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).
ABSTRACT
Objective: Taking thewater extraction of Compound Banlangen Liyan Granules (IsatidisRadix, ScrophulariaeRadix, PlatycodiRadix, GlycyrrhizaeRadix, etc.)as the research object to explore the dynamic migration regular of the active ingredient population of compoundChinesemateriamedica in different apertures in ceramic membrane separation process and compare its membrane filtration flux and solid inclusion removal rate. Methods: The water extraction of Compound Banlangen Liyan Granules was separated with 200 nm and 50 nm aperture of ceramic membrane, respectively. Continuously sampling for many times was done in the ceramic membrane separation process. The optimized HPLC methods were as follows: chromatographic column was Agilent Zorbox Eclipse XDB-C18, mobile phase was acetonitrile-0.05% phosphoric acid in gradient elution at flow rate of 1 mL/min, detection wavelength was wavelength switching, injection volum was 10 μL, the column temperature was 30 ℃. The contents of sixactive ingredients[adenosine, (R,S)-goitrin, liquiritin, harpagosid, platycodinD, and monoammonium glycyrrhizinate]were determined in thecompound at the same time, and the dynamic migration rates were investigated. Results:The simultaneous determination of the sixactive ingredient in thecompound was done with HPLC method. For the water extraction in Compound Banlangen Liyan Granules, in the 200 nm ceramic membrane separation process, the dynamic migration rates of the sixactive ingredientsranged between 71%-104%, the average migration rate was 85%, the membrane filter flux attenuation was smaller, the stable flux was in 426-340 L/(m2∙h), solid inclusion removal rate was 21.0%. But in 50 nm ceramic membrane, the dynamic migration rates of the sixactiveingredients ranged between 83%-107%, the average migration rate was83%, the membrane filter flux attenuation was larger, the stable flux was in 258-228 L/(m2∙h), and solid inclusion removal rate was23.9%. Conclusion :The experiment preliminarily reflects the dynamic migration regular of the active ingredient population of compoundChinesemateriamedica in two different aperture ceramic membrane separation process. It lays a migration theoretical foundation of effective materials for popularization and application of modern ceramic membrane technology in Chinese materiamedica refining.