title: Study on quality control of sulfated polysaccharide drug, propylene glycol alginate sodium sulfate (PSS).
abstract: The combination of biological and chemical analysis methods was developed to improve quality control of propylene glycol alginate sodium sulfate (PSS), a sulfated polysaccharide drug. The allergic and anticoagulant assays revealed that PSS fractions with higher Mw and lower M/G ratio may have allergic response and bleeding risks. HPLC with pre-column derivatization, HPGPC and IC methods were combined to analyze 10 batches of PSS samples from different manufacturers. The results showed that the quality of these PSSs varied greatly which in turn led to the unstable anticoagulant activity and side effects. The study indicated that PSS with high purity, M/G ratio above 1.5, Mw of ∼9kD and DS of 9.0-13.0% can ensure clinical efficacy and low incidence of adverse drug reactions. In conclusion, the combined methods would be in favor of guiding manufacture and quality control of PSS to guarantee its effectiveness and safety.
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China.
authors.forename: Yi-Ting
authors.initials: YT
authors.lastname: Xue
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China.
authors.forename: Li
authors.initials: L
authors.lastname: Ren
authors.affiliation: Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China.
authors.forename: Shuang
authors.initials: S
authors.lastname: Li
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China.
authors.forename: Lin-Lin
authors.initials: LL
authors.lastname: Wang
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China; Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China.
authors.forename: Xiao-Xi
authors.initials: XX
authors.lastname: He
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China; Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China; Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China.
authors.forename: Guang-Li
authors.initials: GL
authors.lastname: Yu
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China; Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China.
authors.forename: Hua-Shi
authors.initials: HS
authors.lastname: Guan
authors.affiliation: Key Laboratory of Marine Drugs, Ministry of Education, School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, China; Shandong Provincial Key laboratory of Glycoscience and Glycoengineering, Ocean University of China, Qingdao 266003, China. Electronic address: lchunxia@ouc.edu.cn.
authors.forename: Chun-Xia
authors.initials: CX
authors.lastname: Li
mesh_terms: D000464:Alginates / Q000737:chemistry* / Q000494:pharmacology; D000818:Animals; D000925:Anticoagulants / Q000737:chemistry* / Q000494:pharmacology; D045744:Cell Line, Tumor; D004355:Drug Stability; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D051379:Mice; D008970:Molecular Weight; D011134:Polysaccharides / Q000737:chemistry* / Q000494:pharmacology; D011786:Quality Control; D013455:Sulfur / Q000737:chemistry
chemical_list: D000464:Alginates; D000925:Anticoagulants; D011134:Polysaccharides; C000613194:propylene glycol alginate sodium sulfate; D013455:Sulfur
keywords: Anaphylaxis; Anticoagulant activity; Quality control; Sulfated polysaccharide