Monitoring of the manufacturing process for ambroxol hydrochloride tablet using NIR-chemometric methods: compression effect on content uniformity model and relevant process parameters testing

This study aimed at using near-infrared (NIR) spectroscopy to monitor compaction pressure for simultaneously determining the tensile strength and content uniformity, as well as moisture and mean particle size of ambroxol hydrochloride tablets. The content uniformity, compression force and tensile strength of the laboratory samples were obtained by pressing a mixture of active principle and excipient components into tablets. To reduce the spectral baseline shift of the laboratory samples, the compaction pressure applied to the mixture was assessed by a variable pressure test. Production samples were added to the test and subjected to principal component analysis. The expanded partial least-squares (PLS) calibration model used to quantify the active content was more accurate than the model constructed from laboratory samples using the production tablets included in the calibration set. The model showed good predictability, with correlation coefficient (R) 0.9977. The validation and reliability of the content model were evaluated to determine trueness and reliability for the measurement of individual production tablets and the laboratory tablets with drug content ranging from 24 to 36?mg. The PLS calibration models for compression force and tensile strength were constructed using the same spectral set assuming both were highly related. These models yielded high R values (0.9955 and 0.9910). The R values of the moisture and mean particle size were 0.9994 and 0.9919, respectively. This study demonstrated that NIR spectroscopy combined with chemometric techniques can be successfully used to quantitatively monitor the tablet manufacturing process in the pharmaceutical industry.     

PVC盐酸氨溴索选择性电极的制备

以四苯硼酸氨溴索离子缔合物做电活性材料,制成氨溴索PVC电极,对影响电极性能的诸因素作了研究,以最佳条件制备的电极线性范围为1.0×10~(-2)～9.0×10~(-6)mol/L,平均斜率为56.2 mV/decade,检测下限为4.5×10~(-6)mol/L,在PH<5.0的范围内适用,电极响应快,重现性和稳定性好,抗干扰能力强,适用于氨溴索样品的快速测定。     

氧驱动雾化吸入氨溴索辅助治疗毛细支气管炎疗效观察

目的探讨氧驱动雾化吸入氨溴索辅助治疗毛细支气管炎临床效果。方法将52例毛细支气管炎患者随机分为治疗组和对照组各26例,对照组常规给以抗感染、平喘、糖皮质激素等基础治疗;治疗组在常规治疗的基础上给以盐酸氨溴索注射液15mg加入生理盐水2ml氧驱动雾化吸入,每日2次,疗程7天。结果治疗组患者咳嗽及肺痰鸣音持续时间明显短于对照组(P<0.05);憋喘、哮鸣音和治愈时间显著短于对照组(P<0.01)。结论氨溴索氧驱动雾化吸入治疗毛细支气管炎可明显提高疗效,缩短治疗时间。