Pilot technological process evaluation of Compound Banlangen Liyan Granules / 中草药

ABSTRACT

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).