CN113654956A - Method for determining particle size and particle size distribution of amoxicillin bulk drug - Google Patents
Method for determining particle size and particle size distribution of amoxicillin bulk drug Download PDFInfo
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- CN113654956A CN113654956A CN202110850352.6A CN202110850352A CN113654956A CN 113654956 A CN113654956 A CN 113654956A CN 202110850352 A CN202110850352 A CN 202110850352A CN 113654956 A CN113654956 A CN 113654956A
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means, e.g. by light scattering, diffraction, holography or imaging
- G01N15/0211—Investigating a scatter or diffraction pattern
Abstract
The invention belongs to the technical field of medicine preparation, and discloses a method for determining particle size and particle size distribution of an amoxicillin raw material medicine. The determination method adopts a dry laser scattering method, and the determination parameters comprise: the particle type is non-spherical, the analytical model is Mie theoretical model, and the dispersion pressure is 0.6bar-1.0 bar. According to the determination method, a proper model is selected according to the optical properties of the amoxicillin bulk drug, and a dry laser scattering method is established by setting measurement parameters. The method for testing the particle size and the particle size distribution of the amoxicillin bulk drug has the advantages of high accuracy, good repeatability and simple operation, and can effectively improve the efficiency of research and development and production of the preparation and ensure the uniformity of the amoxicillin preparation. The test method provides a reliable technical means for quality control in the production of amoxicillin bulk drugs and process research in preparation development.
Description
Technical Field
The invention belongs to the technical field of medicine preparation, and particularly relates to a method for determining particle size and particle size distribution of an amoxicillin raw material medicine.
Background
Amoxicillin is a commonly used broad-spectrum beta-lactam oral antibiotic, has strong bactericidal effect and strong capability of penetrating cell membranes, and has strong killing effect on gram-negative bacteria and gram-positive bacteria. The amoxicillin is widely used for treating infections of respiratory system, urinary system, digestive system and the like in clinic, and is one of the antibiotic varieties with multiple clinical applications, wide application range and reliable curative effect. The preparation formulations mainly comprise capsules, tablets, granules, dry suspensions and the like.
The particle size and the particle size distribution are key factors in the process of drug research and development and are important evaluation indexes of the quality of the raw material drug. The particle size and particle size distribution of the raw material drug can affect the production process (such as fluidity, mixing uniformity, compressibility and the like) and the performance of the preparation (such as dissolution rate, bioavailability, stability and the like). Currently, commonly used methods for measuring particle size and particle size distribution include laser scattering, sieving, electron microscopy, coulter counting, and sedimentation. The laser scattering method is a method for measuring the particle size distribution by analyzing the light scattering characteristics of particles in various two-phase systems, and is suitable for measuring the particle size distribution of particles having a particle size of 0.1 μm to 3 mm. The laser scattering method is classified into a wet method and a dry method, the wet method is that sample particles are dispersed in an insoluble liquid medium and then flow through a measurement area along with the liquid, the dry method is that the sample particles are dispersed by compressed air or vacuum and pass through the measurement area, a detection element obtains light intensities of different angles scattered by the particles, and the particle size distribution is calculated by using a Fraunhofer theoretical model or a Mie theoretical model. Although the measurement result of the wet method is relatively accurate, the detection process is complex and the detection efficiency is low. Compared with the wet method, the dry method has the characteristics of simple operation, low cost and high efficiency. However, in the dry method for determining the particle size and the particle size distribution of the amoxicillin bulk drug, because the pressure titration method is adopted for the dispersion pressure, inflection points are difficult to distinguish, so that the proper dispersion pressure is difficult to determine, the final determination method is inaccurate, and the method has no practical application value.
At present, no special method capable of accurately measuring the particle size and the particle size distribution of an amoxicillin raw material drug is established in the pharmaceutical field, and all enterprises generally use general parameters of a laser scattering method detection instrument to measure the particle size and the particle size distribution of the amoxicillin raw material drug. The common parameters are adopted for determination, and even aiming at the same amoxicillin bulk drug, the results of particle size and particle size distribution determined by different enterprises are greatly different. The method not only increases the difficulty of controlling the quality of the amoxicillin raw material medicine, but also greatly reduces the efficiency of research and development of the preparation.
Therefore, it is necessary to develop a method for determining the particle size and the particle size distribution of the amoxicillin bulk drug, which has the advantages of simple operation, good repeatability and high accuracy.
Disclosure of Invention
The present invention is directed to solving at least one of the problems of the prior art described above. Therefore, the invention provides the method for measuring the particle size and the particle size distribution of the amoxicillin bulk drug, the method is simple to operate, good in repeatability and high in accuracy, the uniformity of the amoxicillin preparation can be ensured, and the research and development efficiency of the preparation is improved.
The invention conception is as follows: the invention establishes a dry laser scattering method specially aiming at amoxicillin bulk drug. The dry laser scattering method is used for measuring the particle size and the particle size distribution of the amoxicillin bulk drug, the operation is simple, the repeatability is good, the accuracy is high, and the efficiency of research and development and production of the preparation can be effectively improved.
The invention provides a method for measuring the particle size and the particle size distribution of an amoxicillin raw material drug.
Specifically, the method for determining the particle size and the particle size distribution of the amoxicillin bulk drug adopts a dry laser scattering method, and the determination parameters comprise: the particle type is non-spherical, the analytical model is Mie theoretical model, and the dispersion pressure is 0.6bar-1.0 bar.
The dispersion pressure in the dry laser scattering method is screened out by the wet laser scattering method. Specifically, a wet laser scattering method for measuring the particle size and the particle size distribution of the amoxicillin bulk drug is established, an accurate result of the particle size and the particle size distribution of the amoxicillin bulk drug is measured, then dispersion pressure is screened according to the result, the problems that inflection points are difficult to distinguish and proper dispersion pressure is difficult to determine by the dispersion pressure in a dry laser scattering method are solved, and finally the dry laser scattering method for measuring the particle size and the particle size distribution of the amoxicillin bulk drug is established by the screened dispersion pressure.
The dispersion pressure is controlled within 0.6bar-1.0bar, so that the amoxicillin raw material drug particles can be effectively prevented from being damaged by overlarge dispersion pressure, and the amoxicillin raw material drug particles can not be well dispersed due to the overlarge dispersion pressure. The dispersion pressure can ensure the accuracy and stability of the test result of the amoxicillin bulk drug of any batch by the dry laser scattering method.
Preferably, the dispersion pressure is between 0.8bar and 1.0 bar; further preferably, the dispersion pressure is from 0.8bar to 0.9 bar.
Preferably, the measurement parameters further comprise the light shading degree of 0.3% -8%; further preferably, the light-shielding degree is 0.5% -5%.
Preferably, the measurement parameters further include refractive index of 1.60-1.90 and absorptivity of 0.01-0.1; further preferably, the refractive index is 1.66 to 1.83, and the absorptivity is 0.01 to 0.1; more preferably, the refractive index is 1.745, and the absorption is 0.1.
Preferably, the measurement parameters further comprise a sample introduction gap of 2.25mm-3mm and a sample introduction rate of 50% -70%.
Preferably, the determination parameters further comprise the sample measurement time is 5s-20 s; further preferably, the sample measurement time is 5s to 15 s.
Preferably, the determination method comprises the following steps:
and opening instrument software, setting the test parameters, performing background measurement, performing sample test, and operating the instrument software after the test is completed to obtain particle size and particle size distribution results.
Preferably, D10, D50 and D90 are taken as particle size distribution characteristic values in the sample testing process. D10, D50 and D90 respectively represent that 10%, 50% and 90% of the particles in the particle size distribution curve have particle sizes smaller than the numerical value.
Preferably, the instrument software is self-contained analysis software, such as Mastersizer 3000 software.
Preferably, the dry laser scattering method screens the dispersion pressure and verifies the determination result by the wet laser scattering method.
Preferably, the wet laser light scattering method comprises the following steps:
(1) dissolving a part of amoxicillin bulk drug in a solvent to prepare a saturated solution, filtering, and taking the filtrate as a dispersion medium;
(2) adding the other part of amoxicillin raw material medicine into the dispersion medium prepared in the step (1), and dispersing to prepare a test sample;
(3) and (3) deducting the dispersion medium prepared in the step (1) as a blank background, and then testing the test sample prepared in the step (2).
Preferably, in step (1), the solvent is ethanol and/or water.
Preferably, in the step (1), the dispersing process is ultrasonic dispersing; further preferably, the ultrasonic frequency is 37-80kHz, and the ultrasonic time is 0.1-3 min.
Preferably, in step (3), the measured parameters of the test include: the particle type is non-spherical, the analytical model is a Mie theoretical model, the refractive index is 1.66-1.83, the absorptivity is 0.01-0.1, the refractive index of the dispersant is 1.3-1.4, the light shading rate is 5-15%, and the sample measurement time is 7-15 s
In a second aspect, the invention provides the use of the assay described above.
Specifically, the method for determining the particle size and the particle size distribution of the amoxicillin bulk drug is applied to the preparation of the amoxicillin drug.
Compared with the prior art, the invention has the following beneficial effects:
according to the method for determining the particle size and the particle size distribution of the amoxicillin bulk drug, a proper model is selected according to the optical properties of the amoxicillin bulk drug, and a dry laser scattering method is established by setting measurement parameters (particularly for dispersion pressure). The method for determining the particle size and the particle size distribution of the amoxicillin bulk drug by using the dry laser scattering method has the advantages of high accuracy, good repeatability and simple operation, avoids complex procedures such as solution preparation and the like in the wet laser scattering method, can effectively improve the efficiency of research and development and production of the preparation, and ensures the uniformity of the amoxicillin preparation. The method provides a reliable technical means for quality control in the production of amoxicillin bulk drugs and process research in preparation development.
Drawings
FIG. 1 is a particle size distribution diagram of amoxicillin bulk drug measured by wet laser scattering in example 1;
FIG. 2 is a graph comparing particle size distributions at different dispersion pressures for example 1;
FIG. 3 is a particle size distribution diagram of amoxicillin bulk drug measured by the dry laser scattering method in example 1;
FIG. 4 is a graph showing a comparison of particle size distributions measured by pressure titration in comparative example 1.
Detailed Description
In order to make the technical solutions of the present invention more apparent to those skilled in the art, the following examples are given for illustration. It should be noted that the following examples are not intended to limit the scope of the claimed invention.
The starting materials, reagents or apparatuses used in the following examples are conventionally commercially available or can be obtained by conventionally known methods, unless otherwise specified.
Example 1
This example describes in detail the establishment of a method for determining particle size and particle size distribution of an amoxicillin bulk drug provided by the present invention, which comprises determining particle size and particle size distribution by a wet laser scattering method, screening dispersion pressure based on the test result of the wet laser scattering method, finally establishing a dry laser scattering method, and performing precision test of the dry laser scattering method.
1. Wet laser scattering method
Two analysts respectively adopt the method of the invention to measure the amoxicillin bulk drug with the batch number of 180221010, and each analyst carries out analysisThe panelists took 6 samples, tested each sample in parallel 5 times, and counted D10、D50、D90Average value of (d) and RSD%. D was calculated for 6 samples from each of two analysts10、D50、D90Average value and RSD% of (1), and D of a total of 12 samples10、D50、D90Average value of (d) and RSD%.
The implementation method comprises the following steps:
(1) preparation of a dispersion medium: weighing about 10g of amoxicillin bulk drug, placing the amoxicillin bulk drug in 3L of 95 percent ethanol, continuously stirring for about 3 hours, standing for 2 to 3 hours, and filtering by using an organic filter membrane with the diameter of 0.2 mu m to obtain the dispersion medium.
(2) Preparing a test sample: and then 0.02g of amoxicillin bulk drug is weighed and placed in a penicillin bottle, 5ml of dispersion medium is added, the amoxicillin bulk drug is shaken uniformly and then placed in an ultrasonic cleaning machine with ultrasonic frequency of 53kHz for ultrasonic treatment for 1.5min, and the test sample is obtained.
(3) And (3) testing the test sample: the stirring speed is set to 2000rpm, the measurement time is 10s, and the light shading degree is 5-10%. Adding 100ml of dispersion medium into a sample cell, focusing light and automatically measuring the background, slowly adding the test article into the sample cell until the light shielding degree reaches a set range, and starting the particle size distribution measurement of the test article.
(4) Data processing: after blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. The particle size distribution diagram of the amoxicillin bulk drug is shown in the figure 1, and the specific determination results are shown in the table 1.
TABLE 1 measurement results of the wet laser scattering method
From the above data, D was measured in 5 replicates per sample10、D50、D90The RSD% of the total content of the total content of all the total content of the total content of all the content of the total content of the total content of all the content of the total content of all the content of all10、D50、D90The RSD% of the strain does not exceed 4%, the strain meets the acceptable standard, the measurement result is stable, and the accuracy is high.
2. Screening of dispersion pressure by dry laser scattering method
Weighing a proper amount of amoxicillin bulk drug which is verified by a wet laser scattering method and is in the same batch, placing the amoxicillin bulk drug in an Aero S dry injector, opening instrument software, setting the particle type to be non-spherical, setting the analysis model to be a Mie theoretical model, adjusting the sample injection gap to be 2.5mm, setting the sample injection rate to be 60%, setting the measurement time to be 10S and setting the shading degree to be 0.5-5%. The available range of the dispersion air pressure of the instrument is 0bar-4bar, the instrument is adjusted from 2bar, and different dispersion pressures are respectively set to measure the same batch of amoxicillin raw material medicines. After blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. FIG. 2 is a graph comparing particle size distributions at different dispersion pressures. Each sample was assayed in duplicate 3 times, statistics D10、D50、D90Average and RSD% of (d), specific test results are shown in table 2.
TABLE 2 measurement results of particle diameter and particle size distribution under different dispersion pressures
And selecting the dispersion pressure with the measured particle size distribution result most similar to the particle size distribution result obtained by wet methodology verification. The particle size distribution result verified by the wet laser scattering method is as follows: d10＝7.20μm、D50＝17.15μm、D90When the dispersion pressure is 0.9bar at 34.01 μm, the particle size distribution is closest to the measured value, and therefore, it is reasonable to set the dispersion pressure to 0.8 to 1bar, preferably 0.8 to 0.9 bar.
3. The dry laser scattering method is suggested and the precision is tested
Measuring the same batch of raw materials by two analysts respectively by the method of the invention, taking 6 samples by each analyst, testing each sample in parallel for 3 times, and counting D10、D50、D90Average value of (d) and RSD%. D was calculated for 6 samples from each of two analysts10、D50、D90Average value and RSD% of (1), and D of a total of 12 samples10、D50、D90Average value of (d) and RSD%.
Weighing a proper amount of amoxicillin bulk drug, placing the amoxicillin bulk drug in an Aero S dry-process sample injector, opening instrument software, setting the particle type to be non-spherical, setting the analysis model to be a Mie theoretical model, adjusting the sample injection gap to be 2.5mm, setting the sample injection rate to be 60%, measuring the time to be 10S, the dispersion pressure to be 0.9bar, and the light shading degree to be 0.5-5%, and determining the particle size distribution of the sample. After blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. The particle size distribution diagram of the amoxicillin bulk drug is shown in figure 3, and the specific measurement results are shown in table 3.
TABLE 3 measurement results of the dry laser scattering method
As can be seen from the data in Table 3, D was measured in parallel 3 times per sample10、D50、D90RSD% of the total amount of the total amounts of the total amounts of the total amounts of the total amounts of the total amounts of the 12 and the amounts of the total amounts of the total amounts of the total amounts of the10、D50、D90The RSD% of the strain does not exceed 0.55%, the strain meets the acceptable standard, and the measuring method is quick, simple, stable in result and high in accuracy.
Example 2
This example is another analyst who directly used the testing method established in the present invention to test the particle size and particle size distribution of the amoxicillin drug substance lot No. 210421203. The operation method comprises the following steps:
for each sample, 3 replicates were tested and the mean and RSD% of D10, D50, D90 were counted. The mean and RSD% of D10, D50, D90 were calculated for the samples.
Weighing a proper amount of amoxicillin bulk drug, placing the amoxicillin bulk drug in an Aero S dry-process sample injector, opening instrument software, setting the particle type to be non-spherical, setting the analysis model to be a Mie theoretical model, adjusting the sample injection gap to be 2.5mm, setting the sample injection rate to be 60%, measuring the time to be 10S, the dispersion pressure to be 0.9bar, and the light shading degree to be 0.5-5%, and determining the particle size distribution of the sample. After blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. The test results are shown in Table 4.
The results were verified by the same analyst using wet laser scattering. The procedure of wet laser scattering was the same as that provided in example 1, and 3 replicates of each sample were used to determine the mean values and RSD% of D10, D50, D90, respectively, for the bulk drug substance. The test results are shown in Table 4.
Table 4 measurement results and verification results of dry laser scattering method
As can be seen from table 4, the particle size and particle size distribution results of the bulk drug substance measured by the dry laser scattering method almost agree with the particle size distribution results measured by the wet method. The dry laser scattering method established by the invention can accurately and stably determine the particle size distribution of amoxicillin bulk drugs in different batches.
Example 3
This example is an analyst (the analyst in example 2) who directly uses the testing method established in the present invention to test the particle size and particle size distribution of amoxicillin bulk drug in the same batch as in example 2. The operation method comprises the following steps:
for each sample, 3 replicates were tested and the mean and RSD% of D10, D50, D90 were counted. The mean and RSD% of D10, D50, D90 were calculated for the samples.
Weighing a proper amount of amoxicillin bulk drug, placing the amoxicillin bulk drug in an Aero S dry-process sample injector, opening instrument software, setting the particle type to be non-spherical, setting the analysis model to be a Mie theoretical model, adjusting the sample injection gap to be 2.75mm, setting the sample injection rate to be 55%, measuring the time to be 15S, the dispersion pressure to be 0.8bar, and the light shielding degree to be 0.5-5%, and determining the particle size distribution of the sample. After blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. The test results are shown in Table 5.
The results were verified by the same analyst using wet laser scattering. The procedure of wet laser scattering was the same as that provided in example 1, and 3 replicates of each sample were used to determine the mean values and RSD% of D10, D50, D90, respectively, for the bulk drug substance. The test results are shown in Table 5.
TABLE 5 measurement results and verification results of the dry laser scattering method
As can be seen from table 5, the particle size and particle size distribution results of the bulk drug substance measured by the dry laser scattering method almost agreed with the particle size distribution results measured by the wet method. The dry laser scattering method established by the invention can accurately and stably determine the particle size distribution of amoxicillin bulk drugs in different batches.
Comparative example 1
Comparative example 1 in the case of measuring the particle diameter and the particle size distribution by the dry laser scattering method, the dispersion pressure was measured by pressure titration. The specific implementation method comprises the following steps:
weighing a proper amount of amoxicillin bulk drug, placing the amoxicillin bulk drug in an Aero S dry-process sample injector, opening instrument software, adjusting the sample injection gap to be 2.5mm, setting the sample injection rate to be 60%, the measurement time to be 10S and the shading degree to be 0.5-5%. The available range of the dispersion air pressure of the instrument is 0bar-4bar, the instrument is adjusted from 4bar, and different dispersion pressures are respectively set to measure the same batch of amoxicillin raw material medicines. After blank background is deducted by software, the particle size and particle size distribution result of the sample is obtained by calculation and analysis. Each sample was assayed in duplicate 3 times.
The particle size distribution results are shown in comparison in FIG. 4. For amoxicillin bulk drugs, pressure titration does not specify an appropriate dispersion pressure. When the dispersion pressure is below 2bar, the particle size decreases sharply with the increase of the dispersion pressure; the particle size tends to decrease more gradually at dispersion pressures of from 2 to 4 bar. Therefore, it is difficult to determine whether the bulk drug is sufficiently dispersed or pulverized at a dispersion pressure of 0 to 2bar, and an appropriate and specific dispersion pressure value cannot be determined, and an accurate dry laser scattering method cannot be established.
Claims (10)
1. The method for measuring the particle size and the particle size distribution of the amoxicillin bulk drug is characterized in that the method adopts a dry laser scattering method, and the measurement parameters comprise: the particle type is non-spherical, the analytical model is Mie theoretical model, and the dispersion pressure is 0.6bar-1.0 bar.
2. The method according to claim 1, wherein the dispersion pressure is 0.8bar to 1.0 bar.
3. The method according to claim 2, wherein the dispersion pressure is 0.8bar to 0.9 bar.
4. The assay of claim 1, wherein the assay parameters further comprise a opacity of 0.3% to 8%.
5. The assay method of claim 1, wherein the assay parameters further comprise: the refractive index is 1.60-1.90, and the absorptivity is 0.01-0.1.
6. The method according to claim 5, wherein the refractive index is 1.66 to 1.83 and the absorbance is 0.01 to 0.1.
7. The assay method of claim 1, wherein the assay parameters further comprise: the sample introduction gap is 2.25mm-3mm, and the sample introduction rate is 50% -70%.
8. The assay method according to any one of claims 1 to 7, comprising the steps of:
and opening instrument software, setting the test parameters, performing background measurement, performing sample test, and operating the instrument software after the test is completed to obtain particle size and particle size distribution results.
9. The method according to claim 8, wherein D10, D50 and D90 are used as particle size distribution characteristics in the sample test.
10. Use of an assay according to any one of claims 1 to 9 in the manufacture of a medicament for amoxycillin.
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| CN114062208A (en) * | 2021-11-18 | 2022-02-18 | 上海新亚药业闵行有限公司 | Method for analyzing particle size of cefalexin |
| CN114527042A (en) * | 2021-12-24 | 2022-05-24 | 湖南醇健制药科技有限公司 | Method for detecting particle size distribution of progesterone in progesterone soft capsule contents |
| WO2024037221A1 (en) * | 2022-08-17 | 2024-02-22 | 扬子江药业集团上海海尼药业有限公司 | Method for measuring particle size of dapagliflozin active pharmaceutical ingredient |
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| CN104089855B (en) * | 2014-07-17 | 2016-08-24 | 清华大学深圳研究生院 | A kind of polarized light scatter measures the method and device of particulate matter |
| CN109115661A (en) * | 2018-09-27 | 2019-01-01 | 湖北省宏源药业科技股份有限公司 | A method of for measuring azithromycin drug partial size and size distribution |
| JP7288345B2 (en) * | 2019-05-23 | 2023-06-07 | 株式会社堀場製作所 | Particle size distribution measuring device, particle size distribution measuring method, and particle size distribution measuring device program |
| CN111650100A (en) * | 2020-06-16 | 2020-09-11 | 辽东学院 | Particle size measuring equipment based on Mie's scattering theory |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114062208A (en) * | 2021-11-18 | 2022-02-18 | 上海新亚药业闵行有限公司 | Method for analyzing particle size of cefalexin |
| CN114527042A (en) * | 2021-12-24 | 2022-05-24 | 湖南醇健制药科技有限公司 | Method for detecting particle size distribution of progesterone in progesterone soft capsule contents |
| WO2024037221A1 (en) * | 2022-08-17 | 2024-02-22 | 扬子江药业集团上海海尼药业有限公司 | Method for measuring particle size of dapagliflozin active pharmaceutical ingredient |
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