CN116930013A - Method for measuring granularity of raw materials in azithromycin dry suspension - Google Patents
Method for measuring granularity of raw materials in azithromycin dry suspension Download PDFInfo
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- 239000000725 suspension Substances 0.000 title claims abstract description 65
- 229960004099 azithromycin Drugs 0.000 title claims abstract description 55
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 title claims abstract description 55
- 239000002994 raw material Substances 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 title claims abstract description 37
- 238000005259 measurement Methods 0.000 claims abstract description 37
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims abstract description 12
- 229920000053 polysorbate 80 Polymers 0.000 claims abstract description 12
- 238000012360 testing method Methods 0.000 claims abstract description 5
- 239000002245 particle Substances 0.000 claims description 34
- 239000002736 nonionic surfactant Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 239000008367 deionised water Substances 0.000 claims description 5
- 229910021641 deionized water Inorganic materials 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- 238000011067 equilibration Methods 0.000 claims description 4
- 238000002835 absorbance Methods 0.000 claims description 3
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 19
- 238000004458 analytical method Methods 0.000 abstract description 9
- 229940079593 drug Drugs 0.000 description 14
- 238000009826 distribution Methods 0.000 description 13
- 239000006185 dispersion Substances 0.000 description 6
- 238000000691 measurement method Methods 0.000 description 4
- 230000009471 action Effects 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000009210 therapy by ultrasound Methods 0.000 description 3
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 239000003120 macrolide antibiotic agent Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000002604 ultrasonography Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000606768 Haemophilus influenzae Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 239000002612 dispersion medium Substances 0.000 description 1
- 238000007905 drug manufacturing Methods 0.000 description 1
- 230000000312 effect on influenza Effects 0.000 description 1
- 229960003276 erythromycin Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 210000002229 urogenital system Anatomy 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Classifications
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- G—PHYSICS
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Dispersion Chemistry (AREA)
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Abstract
The invention discloses a method for measuring the granularity of raw materials in an azithromycin dry suspension, which belongs to the technical field of medicine analysis, adopts a laser granularity wet measurement mode and comprises the following steps: s1, preparing a suspension of an azithromycin dry suspension raw material sample by using Tween 80; s2, selecting and determining the optimal instrument parameters with specificity; s3, collecting the granularity data of the test raw materials under the condition of no ultrasonic. The method can accurately measure the granularity of the raw materials in the azithromycin dry suspension, has good quality stability, intermediate precision and test repeatability, and has important practical significance for improving the effectiveness, safety and quality stability of the medicine.
Description
Technical Field
The invention belongs to the technical field of medicine analysis, and particularly relates to a method for measuring the granularity of raw materials in an azithromycin dry suspension.
Background
Azithromycin is 15-ring macrolide antibacterial, is the 1 st variety of macrolide antibiotics, is stable to acid, is not damaged by gastric acid after being orally taken, has long half-life period, high tissue and intracellular concentration of an infected part, has an enlarged effect on gram negative bacteria, particularly has a reinforced effect on influenza bacillus, and has a wider antibacterial spectrum and a stronger antibacterial effect compared with erythromycin. Clinically, it is commonly used for treating upper and lower respiratory tract, genitourinary system, skin and soft tissue, surgical infection, etc.
The granularity of the azithromycin bulk drug directly affects the production efficiency and the product quality of azithromycin preparations (capsules, tablets and the like), and is a vital ring in quality standard. The azithromycin bulk drugs have different particle sizes, and have larger differences in apparent solubility, dissolution and bioavailability, which can influence the drug production and preparation process and further influence the drug quality. Meanwhile, because the granularity of the azithromycin bulk drug is different, not only is the physical property of the azithromycin bulk drug different, but also the biological activity of the azithromycin bulk drug is obviously different, and the clinical use of the azithromycin bulk drug is interfered. However, azithromycin is poorly soluble in water, which presents a number of inconveniences for formulation studies. In addition, the cohesion between the raw material particles is also large, so that a plurality of inconveniences are brought to the particle size measurement. It is therefore important to the accuracy of the particle size measurement, both for the dispersion of the feedstock and to destroy the cohesion between the feedstock particles. The conventional particle size measurement method comprises a microscope method, a laser scattering measurement method, a screening method, a Coulter counting method, a sedimentation method and the like, wherein the former three methods are relatively widely applied, and the laser scattering measurement method is divided into a dry method and a wet method, and has the advantages of high precision, high measurement speed, wide measurement range and good repeatability. At present, as a detection means for controlling granularity of bulk drugs and preparations, a laser granularity analysis method shows a rapid development trend.
Patent document CN109115661a discloses a method for determining the particle size and particle size distribution of an azithromycin bulk drug, which adopts a dry method for determining the particle size and particle size distribution of the azithromycin bulk drug in a malvern laser particle sizer (Mastersizer 2000), and firstly determines the refractive index of the azithromycin according to the document or experimental data, wherein the refractive index of the azithromycin is 1.536. The measurement method was established according to the operation manual of a malvern laser particle sizer (Mastersizer 2000) and according to the parameter settings for the purpose of investigation. The method is a dry method, and the dispersion degree of the sample depends on the dispersion air pressure. Too much or too little instrument dispersion air pressure may cause distortion of the measurement data.
Because of the specificity of the raw materials, the azithromycin dry suspension has better matching property for the wet detection method of the laser particle size analyzer. However, for the method, proper dispersing agent is selected, what parameters are adopted to disperse the raw materials, and what parameters are selected to carry out sample measurement, so that the accuracy and the repeatability of the granularity measurement result are improved, and the improvement of the effectiveness, the safety and the quality stability of the medicine has important practical significance.
Disclosure of Invention
The invention aims to provide a method for measuring the granularity of raw materials in an azithromycin dry suspension, which can accurately measure the granularity of the raw materials in the azithromycin dry suspension and has good quality stability, intermediate precision and repeatability; and further proves that the azithromycin dry suspension medicine is safe and effective.
The aim of the invention can be achieved by the following technical scheme:
the method for measuring the granularity of the raw materials in the azithromycin dry suspension comprises the following steps:
s1, preparing azithromycin dry suspension raw material sample suspension: and (3) taking a nonionic surfactant at normal temperature (25-30 ℃), taking deionized water as a dispersion medium (with a refractive index of 1.33), dissolving, dispersing, diluting, shaking uniformly, adding an azithromycin dry suspension raw material sample, and stirring (100-500 rpm) to enable the azithromycin dry suspension raw material sample to be moist and dispersed.
S2, setting instrument parameters: the refractive index of the sample is 1.526; the absorbance of the sample was 0.1; the rotating speed is 1000-3000 rpm.
S3, measuring method: in a wet sample injection system of the particle analyzer, the refractive index of the detector is 10% -20%; the sample is not subjected to ultrasonic treatment; sample suspension equilibration time was 5min; the number of measurements was 3.
Preferably, the nonionic surfactant in step S1 is tween 80.
Preferably, the stirring speed in step S1 is 120 rpm.
Preferably, the dosage ratio of the azithromycin dry suspension raw material sample, the nonionic surfactant and the deionized water in the suspension in the step S1 is 0.1-0.3g:1-3g:100mL.
Preferably, the rotation speed in step S2 is 2000 rpm.
The invention has the beneficial effects that:
1. according to the determination method, tween 80 is added when preparing the sample suspension, so that the dispersion of the azithromycin dry suspension bulk drug can be effectively promoted, the azithromycin drug performance can not be influenced, and the safety and effectiveness of the drug are effectively ensured.
2. The invention avoids the problems that the raw material sample of the azithromycin dry suspension is difficult to disperse and operate, and the instrument is difficult to clean and the like by controlling the concentration of Tween 80.
3. The invention does not need ultrasound, effectively avoids the damage of the ultrasound to the particle size, and ensures the accuracy of the measurement result.
4. The invention has the drug specificity on the set instrument parameters, and the measurement parameters can more accurately measure the granularity of the sample.
Drawings
The invention is further described below with reference to the accompanying drawings.
FIG. 1 is a particle size and particle size distribution diagram of example 1 of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described in the following in conjunction with the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
The method for measuring the granularity of the raw materials in the azithromycin dry suspension comprises the following steps:
s1, preparing azithromycin dry suspension raw material sample suspension: at normal temperature (25-30 ℃), 2.0g of Tween 80 is removed, 100mL of deionized water is added for dissolution and dispersion, dilution and shaking are carried out, 0.18g of azithromycin dry suspension raw material sample is added, and the azithromycin dry suspension raw material sample is moistened and dispersed at a stirring speed of 120 revolutions per minute.
S2, setting instrument parameters: the refractive index of the sample is 1.526; the absorbance of the sample was 0.1; the rotation speed was 2000 revolutions per minute.
S3, measuring method: in a wet sample injection system of the particle analyzer, the refractive index of the detector is 10% -20%; collecting data of the sample without carrying out ultrasonic treatment on the sample; sample suspension equilibration time was 5min; the number of measurements was 3.
The test particle size and the particle size distribution diagram are shown in figure 1.
Example 2
Selection of Tween 80 concentration
Taking azithromycin dry suspension raw material samples, and parallelly measuring 3 groups under the concentration condition that tween 80 is 0.01g/mL, 0.02g/mL and 0.03g/mL, wherein the granularity measurement results of tween 80 at different concentrations are shown in table 1:
TABLE 1
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, and the particle size distribution of the detected raw materials is basically unchanged along with the increase of the concentration of Tween. When the concentration is 0.01g/mL, the sample is difficult to disperse and is not easy to operate; when the concentration was 0.03g/mL, the instrument was not well washed, so the Tween 80 concentration was controlled at 0.02g/mL.
Example 3
Examination of the time for which the azithromycin dry suspension raw material sample suspension is placed
Suspensions prepared by using 2% Tween 80 were respectively placed for 0min, 10min and 20min, and then measured in parallel for 3 groups, and the measurement results are shown in Table 2:
TABLE 2
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, and the particle size distribution of the detected raw materials is basically unchanged along with the extension of the standing time. Therefore, the suspension method prepared by adopting 0.02g/mL Tween 80 is feasible.
Example 4
Ultrasonic time selection of azithromycin dry suspension raw material sample suspension
The suspensions were subjected to ultrasonic treatment for 0s, 10s, 30s and 60s, respectively, and the measurement results are shown in Table 3:
TABLE 3 Table 3
From the results, the detected raw material particle size distribution data tends to decrease as the ultrasonic time increases, so that the ultrasonic is not performed in the subsequent measurement of particle size in order to avoid the damage of the particle size by the ultrasonic.
Example 5
Pump speed selection
The sample suspensions of the azithromycin dry suspension raw materials are respectively measured in parallel at the pump speeds of 1000 rpm, 2000 rpm and 3000 rpm for 3 groups, and the particle size measurement results at different pump speeds are shown in table 4:
TABLE 4 Table 4
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, the granularity distribution of the detected raw materials is basically unchanged along with the increase of the pump speed, but in order to ensure that the sample to be detected can be rapidly dispersed, 2000r/min is selected to be moderate.
Example 6
Selection of equilibration time
Taking azithromycin dry suspension raw material sample suspension, respectively stirring for 5min, 10min and 15min, and parallelly measuring 3 groups, wherein the particle size measurement results under different equilibrium time are shown in table 5:
TABLE 5
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, the detected particle size distribution of the raw materials is basically unchanged along with the extension of the balance time, and the relatively short time of 5min is selected as the balance time.
Example 7
Determination of a single measurement time interval
The single measurement time interval of the azithromycin dry suspension raw material sample suspension is respectively 0s, 3s and 6s, 3 groups of azithromycin dry suspension raw material sample suspensions are measured in parallel, and the measurement results of the granularity under different measurement time intervals are shown in table 6:
TABLE 6
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, and the particle size distribution of the detected raw materials is basically unchanged along with the extension of the balance time, so that the single measurement time interval is 0s.
Example 8
Single measurement count determination
The single measurement times of the azithromycin dry suspension raw material sample suspension are respectively 3 times, 6 times and 9 times, 3 groups of azithromycin dry suspension raw material sample suspension are measured in parallel, and the particle size measurement results under different single measurement times are shown in table 7:
TABLE 7
From the results, it can be seen that D was measured 10 、D 50 、D 90 All meet the requirements, and the particle size distribution of the detected raw materials is basically unchanged along with the increase of the measurement times, so that the single measurement times are 3 times.
Example 9
Method repeatability verification
Taking azithromycin dry suspension raw material sample suspension to carry out parallel measurement for 6 times under the determined measurement parameter condition, and calculating D 10 、D 50 、D 90 The results of the repeatability measurements of the average value and RSD of (b) are shown in table 8:
TABLE 8
The results showed that D was 6 times as 10 、D 50 、D 90 RSD less than 10% indicates good reproducibility of this method.
Example 10
Intermediate precision test
Taking azithromycin dry suspension raw material sample suspension under the determined measurement parameter condition, measuring for 6 times according to the method by different people and different dates, and calculating D 10 、D 50 、D 90 The average value and RSD of (c) and the intermediate precision measurement results are shown in table 9:
TABLE 9
Number of times | D 10 (μm) | D 50 (μm) | D 90 (μm) |
1 | 6.098 | 71.631 | 221.883 |
2 | 6.032 | 71.413 | 221.431 |
3 | 5.494 | 68.420 | 214.684 |
4 | 5.955 | 70.786 | 222.202 |
5 | 5.848 | 72.350 | 225.931 |
6 | 5.844 | 71.803 | 223.013 |
Average of | 5.879 | 71.067 | 221.524 |
RSD(%) | 3.629 | 1.961 | 1.677 |
The results showed that D was 6 times as 10 、D 50 、D 90 RSD is less than 10%, which indicates that the intermediate precision of the method is good.
Example 11
Investigation of durability Balancing time
The equilibrium time is changed for 270s and 330s respectively, other conditions are kept unchanged, the sample suspension of the azithromycin dry suspension raw material is respectively measured for 6 times, and D of 6 times of different equilibrium time is respectively counted 10 、D 50 、D 90 Average value and RSD; combining the repeated 6 analysis results with the 6 analysis results of the balance time change, counting the average value and RSD of the 12 analysis results, and examining the influence of the balance time on the measurement result, wherein the results are shown in Table 10:
table 10
The results show that the change of the equilibrium time is 270s and 330s respectively, and the difference of the particle size distribution results can meet the requirements.
Example 12
Pump speed Effect
Changing pump speed (+ -10%), setting pump speed to 1800 rpm and 2000 rpm respectively, keeping other conditions unchanged, taking the product, measuring 6 times, and counting D of 6 times of different pump speeds respectively 10 、D 50 、D 90 Average and RSD, 6 repeated analysis results and 6 pump speed analysis results were combined, the average and RSD of 12 analysis results were counted, and the effect of changing pump speed on measurement results was examined, and the results are shown in table 11:
TABLE 11
The results showed that varying the pump speed (+ -10%) and the particle size distribution results differed to be satisfactory.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (5)
1. The method for measuring the granularity of the raw materials in the azithromycin dry suspension is characterized by comprising the following steps of:
s1, preparing azithromycin dry suspension raw material sample suspension: under the normal temperature condition, the nonionic surfactant is removed, dissolved and dispersed in deionized water, diluted and shaken uniformly, and the azithromycin dry suspension raw material sample is added and stirred to be wetted and dispersed;
s2, setting instrument parameters: the refractive index of the sample is 1.526; the absorbance of the sample was 0.1; the rotating speed is 1000-3000 rpm;
s3, testing the sample: in a wet sample injection system of the particle analyzer, the refractive index of the detector is 10% -20%; sample suspension equilibration time was 5min; the number of measurements was 3.
2. The method for determining the granularity of raw materials in an azithromycin dry suspension according to claim 1, wherein the nonionic surfactant in S1 is tween 80.
3. The method for determining the granularity of the raw materials in the azithromycin dry suspension according to claim 1, wherein the stirring speed in the step S1 is 100-500 revolutions per minute.
4. The method for determining the granularity of the raw materials in the azithromycin dry suspension according to claim 1, wherein the dosage ratio of the azithromycin dry suspension raw material sample, the nonionic surfactant and the deionized water in the S1 suspension is 0.1-0.3g:1-3g:100mL.
5. The method for determining the granularity of the raw materials in the azithromycin dry suspension according to claim 1, wherein the rotating speed in the step S2 is 2000 revolutions per minute.
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CN117368056B (en) * | 2023-12-06 | 2024-04-12 | 山东则正医药技术有限公司 | Method for testing particle size and particle size distribution of azithromycin medicine |
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