技术领域Technical field
本发明属于药物分析检测技术领域，具体涉及一种注射用头孢呋辛钠肌注溶液的粒度测定方法。The invention belongs to the technical field of drug analysis and detection, and specifically relates to a particle size determination method of cefuroxime sodium intramuscular solution for injection.
背景技术Background technique
头孢呋辛钠，英文名为Cefuroxime sodium，分子式为C16H15N4NaO8S，相对分子质量为446.4，化学名称为(6R,7R)-7-[2-呋喃基(甲氧亚胺基)乙酰氨基]3-氨基甲酰氧甲基-8-氧代-5-硫杂-1-氮杂二环[4.2.0]辛-2-烯-2-甲酸钠盐，其结构式为：Cefuroxime sodium, the English name is Cefuroxime sodium, the molecular formula is C16H15N4NaO8S, the relative molecular mass is 446.4, and the chemical name is (6R,7R)-7-[2-furyl (methoxyimino)acetamido]3-amino Formyloxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, its structural formula is:
常温常压下，头孢呋辛钠呈白色、类白色或略带微黄的粉末状或结晶状，无臭，味苦，可潮解，易溶于水，微溶于甲醇，在乙醇、丙酮、氯仿等有机溶剂中不溶。头孢呋辛钠是β-内酰胺类抗生素，属于头孢菌素类，通过与细菌细胞膜上的青霉素结合蛋白(PBPs)结合，抑制细胞分裂和生长，最后使细菌溶解和死亡。头孢呋辛钠在体内不会被肝脏代谢，以原型经肾脏排出体外，对人体的副作用非常小，在医学上广泛应用于敏感菌所致的呼吸道感染、耳、鼻、喉科感染、泌尿道感染、皮肤和软组织感染、骨和关节感染、淋病、包括败血症及脑膜等其他感染。Under normal temperature and pressure, cefuroxime sodium is white, off-white or slightly yellowish powder or crystal, odorless, bitter, deliquescent, easily soluble in water, slightly soluble in methanol, and in ethanol, acetone, Insoluble in organic solvents such as chloroform. Cefuroxime sodium is a β-lactam antibiotic that belongs to the cephalosporin class. It inhibits cell division and growth by binding to penicillin-binding proteins (PBPs) on the bacterial cell membrane, and finally causes bacterial lysis and death. Cefuroxime sodium will not be metabolized by the liver in the body and is excreted unchanged through the kidneys. It has very few side effects on the human body. It is widely used in medicine to treat respiratory tract infections, ear, nose, and throat infections, and urinary tract infections caused by sensitive bacteria. Infections, skin and soft tissue infections, bone and joint infections, gonorrhea, including sepsis and other infections such as meninges.
在原研注射用头孢呋辛钠(西力欣)原研说明书中，该品种在临床使用中有两种使用方法，分别为肌肉注射和静脉注射。其中肌肉注射的方法加水较少，配制的注射用溶液为悬浊液。肌注混悬液不同的粒径范围可能会影响药物在体内的分布速率，进而影响产品的质量和疗效。粒度是头孢呋辛钠肌注混悬液的重要质量控制指标，有关头孢呋辛钠肌注混悬液的粒度测试方法目前还未见文献报道。In the original research instructions of Cefuroxime Sodium for Injection (Cilixin), there are two ways to use this variety in clinical use, namely intramuscular injection and intravenous injection. Among them, the method of intramuscular injection adds less water, and the prepared injection solution is a suspension. Different particle size ranges of intramuscular suspensions may affect the distribution rate of the drug in the body, thereby affecting the quality and efficacy of the product. Particle size is an important quality control indicator for cefuroxime sodium intramuscular suspension. There are currently no literature reports on the particle size testing method for cefuroxime sodium intramuscular suspension.
发明内容Contents of the invention
本发明的目的在于提供一种测定过程简单方便，实验结果直观高效的注射用头孢呋辛钠肌注混悬液的粒度测定方法，从而用于注射用头孢呋辛钠肌注混悬液生产、使用过程中的粒度测试，为其产品质量控制提供技术手段。The object of the present invention is to provide a particle size determination method for cefuroxime sodium for injection intramuscular suspension that has a simple and convenient measurement process and intuitive and efficient experimental results, so that it can be used for the production and production of cefuroxime sodium intramuscular suspension for injection. Particle size testing during use provides technical means for product quality control.
本发明的目的可以通过以下技术方案实现：The object of the present invention can be achieved through the following technical solutions:
一种注射用头孢呋辛钠肌注混悬液的粒度测定方法，利用湿法激光粒度测试仪进行粒度测试，包括以下步骤：A particle size determination method for cefuroxime sodium intramuscular suspension for injection, using a wet laser particle size tester for particle size testing, including the following steps:
S1.头孢呋辛钠样品利用注射用水稀释后，手摇震荡，制得样品溶液；S1. The cefuroxime sodium sample is diluted with water for injection and shaken by hand to prepare a sample solution;
S2.在15min之内取样品溶液加入到装有分散介质的检测器中，以2500rpm-3000rpm的搅拌速度搅拌均匀，设置遮光率为8％～10％，等待5min～10min测定其粒度。S2. Within 15 minutes, take the sample solution and add it to the detector equipped with dispersion medium, stir evenly at a stirring speed of 2500rpm-3000rpm, set the shading rate to 8% to 10%, and wait for 5min to 10min to measure the particle size.
作为优选，所述S1中头孢呋辛钠样品与注射用水的用量比为0.75g:3mL；Preferably, the dosage ratio of cefuroxime sodium sample and water for injection in S1 is 0.75g:3mL;
作为优选，所述S1中手摇时间为60s，约震荡100次；Preferably, the hand-cranking time in S1 is 60 seconds, and the shaking is about 100 times;
作为优选，所述S2中分散介质为异丙醇；Preferably, the dispersion medium in S2 is isopropyl alcohol;
作为优选，所述S2中搅拌速度为3000rpm。Preferably, the stirring speed in S2 is 3000 rpm.
本发明的有益效果：Beneficial effects of the present invention:
1.本发明填补了国内没有注射用头孢呋辛钠肌注混悬液粒度测定方法的空白，为国内该品种仿制药厂家评价与参比制剂的一致性提供方法依据。1. The present invention fills the gap that there is no particle size determination method for cefuroxime sodium for injection intramuscular suspension in China, and provides a methodological basis for domestic generic drug manufacturers of this variety to evaluate the consistency with reference preparations.
2.本发明通过从分散介质选择、振摇时间、搅拌速度、溶液稳定性、方法学验证等多方面进行研究和分析，最终确定了注射用头孢呋辛钠肌注混悬液的粒度测定方法。2. The present invention finally determined the particle size determination method of cefuroxime sodium intramuscular suspension for injection through research and analysis from various aspects such as dispersion medium selection, shaking time, stirring speed, solution stability, methodology verification, etc. .
3.本发明测试方法适用性较好、精密度高，测试过程简单方便，有效节约了测试时间，测定结果准确直观。3. The testing method of the present invention has good applicability and high precision. The testing process is simple and convenient, effectively saving testing time, and the measurement results are accurate and intuitive.
附图说明Description of drawings
下面结合附图对本发明作进一步的说明。The present invention will be further described below in conjunction with the accompanying drawings.
图1是本发明实施例2中以异丙醇作为分散介质注射用头孢呋辛钠肌注混悬液的粒度分布图形的示意图；Figure 1 is a schematic diagram of the particle size distribution pattern of cefuroxime sodium intramuscular suspension for injection using isopropyl alcohol as the dispersion medium in Example 2 of the present invention;
图2是本发明实施例2中以丙酮作为分散介质注射用头孢呋辛钠肌注悬混悬液的粒度分布图形的示意图；Figure 2 is a schematic diagram of the particle size distribution pattern of cefuroxime sodium intramuscular suspension for injection using acetone as the dispersion medium in Example 2 of the present invention;
图3是本发明实施例4中手摇30s注射用头孢呋辛钠肌注悬混悬液的粒度分布图形的示意图；Figure 3 is a schematic diagram of the particle size distribution pattern of cefuroxime sodium intramuscular suspension for injection in Example 4 of the present invention;
图4是本发明实施例4中手摇60s注射用头孢呋辛钠肌注悬混悬液的粒度分布图形的示意图；Figure 4 is a schematic diagram of the particle size distribution pattern of cefuroxime sodium injection intramuscular suspension in Example 4 of the present invention by hand shaking for 60 seconds;
图5是本发明实施例4中手摇90s注射用头孢呋辛钠肌注悬混悬液的粒度分布图形的示意图。Figure 5 is a schematic diagram of the particle size distribution pattern of the cefuroxime sodium intramuscular suspension for injection in Example 4 of the present invention.
具体实施方式Detailed ways
下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.
实施例1Example 1
一种注射用头孢呋辛钠肌注混悬液的粒度测定方法，利用湿法激光粒度测试仪进行粒度测试，仪器为马尔文激光粒度仪(MASTER SIZERS 3000)，头孢呋辛钠样品(批号4409100007E1)，包括以下步骤：A method for particle size determination of cefuroxime sodium intramuscular suspension for injection, using a wet laser particle size tester for particle size testing, the instrument is a Malvern laser particle size analyzer (MASTER SIZERS 3000), cefuroxime sodium sample (batch number 4409100007E1 ), including the following steps:
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s约震荡100次混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, shake it by hand for 60 seconds about 100 times, and mix evenly to prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待5min～10min测定其粒度。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for 5 to 10 minutes to measure the particle size.
其测定结果如表1所示：The measurement results are shown in Table 1:
表1Table 1
实施例2Example 2
分散介质筛选实验Dispersion media screening experiment
根据头孢呋辛钠药品特点，选择丙酮、乙醇和异丙醇作为分散介质进行研究。其中丙酮是头孢呋辛钠原料厂家生产用溶剂；中国药典2020版中描述头孢呋辛钠原料药不溶于乙醇；异丙醇是湿法粒度方法测定中常用分散介质。According to the characteristics of cefuroxime sodium, acetone, ethanol and isopropyl alcohol were selected as dispersion media for research. Among them, acetone is the solvent used by the raw material manufacturer of cefuroxime sodium; the 2020 edition of the Chinese Pharmacopoeia describes that the raw material of cefuroxime sodium is insoluble in ethanol; isopropyl alcohol is a commonly used dispersion medium in the determination of wet particle size method.
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s约震荡100次混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, shake it by hand for 60 seconds about 100 times, and mix evenly to prepare a sample solution;
S2.在15min之内取样品溶液加入到装有甲醇的检测器中，以3000rpm搅拌均匀，使折光为8％～10％，测定样品等待0min、5min和10min时的粒度分布和遮光率。同法操作测定样品在乙醇和丙酮分散介质中等待0min、5min和10min时的粒度分布和遮光率，测定结果见表2。S2. Take the sample solution and add it to the detector filled with methanol within 15 minutes, stir evenly at 3000 rpm to make the refractive index 8% to 10%, and measure the particle size distribution and shading rate of the sample when waiting for 0 minutes, 5 minutes and 10 minutes. Use the same method to measure the particle size distribution and shading rate of the sample when it waits for 0 min, 5 min and 10 min in ethanol and acetone dispersion media. The measurement results are shown in Table 2.
表2Table 2
由表2可知，样品在乙醇中的遮光率持续降低，说明样品微溶于乙醇，不适合作为分散介质；样品在异丙醇中分散较好，粒度分布图符合正态分布，如图1所示；样品在丙酮中遮光度及粒度分布的变化均较小，但粒度分布图为双峰，如图2所示，说明样品在丙酮中分散的不均匀，因此选择异丙醇作为注射用头孢呋辛钠肌注混悬液粒度测定方法的分散介质。As can be seen from Table 2, the shading rate of the sample in ethanol continues to decrease, indicating that the sample is slightly soluble in ethanol and is not suitable as a dispersion medium; the sample is well dispersed in isopropyl alcohol, and the particle size distribution diagram conforms to the normal distribution, as shown in Figure 1 shows; the changes in opacity and particle size distribution of the sample in acetone are small, but the particle size distribution diagram is bimodal, as shown in Figure 2, indicating that the sample is unevenly dispersed in acetone, so isopropyl alcohol is selected as the cephalosporin for injection Dispersion medium for determination of particle size of furoxine sodium intramuscular suspension.
实施例3Example 3
搅拌速度考察实验Stirring speed test
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s约震荡100次混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, shake it by hand for 60 seconds about 100 times, and mix evenly to prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以1000rpm搅拌均匀，设置遮光率为8％～10％，等待5min～10min测定其粒度。同法操作，控制搅拌转速1500rpm、2000rpm、2500rpm和3000rpm，分别制备样品，测定各样品粒度分布，测定结果见表3。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 1000 rpm, set the shading rate to 8% to 10%, and wait for 5 to 10 minutes to measure the particle size. Operate in the same way, control the stirring speed to 1500rpm, 2000rpm, 2500rpm and 3000rpm, prepare samples respectively, and measure the particle size distribution of each sample. The measurement results are shown in Table 3.
表3table 3
根据实验结果可知，随转速增加样品粒度逐渐减小，说明样品颗粒分散越来越均匀，溶液遮光率基本无变化，转速增加至2500rpm和3000rpm后，颗粒的粒度分布不再有显著差异，样品可以分散均匀，因此优选3000rpm作为粒度分布的检测条件。According to the experimental results, it can be seen that the particle size of the sample gradually decreases as the rotation speed increases, indicating that the sample particles are more and more uniformly dispersed, and the shading rate of the solution basically remains unchanged. After the rotation speed increases to 2500rpm and 3000rpm, there is no significant difference in the particle size distribution of the particles, and the sample can The dispersion is uniform, so 3000 rpm is preferred as the detection condition for particle size distribution.
实施例4Example 4
手摇震荡时间考察实验Experiment on hand shaking vibration time
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s，约震荡100次混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g cefuroxime sodium sample, dilute it with 3mL water for injection, shake it by hand for 60s, shake it about 100 times, and mix evenly to prepare the sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待5min～10min测定其粒度。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for 5 to 10 minutes to measure the particle size.
同法操作，手摇30s、90s分别制备样品，测定各样品粒度分布，测定结果见表4，检测图谱见图3-5。Operate in the same way, prepare samples by hand shaking for 30 seconds and 90 seconds, and measure the particle size distribution of each sample. The measurement results are shown in Table 4, and the detection patterns are shown in Figure 3-5.
表4Table 4
根据实验结果可知：手摇30s(约震荡50次)时粒度峰型呈黏连状说明此时样品分布不均匀；手摇60s(约震荡100次)样品分散较好；手摇90s(约震荡150次)时D90明显增大，说明随震荡时间增长，样品颗粒有聚集现象。因此选择手摇60s(约震荡100次)作为注射用头孢呋辛钠肌注混悬液的粒度方法中样品处理的震荡时间。According to the experimental results, it can be seen that the particle size peak shape is sticky when the hand is shaken for 30 seconds (about 50 times of shaking), indicating that the sample is unevenly distributed at this time; the sample is well dispersed when the hand is shaken for 60 seconds (about 100 times of shaking); the sample is well dispersed when the hand is shaken for 90 seconds (about 50 times of shaking); 150 times), D90 increased significantly, indicating that the sample particles aggregated as the shaking time increased. Therefore, hand shaking for 60 seconds (about 100 times of shaking) was selected as the shaking time for sample processing in the particle size method of cefuroxime sodium for injection intramuscular suspension.
实施例5Example 5
超声测试实验Ultrasonic test experiment
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s(约震荡100次)混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, mix it by hand shaking for 60s (about 100 times), and prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待0min、1min、5min测定其粒度。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for 0min, 1min, and 5min to measure the particle size.
同法操作，在等待1min、5min期间对样品进行超声，随后测定其粒度。测定结构如表5所示：Operate in the same way, ultrasonicate the sample while waiting for 1 minute and 5 minutes, and then measure its particle size. The measured structure is shown in Table 5:
表5table 5
由表5可知，超声处理后，样品粒度D50和D90显著增大，说明超声后样品颗粒聚集严重，本方法中，注射用头孢呋辛钠肌注悬浊液不适合进行超声处理。It can be seen from Table 5 that after ultrasonic treatment, the sample particle size D50 and D90 increased significantly, indicating that the sample particles aggregated seriously after ultrasonic treatment. In this method, the intramuscular suspension of cefuroxime sodium for injection is not suitable for ultrasonic treatment.
实施例6Example 6
稳定性实验stability test
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s(约震荡100次)混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, mix it by hand shaking for 60s (about 100 times), and prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待0min、1min、3min、5min、8min和10min时的粒度分布。测试结果如表6所示：S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for 0min, 1min, 3min, 5min, 8min and 10min. Particle size distribution. The test results are shown in Table 6:
表6Table 6
根据实验结果，在0～5min内随着样品池内搅拌的时间增加，本品的D90的测定结果明显减小，遮光率无明显变化，说明样品在该时间段内样品没有分散均匀；在5min～10min范围内粒度保持稳定，遮光率无明显变化，样品已分散均匀，因此拟定样品溶液在加入样品池后5min～10min内进行检测。According to the experimental results, as the stirring time in the sample pool increases within 0 to 5 minutes, the D90 measurement result of this product decreases significantly, and the shading rate does not change significantly, indicating that the sample is not evenly dispersed within this time period; within 5 minutes The particle size remains stable within the range of ~10 minutes, the shading rate does not change significantly, and the sample is evenly dispersed. Therefore, the sample solution is planned to be tested within 5 to 10 minutes after being added to the sample pool.
实施例7Example 7
重复性实验Reproducible experiments
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s(约震荡100次)混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, mix it by hand shaking for 60s (about 100 times), and prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待5min～10min时的粒度分布。同法配制5个样品，重复再测定5次，考察本法的重复性，测试结果的RSD值均符合药典规定，即D10小于5％；D50小于3％；D90小于5％。检测结果见表7。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for the particle size distribution for 5 to 10 minutes. Prepare 5 samples with the same method and repeat the measurement 5 times to examine the repeatability of this method. The RSD values of the test results are all in compliance with the pharmacopoeia regulations, that is, D10 is less than 5%; D50 is less than 3%; D90 is less than 5%. The test results are shown in Table 7.
表7Table 7
如表7所示，样品重复测定6次，全部实测值的相对标准偏差D10为1.99％；D50为2.74％；D90为3.39％，均符合药典规定，说明本法测定本品重复性良好。As shown in Table 7, the sample was repeatedly measured 6 times, and the relative standard deviations of all measured values were 1.99% for D10 ; 2.74% for D50 ; and 3.39% for D90 , all in compliance with the pharmacopoeia regulations, indicating the repeatability of this method for measuring this product. good.
实施例8Example 8
中间精密度测试Intermediate Precision Test
两位实验人员均按照以下方法进行测定：Both experimenters performed the measurement according to the following method:
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s(约震荡100次)混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, mix it by hand shaking for 60s (about 100 times), and prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，设置遮光率为8％～10％，等待5min～10min时的粒度分布。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm, set the shading rate to 8% to 10%, and wait for the particle size distribution for 5 to 10 minutes.
分别平行测定12组。结果如表8所示：12 groups were measured in parallel. The results are shown in Table 8:
表8Table 8
综合十二组数据结果可知，D10的RSD小于5％，D50的RSD小于3％，D90的RSD小于5％，均满足药典要求，本方法中间精密度良好。Based on the twelve sets of data results, it can be seen that the RSD of D10 is less than 5%, the RSD of D50 is less than 3%, and the RSD of D90 is less than 5%, all of which meet the requirements of the Pharmacopoeia. The intermediate precision of this method is good.
实施例9Example 9
耐用性检测Durability testing
S1.准确称取0.75g头孢呋辛钠样品,利用3mL注射用水稀释，手摇60s(约震荡100次)混合均匀后，制得样品溶液；S1. Accurately weigh 0.75g of cefuroxime sodium sample, dilute it with 3mL of water for injection, mix it by hand shaking for 60s (about 100 times), and prepare a sample solution;
S2.在15min之内取样品溶液加入到装有异丙醇的检测器中，以3000rpm搅拌均匀，使遮光率为6％，等待5min～10min时的粒度分布。S2. Within 15 minutes, take the sample solution and add it to the detector containing isopropyl alcohol, stir evenly at 3000 rpm to make the shading rate 6%, and wait for the particle size distribution for 5 to 10 minutes.
同法配制3个样品，分别测定遮光度为8％、10％和12％时样品的粒度分布，结果如表9所示：Prepare three samples in the same way, and measure the particle size distribution of the samples when the opacity is 8%, 10% and 12% respectively. The results are shown in Table 9:
表9Table 9
根据实验结果可知，样品遮光率为8％～10％时各粒径的粒度分布较为一致，在此遮光度范围内样品分散性较好，表明其能够保持不受测试参数的微小变化的影响，从而在日常使用中保证其可靠性。According to the experimental results, it can be seen that when the shading rate of the sample is 8% to 10%, the particle size distribution of each particle size is relatively consistent. The sample has good dispersion within this shading range, indicating that it can remain unaffected by small changes in test parameters. This ensures its reliability in daily use.
需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that these entities or operations are mutually exclusive. any such actual relationship or sequence exists between them. Furthermore, the terms "comprises," "comprises," or any other variations thereof are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that includes a list of elements includes not only those elements, but also those not expressly listed other elements, or elements inherent to the process, method, article or equipment.
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art will understand that various changes, modifications, and substitutions can be made to these embodiments without departing from the principles and spirit of the invention. and modifications, the scope of the invention is defined by the appended claims and their equivalents.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311343683.6ACN117214053A (en) | 2023-10-17 | 2023-10-17 | Particle size determination method of cefuroxime sodium intramuscular injection suspension for injection |
| Application Number | Priority Date | Filing Date | Title |
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| CN202311343683.6ACN117214053A (en) | 2023-10-17 | 2023-10-17 | Particle size determination method of cefuroxime sodium intramuscular injection suspension for injection |
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| CN117214053Atrue CN117214053A (en) | 2023-12-12 |
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| CN202311343683.6APendingCN117214053A (en) | 2023-10-17 | 2023-10-17 | Particle size determination method of cefuroxime sodium intramuscular injection suspension for injection |
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| CN (1) | CN117214053A (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101883563A (en)* | 2007-12-19 | 2010-11-10 | 台湾东洋药品工业股份有限公司 | Injection comprising docetaxel and its preparation |
| CN102716075A (en)* | 2012-07-03 | 2012-10-10 | 哈药集团制药总厂 | Ceftizoxime sodium-containing pharmaceutical composition |
| CN102727451A (en)* | 2012-07-03 | 2012-10-17 | 哈药集团制药总厂 | Cefmetazole-containing pharmaceutical composition |
| CN104363912A (en)* | 2012-04-23 | 2015-02-18 | 大塚制药株式会社 | injection |
| CN115753526A (en)* | 2022-11-15 | 2023-03-07 | 贵州圣济堂制药有限公司 | Method for determining granularity of glimepiride raw material medicine |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101883563A (en)* | 2007-12-19 | 2010-11-10 | 台湾东洋药品工业股份有限公司 | Injection comprising docetaxel and its preparation |
| CN104363912A (en)* | 2012-04-23 | 2015-02-18 | 大塚制药株式会社 | injection |
| CN102716075A (en)* | 2012-07-03 | 2012-10-10 | 哈药集团制药总厂 | Ceftizoxime sodium-containing pharmaceutical composition |
| CN102727451A (en)* | 2012-07-03 | 2012-10-17 | 哈药集团制药总厂 | Cefmetazole-containing pharmaceutical composition |
| CN115753526A (en)* | 2022-11-15 | 2023-03-07 | 贵州圣济堂制药有限公司 | Method for determining granularity of glimepiride raw material medicine |
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| 国家药典委员会: "《中国药典分析检测技术指南》", 30 August 2017, 中国医药科技出版社, pages: 526 - 527* |
| 郝福;胡向青;巴晓雨;许桂玲;张纲;李志刚;: "激光粒度分析技术在药物研究和质量控制中的应用进展", 分析测试技术与仪器, no. 02, 30 June 2017 (2017-06-30), pages 1 - 3* |
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