清开灵注射液制备工艺对增溶性辅料增溶作用的影响

目的：考察清开灵注射液生产中通过调节pH值、活性炭处理、冷藏及灭菌工艺对3种增溶性辅料增溶作用的影响。方法：分别采用吐温80、聚乙二醇400和泊洛沙姆188共3种增溶性辅料对清开灵注射液八混液进行增溶，并经上述各工艺环节处理，以高效液相色谱法测定工艺前后黄芩苷、胆酸和猪去氧胆酸的含量，确定增溶后难溶性成分含量的变化。结果：在清开灵注射液原工艺pH范围(7.2~7.5)内，增溶后难溶性成分含量的变化均很小；活性炭处理步骤导致难溶性成分的损失，与空白相比，增溶后胆酸及猪去氧胆酸含量的损失率均显著降低；经冷藏处理，增溶后难溶性成分的损失率均有不同程度的降低；在灭菌步骤中，黄芩苷经泊洛沙姆188增溶后、胆酸经聚乙二醇400增溶后，损失率有所降低，猪去氧胆酸经3种增溶性辅料增溶后损失率均有所降低。结论：清开灵注射液制备工艺不影响增溶性辅料的增溶作用，增溶后能不同程度地降低各工艺步骤中难溶性成分的损失。

Effect of Preparation of Qingkailing Injection on the Insoluble Ingredients after Solubilization

This work aimed to study the influence of regulating pH, the activated carbon process, cold storage and the sterilization process of Qingkailing Injection on three insoluble ingredients after solubilization by three solubilizers. To investigate the influence of the preparation technique on insoluble ingredients, after the above-mentioned processes, high-performance liquid chromatography was used to determine the contents of baicalin, cholic acid and hyodeoxycholic acid after solubilization by Tween 80, polyethylene glycol 400 and Poloxamer 188. The original pH (7.2 ~ 7.5) range of the Qingkailing injection process had very small impact on the contents of insoluble components after solubilization. The activated carbon processing steps led to the loss of insoluble components. Compared with the blank, the loss of cholic acid and hyodeoxycholic acid was significantly reduced after the solubilization. In the refrigerated process, the loss of insoluble components decreased in varying degrees after the solubilization. In the sterilization step, the loss of baicalin and cholic acid was respectively reduced by P188 and PEG400. The loss of hyodeoxycholic acid had a decrease after the solubilization by the three solubilizers. The results showed that the preparation technique of Qingkailing Injection does not affect the solubilization. The loss of insoluble ingredients after solubilization may be reduced in different processes.