel-plated material.

[0045] The parts of the sink basket are made of corrosion-resistant material, and are made by welding.

[0046] Product Example 2

[0047] The difference from Product Example 1 is that, The middle reinforcing rib 10 is circular or elliptical, and the cross section of the top end 1 is provided with a buckle structure fixed by a hinge; the buckle structure includes a ring-shaped component 9 sleeved on the top end 1, an arc-shaped component connected with the ring-shaped component 9, a line segment component connected with the arc-shaped component, and an arc-shaped buckle 7 connected by the line segment component. Figure 3-4 In some embodiments, the diameters of the cross sections of the top end 1 and the bottom end 3 are both 10 mm; the diameter of the cross section of the middle end is 15 mm. Further, the distance between the top end 1 and the bottom end 3 is 25 mm.

[0048] Product Example 3

[0049] The difference from Product Example 1 is that, The middle reinforcing rib 10 is circular or elliptical, and the cross section of the top end 1 is provided with a buckle structure fixed by a hinge; the buckle structure includes a ring-shaped component 9 sleeved on the top end 1, an arc-shaped component connected with the ring-shaped component 9, a line segment component connected with the arc-shaped component, and an arc-shaped buckle 7 connected by the line segment component. Figure 5 In some embodiments, the diameters of the cross sections of the top end 1 and the bottom end 3 are both 10 mm; the diameter of the cross section of the middle end is 15 mm. Further, the distance between the top end 1 and the bottom end 3 is 25 mm.

[0050] Application Example 1

[0051] I. Experimental purpose: The dissolution curve of mesalazine enteric-coated tablets (No. X230701 0 days) in pH 6.8 medium

[0052] Line determination.

[0053] II. Experimental basis: "Technical Guidelines for Dissolution Test of Ordinary Oral Solid Preparations"

[0054] III. Dissolution parameters are as follows Table 1

[0055] Dissolution medium 0.1 mol / L hydrochloric acid solution / pH 6.8 phosphate solution Apparatus and rotation speed Paddle method 100 rpm Medium volume 1000 ml / 900 ml Medium temperature 37℃ Sampling volume 10ml Sampling time 60 / 90 / 100 / 110 / 120 / 150 / 180 min In-line filter head PE 10 μm Whether to replenish Yes Replenishment volume (ml) 10

[0056] IV. Experimental process

[0057] In the dissolution instrument 1-12 cup respectively pour 900ml pH 6.8 phosphate buffer, preheating, when the dissolution medium temperature reaches 37℃±0.5℃. The removed tablet 1-6 respectively into the dissolution instrument 1-6 cup, the removed tablet 7-12 respectively loaded into the sink basket and then into the dissolution instrument 7-12 cup; start, at each sampling point respectively take 10ml, through 10um PE filter, take the filtrate, namely. And after sampling at each sampling point, 10ml of 37℃±0.5℃ pH 6.8 phosphate buffer solution.

[0058] Dissolution results as follows Table 2

[0059]

[0060] The experimental results show that: as shown in Table 2 and Figure 6 The mesalamine irregular tablet sample without sink basket will rotate with the rotation of the paddle shaft, and the rotation frequency of each mesalamine irregular tablet sample is different. The mesalamine irregular tablet sample with sink basket cannot rotate with the rotation of the paddle shaft, and the dissolution difference between each mesalamine irregular tablet sample is small. The difference between the two dissolution processes is the main reason for the difference in RSD value of the mesalamine irregular tablet sample dissolution. It can be seen that the mesalamine irregular tablet variety uses the sink basket during the dissolution process, so that the tablet sample will not rotate with the paddle, the flushing force is stronger, the dissolution is faster, and the RSD during the dissolution process of each sample is reduced. The sink basket structure of the utility model is simple, will not affect the stability of water flow, can ensure the accurate drug administration and stable dissolution position of mesalamine irregular tablet, and also ensure the stability and uniformity of the flushing force during the drug dissolution process, and reduce the dissolution variation.

[0061] Obviously, those skilled in the art can make various modifications and variations to the utility model without departing from the spirit and scope of the utility model. Thus, if these modifications and variations of the utility model fall within the scope of the claims of the utility model and its equivalent technologies, the utility model also intends to include these modifications and variations.

Claims

1. A sedimentation basket, characterized in that, The side reinforcing ribs are arc-shaped, and the arc-shaped convex part of the side reinforcing ribs forms the cross section of the middle end. The cross sections of the top end and the bottom end are smaller than the cross section of the middle end. The cross-sectional area ratio of the top end and the bottom end is 1:0.5-1.

5.

2. The settling basket of claim 1, wherein, The cross-sectional area of the middle end is 1.1-2 times the cross-sectional area of the top end or the bottom end. The cross sections of the top end, the middle end and the bottom end are circular or elliptical, the diameter of the cross section of the top end is 5-15 mm, the diameter of the cross section of the middle end is 10-20 mm, and the distance between the top end and the bottom end is 5-25 mm.

3. The settling basket of claim 1, wherein, All structures of the settling basket are made of metal or non-metal materials.

4. The settling basket of claim 1, wherein, The parts of the settling basket are made of corrosion-resistant materials, and the parts are made by welding. The cross section of the bottom end is provided with a first cross-linking structure selected from one of "*", "#", "+", "U", "^", "\", "~", "-" and "=" structures.

5. The settling basket of claim 1, wherein, The middle end is provided with a middle reinforcing rib for supporting the side reinforcing ribs.

6. The settling basket of claim 1, wherein, The middle reinforcing rib is selected from none, arc shape, circular shape or elliptical shape.

7. The settling basket of claim 6, wherein, The cross section of the top end is provided with a second cross-linking structure selected from one of "*", "#", "+", "U", "^", "\", "~", "-" and "=" structures.

8. The settling basket of claim 7, wherein, When the middle reinforcing rib is arc-shaped, the middle end is further provided with a buckle structure fixed by a hinge.

9. The settling basket of claim 7, wherein, When the middle reinforcing rib is selected from none, circular shape or elliptical shape, the top end is provided with a buckle structure fixed by a hinge. The buckle structure includes a ring-shaped part sleeved on the top end, an arc-shaped part connected to the ring-shaped part, a line segment part connected to the arc-shaped part, and an arc-shaped buckle connected by the line segment part.

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