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An analyzer for measuring the intrinsic dissolution and dissolution of solid pharmaceuticals

A dissolution and analyzer technology, applied in measurement devices, analysis materials, material analysis by optical means, etc., can solve problems such as particle interference of optical fiber sensors, and achieve the effects of improving mass transfer, improving uniformity, and reducing system deviation

Inactive Publication Date: 2016-02-24
INST OF PROCESS ENG CHINESE ACAD OF SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to solve the technical problem that the optical fiber immersion measurement method can make the drug powder particles deposit on the optical fiber lens in the prior art, thereby causing interference to the detection. The present invention provides a method for measuring solid drug The analyzer of intrinsic dissolution rate and dissolution rate solves the particle interference problem of the submerged optical fiber sensor, improves the uniformity of mass transfer of the measured system, reduces the error of the test system, and improves the uniformity of temperature control

Method used

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  • An analyzer for measuring the intrinsic dissolution and dissolution of solid pharmaceuticals
  • An analyzer for measuring the intrinsic dissolution and dissolution of solid pharmaceuticals
  • An analyzer for measuring the intrinsic dissolution and dissolution of solid pharmaceuticals

Examples

Experimental program
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Embodiment 1

[0049] Such as figure 1 , 2 As shown, the input end of the multi-channel fusion fiber 2 is connected to the light source 8 , and its output end is connected to the input ends of six fiber coupling switches 7 . The output end of each optical fiber coupling switch 7 is connected with the input end of a single-channel optical fiber 6 respectively, and the output end of the single-channel optical fiber 6 is connected with the optical fiber interface 33 of the non-contact detection component main body 32, and the output of the non-contact detection component 3 end is linked with the input end of another multi-channel fusion optical fiber 2, the output end of this multi-channel fusion optical fiber 2 is connected with the detector 1, the non-contact detection part 3 is fixed in the groove of the temperature control bracket 5, and the sample cup 4 It is directly placed in the fixed groove 34 of the non-contact detection part 3, the rotor is placed in the sample cup 4, the temperatur...

Embodiment 2

[0055] Such as Figure 5 As shown, the difference between the analyzer in this embodiment and Embodiment 1 is that the sample cup 4 is a cylindrical sample cup 43, and the cylindrical sample cup 43 is fixed in a circular groove ferrule 92, and the circular groove The ferrule 92 is placed in the fixed groove 34 of the non-contact detection part 3, the rotor is placed in the cylindrical sample cup 43, the temperature control bracket 5 is fixed on the stirrer, and the dissolution of the drug is realized through the stirrer and the rotor. The cylindrical sample cup 43 has a diameter of 10 mm and a height of 100 mm.

[0056] Wherein, the diameter of the rotor is 6mm, and the height is 2mm. The stirrer drives the rotor to rotate in the cylindrical sample cup 43 through the magnetic field, so that the mass transfer of the drug powder is carried out uniformly.

[0057] Additionally, if Image 6 As shown, the sample cup can also be a square sample cup 42 , and the square sample cup ...

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Abstract

The invention provides an analyzer for measuring an intrinsic dissolution rate and a dissolution rate of a solid drug. The analyzer comprises a light source (8), a detector (1), a beam splitting system, a plurality of non-contact detection parts (3) and a plurality of sample cups (4), wherein the input end and the output end of each non-contact detection part (3) are connected with the light source (8) and the detector (1) respectively through the beam splitting system, each non-contact detection part (3) comprises an optical fiber coupling lens (31) and a fixed groove (34), the fixed grooves (34) are provided with vertical planes (35) which are vertical to light paths formed by the optical fiber coupling lens (31), the sample cups (4) are arranged in the fixed grooves (34), and the shape of each sample cup is matched with a space in a groove body of the corresponding fixed groove (34). According to the analyzer, the problem of particle interference of an immersion type optical fiber sensor is solved, the mass transfer uniformity of a system to be measured is improved, the quantity of errors of a testing system is reduced, and the temperature control uniformity is improved.

Description

technical field [0001] The invention relates to the field of measuring the intrinsic dissolution rate and dissolution rate of solid medicines, in particular to an analyzer for measuring the intrinsic dissolution rate and dissolution rate of solid medicines. Background technique [0002] Drug development is a complex system engineering. In order to reduce the risk and cost of development, early druggability evaluation of drugs has become an important link in the drug development process. The research on the solid-state chemical properties of drugs, together with early drug efficacy, safety evaluation and pharmacokinetics, has become an important research content of early druggability evaluation. It is not only related to the biological activity and pharmacodynamic performance of the compound, but also related to key factors such as the metabolic process, safety and quality controllability of the drug in the body. In addition, the promotion and application of process analysis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/00
Inventor 徐建栋徐霞韦宇平
Owner INST OF PROCESS ENG CHINESE ACAD OF SCI
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