Preparation of Salvianolic Acid B Disodium Salt Considering the Water Extract Quality Standard

Abstract

A preparation process of salvianolic acid B (SAB) disodium salt from Salvia miltiorrhiza Bunge (Danshen) is provided in this work. A water extract quality standard was also developed to estimate the influences of Danshen quality on SAB disodium salt quality at an early stage of the preparation process. Crude SAB solution was obtained after water extraction, concentration, acidification, 1-butanol extraction, water washing, basification, and water back extraction. Extraction temperature, extraction pH, and back-extraction pH were identified to be key parameters for the preparation of crude SAB solution. These parameters were optimized with Box–Behnken designed experiments. Crude SAB solution was further purified with a chromatography process. AMBERCHROW CG161M resin was selected as the best adsorbent. SAB disodium salt could be obtained by drying the eluate. Considering the quality of Danshen may affect the purity and yield of SAB disodium salt, different batches of Danshen were used to prepare SAB disodium salt with the optimized parameters. Water extract indices of phenolic compound purity and phenolic compound yield were measured. By developing models between SAB disodium salt purity and yield with water extract indices, the quality standard of Danshen water extract was obtained. The application of water extract quality standards can improve the quality consistency of SAB disodium salt. The effects of different batches of Danshen raw materials on the final product could be evaluated at the beginning of production stages. The present method could prepare about five grams of high-purity SAB disodium salt (>95%) in one preparation cycle. The method reported in this work can also be used to develop process intermediate quality standards for other natural products.

Nanopore analysis of salvianolic acids in herbal medicines

“…4-11. The ratios of interference events removed by DBSCAN are summarized in Supplementary Table 2. The interference events can be from impurities in the analytes derived from plant extraction 49 or chemical degradation of salvianolic acids [50][51][52][53] . Spontaneous pore gating also contributes to the generation of interference events as well.…”

The development of an herbal material quality control strategy considering the effects of manufacturing processes

“…Ye et al used fixed process parameters to treat different batches of Salvia miltiorrhiza to obtain the disodium salt of Salvianolic acid B [19]. The quality standards of water extracts, which were the upstream intermediate, were set to ensure high purity Salvianolic acid B salt preparation [19]. However, the standards of Salvia miltiorrhiza were not developed.…”