PDF(Pubmed)
Abstract：
Ultrasonic-assisted activated carbon separation (UACS) was first employed to improve product quality by regulating adsorption rate and removing bacterial endotoxin from salvia miltiorrhizae injection. The adsorption rate was related to three variables: activated carbon dosage, ultrasonic power, and pH. With the increase of activated carbon dosage from 0.05 % to 1.0 %, the adsorption rates of salvianolic acids and bacterial endotoxin increased simultaneously. The adsorption rates at which bacteria endotoxins increased from 52.52 % to 97.16 % were much higher than salvianolic acids. As the ultrasonic power increased from 0 to 700 W, the adsorption rates of salvianolic acids on activated carbon declined to less than 10 %, but bacterial endotoxin increased to more than 87 %. As the pH increased from 2.00 to 8.00, the adsorption rate of salvianolic acid dropped whereas bacterial endotoxin remained relatively stable. On the basis of response surface methodology (RSM), the optimal separation conditions were established to be activated carbon dose of 0.70 %, ultrasonic power of 600 W, and pH of 7.90. The experimental adsorption rates of bacterial endotoxin were 94.15 %, which satisfied the salvia miltiorrhizae injection quality criterion. Meanwhile, salvianolic acids\' adsorption rates were 1.92 % for tanshinol, 4.05 % for protocatechualdehyde, 2.21 % for rosmarinic acid, and 3.77 % for salvianolic acid B, all of which were much lower than conventional activated carbon adsorption (CACA). Salvianolic acids\' adsorption mechanism on activated carbon is dependent on the component\'s molecular state. Under ideal separation conditions, the molecular states of the four salvianolic acids fall between 1.13 % and 6.60 %. The quality of salvia miltiorrhizae injection can be improved while maintaining injection safety by reducing the adsorption rates of salvianolic acids to less than 5 % by the use of ultrasound to accelerate the desorption mass transfer rate on the activated carbon surface. When activated carbon adsorption was used in the process of producing salvia miltiorrhizae injection, the pH of the solution was around 5.00, and the proportion of each component\'s molecular state was tanshinol 7.05 %, protocatechualdehyde 48.93 %, rosmarinic acid 13.79 %, and salvianolic acid B 10.28 %, respectively. The loss of useful components was evident, and the corresponding activated carbon adsorption rate ranged from 20.74 % to 41.05 %. The average variation rate in plasma His and IgE was significant (P < 0.05) following injection of 0.01 % activated carbon, however the average variation rate of salvia miltiorrhizae injection was dramatically decreased with the use of UACS and CACA (P > 0.05). The ultrasonic at a power intensity of 60 W/L and the power density of 1.20 W/cm2 may resolve the separation contradiction between salvianolic acids and bacterial endotoxin, according to experiments conducted with UACS at different power intensities. According to this study, UACS has a lot of potential applications in the pharmaceutical manufacturing industry and may represent a breakthrough in the field of ultrasonic separation.
摘要：
首次采用超声波辅助活性炭分离(UACS)技术,通过调节丹参注射液的吸附速率和去除细菌内毒素来提高产品质量。吸附率与三个变量有关：活性炭用量，超声波电源,和pH。随着活性炭用量从0.05%增加到1.0%,丹酚酸和细菌内毒素的吸附率同时增加。细菌内毒素的吸附率从52.52％增加到97.16％，远高于丹酚酸。随着超声波功率从0增加到700W，丹酚酸在活性炭上的吸附率下降到10%以下，但细菌内毒素增加到87%以上。随着pH值从2.00增加到8.00，丹酚酸的吸附率下降，而细菌内毒素保持相对稳定。在响应面法(RSM)的基础上，最佳分离条件为活性炭用量0.70%,超声波功率600W,pH值为7.90。细菌内毒素的实验吸附率为94.15%,符合丹参注射液质量标准。同时,丹参酚酸对丹参素的吸附率为1.92%，原儿茶醛为4.05%，迷迭香酸2.21%，丹酚酸B为3.77%，所有这些都远低于传统的活性炭吸附（CACA）。丹酚酸在活性炭上的吸附机制取决于组分的分子状态。在理想的分离条件下，四种丹酚酸的分子状态在1.13％至6.60％之间。采用超声波加速活性炭表面解吸传质速率,将丹酚酸的吸附率降低至5%以下,可在保持注射用安全性的同时提高丹参注射液的质量。在丹参注射液生产过程中采用活性炭吸附,溶液的pH值约为5.00，各组分的分子态比例为7.05%，原儿茶醛48.93%，迷迭香酸13.79%,丹酚酸B10.28%，分别。有用成分的损失是明显的，相应的活性炭吸附率为20.74%～41.05%。注射0.01％活性炭后，血浆His和IgE的平均变化率显着（P<0.05）。然而，使用UACS和CACA可显著降低丹参注射液的平均变异率（P>0.05）。功率强度为60W/L,功率密度为1.20W/cm2的超声波可以解决丹酚酸与细菌内毒素的分离矛盾。根据UACS在不同功率强度下进行的实验。根据这项研究,UACS在制药行业中具有许多潜在的应用，并且可能代表超声分离领域的突破。
