复方板蓝根利咽颗粒中试工艺过程评价研究

目的评价复方板蓝根利咽颗粒的中试工艺过程。方法以6种有效成分腺苷、(R,S)-告依春、甘草苷、安格洛苷C、哈巴俄苷、甘草酸铵]损失量、累积损失率和HPLC特征图谱相似度为指标,评价并比较2批复方板蓝根利咽颗粒陶瓷膜微滤、浸膏真空浓缩、浸膏真空干燥、颗粒常压干燥4个关键工序过程质量。结果 2批甘草酸、哈巴俄苷、(R,S)-告依春、甘草苷的总损失率为50.06%~66.99%,安格洛苷C、腺苷的总损失率为35.49%~41.90%。2批批内各物料6种有效成分总量从高到低顺序均为膜滤前液膜滤后液浓缩液干膏粉成品颗粒,4个关键工序损失率从大到小顺序为浸膏真空干燥陶瓷膜微滤浸膏真空浓缩、颗粒常压干燥,2批浸膏真空干燥损失量分别为0.545 9、0.737 5 mg/g,该工序是主要损失工序;2批全程总损失率分别为48.15%、50.85%。2批批内各物料HPLC特征图谱相似度随工序增加从0.998降到0.818。2批成品间HPLC特征图谱相似度良好(相似度为0.999)。结论批间成品质量一致性良好。该研究为复方板蓝根利咽颗粒中试生产过程控制提供依据。在中药制剂工艺现代化和规范化中,应尽量采用低温短时间加热的温和工艺,减少制备工序,以降低中药提取液(汤剂)中有效成分在制备过程中的损失,更好保持中药制剂和原提取液(汤剂)质量和疗效的一致性。

Pilot technological process evaluation of Compound Banlangen Liyan Granules

Objective To evaluate the pilot technological process of Compound Banlangen Liyan Granules (CBLG). Methods According to the indexes of six effective ingredients loss amount, accumulated loss rate, and HPLC characteristic spectrum similarity, the process quality of four key processes was evaluated and compared, such as microfiltration of ceramic membrane, vacuum concentration of extract, vacuum drying of concrete, and atmospheric drying of granules. Results It was found that the total loss rates of glycyrrhizic acid, harpagoside, (R,S)-epigoitrin, liquiritin in two batches were 50.06%-66.99%, and angoroside C, adenosine were 35.49%-41.90%. The total content of the six effective ingredients of each material within the same batch of the two pilot batches from high to low were as follows:extract solution before membrane filtration > extract solution after membrane filtration > concentrate extract solution > dried concrete powder > granules of finished product. The comparison among four key processes loss rates was as follows:vacuum drying of concrete > ceramic membrane microfiltration > vacuum concentration of extract, atmospheric drying of granules. Loss amount of concrete vacuum drying process of the two pilot batches were 0.545 9 and 0.737 5 mg/g, and the process was the major loss process. The total loss rates of the two pilot batches were 48.15%, 50.85%, respectively. The HPLC characteristic spectrum similarity of each material within the same batch of the two pilot batches decreased from 0.998 to 0.818 with increasing process. The HPLC characteristic between the two batches of finished products was good (the similarity was 0.999). Conclusion The consistency of the finished product quality between two batches was good. The study provided a basis for pilot production process control of CBLG. In the modernization and standardization study of traditional Chinese medicine preparation process, mild process of low temperature and short time heating should be applied as far as possible. It can reduce the effective components loss of original extract (decoction of herbal medicine) in the preparation process and maintain the quality and efficacy consistency of traditional Chinese medicine preparation and original extract (decoction of herbal medicine).